FDA Label for Wera

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Wera Product Label

The following document was submitted to the FDA by the labeler of this product Northstar Rx Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Warnings: Cardiovascular Risk Associated With Smoking



Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including WERATM, should not be used by women who are over 35 years of age and smoke.


Clinical Pharmacology



COMBINED ORAL CONTRACEPTIVES

Combined oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).


Indications And Usage



WERA Tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the NORPLANT® System depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

Table 1: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States.
% of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year3
MethodTypical Use1Perfect Use2
(1)(2)(3)(4)
Chance48585
Spermicides526640
Periodic abstinence2563
Calendar9
Ovulation Method3
Sympto-Thermal62
Post-Ovulation1
Cap7
Parous Women402642
Nulliparous Women20956
Sponge
Parous Women402042
Nulliparous Women20956
Diaphragm720656
Withdrawal194
Condom8
Female (Reality®)21556
Male14361
Pill571
Progestin Only0.5
Combined0.1
IUD
Progesterone T2.01.581
Copper T380A0.80.678
LNg 200.10.181
Depo-Provera®0.30.370
Norplant® and Norplant-2®0.050.0588
Female Sterilization0.50.5100
Male Sterilization0.150.10100
Adapted from Hatcher et al, 1998, Ref. #1.
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9
Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10
Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.
1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
5 Foams, creams, gels, vaginal suppositories, and vaginal film.
6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
7 With spermicidal cream or jelly.
8 Without spermicides.
9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 2 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills)
10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.

WERA has not been studied for and is not indicated for use in emergency contraception.


Contraindications



Oral contraceptives should not be used in women who currently have the following conditions:

  • ●Thrombophlebitis or thromboembolic disorders
  • ●A past history of deep vein thrombophlebitis or thromboembolic disorders
  • ●Known thrombophilic conditions
  • ●Cerebral vascular or coronary artery disease (current or history)
  • ●Valvular heart disease with complications
  • ●Persistent blood pressure values of ≥ 160 mm Hg systolic or ≥ 100 mg Hg diastolic96
  • ●Diabetes with vascular involvement
  • ●Headaches with focal neurological symptoms
  • ●Major surgery with prolonged immobilization
  • ●Known or suspected carcinoma of the breast
  • ●Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
  • ●Undiagnosed abnormal genital bleeding
  • ●Cholestatic jaundice of pregnancy or jaundice with prior pill use
  • ●Acute or chronic hepatocellular disease with abnormal liver function
  • ●Hepatic adenomas or carcinomas
  • ●Known or suspected pregnancy
  • ●Hypersensitivity to any component of this product

Warnings



Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including WERA Tablets, should not be used by women who are over 35 years of age and smoke.


1. General



Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.


2. Physical Examination And Follow Up



It is good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.


3. Lipid Disorders



Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult.


4. Liver Function



If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function.


5. Fluid Retention



Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.


6. Emotional Disorders



Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.


7. Contact Lenses



Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.


8. Drug Interactions



Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

Effects of Other Drugs on Combined Hormonal Contraceptives

Substances decreasing the plasma concentrations of COCs and potentially diminishing the efficacy of COCs:

Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish the effectiveness of CHCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between hormonal contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with CHCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.

Substances increasing the plasma concentrations of COCs:

Co-administration of atorvastatin or rosuvastatin and certain COCs containing EE increase AUC values for EE by approximately 20-25%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations.

Human immunodeficiency virus (HIV)/ Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors:

Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of co-administration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir]) /HCV protease inhibitors (decrease [e.g., boceprevir and telaprevir]) or with non­ nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]).

Colesevelam:

Colesevelam, a bile acid sequestrant, given together with a combination oral hormonal contraceptive, has been shown to significantly decrease the AUC of EE. A drug interaction between the contraceptive and colesevelam was decreased when the two drug products were given 4 hours apart.

Effects of Combined Hormonal Contraceptives on Other Drugs

COCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. Significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.

Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid-binding globulin increases with use of COCs.


9. Interactions With Laboratory Tests



Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:

  • Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.
  • Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG, free T4 concentration is unaltered.
  • Other binding proteins may be elevated in serum.
  • Sex-binding globulins are increased and result in elevated levels of total circulating sex steroids and corticoids; however, free or biologically active levels remain unchanged.
  • Triglycerides may be increased and levels of various other lipids and lipoproteins may be affected.
  • Glucose tolerance may be decreased.
  • Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.

10. Carcinogenesis



See WARNINGS Section.


11. Pregnancy



Pregnancy Category X. See CONTRAINDICATIONS and WARNINGS Sections.


12. Nursing Mothers



Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, combination oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use combination oral contraceptives but to use other forms of contraception until she has completely weaned her child.


13. Pediatric Use



Safety and efficacy of norethindrone and ethinyl estradiol tablets has been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.


14. Geriatric Use



This product has not been studied in women over 65 years of age and is not indicated in this population.


Information For The Patient



See Patient Labeling printed below.


Adverse Reactions



An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (See WARNINGS Section).

  • ●Thrombophlebitis and venous thrombosis with or without embolism
  • ●Arterial thromboembolism
  • ●Pulmonary embolism
  • ●Myocardial infarction
  • ●Cerebral hemorrhage
  • ●Cerebral thrombosis
  • ●Hypertension
  • ●Gallbladder disease
  • ●Hepatic adenomas or benign liver tumors
  • There is evidence of an association between the following conditions and the use of oral contraceptives:

    • ●Mesenteric thrombosis
    • ●Retinal thrombosis
    • The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:

      • ●Nausea
      • ●Vomiting
      • ●Gastrointestinal symptoms (such as abdominal cramps and bloating)
      • ●Breakthrough bleeding
      • ●Spotting
      • ●Change in menstrual flow
      • ●Amenorrhea
      • ●Temporary infertility after discontinuation of treatment
      • ●Edema
      • ●Melasma which may persist
      • ●Breast changes: tenderness, enlargement, secretion
      • ●Change in weight (increase or decrease)
      • ●Change in cervical erosion and secretion
      • ●Diminution in lactation when given immediately postpartum
      • ●Cholestatic jaundice
      • ●Migraine
      • ●Allergic reaction, including rash, urticaria, angioedema
      • ●Mental depression
      • ●Reduced tolerance to carbohydrates
      • ●Vaginal candidiasis
      • ●Change in corneal curvature (steepening)
      • ●Intolerance to contact lenses
      • The following adverse reactions have been reported in users of oral contraceptives and a causal association has been neither confirmed nor refuted:

        • ●Pre-menstrual syndrome
        • ●Cataracts
        • ●Changes in appetite
        • ●Cystitis-like syndrome
        • ●Headache
        • ●Nervousness
        • ●Dizziness
        • ●Hirsutism
        • ●Loss of scalp hair
        • ●Erythema multiforme
        • ●Erythema nodosum
        • ●Hemorrhagic eruption
        • ●Vaginitis
        • ●Porphyria
        • ●Impaired renal function
        • ●Hemolytic uremic syndrome
        • ●Acne
        • ●Changes in libido
        • ●Colitis
        • ●Budd-Chiari Syndrome
        • The following adverse reactions were also reported in clinical trials or during post-marketing experience: Infections and Infestations: vaginal infection, urinary tract infection; Psychiatric Disorders: mood altered, anxiety, insomnia; Gastrointestinal Disorders: flatulence, pancreatitis, diarrhea, constipation; Reproductive System and Breast Disorders: dysmenorrhea; ovarian cyst, vulvovaginal dryness; Neoplasms Benign, Malignant and Unspecified Including Cysts and Polyps): benign breast neoplasm, fibroadenoma of breast, breast cyst; Nervous System Disorders: syncope, convulsion, paraesthesia; Eye Disorders: visual impairment, dry eye; Ear and Labyrinth Disorders: vertigo; Cardiac Disorders: tachycardia, palpitations; Vascular Disorders: hot flush; Respiratory, Thoracic and Mediastinal Disorders: dyspnoea; Hepatobiliary Disorders: hepatitis; Skin and Subcutaneous Tissue Disorders: night sweats, hyperhidrosis, photosensitivity reaction, pruritus; Musculoskeletal, Connective Tissue, and Bone Disorders:muscle spasms, pain in extremity, myalgia, back pain; General Disorders and Administration Site Conditions: chest pain, asthenic conditions.


Overdosage



Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.

NON-CONTRACEPTIVE HEALTH BENEFITS

The following non-contraceptive health benefits related to the use of combination oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing estrogen doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg mestranol.73-78

Effects on menses:

  • ●increased menstrual cycle regularity
  • ●decreased blood loss and decreased incidence of iron deficiency anemia
  • ●decreased incidence of dysmenorrhea
  • Effects related to inhibition of ovulation:

    • ●decreased incidence of functional ovarian cysts
    • ●decreased incidence of ectopic pregnancies
    • Other effects:

      • ●decreased incidence of fibroadenomas and fibrocystic disease of the breast
      • ●decreased incidence of acute pelvic inflammatory disease
      • ●decreased incidence of endometrial cancer
      • ●decreased incidence of ovarian cancer

Dosage And Administration



To achieve maximum contraceptive effectiveness, Wera™ Tablets must be taken exactly as directed and at intervals not exceeding 24 hours. Wera™ Tablets are available in a compact blister card which is preset for a Sunday Start. Day 1 Start stickers are also provided.

Sunday Start

When taking Wera™ , the first “active” tablet should be taken on the first Sunday after menstruation begins. If period begins on Sunday, the first “active” tablet should be taken that day. Take one active tablet daily for 21 days followed by one white “reminder” tablet daily for 7 days. After 28 tablets have been taken, a new course is started the next day (Sunday). For the first cycle of a Sunday Start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.

If the patient misses one (1) “active” tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) “active” tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as condoms or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) “active” tablets in the third week or misses three (3) or more “active” tablets in a row, the patient should continue taking one tablet every day until Sunday. On Sunday the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling (“How to Take the Pill” section).

Day 1 Start

The dosage of Wera™ , for the initial cycle of therapy is one “active” tablet administered daily from the 1st through the 21st day of the menstrual cycle, counting the first day of menstrual flow as “Day 1” followed by one white “reminder” tablet daily for 7 days. Tablets are taken without interruption for 28 days. After 28 tablets have been taken, a new course is started the next day.

If the patient misses one (1) “active” tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) “active” tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as condoms or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) “active” tablets in the third week or misses three (3) or more “active” tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling (“How to Take the Pill” section).

The use of Wera™ for contraception may be initiated 4 weeks postpartum in women who elect not to breast feed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS for “Nursing Mothers.”) The possibility of ovulation and conception prior to initiation of medication should be considered.

(See Discussion of Dose-Related Risk of Vascular Disease from Oral Contraceptives.)

ADDITIONAL INSTRUCTIONS

Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, nonfunctional causes should be borne in mind. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If pathology has been excluded, time or a change to another formulation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.

Use of oral contraceptives in the event of a missed menstrual period:

  • If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and oral contraceptive use should be discontinued if pregnancy is confirmed.
  • If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.

How Supplied



Wera™ Tablets are available in a compact blister card (NDC 16714-370-01) containing 28 tablets, as follows: 21 light peach, biconvex round tablets with “D1” debossed on one side (0.5 mg norethindrone and 0.035 mg ethinyl estradiol) and 7 white, biconvex round tablets with “P” debossed on one side and the “N” on the other side containing inert ingredients.

Wera™ Tablets are available in the following:

Carton of 1 NDC 16714-370-02
Carton of 3 NDC 16714-370-03
Carton of 6 NDC 16714-370-04

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP controlled room temperature].

Rx Only

REFERENCES

1. Trussel J. Contraceptive efficacy. In Hatcher RA, Trussel J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998, in press. 2. Stadel BV, Oral contraceptives and cardiovascular disease. (Pt. 1). N Engl J Med 1981; 305:612-618. 3. Stadel BV, Oral contraceptives and cardiovascular disease. (Pt. 2). N Engl J Med 1981; 305:672-677. 4. Adam SA, Thorogood M. Oral contraception and myocardial infarction revisited: the effects of new preparations and prescribing patterns. Br J Obstet Gynaecol 1981; 88:838-845. 5. Mann JI, Inman WH. Oral contraceptives and death from myocardial infarction. Br Med J 1975; 2(5965):245-248. 6. Mann JI, Vessey MP, Thorogood M, Doll R. Myocardial infarction in young women with special reference to oral contraceptive practice. Br Med J 1975; 2(5956):241-¬245. 7. Royal College of General Practitioners’ Oral Contraception Study: further analyses of mortality in oral contraceptive users. Lancet 1981; 1:541-546. 8. Slone D, Shapiro S, Kaufman DW, Rosenberg L, Miettinen OS, Stolley PD. Risk of myocardial infarction in relation to current and discontinued use of oral contraceptives. N Engl J Med 1981; 305:420-424. 9. Vessey MP. Female hormones and vascular disease – an epidemiological overview. Br J Fam Plann 1980; 6 (Supplement): 1-12. 10. Russell-Briefel RG, Ezzati TM, Fulwood R, Perlman JA, Murphy RS. Cardiovascular risk status and oral contraceptive use, United States, 1976-80. Prevent Med 1986; 15:352-362. 11. Goldbaum GM, Kendrick JS, Hogelin GC, Gentry EM. The relative impact of smoking and oral contraceptive use on women in the United States. JAMA 1987; 258:1339-1342. 12. Layde PM, Beral V. Further analyses of mortality in oral contraceptive users; Royal College of General Practitioners’ Oral Contraception Study. (Table 5) Lancet 1981; 1:541-546. 13. Knopp RH. Arteriosclerosis risk: the roles of oral contraceptives and postmenopausal estrogens. J Reprod Med 1986; 31(9) (Supplement): 913-921. 14. Krauss RM, Roy S, Mishell DR, Casagrande J, Pike MC. Effects of two low-dose oral contraceptives on serum lipids and lipoproteins: Differential changes in high-density lipoproteins subclasses. Am J Obstet 1983; 145:446-452. 15. Wahl P, Walden C, Knopp R, Hoover J, Wallace R, Heiss G, Rifkind B. Effect of estrogen/progestin potency on lipid/lipoprotein cholesterol. N Engl J Med 1983; 308:862¬-867. 16. Wynn V, Niththyananthan R. The effect of progestin in combined oral contraceptives on serum lipids with special reference to high density lipoproteins. Am J Obstet Gynecol 1982; 142:766¬-771. 17. Wynn V, Godsland I. Effects of oral contraceptives on carbohydrate metabolism. J Reprod Med 1986; 31(9)(Supplement):892-897. 18. LaRosa JC. Atherosclerotic risk factors in cardiovascular disease. J Reprod Med 1986; 31(9)(Supplement):906-912. 19. Inman WH, Vessey MP. Investigation of death from pulmonary, coronary, and cerebral thrombosis and embolism in women of child-bearing age. Br Med J 1968; 2(5599):193-199. 20. Maguire MG, Tonascia J, Sartwell PE, Stolley PD, Tockman MS. Increased risk of thrombosis due to oral contraceptives: a further report. Am J Epidemiol 1979; 110(2):188-195. 21. Petitti DB, Wingerd J, Pellegrin F, Ramacharan S. Risk of vascular disease in women: smoking, oral contraceptives, noncontraceptive estrogens, and other factors. JAMA 1979; 242:1150-1154. 22. Vessey MP, Doll R. Investigation of relation between use of oral contraceptives and thromboembolic disease. Br Med J 1968; 2(5599):199-205. 23. Vessey MP, Doll R. Investigation of relation between use of oral contraceptives and thromboembolic disease. A further report. Br Med J 1969; 2(5658):651-657. 24. Porter JB, Hunter JR, Danielson DA, Jick H, Stergachis A. Oral contraceptives and non-fatal vascular disease – recent experience. Obstet Gynecol 1982; 59(3):299¬-302. 25. Vessey M, Doll R, Peto R, Johnson B, Wiggins P. A long-term follow-up study of women using different methods of contraception: an interim report. J Biosocial Sci 1976; 8:375-427. 26. Royal College of General Practitioners: Oral Contraceptives, venous thrombosis, and varicose veins. J Royal Coll Gen Pract 1978; 28:393-399. 27. Collaborative Group for the Study of Stroke in Young Women: Oral contraception and increased risk of cerebral ischemia or thrombosis. N Engl J Med 1973; 288:871-878. 28. Petitti DB, Wingerd J. Use of oral contraceptives, cigarette smoking, and risk of subarachnoid hemorrhage. Lancet 1978; 2:234-236. 29. Inman WH. Oral contraceptives and fatal subarachnoid hemorrhage. Br Med J 1979; 2(6203):1468-1470. 30. Collaborative Group for the Study of Stroke in Young Women: Oral Contraceptives and stroke in young women: associated risk factors. JAMA 1975; 231:718-722. 31. Inman WH, Vessey MP, Westerholm B, Engelund A. Thromboembolic disease and the steroidal content of oral contraceptives. A report to the Committee on Safety of Drugs. Br Med J 1970; 2:203-209. 32. Meade TW, Greenberg G, Thompson SG. Progestogens and cardiovascular reactions associated with oral contraceptives and a comparison of the safety of 50- and 35-mcg oestrogen preparations. Br Med J 1980; 280(6224):1157-1161. 33. Kay CR. Progestogens and arterial disease – evidence from the Royal College of General Practitioners’ Study. Am J Obstet Gynecol 1982; 142:762-765. 34. Royal College of General Practitioners: Incidence of arterial disease among oral contraceptive users. J Royal Coll Gen Pract 1983; 33:75-82. 35. Ory HW. Mortality associated with fertility and fertility control: 1983. Family Planning Perspectives 1983; 15:50-56. 36. The Cancer and Steroid Hormone Study of the Centers for Disease Control and the National Institute of Child Health and Human Development: Oral contraceptive use and the risk of breast cancer. N Engl J Med 1986; 315:405-411. 37. Pike MC, Henderson BE, Krailo MD, Duke A, Roy S. Breast cancer in young women and use of oral contraceptives: possible modifying effect of formulation and age at use. Lancet 1983; 2:926-929. 38. Paul C, Skegg DG, Spears GFS, Kaldor JM. Oral contraceptives and breast cancer: A national study. Br Med J 1986; 293:723-725. 39. Miller DR, Rosenberg L, Kaufman DW, Schottenfeld D, Stolley PD, Shapiro S. Breast cancer risk in relation to early oral contraceptive use. Obstet Gynecol 1986; 68:863-868. 40. Olsson H, Olsson ML, Moller TR, Ranstam J, Holm P. Oral contraceptive use and breast cancer in young women in Sweden (letter). Lancet 1985; 1(8431):748-749. 41. McPherson K, Vessey M, Neil A, Doll R, Jones L, Roberts M. Early contraceptive use and breast cancer: Results of another case-control study. Br J Cancer 1987; 56:653-660. 42. Huggins GR, Zucker PF. Oral contraceptives and neoplasia: 1987 update. Fertil Steril 1987; 47:733-761. 43. McPherson K, Drife JO. The pill and breast cancer: why the uncertainty? Br Med J 1986; 293:709-710. 44. Shapiro S. Oral contraceptives – time to take stock. N Engl J Med 1987; 315:450-451. 45. Ory H, Naib Z, Conger SB, Hatcher RA, Tyler CW. Contraceptive choice and prevalence of cervical dysplasia and carcinoma in situ. Am J Obstet Gynecol 1976; 124:573-577. 46. Vessey MP, Lawless M, McPherson K, Yeates D. Neoplasia of the cervix uteri and contraception: a possible adverse effect of the pill. Lancet 1983; 2:930. 47. Brinton LA, Huggins GR, Lehman HF, Malli K, Savitz DA, Trapido E, Rosenthal J, Hoover R. Long term use of oral contraceptives and risk of invasive cervical cancer. Int J Cancer 1986; 38:339-344. 48. WHO Collaborative Study of Neoplasia and Steroid Contraceptives: Invasive cervical cancer and combined oral contraceptives. Br Med J 1985; 290:961-965 49. Rooks JB, Ory HW, Ishak KG, Strauss LT, Greenspan JR, Hill AP, Tyler CW. Epidemiology of hepatocellular adenoma: the role of oral contraceptive use. JAMA 1979; 242:644¬-648. 50. Bein NN, Goldsmith HS. Recurrent massive hemorrhage from benign hepatic tumors secondary to oral contraceptives. Br J Surg 1977; 64:433-435. 51. Klatskin G. Hepatic tumors: possible relationship to use of oral contraceptives. Gastroenterology 1977; 73:386-394. 52. Henderson BE, Preston-Martin S, Edmondson HA, Peters RL, Pike MC. Hepatocellular carcinoma and oral contraceptives. Br J Cancer 1983; 48:437-440. 53. Neuberger J, Forman D, Doll R, Williams R. Oral contraceptives and hepatocellular carcinoma. Br Med J 1986; 292:1355-1357. 54. Forman D, Vincent TJ, Doll R. Cancer of the liver and oral contraceptives. Br Med J 1986; 292:1357-1361. 55. Harlap S, Eldor J. Births following oral contraceptive failures. Obstet Gynecol 1980; 55:447-452. 56. Savolainen E, Saksela E, Saxen L. Teratogenic hazards of oral contraceptives analyzed in a national malformation register. Am J Obstet Gynecol 1981; 140:521-524. 57. Janerich DT, Piper JM, Glebatis DM. Oral contraceptives and birth defects. Am J Epidemiol 1980; 112:73-79. 58. Ferencz C, Matanoski GM, Wilson PD, Rubin JD, Neill CA, Gutberlet R. Maternal hormone therapy and congenital heart disease. Teratology 1980; 21:225-239. 59. Rothman KJ, Fyler DC, Goldblatt A, Kreidberg MB. Exogenous hormones and other drug exposures of children with congenital heart disease. Am J Epidemiol 1979; 109:433-439. 60. Boston Collaborative Drug Surveillance Program: Oral contraceptives and venous thromboembolic disease, surgically confirmed gallbladder disease, and breast tumors. Lancet 1973; 1:1399-1404. 61. Royal College of General Practitioners: Oral contraceptives and health. New York, Pittman 1974. 62. Layde PM, Vessey MP, Yeates D. Risk of gallbladder disease: a cohort study of young women attending family planning clinics. J Epidemiol Community Health 1982; 36:274¬-278. 63. Rome Group for Epidemiology and Prevention of Cholelithiasis (GREPCO): Prevalence of gallstone disease in an Italian adult female population. Am J Epidemiol 1984; 119:796-805. 64. Storm BL, Tamragouri RT, Morse ML, Lazar EL, West SL, Stolley PD, Jones JK. Oral contraceptives and other risk factors for gallbladder disease. Clin Pharmacol Ther 1986; 39:335-341. 65. Wynn V, Adams PW, Godsland IF, Melrose J, Niththyananthan R, Oakley NW, Seedj A. Comparison of effects of different combined oral contraceptive formulations on carbohydrate and lipid metabolism. Lancet 1979; 1:1045-1049. 66. Wynn V. Effect of progesterone and progestins on carbohydrate metabolism. In: Progesterone and Progestin. Bardin CW, Milgrom E, Mauvis-Jarvis P. eds. New York, Raven Press, 1983; pp. 395-410. 67. Perlman JA, Roussell-Briefel RG, Ezzati TM, Lieberknecht G. Oral glucose tolerance and the potency of oral contraceptive progestogens. J Chronic Dis 1985; 38:857-864. 68. Royal College of General Practitioners’ Oral Contraception Study: Effect on hypertension and benign breast disease of progestogen component in combined oral contraceptives. Lancet 1977; 1:624. 69. Fisch IR, Frank J. Oral contraceptives and blood pressure. JAMA 1977; 237:2499-2503. 70. Laragh AJ. Oral contraceptive induced hypertension – nine years later. Am J Obstet Gynecol 1976; 126:141-147. 71. Ramcharan S, Peritz E, Pellegrin FA, Williams WT. Incidence of hypertension in the Walnut Creek Contraceptive Drug Study cohort: In: Pharmacology of steroid contraceptive drugs. Garattini S, Berendes HW. Eds. New York, Raven Press, 1977; pp. 277-288, (Monographs of the Mario Negri Institute for Pharmacological Research Milan.) 72. Stockley I. Interactions with oral contraceptives. J Pharm 1976; 216:140-143. 73. The Cancer and Steroid Hormone Study of the Centers for Disease Control and the National Institute of Child Health and Human Development: Oral contraceptive use and the risk of ovarian cancer. JAMA 1983; 249:1596-1599. 74. The Cancer and Steroid Hormone Study of the Centers for Disease Control and the National Institute of Child Health and Human Development: Combination oral contraceptive use and the risk of endometrial cancer. JAMA 1987; 257:796-800. 75. Ory HW. Functional ovarian cysts and oral contraceptives: negative association confirmed surgically. JAMA 1974; 228:68-69. 76. Ory HW, Cole P, MacMahon B, Hoover R. Oral contraceptives and reduced risk of benign breast disease. N Engl J Med 1976; 294:419-422. 77. Ory HW. The noncontraceptive health benefits from oral contraceptive use. Fam Plann Perspect 1982; 14:182-184. 78. Ory HW, Forrest JD, Lincoln R. Making choices: Evaluating the health risks and benefits of birth control methods. New York, The Alan Guttmacher Institute, 1983; p. 1. 79. Schlesselman J, Stadel BV, Murray P, Lai S. Breast cancer in relation to early use of oral contraceptives. JAMA 1988; 259:1828-1833. 80. Hennekens CH, Speizer FE, Lipnick RJ, Rosner B, Bain C, Belanger C, Stampfer MJ, Willett W, Peto R. A case-control study of oral contraceptive use and breast cancer. JNCI 1984; 72:39-42. 81. LaVecchia C, Decarli A, Fasoli M, Franceschi S, Gentile A, Negri E, Parazzini F, Tognoni G. Oral contraceptives and cancers of the breast and of the female genital tract. Interim results from a case-control study. Br J Cancer 1986; 54:311-317. 82. Meirik O, Lund E, Adami H, Bergstrom R, Christoffersen T, Bergsjo P. Oral contraceptive use and breast cancer in young women. A Joint National Case-control study in Sweden and Norway. Lancet 1986; 11:650-654. 83. Kay CR, Hannaford PC. Breast cancer and the pill – A further report from the Royal College of General Practitioners’ oral contraception study. Br J Cancer 1988; 58:675-680. 84. Stadel BV, Lai S, Schlesselman JJ, Murray P. Oral contraceptives and premenopausal breast cancer in nulliparous women. Contraception 1988; 38:287-299. 85. Miller DR, Rosenberg L, Kaufman DW, Stolley P, Warshauer ME, Shapiro S. Breast cancer before age 45 and oral contraceptive use: New Findings. Am J Epidemiol 1989; 129:269-280. 86. The UK National Case-Control Study Group, Oral contraceptive use and breast cancer risk in young women. Lancet 1989; 1:973-982. 87. Schlesselman JJ. Cancer of the breast and reproductive tract in relation to use of oral contraceptives. Contraception 1989; 40:1-38. 88. Vessey MP, McPherson K, Villard-Mackintosh L, Yeates D. Oral contraceptives and breast cancer: latest findings in a large cohort study. Br J Cancer 1989; 59:613-617. 89. Jick SS, Walker AM, Stergachis A, Jick H. Oral contraceptives and breast cancer. Br J Cancer 1989; 59:618-621. 90. Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and hormonal contraceptives: collaborative reanalysis of individual data on 53 297 women with breast cancer and 100 239 women without breast cancer from 54 epidemiological studies. Lancet 1996; 347:1713-1727. 91. Palmer JR, Rosenberg L, Kaufman DW, Warshauer ME, Stolley P, Shapiro S. Oral Contraceptive Use and Liver Cancer. Am J Epidemiol 1989; 130:878-882. 92. Improving access to quality care in family planning: Medical eligibility criteria for contraceptive use. Geneva, WHO, Family and Reproductive Health, 1996. 93. Bork K, Fischer B, DeWald G.  Recurrent episodes of skin angioedema and severe attacks of abdominal pain induced by oral contraceptives or hormone replacement therapy. Am J Med 2003;114:294-298. 94. Van Giersbergen PLM, Halabi A, Dingemanse J. Pharmacokinetic interaction between bosentan and the oral contraceptives norethisterone and ethinyl estradiol. Int J Clin Pharmacol Ther 2006;44(3):113-118. 95. Christensen J, Petrenaite V, Atterman J, et al. Oral contraceptives induce lamotrigine metabolism: evidence from a doubleblind, placebo-controlled trial. Epilepsia 2007; 48(3):484-489. 96. Chobanian et al. Seventh report of the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure. Hypertension 2003;42;1206–1252.97.Brown KS, Armstrong IC, Wang A, Walker JR, Noveck RJ, Swearingen D, Allison M, Kissling JC, Kisicki J, Salazar D. Effect of the bile acid sequestrant colesevelam on the pharmacokinetics of pioglitazone, repaglinide, estrogen estradiol, norethindrone, levothyroxine, and glyburide. J Clin Pharmacol 2010;50:554–565.

BRIEF SUMMARY PATIENT PACKAGE INSERT

Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly without missing any pills, have a failure rate of approximately 1% per year. The typical failure rate is approximately 5% per year when women who miss pills are included. For most women oral contraceptives are also free of serious or unpleasant side effects. However, forgetting to take pills considerably increases the chances of pregnancy.

For the majority of women, oral contraceptives can be taken safely. But there are some women who are at high risk of developing certain serious diseases that can be fatal or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:

  • ●smoke
  • ●have high blood pressure, diabetes, high cholesterol
  • ●have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast or sex organs, jaundice or malignant or benign liver tumors.
  • Although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy, non-smoking women (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women.

    You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.


Warning Signals



If any of these adverse effects occur while you are taking oral contraceptives, call your healthcare professional immediately:

  • ●Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in the lung)
  • ●Pain in the calf (indicating a possible clot in the leg)
  • ●Crushing chest pain or heaviness in the chest (indicating a possible heart attack)
  • ●Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke)
  • ●Sudden partial or complete loss of vision (indicating a possible clot in the eye)
  • ●Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast; ask your healthcare professional to show you how to examine your breasts)
  • ●Severe pain or tenderness in the stomach area (indicating a possibly ruptured liver tumor)
  • ●Difficulty in sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression)
  • ●Jaundice or a yellowing of the skin or eyeballs, accompanied frequently by fever, fatigue, loss of appetite, dark colored urine, or light colored bowel movements (indicating possible liver problems)
  • SIDE EFFECTS OF ORAL CONTRACEPTIVES

    1. Vaginal bleeding

    Irregular vaginal bleeding or spotting may occur while you are taking the pills. Irregular bleeding may vary from slight staining between menstrual periods to breakthrough bleeding which is a flow much like a regular period. Irregular bleeding occurs most often during the first few months of oral contraceptive use, but may also occur after you have been taking the pill for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue taking your pills on schedule. If the bleeding occurs in more than one cycle or lasts for more than a few days, talk to your healthcare professional.

    2. Contact lenses

    If you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your healthcare professional.

    3. Fluid retention

    Oral contraceptives may cause edema (fluid retention) with swelling of the fingers or ankles and may raise your blood pressure. If you experience fluid retention, contact your healthcare professional.

    4. Melasma

    A spotty darkening of the skin is possible, particularly of the face, which may persist.

    5. Other side effects

    Other side effects may include nausea, vomiting and diarrhea, muscle cramps, change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash, vaginal infections, pancreatitis, skin sensitivity to the sun or ultraviolet and allergic reactions.

    If any of these side effects bother you, call your healthcare professional.

    GENERAL PRECAUTIONS

    1. Missed periods and use of oral contraceptives before or during early pregnancy

    There may be times when you may not menstruate regularly after you have completed taking a cycle of pills. If you have taken your pills regularly and miss one menstrual period, continue taking your pills for the next cycle but be sure to inform your healthcare professional before doing so. If you have not taken the pills daily as instructed and missed a menstrual period, you may be pregnant. If you missed two consecutive menstrual periods, you may be pregnant. Check with your healthcare professional immediately to determine whether you are pregnant. Do not continue to take oral contraceptives until you are sure you are not pregnant, but continue to use another method of contraception.

    There is no conclusive evidence that oral contraceptive use is associated with an increase in birth defects, when taken inadvertently during early pregnancy. Previously, a few studies had reported that oral contraceptives might be associated with birth defects, but these findings have not been seen in more recent studies. Nevertheless, oral contraceptives should not be used during pregnancy. You should check with your healthcare professional about risks to your unborn child of any medication taken during pregnancy.

    2. While breast feeding

    If you are breast feeding, consult your healthcare professional before starting oral contraceptives. Some of the drug will be passed on to the child in the milk. A few adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. In addition, combination oral contraceptives may decrease the amount and quality of your milk. If possible, do not use combination oral contraceptives while breast feeding. You should use another method of contraception since breast feeding provides only partial protection from becoming pregnant and this partial protection decreases significantly as you breast feed for longer periods of time. You should consider starting combination oral contraceptives only after you have weaned your child completely.

    3. Laboratory tests

    If you are scheduled for any laboratory tests, tell your healthcare professional you are taking birth control pills. Certain blood tests may be affected by birth control pills.

    4. Drug interactions

    Tell your healthcare provider about all medicines and herbal products that you take.

    Some medicines and herbal products may make hormonal birth control less effective, including, but not limited to:

    • certain seizure medicines (carbamazepine, felbamate, oxcarbazepine, phenytoin, rufinamide, and topiramate)

    • aprepitant

    • barbiturates

    • bosentan

    • colesevelam

    • griseofulvin

    • certain combinations of HIV medicines (nelfinavir, ritonavir, ritonavir-boosted protease inhibitors)

    • certain non nucleoside reverse transcriptase inhibitors (nevirapine)

    • rifampin and rifabutin

    • St. John’s wort

    Use another birth control method (such as a condom and spermicide or diaphragm and spermicide) when you take medicines that may make WERA less effective.

    Some medicines and grapefruit juice may increase your level of the hormone ethinyl estradiol if used together, including:

    • acetaminophen

    • ascorbic acid

    • medicines that affect how your liver breaks down other medicines (itraconazole, ketoconazole, voriconazole, and fluconazole)

    • certain HIV medicines (atazanavir, indinavir)

    • atorvastatin

    • rosuvastatin

    • etravirine

    Hormonal birth control methods may interact with lamotrigine, a seizure medicine used for epilepsy.

    This may increase the risk of seizures, so your healthcare provider may need to adjust the dose of lamotrigine.

    Women on thyroid replacement therapy may need increased doses of thyroid hormone.

    Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

    5. Sexually transmitted diseases

    This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

    HOW TO TAKE THE PILL

    IMPORTANT POINTS TO REMEMBER

    BEFORE YOU START TAKING YOUR PILLS:

    • BE SURE TO READ THESE DIRECTIONS:
      Before you start taking your pills.
      Anytime you are not sure what to do.
    • THE RIGHT WAY TO TAKE THE PILL IS TO TAKE ONE PILL EVERY DAY AT THE SAME TIME.
      If you miss pills you could get pregnant. This includes starting the pack late.
      The more pills you miss, the more likely you are to get pregnant.
    • MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST 1-3 PACKS OF PILLS. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn’t go away, check with your healthcare professional.
    • MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even when you make up these missed pills.
      On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.
    • IF YOU HAVE VOMITING OR DIARRHEA, or IF YOU TAKE SOME MEDICINES, including some antibiotics, your pills may not work as well. Use a back-up method (such as condoms or spermicide) until you check with your healthcare professional.
    • IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your healthcare professional about how to make pill-taking easier or about using another method of birth control.
    • IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your healthcare professional.
    • BEFORE YOU START TAKING YOUR PILLS

      • DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL.
        It is important to take it at about the same time every day.
      • LOOK AT YOUR PILL PACK.
        The pill pack has 21 “active” pills (with hormones) to take for 3 weeks. This is followed by 1 week of white “reminder” pills (without hormones).
        Wera : There are 21 light peach “active” pills and 7 white “reminder” pills.
      • ALSO FIND:
        1) where on the pack to start taking pills,
        2) in what order to take the pills, and
        3) the week numbers as shown in the picture below.
      • CHECK PICTURE OF PILL PACK AND ADDITIONAL INSTRUCTIONS FOR USING THIS PACKAGE IN THE BRIEF SUMMARY PATIENT PACKAGE INSERT.

        • BE SURE YOU HAVE READY AT ALL TIMES:
          ANOTHER KIND OF BIRTH CONTROL (such as condoms or spermicide) to use as a back-up method in case you miss pills.
          AN EXTRA, FULL PILL PACK.
        • WHEN TO START THE FIRST PACK OF PILLS

          You have a choice of which day to start taking your first pack of pills. Wera™ is available in a compact blister card which is preset for a Sunday Start. Day 1 Start stickers are also provided. Decide with your healthcare professional which is the best day for you. Pick a time of day which will be easy to remember.

          SUNDAY START:

          Take the first light peach “active” pill of the first pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the pack the same day.

          Use another method of birth control such as condoms or spermicide as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days).

          DAY 1 START:

          Take the first light peach “active” pill of the first pack during the first 24 hours of your period.

          • Pick the day label strip that starts with the first day of your period (this is the day you start bleeding or spotting, even if it is almost midnight when the bleeding begins).
          • Place this day label strip in the cycle tablet dispenser over the area that has the days of the week (starting with Sunday) imprinted in the plastic.
          • You will not need to use a back-up method of birth control, since you are starting the pill at the beginning of your period.

            WHAT TO DO DURING THE MONTH

            • TAKE ONE PILL AT THE SAME TIME EVERY DAY UNTIL THE PACK IS EMPTY.
              Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea).
              Do not skip pills even if you do not have sex very often.
            • WHEN YOU FINISH A PACK OR SWITCH YOUR BRAND OF PILLS:
              Start the next pack on the day after your last white “reminder” pill. Do not wait any days between packs.
            • WHAT TO DO IF YOU MISS PILLS

              If you MISS 1 light peach “active” pill:

              1. Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day.

              2. You do not need to use a back-up birth control method if you have sex.

              If you MISS 2 light peach “active” pills in a row in WEEK 1 OR WEEK 2 of your pack:

              • Take 2 pills on the day you remember and 2 pills the next day.
              • Then take 1 pill a day until you finish the pack.
              • You COULD BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms or spermicide) as a back-up method for those 7 days.
              • If you MISS 2 light peach “active” pills in a row in THE 3RD WEEK:

                1a. If you are a Sunday Starter:

                Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day.

                1b. If you are a Day 1 Starter:

                THROW OUT the rest of the pill pack and start a new pack that same day.

                2. You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your healthcare professional because you might be pregnant.

                3. You COULD BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms or spermicide) as a back-up method for those 7 days.

                If you MISS 3 OR MORE light peach “active” pills in a row (during the first 3 weeks):

                1a. If you are a Sunday Starter:

                Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day.

                1b. If you are a Day 1 Starter:

                THROW OUT the rest of the pill pack and start a new pack that same day.

                2. You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your healthcare professional because you might be pregnant.

                3. You COULD BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms or spermicide) as a back-up method for those 7 days.

                A REMINDER

                If you forget any of the 7 white “reminder” pills in Week 4: THROW AWAY the pills you missed. Keep taking 1 pill each day until the pack is empty. You do not need a back-up method.

                FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED:

                Use a BACK-UP METHOD anytime you have sex.

                KEEP TAKING ONE “ACTIVE” PILL EACH DAY until you can reach your healthcare professional.

                PREGNANCY DUE TO PILL FAILURE

                Combination Oral Contraceptives

                The incidence of pill failure resulting in pregnancy is approximately one percent (i.e., one pregnancy per 100 women per year) if taken every day as directed, but more typical failure rates are 5%. If failure does occur, the risk to the fetus is minimal.

                PREGNANCY AFTER STOPPING THE PILL

                There may be some delay in becoming pregnant after you stop using oral contraceptives, especially if you had irregular menstrual cycles before you used oral contraceptives. It may be advisable to postpone conception until you begin menstruating regularly once you have stopped taking the pill and desire pregnancy.

                There does not appear to be any increase in birth defects in newborn babies when pregnancy occurs soon after stopping the pill.

                OVERDOSAGE

                Serious ill effects have not been reported following ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea and withdrawal bleeding in females. In case of overdosage, contact your healthcare professional or pharmacist.

                OTHER INFORMATION

                Your healthcare professional will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare professional believes that it is a good medical practice to postpone it. You should be reexamined at least once a year. Be sure to inform your healthcare professional if there is a family history of any of the conditions listed previously in this leaflet. Be sure to keep all appointments with your healthcare professional, because this is a time to determine if there are early signs of side effects of oral contraceptive use.

                Do not use the drug for any condition other than the one for which it was prescribed. This drug has been prescribed specifically for you; do not give it to others who may want birth control pills.

                HEALTH BENEFITS FROM ORAL CONTRACEPTIVES

                In addition to preventing pregnancy, use of combination oral contraceptives may provide certain benefits. They are:

                • ●menstrual cycles may become more regular
                • ●blood flow during menstruation may be lighter and less iron may be lost. Therefore, anemia due to iron deficiency is less likely to occur.
                • ●pain or other symptoms during menstruation may be encountered less frequently
                • ●ectopic (tubal) pregnancy may occur less frequently
                • ●noncancerous cysts or lumps in the breast may occur less frequently
                • ●acute pelvic inflammatory disease may occur less frequently
                • ●oral contraceptive use may provide some protection against developing two forms of cancer: cancer of the ovaries and cancer of the lining of the uterus.
                • If you want more information about birth control pills, ask your healthcare professional. They have a more technical leaflet called the Professional Labeling, which you may wish to read.

                  Manufactured for:
                  Northstar Rx LLC., Memphis, TN 38141
                  Toll Free 1-800-206-7821

                  Manufactured by:
                  Novast Laboratories Ltd., Nantong, China 226009

                  Iss. 11/2015


* Please review the disclaimer below.