This leaflet contains important information about Fluconazole Tablets. It is not meant to take the place of your healthcare provider's instructions. Read this information carefully before you take Fluconazole Tablets. Ask your healthcare provider if you do not understand any of this information or if you want to know more about Fluconazole Tablets. |
What is Fluconazole Tablets? Fluconazole Tablets is a prescription medicine used to treat vaginal yeast infections caused by a yeast called Candida. Fluconazole Tablets helps stop too much yeast from growing in the vagina so the yeast infection goes away. Fluconazole Tablets are different from other treatments for vaginal yeast infections because it is a tablet taken by mouth. Fluconazole Tablets are also used for other conditions. However, this leaflet is only about using Fluconazole Tablets for vaginal yeast infections. For information about using Fluconazole Tablets for other reasons, ask your healthcare provider. See the section of this leaflet for information about vaginal yeast infections. |
What is a vaginal yeast infection?
It is normal for a certain amount of yeast to be found in the vagina. Sometimes too much yeast starts to grow in the vagina and this can cause a yeast infection. Vaginal yeast infections are common. About three out of every four adult women will have at least one vaginal yeast infection during their life.
Some medicines and medical conditions can increase your chance of getting a yeast infection. If you are pregnant, have diabetes, use birth control pills, or take antibiotics you may get yeast infections more often than other women. Personal hygiene and certain types of clothing may increase your chances of getting a yeast infection. Ask your healthcare provider for tips on what you can do to help prevent vaginal yeast infections.
If you get a vaginal yeast infection, you may have any of the following symptoms:
- itching
- a burning feeling when you urinate
- redness
- soreness
- a thick white vaginal discharge that looks like cottage cheese
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Do not take Fluconazole Tablets if you. - take the following medicines:
- quinidine
- erythromycin
- pimozide
- are allergic to fluconazole, the active ingredient in Fluconazole Tablets, or any of the ingredients in Fluconazole Tablets. See the end of this Patient Information leaflet for a complete list of ingredients in Fluconazole Tablets.
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Before you take Fluconazole Tablets, tell your healthcare provider about all of your medical conditions, if you: - have liver problems
- have kidney problems
- have heart problems including heart arrythmias
- have hypokalemia (low potassium)
- are pregnant or plan to become pregnant. Tell your healthcare provider right away if you become pregnant while taking Fluconazole Tablets. You and your healthcare provider will decide if Fluconazole Tablets is right for you. If you may become pregnant you should use a birth-control (contraceptive) method while taking Fluconazole Tablets and for 1 week after your final dose.
- are breastfeeding or plan to breastfeed. Fluconazole Tablets can pass into your breastmilk. Talk to your healthcare provider about the best way to feed your baby while you are taking Fluconazole Tablets.
Before you start taking Fluconazole Tablets, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:
- diabetes medicines such as glyburide, tolbutamide, glipizide
- blood pressure medicines like hydrochlorothiazide, losartan, amlodipine, verapamil, nifedipine or felodipine
- blood thinners such as warfarin
- cyclosporine, tacrolimus or sirolimus (used to prevent rejection of organ transplants)
- rifampin or rifabutin for tuberculosis
- phenytoin or carbamazepine to control seizures
- theophylline to control asthma
- quinidine (used to correct disturbances in heart rhythm)
- amiodarone (used for treating uneven heartbeats 'arrhythmias')
- amitriptyline or nortriptyline for depression
- pimozide for psychiatric illness
- amphotericin B or voriconazole for fungal infections
- erythromycin for bacterial infections
- olaparib, cyclophosphamide or vinca alkaloids such as vincristine or vinblastine for treatment of cancer
- fentanyl, alfentanil or methadone for chronic pain
- ibrutinib used for treating blood cancer
- ivacaftor or ivacaftor combinations, such as tezacaftor/ivacaftor and ivacaftor/tezacaftor/elexacaftor, used to treat cystic fibrosis
- lurasidone used to treat schizophrenia or depression
- lemborexant, used for the treatment of insomnia
- lipid lowering drugs such as atorvastatin, simvastatin, and fluvastatin
- non-steroidal anti-inflammatory drugs including celecoxib, ibuprofen, and naproxen
- prednisone, a steroid used to treat skin, gastrointestinal, hematological or respiratory disorders
- antiviral medications used to treat HIV like saquinavir or zidovudine
- tofacitinib for rheumatoid arthritis
- vitamin A nutritional supplement
- tolvaptan used to treat hyponatremia (low levels of sodium in your blood) or to slow kidney function decline
Since there are many brand names for these medicines, check with your healthcare provider or pharmacist if you have any questions.
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How should I take Fluconazole Tablets? - Take Fluconazole Tablets exactly as your healthcare provider tells you to.
- Take Fluconazole Tablets by mouth with or without food.
- If you take too much Fluconazole Tablets, call your healthcare provider or go to the nearest emergency room right away.
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What should I avoid while taking Fluconazole Tablets?
Fluconazole Tablets can cause dizziness and seizures. Do not drive or operate machinery until you know how Fluconazole Tablets affects you.
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What are the possible side effects of Fluconazole Tablets?
Fluconazole Tablets
may cause serious side effects including: - serious liver problems. Some people with serious medical problems have developed serious liver problems that became life-threatening or caused death while taking Fluconazole Tablets. Sometimes these liver problems can be reversed when you stop taking Fluconazole Tablets. Tell your healthcare provider right away if you have symptoms of serious liver problems including:
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- dark colored urine
- severe skin itching
- yellowing of the skin and eyes (jaundice)
| - light-colored stools
- tiredness
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- serious allergic reactions: Serious allergic reactions (anaphylaxis) have happened while taking Fluconazole Tablets. Stop taking Fluconazole Tablets, call your healthcare provider or go to the nearest hospital emergency room right away if you get any signs or symptoms of an allergic reaction including:
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- shortness of breath
- fever
- swelling of the eyelids
| - coughing
- skin rash, hives, blisters or skin peeling
- face, mouth, neck, or any other part of the body
| - wheezing
- throbbing of the heart or ears
- chills
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| | - nausea or upset stomach
- changes in the way food tastes
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Other side effects include: - adrenal insufficiency: Some people who have taken Fluconazole Tablets developed adrenal insufficiency that was reversible. Tell your healthcare provider right away if you have symptoms of adrenal insufficiency including:
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- long lasting fatigue
- weight loss
- nausea
| - muscle weakness
- stomach pain
- vomiting
| - loss of appetite
- dizziness
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- dizziness or seizures.
These are not all the possible side effects of Fluconazole Tablets.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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How should I store Fluconazole Tablets?
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Keep Fluconazole Tablets and all medicines out of the reach of children. |
General information about the safe and effective use of Fluconazole Tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Fluconazole Tablets for a condition for which it was not prescribed. Do not give Fluconazole Tablets to other people, even if they have the same symptoms you have. It may harm them.
You can ask your healthcare provider for information about Fluconazole Tablets that is written for health professionals.
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What are the ingredients in Fluconazole Tablets?
Active ingredient
: fluconazole
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose.
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Manufactured by:
Chartwell Pharmaceuticals, LLC.
Congers, NY 10920
Manufactured for:
Chartwell RX, LLC.
Congers, NY 10920
Made in USA L71184 Rev. 12/2022 |
