NEW ZEALAND CONSUMER MEDICINE INFORMATION

FLUCONAZOLE Fluconazole 50 mg, 150 mg and 200 mg

If it has expired or is damaged, What is in this leaflet Before you take return it to your pharmacist for Fluconazole disposal. This leaflet answers some common questions about Fluconazole If you are not sure whether you capsules. When you must not take should start taking this medicine, it talk to your doctor. It does not contain all the available information. It does not take the Do not take Fluconazole if you Before you start to take place of talking to your doctor or have an allergy to the following: it pharmacist.  any medicine containing Tell your doctor if you have All medicines have risks and fluconazole allergies to any other medicines, benefits. Your doctor has weighed  medicines related to foods, preservatives or dyes. the risks of using Fluconazole fluconazole such as Fluconazole capsules contain capsules against the benefits they miconazole, ketoconazole lactose and should be avoided if expect it will have for you. or clotrimazole you have an intolerance to lactose  any of the ingredients or a deficiency that affects your If you have any concerns about listed at the end of this ability to metabolise or absorb using this medicine, ask your leaflet. lactose. doctor or pharmacist. Symptoms of an allergic reaction Tell your doctor if you have or Keep this leaflet with the may include shortness of breath, have had any of the following medicine. You may need to read it wheezing or difficulty breathing; medical conditions: again. swelling of the face, lips, tongue or other parts of the body; rash, itching  any liver problems or hives on the skin.  any heart problems What Fluconazole is  any kidney problems. Do not take this medicine if you are used for and how it taking any of the following Tell your doctor if you are works medicines: pregnant, plan to become pregnant, or are breastfeeding.  cisapride (a medicine used Your Fluconazole capsules contain Your doctor can discuss with you to treat stomach problems) fluconazole. It belongs to a group of the risks and benefits involved. medicines known as antifungals.  astemizole (an antihistamine used to treat If you have not told your doctor Fluconazole is used to treat certain allergies) about any of the above, tell them fungal and yeast infections. It works  erythromycin (an antibiotic before you take Fluconazole. by preventing the growth of the used in the treatment of fungal and yeast organisms causing infections) Taking other medicines your infection.  pimozide (an antipsychotic medicine) Tell your doctor or pharmacist if you are taking any other Ask your doctor if you have any  quinidine (a medicine used medicines, including any that you questions about why this to treat an irregular get without a prescription from medicine has been prescribed for heartbeat) your pharmacy, supermarket or you.  terfenadine (an health food shop. Your doctor may have prescribed it antihistamine used to treat Some medicines and Fluconazole for another reason. allergies) if you are taking more than 400 mg may interfere with each other. These include: Fluconazole is only available with a fluconazole a day. doctor's prescription. Do not take this medicine/it after  some medicines for the expiry date printed on the diabetes such as pack or if the packaging is torn or chlorpropamide, glipizide, shows signs of tampering.

Page 1 of 4 tolbutamide or  NSAIDs (non-steroidal anti- body weight. In very young children glibenclamide inflammatory drugs) such (below 4 weeks of age),  some antibiotics and as naproxen, lornoxicam, Fluconazole is usually given every antiviral drugs such as meloxicam and diclofenac second or third day. rifampicin, rifabutin,  Olaparib (used in the zidovudine, saquinavir, treatment of breast cancer) However, depending on how voriconazole and  prednisone (used as an serious the infection is, and how amphotericin B anti-inflammatory and also you react to the medicine, your  some medicines used in in some immune system doctor may ask you to take a problems with the immune disorders) different dose. system, such as ciclosporin,  tofacitnib (used in treatment tacrolimus or sirolimus. of rheumatoid arthritis) How to take it  medicines used to stop  vinca alkaloids, such as blood clots such as warfarin vincristine and vinblastine Swallow the capsules whole with or indanedione (used in the treatment of a glass of water.  some medicines used to cancers) treat epilepsy such as  Vitamin A and derivatives. When to take it phenytoin or Take your medicine at about the carbamazepine These medicines may be affected same time each day.  theophylline (used to treat by Fluconazole or may affect how Taking it at the same time each day asthma) well it works. You may need will have the best effect. It will also  some benzodiazepines different amounts of your help you to remember when to take such as midazolam or medicines, or you may need to take it. triazolam different medicines.  hydrochlorothiazide (used It does not matter if you take this for treating fluid problems) This medicine may decrease the medicine before or after food.  alfentanil (used in effectiveness of some birth control anaesthesia) pills. Talk to your pharmacist or  lemborexant (used to treat doctor about the need for an How long to take it insomnia) additional method of contraception Continue taking your medicine  Ibrutinib (used in cancer while taking Fluconazole. until you finish the pack or until treatment) your doctor recommends.  Tolvaptan (used to treat low Your doctor or pharmacist has more The length of time you take levels of sodium in your information on medicines to be Fluconazole will depend on the sort blood) careful with or avoid while taking of infection you have.  amitriptyline and Fluconazole. nortriptyline (used in the Patients with a weakened immune treatment of depression) system or those with difficult  some medicines used to How to take infections may need long-term treat high blood pressure Fluconazole treatment to prevent the infection and angina such as from returning. nifedipine, isradipine, Follow all directions given to you amlodipine, verapamil, Do not stop taking your medicine by your doctor and pharmacist felodipine and losartan because you are feeling better. If carefully.  amiodarone (used to treat you do not complete the full course They may differ from the information irregular heartbeat) prescribed by your doctor, the contained in this leaflet.  celecoxib (used in the infection may not clear completely treatment of arthritic or your symptoms may return. conditions) If you do not understand the instructions on the box, ask your  cyclophosphamide (used in doctor or pharmacist for help. If you forget to take it the treatment of some cancers) If it is almost time for your next  fentanyl (an analgesic used How much to take dose, skip the dose you missed in the treatment of severe and take your next dose when chronic pain) Adults you are meant to. Otherwise, take  halofantrine (used to treat The dose will depend on your it as soon as you remember, then malaria) infection and how you respond to go back to taking your capsules  some medicines used to Fluconazole. It usually ranges from as you would normally. treat high cholesterol such 50 mg to 200 mg once daily. as atorvastatin, simvastatin Do not take a double dose to and fluvastatin Children make up for the dose that you  methadone (used in the missed. treatment of dependence The dose for a child will depend on on opioid drugs) body weight and usually ranges If you are not sure what to do, from 3 mg to 12 mg per kilogram of ask your doctor or pharmacist.

Page 2 of 4 If you have trouble remembering to Do not use Fluconazole to treat Other less common side effects are: take your medicine, ask your any other medical complaints, pharmacist for some hints. unless your doctor tells you to.  ‘pins and needles’ feeling in hands or feet If you take too much Things to be careful of  altered taste (overdose)  tremors Be sure to follow your doctor's  skin rash, itching, dry skin, Immediately telephone your advice if regular checks on your or hives liver are recommended. In rare doctor or the National Poisons  dizziness cases, Fluconazole may affect the Information Centre (0800 POISON  hair loss liver and may need to be stopped. or 0800 764 766) for advice, or go  generally feeling unwell, to Accident and Emergency at tiredness, chills, pain and If you suffer from HIV or have a the nearest hospital, if you think thirst that you or anyone else may have weakened immune system and develop a rash while taking  back pain, kidney pain and taken too much Fluconazole. Do aching muscles this even if there are no signs of Fluconazole, tell your doctor immediately. If this rash worsens,  loss of appetite discomfort or poisoning. You may  altered sight or hearing need urgent medical attention. Fluconazole may need to be stopped.  trouble sleeping or sleepiness While you are taking Be careful driving or operating  irregular, heavy or painful machinery as dizziness or seizures menstrual periods Fluconazole have occurred in isolated cases  increased sweating when taking Fluconazole  hot flushes.

Things you must do Tell your doctor as immediately if Tell your doctor if the symptoms Side effects you notice any of the following: of your infection do not improve within a few days, or if they Tell your doctor or pharmacist as  swelling of the face, lips or become worse. soon as possible if you do not tongue which may cause feel well while you are taking difficulty in swallowing or If you are a woman of child- Fluconazole. breathing bearing age, you should avoid  asthma, wheezing, becoming pregnant while taking All medicines can have some shortness of breath Fluconazole. Tell your doctor unwanted effects. Sometimes they  fainting, seizures or fits immediately if you do become are serious, most of the time they  sudden or severe blisters pregnant while taking are not. You may need medical and bleeding in lips, eyes, Fluconazole. treatment if you get some of the mouth, nose and genitals side effects.  yellowing of the skin or If you are about to be started on any eyes, also called jaundice new medicine, remind your doctor Do not be alarmed by the  bleeding or bruising more or pharmacist that you are taking following lists of side effects. easily than normal, reddish Fluconazole. You may not experience any of or purplish blotches under them. the skin Tell all doctors, dentists and  signs of frequent or pharmacists who treat you that you Ask your doctor or pharmacist to worrying infections such as are taking Fluconazole. answer any questions you may fever, severe chills, sore have. throat or mouth ulcers Things you must not do  fast or irregular heart beat. Tell your doctor or pharmacist if Do not stop taking Fluconazole you notice any of the following These side effects are usually or lower the dosage without and they worry you: rare but can be serious and need checking with your doctor. urgent medical attention.  nausea or feeling sick, If you do not complete the full vomiting Tell your doctor or pharmacist if course prescribed by your doctor,  headache you notice anything that is all of the organisms causing your  stomach pain, indigestion, making you feel unwell. infection may not be killed. These Other side effects not listed above organisms may continue to grow diarrhoea  acne may also occur in some people. and multiply so that your infection Some of these side effects, for may not clear completely or may example, changes in liver function, return. These are some of the more common side effects of can only be found when your doctor Fluconazole. They are usually mild does tests from time to time to Do not give Fluconazole to check your progress. anyone else, even if they have and short-lived. the same condition as you.

Page 3 of 4  Each Fluconazole 50 mg After taking capsule contains 50 mg of fluconazole Fluconazole  Each Fluconazole 150 mg capsule contains 150 mg of Storage fluconazole  Each Fluconazole 200 mg Keep your capsules in the pack capsule contains 200 mg of until it is time to take them. fluconazole If you take the capsules out of the pack they may not keep well. Other ingredients Keep your capsules in a cool dry Each capsule also contains: place where the temperature lactose, maize starch, sodium stays below 25°C. lauryl sulphate, colloidal hydrated silica, magnesium stearate, gelatin Do not store Fluconazole or any and titanium dioxide (E171), patent other medicine in the bathroom or blue V (E131) (50 mg and 200 mg near a sink. Do not leave it on a capsules only), and erythrosine window sill or in the car. (E127) (50 mg capsules only). Heat and dampness can destroy some medicines. If you want to know Keep it where children cannot reach it. more A locked cupboard at least one-and- a half metres above the ground is a Should you have any questions good place to store medicines. regarding this product, please contact your doctor or pharmacist. Disposal Who supplies this If your doctor tells you to stop taking this medicine or the expiry date has medicine passed, ask your pharmacist what Distributed in New Zealand by: to do with any that are left over. Viatris Ltd, PO Box 11183 Product description Ellerslie, AUCKLAND What it looks like www.viatris.co.nz Telephone 0800 168 169 Fluconazole capsules come in four strengths: Date of Preparation  Fluconazole 50 mg – hard gelatin, opaque white/dark 05 August 2021 blue capsule marked “FC (Based on datasheet dated 05 50” and “G” in black August 2021)  Fluconazole 150 mg – hard gelatin, opaque white capsule marked “FC 150” and “G” in black  Fluconazole 200 mg – hard gelatin, opaque white/blue capsule marked “FC 200” and “G” in black.

Ingredients Active ingredient The active ingredient in Fluconazole capsules is fluconazole.

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