Fluconazole 150 Mg Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fluconazole 150 mg Capsules Fluconazole
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet:
1. What Fluconazole is and what it is used for
2. Before you take Fluconazole
3. How to take Fluconazole
4. Possible side effects
5. How to store Fluconazole
6. Further information
1. WHAT FLUCONAZOLE IS AND WHAT IT IS USED FOR
The active substance fluconazole is one of a group of medicines called anti-fungals which are used to treat infections caused by fungi (including yeasts such as one called Candida).
Your doctor has prescribed fluconazole for you because you have vaginal thrush (in women) or candidal balanitis (inflammation of the end of the penis and/or foreskin in men).
2. BEFORE YOU TAKE FLUCONAZOLE
Do not take Fluconazole if you:
- are allergic to fluconazole, to other medicines you have taken to treat fungal infections or to any of the other ingredients of this medicine (listed in section 6)
- are taking multiple doses of 400 mg or more per day of Terfenadine ( an antihistamine for allergies)
- are taking the astemizole (antihistamines for the relief of allergies such as hay fever)
- are taking cisapride (used for certain digestive problems).
- are taking Pimozide (antipsychotic used in the treatment of schizophrenia)
- are taking Quinidine (used for treating an irregular heartbeat and malaria)
- are taking Erythromycin (antibiotic medicine used to treat infections)
Fluconazole must not be taken by people who are taking one of these medicines because of the risk of a serious rhythm disturbance of the heart.
Tell your doctor IMMEDIATELY as the capsules may not be suitable for you.
Take special care with Fluconazole
Tell your doctor before you start taking your medicine if you:
- are under 16 years
- suffer from liver or kidney disease. Did you develop problems with your liver while taking fluconazole previously? If so, fluconazole may not be suitable for you.
- suffer from heart disease, including heart rhythm problems
- have AIDS. You can still take fluconazole but be aware that people who have AIDS are also more likely to develop very severe skin reactions to fluconazole.
- have a serious ongoing illness such as AIDS, cancer or severe problems with your blood, liver or kidneys. Fluconazole is particularly likely to cause changes in blood test results in such people, so your doctor may need to check your blood during treatment.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
• Benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety.
• Anticoagulants (such as warfarin used to prevent blood clots).
• Medicines for diabetes called oral sulphonylureas (such as chlorpropamide, glibenclamide, glipizide or tolbutamide). In particu lar, fluconazole can increase the risk of having a very low blood sugar level due to these medicines.
• Diuretics (water tablets such as hydrochlorothiazide).
• Phenytoin or carbamezepine (for the control of epilepsy).
• Rifampicin, rifabutin, azithromycin (antibiotic medicines used to treat infections).
• Ciclosporin, everolimus, sirolimus or tacrolimus (used to prevent organ rejection after a transplant).
• Theophylline (for the control of asthma).
• Zidovudine (a medicine also known as AZT) which is used in patients infected with HIV and AIDS. Fluconazole can increase the blood level of zidovudine.
• Medicines called HMG-CoA reductase inhibitors such as simvastatin and atorvastatin or fluvastatin, that are used to lower blood cholesterol levels. In particular, there is an increased risk of side-effects that affect the muscles such as muscle pain and weak ness, with a risk also to the normal working of the kidneys.
• Medicines called calcium channel antagonists, including nifedipine, isradipine, amlodipine and felodipine (used to control your angina and/or high blood pressure).
• Losartan (used to control your high blood pressure) because it may not work so well while you are taking fluconazole.
• Prednisone (a steroid). When fluconazole treatment is stopped, you may need to take more prednisone, at least for a while.
• Amitriptyline or nortriptyline (antidepressants).
• Celecoxib (a non-steroidal anti-inflammatory medicine used to treat arthritis).
• Alfentanil or fentanyl, which is used to relieve pain during surgical operations. If you are going to have an anaesthetic, make sure that your anaesthetist knows that you are taking fluconazole because you may need a lower dose of alfentanil or fentanyl.
• Halofantrine (antimalarial)
• Amphotericin B, voriconazole (anti-fungal)
• Methadone (for treating heroin addiction)
• Saquinavir (antiretrovirals used in the treatment of HIV)
• Vinca alkaloids (used to treat cancer)
• Cyclosphosphamide (used in chemotherapy in the treatment of cancer)
• Terfenadine (an antihistamine for allergies) being taken at less than 400 mg total dose per day
• Ibuprofen,flubiprofen,naproxen,lornoxicam, meloxicam,diclofenac (a non-steroidal anti-inflammatory medicine)
• Vitamin A
• Any other medicines - even those not prescribed.
If you have a blood/urine/liver function test you should tell the doctor that you are taking fluconazole because the medicine may affect the result.
Pregnancy and breast-feeding Do not take fluconazole if you are:
- If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take fluconazole while you are pregnant unless your doctor has told you to.
You can continue breast-feeding after taking a single dose of fluconazole up to 200 mg.
You should not breast-feed if you are taking a repeated dose of fluconazole.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Occasionally dizziness or fits can occur in people taking fluconazole so care should be taken when driving or operating machinery. Important information about some of the ingredients of Fluconazole
This medicine contains a small amount of lactose (sugar), if you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicine.
3. HOW TO TAKE FLUCONAZOLE
Always take Fluconazole exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. This capsule is for oral use. The complete course of treatment for vaginal thrush or candidal balantis is one capsule. Take the capsule with a sufficient quantity of liquid - one glass of water. Do not chew the capsule. It can be taken before, with or after food.
If you take more Fluconazole than you should
You need to take only one capsule. If you take many capsules at once contact your doctor immediately or go to the nearest hospital §
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casualty department. Take this leaflet or some capsules with you so the doctor will know what has been taken. §
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If you forget to take Fluconazole
Do not worry if you miss a dose. Wait until the next dose is due and then go on as before. Do not take a double dose to make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fluconazole Capsules can have side effects which can be seen even with a single dose of 150 mg, although not everybody gets them.
Allergic reactions to fluconazole are rarely severe (in more than one in ten thousand people but less than one in a thousand) but can include a drop in blood pressure and unconsciousness, swelling of the face and neck or of other body parts and rashes that involve blistering and peeling of the skin that may affect the eyes, mouth and genitals. If you have any of these symptoms, you should stop taking fluconazole and contact a doctor or the nearest hospital urgently.
Less serious allergic reactions include skin rashes that are not severe but which are sometimes itchy. These are common (in more than one in a hundred people but less than one in ten). Uncommonly (more than one in a thousand but less than one in a hundred), there may also be an increase in a type of white blood cells called eosinophils. If you have any of these symptoms, you should stop taking fluconazole and contact your doctor immediately.
Common side effects (in more than one in a hundred people but less than one in ten) include:
• headache
• feeling or being sick
• stomach pains
• diarrhoea
• changes in blood tests that measure how well the liver is working.
• rash
• vomiting
Uncommon side effects (more than one in a thousand but less than one in a hundred) include:
• tiredness
• generally feeling unwell or weak
• reduction in red blood cells which can make skin pale and cause weakness or breathlessness
• fever
• fits
• sensation of spinning
• tingling, picking or numbness
• dizziness
• indigestion
• excess wind
• constipation
• muscle pains
• dry mouth
• loss of sense of taste
• pale itchy swellings on the skin(hives)
• sweating
• sleep disturbances
• jaundice and other liver problems including liver damage.
Side effects that probably happen rarely (in more than one in ten thousand but less than one in a thousand people) or even very rarely (in less than one in ten thousand people) include:
• thinning or loss of hair/baldness (alopecia).
• low numbers of white blood cells (leading to an increase in risk of infections) or platelets (leading to easy bruising and bleeding for longer than usual) in the blood.
• red or purple discoloration of the skin which may be caused by low platelet count, other blood cell changes
• low blood potassium
• allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reactions, swelling of the lips or face
• shaking
• increases in cholesterol and other fats in the bloodstream,
• Irregular heartbeats (QT prolongation and torsades de pointes) as displayed by an ECG (electrocardigram)
The risk of side effects is higher in people who are infected with the HIV virus but the types of side effects in these people are the same as in other people.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE FLUCONAZOLE
Keep out of the sight and reach of children. Your medicine can harm them.
Do not take this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store in the original package to protect from moisture. Do not store above 25°C. If you notice that the capsule is broken or has an odd colour, take it back to your pharmacist for advice before taking.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Fluconazole contains
- The active substance is fluconazole
- The other ingredients are lactose monohydrate, maize starch, colloidal anhydrous silica, talc, sodium lauryl sulphate and gelatin (capsule shells only). The colouring agents included in the capsule shells are Patent blue (E131) and titanium dioxide (E171).
The ink used to print ‘FCZ 150’contains black iron oxide (E172), shellac, propylene glycol, dehydrated alcohol, isopropyl alcohol, butyl alcohol, strong ammonia solution, potassium hydroxide
What Fluconazole looks like and contents of the pack
The sky blue capsule contains 150 mg fluconazole. It has ‘FCZ 150’ printed on it.
Fluconazole 150 mg Capsules come in a pack containing 1 capsule.
Marketing Authorisation Holder
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom.
Manufacturer
Cipla (EU) Limited, 20 Balderton Street, London, W1K 6TL, United Kingdom Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium
This leaflet was last revised in 07/2015
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Cipla
PACKAGING DEVELOPMENT
Product Name: Fluconazole 150mg
Material No.: 21048992 Item: Leaflet
Date: 31-07-15
Co-ordinator: Shweta
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