Fluconazole 50 Mg Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER Fluconazole 50 mg & 200 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
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 an infection caused by fungi or yeasts. The infection may be affecting the following parts of your body:
• genital candiditis, vaginal thrush (in women) or candidal balanitis (inflammation of the end of the penis and/or foreskin in men).
• thrush of the mouth or throat (mucosal infections).
• fungal infections of the skin e.g. athlete’s foot, ringworm.
• fungal infections of the internal organs caused by Candida e.g. infections of the bloodstream, urinary tract.
• fungal infections of the internal organs caused by Cryptococcus e.g. cryptococcal meningitis.
Fluconazole can also be used to:
• prevent you from getting a fungal infection (e.g. if your immune system is not working properly).
• prevent infections caused by Cryptococcus from coming back in patients with AIDS.
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 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:
- 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 particular, 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 are 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, (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 weakness, 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.
The 200 mg capsules contain Ponceau 4R (E124), which may cause allergic reactions
Always take Fluconazole exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Swallow the capsules with plenty of water - at least one glass of water. Do not chew the capsules. The capsules can be taken before, with or after food.
Fluconazole is also available as a fluid that can be given directly into a vein to start your treatment off. This is then followed by the capsules. If you are given fluconazole into a vein first, you will be given a separate patient information leaflet to explain that medicine.
The dose you are prescribed will depend on the type and severity of your infection. Your doctor will tell you how long your treatment with fluconazole will last.
The usual recommended doses of this medicine for different fungal ADULTS
Mucosal infections of the mouth:
Mucosal infections of the throat or elsewhere:
Fungal skin infections:
Athlete’s foot may need up to 6 weeks treatment
Internal fungal infections caused by Candida:
Cryptococcal meningitis:
Treatment to stop those with a poor immune system from getting a fungal infection:
infections are listed below.
50 - 100 mg once daily for 7 - 14 days.
50 - 100 mg once daily for 14 - 30 days.
50 mg once daily for 2 - 4 weeks.
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400 mg on the first day then 200 - 400 mg once daily.
400 mg loading dose, then 200 - 400 mg daily for up to 8 weeks.
50 - 400 mg once daily while you are at risk of getting an infection.
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Treatment to prevent a cryptococcal infection from coming back: 100 - 200 mg once daily indefinitely.
To treat a genital Candida infection: 150 mg as a single dose.
ELDERLY
If you do not have any problems with your kidneys, you can have the usual adult dose.
CHILDREN
4 weeks to 15 years old : For this age group the dose is based on their bodyweight
• For infections of body surfaces the dose is 3 mg/kg body weight daily. The first dose may sometimes be 6 mg/kg.
• For the treatment of infections that have invaded the body and for cryptococcal meningitis, the dose is 6 to 12 mg/kg body weight daily.
• For the prevention of infection in children with poor immunity due to low numbers of white blood cells (neutropenia), the dose is 3 to 12 mg/kg body weight daily, depending on the severity of the neutropenia.
A maximum dosage of 400 mg daily should not be exceeded in children in this age range.
PATIENTS WITH KIDNEY DISEASE
Special dosing instructions are needed if you have poor kidneys or you are on dialysis to treat your kidney problems. The normal adult dose is usually given on the first day of treatment and then half the usual dose daily. People on dialysis are usually given the usual adult dose after each session.
Duration of treatment
In some cases, your doctor will tell you to stop taking fluconazole before the times mentioned above or may ask you to continue taking fluconazole for longer to make sure that the infection is properly treated.
If you still feel unwell at the end of the course of treatment, tell your doctor.
If you take more Fluconazole than you should
If you take too many capsules at once or if someone else has taken your capsules by mistake contact your doctor immediately or go to the nearest hospital casualty department. Take this leaflet or some capsules with you so the doctor will know what has been taken.
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.
If you stop taking Fluconazole
It is important that you keep taking Fluconazole Capsules until the prescribed course is finished. Do not stop taking the capsules just because you feel better. If you stop too soon, the infection may start up again.
Like all medicines, Fluconazole Capsules can have side effects, 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
• Decreased appetite
• inability to sleep, feeling drowsy
• fever
• fits
• sensation of spinning
• tingling, picking or numbness
• dizziness
• indigestion
• excess wind
• constipation
• muscle pains
• dry mouth
• loss of sense of taste
• sweating
• pale itchy swellings on the skin (hives)
• 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 heart beats (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.
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 capsules are broken or have an odd colour, take them back to your pharmacist for advice before taking them.
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.
What Fluconazole contains
- The active substance is fluconazole
- The other ingredients are lactose monohydrate, maize starch, colloidal anhydrous silica, talc, sodium lauryl sulphate and gelatine (capsule shells only)
Colouring agents included in the 50 mg capsule shells are Patent blue (E131) and titanium dioxide (E171).
Colouring agents included in the 200 mg capsule shells are Ponceau 4R (E124), Patent blue (E131), indigo carmine (E132) and titanium dioxide (E171).
The ink used to print ‘FCZ 50’ and ‘FCZ 200’ 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
Fluconazole 50 mg Capsules: Each sky blue and white capsule contains 50 mg fluconazole. They have ‘FCZ 50’ printed on them.
Fluconazole 200 mg Capsules: Each dark blue and white capsule contains 200 mg fluconazole. They have ‘FCZ 200’ printed on them. Fluconazole 50 mg and 200 mg Capsules come in packs of 7 capsules.
Marketing Authorisation Holder
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom.
Manufacturer ro
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
Date: 31-07-15