Fluconazole 50mg Capsules
I cp.flc.jnt.c.pom.is.V5P2 PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Fluconazole is and what it is used for
2. What you need to know before you take Fluconazole
3. How to take Fluconazole
4. Possible side effects
5. How to store Fluconazole
6. Contents of the pack and other information
Fluconazole is one of a group of medicines called antifungal agents. Fluconazole is used to treat infections caused by fungi/ yeasts. The most common cause of fungal infection is yeast called Candida.
Adults
You may be given Fluconazole to treat fungal infections such as:
• Thrush of the mouth or throat (mucosal infections)
• Skin infections (e.g. athlete's foot, ringworm, nail infection)
• Internal (systemic) fungal infections caused by Candida, e.g. infections of the blood stream, urinary tract or other body organs
• Internal (systemic) fungal infections caused by Cryptococcus,
e.g. cryptococcal meningitis and infections of other sites such as the lungs and skin
• Genital Candida infections like vaginal thrush or candidal balanitis (inflammation of the end of the penis and/or foreskin)
• Coccidioidomycosis (disease of the bronchopulmonary system)
You might also be given Fluconazole to:
- stop cryptococcal meningitis from coming back
- stop mucosal thrush from coming back
- reduce recurrence of vaginal thrush
- stop you from getting an infection caused by Candida (if your immune system is weak and not working properly)
Children and adolescents (0 to 17 years old)
You might be given this medicine by your doctor to treat the following types of fungal infections:
- Mucosal thrush - infection affecting the lining of the mouth, throat
- Infections caused by Candida and found in the blood stream, body organs (e.g. heart, lungs) or urinary tract
- Cryptococcal meningitis - a fungal infection in the brain
You may also be given Fluconazole to:
• Stop you from getting a fungal infection (if your immune system is not working properly)
• Stop an infection caused by Cryptococcus from coming back
DO NOT TAKE FLUCONAZOLE IF YOU:
• are allergic (hypersensitive) to fluconazole, or another drug from the same group of antifungal drugs (i.e. imidazoles), or any of the other ingredients of Fluconazole Capsules (See section 6, Contents of the pack and other information)
• are taking another drug called terfenadine or astemizole (antihistamines), cisapride (a drug used to treat acid reflux, indigestion or decreased gastric motility), pimozide (a psychiatric medicine) or quinidine (for heart disease)
• are taking erythromycin (an antibiotic for treating infections)
• suffer from porphyria
If any of the above applies to you and you have not already discussed this with your doctor or pharmacist, you should do so as soon as possible and before taking Fluconazole Capsules.
Warnings and precautions
Talk to your doctor or pharmacist before taking Fluconazole if you:
• suffer from liver problems
• suffer from kidney problems
• suffer from heart problems, including heart rhythm problems
• have AIDS
• have imbalances in the salt levels in your blood
• have abnormal levels of potassium, calcium or magnesium in your blood
• have problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
• develop severe skin reactions (itching, reddening of the skin or difficulty in breathing)
If you have any of these conditions and you have not already discussed this with your doctor or pharmacist, you should do so as soon as possible and before taking this medicine.
Other medicines and fluconazole
Please tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines:
• rifampicin or rifabutin (types of antibiotics, often used for the treatment of tuberculosis)
• erythromycin or azithromycin (types of antibiotics)
• hydrochlorothiazide or eplerenone (types of diuretic or “water tablet”)
• drugs which thin the blood (known as anticoagulants, e.g. warfarin)
• medicines to help you sleep (such as benzodiazepines, e.g. midazolam or triazolam)
• medicines to treat diabetes (known as sulphonylureas, e.g. chlorpropamide, glibenclamide, glipizide, tolbutamide or nateglinide)
• ciclosporin, tacrolimus, everolimus or sirolimus (drugs which suppress the immune system, which are commonly used following organ transplants)
• zidovudine (AZT), nevirapine, ritanovir, tipranavir, aquinavir or saquinavir (antiviral drugs, used to treat HIV)
• cisapride (a drug used to treat acid reflux, indigestion or decreased gastric motility)
• drugs used to treat psychosis (e.g. pimozide, quetiapine, sertindole)
• anti-depressants (used to treat depression, e.g. amitriptyline, nortriptyline, citalopram, reboxetine and St. John's Wort)
• drugs used to treat cancer (such as vinca alkaloids e.g. vincristine and vinblastine)
• drugs used to treat migraine (such as ergot alkaloids e.g. ergotamine or methylsergide)
• drugs used to control levels of fat in your blood (e.g. atorvastatin, simvastatin or fluvastatin)
• calcium channel antagonists (e.g. nifedipine, amlodipine, nisoldipine, isradipine, felodipine)
• COX-II inhibitors (non-steroidal anti-inflammatory drugs e.g. ibuprofen, celecoxib, flurbiprofen, naproxen, lornoxicam, meloxicam, diclofenac, rofecoxib or parecoxib)
• cyclophosphamide (a drug used to treat cancer and suppress the immune system)
• antimalarial drugs such as artemether and lumefantrine
• bosentan (used to treat hypertension)
• losartan (used to treat high blood pressure)
• any other drugs used to treat fungal infection (e.g. amphotericin)
• prednisone (to treat serious inflammatory diseases)
• fentanyl (used to treat severe pain)
• halofantrine (used to treat malaria)
• phenytoin or carbamazepine (used to treat epilepsy)
• terfenadine or astemizole (types of antihistamines)
• ivabradine (used to treat angina)
• quinidine (an anti-arrhythmic heart drug)
• methadone (to help withdraw from heroin)
• vitamin A (a vitamin supplement)
• theophylline (a drug used to treat asthma)
• an oral contraceptive (the ‘Pill')
• alfentanil (an anaesthetic drug used in surgery)
• voriconazole (an antifungal drug)
• ivacaftor (for treatment of cystic fibrosis)
Pregnancy, breast-feeding and fertility
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. Fluconazole should not be used in pregnancy or in women of childbearing potential unless your doctor has told you to. You can continue breast-feeding after taking a single dose of Fluconazole up to 200mg. You should not breast-feed if you are taking a repeated dose of fluconazole.
Driving and using machines
Fluconazole Capsules are unlikely to affect your ability to drive or use machinery, however, when driving or operating machines it should be taken into account that occasionally dizziness or seizures may occur.
Important information about some of the ingredients in your medicine
Fluconazole Capsules contain lactose monohydrate, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
|
To stop mucosal infections affecting the lining of the mouth, throat |
100 mg to 200 mg once daily, or 200 mg 3 times a week, while you are at risk of getting an infection |
|
To treat genital thrush |
150 mg as a single dose |
|
To reduce recurrence of vaginal thrush |
150 mg every third day for a total of 3 doses (day 1, 4 and 7) and then once a week for 6 months while you are at risk of getting an infection |
|
To treat fungal skin and nail infections |
Depending on the site of the infection 50 mg once daily, 150 mg once weekly, 300 to 400 mg once weekly for 1 to 4 weeks (Athlete's foot may be up to 6 weeks, for nail infection treatment until infected nail is replaced) |
|
To stop you from getting an infection caused by Candida (if your immune system is weak and not working properly) |
200 mg to 400 mg once daily while you are at risk of getting an infection |
Use in children and adolescents
The capsules formulation may be unsuitable for children under 5-6 years of age.
Adolescents from 12 to 17 years old
Follow the dose prescribed by your doctor (either adults or children posology).
Children to 11 years old
The maximum dose for children is 400 mg daily.
The dose will be based on the child's weight in kilograms.
|
Condition |
Daily dose |
|
Mucosal thrush and throat infections caused by Candida - dose and duration depends on the severity of the infection and on where the infection is located |
3 mg per kg of body weight (6 mg per kg of body weight might be given on the first day) |
|
Cryptococcal meningitis or internal fungal infections caused by Candida |
6 mg to 12 mg per kg of body weight |
|
To stop children from getting an infection caused by Candida (if their immune system is not working properly) |
3 mg to 12 mg per kg of body weight |
The following side-effects are usually mild. However, if you suffer from any of these and they are severe or prolonged, please inform your doctor or pharmacist.
Common: may affect up to 1 in 10 people
• headache
• stomach discomfort, diarrhoea, feeling sick, vomiting
• increases in blood tests of liver function
• rash
Uncommon: may affect up to 1 in 100 people
• reduction in red blood cells which can make skin pale and cause weakness or breathlessness
• decreased appetite
• inability to sleep, feeling drowsy
• fits, dizziness, sensation of spinning, tingling, pricking or numbness, changes in sense of taste
• indigestion, wind, dry mouth, constipation
• muscle pain
• increased sweating
• tiredness, general feeling of being unwell, fever
• wheals, blistering (hives), itching
• liver damage and yellowing of the skin and eyes (jaundice)
Rare: may affect up to 1 in 1,000 people
• lower than normal white blood cells that help defend against infections and blood cells that help to stop bleeding
• red or purple discoloration of the skin which may be caused by low platelet count
• allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin rash, swelling of the lips and face
• oedema
• blood chemistry changes (high blood levels of cholesterol, fats)
• shaking
• abnormal electrocardiogram (ECG), change in heart rate or rhythm
• hair loss
• liver failure
• hepatitis
• low blood potassium Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.
■ HOW TO TAKE FLUCONAZOLE
Always take Fluconazole Capsules exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The capsules should always be taken with plenty of water. They can be taken with or without food. Your dose will be dependent on the type and severity of your infection, your age, weight and kidney function. Your doctor will choose the best dose for you.
Adults
|
Condition |
Dose |
|
To treat cryptococcal meningitis |
400 mg on the first day then 200 mg to 400 mg once daily for 6 to 8 weeks or longer if needed. Sometimes doses are increased up to 800 mg |
|
To stop cryptococcal meningitis from coming back |
200 mg once daily until you are told to stop |
|
To treat coccidioidomycosis |
200 mg to 400 mg once daily from 11 months for up to 24 months or longer if needed. Sometimes doses are increased up to 800 mg |
|
To treat internal fungal infections caused by Candida |
800 mg on the first day then 400 mg once daily until you are told to stop |
|
To treat mucosal infections affecting the lining of the mouth, throat and denture sore mouth |
200 mg to 400 mg on the first day then 100 mg to 200 mg until you are told to stop |
|
To treat mucosal thrush - dose depends on where the infection is located |
50 mg to 400 mg once daily for 7 to 30 days until you are told to stop |
Children under 4 weeks of age
In the first two weeks of life, the recommended dose for older children should be followed, but given every 72 hours. In weeks three and four, the recommended dose for older children should be followed, but given every 48 hours.
A maximum dose of 12mg/kg every 72 hours should not be exceeded during the first two weeks of life.
A maximum dose of 12mg/kg every 48 hours should not be exceeded during weeks three and four.
It is very important that you follow your doctor's instructions as to how many Fluconazole Capsules to take, how often to take them and for how long you should continue to take your capsules.
Fluconazole Capsules are not suitable for all dosages described in this leaflet. Other products containing fluconazole are available for this.
Elderly or patients with kidney problems
Your doctor will decide what dose to give you. This may be lower than the usual adult dose depending on your kidney function.
If you take more Fluconazole than you should
It is important to stick to the dose on the label of your medicine. If you or someone else swallows several of these capsules all together, contact your doctor, pharmacist or hospital emergency department immediately. Always take any capsules left over with you and also the box, as this will allow easier identification of the capsules. The symptoms of a possible overdose may include hearing, seeing, feeling and thinking things that are not real (hallucination and paranoid behaviour). Symptomatic treatment (with supportive measures and gastric lavage if necessary) may be adequate.
If you forget to take Fluconazole
If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose. If it is almost time for your next dose do not take the dose that you missed.
If you stop taking Fluconazole
Even when you start to feel better it is important for you to keep on taking your capsules for as long as your doctor tells you. If you stop too soon, the infection may start up again. Sometimes your doctor may want you to continue taking your capsules to prevent your infection from coming back.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Fluconazole Capsules can cause side effects, although not everybody gets them.
STOP taking Fluconazole Capsules straight away and contact your doctor immediately if you experience:
• a serious allergic reaction (anaphylaxis) or hypersensitivity including an itchy rash (hives), itching, sore mouth or eyes, fever, swelling of the face, lips, throat or tongue
• a sudden wheeziness or tightness of the chest
• liver problems such as yellowing of the skin or whites of the eyes (jaundice), dark coloured urine, tiredness, loss of appetite, vomiting or changes in the way your liver works (that may show up in blood tests)
• a severe skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson syndrome)
• a severe rash with reddening, peeling and swelling of the skin that looks like a burn (toxic epidermal necrolysis)
KEEP THIS MEDICEINE OUT OF THE SIGHT AND REACH OF CHILDREN.
No special storage conditions.
Do not use Fluconazole Capsules after the expiry date, which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines 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
What Fluconazole Capsules contain
The active substance is fluconazole. Each capsule contains 50mg or 200mg fluconazole.
The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, sodium lauryl sulphate, colloidal anhydrous silica and magnesium stearate.
The capsule shell contains:
50mg: titanium dioxide (E171), yellow iron oxide (E172), quinoline yellow (E104), patent blue V (E131) and gelatin.
200mg: titanium dioxide (E171) and gelatin.
What Fluconazole Capsules look like and contents of the pack
50mg: green and white capsules. In a blister pack of 7 capsules.
200mg: white capsules. In a blister pack of 7 capsules.
Marketing Authorisation Holder
Athlone Pharmaceuticals Limited, Ballymurray, Co.Roscommon, Ireland
Company responsible for release of this product
Kent Pharmaceuticals Ltd., Crowbridge Road, Ashford, Kent TN24 0GR, U.K. Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
Distributor
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K. PL 30464/0146 and PL 30464/0148
The leaflet was last revised July 2015.
CPFLC.JNTC.P0M.IS.V5P2