Fluconazole 150mg Capsule
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AXP044FUC PATIENT INFORMATION LEAFLET
Fluconazole 150mg Capsules
The name of this medicine is Fluconazole 150mg Capsules, which will be referred to as Fluconazole Capsules throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
This medicine is available without a prescription. However you still need to take Fluconazole Capsules carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- Ask your pharmacist if you need more information or advice.
- 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.
In this leaflet
1. What Fluconazole Capsules are and what they are used for
2. What you need to know before you take Fluconazole Capsules
3. How to take Fluconazole Capsules
4. Possible side effects
5. How to store Fluconazole Capsules
6. Contents of the pack and other Information
1. WHAT FLUCONAZOLE CAPSULES ARE AND WHAT THEY ARE USED FOR
The active ingredient in your medicine is fluconazole, which belongs to a group of medicines called anti-fungals. These are used to treat infections caused by fungi (including yeasts such as one called Candida).
Adults
You might be given this medicine by your doctor to treat the following types of fungal infections:
- Cryptococcal meningitis - a fungal infection in the brain
- Coccidioidomycosis - a disease of the bronchopulmonary system
- Infections caused by Candida and found in the blood stream, body organs (e.g. heart, lungs) or urinary tract
- Mucosal thrush - infection affecting the lining of the mouth, throat and denture sore mouth
- Genital thrush - infection of the vagina or penis
- Skin infections - e.g. athlete's foot, ringworm, jock itch, nail infection 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 might also be given fluconazole to:
- stop you from getting an infection caused by Candida (if your immune system is weak and not working properly).
- stop cryptococcal meningitis from coming back
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCONAZOLE CAPSULES
Do not take Fluconazole Capsules without first asking your pharmacist or doctor if you:
• are or have ever been told that you are allergic to fluconazole or to other drugs of the same type (called triazoles) that are used to treat fungal infections. The symptoms may include itching, reddening of the skin or difficulty in breathing.
• are allergic to any of the other ingredients in these capsules
• are taking the medicines terfenadine or astemizole (antihistamines for the relief of allergies such as hay fever)
• are taking cisapride (used for stomach upsets)
• are taking quinidine to control your heart rate or rhythm
• are taking pimozide (for treating schizophrenia)
• are taking erythromycin (an antibiotic for treating infections)
Warnings and precautions
Talk to your doctor or pharmacist before taking fluconazole if you:
• are aged under 16 years
• have liver or kidney problems
• suffer from heart disease including heart rhythm problems
• have abnormal levels of potassium, magnesium or calcium in your blood
• develop severe skin reactions (itching, reddening of the skin or difficulty in breathing)
Other medicines and fluconazole
Tell your doctor or pharmacist, immediately if you are taking terfenadine or astemizole (an antihistamine for treating allergies) or cisapride (used for stomach upsets) or pimozide (used for treating mental illness) or quinidine (used for treating heart arrhythmia) as these should not be taken with Fluconazole Capsules.
There are some medicines that may interact with Fluconazole Capsules.
Make sure your doctor knows if you are taking any of the following medicines:
• warfarin (or similar drugs) that thin the blood to prevent blood clots
• calcium channel blockers
• losartan, nifedipine, isradipine, amlodipine and felodipine (for lowering blood pressure)
• medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide
• vitamin A (nutritional supplement)
• fluvastatin, atorvastatin, simvastatin or similar medicines (statins for lowering cholesterol)
• benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety
• carbamazepine or phenytoin (used to control epilepsy)
• medicines for treating infections (antibiotics) such as azithromycin, erythromycin, rifampicin or rifabutin
• amphotericin B (used to treat fungal infections), voriconazole (anti-fungal)
• halofantrine (to treat malaria)
• ciclosporin, everolimus, sirolimus or tacrolimus (to prevent transplant rejection)
• theophylline (used to control asthma)
• oral contraceptives
• alfentanil, fentanyl (used as an anaesthetic)
• methadone (for treating pain)
• ibuprofen, celecoxib, flurbiprofen, naproxen, lornoxicam, meloxicam, diclofenac (Non Steroidal Anti-Inflammatory Drugs (NSAIDs))
• amitriptyline, nortriptyline (used to treat migraine)
• cyclophosphamide, or vinca alkaloids (vincristine, vinblastine or similar medicines) used for treating cancer
• saquinavir or zidovudine, also known as AZT (used in HIV-infected patients)
• prednisolone (steroid)
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It may still be alright for you to take Fluconazole Capsules and your doctor will be able to decide what is suitable for you.
Fluconazole with food and drink
Take the capsule with a sufficient quantity of liquid (e.g. one glass of water). Do not chew the capsule.
It can be taken before, with or after food.
Pregnancy, breast-feeding and fertility
You should not take Fluconazole Capsules while you are pregnant or if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Treatment with Fluconazole Capsules has occasionally lead to dizziness or seizures to occur and could affect your ability to drive or use machinery.
Important information about some of the ingredients of Fluconazole Capsules Fluconazole contains lactose.
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 CAPSULES
Always take Fluconazole Capsules exactly as your doctor has told you to do so. You should check with your doctor or pharmacist if you are not sure.
Swallow the capsule whole with a glass of water.
The usual doses of this medicine for different infections are below: Adults
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Condition |
Dose |
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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 |
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To stop cryptococcal meningitis from coming back |
200 mg once daily until you are told to stop |
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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 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 |
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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 |
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To stop mucosal infections affecting the lining of 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 |
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To treat genital thrush |
150 mg as a single dose |
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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 |
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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) |
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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 |
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) |
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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 |
Use in children 0 to 4 weeks of age
Use in children of 3 to 4 weeks of age:
The same dose as above but given once every 2 days. The maximum dose is 12 mg per kg of body weight every 48 hours.
Use in children less than 2 weeks old:
The same dose as above but given once every 3 days. The maximum dose is 12 mg per kg of body weight every 72 hours.
Doctors sometimes prescribe different doses to these. Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Elderly
The usual adult dose should be given unless you have kidney problems.
Patients with kidney problems
Your doctor may change your dose, depending on your kidney function.
Method of administration
This capsule is for oral use.
If you take more Fluconazole Capsules than you should:
If you have accidentally taken more than the recommended dose, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you.
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
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the dose that you missed.
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.
A few people develop allergic reactions although serious allergic reactions are rare. If you get any of the following symptoms, tell your doctor immediately.
• sudden wheezing, difficulty in breathing or tightness in the chest
• swelling of eyelids, face or lips
• itching all over the body, reddening of the skin or itchy red spots
• skin rash
• severe skin reactions such as a rash that causes blistering (this can affect the mouth and tongue)
• if you are an AIDS patient you are more likely to get severe skin reactions to drugs including Fluconazole Capsules.
Fluconazole may affect your liver. The following are signs of liver problems:
• tiredness
• loss of appetite
• vomiting
• yellowing of the skin and eyes (Jaundice)
If any of these happen, stop taking fluconazole and tell your doctor immediately.
Other side effects:
Common side effects which may affect more than 1 to 10 users are listed below:
• feeling sick
• stomach discomfort
• diarrhoea
• rash
• headache
• increase in blood tests in liver function
Uncommon side effects which affect 1 to 10 users in 1,000 are listed below:
• itching
• reduction in red blood cells which can result in weakness or breathlessness
• decreased appetite
• insomnia (difficulty in sleeping)
• somnolence (feeling sleepy)
• fit
• dizziness
• vertigo
• altered sense of taste
• constipation, difficult digestion, wind, dry mouth
• myalgia (muscle pain)
• wheals, blistering (hives), itching, increased sweating
• tiredness, general feeling of being unwell, fever Rare side effects which affect 1 to 10 users in 10,000 are listed below:
• lower than normal white blood cells that help defend against infections and blood cells that help to stop bleeding
• high blood levels of cholesterol, fats or salt
• low blood potassium
• red or purple discoloration of the skin which may be caused by low platelet count, other blood cell changes
• shakes
• liver damage
• liver failure
• hair loss
• change in heart rate or rhythm
• fatigue
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.
5. HOW TO STORE FLUCONAZOLE CAPSULES
Keep out of the sight and reach of children.
Do not take this medicine after the expiry date shown on the carton and blister strip. 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 or doctor.
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. CONTENTS OF THE PACK AND OTHER INFORMATION What Fluconazole Capsules contain:
The active ingredient is fluconazole. Each capsule contains 150mg of fluconazole.
The other ingredients are:
Lactose, 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 contains shellac (E904), dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol (E1520), strong ammonium hydroxide (E527), potassium hydroxide (E525) and black iron oxide (E172).
What Fluconazole Capsules looks like and the contents of the pack:
Fluconazole Capsules are sky blue. They are marked with 'FCZ 150' and 'NEO'.
Your medicine is available in a pack containing 1 capsule.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire,
NN8 6GT, UK.
Manufacturer responsible for batch release:
Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
This leaflet was prepared in July 2015.
AXP044FUC