Fluconazole 50 Mg Capsules
Package leaflet: Information for the user
Teva Fluconazole 50 mg, 100 mg, 150 mg and 200 mg Capsules
(fluconazole)
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 further questions, ask your doctor or 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
1. What Fluconazole is and what it is used for
Fluconazole is one of a group of medicines called "antifungals". The active substance is fluconazole.
Fluconazole is used to treat infections caused by fungi and may also be used to stop you from getting a candidal infection. The most common cause of fungal infections is a yeast 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 trush from coming back
• reduce recurrence of vaginal trush
Only marketed pack sizes will be included in the printed version of the PIL
• 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 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). The symptoms may include itching, reddening of the skin or difficulty in breathing.
• If you are taking astemizole, terfenadine (antihistamine medicines for allergies)
• If you are taking cisapride (used for stomach upsets)
• If you are taking pimozide (used for treating mental illness)
• If you are taking quinidine (used for treating heart arrhythmia)
• If you are taking erythromycin (an antibiotic for treating infections)
• If you are taking amiodarone (used for treating heart problems)
Warnings and precautions
Talk to your doctor or pharmacist before taking Fluconazole
• If you have liver or kidney problems
• If you suffer from heart disease, including heart rhythm problems
• If you have abnormal levels of potassium, calcium or magnesium in your blood.
• If you develop severe skin reactions (itching, reddening of the skin or difficulty in breathing).
Other medicines and Fluconazole
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor immediately if you are taking astemizole, terfenadine (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) or erythromycin (an antibiotic for treating infections) or amiodarone (used for treating heart problems) as these should not be taken with Fluconazole (see section: “Do not take Fluconazole if you”).
There are some medicines that may interact with fluconazole. Make sure your doctor knows if you are taking any of the following medicines:
• rifampicin or rifabutin (antibiotics for infections)
• alfentanil, fentanyl (used as anaesthetic)
• amitriptyline, nortriptyline (used as anti-depressant)
• amphotericin B, voriconazole (anti-fungal)
Only marketed pack sizes will be included in the printed version of the PIL
• medicines that thin the blood to prevent blood clots (warfarin or similar medicines)
• benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety
• carbamazepine, phenytoin (used for treating fits)
• nifedipine, isradipine, amlodipine felodipine and losartan (for hypertension- high blood pressure)
• ciclosporin, everolimus , sirolimus or tacrolimus (to prevent transplant rejection)
• cyclosphosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for treating cancer
• halofantrine (used for treating malaria)
• statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used for reducing high cholesterol levels
• methadone (used for pain)
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (NonSteroidal Anti-Inflammatory Drugs (NSAID))
• oral contraceptives
• prednisone (steroid)
• zidovudine, also known as AZT; saquinavir (used in HIV-infected patients)
• medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide
• theophylline (used to control asthma)
• vitamin A (nutritional supplement)
• hydrochlorothiazide (a ‘water pill’)
Fluconazole with food and drink
You can take your medicine with or without a meal.
Pregnancy and breast-feeding
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.
Driving and using machines
When driving vehicles or using machines, it should be taken into account that occasionally dizziness or fits may occur.
Fluconazole capsules contains Lactose and Azorubine (E122)
• Fluconazole capsules contain a small amount of lactose (milk 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.
• The 200 mg capsules also contain E122 (Azorubine), which can cause an allergic-type reaction, including asthma. This reaction is more common in those people who are allergic to aspirin.
3. How to take Fluconazole
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Swallow the capsule whole with a glass of water. It is best to take your capsules at the same time each day.
The capsules may be taken with or without a meal.
The usual doses of this medicine for different infections are below:
Only marketed pack sizes will be included in the printed version of the PIL
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 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 |
|
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 |
|
To treat genital thrush |
150 mg as a single dose |
|
To reduce recurrence of vaginal trush |
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 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 |
Only marketed pack sizes will be included in the printed version of the PIL
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.
If you take more Fluconazole than you should:
Taking too many capsules at once may make you unwell. Contact your doctor or your nearest hospital casualty department at once. 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 nearly time to take the next dose, do not take the dose that you missed.
If you stop taking Fluconazole
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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).
Fluconazole may affect your liver. The signs of liver problems include:
• Tiredness
• Loss of appetite
• Vomiting
• Yellowing of your skin or the whites of your eyes (jaundice)
• If any of these happen, stop taking Fluconazole Capsules and tell your doctor immediately.
Only marketed pack sizes will be included in the printed version of the PIL
Other side effects:
Additionally, if any of the following side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Common side-effects which may affect up to 1 to 10 people in 100 are listed below):
• Headache
• Rash
• Stomach discomfort, feeling sick, vomiting, diarrhoea
• Increases in blood tests of liver function.
Uncommon side effects which may affect up to 1 to 10 people in 1,000 are listed below:
• Reduction in red blood cells which can make skin pale and cause weakness or breathlessness
• Decreased appetite
• Inability to sleep, feeling drowsy
• Fit, dizziness, sensation of spinning, tingling, pricking or numbness, changes in sense of taste,
• Constipation, difficult digestion, wind, dry mouth
• Muscle pain
• Liver damage and yellowing of the skin and eyes (jaundice)
• Wheals, blistering (hives), itching, increased sweating
• Tiredness, general feeling of being unwell, fever
Rare side effects which may affect up to1 to 10 people 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
• Red or purple discoloration of the skin which may be caused by low platelet count, other blood cell changes
• Blood chemistry changes (high blood levels of cholesterol, fats)
• Low blood potassium
• Shaking
• Abnormal electrocardiogram (ECG), change in heart rate or rhythm
• Liver failure
• Allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reactions, swelling of the lips or face
• Hair loss
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 national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Fluconazole
Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Do not transfer the capsules to another container.
Do not use this medicine after the expiry date which is stated on the carton after ‘EXP’. The expiry date refers to the last day of that month.
Only marketed pack sizes will be included in the printed version of the PIL
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Fluconazole contains:
• The active substance is fluconazole 50 mg, 100 mg, 150 mg and 200 mg.
• The other ingredients are lactose monohydrate, maize starch, colloidal anhydrous silica, sodium laurilsulfate and magnesium stearate. The capsule shell contains gelatin and the following colours:
• 50, 100 and 150 mg capsules: titanium dioxide (E171) and brilliant blue (E133)
• 200 mg capsules: titanium dioxide (E171), azorubine (E122) and brilliant blue (E133).
What Fluconazole look like and contents of the pack:
• Fluconazole 50 mg are hard gelatine capsules with a light blue opaque cap and white opaque body.
• Fluconazole 100 mg are hard gelatine capsules with a blue opaque cap and white opaque body.
• Fluconazole 150 mg are hard gelatine capsules with a light blue opaque cap and light blue opaque body.
• Fluconazole 200 mg are hard gelatine capsules with a purple opaque cap and white opaque body.
• The 50 mg capsules are available in pack sizes * of 1, 7, 10, 20, 28, 30, 50, 100 and 500 capsules.
• The 100 mg capsules are available in pack sizes* of 7, 10, 28, 30, 50 (1x50), 60 and 100 capsules.
• The 150 mg capsules are available in pack sizes* of 1, 2, 4 and 12 capsules.
• The 200 mg capsules are available in pack sizes* of 1, 4, 7, 10, 12, 20, 30, 50 and 100 capsules.
Marketing Authorisation Holder and Manufacturer
To be completed nationally
This leaflet was last revised in: October 2015
Only marketed pack sizes will be included in the printed version of the PIL
This is a representation of an electronic record that was signed electronically and this
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE
Teva Pharmaceuticals Europe B.V 1.3.1 pil-eu-50mg-100mg-150mg-200mg clean
Approvals
|
Signed by |
Meaning of Signature |
Server Date |
|
Sneha Patel |
Regulatory Affairs Approval |
27-Oct-2015 10:00:02 AM |
REG0170866 Version 0.4 Approved Page 8 of 8