Patient leaflet - Fluconazole 50 mg capsules
1. WHAT FLUCONAZOLE CAPSULES ARE AND WHAT THEY ARE USED FOR
Fluconazole belongs to a group of medicines called “antifungal”.
Fluconazole Capsules is used to treat infections caused by fungi and may also be used to stop you from getting candida infection. The most common cause of fungal infection 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 capsules 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 capsules 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
If you have any doubts about whether you should take these capsules then discuss with your doctor before taking them.
Do not take Fluconazole Capsules
- 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 (antihistamines medicines for allergies)
- if you are taking cisapride (used for stomach upset),
- if you are taking primozide (used for treating mental illness)
- if you are taking quinidine (used treating heart arrhythmia)
- if you are taking erythromycin (an antibiotic for treating infections)
Warnings and precautions
Talk to your doctor or pharmacist before taking Fluconazole Capsules
- if you have liver or kidney problems
- develop 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)
- if you signs of ‘adrenal insufficiency’ where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic, or long lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)
Other medicines and fluconazole
Tell your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for treating allergies) or cisapride (used for stomach upsets) or primozide (used for treating mental illness) or quinidine (used for treating heart arrhythmia) or erythromycin(an antibiotic for treating infections) as these should not be taken with Fluconazole capsules. (see section “Do not take Fluconazole capsules if you”).
Other medicines and Fluconconazole
This medicine 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) • 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,verapamil, 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 (Non-Steroidal 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) • ivacaftor (used for treating cystic fibrosis) • amiodarone (used for treating uneven heartbeats ‘arrhythmias’) • hydrochlorothiazide (a diuretic)
Tell your doctor or pharmacist if you are taking, or have recently taken any other medicines.
Fluconazole capsules with food and drink
You can take your medicine with or without a meal.
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.
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 capsules up to 200 mg.
You should not breast-feed if you are taking a repeated dose of fluconazole capsules
Driving and using machines
When driving vehicles or using machines, it should be taken into account that occasionally dizziness or fits may occur.
Fluconazole contains lactose (milk sugar)
This medicine contains small amount of lactose monohydrate (milk sugar). If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE FLUCONAZOLE CAPSULES
Always take Fluconazole capsules exactly as directed by your doctor or pharmacist has told you. .you should check with your doctor or pharmacist if you are not sure.
Swallow the capsules whole with a glass of water. It is best to take your capsules at the same time each day.
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 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 |
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 |
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.
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 capsules than you should:
Taking too many capsules at once may make you unwell. Contact your doctor or your nearest 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 treatments (with supportive measures and gastric lavage if necessary) may be adequate.
If you forget to take Fluconazole capsules:
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines Fluconazole 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 a s that causes blistering (this can affect the mouth and tongue).
Fluconazole capsules 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)
Other Possible 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 (may affect up to 1 in 10 people) are:
- headache,
- rash
- stomach pain or discomfort, , diarrhoea (feeling sick, vomiting)
- increases in blood test of liver
Uncommon side effects (may affect up to 1 in 100 people) are:
- reduction in red blood cells which can make skin pale and cause weakness or breathlessness
- decreased appetite, changes in sense of taste
- inability to sleep, feeling drowsy
- fit, dizziness , sensation of spinning (vertigo), tingling, pricking or numbness,
- constipation, difficult digestion, dry mouth, flatulence (wind)
- muscle pain, feeling weak
- 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 (may affect up to 1 in 1,000 people) are:
- 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)
- shaking, trembling of the body
- 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
- low blood potassium symptoms include muscle weakness, muscle cramps, palpitations/irregular heartbeats
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 national reporting system listed in the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA yellow card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE FLUCONAZOLE CAPSULES
There are no special storage requirements.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label or carton after EXP.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist to throw away medicines you no longer require. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Fluconazole capsules contain:
The ingredient which makes the capsule work is fluconazole.
The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinised maize starch, colloidal silica dioxide, magnesium stearate and sodium lauryl sulphate. The capsule shell contains titanium dioxide (E171), quinoline yellow (E104), yellow iron oxide (E172), patent blue V (E131) and gelatin.
What Fluconazole capsules look like and content of the pack
Fluconazole 50mg capsules are green and white.
Fluconazole 200mg capsules are white capsules.
Fluconazole 50mg and 200mg capsules come in packs of 7 seven capsules.
Marketing authorisation holder and Manufacturer
Medreich PLC, Warwick House,
Plane Tree Crescent,
Feltham,
TW13 7HF.
Email: info@medreich.co.uk
To listen to or request a copy of this leaflet in Braille, large print or audio please call,
02088311580 (UK only)
Please be ready to give the following information:
Product name Reference number
Fluconazole 50mg Capsules PL 21880/0134
Fluconazole 200mg Capsules PL 21880/0136
This leaflet was last revised in 12/2017.