Fluconazole 200 mg Capsules

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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is 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

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

Do not take Fluconazole Capsules

• if you are allergic to fluconazole, to other medicines you have taken to treat fungal infections or 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)

Warnings and precautions

Talk to your doctor or pharmacist before taking Fluconazole Capsules

• 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)
• if you develop 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)
• if the fungal infection does not improve, as alternative antifungal therapy may be needed
• if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Fluconazole Capsules

Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with Fluconazole Capsules treatment. Stop taking Fluconazole Capsules and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Other medicines and Fluconazole Capsules

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) as these should not be taken with Fluconazole Capsules (see section: “Do not take Fluconazole Capsules if you”).

There are some medicines that may interact with Fluconazole Capsules. 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, isradipine, amlodipine, verapamil, felodipine and losartan (for hypertension- high blood pressure)
• olaparib (used for treating ovarian cancer)
• ciclosporin, everolimus, sirolimus or tacrolimus (to prevent transplant rejection)
• cyclophosphamide, 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)
• tofacitinib (used for treating rheumatoid arthritis)
• tolvaptan used to treat hyponatremia (low levels of sodium in your blood) or to slow kidney function decline
• vitamin A (nutritional supplement)
• ivacaftor (used for treating cystic fibrosis)
• amiodarone (used for treating uneven heartbeats ‘arrhythmias’)
• hydrochlorothiazide (a diuretic)
• ibrutinib (used for treating blood cancer)

Fluconazole Capsules with food

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 Capsules if you are pregnant, think you may be pregnant, are trying to become pregnant or breast-feeding, unless your doctor has told you so. You can continue breast-feeding after taking a single dose of Fluconazole Capsules up to 150 mg. You should not breast-feed if you are taking a repeated dose of Fluconazole Capsules.

Fluconazole taken during the first trimester of pregnancy may increase the risk of miscarriage.

Fluconazole taken at low doses during the first trimester may slightly increase the risk of a baby being born with birth defects affecting the bones and/or muscles.

Ask your doctor or pharmacist for advice before taking any medicines.

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 contain lactose

This medicine contains a small amount of lactose (milk 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.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

Adults

• 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 once daily 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 from coming back: 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.

• 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 once daily (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 once daily
• To stop cryptococcal meningitis from coming back: 6 mg per kg of body weight once daily
• 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 once daily

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 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 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.

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 (may affect up to 1 in 10 people):

• headache
• stomach discomfort, diarrhoea, feeling sick, vomiting
• increases in blood tests of liver function
• rash

Uncommon side effects (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
• 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 (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, 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

Frequency not known, but may occur (cannot be estimated from the available data):

• hypersensitivity reaction with skin rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia) and inflammation of internal organs (liver, lungs, heart, kidneys and large intestine) (Drug Reaction or rash with Eosinophilia and Systemic Symptoms (DRESS))

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 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.

What Fluconazole Capsules contain

Your medicine is called Fluconazole 50 mg Capsules or Fluconazole 200 mg Capsules. The carton and blister foil will show the capsule strength.

• The active substance is fluconazole.
• Each hard capsule contains 50 mg or 200 mg of fluconazole.
• The other ingredients are:

Capsule content: lactose monohydrate, maize starch, colloidal anhydrous silica, magnesium stearate and sodium lauryl sulphate.

Capsule shell composition:

50 mg capsules: gelatin, patent blue (E131) and titanium dioxide (E171) as colouring agents

200 mg capsules: gelatin, patent blue (E131), titanium dioxide (E171) and erythrosine (E127) as colouring agents.

Printing ink: The black printing ink contains shellac, propylene glycol and black iron oxide (E172).

What Fluconazole Capsules look like and content of the pack

The 50 mg capsules are blue/ white coloured capsules, printed with ‘RANBAXY’.

The 200 mg capsules are purple/ white coloured capsules, printed with ‘RANBAXY’.

Fluconazole Capsules are available in blister strips in packs of 7 or 28 capsules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturers