FLUCONAZOLE 50 MG CAPSULES HARD - patient leaflet, side effects, dosage

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 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

(an antibiotic for treating infections) 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 antidepressant)

• – 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)

• – olarapib (used for treating ovarian cancer)

• – 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 AntiInflammatory 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 (used to treat fluid retention)

• – ibrutinib (used for treating blood cancer)

Fluconazole with food and drink and alcohol

You can take your medicine with or without a meal.

Pregnancy and 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 if you are pregnant, think you may be pregnant, are trying to become pregnant or breast-feeding, unless your doctor has told you so. 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.

You can continue breast-feeding after taking a single dose of 150 mg Fluconazole.

You should not breast-feed if you are taking a repeated dose of Fluconazole.

Driving and using machines

When driving vehicles or using machines, it should be taken into account that occasionally dizziness or fits may occur.

Fluconazole capsule contains lactose monohydrate, a type of sugar. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

Fluconazole capsule contains sodium

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

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)

Warnings and precautions

Talk to your doctor or pharmacist before using 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).

• – 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 Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with Fluconazole treatment. Stop taking Fluconazole 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

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

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.

Instructions to remove the capsule from blister pocket:

Pushing the capsule pocket in its middle portion may cause deformation/ breakage of capsule as shown in Fig. A. In order to avoid such damage remove the capsule by pushing the capsule pocket at its edge as shown in Fig. B.

Fig. A

The recommended doses of this medicine for different infections are below:

Adults

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.

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 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 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 medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Fluconazole and seek medical attention immediately if you notice any of the following symptoms:

• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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 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 and tell your doctor immediately.

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) are :

• 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) are:

• 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) 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)
• 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 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 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.

Keep out of the sight and reach of children.

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.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

What Fluconazole contains

• The active substance is fluconazole.
• Each capsule contains 50 mg/100 mg/ 150 mg or 200 mg fluconazole.
• The other ingredients are lactose monohydrate, maize starch, sodium lauril sulfate, colloidal anhydrous silica and magnesium stearate.

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