FLUCONAZOLE 200 MG CAPSULES - patient leaflet, side effects, dosage

Fluconazole 50 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 any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you. 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 is and what it is used for

• 2. 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’.

Fluconazole is used to treat infections caused by fungi and may also be used to stop you from getting a candida 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 can 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

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 quin idine (used for treating heart arrhythmia)

• – if you are taking erythromycin (an antibiotic used to treat infections)

Warnings and precautions

Talk to your doctor or pharmacist before taking fluconazole

• – if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores fter

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)

• – 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.

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 immediately if you are taking astemizole, terfenadine (an histamine 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 (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 (antibiotic 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 (e.g. midazolam, triazolam or other 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, tacrolimus or sirolimus (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 (NSAIDs))
• 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 (usded to treat asthma)
• tofacitinib (used for treating rheumatoid arthritis)
• vitamin A (nutritional supplement)
• ivacaftor (used for treating cystic fibrosis)
• amiodarone (used for treating uneven heart beats ‘arrhythmias’)
• hydrochlorothiazide (a diuretic)
• ibrutinib (used for treating blood cacer)

Fluconazole 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 Fluconazoleif 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 150 mg Fluconazole.

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

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.

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 and azo colouring agents

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Fluconazole 200 mg capsules contain Ponceau 4R (E124), which may cause allergic reactions.

Information on sodium content of Fluconazole

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

3. how to take fluconazole

Always take your medicines exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Swallow the capsules whole with plenty of water. It is best to take your capsules at the same time each day.

The recommended doses of this medicine for different fungal infections are below.

Adults

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.

Daily dose

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 behavior). 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.

If you stop taking Fluconazol

It is important that you keep taking Fluconazole Capsules until the prescribed course is finished. Do not stop talcing the capsules just because you feel better. If you stop too soon, the infection may start up again.

4. possible side effects

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 functiion
• 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, 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 website: 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

Keep this medicine out of the sight and reach of children.

Do not take 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.

Store in the original package to protect from moisture.

Do not store above 25°C.

If you notice that the capsules are broken or have an odd colour, take them back to your pharmacist for advice before taking them.

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. CONTENT OF THE PACK AND OTHER INFORMATION

What Fluconazole contains

• – The active substance is fluconazole

• – Each capsule contains 50 mg or 200 mg of fluconazole.

• – The other ingredients are:

What Fluconazole looks like and contents of the pack

Fluconazole 50 mg Capsules have a white body and sky blue cap. They have ‘FCZ 50’ printed on them.

Fluconazole 200 mg Capsules have a white body and dark blue cap. They have ‘FCZ 200’ printed on them.

Fluconazole 50 mg and 200 mg Capsules come in packs of 7 capsules.

Marketing Authorisation Holder

Torrent Pharma (UK) Ltd.

3rd Floor, Nexus Building

4 Gatwick Road

Crawley

West Sussex

RH10 9BG

United Kingdom

Manufacturer

APC Pharmaceuticals & Chemicals (Europe) Ltd.

9th floor, C.P. House, 97 – 107 Uxbridge Road, Ealing, London W5 5TL

This leaflet was last revised in 07/2021.

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