Fluconazole 200 mg capsules – patient leaflet, side effects, dosage

1. WHAT FLUCONAZOLE CAPSULES

ARE AND WHAT THEY ARE USED FOR

Fluconazole belongs to 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 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.

  1. 2. WHAT YOU NEED TO KNOW

BEFORE YOU TAKE FLUCONAZOLE CAPSULES

Do not take Fluconazole capsules

• If you are allergic to any of the ingredients of Fluconazole capsules (listed in section 6 of leaflet)
• If you are allergic to any other medicines that you have taken to treat a fungal infection. The symptoms may include itching, reddening of the skin or difficulty in breathing
• If you are taking terfenadine or astemizole (an antihistamine medicines for allergies)
• If you are taking cisapride (used for stomach upsets)
• If you are taking quinidine (used for treating heart arrhythmia).
• If you are taking pimozide (for treating a mental disorder (Schizophrenia).
• 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 are suffering from liver or kidney problems
• you are suffering from heart disease, including heart rhythm problems
• you have abnormal levels of potassium, calcium or magnesium in your blood
• you develop severe skin reactions (itching, reddening of the skin or difficulty in breathing)
• 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)
• the fungal infection does not improve, as alternative antifungal therapy may be needed
• 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 or have recently taken or might take any other medicines.

Tell your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for treating allergies), cisapride (used for stomach upsets), pimozide (used for treating mental illness), 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 other medicines that may interact with Fluconazole. Make sure your doctor knows if you are taking any of the following medicines as a dose adjustment or monitoring may be required to check that the medicines are still having the desired effect:

• rifampicin or rifabutin (antibiotics for infections)
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema)
• 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, felodipine and losartan (for hypertension- high blood pressure)
• olaparib (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 Anti-Inflammatory Drugs (NSAID))
• oral contraceptives
• prednisolone (steroids)
• 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 (alone or combined with other drugs used for treating uneven heartbeats ‘arrhythmias’)
• hydrochlorothiazide (a diuretic)
• ibrutinib (used for treating blood cancer)
• lurasidone (used to treat schizophrenia)

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.

If you are planning to become pregnant, it is recommended to wait a week after a single dose of fluconazole before becoming pregnant.

For longer courses of treatment with fluconazole, talk to your doctor on the need for appropriate contraception during treatment which

should continue for one week after the last dose.

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. If you become pregnant while

taking this medicine or within 1 week of the most recent dose, contact your doctor.

Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken during the first trimester may increase the risk of a baby being born with birth defects affecting the heart, bones and/or muscles.

There have been reports of babies born with birth defects affecting the skull, ears, and bones of the thigh and elbow in women treated for three months or more with high doses (400-800 mg daily) of fluconazole for coccidioidomycosis. The link between fluconazole and these cases is not clear.

You can continue breast-feeding after taking a single dose of Fluconazole capsules of 150 mg or less. You should not breast-feed if you are taking a repeated dose of Fluconazole capsules.

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

Driving and using machines

Fluconazole capsules occasionally cause dizziness or fits may occur which could affect your ability to drive or use machinery.

Important information about some of the ingredients

Fluconazole capsules contains lactose. If you have been told by your doctor that you have intolerance to some sugars, please contact your doctor before taking this medicine.

Fluconazole capsules contain less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

3. HOW TO TAKE FLUCONAZOLE CAPSULES

Always take your medicine exactly as your doctor has told you. You should 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 recommended doses of this medicine for different infections are below:

Adults

Condition Dose

To treat cryptococcal 400 mg on the first day meningitis 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 200 mg once daily until meningitis from coming you are told to stop back

To treat coccidioidomycosis 200 mg to 400 mg once daily from 11 months for up

(6029650) Date: 14/03/2024, 11/04/2024, (R) 24_06_2024

PACKAGE LEAFLET: INFORMATION FOR THE USER Fluconazole 50mg Capsules Fluconazole 200mg Capsules

(Fluconazole)

Front Side

to 24 months or longer if needed. Sometimes

doses are

increased up to 800 mg

To treat internal 800 mg on the first fungal day then 400 mg infections once daily until caused by you are told to stop Candida To treat mucosal 200 mg to 400 mg

infections on the first day affecting the then 100 mg to lining of mouth, 200 mg until you throat and denture are told to stop sore mouth

To treat mucosal thrush – 50 mg to 400 mg once dose depends on where daily for 7 to 30 days until the infection is located you are told to stop To stop mucosal infections 100 mg to 200 mg once affecting the lining of daily, or 200 mg 3 times a mouth, throat from coming week, while you are at risk back of getting an infection To treat genital thrush 150 mg as a single dose To reduce recurrence of 150 mg every third day for vaginal thrush 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 Depending on the site of skin and nail the infection 50 mg once infections 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 200 mg to 400 mg an infection caused by once daily while you are Candida (if your immune at risk of getting an system is weak and not infection

working properly)

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 3 mg per kg of body weight infections caused by (6 mg per kg of body Candida – dose and weight might be given on duration depends on the the first day)

severity of the infection

and on where the infection

is located

Cryptococcal meningitis 6 mg to 12 mg per kg of or internal fungal infections body weight

caused by Candida

To stop cryptococcal 6 mg per kg of body weight meningitis from coming once daily

back

To stop children from 3 mg to 12 mg per kg of getting an infection body weight

caused by Candida (if

their immune system is

not working properly)

Use in children 0 to 4 weeks of age

Use in children 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 modify 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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Fluconazole capsules 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 as a rash 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)

Stop taking Fluconazole capsules 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).

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: may affect up to 1 in 10 people

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

Uncommon: 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: 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

Not known: frequency 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: 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

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

Do not store above 25°C. Store in the original package.

Do not use this medicine after the expiry date stated on the label or carton after EXP. The expiry date refers to the last day of that month.

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Fluconazole Capsules contains

The active substance is Fluconazole.

The other ingredients are lactose monohydrate, maize starch, sodium lauryl sulphate, colloidal anhydrous silica, magnesium stearate, titanium dioxide (El71) and gelatin.

• In addition to these ingredients Fluconazole 50mg Capsules also contain yellow iron oxide (El72) and indigo carmine (E132). (see section 2 for Important information about some of the ingredients of Fluconazole Capsules).

What Fluconazole Capsules look like and contents of the pack

Fluconazole 50mg Capsules are hard gelatin capsules size 4, white/green capsules containing white crystalline powder.

Fluconazole 200mg Capsules are hard gelatin capsules size 0, white/white capsules containing white crystalline powder.

Fluconazole Capsules are available in blister packs of 7 capsules.

Marketing Authorisation Holder and Manufacturer

Accord Healthcare Limited,

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, United Kingdom

This leaflet was last revised in 06/2024.

(6029650) Date: 14/03/2024, 11/04/2024, (R) 24_06_2024

Back Side

INP113 10 1226 8 6029650