Fluconazole Leaflet 150mg 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 150mg Capsules are and what they are used for
2. What you need to know before you take Fluconazole 150mg Capsules
3. How to take Fluconazole 150mg Capsules
4. Possible side effects
5. How to store Fluconazole 150mg Capsules
6. Contents of the pack and other information

WHAT FLUCONAZOLE 150mg 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

WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCONAZOLE 150MG CAPSULES

Do not take Fluconazole 150mg capsules

• If you are allergic to any of the ingredients of Fluconazole 150mg 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 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
• 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)

Other medicines and Fluconazole 150mg 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 other 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 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 (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)

Fluconazole 150mg 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 capsules while you are pregnant unless your doctor has told you to.

You can continue breast-feeding after taking a single dose of Fluconazole capsules of 150mg. 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 150mg capsules occasionally causes dizziness or fits may occur which could affect your ability to drive or use machinery.

Important information about some of the ingredients

Fluconazole 150mg capsules contain a small amount of lactose (milk sugar). If you have been told by your doctor that you have intolerance to some sugars, please contact your doctor before taking this medicine.

HOW TO TAKE FLUCONAZOLE 150mg 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 usual doses of this medicine for different infections are below:

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 areincreased 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 orlonger if needed. Sometimes doses areincreased up to 800 mg
To treat internal fungal infections caused byCandida	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 from coming back	100 mg to 200 mg once daily, or200 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 of3 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 isreplaced)
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 theinfection 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 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

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.

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 150mg 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 150mg 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.

POSSIBLE SIDE EFFECTS

Like all medicines, Fluconazole 150mg 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 150mg 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)

If any of these happen, stop taking Fluconazole 150mg capsules 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, 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.

HOW TO STORE FLUCONAZOLE 150mg 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 your capsules after the expiry date stated on the label or carton.

Medicines should not be disposed of 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.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Fluconazole 150mg 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 (E l71), patent blue V (E 131)

and gelatin.(see section 2 for Important information about some of the ingredients of Fluconazole 150mg Capsules).

What Fluconazole 150mg Capsules looks like and contents of the pack

Fluconazole 150mg Capsules are blue/blue capsules containing white crystalline powder. Fluconazole 150mg Capsules are available in blister pack of 1 capsule.

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 04/2018.