Document: Fluconazole Accord capsule, hard ENG PL change

• Fluconazole Accord capsule, hard PL
• Fluconazole Accord capsule, hard ENG PL

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Package leaflet: Information for the user

Fluconazole Accord 50 mg hard capsule

Fluconazole Accord 100 mg hard capsule

Fluconazole Accord 150 mg hard capsule

Fluconazole Accord 200 mg hard capsule

(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 or pharmacist.

• 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 or pharmacist.This includes any possible side effects not listed in this leaflet.

What is in this leaflet

Fluconazole Accord is one of a group of medicines called “antifungals”. The active substance is fluconazole. Fluconazole Accord 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 type 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 Accord to:

• stop cryptococcal meningitis from coming back

• stop mucosal trush from coming back

• reduce recurrence of vaginal trush

• 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

Do not take Fluconazole Accord 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

• are taking astemizole, terfenadine (antihistamine medicines for allergies)

• are taking cisapride (used for stomach upsets)

• are taking pimozide (used for treating mental illness)

• are taking quinidine (used for treating heart arrhythmia)

• are taking erythromycin (an antibiotic for treating infections)

Warnings and precautions

Talk to your doctor or pharmacist before taking Fluconazole Accord if you

• have liver or kidney problems

• suffer from heart disease, including heart rhythm problems

• have abnormal levels of potassium, calcium or magnesium in your blood.

• develop severe skin reactions (itching, reddening of the skin or difficulty in breathing).

Other medicines and Fluconazole Accord

Tell your doctor immediatelyif 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 Accord (see section: "Do not take Fluconazole Accord if you").

There are some medicines that may interact with Fluconazole Accord. 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)

• 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

• 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)

• vitamin A (nutritional supplement)

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Fluconazole Accord 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 Accord while you are pregnant or breast-feeding unless your doctor has told you to.

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

Driving and using machines

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

Fluconazole Accord contains lactose monohydrate

This medicine contains lactose monohydrate (a type of 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.

Always take this medicine exactly as your doctor or pharmacist 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.

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 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 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	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 trush	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.

Condition	Daily dose
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 (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 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 change your dose, depending on your kidney function.

If you take more Fluconazole Accord 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 Accord

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, this medicine can cause side effects, although not everybody gets them.

A few people develop allergic reactionsalthough serious allergic reactions are rare. 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 Accord 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 Accord 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 (affect 1 to 10 users in 100) side effects are listed below:

• headache

• stomach discomfort, diarrhoea, feeling sick, vomiting

• increases in blood tests of liver function

• rash

Uncommon (affect 1 to10 users in 1,000) side effects are listed below:

• 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 (affect 1 to 10 users in 10,000) side effects are listed below:

• 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

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Fluconazole Accord

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

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

• Store below 30C. Store in the original package in order to protect from moisture.

• 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. Contents of the pack and other information

What Fluconazole Accord contains

The active substance is fluconazole. Each hard capsule contains 50 mg, 100mg, 150mg or 200 mg of fluconazole.

The other ingredients are lactose monohydrate, maize starch, sodium laurilsulfate, colloidal silica anhydrous and magnesium stearate.

Capsule shell:

50 mg:

Gelatin

Titanium dioxide (E171)

Indigo Carmine (E132)

Iron oxide yellow (E172)

100 mg and 150 mg:

Gelatin

Titanium dioxide (E171)

Patent blue V (E131)

200 mg:

Gelatin

Titanium dioxide (E171)

What Fluconazole Accord looks like and contents of the pack

50 mg: Capsule shell: Size 4, white body and green cap.

100 mg: Capsule shell: Size 2, white body and blue cap.

150 mg: Capsule shell: Size 1, blue body and blue cap.

200 mg: Capsule shell: Size 0, white body and white cap.

Fluconazole Accord Capsules are available in PVC-Aluminium blister packs.

50 mg and 200 mg capsules

Pack size of 7, 14, 20, 28, 50, 100 hard capsules

100 mg capsules

Pack size of 7, 10, 20, 28, 50, 60, 100 hard capsules

150 mg capsules

Pack size of 1, 2, 4, 6, 10 hard capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Accord Pharmaceuticals Limited

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, United Kingdom

Manufacturer

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names:

Name of the Member State	Name of the medicinal product
Belgium	Fluconazole Accord 50/100/150/200 mg Capsules, hard/ gélule/ hartkapseln
Denmark	Fluconazol Accord 50/100/150/200 mg kapsler hårde
Germany	Fluconazol Accord 50/100/150/200 mg Hartkapseln
Ireland	Fluconazole 50/150/200 mg Hard capsules
Italy	Fluconazolo Accord 50/100/150/200 mg capsule rigide
Netherlands (The)	Fluconazol Accord 50/100/2/150/200 mg capsules, hard
Poland	Fluconazol Accord 50/100/150/200 mg kapsułki twarde
Sweden	Fluconazole Accord

This leaflet was last revised in 2015-07-13