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Diflucan 150mg Capsules

Document: leaflet MAH BRAND_PLPI 16369-0212 change

3. How to take Diflucan


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 thrush

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


PACKAGE LEAFLET- INFORMATION FOR THE USER DIFLUCAN® 150mg CAPSULE (fluconazole)

This product will be referred to as Diflucan throughout this leaflet.

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 Diflucan is and what it is used for

2.    What you need to know before you take Diflucan

3.    How to take Diflucan

4.    Possible side effects

5.    How to store Diflucan

6.    Contents of the pack and other information

1. What Diflucan is and what it is used for

Diflucan is one of a group of medicines called “antifungals”. The active substance is fluconazole.

Diflucan 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 Diflucan 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 Diflucan 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 Diflucan Do not take Diflucan

-    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 taking Diflucan

-    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)

Other medicines and Diflucan

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 Diflucan (see section: “Do not take Diflucan if you”).

There are some medicines that may interact with Diflucan. 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)

-    ivacaftor (used for treating cystic fibrosis)

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

Diflucan 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 Diflucan while you are pregnant unless your doctor has told you to.

You can continue breast-feeding after taking a single dose of Diflucan up to 200 mg.

You should not breast-feed if you are taking a repeated dose of Diflucan. Driving and using machines

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

Diflucan contains lactose (milk sugar)

This medicine contains a small amount of lactose (milk 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 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:

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.