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Sainsburys Pharmacy Fluconazole 150mg Capsule

Document: leaflet MAH GENERIC_PL 16028-0108 change

[Product Name]

(Fluconazole)

Package Leaflet: Information For the user

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take this medicine carefully to get the best results from it.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve after 7 days.

•    If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What this medicine is and what it is used for

2.    Before you take this medicine

3.    How to take this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Further information

1. What this medicine is and what it is used for

[Product name] is the brand name of this medicine. Each capsule contains 150mg of the active substance fluconazole.

Fluconazole belongs to a group of drugs called antifungal agents and is used to treat infections such as thrush.

Fluconazole is used to treat:

• Female vaginal thrush, and can also be used by your partner if he has thrush on his penis.

Thrush is caused by a yeast called Candida albicans, which lives problem free in the bodies of many women, but occasionally the natural balance that keeps the yeast under control is disturbed and this results in an infection.

Vaginal Thrush

The most common symptoms are:

•    itching around the outside of the vagina

•    soreness which becomes worse with rubbing and scratching

•    a white, non-smelling discharge from the vagina.

Not every woman who has thrush will have all of these symptoms.

To help prevent thrush coming back it is advised that you:

•    wash regularly

•    gently dry yourself, as rubbing and scratching can aggravate thrush

•    avoid tight synthetic clothing

•    wear cotton underwear, stockings and loose fitting clothes

•    avoid perfumed soaps and bath additives

•    change your sanitary protection frequently.

Thrush may be aggravated by sexual intercourse. Thrush is not VD and is not usually passed on by sexual contact. However, thrush can be passed to your partner through sexual intercourse. If your thrush was successfully treated but keeps coming back, it is advised your partner is seen by a doctor.

Penile Thrush (Candidal Balanitis)

It is important to note that only the male partners of affected women should take this medicine.

The most common symptoms are:

•    soreness and redness of the penis

•    tightness of the foreskin

•    an abnormal penile discharge.

Not every man who has thrush on his penis will have all of these symptoms.

2. Before you take this medicine Do NOT take this medicine if you:

•    are allergic (hypersensitive) to fluconazole, any of the other ingredients of this medicine or any antifungals and thrush treatments

•    are taking terfanadine or cisapride. (See section “Taking other medicines”).

Take special care with this medicine

Do NOT use this medicine without first talking to your doctor if:

•    you are under 16 or over 60 years of age

•    you are taking any other medication other than “the Pill” (oral contraceptives)

•    you have had thrush more than twice in the last six months

•    you have any disease affecting your liver or kidneys or if you have had unexplained jaundice

•    you suffer from any other chronic disease or illness

•    you or your partner have had exposure to a sexually transmitted disease

•    you are unsure about the cause of your symptoms.

Women only:

•    you have abnormal or irregular vaginal bleeding or a blood stained discharge

•    you have vaginal or vulval sores, ulcers or blisters

•    you are experiencing lower abdominal pain or a burning sensation on passing urine

•    you are pregnant, trying to become pregnant or are breast-feeding.

Men only:

•    your sexual partner does not have thrush

•    you have penile sores, ulcers or blisters

•    you have an abnormal penile discharge (leakage)

•    your penis has started to smell

•    you have pain on passing urine.

Taking other medicines

Do NOT take this medicine if you are taking:

•    terfenadine, an antihistamine

•    cisapride used for stomach upsets.

Talk to your doctor if you are taking any of the following:

•    rifampicin, rifabutin (antibiotics)

•    diuretics (“water tablets”) such as hydrochlorothiazide

•    anticoagulants such as warfarin which prevents blood clots

•    sulphonylureas e.g. chlorpropamide, glibenclamide, glipizide and tolbutamide

•    phenytoin (used to control epilepsy)

•    ciclosporin or tacrolimus (used to reduce the effect of the immune system e.g. to prevent the rejection of an organ transplant or graft)

•    theophylline (used to increase the air flow to the lungs and improve breathing)

•    zidovudine (used in HIV-positive patients)

•    astemizole (an antihistamine).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Important information about some of the ingredients of this medicine

•    Patients who are intolerant to lactose should note that this medicine contains a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Taking this medicine with food and drink

•    This medicine does not interact with alcohol, and may be taken with or without food, at any time of the day.

Pregnancy and Breast-feeding

•    Do NOT take this medicine if you are pregnant, planning to become pregnant or are breast-feeding.

•    This medicine should not be used in women of child bearing age unless adequate contraception is used.

Driving and using machines

•    This medicine is not expected to affect your ability to drive or operate machinery.

3. How to take this medicine

If your doctor has prescribed this medicine, always take this medicine exactly as your doctor has told you. Otherwise, follow the instructions below.

If you are not sure how to take this medicine, talk to your doctor or pharmacist.

The capsule should be swallowed whole with a drink of water.

   Adults (aged 16 to 60 years of age)

One 150mg capsule is the complete course of treatment.

   The Elderly

This medicine is not recommended for use in patients over 60 years of age.

   Children

This medicine is not recommended for use in children under 16 years of age.

How quickly will the treatment start to work?

•    Your condition should begin to clear up within two days. For some women the effect can be noticed in one day

•    If your condition does not improve after seven days, you should tell your doctor

•    You should not take another capsule unless thrush recurs after seven days or more.

   If the thrush recurs more than twice within six months, you should see your doctor.

If you take more of this medicine than you should

If you (or someone else) swallow a lot of the capsules all together, or if you think a child has swallowed any of the capsules, contact your nearest hospital casualty department or your doctor immediately.

Please take this leaflet, any remaining capsules, and the container with you to the hospital or doctor so that they know which capsules were consumed.

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

4. Possible side effects

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

Stop taking the capsules and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens:

•    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

If you experience an allergic reaction or rash after you take this medicine, you should never take it again.

The most commonly reported side effects are:

•    stomach pain

•    diarrhoea

•    wind

•    feeling sick.

The following side effects have been reported rarely:

•    liver problems

•    headache

The following side effects have also been reported rarely, but may not be directly due to using this medicine:

•    hair loss

•    skin reactions

•    blood disorders

•    fits.

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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store this medicine

Keep out of the sight and reach of children. Do not store above 30°C. Do not transfer the capsule to another container. Do not use this medicine after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Further Information

What this medicine contains:

•    The active ingredient is fluconazole.

•    The other ingredients are lactose, maize starch, colloidal anhydrous silica, sodium laurilsulfate and magnesium stearate. The capsule shell contains gelatin and the colours brilliant blue (E133) and titanium dioxide (E171).

What this medicine looks like and contents of the pack:

•    Hard gelatine capsules filled with white to yellowish white homogeneous powder, with a light blue opaque cap and light blue opaque body.

•    This medicine is available in a blister pack containing one 150mg capsule.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder is: Galpharm Healthcare Limited, Wrafton, Braunton, Devon, EX33 2DL, United Kingdom..

The company responsible for manufacture is: TEVA UK Limited, Eastbourne BN22 9AG. This leaflet was last revised: April 2014

PL 16028/0108