PATIENT INFORMATION LEAFLET

Fluconazole 150 mg Capsule

| What you should know about your Fluconazole 150 mg Capsule |

This leaflet provides a summary of the information available on your medicine. Keep this leaflet. You may need to read it again. If you have any questions or are not sure about anything, ask your pharmacist.

| What is in your medicine? |

The sky blue capsule contains 150 mg fluconazole. It has ‘FCZ 150’ printed on it.

Other ingredients: Lactose, maize starch, colloidal anhydrous silica, talc, sodium lauryl sulphate and gelatin (capsule shells only). The colouring agents included in the capsule shells are Patent blue (E131) and titanium dioxide (E171). The ink used to print‘FCZ 150' contains black iron oxide (E172), shellac and propylene glycol.

Fluconazole 150 mg Capsules come in a pack containing 1 capsule.

| Uses|

The active substance fluconazole is one of a group of medicines called anti-fungals which are used to treat infections caused by fungi (including yeasts such as one called Candida).

Single fluconazole 150mg capsules may be bought from your pharmacist (chemist) for the treatment of vaginal thrush in women and thrush infections of the skin around the tip of the penis in men (including under the foreskin in uncircumcised men). These infections are due to a yeast that is called Candida. The medical names for these conditions are vaginal candidiasis in women and candidal balanitis in men. The single 150mg dose treatment is suitable only for treating these specific infections in men and women. It is not enough to treat other infections caused by fungi (yeasts and moulds).

You should take a Fluconazole 150mg Capsule only if you are sure that you have a thrush infection in the vagina or on the penis. Remember that other infections can cause similar symptoms to thrush and that you could have more than one type of infection at the same time. If you are in any doubt that you have thrush or think you could have another infection at the same time, you should see your doctor before you take fluconazole.

Thrush infections can be passed between sexual partners during intercourse. If you are going to take a Fluconazole 150mg Capsule to treat your infection, you should ask your partner if he/she also has symptoms of thrush. If so, you should both take the treatment at the same time otherwise the untreated partner can continue to cause infections in the other partner. If one partner does not have any symptoms of thrush, it is still possible that they have Candida in the vagina or on the penis so they might still cause repeated infections in the other partner if not treated.

| Before taking your medicine |

Do not use this Fluconazole 150 mg Capsule without first asking your pharmacist or doctor if:

•    You are under 16 or over 60 years of age.

•    You are or have ever been told that you are allergic to fluconazole or to other drugs of the same type (called triazoles) that are used to treat fungal infections.

•    You are allergic to any of the other ingredients in these capsules. Although the capsules contain lactose, the amount is not thought likely to cause symptoms in people with lactose intolerance.

•    You are taking the medicines terfenadine or astemizole (antihistamines for the relief of allergies such as hay fever) or cisapride (used for certain digestive problems). Fluconazole must not be taken by people who are taking one of these medicines because there is a risk of a serious rhythm disturbance of the heart.

•    You take medicine(s) to control your heart rate or rhythm. These include quinidine, amiodarone, sotalol, disopyramide, but there are many others so check with your doctor or pharmacist before you take fluconazole.

•    You have a very slow heart rate, a serious heart rhythm disturbance or heart failure. Also, have you ever been told that you have a long QT interval (a type of heart rhythm disturbance that is found on ECG’s)?

•    You suffer from low levels of potassium or magnesium in your blood.

•    You have a serious ongoing illness, such as cancer, or severe problems with your body, liver or kidneys. Fluconazole is particularly likely to cause changes in blood test results in such people.

•    You have AIDS. You can still take fluconazole but be aware that people who have AIDS are more likely to develop very severe skin reactions to fluconazole.

•    You developed problems with your liver while taking fluconazole previously. If so, you should not take fluconazole to treat vaginal thrush.

Women Only:

•    You are pregnant or trying to become pregnant or are breast feeding (see below).

•    You have any abnormal or irregular vaginal bleeding or a blood stained discharge.

•    You have vulval or vaginal sores, ulcers or blisters.

•    You are experiencing lower abdominal pain or burning on passing urine.

Men Only:

•    Your sexual partner does not have vaginal thrush.

•    You have penile sores, ulcers or blisters.

•    You have an abnormal penile discharge (leakage).

•    Your penis has started to smell.

•    You have pain passing urine.

If any of the above points apply to you now, applied to you in the past, or if you are unsure about anything, please ask your pharmacist before you take fluconazole. It may also be necessary to check with your doctor.

Pregnancy and breastfeeding

Pregnant women should not take fluconazole for treating vaginal thrush because it may harm the growth of the unborn baby. Pregnant women are given fluconazole only if they have a very serious fungal infection that must be treated immediately.

Fluconazole enters breast milk so women who are breastfeeding should not take fluconazole to treat vaginal thrush.

Driving or using machines

Occasionally dizziness or fits can occur in people taking fluconazole so care should be taken when driving or operating machinery.

Please read the back of this leaflet.

VERSION 3 (DEC 2011)