Gyno-Pevaryl Cream

• 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. See section 4

1. What Gyno-Pevaryl is and what it is used for
2. What you need to know before you use Gyno-Pevaryl
3. How to use Gyno-Pevaryl
4. Possible side effects
5. How to store Gyno-Pevaryl
6. Contents of the pack and other information

• You are allergic to econazole nitrate or any of the other ingredients of this medicine (listed in section 6)
• You are allergic to any other medicine used to treat thrush or other fungal infections
• You are under 16 years old

Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Gyno-Pevaryl.

Talk to your doctor or pharmacist before using this medicine if:

• You are using any other treatment for your genitalia (vagina or penis)

Talk to your doctor about using another type of contraception while you are using this medicine if;

• You are using a ‘barrier’ method of contraception. This includes condoms or diaphragms. This is because Gyno-Pevaryl can damage the rubber and stop them working properly.
• You are using a spermicidal contraceptive

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription or herbal medicines.

In particular tell your doctor if you are taking:

• Medicines to thin the blood (anticoagulants) such as warfarin or acenocoumarol. Your doctor may check that the anticoagulant is working properly.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You may still be able to use Gyno-Pevaryl if your doctor thinks you need to.

This medicine is not likely to affect you being able to drive or use any tools or machines.

Gyno-Pevaryl contains Benzoic Acid (E210) and Butylated hydroxyanisole (E320):

• Benzoic Acid (E210) – This medicine contains 30 mg of benzoic acid in each 15 g tube or 60 mg of benzoic acid in each 30 g tube, which is equivalent to 2 mg/g cream. Benzoic acid may cause local irritation.
• Butylated hydroxyanisole (E320) - May cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

• Always wash your hands thoroughly before using this medicine. This is particularly important if you are pregnant
• If you are pregnant, you should use Gyno-Pevaryl without an applicator
• Use the cream once a day just before going to bed
• The cream is used inside and outside of your vagina
• Place an applicatorful (about 5 g) of cream into your vagina
• Also lightly cover your vagina and the skin around your vagina with a thin, even layer of cream
• Keep using the cream for 14 days

Gyno-Pevaryl does not include a vaginal applicator. It can be bought separately at the chemist.

• Use the cream once a day
• Lightly cover the penis and the skin around the penis (including under your foreskin if you have one) with a thin, even layer of cream
• Keep using the cream for 14 days

Keep using the cream until the course is finished (14 days). Do this, even if the soreness, itching and discharge go away before 14 days.

If a large amount of cream is eaten or swallowed talk to a doctor or go to the nearest hospital casualty department straight away.

• Sudden swelling of the face or throat. Hives (also known as nettle rash or urticaria), severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction (affects fewer than 1 in 10,000 people)

Common side effects (affects more than 1 in 100 patients)

• Itchy skin
• Burning sensation (skin)

Uncommon side effects (affects fewer than 1 in 100 patients)

• Rash
• Burning sensation (around or inside the vagina)

Rare side effects (affects fewer than 1 in 1000 patients)

• Reddening of your skin

Frequency unknown:

• Pain, swelling or irritation (around or inside the vagina)
• Inflammation of the skin (contact dermatitis)
• Peeling flaky skin

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.

The active substance in Gyno-Pevaryl is econazole nitrate. The cream contains 1% econazole nitrate.

The other ingredients are Tefose 63, labrafil M 1944 CS, mineral oil, butylated hydroxyanisole (E320), benzoic acid (E210), purified water.

The cream is white and comes in a 15 g or 30 g white and blue aluminium tube.

The Marketing Authorisation is held by:

Gyno-Pevaryl is made by: