FUTASOLE 2%CREAM

FUTASOLE Ointment contains sodium fusidate. It is a type of antibiotic.

FUTASOLE Cream contains Fusidic acid. It is a type of antibiotic.

FUTASOLE works by killing germs (bacteria) that cause infections.

FUTASOLE is used to treat conditions where the skin is infected by germs (bacteria), such as:

•   Impetigo (a weeping, crusty and swollen patch of skin)

•   Infected dermatitis (inflammation of the skin) and spots

Infected cuts and grazes.

Do not use FUTASOLE

•   If you are allergic to fusidic acid or sodium fusidate or any of the other ingredients in this medicine (listed in section 6).

Warnings and Precautions

Talk to your doctor, pharmacist or nurse before using FUTASOLE

•   Take special care if you are going to use this medicine near your eyes or the eyes of a child.

•   If you use this medicine over a long time or in large amounts it may make the chance of getting any side effects higher. Also your skin may get more sensitive to this medicine.

Other medicines and FUTASOLE

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

Pregnancy and breast-feeding

•   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 using this medicine. Tell your doctor if you become pregnant while using this medicine.

•   You must not use your medicine for a long time or in large amounts.

Driving and using machines

Usually your medicine will have very little effect on your ability to drive or use machines.

Check with your doctor if you feel any side effect that may stop you from driving or using machines.

Important information about some of the ingredients of FUTASOLE

FUTASOLE Cream contains butylated hydroxyanisole. This may give you an itchy rash and inflammation on your skin where your medicine is used. This may also cause irritation to the eyes and mucous membranes (such as lips or genital area).

FUTASOLE Ointment contains cetyl alcohol. This may give you an itchy rash and inflammation on your skin where your medicine is used.

Please ask your doctor if you are worried about any of the ingredients in this medicine

Always use FUTASOLE exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How to put on FUTASOLE

This medicine is only for using on your skin or the skin of a child. Do not swallow it.
Do not put it inside your body.

Before using for the first time, open as follows:

Remove the cap. Check the seal is not broken before you first use FUTASOLE. Then push the spike in the cap through the seal on the tube. Do not use if seal is broken.

Always wash your hands before using FUTASOLE. Rub the medicine gently on the skin.

If you use it on your face be careful to avoid your eyes.

Unless you are using this medicine to treat your hands, always wash your hands after using FUTASOLE.

If you accidentally get any medicine in your eye, wash it out with cold water straight away.

Then bathe your eye with eyewash if possible.

Your eye may sting. If you start to have any problems with your sight or your eye is sore, contact your doctor immediately.

How much FUTASOLE to use

Your doctor will tell you how much FUTASOLE to use.

Usually, you should use this medicine three or four times each day.

If you have been told to cover the skin with any dressings or bandages you may not need to use the medicine so often. A nappy on a baby may act as a dressing. Follow the advice of your doctor.

If you use more FUTASOLE than you should

If you accidentally apply too much FUTASOLE or a small quantity of the FUTASOLE is accidentally swallowed, it is unlikely to cause any harm. If a larger quantity of this medicine is accidentally swallowed or you are worried contact your doctor, pharmacist or A&E department for advice.

If you forget to use FUTASOLE

If you forget to use FUTASOLE, use it as soon as you remember. Then next use this medicine at the usual time.

If you have any further questions about using this medicine, please ask your doctor, pharmacist or nurse.

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

Important side effects to look out for:

Rare (probably affect less than 1 in 1,000 people)

You must get urgent medical help if you have any of the following symptoms.

You may be having an allergic reaction:

•   You have difficulty breathing

•   Your face or throat swell

•   Your skin develops a severe rash.

Other possible side effects:

Uncommon side effects (probably affect up to 1 in 100 people)

•   Irritation at site of application (including pain, burning, irritation, stinging and skin redness)

•   Itching

•   Rash

•   Eczema

Rare side effects (probably affect less than 1 in 1,000 people)

•   Conjunctivitis

•   Hives

•   Skin swelling

•   Blistering of the skin

If any of the side effects become serious or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet.  You can also report side effects directly via:

The National Pharmacovigilance and Drug Safety Center (NPC)

Fax: +966-11-205-7662

Call NPC at +966-11-2038222,

Exts: 2317-2356-2340

Reporting Hotline: 19999

E-mail: [email protected]

Website: www.sfda.gov.sa/npc

By reporting side effects, you can help provide more information on the safety of this medicine.

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

-   Do not use FUTASOLE after the expiry date on the carton and tube.

-   Store below 30°C. Best use within one month of opening.

-   Do not use FUTASOLE if you notice any visible sign of deterioration.

Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need any more. If you do this you will help protect the environment

What FUTASOLE contains

FUTASOLE Cream 2%

Each gram of the cream contains:

Active ingredient: Fusidic acid 20mg, in neutral cream base.

Excipients: White soft paraffin, cetostearyl alcohol, cetomacrogol, liquid paraffin, butylated hydroxyanisole, chlorocresol, methyl and propyl paraben, sodium phosphate dibasic, tween 60 and purified water.

FUTASOLE Ointment 2%          

Each gram of the ointment contains:

Active ingredient: Sodium fusidate 20mg, in neutral ointment base.

Excipients: White soft paraffin, cetyl alcohol, lanolin anhydrous, liquid paraffin, and propylene glycol.

You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet.

What are the available packs of FUTASOLE

FUTASOLE cream or ointment is available in packs containing collapsible tubes of 15gm each.