The active ingredient of Balad cream is fusidic acid, while the active ingredient of Balad ointment is sodium fucidate. This is an antibiotic (this means that it kills bacteria that cause infections). Balad should be used on the skin. It is used for the local treatment of skin infections caused by bacteria that are sensitive to Balad (especially staphylococcus infections) such as impetigo (a weeping, crusty and swollen patch of skin), folliculitis (inflammation of one or more hair follicles), sycosis barbae (infection of the bearded skin), paronychia (infection of the tissue surrounding a fingernail or toenail), erythrasma (infection with brown, scaly skin patches, especially in the folds of the body).

Do not use Balad if you are allergic (hypersensitive) to Balad or any of its’ other ingredients. Therefore, always tell your doctor which medicines or other substances you are allergic to.

Take special care with Balad

•  If you use Balad on the face. The cream or ointment should not be applied in or near the eye because it can lead to a prickling feeling in the eye.
•  If you use it for a long time or in large amounts as it may make the chance of getting any side effects higher. Also your skin may get more sensitive to Balad. Please tell your doctor if one of the above warnings applies to you or has applied to you in the past.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained with or without a prescription. There is no known effect of Balad with other medicines.

Pregnancy and breast-feeding

Pregnancy:

There is not enough evidence to say that it is safe to use Balad during pregnancy. You need to discuss your specific circumstances with your doctor to weigh up the overall risks and benefits of using this medicine. You and your doctor can make a decision about whether you are going to use this medicine during pregnancy.

You should only use this medicine during pregnancy if your doctor thinks that you need it.

Breast-feeding:

There is not enough evidence to say that it is safe to use Balad while breastfeeding.

However, using Balad topically and breast-feeding is unlikely to harm your baby.

You should only breast-feed your baby while using this medicine on the advice of your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

This medicine does not affect your ability to drive or operate machinery.

Always use Balad exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage

Your doctor will tell you how much Balad you should use.

Adults and children

Usually a small amount of Balad is applied to the infected skin three or four times each day.

If your doctor advises you to use a sterile bandage or dressing, you usually can reduce the number of applications.

A nappy on a baby may act as a dressing. Follow the advice of your doctor.

If you think that the effect of Balad is too strong or too weak, ask your doctor or pharmacist for advice.

How to apply Balad

Balad should be applied to the skin. Do not swallow it.

1. Always wash your hands before you use cream or ointment.
2. Remove the cap.
3. Check that the seal is not broken before you use the medicine for the first time.
4. Push the spike in the cap through the seal of the tube.
5. Rub the cream or ointment gently on the skin.
6. If you use the cream or ointment on your face be careful to avoid your eyes.
7. Always wash your hands after using the medicine, unless you are using it to treat your hands.

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

Then rinse your eye with eye wash 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.

Duration of treatment

The duration of the treatment will be decided by your doctor. Treatment is usually 1 to 2 weeks, although it may be longer. This depends on the type of infection and the result of the treatment. Take special care if you use balad for a long time or in large amounts, because then there is a higher chance of getting side effects. Therefore, always follow the advice of your doctor.

If you use more Balad than you should if you apply too much or accidentally swallow Balad, it is unlikely to cause any harm. However, if you notice any effect or are worried, contact your doctor or pharmacist.

You should contact the doctor if Balad is accidentally swallowed by an infant.

If you forget to use Balad

If you forget to use Balad, apply the usual amount of medicine as soon as you remember. Do not apply a double dose to make up for a forgotten dose.

If you stop using Balad

Always use Balad for duration directed by your doctor. Speak to your doctor if unsure. If you stop using Balad prematurely, it is possible that the skin infection returns or does not cure.

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

Like all medicines, Balad can cause side effects, although not everybody gets them. The most frequently reported side effects are various skin reactions and in particular application site reactions.

Some Balad content may cause an itchy and inflammation in the skin such as Butylated hydroxyanisole (E320), Cetyl alcohol, and potassium sorbate.

The frequency of occurrence of side effects is as follows:

Very common: Affects more than 1 in 10 users

Common: Affects up to 1 in 10 users

Uncommon: Affects up to 1 in 100 users

Rare: Affects up to 1 in 1,000 users

Very rare: Affects up to 1 in 10,000 users

Not known: Frequency cannot be estimated from the available data

Uncommon

Skin and subcutaneous tissue disorders

• Itching

• Rash

• Skin sensitivity reactions (contact dermatitis)

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

Rare

Immune system disorders

• 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.

Eye disorders

• Inflammation of the eye (conjunctivitis)

Not known

• Hives

• Angioedema (sudden swelling in the skin and mucous membranes (for example throat and tongue), breathing problems and/or itching and skin rash, often the symptoms of an allergic reaction)

Immediately contact your doctor or pharmacist if this occurs.

• Eczema

• Sudden swelling around the eye (periorbital oedema)

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

Keep out of the reach and sight of children.

Do not use Balad after the expiry date, which is stated on the carton or the tube after “EXP”. The expiry date refers to the last day of that month.

Store below 30°C.

Discard the tube after 1 month of first opening the tube even if there is still some medicine left in it.

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.