Betacap Scalp Application

PACKAGE LEAFLET Information for the user

Betacap™ Scalp Application

0.1% w/w cutaneous solution

betamethasone (as betamethasone valerate)

1. WHAT BETACAP SCALP APPLICATION IS AND WHAT IT IS USED FOR

• Betacap Scalp Application is for use on the scalp to treat skin diseases including psoriasis (scaly, pink patches of thickened skin) and seborrhoeic dermatitis (scaly, itchy patches of skin).
• Betacap Scalp Application is suitable for use by adults, the elderly and children over the age of one year.
• The active ingredient in this product is betamethasone. This is one of a group of medicines called corticosteroids (which should not be confused with ‘anabolic steroid’ tablets or injections misused by some athletes).
• Betamethasone is a strong and fast acting corticosteroid and is intended for use on the scalp which tends not to respond very well to weaker medicines of this type.
• Betamethasone works by reducing inflammation and calming down your immune system.
• The product also works as an antiseptic, and includes an emollient (moisturiser) to help make the scalp feel more comfortable.

2. BEFORE YOU USE BETACAP SCALP APPLICATION

Do not use Betacap Scalp Application:

• if you are allergic (hypersensitive) to betamethasone or any of the other ingredients of Betacap Scalp Application listed in Section 6;
• to treat any other skin problems, especially skin infections, as it may make them worse;
• to treat any scalp problem other than the one your doctor prescribed it for;
• on children under one year of age.

Take special care when using this product:

• Tell your doctor if at any stage you think your scalp has become infected. Your doctor may advise you to stop using Betacap for a while and start using an alternative anti-microbial treatment instead.
• Keep the product away from your eyes and mouth.
• Betacap is highly flammable. Do not use it near flames or ignition sources (e.g. burning cigarettes or anything else that might ignite it).
• If you are treating scalp psoriasis, it is important that your doctor checks your progress regularly to avoid a possible complication that can occur (see Section 4).
• Do not use this product excessively:
  • avoid using this product continuously or frequently for long periods (weeks or months on end);
  • this is especially important for infants and young children, because long term use increases the chance of local and generalised side effects (see Section 4);
  • for children with scalp seborrhoeic dermatitis, treatment should normally be limited to no more than 7 days.

3. HOW TO USE BETACAP SCALP APPLICATION

Use Betacap Scalp Application only on psoriasis and seborrhoeic dermatitis affecting the scalp.

Before using this bottle of Betacap Scalp Application for the first time, turn the bottle cap anti-clockwise to break the seal.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Betacap Scalp Application can cause side effects, although not everybody gets them:

• In rare cases skin irritation may occur. If this happens stop using the product.
• In rare cases, treating psoriasis with this type of product may cause the development of the pustular form of the disease (blisters filled with pus). This explains why careful supervision by your doctor is required if you are treating scalp psoriasis.
• Topical corticosteroids are usually well tolerated when used in the right amount and for the correct length of time. However, prolonged, excessive use, particularly in children or on skin that is bandaged or wrapped up, can cause local skin thinning (making the skin damage easily), and adrenal suppression (a type of hormone imbalance that causes generalised effects on the body). Stopping treatment normally corrects these side effects.

If you are in any doubt about the treatment, or experience any of the above side effects or any other side effect not mentioned in this leaflet, stop using this product and tell your doctor or pharmacist.

5. HOW TO STORE BETACAP SCALP APPLICATION

• Keep out of the reach and sight of children.
• Do not use Betacap Scalp Application after the expiry date shown on the bottle and carton. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• Always replace the cap tightly and return the bottle to the carton after use (to protect the contents from light).
• Betacap Scalp Application is highly flammable. Do not use it near flames or ignition sources.
• 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 ABOUT BETACAP SCALP APPLICATION