Betacap™ Scalp Application

0.1% w/w cutaneous solution

betamethasone (as betamethasone valerate)

• 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).
• Corticosteroid creams, ointments and other topical preparations come in four different strengths. These are known as mild, moderately potent, potent or very potent. Healthcare professionals will usually refer to topical corticosteroid potency rather than strength. A potent corticosteroid has a much stronger effect than a mild corticosteroid. The percentage of active ingredient that is sometimes included on product packaging does not indicate potency. Betacap Scalp Application is classed as a potent (group III), corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition.
• 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.

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.

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.

For adults and the elderly:

Repeat the following twice a day, morning and evening, until you notice an improvement in your scalp condition. On days when you shampoo your hair, apply Betacap Scalp Application after drying the hair:

• Carefully turn the bottle upside-down over your head, holding the nozzle against the part of the scalp to be treated.
• Gently squeeze the bottle until the affected area is coated with a thin layer of the preparation.
• Gently massage the application into the scalp to prevent it from running off.
• Allow the treated scalp to dry naturally. Do not use a hair drier.
• Your scalp will feel cool until the liquid has dried. The active ingredient is then left on your scalp.
• Always wash your hands after use.

When you can see that your scalp condition is getting better, you can start to apply Betacap Scalp Application less often, only once a day or even less. The frequency of application should be reduced to the minimum necessary to keep your scalp condition under control.

For children (over one year old):

• Follow the same instructions as for adults (see above), but use the product more sparingly.
• Never apply more than is needed to cover the affected area.
• Do not cover the treated scalp with an airtight dressing.
• When treating seborrhoeic dermatitis in children, do not use the product for longer than 7 days.

If Betacap Scalp Application gets into the eyes it may cause damage. If it gets into the eyes, rinse immediately with plenty of water. If rinsing one eye, take care to avoid washing product into the other eye. If irritation persists tell your doctor or pharmacist.

Betacap Scalp Application is dangerous if swallowed. If someone swallows this product by mistake, take the following emergency action: if they are drowsy or unconscious, give nothing by mouth. If they are conscious, encourage them to drink 1 or 2 cups of milk or water (one cup in the case of a child), but do not carry on if they are vomiting. In all cases, take them to a doctor or hospital straight away. Take this leaflet and the container of Betacap Scalp Application with you.

If you apply too much Betacap Scalp Application, use a tissue to mop up any excess and stop it spreading onto uninvolved skin areas.

If you occasionally forget to use Betacap Scalp Application, do not worry, just carry on using it when you remember.

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

Like all medicines, Betacap Scalp Application can cause side effects, although not everybody gets them. Betacap Scalp Application may cause the following side effects of unknown frequency (frequency cannot be estimated from the available data):

• Skin irritation may occur. If this happens stop using the product.
• 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.
• Steroid withdrawal reaction: If used over prolonged periods a withdrawal reaction, which might appear to be different from the previous condition, may occur in some patients during treatment or within days to weeks after stopping treatment, with some or all of the following features: redness of the skin which can extend beyond the initial area treated, a burning or stinging sensation, intense itching, peeling of the skin, oozing open sores.
• Blurred vision.

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.

• Keep this medicine out of the sight and reach 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.