PACKAGE LEAFLET Information for the user

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0.1% w/w cutaneous solution betamethasone (as betamethasone valerate)

Read all of this leaflet carefully before you start using this product.

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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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.

In this leaflet:

1.    What Betacap Scalp Application is and what it is used for

2.    Before you use Betacap Scalp Application

3.    How to use Betacap Scalp Application

4.    Possible side effects

5.    How to store Betacap Scalp Application

6.    Further information

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.

Using other medicines

Betacap Scalp Application is not known to affect, or to be affected by, any other medicines.

Pregnancy and breast-feeding

It is unclear whether this product is safe for use during pregnancy and breast-feeding. Animal birth defects have occurred with similar medicines containing corticosteroids, so there may be a very small risk of these problems in humans. You should therefore not normally use this product if you are pregnant or breast-feeding unless your doctor has recommended you to do so.

Driving and using machinery

Using this product is not known to affect your ability to drive or use machinery.

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.

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.

continued...

•    Your scalp will feel cool until the liquid has dried. The active ingredient is then left on your scalp.

•    Alwayswashyourhandsafteruse.

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.

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.

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance, Earlsfort Terrace,

IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

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

What Betacap Scalp Application contains:

The active ingredient is betamethasone (as betamethasone valerate) 0.1% w/w.

The other ingredients are macrogol 7 glycerol cocoate, isopropyl alcohol, carbomer, sodium hydroxide and purified water.

What Betacap Scalp Application looks like and contents of the pack

•    Betacap Scalp Application is a clear, colourless, slightly thickened liquid.

•    The product is available in plastic bottles containing 100 ml, incorporating a specially designed nozzle applicator for convenient direct application to the scalp.

The Marketing Authorisation holder is:

Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Hertfordshire, SG4 7QR, UK.

The Manufacturer is: Fleet Laboratories Ltd,

94 Rickmansworth Rd, Watford, Hertfordshire, WD18 7JJ, UK.

This Patient Information Leaflet was last revised in March 2015.

To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of charge: 0800 198 5000 (UK only).

Please be ready to give the following information: Betacap, 00173/0149.

This is a service provided by the Royal National Institute of Blind People (RNIB).