PACKAGE LEAFLET: INFORMATION FOR THE USER

Your medicine is available using the name Betnovate scalp application 0.1% w/w Cutaneous Solution but will be referred to as Betnovate throughout this leaflet.

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

■    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 Betnovate is and what it is used for

2.    Before you use Betnovate

3.    How to use Betnovate

4.    Possible side effects

5.    How to store Betnovate

6.    Further information

1.    What Betnovate is and what it is used for

Betnovate contains a medicine called betamethasone valerate. It belongs to a group of medicines called steroids that help to reduce swelling and irritation.

Betnovate is used to reduce the redness and itchiness of certain scalp problems, such as psoriasis and dermatitis.

2.    Before you use Betnovate

Do not use Betnovate:

■    if you are allergic (hypersensitive) to betamethasone valerate or any of the other ingredients of Betnovate (listed in Section 6)

■    if you have a skin infection on your scalp

■    on a child under 1 year.

Do not use Betnovate if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Betnovate.

Take special care with Betnovate

Check with your doctor or pharmacist before you use this medicine if:

■    you have previously had an allergic reaction with another steroid

■    you are applying the liquid under an airtight dressing. These dressings make it easier for the active ingredient to pass through the skin. It is possible to accidentally end up using too much.

■    you have psoriasis, your doctor will want to see you more often.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before using this medicine if you are pregnant, might become pregnant or are breast-feeding.

3. How to use Betnovate

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

Using this medicine

■    You usually put Betnovate on your scalp in the morning and at night. This may be reduced as your scalp problem begins to get better.

■    Do not use Betnovate more often than prescribed.

■    Do not use it for a long time (such as every day for many weeks or months) - unless your doctor tells you to.

■    Be very careful not to get the liquid in your eyes. Do not touch your eyes until you have washed your hands.

■    If you wash or shampoo your hair it should be dried before applying the liquid.

■    If you are applying Betnovate on someone else make sure you wash your hands after use or wear disposable plastic gloves.

■    The liquid is flammable, you should keep it away from fire.

■    Do not dry your hair with a hairdryer or be near a fire.

Guidance on how to apply the liquid

1.    Wash your hands.

2.    Unscrew the bottle cap and place the nozzle on the scalp that needs treating.

3.    Gently squeeze the bottle to cover the area with a thin and even layer of liquid.

4.    You can rub this liquid in, but you don't have to.

5.    Your scalp will feel cool until the liquid has dried.

6.    Wash your hands again.

If you use more Betnovate than you should

If, by mistake on a few occasions you use more than you should, do not worry. If you apply a lot or if a lot is accidentally swallowed, it could make you ill. Talk to your doctor or go to hospital as soon as possible.

If you forget to use Betnovate

If you forget to apply Betnovate, apply it as soon as you remember. If it is close to the time you are next meant to apply it you can wait until this time.

If you stop using Betnovate

If you use Betnovate regularly make sure you talk to your doctor before you stop using it.

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

4. Possible side effects

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

Stop using Betnovate and tell your doctor as soon as possible if:

■    you find that your skin condition gets worse or becomes swollen during treatment.

You may be allergic to Betnovate, have an infection or need other treatment.

■    you have psoriasis and you get raised bumps with pus under the skin. This can happen very rarely during or after treatment and is known as pustular psoriasis.

Other side effects you may notice when using Betnovate include:

Common

(affects less than 1 in 10 people)

■    a feeling of burning, irritation or itching where the liquid is applied.

Side effects if you use Betnovate for a long time, you use a lot each time you apply it, or you apply it under an airtight dressing:

Very rare

(affects less than 1 in 10,000 people)

■    stretch marks may develop

■    veins under the surface of your skin may become more noticeable

■    increased hair growth and changes in skin colour

■    thinning of your skin and it may also damage more easily

■    weight gain, rounding of the face and high blood pressure. These are more likely to happen in infants and children.

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.

5. How to store Betnovate

■    Keep out of the sight and reach of children.

■    Do not use Betnovate after the expiry date on the bottle label or carton (Exp). The expiry date refers to the last day of that month.

■    Do not store above 25°C. Store in the original package.

■    Caution: Inflammable. Do not use or dry the hair near a fire or naked flame.

■    If your doctor decides to stop your treatment, take any leftover medicine back to the pharmacy.

■    If your medicine appears to be discoloured or shows any other signs of deterioration, take it back to your pharmacist who will advise you.

■    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

What Betnovate contains

Betnovate contains the active ingredient betamethasone 0.1% w/w (as betamethasone valerate).

The other ingredients are: carbomer, isopropyl alcohol, sodium hydroxide and purified water.

What Betnovate looks like and contents of the pack

Betnovate is a colourless solution available in 100 ml plastic bottles with a nozzle and a tamper proof screw cap.

Manufacturer

Manufactured by: Aspen Bad Oldesloe GmbH,

Industriestrasse 32-36, 23843 Bad Oldesloe, Germany.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

PL No: 21828/0531 POM

More information

If you have any questions or are not sure about anything, ask your doctor or pharmacist who will advise you.

Other sources of information are:

National Eczema Society,

Hill House, Highgate Hill,

London, N19 5NA.

The Psoriasis Association,

2 Queensbridge,

Northampton, NN4 7BF.

You may also be able to find out more from books in public libraries.

Other formats

To request a copy of this leaflet in Braille, large print or audio please call 01302 365000 and ask for the Regulatory Department.

Please be ready to give the following information:

Product name    Betnovate® scalp application

0.1% w/w Cutaneous Solution

Reference number    21828/0531

Leaflet revision date: 11.02.13

Betnovate® is a registered trademark of the GlaxoSmithKline group of companies.

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