Betnovate Lotion

12000000104439 GlaxoSmithKline

Betnovate® Lotion

betamethasone valerate

Package Leaflet: Information for the User

Read all of this leaflet carefully before

you start using this medicine because it

contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1 What Betnovate is and what it is used for

2 What you need to know before you use Betnovate

3 How to use Betnovate

4 Possible side effects

5 How to store Betnovate

6 Contents of the pack and other 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 reduce swelling and irritation.

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

2 What you need to know 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)

• on a child under 1 year

• to treat any of the following skin problems, it could make them worse:

- acne

- severe flushing of skin on and around your nose (rosacea)

- spotty red rash around your mouth (perioral dermatitis)

- itching around your back passage or private parts

- infected skin (unless the infection is being treated with an anti-infective medicine at the same time)

- itchy skin which is not inflamed

Do not use if any of the above apply to you.

If you are not sure, talk to your doctor or pharmacist before using Betnovate.

Warnings and precautions

Talk to your doctor or pharmacist before using

Betnovate if:

• you have previously had an allergic reaction with another steroid

• you are applying the lotion under an airtight dressing, including a child's nappy. 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.

• using for a chronic leg ulcer as you may be at increased risk of local allergic reaction or infection.

• you are applying to a large surface area

• you are applying the lotion on broken skin or within the skin folds.

• you are applying near eyes or on eyelids, as cataracts or glaucoma may result if the lotion repeatedly enters the eye.

• you are applying to thin skin such as the face or on children as their skin is thinner than adults and as a result may absorb larger amounts.

• Dressing or bandages should not be used on children or on the face where the lotion is applied.

• Use on children or on the face should be limited to 5 days.

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

Other medicines and Betnovate Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine, especially if you are taking ritonavir and itraconazole medications.

Pregnancy and breast-feeding and fertility If you are pregnant or are breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Betnovate Lotion contains cetostearyl alcohol

Betnovate Lotion contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

3 How to use Betnovate

Always use this medicine exactly as your

doctor has told you. Check with your doctor or

pharmacist if you are not sure.

Using this medicine

• You usually apply Betnovate once or twice a day. This may be reduced as your skin begins to get better.

• This lotion is for use on your skin only.

• Do not use more than the amount prescribed for you.

• Do not use on large areas of the body for a long time (such as every day for many weeks or months) - unless your doctor tells you to.

• The germs that cause infections like warm, moist conditions under bandages or dressings so always clean the skin before a fresh dressing is put on.

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

• If your skin problem does not improve in 2 to 4 weeks, talk to your doctor.

• This product is flammable. Keep the lotion away from open fire and flames and all sources of ignition including smoking during application and immediately after use.

Guidance on how to apply the lotion

1 Wash your hands.

2 Gently rub a small amount of lotion into the skin until it has all disappeared.

3 Unless you are meant to apply the lotion to your hands as a part of the treatment, wash them again after using the lotion.

For a child

• Do not use it on children under 1 year of age.

• It is especially important in children not to exceed the prescribed amount. The smaller the child the less lotion you will need to use.

• A course of treatment for a child should not normally last more than 5 days unless your doctor has told you to use it for longer.

If you have psoriasis If you have thick patches of psoriasis on your elbows or knees, your doctor may suggest applying the lotion under an airtight dressing. It will only be at night to help the lotion to start working. After a short period of time you will then apply the lotion as normal.

If you apply Betnovate to your face You should only apply the lotion to your face if your doctor tells you to. It should not be used for more than 5 days, as the skin on your face thins easily. Do not let the lotion get into your eyes. If you use more Betnovate than you should If you apply too much or if accidentally swallowed, it could make you ill. Talk to your doctor or go to the hospital as soon as possible. If you forget to use Betnovate If you forget to apply your lotion, apply it as soon as you remember. If it is close to the time you are next meant to apply it, 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 as your condition may get worse if stopped suddenly.

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

4 Possible side effects

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

Stop using Betnovate and tell your doctor immediately if:

• you find that your skin condition gets worse, you develop a generalised rash or your skin becomes swollen during treatment. You may be allergic to Betnovate, have an infection or need other treatment.

• you have psoriasis and 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 (may affect up to 1 in 10 people)

• a feeling of burning, pain, irritation or itching where the lotion is applied.

Very rare (may affect up to 1 in 10,000 people)

• an increased risk of infection

• an allergic skin reaction where the lotion is applied

• rash, itchy bumpy skin or redness of the skin

• thinning and dryness of your skin and it may also damage or wrinkle more easily

• stretch marks may develop

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

• an increase or reduction in hair growth or hair loss and changes in skin colour

• weight gain, rounding of the face

• delayed weight gain or slowing of growth in children

• bones can become thin, weak and break easily

• cloudy lens in the eye (cataract) or increased pressure in eye (glaucoma)

• increased blood sugar levels or sugar in the urine

• high blood pressure

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Betnovate

• Keep out of the sight and reach of children.

• Do not use this medicine after the expiry date which is stated on the bottle or carton after (Exp). The expiry date refers to the last day of that month.

• Do not store above 25°C.

• Keep the container tightly closed when not in use. Contents are flammable. Keep Betnovate Lotion away from all sources of fire, flame and heat.

• Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other information

What Betnovate Lotion contains

• The active ingredient is betamethasone valerate. Each 10 ml contains 0.01 ml of betamethasone (0.1% w/w) as valerate.

• The other ingredients are methyl hydroxybenzoate, xanthan gum, cetostearyl alcohol, liquid paraffin, isopropyl alcohol, glycerol, macrogol cetostearyl ether, sodium citrate, citric acid and purified water.

What Betnovate looks like and contents of the pack

Within each carton is a plastic bottle with a nozzle and cap that contains 100 ml of lotion. Marketing Authorisation Holder and Manufacturer

Product Licence held by Glaxo Wellcome UK Ltd,

Stockley Park West, Uxbridge, Middlesex UB11 1BT

Manufactured by

Aspen Bad Oldesloe GmbH

Industriestrasse 32-36

23843 Bad Oldesloe

Germany

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

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

Other formats:

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:

Product name: Betnovate Lotion

Reference number 10949/0044

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

This leaflet was last revised in: June 2014 Betnovate is a registered trade mark of the GSK group of companies.

GlaxoSmithKline

12000000104439