Betnovate RD ointment – patient leaflet, side effects, dosage

1 What Betnovate RD is and what it is used for

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

Betnovate RD is used to help reduce the redness and itchiness of certain skin problems, such as eczema, psoriasis and dermatitis. RD stands for ‘Ready Diluted’, it contains less active ingredient than Betnovate. It is used:

• for milder skin problems, or
• to keep your skin problem under control after Betnovate has improved it.

2 What you need to know before you use Betnovate RD

Do not use Betnovate RD:

• if you are allergic (hypersensitive) to betamethasone valerate or any of the other ingredients of Betnovate RD (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 RD. 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 ointment 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 ointment on broken skin or within the skin folds.
• you are applying near eyes or on eyelids, as cataracts or glaucoma may result if the ointment repeatedly enters the eye.
• you have an infection of the skin as this will need to be treated
• 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 ointment is applied.

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

Contact your doctor if you experience blurred vision or other visual disturbances.

Do not smoke or go near naked flames due to the risk of severe burns. Fabric (clothing, bedding, dressing etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine. Topical steroid withdrawal syndrome

Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered. 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.

3 How to use Betnovate RD

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 RD once or twice a day. This may be reduced as your skin begins to get better.
• This ointment 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 ointment 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.

Guidance on how to apply the ointment

1 Wash your hands.

2 Apply a thin layer to the affected area(s) and gently rub into the skin until it has all disappeared. You can measure how much Betnovate to use with your fingertip. For children you will need to use less ointment but still use an adult finger to measure out the fingertip unit. This picture shows one fingertip unit.

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

Do not worry if you find you need a little more or less than this. It is only a rough guide.

For a child aged 1 – 10

Number of fingertip units needed Child’s age Face and neck Arm and hand Leg and foot Front Back including buttocks 1-2 years 1 ½ 1 ½ 2 2 3 3-5 years 1 ½ 2 3 3 3 ½ 6-10 years 2 2 ½ 4 ½ 3 ½ 5

• Do not use it on children under 1 year of age.
• It is especially important in children not to exceed the prescribed amount.
• 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 ointment under an airtight dressing. It will only be at night to help the ointment to start working. After a short period of time you will then apply the ointment as normal.

If you apply Betnovate RD to your face

You should only apply the ointment 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 ointment get into your eyes.

If you use more Betnovate RD 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.

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Page 1 of 2 If you forget to use Betnovate RD

If you forget to apply your ointment, 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 RD

If you use Betnovate RD 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 RD 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 RD, 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 RD include:

Common (may affect up to 1 in 10 people)

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

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

• an increased risk of infection
• an allergic skin reaction where the cream 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
• blood vessels 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)
• a decrease in the level of the hormone cortisol in your blood
• increased blood sugar levels or sugar in the urine
• high blood pressure

Not Known (frequency cannot be estimated from the available data)

• blurred vision
• 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.

Corticosteroid creams, ointments and other topical preparations come in four different potencies or 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 or strong corticosteroid has a much stronger effect than a mild corticosteroid when using the same amount. The percentage of active ingredient that is sometimes included on product packaging does not indicate potency. Betnovate RD Ointment is classed as a strong corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition 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 Yellow Card Scheme Website:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5 How to store Betnovate RD

• Keep out of the sight and reach of children.
• Do not use Betnovate RD after the expiry date on the tube or carton after (EXP). The expiry date refers to the last day of that month.
• Do not store above 30°C.
• 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 RD ointment contains

• The active ingredient is betamethasone valerate. Each 1 g contains 0.25 mg of betamethasone (0.025% w/w) as valerate.
• The other ingredients are liquid paraffin and white soft paraffin.

What Betnovate RD looks like and contents of the pack

Within each carton is a tube with a plastic screw cap, which contains 100 g of ointment.

Marketing Authorisation Holder and Manufacturer

Product Licence held by Glaxo Wellcome UK Ltd, GSK Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK Manufactured by Glaxo Wellcome Operations, Barnard Castle, Durham DL12 8DT

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.

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This leaflet was last revised in:

April 2024

Trade marks are owned by or licensed to the GSK group of companies.

© 2024 GSK group of companies or its licensor.

NOTE TO MARKET Local approvers must ensure that trade mark and copyright statements included in the brief comply with guidance provided by Legal: Global Trade Marks. IMPORTANT GSK LOC is responsible to and complete.

pre-press suitability.

GSK Market is responsible to advise SDC when changes required impact the following:

Formulation

Tablet embossing Storage conditions

Shelf Life

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