Read all of this leaflet carefully before you start using this medicine.
- Save this leaflet, you may need to read about it.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not give it to others. It may harm them, even if they show symptoms similar to 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. See section 4.
In this leaflet:
1. What Betnovat 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 Betnovat 6. Contents of the pack
and other ingredients information
1. What Betnovat is and what it is used for
Betnovate is a strong-acting cortisone preparation (group III) that counteracts inflammation and has an antipruritic effect. Betnovate is used to treat psoriasis, eczema, and certain other skin conditions. The ointment is primarily used for dry, scaly skin changes, while the cream is better suited for exfoliating skin changes. The emulsion is used on large and/or hairy surfaces. The solution is intended for the treatment of the scalp and in case of inflammation in the ear canal but can be used on other parts of the body.
2. What you need to know before using Betnovate
Do not use Betnovate
If you are allergic (hypersensitive) to betamethasone or any of the other ingredients of Betnovate (listed in section 6).
- in infected skin (unless the infection is treated with anti-infective drugs at the same time)
- in acne
- in rosacea (skin problems where the nose, cheeks, chin, forehead, or whole face are unusually red, with or without visible blood vessels)
- in case of rash around the mouth (perioral dermatitis )
- on itchy skin that is not inflamed
- around the anus or genitals
- to children under 1 year
- the solution should not be used for holes in the eardrum
- If you think any of these apply to you, talk to your doctor or pharmacist before using Betnovate.
Warnings and cautions
- Local hypersensitivity reactions, such as redness of the skin, rash, itching, hives, burning sensation, and contact dermatitis may occur. Should any skin reaction occur, treatment must be stopped immediately?
- Talk to your doctor if you have previously had a hypersensitivity reaction to any cortisone preparation.
- Only use Betnovate for as long as your doctor recommends. If your condition does not improve after 4 weeks of treatment, talk to your doctor.
- Be careful when applying Betnovat to the eyelids. Avoid getting Betnovat in your eyes.
- Be careful when applying Betnovat to the face for a long time as it may lead to thinning of the skin.
- If you have dermatitis ( inflammation of the skin) around a leg ulcer, using a cortisone cream or ointment may increase the risk of an allergic reaction or infection around the wound.
- If you have psoriasis, your doctor will want to see you more often as there is a risk of tolerance development and relapse.
- Bandages should be avoided in infected eczema. Use it only after a doctor’s prescription. If you use Betnovate under a cover bandage (including a baby’s nappy), make sure your skin is cleansed before applying a new bandage to avoid infection.
- Betnovate is not normally suitable for the treatment of children. Do not use in children without a doctor’s prescription.
- Sensitive skin areas, such as the face, armpits, groin, and eye region should only be treated for a short time.
- The solution contains alcohol and is therefore flammable.
- The use of high- dose Betnovate for a long time can cause cortisone to affect the entire body. Symptoms such as weight gain with altered fat distribution (abdomen, neck, face), thin and brittle skin, increased body hair, decreased bone density, high blood pressure can then occur (Cushing’s syndrome). In children and young people, growth retardation can be seen. If any of these are observed, contact your treating physician for gradual discontinuation of treatment by reducing the frequency of application or by switching to a less potent corticosteroid. Abrupt discontinuation of treatment may result in glucocorticoid deficiency (see section 4 Possible side effects ).
- Cortisone preparations can mask, activate, or aggravate a skin infection.
- Contact a doctor if you experience blurred vision or other visual disturbances.
- Contact your doctor if an infection occurs (see section 4 Possible side effects )
Taking other medicines
Some medicines may affect the way Betnovat works or increase the risk of side effects. Examples of these drugs are:
- Ritonavir (drugs used in HIV – infection s).
- Itraconazole (a medicine used to treat fungal infections).
- Tell your doctor if you are taking any of these. There are other drugs that can have a similar effect. Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, do not use Betnovate before talking to your doctor.
If you are breast-feeding, talk to your doctor before using Betnovate.
- If you are going to use Betnovate while breast-feeding, do not use Betnovate on your breasts to avoid accidentally getting the baby Betnovat in your mouth.
Driving and using machines
No known effect on the ability to drive or perform precision work with concomitant use of Betnovate.
3. How to use Betnovate
Always use Betnovate exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- Apply thinly according to a doctor’s prescription. Use only the amount needed to cover the entire affected area.
- Wash your hands afterward, if it is not the hands that are being treated.
- If you are using an emollient cream, wait a while for Betnovat to be absorbed before applying the emollient cream.
This medicine should not be used every day for more than 4 weeks at a time.
Children, the elderly, and patients with impaired liver or kidney function should use the least amount for the shortest possible time.
Betnovate solution: If you wash your hair, it should be dried before using the solution. Unscrew the cap on the bottle and place the tip of the bottle against the scalp. Gently press on the bottle to cover the affected area with an even and thin layer of liquid. You can massage in the liquid but you do not have to. The scalp will feel cool until the liquid has dried.
The solution is flammable. Do not store near heat, fire, or open flame, and do not smoke when applying Betnovate solution or immediately after doing so.
When treating inflammation in the ear canal, the area must first be thoroughly cleaned. 2-3 drops are applied 2-3 times daily. In the case of chronic complaints, treatment should be carried out under the supervision of an ear doctor.
If you forget to use Betnovate
- If you forget to use Betnovate, iron it as soon as you remember, then continue as usual.
- Do not apply extra Betnovat to make up for a forgotten dose.
If you stop using Betnovate
- If you use Betnovate regularly, talk to your doctor before stopping using it. Doseone should be reduced gradually.
If you have any further questions on the use of this product, ask your doctor or pharmacist
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
When treating large areas for a long time or when treating with dressings, the risk of side effects increases.
If your skin symptoms get worse or if your skin swells during treatment, you may be allergic to the medicine, have an infection, or need another treatment.
- Stop using Betnovate and contact your doctor as soon as possible.
Common side effects are (may affect up to 1 in 10):
- itchy skin
- local burning sensation or pain.
Uncommon (may affect up to 1 in 100 people):
- thinning skin that can cause stretch marks
- rash on the face.
Rare (may affect up to 1 in 1,000 people):
- pigment changes
- increased body hair.
Very rare side effects are (may affect up to 1 in 10 000 users):
- Local hypersensitivity s
- inhibition of adrenal cortex function
- weight gain/obesity
- Cushingoid features (moon face, central obesity).
- dry skin
- visible blood vessels under the skin
- hair loss, lack of hair growth, damaged hair
- contact dermatitis/skin infection at the application site.
- worsening symptoms
- reddening of the skin
- rash or hives
- burning sensation/pain.
- if you have psoriasis you can get blisters under the skin. This occurs very rarely during or after treatment and is called pustular psoriasis.
- delayed weight gain / slow growth in children.
- reduction of the hormone cortisol in the blood
- increased levels of sugar in the blood or urine
- infection that occurs due to a weakened immune system ( opportunistic infection).
- increased blood pressure
- a cloudy lens in the eye (cataracts)
- increased pressure in the eye ( glaucoma )
- weakened skeleton ( osteoporosis ).
Has been reported (occurs in an unknown number of users):
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address
5. How to store Betnovate
- Keep out of sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
- Do not store above 25 ° C.
- The medicine 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. Contents of the packaging and other information
The active substance in Betnovat is betamethasone.
1 g ointment contains 1 mg betamethasone (as betamethasone valerate). The other ingredients are liquid paraffin, white Vaseline.
1 g of cream contains 1 mg of betamethasone (as betamethasone valerate). The other ingredients are chlorocresol ( preservative ), macrogol cetostearyl ether, cetostearyl alcohol, white petrolatum, liquid paraffin, sodium dihydrogen phosphate, phosphoric acid, sodium hydroxide, purified water.
1 ml of cutaneous emulsion contains 1 mg betamethasone (as betamethasone valerate). The other ingredients are methyl parahydroxybenzoate ( preservativeE218), xanthan gum, cetostearyl alcohol, liquid paraffin, isopropyl alcohol, glycerol, macrogol cetostearyl ether, sodium citrate, citric acid monohydrate, purified water.
1 ml of cutaneous solution contains 1 mg betamethasone (as betamethasone valerate). Other ingredients are
carbomer, isopropyl alcohol, sodium hydroxide, water.
What the medicine looks like and the contents of the pack
Betnovate ointment is white to translucent and is supplied in aluminum tubes containing 30 g or 100 g.
Betnovate cream is white and is supplied in aluminum tubes containing 30 g or 100 g.
The betnovate cutaneous emulsion is white and is supplied in a plastic bottle containing 100 ml.
The betnovate cutaneous solution is clear, clear with a scent of isopropyl alcohol, and is supplied in a plastic bottle containing 30 ml or 100 ml.
Marketing Authorisation Holder
GlaxoSmithKline AB, Box 516, 169 29 Solna
Tel: 08-638 93 00
Manufacturer (Betnovat cutaneous solution 1 mg / ml and cutaneous emulsion 1 mg / ml):
Aspen Bad Oldesloe GmbH
Industriestrasse 32-36, 23843 Bad Oldesloe, Germany