betamethasone and clioquinol
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 you will find information about:
1. What Betnovat with chinoform is and what it is used for
2. What you need to know before you use Betnovate with chinoform
3. How to use Betnovat with chinoform
4. Possible side effects
5. How Betnovat with chinoform must be stored
6. Package contents and other information
1. What Betnovat with chinoform is and what it is used for
Betnovate with chinoform is a strong-acting cortisone preparation (group III) that counteracts inflammation and has an antipruritic effect, combined with chinoform which has an effect against bacterial and fungal infections. Betnovate with chinoform is used when the skin changes are infected. The cream one is suitable for exfoliating skin changes.
2. What you need to know before using Betnovate with chinoform
Do not use Betnovate with chinoform
- if you are allergic (hypersensitive) to betamethasone or any of the other ingredients of Betnovat with chinoform (listed in section 6)
- to children under 1 year
- to treat any of the following skin problems:
- viral infections, such as cold sores, herpes, or chickenpox
- fungal infections, such as ringworm, athlete’s foot, or cod
- in the face disease rosacea (a condition in which the nose, cheeks, chin, forehead, or whole face are unusually red with or without small visible blood vessels, nodules, or blisters)
- in case of rash around the mouth (perioral dermatitis )
- on itchy skin that is not inflamed
- for itching around the genitals (penis and vagina )
- on open wounds
Warnings and cautions
- Betnovate with chinoform should not be diluted
- Use only for as long as your doctor recommends. If your condition does not improve after 2-4 weeks, talk to your doctor.
- Do not use in children without a doctor’s prescription. Children are only treated in special cases.
- Only use a dressing if your doctor has told you to. If you apply Betnovat with chinoform under a dressing, including a diaper, make sure the skin is properly cleansed before applying a new dressing. This is to avoid infection. Bandages should be avoided in case of infected skin changes.
- Be careful when applying Betnovat with chinoform on the face for an extended period of time as skin thinning may occur. Sensitive skin areas, such as the armpits, groin, and eye region, should only be treated briefly.
- Be careful when applying Betnovat with chinoform on the eyelids. Avoid getting Betnovat with a chino from in your eyes.
- If you have dermatitis ( inflammation of the skin) around a leg ulcer, local corticosteroids may increase the risk of an allergic reaction or infection around the leg ulcer.
- If you have psoriasis, your doctor will want to see you more often as there is a risk of tolerance development and relapse.
- There is a small theoretical risk of nervous disorders ( subacute myeloid optic neuropathy, SMON) in long term treatment, especially under occlusive dressings.
- Betnovate with chinoform can color skin, hair, and clothes.
- The use of Betnovate may cause betamethasone to affect the whole 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 side effects ).
- Cortisone preparations can mask, activate, or aggravate a skin infection.
- Talk to your doctor if you have previously had a hypersensitivity reaction to any cortisone preparation or to iodine.
- Contact a doctor if you experience blurred vision or other visual disturbances.
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?
- Contact your doctor if an infection develops (see section 4 Side effects ).
Other medicines and Betnoval with chinoform
Some medicines may affect the way chinoform Betnovat works or increase the risk of side effects. Examples of such drugs include:
- Ritonavir (drugs for HIV – infection s) and itraconazole (antifungal medicines)
- Vigabatrin (a medicine used to treat epilepsy )
- Tell your doctor or pharmacist if you are taking any of these. There are other drugs that can have a similar effect. It is therefore important to tell your doctor or pharmacist if you have or have recently taken any other medicines, or if you are going to start taking new, even over-the-counter medicines.
Pregnancy and breastfeeding
If you are pregnant or think you may be pregnant or are planning to have a baby, do not use Betnovate Chinoform without consulting your doctor before using Betnovate Chinoform.
Talk to your doctor when using Betnovate with chinoform during breast-feeding.
- If you use Betnovate with chinoform during breast-feeding, do not use Betnovate with chinoform on the area of the breast to prevent the baby from accidentally ingesting Betnovat with chinoform in the mouth.
Driving and using machines
No known effect on the ability to drive or perform precision work with concomitant use of Betnovat with chinoform.
3. How to use Betnovate with chinoform
Always use Betnovate with chinoform exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Use once or twice a day. Your doctor will tell you how often to use this medicine. The number of times you use the medicine may decrease as your skin improves. Your doctor may prescribe a weaker steroid for you to use instead.
Apply thinly and gently, using only a sufficient amount to cover the area to be treated. Allow enough time for absorption before applying emollient cream.
Wash your hands afterward unless it is the hands to be treated. 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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you forget to use Betnovate with chinoform
- Iron on it as soon as you remember, and then continue as usual.
- Do not apply extra Betnovat with chinoform to compensate for a missed dose.
If you stop using Betnovate with chinoform
- If you use Betnovate with chinoform regularly, talk to your doctor before stopping using it. Dose one should be reduced gradually.
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 allergic reactions at the application site (which may be caused by betamethasone or the preservative, chlorocresol, in cream one) occur. Discontinue treatment and consult a physician.
Common(may affect up to 1 in 10 people):
- local burning sensation/pain in the skin.
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(may affect up to 1 in 10,000 people):
- inhibition of adrenal cortex function
- weight gain / Obesity
- moon face/rounder face
- dry skin
- visible blood vessels under the skin
- hair loss, lack of hair growth, damaged hair
- worsened symptoms
- irritation/pain at the application site
- reddening of the skin
- rash or hives
- if you have psoriasis you can get blisters under the skin. This occurs very rarely during or after treatment and is called pustular psoriasis.
- infection that occurs due to a weakened immune system (opportunistic infection )
- discoloration of hair, skin, and clothing.
- delayed weight gain
- slow growth in children.
- reduction of the hormone cortisol in the blood
- increased levels of sugar in the blood or urine
- increased blood pressure
- the cloudy lens in the eye (cataracts) or increased pressure in the eye ( glaucoma )
- weakened skeleton ( osteoporosis ).
- allergic reactions in the form of increased skin irritation
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.
5. How to store Betnovat with chinoform
- 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 substances in Betnovat with chinoform are betamethasone and clioquinol.
1 g of cream contains 1 mg of betamethasone (as betamethasone valerate) and 30 mg of clioquinol. The other ingredients are cetostearyl alcohol, macrogol cetostearyl ether, liquid paraffin, white petrolatum, sodium dihydrogen phosphate, phosphoric acid, sodium hydroxide, water, chlorocresol ( preservative ).
What the medicine looks like and the contents of the pack
Betnovate with chinoform cream is pale yellow and is supplied in an aluminum tube containing 30 g.
Marketing Authorization Holder and Manufacturer
GlaxoSmithKline AB, Box 516, 169 29 Solna
Tel: 08-638 93 00