0.05% ointment and cream 
clobetasone

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Emovat is and what it is used for 
2. What you should know before using Emovat 
3. How to use Emovat 
4. Possible side effects 
5. How to store Emovat 6. Contents of the pack 
and other ingredients information

1. What Emovat is and what it is used for

Emovat is a medium-acting cortisone preparation (group II) that counteracts inflammation and has an antipruritic effect. Emovat is used in the treatment of acute and chronic eczema of various origins. The ointment is used to treat dry and scaly eczema and the cream is intended for acute and liquid eczema.

2. What you should know before using Emovat

Do not use Emovat

  • if you are allergic (hypersensitive) to clobetasone or any of the other ingredients of Emovat (see section 6)
  • in infected skin (unless the infection is treated with anti-infective drugs at the same time)
  • in rosacea (skin problems where the nose, cheeks, chin, forehead, or whole face are unusually red, with or without visible blood vessels)
  • in acne
  • on itchy skin that is not inflamed
  • in skin atrophy (skin changes that cause thin and brittle skin)
  • in case of rash around the mouth (perioral dermatitis )
  • reactions after vaccination.

→ if you think any of these apply to you, talk to your doctor or pharmacist before using Emovat.

Warnings and cautions

  • Local hypersensitivity reactions with symptoms 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?
  • If you have previously had a hypersensitivity reaction to any cortisone preparation.
  • Be careful when applying Emovat to the eyelids. Avoid getting Emovat in your eyes.
  • Be careful when applying Emovat to the face for a long time as it can lead to thinning of the skin.
  • If you have eczema around a leg ulcer, using a cortisone cream or ointment may increase the risk of an allergic reaction or infection around the leg ulcer.
  • Only use a dressing over this medicine if your doctor has told you to. If you apply Emovat under an airtight dressing, including a baby’s diaper, make sure the skin is well cleansed before applying a new dressing to avoid infection.
  • When treating large areas for a long time, when treating with a dressing or treating damaged skin, the risk increases and can lead to cortisone affecting 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 termination 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 ).
  • Used with caution in children under 12 years.
  • Contact your doctor if an infection occurs (see section 4 Possible side effects ).
  • Contact a doctor if you experience blurred vision or other visual disturbances.

You should not stop using Emovat abruptly as the skin problems may then return.

Other medicines and Emovat

Some medicines may affect the way Emovat works or increase the risk of side effects. Examples of these drugs are:

  • Ritonavir (used in HIV – infection s)
  • Itraconazole (against fungal infections)

→ Tell your doctor or pharmacist if you are taking any of these. Other drugs 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, ask your doctor for advice before taking this medicine.

If you are breast-feeding, talk to your doctor before using Emovat.

  • If you use Emovat while breast-feeding, do not use Emovat on your breasts to ensure that your baby does not accidentally get Emovat in his mouth.

Driving and using machines

No known effect on the ability to drive or perform precision work with concomitant use of Emovat.

Emovat contains

Emovat cream contains chlorocresol which may cause allergic reactions and cetostearyl alcohol which may cause local skin reactions (eg contact dermatitis).

3. How to use Emovat

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Apply thinly according to a doctor’s prescription.

  • Apply a thin layer and massage in gently. Use only the amount needed to cover the entire affected area.
  • After applying Emovat, hands should be washed thoroughly, unless hands are to be treated.
  • If you are also using an emollient cream, wait a while for Emovat to be absorbed by the skin before applying the emollient cream.

This medicine should not be used every day for more than 4 weeks at a time.

Use for children  

Children should be treated with the least possible amount for the shortest possible time. The treatment should not normally exceed seven days. When the ointment/cream seems to help, you can apply it less often and reduce the treatment time. If the symptoms worsen or do not improve within seven days, contact your doctor again. Regular daily use for longer than four weeks is not recommended for children.

Elderly and patients with hepatic or renal impairment

Elderly and patients with hepatic or renal impairment should be treated with the least possible amount for the shortest possible time.

If you forget to use Emovat

  • If you forget to use Emovat, apply it as soon as you remember, then continue treatment as usual.
  • Do not apply extra Emovat to make up for a forgotten dose.

If you stop using Emovat

  • If you use Emovat regularly, talk to your doctor before stopping treatment.

If you use more Emovat than you should

Acute overdose is unlikely, but in case of prolonged overdose or misuse, always contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

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. In toddlers and infants, the diaper can act as a cover bandage and increase absorption through the skin.

If your skin symptoms get worse or if your skin swells during treatment, you may be allergic to the medicine, get an infection or need another treatment.

→ Stop using Emovat and contact your doctor as soon as possible.

Uncommon (may affect up to 1 in 100 people):

  • thinning skin that can cause stretch marks
  • rash on the face ( rosacea )
  • stretch marks in superficial blood vessels
  • hypersensitivity chlorocresol ( preservatives in the cream a).

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

  • inhibition of adrenal cortex function
  • cushingoid features (moon face / central obesity)
  • delayed weight gain / growth retardation in children
  • weakened skeleton ( osteoporosis )
  • the cloudy lens in the eye (cataracts)
  • increased pressure in the eye ( glaucoma )
  • increased levels of sugar in the blood or urine
  • high blood pressure
  • weight gain / obesity
  • reduction of the hormone cortisol in the blood
  • infection that occurs due to a weakened immune system ( opportunistic infection )
  • allergic reactions at the application site
  • rash or urticaria ( hives )
  • skin thinning
  • worsening of the skin disease
  • pigment changes
  • local burning sensation in the skin
  • increased body hair
  • itching
  • reddening of the skin.

Has been reported (occurs in an unknown number of users):

  • dimsyn.

5. How to store Emovat

  • 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 expiration date is the last day of the specified 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

Content declaration

The active substance is clobetasone.

1 g ointment contains 0.5 mg clobetasone (as clobetasone butyrate). The other ingredients are liquid paraffin, white Vaseline.

1 g of cream contains 0.5 mg of clobetasone (as clobetasone butyrate). The other ingredients are glycerol monostearate, cetostearyl alcohol, stearoyl macrogol glycerides, white wax, sodium citrate, citric acid monohydrate, dimethicone, glycerol, purified water, chlorocresol ( preservative ).

What the medicine looks like and contents of the pack

Emovat ointment is white to translucent and is supplied in aluminum tubes containing 25 g, 30 g, or 100 g.

Emovat cream is white and is supplied in aluminum tubes containing 25 g, 30 g, or 100 g.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

GlaxoSmithKline AB, Box 516, 169 29 Solna

Tel: 08-638 93 00

Email: info.produkt@gsk.com

Muhammad Nadeem

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