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Leaflet: Information for the user

Dermovat cream 0.05%, Dermovat ointment 0.05%, Dermovat cutaneous solution 0.5 mg / ml

clobetasol propionate

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 may harm them, even if they show symptoms 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 Dermovat is and what it is used for 
2. What you need to know before using Dermovat 
3. How to use Dermovat 
4. Possible side effects 
5. How to store Dermovat 6. Contents of the pack 
and other ingredients information

1. What Dermovat is and what it is used for

Dermovat is used in the treatment of severe cases of psoriasis (uncommon plaque psoriasis) and eczema.

The ointment is suitable for dry and scaly skin changes, while the cream is better suited for exfoliating skin changes. The solution is intended for the treatment of the scalp but can also be used on other parts of the body.

Dermovat is an extra strong-acting cortisone preparation (group IV) that counteracts inflammation and has an antipruritic effect.

2. What you need to know before using Dermovat

Do not use Dermovat

If you are allergic to clobetasol or any of the other ingredients of this medicine (listed in section 6).

  • in infected skin (unless the infection is co-treated with an antimicrobial therapy)
  • 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 )
  • in case of itching of the skin without inflammation
  • around the anus or genitals (penis and vagina )
  • in the treatment of children under 1 year.

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 Dermovat for as long as your doctor recommends it. If no improvement occurs within 2-4 weeks of treatment, talk to your doctor.
  • Be careful when applying Dermovat to the eyelids. Avoid getting Dermovat in your eyes.
  • Be careful when applying Dermovat to the face for a long time as it can lead to skin thinning.
  • If you have dermatitis ( inflammation of the skin) around a leg ulcer, your corticosteroid 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.
  • Bandages should be avoided in infected eczema. Only use a dressing if your doctor has recommended it. If Dermovat is applied under a dressing, clean the skin before applying a new dressing to prevent infection.
  • Dermovat is not normally suitable for the treatment of children. Do not use it in children without a doctor’s prescription.
  • Sensitive skin areas e.g. The face, armpits, groin, and eye region should only be treated briefly.
  • Cortisone preparations can mask, activate or aggravate a skin infection.
  • Using a high dose of Dermovat for a long time can cause cortisone 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 ).
  • Contact a doctor if you experience blurred vision or other visual disturbances.

After applying Dermovat, hands should be washed thoroughly, unless hands are to be treated.

Other medicines and Dermovat

Some medicines may affect the way Dermovat works or increase the risk of side effects. Examples of

these drugs are:

  • Ritonavir (drug against HIV – infection s).
  • Itraconazole (a medicine used to treat fungal infections).

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy, breastfeeding, and fertility

There is a risk that the fetus is affected. Therefore, always consult a doctor before using Dermovat during pregnancy.

Talk to your doctor before using Dermovat during breast-feeding. Never apply Dermovat to your breasts while breast-feeding to avoid accidentally getting Dermovat in your mouth.

Driving and using machines

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

Excipients

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

Dermovat cream and ointment contain propylene glycol.

Dermovat cream contains 475 mg of propylene glycol per gram.

Dermovat ointment contains 50 mg of propylene glycol per gram.

Propylene glycol may cause skin irritation.

3. How to use Dermovat

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

Recommended dosage:

  • Use Dermovat once or twice daily for a maximum of four weeks. How often your iron can be reduced as your skin improves or your doctor will prescribe a weaker steroid for you to use instead.

How to use Dermovat:

Cream and ointment

  • Apply thinly and lubricate carefully according to the doctor’s prescription. Use only so much that it just covers the area to be treated.
  • After applying Dermovat, hands should be washed thoroughly, unless hands are to be treated.
  • This medicine should not be used every day for more than four weeks at a time.

If your eczema flares up frequently, your doctor may suggest using a less frequent dose of Dermovat when your eczema is under control, to prevent your eczema from returning.

Cutaneous solution

If you wash or shampoo your hair, it should be dry before applying the cutaneous solution.

  • Unscrew the cap and place the nozzle on the scalp to be treated. Gently press on the bottle to cover with a thin and even layer of solution. You can massage in the solution, but you do not have to. Your scalp may feel cold until the solution has dried.
  • In case of very strong scaling on the scalp, the scalp should first be cleaned with salicylic acid-containing preparations and/or shampooing before the solution is dripped on and massaged into the changed skin area.

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

If you use more Dermovat then 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.

If a skin reaction occurs, your skin problem gets worse or if your skin becomes swollen during treatment, you may be allergic to the medicine, have an infection, or need another treatment.

  • Discontinue Dermovat immediately, contact your doctor as soon as possible.

Common(may affect up to 1 in 10 people):

  • skin itching
  • local burning sensation or pain in the skin.

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 to the preservative chlorocresol in cream one.

Rare(may affect up to 1 in 1,000 people):

  • hypersensitivity to the active substance clobetasol in cream, ointment, and cutaneous solution.

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

  • inhibition of adrenal cortex function
  • pigment changes
  • increased hair
  • worsening of the skin disease
  • Local hypersensitivity s
  • reddening of the skin
  • rash
  • urticaria ( hives )
  • itching
  • irritation/pain at the application site
  • contact dermatitis/skin infection at the application site
  • visible blood vessels under the skin
  • skin thinning
  • wrinkles on the skin
  • dry skin
  • If you have psoriasis, lumps may appear under the skin. This is uncommon and can occur during or after treatment and is known as pustular psoriasis
  • cushingoid features (moon face, central obesity)
  • weight gain/obesity
  • delayed weight gain/growth retardation in children
  • the weakening of the skeleton ( osteoporosis )
  • increased pressure in the eye ( glaucoma )
  • cataract ( cataract )
  • vision problems caused by detachment of the retina of the eye (central serous chorioretinopathy)
  • increased blood sugar and urine levels
  • high blood pressure
  • hair loss, lack of hair growth, damaged hair
  • decreased levels of cortisol in the blood
  • infection that occurs due to a weakened immune system ( opportunistic infection )
  • acne.

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

  • Tamsyn.

5. How to store Dermovat

  • Keep this medicine out of the 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.
  • Store cream and ointment at a maximum of 30 ° C.
  • The cutaneous solution is stored at a maximum of 25ºC. Keep the container tightly closed when not in use. Do not store Dermovat cutaneous solution in direct sunlight.
  • Medicines 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 clobetasol.

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

1 g ointment contains 0.5 mg clobetasol (as clobetasol propionate). The other ingredients are propylene glycol, sorbitan sesquiplane, white petrolatum.

1 ml of cutaneous solution contains 0.5 mg clobetasol (as clobetasol propionate). The other ingredients are carbomer, isopropyl alcohol, sodium hydroxide, purified water.

What the medicine looks like and the contents of the pack

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

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

Demovat cutaneous solution is a clear, clear solution and is supplied in a plastic bottle containing 100 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

GlaxoSmithKline AB, Box 516, 169 29 Solna

Tel: 08-638 93 00

Email: info.produkt@gsk.com

Muhammad Nadeem

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