1 mg / g ointment 
mometasone furoate

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 Demoson is and what it is used for 
2. What you need to know before you use Demoson 
3. How to use Demoson 
4. Possible side effects 
5. How to store Demoson 6. Contents of the pack 
and other ingredients information

1. What Demoson is and what it is used for

Demoson contains the active substance mometasone furoate and is a cortisone preparation (or corticosteroid ) for topical use. Cortisone preparations for topical use are divided into four classes depending on strength or effect: mild-acting, medium-acting, strong-acting, and extra-strong. Demoson belongs to the class “strong-acting cortisone preparations”.

Adults and children over 2 years of age: Demoson is used to reduce symptoms caused by certain inflammatory skin diseases, such as psoriasis (except widespread plaque psoriasis) and atopic dermatitis. This ointment is best suited for the treatment of very dry, scaly, and cracked skin changes. It does not cure your skin disease but relieves your symptoms.

Mometasone furoate contained in Demoson may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Demoson

Do not use Demoson

  • if you are allergic to mometasone, other cortisone preparations, or any of the other ingredients of this medicine (listed in section 6).
  • if the skin change is infected without simultaneously treating infection one
  • for other skin conditions that can be aggravated, especially rosacea (skin disease of the face), acne, skin atrophy (skin loss), rash around the mouth ( dermatitis ), itching in the abdomen, diaper rash, bacterial infections such as impetigo, tuberculosis (skin infection), syphilis (sexually transmitted disease), viral infections such as cold sores, shingles, chickenpox, warts, parasitic infections such as scabies, fungal infections such as athlete’s foot (red itchy scaly skin on the feet), or Candida infection in the abdomen that can cause discharge and itching or other skin infections.
  • on open wounds or sore skin.
  • if you have recently had any side effects from vaccination (for example against the flu )

Warnings and cautions

Talk to your doctor or pharmacist before or during treatment if any of the following affect you before or during your use of Demoson.

Cortisone drugs can mask, activate or aggravate a skin infection.

Tell your doctor immediately if you develop irritation or hypersensitivity when using Demoson.

When this medicine is used for psoriasis, the condition can get worse (for example, a pustular form with many small blisters on the skin can be triggered by the disease). Your doctor should review the development of your symptoms regularly, as this type of treatment requires close monitoring.

Talk to your doctor as soon as possible if you get an infection in the skin where you are using Demoson. If an infection does not respond to treatment, you may need to stop using Demoson until the infection is under control.

Applying Demoson to a large area of ​​the body or covered skin (eg under a baby diaper, under or in a fold of skin, or under a dressing) may increase the risk of an asteroid being absorbed through the skin. If taken up, Demoson can cause certain side effects in the body. If you need to apply on a large area, under a bandage or diaper, or in skin folds, consult a doctor or pharmacist for advice before applying.

Any adverse events are reported with systemic use of corticosteroids (when the drug affects the entire body), such as impaired adrenal, can also occur as local topical treatment with cortisone, especially in infants and children.

Do not apply ointment to eyelids. Be careful and avoid getting ointment in the eyes as in very rare cases it can cause cataracts (the eye lens becomes cloudy) or glaucoma (increased pressure in the eye). Normally you should not apply the ointment to your face. If your doctor recommends applying the ointment on your face, it should not normally be done for more than 5 days.

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

When Demoson is used in the area around the genitals or rectal opening and you use a latex condom at the same time, the white Vaseline that is included as an excipient in the ointment can impair the condom’s tensile strength and increase the risk of it breaking.

Demoson can be used in children over 2 years of age, however, special care should be taken (see information below).

Other medicines and Demoson

Tell your doctor or pharmacist if you are taking or using, have recently taken or used or might take or should take any other medicines, including medicines obtained without a prescription and other cures or supplements such as vitamins. Talk to your doctor before using any medicine.

Pregnancy and breastfeeding

If you are pregnant or 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.

If your doctor prescribes the use of the ointment during pregnancy or breastfeeding, you should avoid using large amounts and only for a short period. It is not known if the medicine passes into breast milk after you have applied it to the skin. To avoid accidental ingestion, Demoson should not be applied to breasts or skin in nearby areas.

Ask your doctor or pharmacist for advice before taking any medicine.

Demoson contains propylene glycol and butylhydroxytoluene

Demoson contains propylene glycol which may cause skin irritation and butylhydroxytoluene (E321) which may cause local skin reactions (eg contact dermatitis) or be irritating to eyes or mucous membranes.

3. How to use Demoson

Dosage instructions:

Demoson is for cutaneous use (use on the skin).

This medicine is for external use only.

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

Use for children

Demoson is not recommended for children under 2 years.

Your doctor should check your treatment regularly.

Adults, the elderly, and children aged 2 and over:

The recommended dose is a thin layer of ointment that is gently applied once a day on affected skin areas.

Normally, one click of ointment on your fingertip (from fingertip to the first-line) is enough to cover an area equivalent to the size of two adult hands. Never use in large quantities and not more often than instructed by your doctor or pharmacist.

Take special care:

  • If you are advised to apply the ointment on your face, do not use the ointment for more than 5 days without the special supervision of your doctor.
  • Do not use ointment over large areas of the body (over 20% of the body surface) or for a long time (for example, every day for more than 3 weeks)
  • Avoid getting ointment in your eyes.
  • Unless instructed to do so by your doctor, do not cover the treated area with a compressor dressing. This is to not increase the uptake of the ointment and increase the possible risk of side effects.

Use for children and adolescents:

  • Do not use the ointment on children over 2 years of age, on any part of the body, without the close supervision of a physician. Do not apply ointment on more than 10% of the baby’s skin surface for a maximum of 5 days. Do not apply the ointment under a baby’s diaper as it may make it easier for the medicine to be absorbed through the skin (see also Warnings and Precautions).

If you use more Demoson than you should

If you accidentally swallow the ointment, it should not normally lead to any side effects. Contact a doctor, pharmacist, or the Poison Information Center if you are worried, for risk assessment and advice. If you use ointment more often than directed, or on large areas of the body, your hormones may be affected. In children, height growth and development can be affected.

If you have not followed the instructions or doctor’s instructions and have used the ointment too often and/or for a long period of time, you should consult your doctor or pharmacist.

If you forget to use Demoson

If you forget to apply the ointment at the time when you should do it, do it as soon as you remember and then continue as before. Do not use double the amount and do not apply ointment twice in one day to compensate for forgotten treatment.

If you stop using Demoson

Do not suddenly stop using Demoson if you have been using it for a long time, as this may be harmful. Treatment should be stopped gradually according to the instructions of your doctor as you may get severe rashes that are very red, itchy, and painful. To stop using Demoson, use a smaller amount with each application or use Demoson less often (eg every other day).

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. If your symptoms do not improve after use according to your doctor’s instructions or if they get worse, contact your doctor.

If you notice any of the following side effects, stop using this medicine and contact your doctor or go to the emergency department of the nearest hospital:

  • Cushing’s syndrome can include many symptoms such as rapid weight gain, especially on the torso and face, and general weakness, especially in children treated with cortisone as they may absorb more of this drug through the skin.

Other side effects are in children and adults who have reported on corticosteroids for topical use include:

Common (may affect up to 1 in 10 people)

  • A stinging or stinging sensation

Uncommon (may affect up to 1 in 100 people)

  • The emergence of small nodules and pimples
  • During long-term and intensive treatment, skin thinning ( skin atrophy ) can occur, which can lead to increased absorption and increased risk of side effects, stretch marks in superficial blood vessels, skin infections, irregular skin marks or streaks on the skin (including stretch marks) and rosacea-like redness of the face.

Rare (affects up to 1 in 1000 people)

  • When large body areas are treated, effects on the adrenal glands can occur. It disappears when the treatment is stopped.
  • Strong hair growth (hypertrichosis).
  • Allergic reactions in the form of increased redness, itching, tingling, and skin irritation. 

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

  • Inflamed hair follicles
  • Burning sensation
  • Itching

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

  • Skin infection, or blisters. You should talk to your doctor as soon as possible (see also Warnings and Precautions).
  • Tingling or numbness in the arms and legs ( paresthesia ).
  • Pain at the application site, skin reactions at the application site.
  • Visible small blood vessels under the skin, skin inflammation (including acne-like reactions), red, itchy, scaly rashes that may be around the mouth, changes in skin color, purple or dark blue discoloration of the skin, increased sensitivity, burning, dryness, skin maceration (softening and whitening of the skin ), heat rash (very itchy rash).
  • Dimsyn.

Increased use, treatment of larger skin areas, long-term use, and treatment with compresses can increase the risk of side effects.

Cortisone preparations can affect the body’s normal hormone production. This is more likely when using high doses for a longer period of time.

Additional side effects are in children and adolescents

Growth in children can be inhibited by long-term use. Your doctor will prevent this risk by prescribing the lowest possible cortisone dose for a controlled treatment of your symptoms.

5. How to store Demoson

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 tube and carton after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Opened tube with the remaining ointment is discarded after 12 weeks.

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 mometasone furoate

1 gram Demoson contains 1 mg of the active substance mometasone furoate.

  • The other ingredients are hexylene glycol, concentrated phosphoric acid (for adjustment), propylene glycol monopalmitostearate, white wax, white petrolatum, butylhydroxytoluene (E321) (antioxidant), and purified water.

What the medicine looks like and the contents of the pack

Demoson is a translucent, w, White, and soft ointment.

Ointment in an aluminum tube with a white screw cap made of polyethylene packed in cardboard.

Pack sizes:

Tubes containing 10 g, 15 g, 20 g, 30 g, 50 g, 60 g, or 100 g of ointment.

Not all packaging may be marketed.

Manufacturer

McDermott Laboratories Limited to Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL, UK

Mylan UK Healthcare Limited, Building 20, Station Close, Potters Bar, EN6 1TL, UK

Muhammad Nadeem

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