CELECREM 0.5 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Celecrem 0.5 mg/g Cream

Betamethasone

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Celecrem 0.5 mg/g cream and what is it used for
2. What you need to know before you use Celecrem 0.5 mg/g cream
3. How to use Celecrem 0.5 mg/g cream
4. Possible side effects
5. Storage of Celecrem 0.5 mg/g cream
6. Contents of the pack and further information

1. What is Celecrem 0.5 mg/g cream and what is it used for

Celecrem 0.5 mg/g cream contains betamethasone, which is an anti-inflammatory (a corticosteroid), for use on the skin.

It is indicated for: Local treatment of inflammatory and pruritic (itchy) skin manifestations that respond to corticosteroids, such as: allergy to a substance that has come into contact with the skin or reaction to substances of habitual use, such as soap (allergic contact dermatitis and irritant contact dermatitis), coin-shaped eruption (nummular eczema) and itchy eruption on hands and feet (dyshidrotic eczema). Atopic dermatitis and neurodermatitis (eruptive or eczematous conditions related to patient factors), exfoliative dermatitis (generalized red scaling), seborrheic dermatitis (skin eruption with inflammation and scaling), stasis dermatitis (inflammation of the skin near the ankles in venous insufficiency), psoriasis (scaly red condition).

Celecrem 0.5 mg/g cream is indicated for adults and children over 12 years of age.

Another medicine of the same brand but with a higher concentration of active ingredient, Celecrem 1 mg/g cream, is also marketed. The doctor will decide between the two, depending on the intensity of the condition.

2. What you need to know before you use Celecrem 0.5 mg/g cream

Do not use Celecrem 0.5 mg/g cream

• if you are allergic to betamethasone, other corticosteroids or any of the other ingredients of this medicine (listed in section 6).
• if you have tuberculosis, syphilis, or viral infections (such as herpes or chickenpox).
• on areas of skin affected by rosacea (inflammation with redness of the skin on the face) or on an inflammation around the mouth (perioral dermatitis)
• on skin diseases with thinning of the skin (atrophy)
• on areas of skin showing a vaccination reaction, i.e. redness or inflammation after vaccination
• in the eyes or in deep wounds
• in children under 1 year of age
• if you have a fungal infection in any part of your body.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Celecrem 0.5 mg/g cream.

• Anti-inflammatory drugs (corticosteroids) have significant effects on the body. The cream should not be applied to large areas of the body or for prolonged periods, as this significantly increases the risk of side effects.
• If a hypersensitivity reaction occurs, discontinue treatment and appropriate therapy should be indicated.
• If an infection develops during the use of this medicine, you should consult your doctor about its treatment.
• The side effects described with the use of corticosteroids, including adrenal gland disorders, may also occur with topical use by absorption into the body, especially if large areas are treated, in prolonged treatments or with occlusive dressings (see section 4 and section 3, If you use more Celecrem 0.5 mg/g cream than you should).
• The medicine should not be applied with occlusive dressings (or air-impermeable materials, such as some diapers), nor in skin folds, such as the groin or armpits.
• Do not apply to the face.
• This medicine should not come into contact with the eyes, mouth, open wounds or mucous membranes (such as the genital area).
• If you use this medicine for diseases other than those for which it has been prescribed, it may mask symptoms and make diagnosis and correct treatment more difficult.
• If you are being treated for psoriasis, strict medical supervision of your disease is recommended to observe any possible worsening.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children

This medicine is contraindicated in children under 1 year of age and is not recommended for use in children under 12 years of age.

In children, it is more likely that the corticosteroid will pass through the skin and have side effects in other areas of the body than in adult patients.

In children treated with topical corticosteroids, disorders of the adrenal glands have been reported, which can cause symptoms such as obesity, growth retardation, etc. (Cushing's syndrome) or an increase in intracranial pressure (intracranial hypertension) that can manifest, among other signs, as bulging of the fontanelle in infants and headaches.

Other medicines and Celecrem 0.5 mg/g cream

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

No interactions with other medicines are known for Celecrem cream.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

As a general rule, during the first trimester of pregnancy, the cream should not be applied.

This medicine will not be used during pregnancy unless your doctor considers that the potential benefit of its use justifies the potential risk to the fetus.

Pregnant women or those planning to become pregnant should not use Celecrem 0.5 mg/g cream on large areas of skin, for prolonged periods, or with occlusive dressings.

Breastfeeding

Do not apply this medicine to the breasts during breastfeeding; do not let the child come into contact with treated areas.

Do not use Celecrem 0.5 mg/g cream during breastfeeding unless your doctor tells you to, and do not use it on large areas of skin, for prolonged periods, or with occlusive dressings.

Driving and using machines

Treatment with this medicine does not affect the ability to drive or use machines.

Celecrem 0.5 mg/g cream contains cetoconazole and chlorocresol

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetoconazole.

This medicine may cause allergic reactions because it contains chlorocresol.

3. How to use Celecrem 0.5 mg/g cream

Follow the instructions for administration of this medicine exactly as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children over 12 years of age

Apply a thin layer of the cream to the affected area, one to three times a day. Application once or twice a day is usually effective. However, the frequency of application should be determined according to the intensity of the condition.

Your doctor will indicate the frequency of application according to the severity of the condition. While mild cases may respond to application once a day, more severe cases may require more frequent application.

Treatment should not exceed 2 weeks.

Topical use.

The cream should be applied in a thin layer with gentle massage, covering the affected area.

Use in children

Celecrem 0.5 mg/g cream is not indicated for children under 12 years of age (see, in section 2, the sections Do not use Celecrem 0.5 mg/g creamand Children).

If you use more Celecrem 0.5 mg/g cream than you should

Excessive use of topical corticosteroids (repeated overdoses) can cause side effects (see section 4).

If you use the cream more often than you should or on large areas of skin, it may be absorbed through the skin and cause various disorders; in children, this can affect their growth and development.

In cases of chronic toxicity, it is recommended that corticosteroids be withdrawn gradually.

Treatment of overdose is symptomatic. The acute symptoms of excessive use of corticosteroids are generally reversible.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center, or call the Toxicology Information Service. Phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Celecrem 0.5 mg/g cream

Do not apply a double dose to make up for forgotten doses.

Apply the dose as soon as possible and then continue with your usual treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported with the use of Celecrem 0.5 mg/g cream: allergies, eruptions and changes in skin color.

The following reactions have also been reported with the use of topical corticosteroids, especially after prolonged application, on large areas, with occlusive dressings, and/or in children:

• Thinning of the skin (atrophy)
• Dryness or cracking of the skin
• Itching or burning
• Miliaria (red or white grains in various parts of the body)
• Redness (erythema)
• Bruises
• Inflammation of the hair follicles (folliculitis)
• Stretch marks
• Acne
• Macération of the skin
• Allergic skin reaction (contact dermatitis)
• Infections, including fungal infections
• Paresthesia (an abnormal sensation of the skin, such as numbness, tingling, stabbing, burning or tickling of the skin).
• Hair loss
• Increased hair growth
• Perioral dermatitis (inflammation around the mouth).
• Blurred vision

Side effects may occur not only in the treated area but also in completely different areas of the body, which can happen if the active ingredient passes through the skin into the body.

This, for example, can increase eye pressure (glaucoma) or could cause a condition characterized by a rounded face, fat accumulation, hump, delayed healing, psychiatric symptoms, etc. (Cushing's syndrome); increased intracranial pressure, increased blood pressure, fluid retention (edema), osteoporosis, increased cholesterol and triglycerides, cataracts.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Celecrem 0.5 mg/g cream

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

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 protect the environment.

6. Contents of the pack and further information

Composition of Celecrem 0.5 mg/g cream

• The active substance is betamethasone (as valerate).

Each gram of cream contains 0.5 mg of betamethasone.

(0.61 mg of betamethasone valerate)

• The other ingredients (excipients) are: chlorocresol, sodium dihydrogen phosphate dihydrate, phosphoric acid, cetoconazole, macrogol cetoconazole ether, white petrolatum, liquid paraffin and purified water.

Appearance of the product and pack contents

Celecrem 0.5 mg/g is a cream, white in color, with a smooth and uniform texture.

It is available in tubes containing 30 and 60 g of cream.

Marketing authorization holder and manufacturer

Marketing authorization holder

Galenicum Derma, S.L.U.

Cra N-1, Km 36

28750 San Agustin del Guadalix (Madrid)

Spain

Manufacturer

SAG Manufacturing S.L.U.

Carretera N-I, Km 36

28750 San Agustin de Guadalix

Madrid - Spain

Date of last revision of this leaflet: May 2019.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/