Label: information for the user

Celecrem 1 mg/g cream

Betametasona

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Celecrem 1 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 manifestations (with itching) of the skin that respond to corticosteroids, such as: Allergy to a substance that has come into contact with the skin or reaction to habitual substances such as, for example, soap (allergic and irritative contact dermatitis), coin-shaped eruption (nummular eczema) and itchy eruption on hands and feet (dishydrotic eczema). Atopic dermatitis and neurodermatitis (eruptions or eczemas related to patient factors), exfoliative dermatitis (generalized reddish peeling), seborrheic dermatitis (eruption on the skin with inflammation and peeling), stasis dermatitis (inflammation on the skin near the ankles in venous insufficiency), psoriasis (red scaly affection).

Celecrem 1 mg/g cream is indicated for adults and children over 12 years old.

Another medication from the same brand with a lower concentration of active ingredient is available, Celecrem 0.5 mg/g cream. The doctor will decide between the two, depending on the intensity of the patient's condition.

Do not use Celecrem 1 mg/g cream

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Celecrem 1 mg/g cream.

• Topical corticosteroids have significant effects on the body. Do not apply the cream to large areas of the body or for prolonged periods, as this significantly increases the risk of adverse effects.
• If a hypersensitivity reaction occurs, discontinue treatment and seek appropriate therapy.
• If you develop an infection during use of this medication, consult your doctor about treatment.
• Systemic effects described with the use of corticosteroids, including adrenal suppression, may also occur with topical use of the active ingredient, especially if large areas are treated, treatment is prolonged, or occlusive dressings are used (see section 4 and section 3, subsectionIf you use more Celecrem 1 mg/g cream than you should).
• Do not apply the medication with occlusive dressings (or impermeable materials, such as some diapers), or in skin folds, such as the groin or armpits.
• Do not apply to the face.
• This medication should not come into contact with the eyes, mouth, open wounds, or mucous membranes (such as the genital area).
• Using this medication for conditions other than those for which it was prescribed may mask symptoms and make diagnosis and treatment more difficult.
• Patients with psoriasis should be under strict medical supervision to monitor for possible worsening of the condition.
• Consult your doctor if you experience blurred vision or other visual disturbances.

Children

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

In children, it is more likely that the corticosteroid will pass through the skin and cause adverse effects in other parts of the body compared to adults.

In children treated with topical corticosteroids, adrenal suppression has been reported, which may manifest as symptoms such as obesity, growth retardation, etc. (Cushing's syndrome) or increased intracranial pressure, which may be manifested by other signs, such as fontanelle bulging in infants and headaches.

Other medications and Celecrem 1 mg/g cream with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

No interactions with Celecrem cream and other medications are known.

Pregnancy, breastfeeding, and fertility

Consult your doctor before using this medication if you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant.

Pregnancy

As a general rule, do not apply the cream during the first trimester of pregnancy.

This medication should not be used during pregnancy unless your doctor considers that the potential benefits of its use outweigh the potential risks to the fetus.

Pregnant women or those planning to become pregnant should not use Celecrem 1 mg/g cream on large areas of the skin, for prolonged periods, or with occlusive dressings.

Breastfeeding

Do not apply this medication to the breasts during breastfeeding; do not put the baby in contact with treated areas.

Do not use Celecrem 1 mg/g cream during breastfeeding unless your doctor advises you to do so and do not use it on large areas of the skin, for prolonged periods, or with occlusive dressings.

Driving and operating machinery

Use of this medication does not affect the ability to drive or operate machinery.

Celecrem 1 mg/g cream contains cetoestearic alcohol and chlorocresol

This medication may cause local skin reactions (such as contact dermatitis) due to the presence of cetoestearic alcohol.

This medication may cause allergic reactions due to the presence of chlorocresol.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children over 12 years old

Apply a thin layer of cream to the affected area, one to three times a day. One or two applications a day are usually effective. However, the frequency of application must be determined according to the severity of the condition.

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

The duration of treatment should not exceed 2 weeks.

Cutaneous use.

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

Use in children

Celecrem 1 mg/g cream is not indicated for children under 12 years old (see, in section 2, the subsectionsDo not use Celecrem 1 mg/g creamandChildren).

If you use more Celecrem 1 mg/g cream than you should

Excessive use of topical corticosteroids (repeated overdoses) may cause adverse effects (see section 4).

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

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

The treatment of overdose is symptomatic. Acute symptoms of excessive corticosteroid use are usually reversible.

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

If you forgot to use Celecrem 1 mg/g cream

Do not apply a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The following adverse effects have been reported with the use of Celecrem 1 mg/g cream: allergies, rashes, and changes in skin color.

In addition, the following reactions have been reported with the use of topical corticosteroids, especially after prolonged application, in extensive areas, with bandages or occlusive materials, and/or in children:

• Thinning of the skin (atrophy)
• Dryness or cracking of the skin
• Itching or burning
• Miliaria (red or white papules in various parts of the body)
• Redness (erythema)
• Bruising
• Inflammation of hair follicles (folliculitis)
• Striae (skin stretch marks)
• Acne
• Skin maceration
• Contact dermatitis (skin allergic reaction)
• Infections, including fungal infections
• Paresthesia (an abnormal sensation of the skin, such as numbness, tingling, stinging, burning, or prickling in the skin)
• Hair loss
• Excessive hair growth
• Perioral dermatitis (inflammation around the mouth)
• Blurred vision

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

This, for example, may increase eye pressure (glaucoma) or could produce a condition characterized by a rounded face, accumulation of fat, 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 Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Celecrem 1 mg/g cream

• The active ingredient is betamethasone (as valerate).

Each gram of cream contains 1 mg of betamethasone.

(1.22 mg of betamethasone valerate)

• The other components (excipients) are: chlorocresol, dihydrogen phosphate dihydrate, phosphoric acid, cetoestearic alcohol, cetoestearic ether of macrogol, white vaseline, liquid paraffin, and purified water.

Appearance of the product and contents of the packaging

Celecrem 1 mg/g is a cream, white in color, with a smooth and uniform texture.

It is presented in tubes with 30 and 60 g of cream.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Galenicum Derma, S.L.U.

Ctra N-1, Km 36

28750 San Agustin del Guadalix (Madrid)

Spain

Responsible for manufacturing

SAG Manufacturing S.L.U.

Crta. N-I, Km 36

28750 San Agustin de Guadalix

Madrid

Spain

Last review date of this leaflet: May 2019.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/