Package Insert: Information for the User

Celecrem 0.5 mg/g Cream

Betamethasone

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may 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 package insert. See section 4.

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 manifestations (itching) of the skin that respond to corticosteroids, such as: Allergic reactions to substances that have come into contact with the skin or reactions to commonly used substances such as soap (allergic and irritative contact dermatitis), coin-shaped rash (nummular eczema) and itchy rash on hands and feet (dishydrotic eczema). Atopic dermatitis and neurodermatitis (rashes or eczemas related to patient factors), exfoliative dermatitis (generalized reddish peeling), seborrheic dermatitis (skin eruption with inflammation and peeling), stasis dermatitis (inflammation in the skin near the ankles in venous insufficiency), psoriasis (red scaly skin condition).

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

Another medication from the same brand with a higher concentration of active ingredient is available, Celecrem 1 mg/g cream. The doctor will decide between the two, depending on the severity of the condition.

Do not use Celecrem 0.5 mg/g cream

• if you are allergic to betamethasone, other corticosteroids, or any of the other components of 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 vaccination reaction, that is, redness or inflammation after the vaccine
• in the eyes or in 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 0.5 mg/g cream.

• Corticosteroid medications 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.
• Adverse effects described with the use of corticosteroids, including adrenal gland alteration, may also occur with topical use of the active ingredient, especially if treating large areas, prolonged treatment, or with occlusive dressings (see section 4 and section 3, subsectionIf you use more Celecrem 0.5 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).
• If you use this medication for conditions other than those for which it was prescribed, you may mask symptoms and make it difficult to diagnose and treat correctly.
• If you are being treated for psoriasis, it is recommended to have strict medical supervision of your condition to observe any possible worsening.
• Contact 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 have adverse effects in other parts of the body than in adult patients.

In children treated with topical corticosteroids, adrenal gland alteration has been reported, resulting in symptoms such as obesity, growth delay, etc. (Cushing's syndrome) or increased intracranial pressure, which may manifest as, among other signs, a bulge in the fontanelle in infants and headaches.

Other medications and Celecrem 0.5 mg/g cream

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

No interactions of Celecrem cream with other medications are known.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Pregnancy

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

This medication will not be used during pregnancy unless your doctor considers that the potential benefits of its use justify the potential risk to the fetus.

Women who are pregnant or planning to become pregnant should not use Celecrem 0.5 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 0.5 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

This medication treatment does not affect the ability to drive or operate machinery.

Celecrem 0.5 mg/g cream contains cetearyl alcohol and chlorocresol

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetearyl alcohol.

This medication may cause allergic reactions because it contains 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 the 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 should 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 one application a day, 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 0.5 mg/g cream is not indicated for children under 12 years old (see, in section 2, the subsectionsDo not use Celecrem 0.5 mg/g creamandChildren).

If you use more Celecrem 0.5 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, corticosteroids should 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 0.5 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 everyone will experience them.

The following adverse effects have been reported with the use of Celecrem 0.5 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 grains 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 (abnormal skin sensation, 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, 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 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 that appears 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 of 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 0.5 mg/g cream

• The active ingredient is betamethasone (as valerate).

Each gram of cream contains 0.5 mg of betamethasone.

(0.61 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 0.5 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.

Cra N-1, Km 36

28750 San Agustin del Guadalix (Madrid)

Spain

Responsible for manufacturing

SAG Manufacturing S.L.U.

Carretera 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 medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/