Celecrem 0.5 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Celecrem 0.5 mg/g cream

Betamethasone

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Contents of the leaflet

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

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

Celecrem 0.5 mg/g cream contains betamethasone, which is an anti-inflammatory (a corticosteroid) for topical 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 commonly used, for example, soap (allergic and irritant contact dermatitis), coin-shaped rash (nummular eczema), and itchy rash on the hands and feet (dyshidrotic eczema). Atopic dermatitis and neurodermatitis (rashes or eczemas related to patient-specific factors), exfoliative dermatitis (widespread reddish scaling), seborrheic dermatitis (rash on the skin with inflammation and scaling), stasis dermatitis (inflammation of the skin near the ankles due to venous insufficiency), psoriasis (reddish scaly condition).

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

Another medicine of the same brand but with a higher concentration of active ingredient is also commercially available: Celecrem 1 mg/g cream. The physician will decide between the two options depending on the severity of the condition.

2. What you need to know before using 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 (for example: herpes or chickenpox).
• in areas of skin affected by rosacea (inflammation with redness of the facial skin) or perioral inflammation (perioral dermatitis).
• in skin conditions involving skin thinning (atrophy).
• in areas of skin showing a vaccine reaction, i.e., redness or inflammation after vaccination.
• in the eyes or on deep wounds.
• in children under 1 year of age.
• if you have a fungal infection anywhere in your body.

Warnings and precautions

Talk to 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 over large areas of the body or for prolonged periods, as this significantly increases the risk of adverse effects.
• If any hypersensitivity reaction occurs, stop treatment and seek appropriate therapy advice.
• If you develop an infection during treatment with this medicine, consult your doctor regarding its management.
• Adverse effects associated with corticosteroid use, including adrenal gland suppression, may also occur with topical application due to systemic absorption of the active ingredient, especially when treating large areas, during prolonged treatment, or when using occlusive dressings (see section 4 and section 3, If you use more Celecrem 0.5 mg/g cream than you should).
• Do not apply the medicine with occlusive dressings (or air-impermeable materials, such as certain diapers), or in skin folds such as the groin or armpits.
• Do not apply on the face.
• This medicine must not come into contact with the eyes, mouth, open wounds, or mucous membranes (e.g., the genital area).
• If you use this medicine for conditions other than those for which it was prescribed, it may mask symptoms and hinder correct diagnosis and treatment.
• If you are being treated for psoriasis, strict medical supervision is recommended to monitor for 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 its use is not recommended in children under 12 years of age.

In children, corticosteroids are more likely to be absorbed through the skin, increasing the risk of adverse effects in other parts of the body compared to adult patients.

In children treated with topical corticosteroids, suppression of the adrenal glands located near the kidneys has been reported, leading to symptoms such as obesity and growth retardation (Cushing's syndrome), or increased intracranial pressure (intracranial hypertension), which may manifest, among other signs, as bulging of the fontanelle in infants and headaches.

Other medicines and Celecrem 0.5 mg/g cream

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

No interactions between Celecrem cream and other medicines are known.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Pregnancy

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

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

Pregnant women or those planning pregnancy should not use Celecrem 0.5 mg/g cream over large skin areas, for prolonged periods, or with occlusive dressings.

Breastfeeding

Do not apply this medicine on the breasts during breastfeeding; avoid contact between the child and treated areas.

Do not use Celecrem 0.5 mg/g cream during breastfeeding unless instructed by your doctor, and do not use it over large skin areas, for prolonged periods, or with occlusive dressings.

Driving and operating machinery

Treatment with this medicine does not affect the ability to drive or operate machinery.

Celecrem 0.5 mg/g cream contains cetostearyl alcohol and chlorocresol

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

This medicine may cause allergic reactions because it contains chlorocresol.

3. How to use Celecrem 0.5 mg/g cream

Follow exactly the instructions for use of this medicine as given by your doctor.

If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children over 12 years of age

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

Your doctor will determine the frequency of application based on the severity of the condition. While mild cases may respond to once-daily application, more severe cases may require more frequent application.

The duration of treatment should not exceed 2 weeks.

For topical use only.

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 sections Do not use Celecrem 0.5 mg/g cream and Children in section 2).

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

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

If you use the cream more often than you should or over large areas of 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 advisable to gradually withdraw corticosteroids.

Treatment of overdose is symptomatic. Acute symptoms due to excessive use of corticosteroids are generally reversible.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service. Tel.: 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 missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine may cause 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.

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

• Skin thinning (atrophy)
• Dryness or cracking of the skin
• Itching or burning
• Miliaria (red or white pimples in various parts of the body)
• Redness (erythema)
• Bruising
• Inflammation of hair follicles (folliculitis)
• Skin striae (stretch marks)
• Acne
• Skin maceration
• Allergic skin reaction (contact dermatitis)
• Infections, including fungal infections
• Paresthesia (an abnormal sensation of the skin, such as numbness, tingling, pricking, burning, or itching of the skin)
• Hair loss
• Increased 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 parts of the body, which may happen if the active substance passes into the body through the skin.

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

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return empty containers and unused medicines to the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other 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 components (excipients) are: chlorocresol, sodium dihydrogen phosphate dihydrate, phosphoric acid, cetostearyl alcohol, cetostearyl macrogol ether, white soft paraffin, liquid paraffin, and purified water.

Appearance of the medicinal product and contents of the pack

Celecrem 0.5 mg/g is a white cream with a soft and uniform texture.

It is available in tubes containing 30 g 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 the most recent revision of this leaflet: May 2019.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/