Celecrem 1 mg/g cream

Patient Information Leaflet

Introduction

Patient Information Leaflet

Celecrem 1 mg/g cream

Betamethasone

Read the entire leaflet carefully before you start using this medicine, as 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 other people, even if they have the same symptoms as you, because it could 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.

Leaflet Contents

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

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

Celecrem 1 mg/g cream contains betamethasone, an anti-inflammatory (a corticosteroid), for topical use on the skin.

It is indicated for: Local treatment of inflammatory and pruritic (itchy) skin manifestations responsive 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 affecting the hands and feet (dyshidrotic eczema). Atopic dermatitis and neurodermatitis (rashes or eczema related to patient-specific factors), exfoliative dermatitis (generalized red, peeling skin), seborrheic dermatitis (skin eruption with inflammation and scaling), stasis dermatitis (skin inflammation near the ankles due to venous insufficiency), psoriasis (red, scaly skin condition).

Celecrem 1 mg/g cream is indicated in adults and children over 12 years of age.

Another product of the same brand but with a lower concentration of active substance is also marketed: Celecrem 0.5 mg/g cream. Your doctor will decide between these two options depending on the severity of your condition.

2. What you need to know before using Celecrem 1 mg/g cream

Do not use Celecrem 1 mg/g cream

• if you are allergic to betamethasone, to other corticosteroids, or to 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 (dermatitis around the mouth).
• in skin diseases with thinning of the skin (atrophy).
• in areas of skin showing a vaccine 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 anywhere in your body.

Warnings and precautions

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

• Anti-inflammatory drugs (corticosteroids) have significant effects on the body. This 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 medical advice.
• If you develop an infection while using this medicine, consult your doctor regarding treatment.
• Adverse effects associated with corticosteroid use, including impairment of the adrenal glands, 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 1 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., genital area).
• If you use this medicine for conditions other than those for which it was prescribed, it may mask symptoms and make correct diagnosis and treatment more difficult.
• 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, impairment of glands located near the kidneys has been reported, leading to symptoms such as obesity and growth retardation (Cushing's syndrome), or increased pressure inside the skull (intracranial hypertension), which may manifest, among other signs, as bulging of the fontanelle in infants and headaches.

Other medicines and Celecrem 1 mg/g cream

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

No interactions between Celecrem cream and other medicines are known.

Pregnancy, breastfeeding, and fertility

If you are pregnant or 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 to become pregnant should not use Celecrem 1 mg/g cream over large areas of skin, for prolonged periods, or with occlusive dressings.

Breastfeeding

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

Do not use Celecrem 1 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 using machines

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

Celecrem 1 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 1 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.

Apply the cream in a thin layer with gentle massage, covering the affected area.

Use in children

Celecrem 1 mg/g cream is not indicated for children under 12 years of age (see sections under Do not use Celecrem 1 mg/g cream and Children in section 2).

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

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

If you apply 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 growth and development.

In cases of chronic toxicity, it is advisable to gradually withdraw the 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 1 mg/g cream

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody experiences them.

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

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:

• Thinning of the skin (atrophy)
• Dryness or cracking of the skin
• Itching or burning sensation
• Miliaria (red or white pimples in various parts of the body)
• Redness (erythema)
• Bruising
• Inflammation of hair follicles (folliculitis)
• Skin striae (stretch marks)
• Acne
• Maceration of the skin
• Allergic skin reaction (contact dermatitis)
• Infections, including fungal infections
• Paresthesia (abnormal sensation of the skin, such as numbness, tingling, prickling, burning, or itching)
• 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.

For example, this could increase eye pressure (glaucoma) or could cause a condition characterised by a rounded face, fat accumulation, buffalo hump, delayed wound healing, psychiatric symptoms, etc. (Cushing's syndrome); increased intracranial pressure, increased 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 via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Celecrem 1 mg/g cream

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicinal product after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are in doubt, 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 1 mg/g cream

• The active substance 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, sodium dihydrogen phosphate dihydrate, phosphoric acid, cetostearyl alcohol, cetostearyl ether of macrogol, white soft paraffin, liquid paraffin, and purified water.

Appearance of the product and contents of the container

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

Ctra N-1, Km 36

28750 San Agustin del Guadalix (Madrid)

Spain

Manufacturer

SAG Manufacturing S.L.U.

Crta. 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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/