Celestoderm 1 mg/g + 1 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Celestoderm 1mg/g+1mg/g cream

Betamethasone (as valerate)/Gentamicin (as sulfate)

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

1. What Celestoderm cream is and what it is used for

It is a combination of an anti-inflammatory (a corticosteroid) and an aminoglycoside antibiotic for topical administration.

It is indicated for the local treatment of dermatoses (skin conditions) responsive to corticosteroids complicated by secondary infection caused by microorganisms sensitive to gentamicin.

2. What you need to know before using Celestoderm cream

Do not use Celestoderm cream

• if you are allergic to the active substances, to other corticosteroids, to other aminoglycoside antibiotics, or to any of the other ingredients of this medicine (listed in section 6).
• if you have tuberculosis, fungal infections, viral infections (e.g.: herpes or chickenpox), syphilis.
• on areas of skin affected by rosacea (inflammation with redness of the facial skin) or around the mouth (perioral dermatitis).
• in skin diseases associated with thinning of the skin (atrophy).
• on skin areas 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.

Warnings and precautions

Talk to your doctor or pharmacist before using Celestoderm cream.

• The cream should not be applied over large areas of the body or for prolonged periods.

• The cream must not be applied under occlusive dressings (or air-impermeable materials), or in skin folds such as the groin or armpits.

• If any hypersensitivity reaction occurs during treatment with Celestoderm cream, treatment must be discontinued and appropriate therapy should be initiated.

• Cross-allergic reactions with aminoglycoside-type antibiotics have been reported.

• Adverse effects associated with corticosteroids, including adrenal gland suppression, may also occur with topical use due to systemic absorption of the active substance, especially when large areas are treated, during prolonged treatment, or in children.

• With the use of the second component of this medicine (gentamicin), adverse reactions typical of systemic use may also occur, particularly with excessive use or when skin lesions are present.

• Prolonged use of topical antibiotics may occasionally lead to overgrowth of non-susceptible organisms, including fungi. In such cases, treatment should be discontinued and medical advice sought.

• This medicine must not come into contact with the eyes, mouth, open wounds, or mucous membranes (e.g., genital area). If accidental contact with the eyes occurs, rinse thoroughly with water and consult an ophthalmologist if necessary.

• If you are being treated for psoriasis, strict medical supervision is recommended.

• If you use Celestoderm cream for conditions other than those for which it was prescribed, it may mask symptoms and complicate correct diagnosis and treatment.

• Contact your doctor if you experience blurred vision or other visual disturbances.

Children

The use of this medicine is not recommended in children under 12 years of age.

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

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

Use of Celestoderm cream with other medicines

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

No interactions of Celestoderm cream with other medicines are known.

Pregnancy and breastfeeding

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

Pregnancy

As a general rule, the cream should not be used 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 this medicine over large skin areas, for prolonged periods, or under occlusive dressings.

Breastfeeding

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

Do not use this medicine on large skin areas, for prolonged periods, or under occlusive dressings.

Driving and using machines

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

Celestoderm 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 Celestoderm cream

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. 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 this medicine to the entire affected area twice daily, in the morning and at night.

The frequency of application should be determined by your doctor according to the severity of the condition.

In some mild cases, once-daily application may be sufficient, but in more complicated cases, three applications per day may be required.

The duration of treatment should not exceed 2 weeks. If you are using the medicine for a condition affecting the face, treatment should be as short as possible, no longer than one week.

If you do not observe improvement within these time periods, consult your doctor.

For topical use only.

The cream should be applied with gentle massage to the entire affected area.

Use in children

Celestoderm cream is not recommended for children under 12 years of age.

If you use more Celestoderm cream than you should

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

A single overdose of gentamicin is not expected to produce symptoms. Excessive or prolonged use of topical antibiotics may lead to overgrowth of fungi or bacteria that are not sensitive to the antibiotic in the lesions.

Treatment of overdose is symptomatic. Acute symptoms due to excessive use of corticosteroids are generally reversible. In cases of chronic toxicity, it is advisable to gradually withdraw the corticosteroid. If overgrowth of non-sensitive microorganisms occurs, treatment with Celestoderm cream should be discontinued and appropriate therapy initiated.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, 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 Celestoderm cream

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

Apply the 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 everyone will experience them.

The following adverse effects have been reported very rarely with the use of Celestoderm cream: allergies, rashes, and changes in skin color.

Treatment with gentamicin has caused transient irritation (erythema and itching), which generally has not required discontinuation of treatment.

The following reactions have been reported with the use of topical corticosteroids, especially 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
• Redness (erythema)
• Appearance of red spots
• Bruising
• Inflammation of hair follicles (folliculitis)
• Cutaneous striae (stretch marks)
• Acne
• Allergic skin reaction (contact dermatitis)
• Infections

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 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 blood pressure, fluid retention (edema), decreased blood potassium levels (hypokalemia), osteoporosis, thyroid disorders (hyperthyroidism), increased cholesterol and triglycerides, increased blood sugar levels (hyperglycemia), gastric ulcer, cataracts, blurred vision with frequency unknown (frequency cannot be estimated from available data), hair loss, increased hair growth, specific skin inflammation around the upper lip and chin (perioral dermatitis), changes in skin pigmentation, paresthesia (an abnormal sensation of the skin, such as numbness, tingling, pricking, burning, or itching of the skin).

Reporting of adverse effects:

If you experience any type of 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 Celestoderm cream

Keep this medicine out of the sight and reach of children.

No special storage conditions are required. Use within 3 months after opening. Enter the date of opening in the box on the outer packaging.

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. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If 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 Celestoderm cream

• The active substances are betamethasone (as valerate) and gentamicin (as sulfate).

Each gram of cream contains 1 mg of betamethasone and 1 mg of gentamicin.

• The other components are chlorocresol, macrogol cetyl stearyl ether, cetyl alcohol, white soft paraffin, liquid paraffin, disodium hydrogen phosphate dihydrate, concentrated phosphoric acid and purified water.

Appearance of the product and contents of the pack

Celestoderm cream is a white cream.

It is available in tubes containing 30 and 50 grams of cream.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

Date of the most recent revision of this leaflet: September 2017.

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