CELESTODERM 1 mg/g + 1 mg/g CREAM

2. What you need to know before starting to use Celestoderm cream

Do notuse Celestodermcream

• if you are allergic to the active substances, other corticosteroids, other aminoglycoside antibiotics, or any of the other components of this medicine (listed in section 6).
• if you have tuberculosis, fungal infections, viral infections (such as herpes or chickenpox), or syphilis.
• on areas of skin affected by rosacea (inflammation with redness of the skin on the face) or on inflammation around the mouth (perioral dermatitis).
• on skin diseases with skin thinning (atrophy).
• on areas of skin showing a vaccination 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

Consult your doctor or pharmacist before starting to use Celestoderm cream.

• The cream should not be applied to large areas of the body or for prolonged periods.
• The cream should not be applied with occlusive dressings (or airtight materials) or in skin folds, such as the groin or armpits.
• If a hypersensitivity reaction occurs with the use of Celestoderm cream, treatment should be discontinued, and appropriate therapy should be indicated.
• Cross-allergic reactions with aminoglycoside antibiotics have been described.
• The adverse effects described with the use of corticosteroids, including adrenal gland disorders, may also occur with topical use by absorption into the body, especially if large areas are treated, in prolonged treatments, and in children.
• With the use of the second component of this medicine (gentamicin), adverse reactions typical of internal use may also occur, especially with excessive use and in the presence of skin wounds.
• Prolonged use of topical antibiotics may occasionally lead to the proliferation of non-sensitive organisms, including fungi. In these cases, treatment should be discontinued, and the doctor should be consulted.
• This medicine should not come into contact with the eyes, mouth, open wounds, or mucous membranes (e.g., the genital area). If accidental contact with the eyes occurs, rinse with plenty of 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 diseases other than those for which it has been prescribed, it may mask symptoms and make diagnosis and correct treatment more difficult.

• 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, it is more likely that the corticosteroid will pass into the body through the skin and have adverse effects in other areas of the body than in adult patients.

In children treated with topical corticosteroids, adrenal gland disorders have been reported, which can cause symptoms such as obesity, growth retardation, etc. (Cushing's syndrome) or increased intracranial pressure (intracranial hypertension) that can manifest as, among other signs, bulging fontanelle in infants and headaches.

Using Celestoderm cream with other medicines

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

No interactions with other medicines are known for Celestoderm cream.

Pregnancy and breastfeeding

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

Pregnancy

As a general rule, during the first trimester of pregnancy, the cream should not be applied.

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

Pregnant women or those planning to become pregnant should not use this medicine on large areas of skin, for prolonged periods, or with occlusive dressings.

Breastfeeding

Do not apply this medicine to the breasts during breastfeeding; do not let the child come into contact with treated areas.

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

Driving and using machines

Treatment with this medicine does not affect the ability to drive or use machines.

Celestoderm cream contains cetyl stearyl alcohol and chlorocresol

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

This medicine may cause allergic reactions because it contains chlorocresol.

3. How to use Celestoderm cream

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children over 12 years

Apply a thin layer of this medicine to the entire affected area 2 times a day, 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, one application may be sufficient, but in more complicated cases, 3 applications per day may be needed.

The treatment duration should not exceed 2 weeks. If you use the medicine for a condition on the face, the treatment should be as short as possible, up to a maximum of one week.

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

Topical use.

The cream should be applied with a 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 overdoses) may cause adverse effects (see section 4).

A single overdose of gentamicin is not expected to cause symptoms. Excessive or prolonged use of topical antibiotics may lead to the proliferation of non-sensitive fungi or bacteria in the lesions.

Treatment of overdose is symptomatic. The acute symptoms of excessive corticosteroid use are generally reversible. In cases of chronic toxicity, it is recommended that corticosteroids be withdrawn gradually, and if non-sensitive microorganism proliferation occurs, treatment with Celestoderm cream should be discontinued, and appropriate therapy should be applied.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or 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 forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side 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 pruritus) that generally did not require treatment discontinuation.

The following reactions have been reported with the use of topical corticosteroids, especially after prolonged application, on large areas, with occlusive dressings, and/or in children:

• Skin thinning (atrophy)
• Skin dryness or cracking
• Itching or burning
• Redness (erythema)
• Appearance of red spots
• Bruises
• Inflammation of hair follicles (folliculitis)
• Stretch marks
• Acne
• Allergic skin reaction (contact dermatitis)
• Infections
• Side effects may occur not only in the treated area but also in completely different areas of the body, which occurs if the active substance passes into the body through the skin.

This, for example, can increase eye pressure (glaucoma) or may cause a condition characterized by a rounded face, fat accumulation, hump, delayed wound healing, psychiatric symptoms, etc. (Cushing's syndrome); increased blood pressure, fluid retention (edema), decreased potassium levels in the blood (hypokalemia), osteoporosis, thyroid disorders (hyperthyroidism), increased cholesterol and triglycerides, increased blood sugar levels (hyperglycemia), stomach ulcers, cataracts, blurred vision with 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 skin sensation, such as numbness, tingling, pins and needles, burning, or itching of the skin).

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website (https://www.notificaram.es). By reporting side 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. Indicate the opening date on the outer packaging.

Do not use this medicine after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Celestoderm cream composition

• 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, cetyl stearyl alcohol, white petrolatum, liquid paraffin, sodium dihydrogen phosphate dihydrate, concentrated phosphoric acid, and purified water.

Appearance of the product and pack contents

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 Health, 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 last revision of this leaflet: September 2017.

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