Label:Information for the User

Celestoderm 1mg/g+1mg/g cream

Betametasona (as valerate)/Gentamicina (as sulfate)

Read this label carefully before starting to use this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribedonlyto you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects,consult your doctor or pharmacist,evenif they are not listed in this label. See section4.

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

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

3.How to use Celestoderm cream

4.Possible adverse effects

5.Storage of Celestoderm cream

6.Contents of the package and additional information

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) that respond to corticosteroids complicated by secondary infection caused by sensitive microorganisms to gentamicin.

No use Celestoderm crema

• if you are allergic to the active ingredients, to other corticosteroids, to other aminoglycoside antibiotics, or to any of the other components of this medication (listed in section6).
• if you have tuberculosis, fungal infections, viral infections (such as herpes or chickenpox), or syphilis.
• in areas of skin affected by rosacea (inflammation with redness of the skin on the face) or in inflammation around the mouth (perioral dermatitis).
• in skin conditions with thinning of the skin (atrophy).
• in areas of skin showing a vaccine reaction, that is, redness or inflammation after the vaccine.
• in the eyes or in deep wounds.
• in children under 1year.

Warnings and precautions

Consult your doctor or pharmacist before starting to useCelestoderm crema.

• Do not apply the cream to large areas of the body or for prolonged periods.
• Do not apply thecream with occlusive dressings (or impermeable materials), or in skin folds, such as the groin or armpits.
• If any hypersensitivity reaction occurs with the use of Celestoderm crema, discontinue treatment and seek appropriate therapy.
• Cross-reactive allergic reactions with aminoglycoside antibiotics have been described.
• The adverse effects described with the use of corticosteroids, including adrenal suppression, may also occur with topical use of the active ingredient, especially if large areas are treated, treatment is prolonged, and in children.
• With the use of the second component of this medication (gentamicin), adverse reactions specific to 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-susceptible organisms, including fungi. In these cases, discontinue treatment and consult a doctor.
• This medication should not come into contact with the eyes, mouth, open wounds, or mucous membranes (such as 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, a strict medical supervision is recommended.

• UsingCelestodermcrema for conditions other than those for which it has been prescribed may mask symptoms and make it difficult to diagnose and treat correctly.

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

Children

This medication is not recommended for use in children under 12years.

In children, it is morelikely that the corticosteroid will pass through the skin and cause adverse effects in other parts of the bodythan in adult patients.

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

Use of Celestoderm crema with other medications

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

No interactions of Celestoderm crema with other medications are known.

Pregnancy and breastfeeding

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

Pregnancy

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

This medication will 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 women planning to become pregnant should not use this medication on large areas of the skin, for prolonged periods, or with occlusive dressings.

Breastfeeding

Do not apply this medicationto the breasts during breastfeeding; do not put the baby in contact with treated areas.

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

Driving and operating machinery

The treatment with this medication does not affectthe ability to drive or operate machinery.

Celestoderm crema contains alcohol cetoestearílico and chlorocresol

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

This medication may cause allergic reactions because it contains chlorocresol.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children over 12 years oldyears old

Apply a thin layer of this medicationon the entire affected area 2times a day, in the morning and at night.

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

In some mild cases, one application may be sufficient, but in other more complicated cases, up to 3applications per day may be needed.

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

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

Cutaneous use.

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

Use in children

Celestoderm cream is not recommendedfor children under 12years of age.

If you use more Celestoderm cream than you should

The excessive use of topical corticosteroids (repeated overdoses) may cause adverse effects (see section4).

A single overdose of gentamicin is not expected to cause symptoms. The excessive or prolonged use of topical antibiotics may cause an overgrowth of fungi or bacteria that are not sensitive.

The treatment of an overdose is symptomatic. The acute symptoms of excessive use of corticosteroids are usually reversible. In cases of chronic toxicity, it is recommended to withdraw the corticosteroids gradually and, if there is an overgrowth of non-sensitive microorganisms, to interrupt the treatment with Celestoderm cream and apply the appropriate therapy.

In case of overdose or accidental ingestion, consult your doctor or pharmacist orgo to a medical center, or callthe Toxicological Information Service. Tel.:91 562 04 20indicating the medication and the amount ingested.

If you forgot to use Celestoderm 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 medicines, this medicine may cause side effects, although not everyone will experience 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 produced transient irritation (erythema and pruritus) that generally has not required discontinuation of treatment.

The following reactions have been reported with the use of topical corticosteroids, especiallyafter prolonged application, in extensive areas,with 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 patches
• Bruising
• Inflammation of hair follicles (folliculitis)
• Striae
• Acne
• 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 ingredient passes into the body through the skin.

For example, this may increase eye pressure (glaucoma) or could produce a condition characterized by a rounded face, accumulation of fat, hump, delayed healing, psychiatric symptoms, etc. (Cushing's syndrome); increased blood pressure, fluid retention (edema), decreased potassium levels in the blood (hypokalemia), osteoporosis, thyroid alterations (hyperthyroidism), increased cholesterol and triglycerides, increased blood sugar levels (hyperglycemia), gastric ulcers, cataracts,blurred vision of unknown frequency (cannot be estimated from available data),hair loss, increased hair growth, specific inflammation of the skin around the upper lip and chin (perioral dermatitis), changes in skin color, paresthesia (an abnormal sensation of the skin, such as numbness, tingling, stinging, burning, or prickling in the skin).

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.By doing so, you will help protect the environment.

Composition of Celestoderm cream

• The active principles 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, cetoestearic ether of macrogol, cetoestearic alcohol, white vaseline, liquid paraffin, dihydrogen phosphate dihydrate of sodium, concentrated phosphoric acid, and purified water.

Appearance of the product and contents of the packaging

Celestoderm cream is a white cream.

It is presented in tubes with 30 and 50 grams of cream.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Responsible for manufacturing

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

Last review date of this leaflet: September 2017.

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)