Leaflet: information for the user

Diproderm 0.5 mg/g cream

Betametasona dipropionate

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Diproderm cream is an anti-inflammatory medication (a corticosteroid) for use on the skin.

It is indicated for: Local treatment of inflammatory and pruritic skin manifestations that respond to corticosteroids, such as: Acute forms of allergic contact dermatitis, allergic reactions to commonly used substances such as soap, nummular eczema, and pruritic eczema on hands and feet. Atopic dermatitis and neurodermatitis (skin eruptions or eczemas related to patient factors). Seborrheic dermatitis (inflammatory skin eruption with scaling), psoriasis (red scaly skin condition), exfoliative dermatitis (generalized red scaling), stasis dermatitis (inflammation in the skin near the ankles in venous insufficiency), lichen planus (pruritic skin eruption with blue and white patches).

Diproderm 0.5 mg/g cream is indicated for adults and children over 12 years old.

Do not use Diproderm 0.5 mg/g cream

• if you are allergic to betamethasone (dipropionate), other corticosteroids, or any of the other ingredients in this medication (listed in section 6).
• if you have tuberculosis, syphilis, or viral infections (such as herpes or chickenpox)
• on skin areas affected by inflammation with redness of the skin on the face (rosacea) or inflammation around the mouth (perioral dermatitis)
• in skin diseases with thinning of the skin (atrophy)
• on skin areas showing a vaccine reaction, i.e., redness or inflammation after the vaccine
• on the eyes or in deep wounds
• in children under 1 year
• if you have any fungal infections in any part of your body.

Warnings and precautions

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

• Corticosteroid medications, like the active ingredient in Diproderm cream, have significant effects on the body. It is not recommended to use Diproderm cream on large areas of the body or for prolonged periods, as this significantly increases the risk of adverse effects.
• Do not apply the medication with occlusive dressings (or impermeable materials, such as some diapers).
• Do not apply the medication in skin folds, such as the groin or armpits.
• Do not apply the medication on the face.
• If a hypersensitivity reaction appears, discontinue treatment and seek appropriate therapy.
• If you develop an infection during the use of this medication, consult your doctor about its treatment.
• Diproderm cream should not come into contact with the eyes, mouth, open wounds, or mucous membranes (such as the genital area).
• The adverse effects described with the use of corticosteroids, including adrenal gland alteration, may also occur with the topical use of the active ingredient, in treatments on large areas or for prolonged periods.
• If you use Diproderm cream for conditions other than those for which it was prescribed, you may mask symptoms and make it difficult to diagnose and treat the condition correctly.
• If you are being treated for psoriasis, your doctor should regularly monitor your condition to observe any possible worsening.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children

This medication is contraindicated in children under 1 year and is not indicated in children under 12 years.

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

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

Use of Diproderm 0.5 mg/g cream 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 Diproderm 0.5 mg/g cream with other medications are known.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

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

Diproderm cream will not be used during pregnancy unless your doctor considers that the potential benefits of its use justify the potential risk to the fetus.

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

Breastfeeding

Do not apply Diproderm cream to the breasts during breastfeeding; do not put the baby in contact with treated areas.

Do not use this medication during breastfeeding unless your doctor advises you to do so and do not use it on large areas of the skin, for prolonged periods, or with occlusive dressings.

Driving and operating machinery

Diproderm cream does not affect the ability to drive or operate machinery.

Diproderm 0.5 mg/g cream contains cetearyl alcohol and chlorocresol.

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

This medication may cause allergic reactions because it contains chlorocresol.

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

The recommended dose is:

Adults and children over 12 years old:

Apply a thin layer of the cream to the affected area 1 or 2 times a day, in the morning and at night.

Your doctor should indicate the application frequency according to the severity of the condition.

The treatment duration should not exceed 2 weeks.

Cutaneous use.

The cream should be applied in a thin layer with a gentle massage, covering the affected area.

Use in children

Diproderm cream is not indicated for children under 12 years of age and is contraindicated in children under 1 year.

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

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

If you use the cream more frequently than you should or on large areas of the 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 recommended that corticosteroids be gradually withdrawn.

The treatment of overdose is symptomatic. Acute symptoms of excessive corticosteroid use are usually reversible.

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

If you forgot to use Diproderm 0.5 mg/g 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 can cause side effects, although not everyone will experience them.

The following side effects have been reported, very rarely, with the use of Diproderm 0.5 mg/g cream: allergies and changes in skin color. With the use of the active ingredient in the medicine, irritation and, primarily, burning and itching can also occur.

In addition, the following reactions have been reported with the use of topical corticosteroids, especially after 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
• Miliaria (red and white bumps in various parts of the body)
• Redness (erythema)
• Appearance of red spots
• Bruises
• Inflammation of hair follicles (folliculitis)
• Excessive hair growth
• Skin striations
• Acne
• Skin maceration
• Inflammation of the skin around the upper lip and chin (perioral dermatitis).
• Contact dermatitis (skin allergic reaction)
• Infections
• Hair loss
• An abnormal sensation of the skin, such as numbness, tingling, stinging, or burning (paresthesia).

Side effects can occur not only in the treated area, but also in completely different areas of the body, which occurs if the active ingredient passes through the skin into the body.

This, for example, can increase eye pressure (glaucoma) or could cause a condition characterized by a rounded face, accumulation of fat, hump, delayed healing, psychiatric symptoms, etc. (Cushing's syndrome); increased intracranial pressure, increased blood pressure, fluid retention (edema), decreased potassium levels in the blood, osteoporosis, thyroid dysfunction (hyperthyroidism), increased cholesterol and triglycerides, increased blood sugar and urine glucose levels (hyperglycemia and glucosuria), gastric ulcers, cataracts, and blurred vision of unknown frequency (cannot be estimated from available data).

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use. 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.

Do not use Diproderm 0.5 mg/g cream after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated. Use within 3 months after opening.

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

Composition of Diproderm 0.5 mg/g cream

• The active ingredient is betamethasone (dipropionate).

Each gram of cream contains 0.5 mg of betamethasone (0.05%).

(0.64 mg of betamethasone dipropionate).

• The other components (excipients) are: chlorocresol, dihydrogen phosphate of sodium dihydrate, phosphoric acid, white vaseline, liquid paraffin, cetoestearic ether of macrogol, cetoestearic alcohol, sodium hydroxide (pH adjustment) and purified water.

Appearance of the product and contents of the packaging

Diproderm 0.5 mg/g cream is a white cream with a smooth texture.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Organon Health, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Responsible for manufacturing

Organon Heist bv

Industriepark30

2220Heist-op-den-Berg

Belgium

Last review date of this leaflet:September 2017.

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