Diproderm 0.5 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diproderm 0,5 mg/g cream

Betamethasone dipropionate

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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Diproderm 0,5 mg/g cream is and what it is used for
2. What you need to know before using Diproderm 0,5 mg/g cream
3. How to use Diproderm 0,5 mg/g cream
4. Possible adverse effects
5. How to store Diproderm 0,5 mg/g cream
6. Contents of the pack and other information

1. What Diproderm 0.5 mg/g cream is and what it is used for

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

It is indicated for: Local treatment of inflammatory and pruritic (itchy) skin manifestations that respond to corticosteroids, such as: acute forms of allergy to a substance that has come into contact with the skin (allergic contact dermatitis), allergic reaction to substances commonly used, for example, soap (irritant contact dermatitis), coin-shaped rash (nummular eczema), and itchy rash on the hands and feet (dyshidrotic eczema). Atopic dermatitis and neurodermatitis (rashes or eczemas related to patient-specific factors). Seborrheic dermatitis (skin rash with inflammation and scaling), psoriasis (reddish scaly condition), exfoliative dermatitis (generalized reddish scaling), stasis dermatitis (skin inflammation near the ankles in venous insufficiency), lichen planus (itchy rash appearing as bluish and white patches).

Diproderm 0.5 mg/g cream is indicated in adults and children over 12 years of age.

2. What you need to know before using Diproderm 0.5 mg/g cream

Do not use Diproderm 0.5 mg/g cream

• if you are allergic to betamethasone (dipropionate), other corticosteroids, or 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 skin inflammation with redness of the face (rosacea) or inflammation around the mouth (perioral dermatitis)
• in skin diseases with thinning of the skin (atrophy)
• in 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
• if you have a fungal infection anywhere in your body.

Warnings and precautions

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

• Anti-inflammatory drugs (corticosteroids), such as the active ingredient in Diproderm cream, have significant effects on the body. The use of Diproderm cream over large areas of the body or for prolonged periods is not recommended, as this significantly increases the risk of adverse effects.
• The medicine must not be applied under occlusive dressings (or air-impermeable materials, such as certain diapers).
• The medicine must not be applied to skin folds, such as the groin or armpits.
• It must not be applied to the face.
• If any hypersensitivity reaction occurs, treatment must be discontinued and appropriate therapy must be prescribed.
• If you develop an infection during treatment with this medicine, consult your doctor about its management.
• Diproderm cream must not come into contact with the eyes, mouth, open wounds, or mucous membranes (e.g., genital area).
• Adverse effects associated with corticosteroid use, including adrenal gland suppression, may also occur with topical application due to systemic absorption of the active ingredient, especially when used over large areas or for prolonged periods.
• If you use Diproderm cream for conditions other than those for which it was prescribed, it may mask symptoms and hinder correct diagnosis and treatment.
• If you are being treated for psoriasis, your doctor should monitor your condition frequently to detect any 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 is not indicated in children under 12 years of age.

In children, corticosteroids are more likely to be absorbed through the skin and cause adverse systemic effects compared to adult patients.

In children treated with topical corticosteroids, suppression of the adrenal glands (located near the kidneys) has been reported, leading to symptoms such as obesity, growth retardation, etc. (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.

Use of Diproderm 0.5 mg/g cream with other medicines

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

No interactions between Diproderm 0.5 mg/g 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, Diproderm cream should not be used during the first trimester of pregnancy.

Diproderm cream should not be used during pregnancy unless your doctor considers that the potential benefit justifies the potential risk to the fetus.

Pregnant women or women planning pregnancy should not use Diproderm cream over large areas of skin, for prolonged periods, or under occlusive dressings.

Breastfeeding

Do not apply Diproderm cream to the breasts during breastfeeding; avoid contact of the infant with treated areas.

Do not use this medicine during breastfeeding unless your doctor instructs you to do so, and do not use it over large skin areas, for prolonged periods, or with occlusive dressings.

Driving and using machines

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

Diproderm 0.5 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 Diproderm 0.5 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 1 or 2 times daily, in the morning and at night.

Your doctor will determine the frequency of application depending on the severity of the condition.

The duration of treatment should not exceed 2 weeks.

For topical use only.

The cream should be applied in a thin layer with 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 of age.

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 recommended 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 recommended that corticosteroids be gradually withdrawn.

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 Diproderm 0.5 mg/g cream

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

Apply the dose as soon as possible and 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 Diproderm 0.5 mg/g cream: allergies and changes in skin color. With the use of the active substance in the medicine, irritation, and mainly burning and itching, may also occur.

The following reactions have additionally been reported with the use of topical corticosteroids, especially after prolonged use, on large skin areas, with bandages 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
• Bruising
• Inflammation of hair follicles (folliculitis)
• Increased hair growth
• Skin striae (stretch marks)
• Acne
• Skin maceration
• Inflammation specifically affecting the skin around the upper lip and chin (perioral dermatitis)
• Allergic skin reaction (contact dermatitis)
• Infections
• Hair loss
• Abnormal skin sensations such as numbness, tingling, pricking, or burning of the skin (paresthesia)

Adverse effects may occur not only in the treated area but also in completely different areas 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 cause a condition characterized by a rounded face, fat accumulation, buffalo hump, delayed wound healing, psychiatric symptoms, etc. (Cushing's syndrome); increased intracranial pressure, elevated blood pressure, fluid retention (edema), decreased blood potassium levels, osteoporosis, thyroid disorders (hyperthyroidism), increased cholesterol and triglyceride levels, increased blood and urine sugar levels (hyperglycemia and glucosuria), gastric ulcer, cataracts, and blurred vision, with frequency unknown (frequency cannot be estimated from available data).

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diproderm 0.5 mg/g cream

Keep this medicine 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 expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated. Use within 3 months of opening.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and additional information

Composition of Diproderm 0.5 mg/g cream

• The active substance 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, sodium dihydrogen phosphate dihydrate, phosphoric acid, white soft paraffin, liquid paraffin, cetostearyl alcohol macrogol ether, cetostearyl alcohol, sodium hydroxide (for pH adjustment), and purified water.

Appearance of the product and contents of the container

Diproderm 0.5 mg/g cream is a white, smooth-textured cream.

It is available in tubes containing 30 g and 50 g 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 latest review of this leaflet: September 2017.

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