Diprodine 0.5 mg/g ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diproderm 0.5 mg/g ointment

Betamethasone dipropionate

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. 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. It could harm them.
• If you experience any adverse effects, talk to 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 ointment is and what it is used for
2. What you need to know before using Diproderm 0.5 mg/g ointment
3. How to use Diproderm 0.5 mg/g ointment
4. Possible side effects
5. How to store Diproderm 0.5 mg/g ointment
6. Contents of the pack and other information

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

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

It is indicated for: Local treatment of inflammatory and pruritic (itchy) skin conditions 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 (rash affecting the skin with inflammation and scaling), psoriasis (reddish scaly condition), exfoliative dermatitis (generalized reddish scaling), stasis dermatitis (inflammation of the skin near the ankles in venous insufficiency), lichen planus (itchy rash appearing as bluish-white patches).

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

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

Do not use Diproderm 0.5 mg/g ointment

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Diproderm ointment.

• Anti-inflammatory drugs (corticosteroids), such as the active substance in Diproderm ointment, have significant effects on the body. The use of Diproderm ointment 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 in 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 should be prescribed.
• If you develop an infection during treatment with this medicine, consult your doctor regarding its management.
• Diproderm ointment must not come into contact with the eyes, mouth, open wounds, or mucous membranes (for example, the 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 substance, particularly during treatment over large skin areas or for prolonged periods.
• If you use Diproderm ointment for conditions other than those for which it was prescribed, you may mask symptoms and make correct diagnosis and treatment more difficult.
• If you are being treated for psoriasis, your doctor should monitor your condition regularly 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 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, suppression of 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.

Using Diproderm 0.5 mg/g ointment 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 ointment 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 ointment should not be used during the first trimester of pregnancy.

Diproderm ointment 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 pregnancy should not use Diproderm ointment over large areas of skin, for prolonged periods, or under occlusive dressings.

Breastfeeding

Do not apply Diproderm ointment to the breasts during breastfeeding; avoid contact between the child and 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 ointment does not affect the ability to drive or operate machinery.

3. How to use Diproderm 0.5 mg/g ointment

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

Use in children

Diproderm ointment 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 ointment than you should

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

If you use the ointment 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 their growth and development.

In cases of chronic toxicity, it is recommended that corticosteroids be gradually withdrawn.

Treatment of overdose is symptomatic. Acute symptoms caused by excessive use of corticosteroids are generally reversible.

In case of overdose or accidental ingestion, contact 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 ointment

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 can 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 ointment: allergies and changes in skin color. With the use of the active substance in the medicine, irritation, and primarily burning and itching, may also occur.

The following reactions have additionally been reported with the use of topical corticosteroids, especially after prolonged application, over large 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 pimples 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 around the upper lip and chin (perioral dermatitis)
• Allergic skin reaction (contact dermatitis)
• Infections
• Hair loss
• Abnormal skin sensation, 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 parts of the body, which may happen if the active substance passes into the body through the skin.

This, for example, could increase pressure in the eye (glaucoma) or could cause a condition characterized by a rounded face, fat accumulation, buffalo hump, delayed wound healing, psychiatric symptoms, etc. (Cushing's syndrome); increased intracranial pressure, increased blood pressure, fluid retention (edema), decreased potassium levels in blood, osteoporosis, thyroid disorders (hyperthyroidism), increased cholesterol and triglycerides, elevated blood and urine sugar levels (hyperglycemia and glucosuria), gastric ulcer, cataracts, and blurred vision with unknown frequency (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 through the Spanish Pharmacovigilance System for Human Medicines: 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 ointment

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

Store below 30°C.

Do not use Diproderm 0.5 mg/g ointment after the expiry date which is stated on the packaging 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 Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diproderm 0.5 mg/g ointment

• The active substance is betamethasone (dipropionate).

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

(0.64 mg of betamethasone dipropionate).

• The other components (excipients) are white soft paraffin and liquid paraffin.

Appearance of the product and contents of the container

Diproderm 0.5 mg/g ointment is a white, soft-textured ointment.

It is available in tubes containing 30 g and 50 g of ointment.

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 medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/