DIPRODERM 0.5 mg/g OINTMENT

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Diproderm 0.5 mg/g Ointment and what is it used for
2. What you need to know before you use Diproderm 0.5 mg/g Ointment
3. How to use Diproderm 0.5 mg/g Ointment
4. Possible side effects
5. Storage of Diproderm 0.5 mg/g Ointment
6. Contents of the pack and other information

1. What is Diproderm 0.5 mg/g Ointment and what is it 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 manifestations of the skin 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 of habitual use such as, for example, soap (irritant contact dermatitis), coin-shaped eruption (nummular eczema) and itchy eruption on hands and feet (dyshidrotic eczema). Atopic dermatitis and neurodermatitis (eruptions or eczema related to patient factors). Seborrheic dermatitis (skin eruption with inflammation and scaling), psoriasis (scaly red condition), exfoliative dermatitis (generalized red scaling), stasis dermatitis (inflammation of the skin near the ankles in venous insufficiency), lichen planus (itchy eruption in the form of blue and white spots).

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

2. What you need to know before you use 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 ingredients of this medicine (listed in section 6).
• if you have tuberculosis, syphilis, or viral infections (such as herpes or chickenpox)
• in areas of skin affected by inflammation with redness of the skin on the face (rosacea) or in 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 any fungal infection in any part of your body.

Warnings and precautions

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

• Anti-inflammatory drugs (corticosteroids), such as the active ingredient of Diproderm Ointment, have significant effects on the body. It is not recommended to use Diproderm Ointment on large areas of the body or for prolonged periods, as this significantly increases the risk of side effects.
• The medicine should not be applied with occlusive dressings (or air-impermeable materials, such as some diapers).
• The medicine should not be applied to skin folds, such as the groin or armpits.
• The medicine should not be applied to the face.
• If a hypersensitivity reaction occurs, treatment should be discontinued and appropriate therapy should be indicated.
• If an infection develops during the use of this medicine, you should consult your doctor about your treatment.
• Diproderm Ointment should not come into contact with the eyes, mouth, open wounds, or mucous membranes (such as the genital area).
• The side effects described with the use of corticosteroids, including adrenal gland disorders, may also occur with topical use by absorption into the body of the active ingredient, in treatments on large areas or for prolonged periods.
• If you use Diproderm Ointment for diseases other than those for which it has been prescribed, you may mask the symptoms and make it difficult to diagnose and treat correctly.
• If you are being treated for psoriasis, your doctor should frequently monitor your disease to observe 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, it is more likely that the corticosteroid will pass into the body through the skin and have side effects in other areas of the body than in adult patients.

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

Using Diproderm 0.5 mg/g Ointment 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 Diproderm 0.5 mg/g Ointment.

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 medicine.

Pregnancy

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

Diproderm Ointment 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 Diproderm Ointment on large areas of the skin, for prolonged periods, or with occlusive dressings.

Breastfeeding

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

Do not use this medicine during breastfeeding unless your doctor indicates it and do not use it on large areas of the skin, for prolonged periods, or with occlusive dressings.

Driving and using machines

Diproderm Ointment does not affect the ability to drive or use machines.

3. How to use Diproderm 0.5 mg/g Ointment

Follow exactly the instructions for administration of this medicine indicated by your doctor. In case of 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 a day, in the morning and at night.

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

The duration of treatment should not exceed 2 weeks.

Topical use.

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 of age.

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

Excessive use of topical corticosteroids (repeated overdoses) can produce side effects (see section 4).

If you use the ointment more frequently than you should or on large areas of the skin, it can be absorbed and pass into the body, producing various disorders; in children, this can affect their growth and development.

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

Treatment of overdose is symptomatic. The acute symptoms of excessive use of corticosteroids are generally reversible.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately 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 Diproderm 0.5 mg/g Ointment

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 Diproderm 0.5 mg/g Ointment: allergies and changes in skin color. With the use of the active ingredient of the medicine, irritation and, mainly, burning and itching can also occur.

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

• Thinning of the skin (atrophy)
• Dryness or cracking of the skin
• Miliaria (red and white spots on several parts of the body)
• Redness (erythema)
• Appearance of red spots
• Bruises
• Inflammation of hair follicles (folliculitis)
• Increased hair growth
• Stretch marks
• Acne
• Skin maceration
• Inflammation of the skin around the upper lip and chin (perioral dermatitis).
• Allergic skin reaction (contact dermatitis)
• Infections
• Hair loss
• An abnormal sensation of the skin, such as numbness, tingling, pinching, or burning of the skin (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 into the body through the skin.

This, for example, can increase the pressure in the eye (glaucoma) or could produce a condition characterized by a rounded face, fat accumulation, 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 disorders (hyperthyroidism), increased cholesterol and triglycerides, increased blood sugar and urine levels (hyperglycemia and glucosuria), gastric ulcer, cataracts, and blurred vision with unknown frequency (cannot be estimated from available data).

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet.

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 Medicines and Health Products Agency's website. www.notificaRAM.es.

By reporting side 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 expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated. Use within 3 months after opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Diproderm 0.5 mg/g Ointment

• The active ingredient is betamethasone (dipropionate).

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

(0.64 mg of betamethasone dipropionate).

• The other ingredients (excipients) are white petrolatum and liquid paraffin.

Appearance of the product and contents of the pack

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

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

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 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/