DIPROSALIC OINTMENT

Introduction

Package Leaflet: Information for the User

Diprosalic Ointment

Betamethasone Dipropionate / Salicylic Acid

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 pack

1. What Diprosalic Ointment is and what it is used for
2. What you need to know before you use Diprosalic Ointment
3. How to use Diprosalic Ointment
4. Possible side effects
1. Storage of Diprosalic Ointment
2. Contents of the pack and other information

1. What Diprosalic Ointment is and what it is used for

Diprosalic Ointment is a medicine that contains the active ingredients betamethasone (dipropionate) and salicylic acid. Betamethasone (dipropionate) is a corticosteroid (anti-inflammatory), which when applied to the skin reduces redness, inflammation, and itching caused by certain skin problems. Salicylic acid reduces the thickness of the scaly layer on the surface of the skin caused by the disease (keratolytic effect), allowing betamethasone to reach the affected area of the skin.

Diprosalic Ointment is indicated for the treatment of inflammatory manifestations of certain skin diseases where the outer surface has scaly layers (hyperkeratotic) and dry, sensitive skin that responds to corticosteroids, such as psoriasis and lichen planus.

2. What you need to know before you use Diprosalic Ointment

Do not use Diprosalic Ointment

• if you are allergic to betamethasone (dipropionate), salicylic acid, or 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).
• on areas of skin affected by rosacea, acne, or perioral dermatitis.
• on skin diseases with thinning of the skin (atrophy).
• on areas of skin that show a vaccination reaction, i.e., redness or inflammation after vaccination.

• in the eyes or on wounds.
• if you have diabetes.
• in children under 2 years of age.
• if you have any fungal infections on any part of your body.

Warnings and precautions

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

• Corticosteroids, such as one of the active ingredients of this medicine, have significant effects on the body. The use of Diprosalic Ointment is not recommended 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 irritation or hypersensitivity occurs, treatment should be discontinued and the doctor consulted.
• If an infection develops during the use of this medicine, the doctor should be consulted about treatment.
• Diprosalic Ointment should not come into contact with the eyes, open wounds, or mucous membranes (such as the genital area). In case of contact with the eyes, rinse with water for about 15 minutes.

• The side effects described for the use of corticoids, including adrenal gland disorders, can also occur with topical use by absorption into the body of the active ingredient, in treatments on large areas or for prolonged periods, or with occlusive dressings. This occurs especially in children.
• If you use Diprosalic Ointment for diseases other than those for which it has been prescribed, it may mask symptoms and make diagnosis and correct treatment more difficult.
• If you have circulation problems, inform your doctor.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children

This medicine is contraindicated in children under 2 years 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 as bulging fontanelles in infants and headaches.

Using Diprosalic 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 Diprosalic Ointment.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

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

Diprosalic 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 Diprosalic Ointment on large areas of skin, in large quantities, or for prolonged periods, nor should they use occlusive dressings.

Breastfeeding

Do not apply Diprosalic 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 advises you to do so, and do not use it on large areas of skin, in large quantities, or for prolonged periods, nor with occlusive dressings.

Driving and using machines

Not applicable.

3. How to use Diprosalic Ointment

Follow exactly the instructions of administration of this medicine given to you by your doctor. If you are in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children over 12 years:

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

In some cases, your doctor may indicate a lower frequency of application if it is sufficient for your 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

Diprosalic Ointment is not indicated for children under 12 years of age and is contraindicated in children under 2 years of age.

If you use more Diprosalic 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 skin, it can be absorbed into the body and cause various disorders; in children, this can affect their growth and development. Nausea, vomiting, and ringing in the ears can also occur.

In cases of chronic toxicity, it is recommended that corticosteroids be withdrawn gradually. The treatment of overdose is symptomatic. The acute symptoms of excessive corticosteroid use 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 Diprosalic 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.

If you stop using Diprosalic Ointment

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

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

This, for example, can increase eye pressure (glaucoma) or could produce a condition characterized by a rounded face, fat accumulation, hump, delayed wound healing, psychiatric symptoms, etc. (Cushing's syndrome); increased intracranial pressure, cataracts, and blurred vision with unknown frequency (cannot be estimated from available data).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Diprosalic Ointment

No special storage conditions are required.

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month stated.

Use within 3 months of opening.

Do not use this medicine if you notice any visible signs of deterioration. Inform your doctor if you notice any change in the appearance of Diprosalic Ointment.

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 Diprosalic Ointment

• The active ingredients are betamethasone (dipropionate) and salicylic acid.

Each gram of ointment contains 0.5 mg of betamethasone (0.05%) (0.64 mg of betamethasone dipropionate) and 30 mg of salicylic acid (3%).

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

Appearance and packaging

Diprosalic Ointment is a white ointment with a smooth texture.

It is available in tubes containing 30 g 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/