Leaflet: information for the user

Diprosalic cream

Betamethasone dipropionate / Salicylic acid

Read this leaflet carefully before you start using this medicinebecause 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 youonly, and you must not give it to others even if they have the samesymptoms as you,as it may harm them.

• Ifyou experienceside effects,consult your doctor or pharmacist,even if the side effects are not listed in this leaflet. See section 4.

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

2.What you need to knowbefore starting to use Diprosalic cream

3.How to use Diprosalic cream

4.Side effects

1. Storage ofDiprosalic cream
2. Contents of the pack and additional information

Diprosalic ointment is a medication that contains as active principles an association of betamethasone (dipropionate) and salicylic acid. Betamethasone (dipropionate) is a corticosteroid (anti-inflammatory), which applied to the skin reduces the redness, inflammation, and itching caused by certain skin problems.Thesalicylic 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 in which the outer surface has scaly (hyperkeratotic) and dry layers sensitive to corticosteroids, such as for example a scaly red rash (psoriasis) and a pruritic rash in the form of blue and white spots (lichen planus).

Do not use Diprosalic ointment:

-if you are allergic to betamethasone (dipropionate), salicylic acid, or any of the other components of this medication (listed in section 6).

• if you have tuberculosis, syphilis, or viral infections (e.g. herpes or chickenpox).
• on skin areas affected by inflammation with redness of the skin on the face (rosacea), acne, or around the mouth (perioral dermatitis).
• in skin diseases with thinning of the skin (atrophy).
• in skin areas showing a vaccination reaction, i.e. redness or inflammation after vaccination.

• in the eyes or over open wounds.
• if you have diabetes.
• in children under 2 years.
• 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, like one of the active ingredients of this medication, have significant effects on the body. Do not use Diprosalic ointment 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 in the face.
• If irritation or hypersensitivity appears, discontinue treatment and consult your doctor.
• If you develop an infection during use of this medication, consult your doctor about treatment.
• Diprosalic ointment should not come into contact with the eyes, open wounds, or mucous membranes (e.g. the genital area). In case of contact with the eyes, rinse with water for 15 minutes.

-The adverse effects described of corticosteroid use, including alteration of the adrenal glands, can also occur with topical use of the active ingredient, through absorption into the body, in treatments on large areas or prolonged periods, or with occlusive dressings. This occurs especially in children.

• If you use Diprosalic ointment for conditions other than those for which it was prescribed, you may mask symptoms and make it difficult to diagnose and treat correctly.
• If you have circulation problems, inform your doctor.
• Notify your doctor if you experience blurred vision or other visual disturbances.

Children

This medication is contraindicated in children under 2 years and is not indicated in children under 12 years.

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

In children treated with topical corticosteroids, alteration of glands located near the kidneys has been reported, resulting in symptoms such as obesity, growth delay, etc. (Cushing's syndrome) or increased intracranial pressure, which may manifest as a bulge in the fontanelle in infants and headaches.

Use of Diprosalic ointment 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 Diprosalic ointment with other medications are known.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

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

Diprosalic ointment 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 Diprosalic ointment on large areas of the skin, in large quantities, or for prolonged periods, or use occlusive dressings.

Breastfeeding

Do not apply Diprosalic ointment 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 and do not use it on large areas of the skin, in large quantities, or for prolonged periods, or with occlusive dressings.

Driving and operating machinery

Not applicable.

Follow exactly the administration instructionsof this medicationindicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended doseis:

Adults and children over 12years:

Applya thin layer ofthecreamto the affected area1or2times a day, in the morning and/or at night.

In some cases, your doctor may indicate a lowerfrequency of applicationif it is sufficient for your condition.

The duration of treatmentshould not exceed 2weeks.

Cutaneous use.

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

Use in children

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

If you use more Diprosalic cream thanyou should

The excessive use of topical corticosteroids (repeated overdose) may cause adverse effects (see section4).

If you use the cream more often than you should or inlarge areas of the skin, it may be absorbed into the bodyand cause various disorders; in children, thismay affecttheirgrowth and development.It may alsocausenausea, vomiting, and tinnitus.

In cases of chronic toxicity, it is recommended that corticosteroids be withdrawn gradually. The 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 orgo to a medical center, or callthe Toxicological Information Service. Tel.:91 562 04 20(indicating the medication and the amount ingested).

If you forgot to use Diprosalic cream

Do notapply a double dose to compensate for the missed doses.

Apply the dose as soon as possible and then continue with your regular treatment.

If you interrupt treatment with Diprosalic cream

If you have any other doubts about the use of thismedication, ask your doctor or pharmacist.

Like all medicines,this medicinecanproduceside effects, although not everyone will experience them.

The following reactions have been reported with the use of topical corticosteroids, especiallyafter prolonged application, in extensive areas,with dressings or occlusive materials,and/or in children:

• Burning or stinging sensation
• Itching
• Skin thinning (atrophy)
• Skin irritation
• Changes in skin color
• Dryness or cracking of the skin
• Peeling of the skin
• Redness (erythema)
• Bruising
• Appearance of red spots
• Folliculitis (inflammation of hair follicles)
• Excessive hair growth
• Inflammation of the skin around the upper lip and chin (perioral dermatitis).
• Striae (stretch marks)
• Acne
• Moisturizing skin
• Contact dermatitis (allergic skin reaction)
• Miliaria (red and white bumps on various parts of the body)
• Hair loss
• An abnormal sensation of the skin, such as numbness, tingling, pricking, or burning (paresthesia)
• Infections

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 produce a condition characterized by a rounded face, accumulation of fat, hump, delayed healing, psychiatric symptoms, etc. (Cushing's syndrome); increased intracranial pressure, cataractsand blurred vision with unknown frequency (cannot be estimated from available data).

Reporting 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 System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

No requires special conservation conditions.

Keepthis medicationout of sight andout of reach of children.

Do not usethis medicationafter the expiration date that appears on thecontainerafter CAD.The expiration date is the last day of the month indicated.Use within three months following opening.

Do not usethis medication if you observeany visible sign of deterioration. Inform your doctor if you observe any change in the appearance of Diprosalic ointment.

Medications should not be disposed of through drains or in the trash.Deposit containers and medications you no longer need at the SIGRE disposal point of the pharmacy. If in doubt, askyour pharmacist how to dispose of containers and medications you no longer need. In this way,, you will help protect the environment.

Composition of Diprosalic ointment

• The active principles arebetamethasone(dipropionate)and salicylic acid.

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

• The other components(excipients)areliquid paraffin and white vaseline.

Appearance of the product and contents of the packaging

Diprosalic ointment is a white ointment with a smooth texture.

It is presented in tubes with 30g of ointment.

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 thisleaflet: September 2017.

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/