Leaflet:information for the user

Diprogenta 0.5 mg/g + 1 mg/g cream

Betametasona/Gentamicina

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects,consult your doctor or pharmacist, evenifthey are not listed in this leaflet. See section4.

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

2.What you need to know before starting to use Diprogenta cream

3.How to use Diprogenta cream

4.Possible side effects

5.Storage of Diprogenta cream

6.Contents of the pack and additional information

It is a combination of an anti-inflammatory (a corticosteroid) and an aminoglycoside antibiotic for topical administration on the skin.

It is indicated for the local treatment of inflammatory manifestations of dermatoses (skin conditions) that respond to corticosteroids complicated by secondary infection.

No use Diprogenta crema

• if is allergic to the active ingredients, to other corticosteroids, to other aminoglycoside antibiotics, or to any of the other components of this medication (listed in section6).
• if has tuberculosis, fungal infections, viral infections (such as herpes or chickenpox), syphilis.
• in areas of skin affected by rosacea (inflammation with redness of the skin on the face) or in an inflammation around the mouth (perioral dermatitis).
• in skin diseases with thinning of the skin (atrophy).
• in areas of skin showing a vaccination reaction, that is, redness or inflammation after the vaccine.
• in the eyes or in deep wounds.
• in children under 1year.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Diprogenta.

• Do not apply the cream to large areas of the body or for prolonged periods.
• Do not apply the cream with occlusive dressings (or impermeable materials), or in skin folds, such as the groin or armpits.
• If a hypersensitivity reaction occurs with the use of Diprogenta, discontinue treatment and seek appropriate therapy.
• Cross-reactive allergic reactions with aminoglycoside antibiotics have been described.
• Adverse effects described with the use of corticosteroids, including adrenal gland alteration, may also occur with topical use of the active ingredient, especially in children, in treatments of large areas or prolonged periods.
• With the use of the second component of this medication (gentamicin), adverse reactions specific to internal use may also occur, especially with excessive use and in the presence of skin wounds.
• Do not apply the cream to the face.
• Prolonged use of topical antibiotics may occasionally lead to the proliferation of non-susceptible organisms, including fungi. In these cases, discontinue treatment and consult a doctor.
• Do not come into contact with the eyes, mouth,open wounds or mucous membranes (such as the genital area). If accidental contact with the eyes occurs, rinse with abundant water and consult an ophthalmologist if necessary.
• If being treated for psoriasis, strict medical supervision is recommended.
• If using Diprogenta for conditions other than those for which it has been prescribed, symptoms may be masked and correct diagnosis and treatment may be hindered.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

This medication is not indicated for children under 12years.

In children, it is morelikely that the corticosteroid will pass through the skin and cause adverse effects in other parts of the bodythan in adult patients.

In children treated with topical corticosteroids, adrenal gland alteration has been reported, which may manifest as symptoms such as obesity, growth retardation, etc. (Cushing's syndrome) or increased intracranial pressure, which may manifest as, among other signs, a bulging fontanelle in infants and headaches.

Use of Diprogenta cream 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 Diprogenta with other medications are known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant,consult your doctor or pharmacist before using any medication.

Pregnancy

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

This medicationwill not be usedduring 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 usethis medicationon large areas of the skin, for prolonged periods, or with occlusive dressings.

Breastfeeding

Do not apply this medicationto the breast during breastfeeding; do not put the baby in contact with treated areas.

Driving and operating machinery

Treatment with this medication does not affectthe ability to drive or operate machinery.

Diprogenta cream contains cetoestearic alcohol and chlorocresol

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetoestearic alcohol.

This medication may cause allergic reactions because it contains chlorocresol.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Administration: Topical use. The cream should be applied with a gentle massage to the entire affected area.

The recommended dose is:

Adults and adolescents over 12 years old

Apply a thin layer of this medication to the entire affected area 2 times a day, in the morning and at night.

For some patients, a maintenance therapy may be applied once a day.

The duration of treatment should not exceed 2 weeks.

If you do not observe an improvement within these periods of time, consult your doctor.

Use in children (see section 2).

Diprogenta cream is not indicated for children under 12 years of age.

If you use more Diprogenta cream than you should

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

A single overdose of gentamicin is not expected to cause symptoms. Excessive or prolonged use of topical antibiotics may cause an overgrowth of fungi or bacteria that are not sensitive.

Information for healthcare professionals

The treatment of overdose is symptomatic. Acute symptoms of excessive use of corticosteroids are usually reversible. In cases of chronic toxicity, it is recommended to withdraw corticosteroids gradually and, if there is an overgrowth of non-sensitive microorganisms, to interrupt treatment with Diprogenta and apply the appropriate therapy.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or go to a medical center, or call the Toxicological Information Service. Tel.: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Diprogenta cream

Do not apply a double dose to compensate for the missed doses.

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

Like all medications,this medicationcan cause side effects, although not everyone will experience them.

The following side effects have been reported, very rarely, with the use of Diprogenta cream: allergies and changes in skin color.

Treatment with gentamicin has produced transient irritation (erythema and pruritus) that generally has not required interruption of treatment.

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:

• Thinning of the skin (atrophy)
• Dryness or cracking of the skin
• Itching or burning
• Redness (erythema)
• Appearance of red patches
• Bruising
• Inflammation of hair follicles (folliculitis)
• Striae
• Acne
• Contact dermatitis
• 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 into the body through the skin.

For example, this can increase eye pressure (glaucoma) or could cause a condition characterized by a rounded face, accumulation of fat, hump, delayed healing, psychiatric symptoms, etc. (Cushing's syndrome); increased intracranial pressure, increased blood pressure, fluid retention (edema), decreased potassium levels in the blood (hypokalemia), osteoporosis, thyroid dysfunction (hyperthyroidism), increased cholesterol and triglycerides, increased blood sugar levels (hyperglycemia), increased glucose levels in the urine (glycosuria), gastric ulcers, cataracts,blurred vision of unknown frequency (cannot be estimated from available data),hair loss, increased hair growth, specific inflammation of the skin around the upper lip and chin (perioral dermatitis), changes in skin color, paresthesia (an abnormal sensation of the skin, such as numbness, tingling, stinging, or burning sensation in the skin).

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 System of 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 medication.

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

No special storage conditions are required.Store in the original packaging.

Before first use: Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

After opening:Use within 3 months. Indicate the opening date in the outer packaging box.

Medications should not be disposed of through drains or in the trash. Deposit empty containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications.This will help protect the environment.

Composition of Diprogenta cream

• The active principles are betamethasone (as dipropionate) and gentamicin (as sulfate).

Each gram of cream contains 0.5mg of betamethasone and 1mg of gentamicin.

• The other components are cetearyl alcohol, chlorocresol, dihydrogen phosphate dihydrate of sodium, concentrated phosphoric acid, white vaseline, liquid paraffin, cetearyl ether of macrogol, sodium hydroxide (pH adjustment) and purified water.

Appearance of the product and contents of the packaging

Diprogentais a white cream, of smooth and uniform texture.

It is presented in aluminum tubes with an inner epoxy resin coating, with a polyethylene stopper.

The tubes contain 30 and50grams of cream.

Holder of the marketing authorization and responsible for manufacturing

Last review date of this leaflet:September 2017

The 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/)