Diprogenta 0.5 mg/g + 1 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diprogenta 0.5 mg/g + 1 mg/g cream

Betamethasone/Gentamicin

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Diprogenta cream is and what it is used for
2. What you need to know before using Diprogenta cream
3. How to use Diprogenta cream
4. Possible side effects
5. How to store Diprogenta cream
6. Contents of the pack and other information

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

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

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

2. What you need to know before using Diprogenta cream

Do not use Diprogenta cream

• if you are allergic to the active substances, to other corticosteroids, to other aminoglycoside antibiotics, or to any of the other ingredients of this medicine (listed in section 6).
• if you have tuberculosis, fungal infections, viral infections (for example: herpes or chickenpox), or syphilis.
• on areas of skin affected by rosacea (inflammation with redness of the facial skin) or around the mouth (perioral dermatitis).
• in skin conditions involving skin thinning (atrophy).
• on skin areas showing a vaccine reaction, i.e. redness or inflammation after vaccination.
• in the eyes or on deep wounds.
• in children under 1 year of age.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Diprogenta.

• The cream should not be applied over large areas of the body or for prolonged periods.
• The cream should not be used under occlusive dressings (or air-impermeable materials), or in skin folds such as the groin or armpits.
• If any hypersensitivity reaction occurs during use of Diprogenta, treatment must be discontinued and appropriate therapy prescribed.
• Cross-allergic reactions with aminoglycoside-type antibiotics have been reported.
• Adverse effects associated with corticosteroids, including adrenal gland suppression, may also occur with topical use due to systemic absorption of the active substance, especially in children, or when used over large areas or for prolonged periods.
• With the use of the second component of this medicine (gentamicin), adverse reactions typical of systemic use may also occur, particularly with excessive use or when skin wounds are present.
• The cream must not be applied to the face.
• Prolonged use of topical antibiotics may occasionally lead to overgrowth of non-susceptible organisms, including fungi. In such cases, treatment should be discontinued and medical advice sought.
• The cream must not come into contact with the eyes, mouth, open wounds, or mucous membranes (e.g. genital area). If accidental contact with the eyes occurs, rinse thoroughly with water and consult an ophthalmologist if necessary.
• If you are being treated for psoriasis, strict medical supervision is recommended.
• If you use Diprogenta for conditions other than those for which it was prescribed, it may mask symptoms and complicate correct diagnosis and treatment.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

This medicine is not indicated for children under 12 years of age.

In children, corticosteroids are more likely to be absorbed through the skin into the body, increasing the risk of adverse effects in other parts of the body compared to adult patients.

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

Using Diprogenta cream 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 of Diprogenta with other medicines are known.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

This medicine 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 to become pregnant should avoid applying this medicine over large skin areas, for prolonged periods, or under occlusive dressings.

Breast-feeding

Do not apply this medicine to the breast during lactation; avoid contact between the infant and treated areas.

Driving and using machines

Treatment with this medicine does not affect the ability to drive or operate machinery.

Diprogenta cream contains cetostearyl alcohol and chlorocresol

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

This medicine may cause allergic reactions because it contains chlorocresol.

3. How to use Diprogenta cream

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Administration: For topical use. The cream should be applied gently by light massage to the entire affected area.

Recommended dose:

Adults and adolescents over 12 years of age

Apply a thin layer of this medicine to the entire affected area twice daily, in the morning and at night.

For some patients, a maintenance therapy with once-daily application may be used.

The duration of treatment should not exceed 2 weeks.

If no improvement is observed within this 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 overdose) 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 lead to overgrowth in the lesions of fungi or bacteria that are not sensitive.

Information for healthcare professionals

Treatment of overdose is symptomatic. Acute symptoms due to excessive use of corticosteroids are generally reversible. In cases of chronic toxicity, corticosteroids should be withdrawn gradually. If overgrowth of non-sensitive microorganisms occurs, treatment with Diprogenta should be discontinued and appropriate therapy initiated.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, 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 Diprogenta cream

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 may cause adverse effects, although not everyone will experience them.

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

Treatment with gentamicin has caused transient irritation (erythema and itching), which generally has not required discontinuation of treatment.

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

• Thinning of the skin (atrophy)
• Dryness or cracking of the skin
• Itching or burning
• Redness (erythema)
• Appearance of red spots
• Bruising
• Inflammation of hair follicles (folliculitis)
• Stretch marks (striae)
• Acne
• Allergic skin reaction (contact dermatitis)
• Infections

Adverse effects may occur not only in the treated area but also in completely different areas of the body, which may happen if the active substance passes into the body through the skin.

This, for example, could increase eye pressure (glaucoma) or lead to a condition characterized by a rounded face, fat accumulation, buffalo hump, delayed wound healing, psychiatric symptoms, etc. (Cushing's syndrome); increased intracranial pressure, elevated blood pressure, fluid retention (edema), decreased blood potassium levels (hypokalemia), osteoporosis, thyroid disturbances (hyperthyroidism), increased cholesterol and triglycerides, increased blood sugar levels (hyperglycemia), increased glucose in urine (glucosuria), gastric ulcer, cataracts, blurred vision (frequency unknown, cannot be estimated from available data), hair loss, increased hair growth, specific skin inflammation around the upper lip and chin (perioral dermatitis), changes in skin pigmentation, paresthesia (abnormal skin sensations such as numbness, tingling, prickling, or burning of the skin).

Reporting of adverse effects:

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

5. Storage of Diprogenta cream

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

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

Before first opening: Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

After opening: Use within 3 months. Record the date of opening in the box provided on the outer packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diprogenta cream

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

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

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

Appearance of the product and contents of the container

Diprogenta is a white cream with a smooth and uniform texture.

It is supplied in aluminium tubes internally coated with epoxy resin, with a polyethylene cap.

The tubes contain 30 and 50 grams of cream.

Marketing Authorization Holder and Manufacturer

Date of the most recent review 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/)