DIPRODERM 0.5 mg/g CUTANEOUS SOLUTION

2. What you need to know before you start using Diproderm 0.5 mg/g Cutaneous Solution

Do not use Diproderm 0.5 mg/g Cutaneous Solution

• 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 cutaneous solution.

• Anti-inflammatory drugs (corticosteroids), such as the active ingredient of Diproderm cutaneous solution, have significant effects on the body. It is not recommended to use Diproderm cutaneous solution 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 cutaneous solution 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 due to absorption into the body, in treatments on large areas or for prolonged periods.
• If you use Diproderm cutaneous solution for diseases other than those for which it has been prescribed, you may mask 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 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, among other signs, bulging of the fontanelle in infants and headaches.

Using Diproderm 0.5 mg/g Cutaneous Solution with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

No interactions of Diproderm 0.5 mg/g cutaneous solution with other medicines are known.

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, Diproderm cutaneous solution should not be applied during the first trimester of pregnancy.

Diproderm cutaneous solution 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 cutaneous solution on large areas of skin, for prolonged periods, or with occlusive dressings.

Breastfeeding

Do not apply Diproderm cutaneous solution 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 skin, for prolonged periods, or with occlusive dressings.

Driving and Using Machines

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

3. How to use Diproderm 0.5 mg/g Cutaneous Solution

Follow exactly the instructions of 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 few drops of the cutaneous solution 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 cutaneous solution should be applied with a gentle massage covering the affected area.

Use in Children

Diproderm cutaneous solution 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 Cutaneous Solution than you should

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

If you use the cutaneous solution more frequently than you should or on large areas of skin, it can be absorbed through the skin and produce 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. 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 Cutaneous Solution

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 cutaneous solution: 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
• Macération of the skin
• 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 through the skin into the body.

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 wound 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 not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines. 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 Cutaneous Solution

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

No special storage conditions are required.

Do not use Diproderm 0.5 mg/g cutaneous solution after the expiry date that appears on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Diproderm 0.5 mg/g Cutaneous Solution

• The active ingredient is betamethasone (dipropionate).

Each gram (1.067 ml) of cutaneous solution contains 0.5 mg of betamethasone (0.05%).

(0.64 mg of betamethasone dipropionate).

• The other ingredients (excipients) are carbomers, isopropyl alcohol, sodium hydroxide (pH adjustment), and purified water.

Appearance of the Product and Contents of the Pack

Diproderm 0.5 mg/g cutaneous solution is a colorless, viscous solution.

It is presented in a dropper bottle (bottle) containing 60 ml of cutaneous solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN, Haarlem

Netherlands

or

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

Date of the 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/