BATMEN 2.5 mg/g OINTMENT

2. What you need to know before using Batmen

Do not use Batmen

• If you are allergic to prednicarbate, other corticosteroids, or any of the other components of this medication (listed in section 6)
• In the eyes, or on open wounds
• In areas of the skin that show a vaccination reaction, i.e., redness or inflammation after vaccination
• If you have tuberculosis, syphilis, or viral infections (e.g., chickenpox or herpes)
• In rosacea, acne vulgaris, or skin diseases with skin thinning (atrophy)
• In inflammation around the mouth (perioral dermatitis)
• In extensive areas (more than 30% of the body surface) during the first three months of pregnancy, as in these cases, the secondary effects of systemically administered corticosteroids cannot be ruled out.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Batmen.

• Topical corticosteroids, when used on extensive areas, in high doses for a prolonged period, or under an airtight dressing, are more likely to be absorbed into the bloodstream and cause side effects. Apply only the necessary amount to cover the affected areas. Batmen should not be applied to extensive areas unless indicated by your doctor.
• Avoid getting Batmen in contact with the eyes, open wounds, and mucous membranes.
• In case of skin infections caused by bacteria or fungi, consult your doctor, who will establish additional specific treatment.
• If you use the medication on skin folds (e.g., armpits or groin), you should be very cautious because it can increase the absorption of the active ingredient.
• This medication should not be used under impermeable materials to air and water, such as bandages, dressings, or diapers, which are not very breathable.
• If you are being treated for psoriasis, strict medical supervision is recommended.
• The non-professional use of topical corticosteroids can mask symptoms and make it difficult to diagnose and treat correctly.
• Contact between Batmen and latex condoms should be avoided, as it can cause leaks or breaks in them.
• Contact your doctor if you experience blurred vision or other visual disturbances (see section 4 "possible side effects").

Children

The use of this medication is not recommended in children under 2 years of age due to the lack of data on its efficacy and safety in this population.

The use of topical corticosteroids should be done with caution, limiting the dose to the lowest effective dose.

Other medications and Batmen

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

No interactions with Batmen are known; however, other preparations should not be applied to the area being treated.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

The application of Batmen to extensive areas (more than 30% of the body surface) is contraindicated during the first three months of pregnancy, as in these cases, the effects of systemic corticosteroids cannot be ruled out. However, if there are compelling medical reasons, therapy with Batmen may be carried out, but only on small areas of the skin.

Adequate and well-controlled studies on the teratogenic effects of prednicarbate in pregnant women do not exist. Therefore, Batmen should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breastfeeding

The safety of Batmen during breastfeeding has not been established, so its use is not recommended. Women who are breastfeeding should not apply the medication to their breasts.

Driving and using machines

The influence of Batmen on the ability to drive and use machines is nil or insignificant.

Batmen contains benzyl alcohol

This medication contains 10 mg of benzyl alcohol per gram of ointment.

Benzyl alcohol may cause allergic reactions and moderate local irritation.

3. How to use Batmen

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

This medication is for external use only (to be applied to the skin).

The recommended dose is:

Adults and children over 2 years of age

Apply a thin layer of ointment to the affected area once a day, which can be increased to twice a day, depending on the severity of the condition, rubbing gently.

Treatment can be reduced to once a day when significant improvement is observed.

Generally, 2 or 3 weeks of treatment are sufficient. The duration of treatment should not exceed 4 weeks as a general rule.

If you use the medication for a condition on the face, the duration of treatment should be as short as possible and no more than one week.

Use in children

The use of Batmen is not recommended in children under 2 years of age due to the lack of safety data.

In children, the use of topical corticosteroids should be done with caution, limiting the dose to the lowest effective dose (see section 4 "possible side effects").

If you stop treatment with Batmen

If you need to suddenly stop treatment with Batmen after prolonged use, make sure to discuss it with your doctor before doing so.

Abruptly stopping treatment with corticosteroids after prolonged use can cause:

• corticosteroid withdrawal syndrome (see section 4 "possible side effects")
• adrenal insufficiency (low cortisol levels) or
• a relapse (return) of the underlying disease being treated may occur.

Dosing error

Short-term treatment with high doses (using excessive amounts of Batmen, applying to excessively large areas, or applying too frequently) or missing a treatment will not produce harmful effects. It is recommended that patients inform their doctor if they deviate from the planned treatment.

If you use more Batmen than you should

If the recommended doses are significantly exceeded, local side effects and those typical of systemic corticosteroids cannot be ruled out.

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

If you forget to use Batmen

Do not apply a double dose to make up for forgotten doses.

Apply the corresponding dose when you remember, or wait until the next application if it is soon.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

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

The side effects of topical prednicarbate are generally local, mild, and transient. As with other topical corticosteroids, prolonged use of large quantities or treatment of extensive areas can lead to systemic corticosteroid effects due to absorption. If this occurs, topical treatment should be discontinued.

The possible side effects that may occur with the use of this medication are listed below according to their frequency:

Common side effects (may affect up to 1 in 10 people)

Skin and subcutaneous tissue disorders

• mild to moderate burning sensation at the application site
• itching / tingling sensation (paresthesia)
• bacterial infections
• furunculosis

Uncommon side effects (may affect up to 1 in 100 people)

Skin and subcutaneous tissue disorders

• striae
• irritation
• hair growth on the skin (hypertrichosis)
• skin discoloration (hypopigmentation)
• skin condition around the mouth (perioral dermatitis)
• skin maceration
• allergic contact dermatitis
• rosacea-like dermatitis (facial skin)
• acne-like reactions
• capillary fragility (ecchymosis)
• red or white bumps on various parts of the body (miliaria)
• dry skin

Infections and infestations

• secondary infection

Rare side effects (may affect up to 1 in 1,000 people)

Skin and subcutaneous tissue disorders

• folliculitis (inflammation of the hair follicles)
• itching (pruritus)
• allergic skin reaction (burning, redness, or exudation)

Side effects with unknown frequency (cannot be estimated from available data)

Endocrine disorders

• reversible suppression of the hypothalamic-pituitary-adrenal axis (corticosteroid class effect)
• corticosteroid withdrawal syndrome (corticosteroid class effect)

Eye disorders

• alteration of the central region of the retina with decreased visual field and partial loss of visual field (chorioretinopathy)
• blurred vision

Skin and subcutaneous tissue disorders

• atrophy of the skin (skin thinning, atrophy, skin discoloration, dilation of skin blood vessels, or spider veins (telangiectasia) that may occur with the use of Batmen for more than three weeks.

Other side effects in children

Children and adolescents may demonstrate greater susceptibility than adult patients to suppression of the hypothalamic-pituitary-adrenal axis and Cushing's syndrome induced by topical corticosteroid administration, due to the greater skin surface area / body weight ratio. Chronic therapy with corticosteroids could interfere with growth and development in children.

Intracranial hypertension has been reported in children treated with topical corticosteroids. The manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Batmen

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

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

Store below 25°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Batmen 2.5 mg/g ointment composition

• The active ingredient is prednicarbate.

Each gram of ointment contains 2.5 mg of prednicarbate (0.25%)

• The other components (excipients) are: octyldodecanol, glycerol monooleate, solid paraffin, edetic acid, magnesium sulfate heptahydrate, benzyl alcohol, purified water.

Product appearance and package contents

Batmen 2.5 mg/g ointment is a white ointment that comes in aluminum tubes containing 30 and 60 grams of ointment.

Other presentations:

Batmen 2.5 mg/g cream and Batmen 2.5 mg/g ointment.

Marketing Authorization Holder

A.Menarini Latin America, S.L.U.

Alfons XII, 587

08918 Badalona (Barcelona) Spain

Manufacturer

Laboratorios Menarini, S.A.

Alfons XII, 587

08918 Badalona (Barcelona) Spain

You can request more information about this medication by contacting the local representative of the Marketing Authorization Holder:

Laboratorios Menarini, S.A.

Alfons XII, 587

08918 Badalona (Barcelona) Spain

Date of the last revision of this package leaflet:September 2022.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).