BATMEN 2.5 mg/g CREAM

2. What you need to know before you start using Batmen

Do not use Batmen

• If you are allergic to prednicarbate, other corticosteroids, or any of the other ingredients of this medicine (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 produced by systemic corticosteroids cannot be ruled out

Warnings and precautions

Consult your doctor or pharmacist before starting to use Batmen.

• Topical corticosteroids, when used on large 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. Only apply the amount needed to cover the affected areas. Batmen should not be applied to large areas unless your doctor indicates it.
• Avoid getting Batmen in contact with the eyes, open wounds, and mucous membranes.
• If skin infections caused by bacteria or fungi develop, consult your doctor, who will establish additional specific treatment.
• If you use the medicine on skin folds (e.g., armpits or groin), you should be very careful because it can increase the absorption of the active ingredient.
• This medicine should not be used under airtight and waterproof materials, such as bandages, dressings, or diapers, that 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 may 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 medicine 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 to the lowest effective dose.

Other medicines and Batmen

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

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 medicine.

Pregnancy

The application of Batmen to large 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 glucocorticoids 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.

There are no adequate and well-controlled studies in pregnant women on the teratogenic effects of prednicarbate. 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 medicine to their breasts.

Driving and using machines

Batmen has no influence or negligible influence on the ability to drive and use machines.

Batmen contains cetyl alcohol, stearyl alcohol, and benzyl alcohol

It may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and stearyl alcohol.

This medicine contains 10 mg of benzyl alcohol per gram of cream. Benzyl alcohol may cause allergic reactions and moderate local irritation.

3. How to use Batmen

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

This medicine 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 cream to the affected area once a day, extendable to twice depending on the severity of the condition, rubbing gently.

Treatment may be reduced to one daily application when significant improvement is observed.

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

If you use the medicine 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 to the lowest dose compatible with effective treatment (see section 4 "possible side effects").

If you stop treatment with Batmen

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

Abrupt interruption of 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 (use of excessive amounts of Batmen, application to excessively large areas, or too many applications) or omission of treatment once will not produce harmful effects. It is recommended that patients inform their doctor if they incur such deviations from the planned treatment.

If you use more Batmen than you should

If the recommended doses are significantly exceeded, local side effects and those 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 medicine 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 the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

The possible side effects that may be observed with the use of this medicine are detailed 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

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

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

Endocrine disorders

• reversible suppression of the hypothalamic-pituitary-adrenal axis (corticosteroid class effect)
• steroid 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, skin atrophy, skin discoloration, dilation of skin blood vessels or spider veins (telangiectasia) that may occur with the use of Batmen for a period of more than three weeks.

Other side effects in children

Children and adolescents may demonstrate a greater susceptibility than adult patients to the suppression of the hypothalamic-pituitary-adrenal axis and Cushing's syndrome induced by the administration of corticosteroids for topical use, 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's Pharmacovigilance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Batmen

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Place the cartons and any remaining medicine in the SIGRE collection point at your pharmacy. If you have any further questions on the disposal of the unused medicine or its packaging, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Batmen 2.5 mg/g cream

• The active substance is prednicarbate.

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

• The other ingredients (excipients) are: octyldodecanol, light liquid paraffin, stearyl alcohol, cetyl alcohol, myristyl alcohol, sorbitan stearate, polysorbate 60 (E-435), benzyl alcohol, disodium edetate, purified water.

Appearance of the product and contents of the pack

Batmen 2.5 mg/g cream is a uniform cream, creamy consistency, and white color.

It is presented in aluminum tubes containing 30 and 60 grams of cream.

Other presentations:

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

Marketing authorization holder

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

Alfons XII, 587

08918 Badalona (Barcelona) Spain

Manufacturer

Menarini Laboratories, S.A.

Alfons XII, 587

08918 Badalona (Barcelona) Spain

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Menarini Laboratories, S.A.

Alfons XII, 587

08918 Badalona (Barcelona) Spain

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

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