Label: information for the user

Batmen2,5 mg/g cream

prednicarbato

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should 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, even if they are not listed in this label. See section 4.

Batmen contains prednicarbato as its active ingredient, and it belongs to a group of medications called topical corticosteroids; for use on the skin; to reduce inflammation, cell proliferation, allergic reactions, redness, itching, and exudate on inflamed skin.

Batmen is indicated for the treatment of symptoms (redness and itching) caused by certain inflammatory skin disorders that respond to treatment with topical corticosteroids, such as atopic dermatitis (allergy to a substance that has come into contact with the skin) and psoriasis (scaly, red skin condition) (excluding extensive plaque psoriasis).

Batmen is indicated for use in adults and children over 2 years old.

Do not use Batmen

• If you are allergic to prednicarbato, other corticosteroids, or any of the other components of this medication (listed in section 6)
• In the eyes, or in deep open wounds
• In areas of the skin that show a vaccination reaction, that is, redness or inflammation after the vaccine
• If you have tuberculosis, syphilis, or viral infections (for example, chickenpox or herpes)
• In acne rosacea, acne vulgar, 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 systemic effects of corticosteroids cannot be ruled out

Warnings and precautions

Consult your doctor or pharmacist before starting to use Batmen.

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

Children

This medication is not recommended for use 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 it to the lowest effective dose.

Other medications and Batmen

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

No interactions with Batmen are known; however, do not apply other preparations to the affected area.

Pregnancy,breastfeeding, and fertility

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

Pregnancy

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

No adequate and well-controlled studies have been conducted in pregnant women on the teratogenic effects of prednicarbato. 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 it is not recommended to use it. Women who are breastfeeding should not apply the medication to the breasts.

Driving and operating machinery

The influence of Batmen on the ability to drive and operate machinery is negligible or insignificant.

Batmen contains cetomacrogol, cetearyl alcohol, and benzyl alcohol

It may cause local reactions in the skin (such as contact dermatitis) because it contains cetomacrogol and cetearyl alcohol.

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

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

This medication is for exclusive topical use (to apply on the skin).

The recommended dose is:

Adults and children over 2 years old

Apply a thin layer of cream to the affected area once a day, expandable to two depending on the severity of the condition, gently rubbing.

The treatment can be reduced to a daily application when a noticeable 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 medication for any condition on the face, the duration of treatment should be as short as possible and no more than one week.

Use in children

Do not recommend the use of Batmen in children under 2 years old due to the scarcity of data on safety.

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

If you interrupt treatment with Batmen

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

Brusquely interrupting treatment with corticosteroids after prolonged use may cause:

- steroid withdrawal syndrome (see section 4 "possible adverse effects") or

- may result in a recurrence (return) of the underlying disease being treated.

Dosing error

A short-term treatment of 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 you significantly exceed the recommended doses, adverse effects locally 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 Toxicological Information Service. Tel.: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Batmen

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

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

If you have any other doubt about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects of prednicarbato topical are generally local, mild, and transient. Like with other topical corticosteroids, prolonged use of large quantities or treatment of extensive areas may lead to systemic corticosteroid effects due to 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 in accordance with their frequency:

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

Dermatological and subcutaneous tissue disorders

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

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

Dermatological and subcutaneous tissue disorders

• skin striations
• irritation
• excessive hair growth on the skin (hypertrichosis)
• skin color loss (hypopigmentation)
• skin around the mouth affected (perioral dermatitis)
• skin maceration
• contact allergic dermatitis
• rosacea-like papular dermatitis (facial skin)
• acneiform reactions
• capillary fragility (ecchymosis)
• red or white papules in various parts of the body (miliaria)
• skin dryness

Infections and infestations

• secondary infection

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

Dermatological and subcutaneous tissue disorders

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

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

Endocrine disorders

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

Ocular disorders

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

Dermatological and subcutaneous tissue disorders

• skin atrophy effects (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 to suppression of the hypothalamic-pituitary-adrenal axis function and Cushing's syndrome induced by topical corticosteroid administration, due to the greater skin surface-to-body weight ratio. Chronic corticosteroid therapy could interfere with infant growth and development.

Increased intracranial pressure has been reported in children treated with topical corticosteroids. Manifestations of increased intracranial pressure include fontanelle bulging, headaches, and bilateral papilledema.

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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 25 °C.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Batmen 2.5 mg/g cream

- The active ingredient is prednicarbato.

Cada gramo of cream contains 2.5 mg of prednicarbato (0.25%)

- The other components (excipients) are: octyldodecanol, light liquid paraffin, stearic alcohol, cetyl alcohol, myristic alcohol, sorbitan stearate, polisorbate 60 (E-435), benzyl alcohol, disodium edetate, purified water.

Appearance of the product and contents of the packaging

Batmen 2.5 mg/g cream is a uniform cream with a 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 ointment.

Marketing Authorization Holder

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

Alfons XII, 587

08918 Badalona (Barcelona) Spain

Responsible for manufacturing

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

Last review date of this prospectus:September 2022.

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).