Label: information for the user

Batmen2,5 mg/g ointment

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 adverse 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 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.

No 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 rosacea, acne vulgar, or skin diseases with skin thinning (atrophy)
• In a mouth inflammation (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 sealed 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 your doctor instructs you to do so.
• Avoid Batmen from coming into contact with the eyes, open wounds, and mucous membranes.
• If skin infections caused by bacteria or fungi develop, consult your doctor, who will establish a specific additional treatment.
• If you use the medication on skin areas with folds (e.g., 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 bandages, dressings, or diapers, which are poorly breathable.
• If you are being treated for psoriasis, a strict medical supervision is recommended.
• 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,Lactation, and Fertility

If you are pregnant, 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 glucocorticoids 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.

Lactation

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

Driving and Operating Machines

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

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 use on the skin (to apply on the skin).

The recommended dose is:

Adults and children over 2 years old

Apply a thin layer of ointment to the affected area once a day, extendable to twice 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 not exceed one week.

Use in children

The use of Batmen in children under 2 years old is not recommended 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 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

- low cortisol levels (adrenal insufficiency) or

- it may cause a recurrence (return) of the underlying disease being treated.

Dosage error

A short-term treatment of high doses (excessive use 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

Exceeding the recommended doses significantly cannot be ruled out adverse local effects and those of systemic corticosteroids.

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 doubts 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

• 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 to suppression of the hypothalamic-pituitary-adrenal axis and Cushing's syndrome induced by topical corticosteroid administration, due to a greater skin surface area 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 bulging fontanelles, 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 ointment

-The active ingredient is prednicarbate.

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

-The other components (excipients) are: octyldodecanol, monooleate of glycerol, solid paraffin.

Appearance of the product and contents of the packaging

Batmen2.5 mg /g ointment is a nearly transparent, greasy paste.

It is presented in aluminum tubes containing 30 and 60 g of ointment.

Other presentations:

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

Holder of the marketing authorization

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

Date of the last review of this prospectus:September 2022.

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