Brand name Batmen 2.5 mg/g cream

Form cream

Active substance / Dosage

PREDNICARBATE · 0,250 g

Prescription type Prescription Only Medicine

ATC code

D07A D07AC D07AC18

Registration number 60458

Manufacturer A. Menarini Latin America S.L.

Table of Contents

Package Leaflet: Information for the User
Introduction
1. What Batmen is and what it is used for
2. What you need to know before using Batmen
3. How to use Batmen
4. Possible adverse effects
5. Storage of Batmen
6. Contents of the container and additional information

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the user

Batmen 2.5 mg/g cream

prednicarbate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

What Batmen is and what it is used for
What you need to know before using Batmen
How to use Batmen
Possible adverse effects
How to store Batmen
Contents of the pack and other information

1. What Batmen is and what it is used for

Batmen contains the active substance prednicarbate and belongs to a group of medicines called corticosteroids for topical use on the skin, which reduce inflammation, cell proliferation, allergic reactions, redness, itching, and exudation in 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 (a scaly red condition) (excluding extensive plaque psoriasis).

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

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 medicine (listed in section 6)
In the eyes, or on deep open wounds
On areas of skin showing a vaccine reaction, i.e., redness or inflammation after vaccination
If you have tuberculosis, syphilis, or viral infections (e.g., chickenpox or herpes)
In rosacea acne, vulgar acne, or skin conditions associated with skin thinning (atrophy)
In inflammation around the mouth (perioral dermatitis)
On extensive areas (more than 30% of body surface) during the first three months of pregnancy, as systemic side effects from corticosteroids cannot be ruled out in such cases

Warnings and precautions

Consult your doctor or pharmacist before using Batmen.

Topical corticosteroids, when used over large areas, at high doses, for prolonged periods, or under occlusive dressings, are more likely to be absorbed into the bloodstream and cause side effects. Apply only the amount necessary to cover affected areas. Batmen should not be applied over large areas unless directed by your doctor.
Avoid contact of Batmen with eyes, open wounds, and mucous membranes.
If bacterial or fungal skin infections develop, consult your doctor, who will determine appropriate additional treatment.
If using the medicine on skin folds (e.g., armpits or groin), exercise great caution, as absorption of the active ingredient may increase.
This medicine should not be used under air- and water-impermeable materials, such as non-breathable bandages, dressings, or diapers.
If you are being treated for psoriasis, strict medical supervision is recommended.
Non-professional use of topical corticosteroids may mask symptoms and hinder correct diagnosis and treatment.
Avoid contact between Batmen and latex condoms, as it may cause leakage or rupture.
Contact your doctor if you experience blurred vision or other visual disturbances (see section 4, "Possible side effects").

Children

Use of this medicine is not recommended in children under 2 years of age due to lack of data on efficacy and safety in this population.

Topical corticosteroid use should be cautious and limited to the lowest effective dose.

Other medicines and Batmen

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

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

Application of Batmen over extensive areas (more than 30% of body surface) is contraindicated during the first three months of pregnancy, as systemic effects of glucocorticoids cannot be ruled out. However, if medically justified, Batmen therapy may be used, but only on small skin areas.

There are no adequate and well-controlled studies in pregnant women regarding 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 the breasts.

Driving and using machines

The influence of Batmen on the ability to drive and operate machinery is negligible or none.

Batmen contains cetyl alcohol, stearyl alcohol, and benzyl alcohol

May cause local skin reactions (such as contact dermatitis) due to 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 for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine is for topical 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 daily, which may be increased to twice daily depending on the severity of the condition, gently rubbing it in.

The treatment may be reduced to once daily application when a clear 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 using the medicine for a condition affecting the face, the treatment duration should be as short as possible and no longer than one week.

Use in children

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

In children, the use of topical corticosteroids should be carried out with caution and limited to the lowest dose compatible with effective treatment (see section 4 “Possible side effects”).

If you interrupt treatment with Batmen

If you need to stop treatment with Batmen suddenly after prolonged use, make sure to discuss this with your doctor beforehand.

Abrupt interruption of corticosteroid treatment after prolonged use may 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.

Dosage errors

Short-term treatment with high doses (using excessive amounts of Batmen, application over excessively large areas, or too frequent applications) or missing a single dose is unlikely to cause harmful effects. Patients are advised to inform their doctor if such deviations from the prescribed treatment occur.

If you use more Batmen than you should

If the recommended doses are significantly exceeded, local adverse effects and systemic corticosteroid-related effects cannot be ruled out.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, 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 Batmen

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

Apply the missed dose as soon as you remember, or wait until the next scheduled application if it is almost time for it.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

Frequent adverse 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 adverse effects (may affect up to 1 in 100 people)

Skin and subcutaneous tissue disorders

cutaneous striae
irritation
excessive hair growth on the skin (hypertrichosis)
loss of skin color (hypopigmentation)
skin condition around the mouth (perioral dermatitis)
maceration of the skin
allergic contact dermatitis
rosacea-like papular dermatitis (facial skin)
acneiform reactions
capillary fragility (bruising)
red or white bumps in various parts of the body (miliaria)
dry skin

Infections and infestations

secondary infection

Rare adverse 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 oozing)

Adverse effects with frequency not known (cannot be estimated from available data)

Endocrine disorders

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

Eye disorders

changes in the central region of the retina with reduced visual field and partial loss of visual field (chorioretinopathy)
blurred vision

Skin and subcutaneous tissue disorders

Atrophogenic effects on the skin (thinning of the skin, skin atrophy, skin discoloration, dilation of blood vessels in the skin, or spider veins (telangiectasia), which may occur with use of Batmen for more than three weeks.

Other adverse effects in children

Children and adolescents may show greater susceptibility than adult patients to suppression of the hypothalamic-pituitary-adrenal axis function and to corticosteroid-induced Cushing's syndrome (swelling and weight gain in the body and face), due to the higher ratio of skin surface area to body weight. Chronic therapy with corticosteroids could interfere with growth and development in children.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 25 °C.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be handed over to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional 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 components (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 container

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.