Brand name Batmen 2.5 mg/g ointment

Form ointment

Active substance / Dosage

PREDNICARBATE · 0,250 g

Prescription type Prescription Only Medicine

ATC code

D07A D07AC D07AC18

Registration number 60456

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 pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Batmen 2.5 mg/g ointment

prednicarbate

Read all of this 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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

What Batmen is and what it is used for
What you need to know before you use Batmen
How to use Batmen
Possible side 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, reddish 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 to any of the other ingredients of this medicine (listed in section 6)
In the eyes, or on deep open wounds
On areas of skin showing a vaccination reaction, such as redness or inflammation after vaccination
If you have tuberculosis, syphilis, or viral infections (e.g., chickenpox or herpes)
In rosacea acne, common acne (acne vulgaris), or in skin diseases associated with skin thinning (atrophy)
In inflammation around the mouth (perioral dermatitis)
Over large areas (more than 30% of body surface area) during the first three months of pregnancy, as systemic side effects from corticosteroids cannot be ruled out in these cases.

Warnings and precautions

Consult your doctor or pharmacist before starting to use 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 the 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 establish an appropriate additional treatment.
If you apply the medicine to skin areas with folds (e.g., armpits or groin), exercise great caution, as absorption of the active ingredient may increase.
This medicine should not be used under airtight and waterproof 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 leaks or rupture.
Contact your doctor if you experience blurred vision or other visual disturbances (see section 4 “Possible adverse effects”).

Children

The 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.

The use of topical corticosteroids should be done with caution 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, 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 large areas (more than 30% of body surface area) is contraindicated during the first three months of pregnancy, as systemic effects of glucocorticoids cannot be ruled out. However, if there are strong medical reasons, treatment with Batmen may be considered, 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 use machines is none or negligible.

Batmen contains benzyl alcohol

This medicine contains 10 mg of benzyl alcohol in each gram of ointment.

Benzyl alcohol may cause allergic reactions and moderate local irritation.

3. How to use Batmen

Follow exactly the administration instructions for this medicine as indicated 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 ointment 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 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 you are 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, topical corticosteroids should be used with caution and restricted 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 error

Short-term use of high doses (excessive amounts of Batmen, application over excessively large areas, or too many 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 those typical of systemic corticosteroids 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 missed doses.

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

If you have any other 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 experiences 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)

Disorders of the skin and subcutaneous tissue

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)

Disorders of the skin and subcutaneous tissue

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 pimples 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)

Disorders of the skin and subcutaneous tissue

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

Adverse effects with unknown frequency (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

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

Disorders of the skin and subcutaneous tissue

Skin atrophogenic effects (thinning of the skin, skin atrophy, skin discoloration, dilation of blood vessels in the skin, or spider veins (telangiectasia)) which may occur with the 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 Cushing's syndrome (swelling and weight gain of the body and face) induced by cutaneous administration of corticosteroids, due to the higher skin surface area to 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. Manifestations of intracranial hypertension include bulging of 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 Medicines: 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 is the last day of the month indicated.

Store below 25 ºC.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Batmen 2.5 mg/g ointment

The active substance is prednicarbate.

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

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

Appearance of the medicinal product and contents of the pack

Batmen 2.5 mg/g ointment is a whitish ointment supplied in aluminium tubes containing 30 and 60 grams of ointment.