Batmen 2.5 mg/g ointment
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Batmen 2.5 mg/g ointment
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, ask 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 effects, consult your doctor or pharmacist, even if they are effects 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 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 (an allergic reaction 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 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, 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 skin conditions involving skin thinning (atrophy)
- In inflammation around the mouth (perioral dermatitis)
- On large areas (more than 30% of body surface) during the first three months of pregnancy, as systemic effects of corticosteroids cannot be ruled out in these cases.
Warnings and precautions
Talk to your doctor or pharmacist before using Batmen.
- Topical corticosteroids, when used over large areas, in 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 determine appropriate additional treatment.
- If you apply the medicine to skin areas with folds (e.g., armpits or groin), exercise great caution, as this may increase absorption of the active ingredient.
- 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
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.
Topical corticosteroid use should be performed cautiously, limited to the lowest effective dose.
Other medicines and Batmen
Inform your doctor or pharmacist if you are using, have recently used, or might need to use 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 are planning 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) 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 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; therefore, its use is not recommended. Women who are breastfeeding should not apply the medicine to the breasts.
Driving and using machines
The effect of Batmen on the ability to drive and use machines is none or negligible.
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 cutaneous 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, 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 adverse 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.
Sudden interruption of corticosteroid treatment after prolonged use may cause:
- corticosteroid withdrawal syndrome (see section 4 “Possible adverse effects”), adrenal insufficiency (low cortisol levels), or
- a relapse (return) of the underlying disease being treated.
Dosage error
Short-term treatment with high doses (use of excessive amounts of Batmen, application over excessively large areas, or too frequent applications), or missing a single dose, will not produce 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 or 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 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 may 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
- papular rosacea-like skin condition (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)
Skin and subcutaneous tissue disorders
- inflammation of hair follicles (folliculitis)
- itching (pruritus)
- skin allergic reaction (burning, redness, or oozing)
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
- disturbance 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
- 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 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 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 can 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 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 °C.
Medicines should not be disposed of via wastewater drains or in household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. 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, glycerol monooleate, solid paraffin.
Appearance of the product and contents of the container
Batmen 2.5 mg/g ointment is an almost transparent, greasy paste.
It is supplied in aluminum tubes containing 30 g and 60 g of ointment.
Other pack sizes:
Batmen 2.5 mg/g ointment and Batmen 2.5 mg/g cream.
Marketing Authorization Holder
A. Menarini Latin América, S.L.U.
Alfons XII, 587
08918 Badalona (Barcelona), Spain
Manufacturer
Laboratorios Menarini, S.A.
Alfons XII, 587
08918 Badalona (Barcelona), Spain
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Laboratorios Menarini, S.A.
Alfons XII, 587
08918 Badalona (Barcelona), Spain
Date of the most recent revision of this leaflet: September 2022.
Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).