Patient Information Leaflet: Information for the User

MENADERM 0.25 mg/g + 5 mg/g cream, 0.25 mg/g + 5 mg/g ointment, 0.25 mg/g + 5 mg/g cutaneous solution

Beclometasone dipropionate + neomycin sulfate
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.

Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT MENADERM IS AND WHAT IT IS USED FOR

MENADERM contains the active substances betamethasone, belonging to the class of corticosteroids (anti-inflammatory drugs), and neomycin (an antibiotic drug).
MENADERM is used in the treatment of skin diseases for which therapy with local corticosteroids is indicated and which are complicated by infections with germs sensitive to neomycin, such as:

Allergic and inflammatory dermatitis (skin inflammations of allergic or inflammatory nature), acute and chronic (short-term or long-term), exogenous and endogenous (caused by external or internal agents).
Various types of contact dermatitis, eczema (an itchy inflammatory skin reaction) in children and eczematous dermatitis, erythemato-exudative skin disorders (with production of exudate, a fluid formed during inflammation).
Pustular acne (with circumscribed, raised skin lesions).
Intertrigo (a skin condition caused by continuous friction between two adjacent body surfaces).

2. WHAT YOU SHOULD KNOW BEFORE USING MENADERM

Do not use MENADERM

If you are allergic to the active substances or to any of the other ingredients of this medicinal product (listed in section 6).
If you have a skin lesion of tubercular nature (originating from tuberculosis), viral (caused by a virus), or luetic (originating from syphilis, an infectious disease primarily transmitted sexually).
As occlusive dressing (covering the affected area with bandages after application of the medicine) in cases of atopic dermatitis (chronic inflammatory skin disease, with intense itching and dryness) (see "Warnings and precautions").

Warnings and precautions
Talk to your doctor or pharmacist before using MENADERM.
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The use, especially if prolonged, of topical products may lead to sensitization phenomena (increased reactivity to certain substances); in such case, you must discontinue treatment and your doctor will initiate, if necessary, an appropriate therapy for the sensitization reaction that has occurred.
When using occlusive therapy, especially in cases of extensive skin lesions, it is advisable to treat one area at a time, as this technique may enhance absorption of the components, possibly leading to systemic effects (affecting the whole organism). Treating one area at a time may help prevent potential disturbances in thermal homeostasis, which could manifest as an increase in body temperature. If such disturbances occur, discontinue treatment immediately.
The material used for occlusive bandaging may cause individual sensitization reactions, requiring replacement of the material used.
In infants, diapers may act as occlusive dressings, thereby increasing the risk of adverse effects.
Occlusive therapy is contraindicated in atopic dermatitis (see "Do not use MENADERM").
This product is not for ophthalmic use (for the eyes).

Children and adolescents
During the first months of life, application of MENADERM should be carried out only when strictly necessary and under direct medical supervision.

Other medicines and MENADERM
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No drug interactions with MENADERM are known.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicinal product.
If you are pregnant or breastfeeding, use MENADERM only when strictly necessary and under direct medical supervision, especially when applied over large skin areas or with occlusive bandaging.

Driving and using machines
No effects on the ability to drive vehicles or operate machinery are known following the use of MENADERM.

MENADERM contains parahydroxybenzoic acid esters which may cause allergic reactions (including delayed reactions).

3. HOW TO USE MENADERM

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply a small amount (a thin layer) of the product twice daily to the affected area of skin and gently massage.
Occlusive dressing may be appropriate in specific cases, according to the doctor's judgment.
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MENADERM cream is preferred for the treatment of delicate or moist skin surfaces.
MENADERM ointment is indicated for the treatment of dry, lichenified (thickened), or scaly lesions, and when occlusive bandaging is used.
MENADERM cutaneous solution is indicated for the treatment of extensive skin lesions, skin folds, and hairy areas (areas with hair).
If you use more MENADERM than you should
There are no known cases of overdose following the use of MENADERM.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Stop treatment and contact your doctor, who will prescribe appropriate therapy, if you notice the
appearance of any of the adverse reactions listed below:

Burning sensation, irritation, dryness of the skin, folliculitis (skin infections), acneiform eruptions (acne-like skin eruptions), hypertrichosis (increased hair growth), hypopigmentation (change in skin color), and, especially when using occlusive dressings, cutaneous atrophy (thinning of the skin). These effects are typical disorders associated with local corticosteroid therapy and mostly occur in mild and reversible forms. They may be favored by occlusive therapy or by the use of high doses of the medicine for prolonged periods over extensive skin areas (see "Warnings and precautions").
Development of non-susceptible microorganisms (which do not respond to treatment with MENADERM), including fungi, which may occur following prolonged use of the antibiotic (neomycin).

Systemic adverse effects caused by corticosteroids are very unlikely to occur.
However, if your renal function is impaired, you may exceptionally experience, following application of high doses over large skin areas for prolonged periods—especially with occlusive dressing—symptoms of ototoxicity (toxicity affecting the ears) and nephrotoxicity (toxicity affecting the kidneys) due to systemic absorption (entry into the bloodstream) of neomycin.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) at the following website: http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MENADERM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of
that month and to the product in its original, unopened packaging, correctly stored.
MENADERM cream and MENADERM ointment
Store below 30°C.
MENADERM cutaneous solution
No special storage precautions are required.
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Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What MENADERM contains
MENADERM cream
1 g of cream contains:
Active substances: beclometasone dipropionate 0.25 mg, neomycin sulfate 5 mg.
Other components: glycerol monostearate, cetomacrogol, liquid paraffin, white soft paraffin, isopropyl myristate,
myristyl alcohol, p-hydroxybenzoic acid esters, purified water.
MENADERM ointment
1 g of ointment contains:
Active substances: beclometasone dipropionate 0.25 mg, neomycin sulfate 5 mg.
Other components: decyl oleate, liquid paraffin, p-hydroxybenzoic acid esters, white soft paraffin.
MENADERM cutaneous solution
1 g of cutaneous solution contains:
Active substances: beclometasone dipropionate 0.25 mg, neomycin sulfate 5 mg.
Other components: glycerol monostearate, cetomacrogol, liquid paraffin, white soft paraffin, isopropyl myristate,
myristyl alcohol, p-hydroxybenzoic acid esters, purified water.

Description of the appearance of MENADERM and packaging contents
MENADERM cream
Cream. 30 g tube containing a soft, white, homogeneous, practically odourless cream.
MENADERM ointment
Ointment. 30 g tube containing a soft, white-grey, homogeneous, greasy-to-the-touch, practically odourless ointment.
MENADERM cutaneous solution
Cutaneous solution. 30 g bottle with dropper containing a semi-liquid, white, homogeneous, practically odourless lotion.

Marketing Authorization Holder
Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, 3 - Florence.

Manufacturer
MENADERM ointment
A. Menarini Manufacturing Logistics and Services s.r.l., Via Sette Santi, 3, Florence.
MENADERM cream and MENADERM cutaneous solution
A. Menarini Manufacturing Logistics and Services s.r.l., Via Sette Santi, 3, Florence.
Laboratorios Menarini S.A., Alfonso XII, 587 – 08918 Badalona, Barcelona (Spain).
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