Package leaflet: Information for the user

MENADERM SIMPLEX 0,25 mg/g cream, cutaneous solution

Beclometasone dipropionate
Read this leaflet carefully before using this medicine because 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT MENADERM SIMPLEX IS AND WHAT IT IS USED FOR

MENADERM SIMPLEX contains the active substance beclometasone dipropionate, which belongs to the class of corticosteroids (anti-inflammatory medicines).
MENADERM SIMPLEX is used in the treatment of skin diseases where therapy with topical corticosteroid medicines is indicated, such as:

allergic dermatitis (skin inflammations of allergic origin), acute and chronic (short-term or long-term), exogenous and endogenous (caused by external or internal agents);
various types of contact dermatitis, eczema (a non-infectious, itchy inflammatory skin reaction) in children, and eczematous dermatitis.

MENADERM SIMPLEX is also used in cases of:

dyshidrosis (an inflammatory skin disease characterized by itchy blisters on the hands and feet);
anogenital pruritus;
burns and solar erythema (skin redness caused by excessive exposure to sunlight);
reactions to chemical agents or plant substances;
psoriasis (a chronic, non-infectious and non-contagious autoimmune inflammatory skin disease, characterized by erythematous-scaling lesions), as an adjunctive treatment.

2. WHAT YOU NEED TO KNOW BEFORE USING MENADERM SIMPLEX

Do not use MENADERM SIMPLEX

If you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6).
If you have a skin lesion of tuberculous (caused by tuberculosis), viral (caused by a virus), or luetic nature (caused by syphilis, an infectious disease mainly transmitted through sexual contact).
For occlusive dressing (covering the treated area with bandages after application of the medicine) in case of atopic dermatitis (chronic inflammatory skin disease characterized by intense itching and dryness) (see "Warnings and precautions").

Warnings and precautions
Talk to your doctor or pharmacist before using MENADERM SIMPLEX.
Contact your doctor if you experience blurred vision or other visual disturbances.
The use, especially prolonged use, of topical products may lead to sensitization phenomena (increased reactivity to certain substances); in such cases, you must stop treatment, and your doctor will initiate, if necessary, appropriate therapy for the sensitization reaction that has occurred.
When using occlusive therapy, particularly in cases of extensive skin lesions, it is advisable to treat one area at a time, as occlusive bandaging may enhance absorption of the components through the skin, possibly leading to systemic effects (affecting the whole organism). Treating one area at a time may help prevent possible alterations (increases) in body temperature. If such changes 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.
If using this medicine in the presence of skin infections, appropriate therapy should be initiated, and if such therapy fails, treatment should be discontinued.
Occlusive therapy is contraindicated in atopic dermatitis (see "Do not use MENADERM SIMPLEX").
This product is not intended for ophthalmic use (for the eyes).

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

Other medicines and MENADERM SIMPLEX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No drug interactions with MENADERM SIMPLEX are known.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use MENADERM SIMPLEX only when strictly necessary and under direct medical supervision, especially when applied over large areas of the body or with occlusive bandaging.

Driving and using machines
Not applicable.

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

3. HOW TO USE MENADERM SIMPLEX

Use this medicine exactly as directed 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 physician's judgment.
MENADERM SIMPLEX cream is preferred for treating delicate or moist areas of skin.
MENADERM SIMPLEX topical solution is indicated for treating extensive skin lesions, skin folds, and hairy areas (areas with hair).
If you use more MENADERM SIMPLEX than you should
There are no known cases of overdose following the use of MENADERM SIMPLEX.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

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

Burning sensation, irritation, dryness of the skin, folliculitis (inflammation and/or infection of the hair follicle), acneiform eruptions (skin eruptions similar to acne), hypertrichosis (increased hair growth), hypopigmentation (change in skin color), and, especially when using occlusive dressings, cutaneous atrophy (thinning of the skin).
Blurred vision (frequency not known).

These effects are typical disorders associated with topical corticosteroid therapy and mostly occur in mild and reversible forms. They may be favored by occlusive therapy (dressings) or by the use of high doses of the medicine and for prolonged periods over extensive areas of skin (see "Warnings and precautions").
Systemic adverse effects caused by topical corticosteroids are very unlikely to occur.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MENADERM SIMPLEX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month and to the product in its original, unopened packaging stored correctly.
This medicine does not require any special storage precautions.
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. PACK CONTENTS AND OTHER INFORMATION

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

Description of the appearance of MENADERM SIMPLEX and pack contents
MENADERM SIMPLEX cream
Homogeneous white cream. Tube of 30 g.
MENADERM SIMPLEX cutaneous solution
Cutaneous solution, homogeneous and white in colour. 30 g bottle with dropper and screw cap.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Menarini Industrie Farmaceutiche Riunite s.r.l., Via Sette Santi, 3 - Florence, Italy.
Sales Licensee:
Relife Italia s.r.l. – Via Sette Santi, 3 - Florence, Italy

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