MENADERM 0,25 MG/G Cream

Зміст інструкції

1. MENADERM SIMPLEX 0.25 mg/g cream, cutaneous solution
   1. WHAT MENADERM SIMPLEX IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING MENADERM SIMPLEX
   3. HOW TO USE MENADERM SIMPLEX
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE MENADERM SIMPLEX
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

MENADERM SIMPLEX 0.25 mg/g cream, cutaneous solution

Beclometasone dipropionate

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What MENADERM SIMPLEX is and what it is used for
• 2. What you need to know before you use MENADERM SIMPLEX
• 3. How to use MENADERM SIMPLEX
• 4. Possible side effects
• 5. How to store MENADERM SIMPLEX
• 6. Contents of the pack and other information

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

MENADERM SIMPLEX contains the active ingredient beclometasone dipropionate, belonging to the class
of corticosteroids (anti-inflammatory drugs).
MENADERM SIMPLEX is used in the treatment of skin diseases in which therapy with
local corticosteroid drugs is indicated, such as:

• allergic dermatitis (skin inflammation of an allergic nature), acute and chronic (short or long duration), exogenous and endogenous (caused by external or internal agents);
• contact dermatitis of various types, eczema (non-infectious itchy inflammatory skin reaction) in children and eczematous dermatitis.

MENADERM SIMPLEX is also used in cases of:

• dyshidrosis (inflammatory skin disease characterized by the appearance of itchy blisters on hands and feet);
• ano-genital pruritus;
• burns and solar erythema (redness of the skin caused by excessive exposure to sunlight);
• reactions to chemical agents or plant substances;
• psoriasis (chronic inflammatory skin disease, non-infectious and non-contagious, of autoimmune nature, characterized by erythema and scaling), as an adjunct.

2. WHAT YOU NEED TO KNOW BEFORE USING MENADERM SIMPLEX

Do not use MENADERM SIMPLEX

• If you are allergic (hypersensitive) to the active ingredient or to any of the other ingredients of this medicine (listed in section 6).
• If you have a skin lesion of a tuberculous (derived from tuberculosis), viral (caused by a virus) and luetic (derived from syphilis, a sexually transmitted infectious disease) nature.
• For occlusive dressing (covering the affected area with bandages after applying the medicine) in case of atopic dermatitis (chronic inflammatory skin disease, with intense itching and dryness) (see “Warnings and precautions”).

Warnings and precautions
Consult your doctor or pharmacist before using MENADERM SIMPLEX.
Contact your doctor if you experience blurred vision or other visual disturbances.
The use, especially if prolonged, of topical products can give rise to sensitization phenomena
(increased reactivity to certain substances); in this case it is necessary to interrupt the treatment and your
doctor will eventually establish an appropriate therapy for the sensitization phenomenon that has
manifested itself.
In case of occlusive therapy, especially in cases of extensive lesions, it is advisable to treat one part at
a time, as occlusive bandaging can promote the absorption of components through the skin with
consequent possible appearance of systemic effects (relating to the whole organism). By treating one area at
a time it is possible to avoid any alterations (increases) in your body temperature. If such alterations were to
occur, discontinue treatment immediately.
The material used for occlusive bandaging can cause individual sensitization phenomena that
require replacement of the material used.
In newborns, the diaper can act as an occlusive bandage, thus increasing the risk of adverse
effects.
In case of use of the medicine in the presence of skin infections, institute appropriate therapy and, in case
of failure of this, discontinue treatment.
Occlusive therapy is contraindicated in atopic dermatitis (see “Do not use MENADERM SIMPLEX”).
The product is not intended for ophthalmic use (for the eyes).

Children and adolescents
In the first months of life, the application of MENADERM SIMPLEX should be carried out only in cases of actual
need and under the direct control of the doctor.

Other medicines and MENADERM SIMPLEX
Tell 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, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use MENADERM SIMPLEX only in cases of actual
need and under the direct control of the doctor, especially in case of application on large areas of
your body or with occlusive bandaging.

Driving and operating machinery
Not applicable.

MENADERM SIMPLEX containsesters of p-hydroxybenzoic acidwhich can cause allergic
reactions (including delayed ones).

3. HOW TO USE MENADERM SIMPLEX

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
Apply a small amount of product (thin layer) to the affected skin area 2 times a day and
massage gently.
Occlusive dressing may be appropriate in particular cases according to the doctor's judgment.
MENADERM SIMPLEX cream is preferred in the treatment of delicate or moist skin surfaces.
MENADERM SIMPLEX cutaneous solution is indicated in the treatment of extensive skin lesions, skin
folds and hairy areas (with the presence of hair).

If you use more MENADERM SIMPLEX than you should
No cases of overdose are known following the use of MENADERM SIMPLEX.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop treatment and contact your doctor who will prescribe suitable therapy if you notice the
appearance of any of the following side effects:

• burning sensation, irritation, dryness of the skin, folliculitis (inflammation and/or infection of the hair follicle), acneiform eruptions (skin rashes similar to acne), hypertrichosis (increased hairiness), hypopigmentation (alteration of skin color) and, especially when using occlusive bandages, skin atrophy (thinning of the skin).
• Blurred vision (frequency not known).

These effects are classic disorders associated with topical corticosteroid therapy and usually manifest
in a mild and reversible form. They may be favored by occlusive therapy (bandages) or by the use of
high doses of medicine for prolonged periods on large areas of skin (see "Warnings and
precautions").
Systemic side effects caused by topical corticosteroids are very rare.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects 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 which is stated on the pack. The expiry date refers to the last day of that month and the product in intact packaging, correctly stored.
This medicine does not require particular precautions for storage.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What MENADERM SIMPLEX contains
MENADERM SIMPLEX cream
1 g of cream contains:

Active ingredients: beclometasone dipropionate 0.25 mg.

Other ingredients: glyceryl monostearate, cetomacrogol, liquid paraffin, white soft paraffin, isopropyl myristate,
myristyl alcohol, p-hydroxybenzoic acid esters, purified water.
MENADERM SIMPLEX cutaneous solution
1 g of cutaneous solution contains:

Active ingredients:beclometasone dipropionate 0.25 mg.

Other ingredients:glyceryl monostearate, cetomacrogol, liquid paraffin, white soft paraffin, isopropyl myristate,
myristyl alcohol, p-hydroxybenzoic acid esters, purified water.

Description of the appearance of MENADERM SIMPLEX and contents of the pack
MENADERM SIMPLEX cream
Homogeneous white cream. Tube containing 30 g.
MENADERM SIMPLEX cutaneous solution
Homogeneous white cutaneous solution. 30 g bottle with dropper and screw cap.

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

Distributor:
Relife Italia s.r.l. – Via Sette Santi, 3 - Florence

Manufacturer

• 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).