MENADERM 0.025% + 0.5% Cream

Зміст інструкції

1. 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
   1. WHAT IS MENADERM AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING MENADERM
   3. HOW TO USE MENADERM
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE MENADERM
   6. PACKAGE CONTENTS AND OTHER INFORMATION

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

Read this 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT IS MENADERM AND WHAT IT IS USED FOR

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

• Allergic and inflammatory dermatoses (skin inflammations of an allergic or inflammatory nature), acute and chronic (short or long duration), exogenous and endogenous (caused by external or internal agents).
• Contact dermatitis of various types, eczema (pruritic inflammatory reaction of the skin) in children and eczematous dermatitis, erythematous-exudative skin pathologies (with production of exudate, a liquid that forms with inflammation).
• Pustular acne (with circumscribed, raised skin lesions).
• Intertrigo (skin condition caused by continuous rubbing of two nearby body surfaces).

2. WHAT YOU NEED TO KNOW BEFORE USING MENADERM

Do not use MENADERM

• If you are allergic to the active ingredients or to any of the other ingredients of this medicine (listed in section 6).
• If you have a skin lesion of a tuberculous (resulting from tuberculosis), viral (caused by a virus) and luetic (resulting from syphilis, a sexually transmitted infectious disease) nature.
• As an 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.
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The use, especially if prolonged, of topical products can give rise to sensitization phenomena
(increased reactivity to certain substances); in such a case it is necessary for you 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 that you treat one part at
a time, as this technique can favor the absorption of the components with consequent possible appearance
of systemic effects (related to the whole organism). Treating one area at a time can avoid any
alterations of thermal homeostasis that can manifest with an increase in body temperature. If
such alterations occur, immediately stop the treatment.
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.
Occlusive therapy is contraindicated in atopic dermatitis (see “Do not use MENADERM”).
The product is not for ophthalmic use (for the eyes).

Children and adolescents
In the first months of life, the application of MENADERM should only be carried out in cases of actual necessity and under
direct medical supervision.

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

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use MENADERM only in cases of actual necessity and under
direct medical supervision, especially in case of application to large areas or with occlusive
dressing.

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

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

3. HOW TO USE MENADERM

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
Apply 2 times a day a small amount of product (thin layer) to the affected skin area and
massage gently.
Occlusive dressings may be appropriate in particular cases according to the doctor's judgment.
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MENADERM cream is preferred in the treatment of delicate or moist skin surfaces.
MENADERM ointment is indicated in the treatment of dry, lichenified (thickened) or scaly
lesions and when using occlusive bandaging.
MENADERM 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 than you should
No cases of overdose are known following the use of MENADERM.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

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

• Burning sensation, irritation, dryness of the skin, folliculitis (skin infections), acneiform eruptions (skin rashes similar to acne), hypertrichosis (increased hairiness), hypopigmentation (alteration of skin color) and, especially when using occlusive dressings, skin atrophy (thinning of the skin). These effects are classic disorders associated with local corticosteroid therapy (therapy based on corticosteroids) and usually manifest in a mild and reversible form. They may be favored by occlusive therapy or by the use of high doses of medicine for prolonged periods on extensive areas of the skin (see “Warnings and precautions”).
• Development of microorganisms that are not sensitive (that do not respond to treatment with MENADERM), including fungi, which may occur as a result of prolonged use of the antibiotic (neomycin).

It is very difficult for systemic side effects caused by corticosteroids to occur.
However, if your kidney function is impaired, you may exceptionally experience, in
case of application of high doses to extensive surfaces and for prolonged periods, especially in
case of occlusive dressings, phenomena of ototoxicity (toxicity at the level of the ears) and nephrotoxicity
(toxicity at the level of the kidneys) caused by systemic absorption (passage into the blood) of neomycin.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the Italian Medicines Agency,
Website: http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects 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 which is reported on the packaging. The expiry date refers to the last day of that month and the product in intact packaging, correctly stored.
MENADERM cream and MENADERM ointment
Store at a temperature below 30°C.
MENADERM cutaneous solution
No special precautions for storage are required.
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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. PACKAGE CONTENTS AND OTHER INFORMATION

What MENADERM contains
MENADERM cream
1 g of cream contains:

Active ingredients: beclometasone dipropionate 0.25 mg, neomycin sulfate 5 mg.

Other ingredients: glyceryl 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 ingredients: beclometasone dipropionate 0.25 mg, neomycin sulfate 5 mg.

Other ingredients: decyl oleate, liquid paraffin, p-hydroxybenzoic acid esters, white soft paraffin.
MENADERM cutaneous solution
1 g of cutaneous solution contains:

Active ingredients:beclometasone dipropionate 0.25 mg, neomycin sulfate 5 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 and package contents
MENADERM cream
Cream. Tube containing 30 g of a soft, white, homogeneous cream, practically odorless.
MENADERM ointment
Ointment. Tube containing 30 g of a soft, white-grey, homogeneous ointment, greasy to the
touch, practically odorless.
MENADERM cutaneous solution
Cutaneous solution. Bottle containing 30 g with dropper containing a semi-liquid, white, homogeneous lotion,
practically odorless.

Marketing Authorisation 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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