ITAMIDOL "3% SKIN FOAM" PRESSURIZED CONTAINER 50 G"

Name
ITAMIDOL 3% Skin foam
Diclofenac


What it is and what it is used for
Itamidol contains the active substance diclofenac which belongs to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and inflammation.

Itamidol is indicated for the local treatment of painful and inflammatory conditions of rheumatic or traumatic nature affecting:
- joints;
- muscles;
- tendons and ligaments.

Talk to your doctor if you do not feel better or if you feel worse after 7 days of treatment.


What you need to know before taking the medicine
Do not use Itamidol
- if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
- if you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) and, following the use of these medicines, you have experienced asthma attacks, allergic skin reactions (urticaria) or nasal irritation (rhinitis);
- if you are allergic to isopropanol, a type of alcohol;
- if you are in the third trimester of pregnancy (See the section "Pregnancy and breast-feeding and fertility" );
- if the person who is to use this medicine is a child or adolescent under 14 years of age (see section "Children" );


Warnings and precautions
Talk to your doctor or pharmacist before using Itamidol.
Talk to your doctor before using Itamidol:
- if you suffer or have suffered from asthma;
- if you suffer or have suffered from chronic diseases with bronchial obstruction;
- if you suffer or have suffered from allergic rhinitis (inflammation of the nose due to allergy);
- if you suffer or have suffered from inflammation of the nasal mucosa (nasal polyp);
because he may experience asthma attacks, local inflammation of the skin, mucosa (Quincke's edema) or urticaria more easily than other patients.

Pay special attention:
- do not ingest Itamidol;
- do not apply Itamidol on damaged, diseased or open wounds;
- avoid contact of Itamidol with eyes or mucous membranes;
- if you are an elderly patient and/or have stomach problems, do not use Itamidol with other anti-inflammatory medicines taken by mouth, injection or rectally;
- do not use Itamidol with an occlusive dressing, i.e. covering the affected area with a plastic film that does not allow air to pass through. Instead, you can use Itamidol with a gauze that allows air to pass through;
- the use, especially if for long periods of time, of local medicines can cause allergic reactions such as skin eruption (rash). If this occurs, stop treatment with Itamidol and consult your doctor who will give you an appropriate therapy;
- avoid excessive exposure to sunlight while using Itamidol, this will reduce the risk of having skin reactions due to the sun;
- if you use diclofenac on large areas of skin and for long periods of time, you may experience side effects that involve the whole body.

Children
Itamidol should not be used in children and adolescents under 14 years of age.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
After application to the skin, the amount of diclofenac that reaches the blood is very low, so the risk of experiencing side effects involving the body is limited.
However, stomach and intestinal problems may occur following applications for long periods and on large areas.

The following side effects may occur:
Common (may affect up to 1 in 10 people)
- skin irritations (rash, eczema);
- redness (erythema);
- inflammation of the skin (dermatitis), including contact dermatitis;
- itching.

Rare (may affect up to 1 in 1000 people)
- inflammation of the skin with blistering (bullous dermatitis).

Very rare (may affect up to 1 in 10,000 people)
- allergic reactions including hives and swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing which can be life-threatening (angioedema);
- skin irritation with the formation of vesicles (rash with pustules);
- asthma;
- sensitivity to light (photosensitivity).

Not known
- burning sensation at the application site;
- dry skin.

If you use this medicine together with other medicines containing diclofenac, serious skin reactions (Stevens-Johnson syndrome, Lyell syndrome) may occur.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.