ITAMIDOL 3 % Cutaneous foam

Зміст інструкції

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

ITAMIDOL 3% Cutaneous Foam

diclofenac

Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

1. What is Itamidol and what is it used for

Itamidol contains the active ingredient 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 origin
affecting:

• joints
• muscles
• tendons and ligaments

See a doctor if you do not feel better or if you feel worse after 7 days of treatment.

2. What you need to know before using Itamidol

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 shown asthma attacks, allergic skin reactions (urticaria) or nasal irritation (rhinitis);
• if you are allergic to isopropyl alcohol, a type of alcohol;
• if you are in the third trimester of pregnancy (See the section “ Pregnancy and breastfeeding and fertility”);
• if the person who needs to use this medicine is a child or adolescent under the age of 14 (see the section “ Children”);

Warnings and precautions
Talk to your doctor or pharmacist before using Itamidol.
Talk to your doctor before using Itamidol:

• if you suffer from or have suffered from asthma
• if you suffer from or have suffered from chronic bronchial obstruction diseases
• if you suffer from or have suffered from allergic rhinitis (inflammation of the nose due to allergy)
• if you suffer from or have suffered from inflammation of the nasal mucosa (nasal polyps) because you may experience asthma attacks, local skin inflammation, mucosal inflammation (angioedema) or urticaria more easily than other patients.

Take special care:

• do not ingest Itamidol
• do not apply Itamidol to broken, diseased or open-wound skin
• avoid getting Itamidol into your 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 orally, by injection or rectally
• do not use Itamidol with an occlusive bandage, i.e. covering the affected area with a plastic film that does not allow air to pass through. You can instead use Itamidol with a gauze that allows air to pass through
• the use, especially if for long periods of time, of medicines for local use can cause allergic reactions, for example skin rash (rash). If this occurs, stop treatment with Itamidol and consult your doctor who will give you suitable therapy
• avoid excessive exposure to sunlight during the use of Itamidol, this will reduce the risk of having sun-related skin reactions
• if you use diclofenac on large areas of skin and for long periods of time, you may experience undesirable effects involving the whole body.

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

Other medicines and Itamidol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.
Because the absorption of Itamidol through the skin is very low, interactions with other medicines are
very unlikely.
However, in high-dose and prolonged treatments, interactions with other
medicines cannot be ruled out.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding with breast milk
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Oral forms (e.g. tablets) of diclofenac can increase the risk of abortion/cause adverse effects
in the unborn child. It is not known whether the same risk occurs with ITAMIDOL when used on the skin.
Do not use ITAMIDOL during the last trimester of pregnancy as it could expose your baby to serious
problems with the heart, lungs, kidneys. At the end of pregnancy diclofenac can expose both the mother and
the newborn to complications during childbirth, such as inhibition of uterine contractions (delay or prolongation
of labor), possible prolongation of bleeding time and antiplatelet effect that can
occur even at very low doses of the medicine.
Do not use ITAMIDOL during the first 6 months of pregnancy or if you are planning a pregnancy unless
strictly necessary and as directed by your doctor. If necessary, treatment during this period
must use the lowest dose for the shortest possible time.
Breastfeeding
If you are breastfeeding, do not apply Itamidol to the breast, to large areas of skin and for long periods of time as
diclofenac passes into breast milk in small amounts, although no effects on the baby are expected if
Itamidol is used at the recommended doses.
Do not use Itamidol during breastfeeding unless you have first consulted your doctor.
If you have fertility problems or need to undergo fertility investigations, stop using this medicine.

Driving and operating machinery
Itamidol does not impair the ability to drive vehicles and operate machinery.

Itamidol contains soy lecithin, potassium sorbate, polysorbate and benzyl alcohol
Itamidol contains a derivative of soy, if you are allergic to peanuts or soy, do not use this medicine.
Itamidol contains potassium sorbate which may cause localized skin reactions (e.g. contact dermatitis).
Polysorbates can cause allergic reactions.
This medicine contains 4.75 mg of benzyl alcohol per 1 g of product.
Benzyl alcohol can cause allergic reactions. Benzyl alcohol can cause mild local irritation.

3. How to use Itamidol

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The duration of treatment should be as short as possible. If you do not notice any improvement after 7 days of
treatment, consult your doctor.

Use in adults
Apply this medicine 1-3 times a day.
Method of administration
Itamidol is for external use only.
Use the medicine as follows:

• shake the canister before use;
• spray a small amount of foam with a diameter of 3-5 cm onto the palm of your hand, holding the canister upside down;
• apply the foam to the affected area, massaging gently until completely absorbed;
• afterwards, rub your hands with a paper towel and then wash them, also to avoid the action of the medicine on your hands, unless your hands themselves are the area to be treated.
• if too much foam has been applied accidentally, the excess foam should be removed with a paper towel. The paper towel should be disposed of in household waste to prevent unused product from reaching the aquatic environment.
• before applying a bandage, the foam should be allowed to dry for a few minutes on the skin.

This medicine can be applied by ultrasound and by iontophoresis; in the latter case the
product must be applied to the negative pole.

Use in adolescents aged 14 to 18 years
Apply this medicine 1-3 times a day
Method of administration
Itamidol is for external use only.
Use the medicine as follows:

• shake the canister before use;
• spray a small amount of foam with a diameter of 3-5 cm onto the palm of your hand, holding the canister upside down;
• apply the foam to the affected area, massaging gently until completely absorbed;
• afterwards, rub your hands with a paper towel and then wash them, to avoid the action of the medicine on your hands, unless your hands themselves are the area to be treated.
• if too much foam has been applied accidentally, the excess foam should be removed with a paper towel. The paper towel should be disposed of in household waste to prevent unused product from reaching the aquatic environment.
• before applying a bandage, the foam should be allowed to dry for a few minutes on the skin.

This medicine can be applied by ultrasound and by iontophoresis; in the latter case the
product must be applied to the negative pole.

Use in children and adolescents under 14 years
Do not use this medicine in children and adolescents under 14 years of age.

Use in elderly patients
Elderly patients can use the doses prescribed for adults.

If you use more Itamidol than you should
In case of accidental ingestion of Itamidol, immediately inform your doctor or go to the nearest
hospital.
Cases of overdose with this medicine are unlikely.

If you forget to use Itamidol
Do not use a double dose to make up for a missed dose.
If you have any questions about using 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.
After application to the skin, the amount of diclofenac reaching the blood is very low, therefore the
risk of experiencing side effects involving the body is limited.
However, problems with the stomach and intestines may occur, following long-term
applications and on extensive areas.
The following side effects may occur:

Common(may affect up to 1 in 10 people)

• skin irritation (rash, eczema);
• redness (erythema);
• skin inflammation (dermatitis), including contact dermatitis;
• itching.

Rare(may affect up to 1 in 1,000 people)

• skin inflammation with blister formation (bullous dermatitis).

Very rare(may affect up to 1 in 10,000 people)

• allergic reactions including urticaria and swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing potentially fatal (angioedema);
• skin irritation with blister formation (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's syndrome) may occur.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, 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 Itamidol

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 packaging after “ Scad.”.
The expiry date refers to the last day of that month.
Store at a temperature below 30 °C. Pressurized container: may explode if heated. Itamidol 3%
Cutaneous foam contains flammable propellant. Keep away from heat sources, hot surfaces, sparks,
open flames or other sources of ignition. Do not smoke. Do not spray on an open flame or other source of ignition.
Do not puncture or burn, even after use. Protect from sunlight. Do not expose to temperatures above
50 °C.
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 Itamidol 3% Cutaneous Foam contains

• The active ingredient is diclofenac. 100 g of cutaneous foam contains 3 g of diclofenac
• The other ingredients are: sodium hydroxide, macrogolglycerides caprylocaprate, hydrogenated soy lecithin, polysorbate 80, benzyl alcohol, potassium sorbate, disodium phosphate dodecahydrate all- rac-α- tocopheryl acetate, mint/eucalyptus fragrance, purified water. Each pressurised container (50 g) contains: 47.5 g of solution and 2.5 g of propellant (isobutane; n-butane; propane)

Description of the appearance of Itamidol and contents of the pack
Pack containing an aluminium pressurised container of 50 g of cutaneous foam.

Marketing Authorisation Holder
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD) – Italy.

Manufacturer
Farmol Health Care S.r.l.
Via del Maglio, 6
23868 Valmadrera (LC) – Italy.