Itami

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Itami, 140 mg, medicinal patch
For use in adults and adolescents over 16 years of age
Diclofenacum natricum
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

• This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. Keep this leaflet so that you can read it again if necessary.
• Consult your pharmacist if you need advice or further information.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.

Contents of the leaflet:

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

1. What Itami is and what it is used for

Itami is a pain-relieving medicine. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
Itami is used for local, short-term (no longer than 7 days) symptomatic treatment of pain in adults and adolescents over 16 years of age due to acute strains, sprains or bruises of limbs resulting from blunt injuries, such as sports injuries.
If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.

2. Important information before using Itami

When not to use Itami:

• if the patient is allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to any other non-steroidal anti-inflammatory drug (NSAID, e.g. acetylsalicylic acid or ibuprofen);
• if the patient has ever experienced an asthma attack, chills, swelling, or irritation inside the nose after taking acetylsalicylic acid or other NSAIDs;
• in patients with active gastric or duodenal ulcer disease;
• on damaged skin (e.g. abrasions, cuts, skin burns), infected skin, or skin affected by exudative dermatitis or eczema;
• during the last three months of pregnancy;
• if the patient is a child or adolescent under 16 years of age.

Warnings and precautions
Exercise particular caution when using Itami if:

• the patient suffers or has suffered from bronchial asthma or allergies; muscle spasms (bronchospasm) may occur, making breathing difficult.
• a skin rash develops after applying the medicated patch. If this occurs, the patch must be removed immediately and treatment discontinued.
• the patient has kidney, heart or liver disorders, or has suffered or suffers from gastric and/or duodenal ulcer disease, inflammatory bowel disease, or has a tendency to bleeding.

The risk of adverse effects can be minimized by using the lowest effective dose for the shortest possible duration.
IMPORTANT precautions

• The medicated patch must not be used and must not come into contact with the eyes or mucous membranes.
• Itami should be used with great caution in elderly patients, as they are more susceptible to adverse effects.

After removing the patch, avoid exposing the treated areas to sunlight or sunbeds to reduce the risk of photosensitivity reactions.
Do not use other topical or oral medicinal products containing diclofenac, or any other non-steroidal analgesic or anti-inflammatory drugs, concurrently with Itami.
Other medicines and Itami
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Only a small amount of diclofenac is absorbed into the body when Itami is used correctly; therefore, drug interactions described for orally administered diclofenac-containing medicines are unlikely.
Pregnancy and breastfeeding
Pregnancy
Consult your doctor or pharmacist before using Itami if you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant.
Itami should not be used during the first and second trimesters of pregnancy or during pregnancy planning, unless clearly necessary and only after consultation with a doctor. If use is necessary, the lowest possible dose for the shortest possible time should be administered.
Itami must not be used during the last trimester of pregnancy.
After oral administration of diclofenac (e.g. tablets), complications in the mother and adverse effects in the child may occur (see "When not to use Itami"). It is unknown whether the same risk applies to Itami when applied to the skin.
Breastfeeding
Small amounts of diclofenac may pass into breast milk.
Consult your doctor before using Itami during breastfeeding. Itami must not be applied under any circumstances directly to the skin of the breast during breastfeeding.
Driving and operating machinery
Itami has no influence on the ability to drive or operate machinery.

3. How to use Itami

This medicine should always be used according to the instructions provided in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor, pharmacist, or nurse.
The recommended dose is one medicated patch applied twice daily.
The medicated patch should be applied to the painful area twice a day: in the morning and in the evening. The maximum dose is 2 medicated patches per day, even if more than one affected area requires treatment.
Only one painful area should be treated at any given time.

Use in children and adolescents
Itami is contraindicated in children and adolescents under 16 years of age. There is insufficient data on safety and efficacy in children and adolescents under 16 years of age (see also section 2).
In adolescents over 16 years of age, if use of this medicine is required for longer than 7 days, or if symptoms worsen, it is recommended that the patient or their caregivers consult a doctor.

Method of administration
For external use only (on the skin).
Instructions for use:

1. Tear open the sachet along the perforated line and remove the medicated patch. Applying the patch:

2. Remove one of the two protective liners from the patch.
3. Apply to the affected area and remove the second protective liner.

4. Gently press with the hand to ensure the patch adheres properly to the skin.

Removing the patch:

5. Moisten the patch with water, lift the edge of the patch, and gently peel it off.
6. To remove any residual medicine, wash the treated area with water, gently massaging with circular motions using the fingers.

If necessary, the medicated patch may be secured with a knitted bandage.
The medicated patch should only be applied to intact, healthy skin.
Do not use the medicated patch with an air-impermeable dressing (occlusive dressing).
Do not use during bathing or showering.
The medicated patch must not be divided.

Duration of use
Do not use Itami for longer than 7 days.
If symptoms worsen or persist beyond 7 days, consult a doctor.
Consult a doctor or pharmacist if you feel that the effect of Itami is too strong or too weak.

Use of a higher than recommended dose of Itami
If significant adverse reactions occur due to improper use or accidental overdose (e.g., by children), contact a doctor. The doctor will decide on further management.

Missed dose of Itami
Do not apply a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following symptoms occur, contact your doctor immediately and stop using the patch:
sudden itchy rash (urticaria); swelling of hands, feet, ankles, face, lips, mouth or throat;
difficulty breathing; drop in blood pressure or weakness.

The following adverse reactions may occur:

Common adverse reactions (may occur in 1 to 10 out of 100 patients):
local skin reactions such as redness, burning, itching, red inflamed skin, rash, sometimes with pustules or urticarial blisters.

Uncommon adverse reactions (may occur in less than 1 out of 1,000 patients):
dry skin.

Very rare adverse reactions (may occur in up to 1 out of 10,000 patients):
hypersensitivity reactions or local allergic reactions (contact dermatitis).

In patients using medicines from the same pharmacological group as diclofenac, there have been isolated reports of generalized skin rash, hypersensitivity reactions such as skin and mucous membrane swelling, as well as anaphylactic-type reactions with acute circulatory disturbances and photosensitivity.

Compared to the concentration of active substance in the blood achieved after oral administration, diclofenac applied to the skin is absorbed to a very minimal extent. Therefore, the likelihood of systemic adverse reactions (such as gastrointestinal, liver, kidney disorders or breathing difficulties) is very low.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store the Itami medicinal product

Keep the medicinal product out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Do not use Itami if the patient notices any damage to the patch.
Used patches should be folded in half with the adhesive side turned inwards.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Itami contains

• The active substance is sodium diclofenac. Each medicated patch contains 140 mg of sodium diclofenac.
• Other ingredients are: Butyl acrylate - acrylic acid copolymer, Basic butyl methacrylate copolymer, Polyglycol 12 stearate, Sorbitan oleate.

Polyester backing layer
Silicone-coated protective paper liner.

What Itami looks like and contents of the pack
Itami is a white transdermal patch measuring 10x14 cm, with one side made of non-woven fabric and the other side of paper.
Each Itami package contains 2, 5 or 10 medicated patches. Each patch is individually enclosed in a sachet.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Italy, country of export:
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)
Italy

Manufacturer:
IBSA Farmaceutici Italia S.r.l.
S.S. Strada Statale 11, Padana Superiore km 160
20051 Cassina de’ Pecchi (MI)
Italy
Fidia Farmaceutici S.p.A.
Via Ampère 29
20037 Paderno Dugnano (MI)
Italy
Falorni S.r.l.
Via dei Frilli, 25
50019 Sesto Fiorentino (FI)
Italy

Parallel importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw

Marketing authorisation number in Italy, country of export: 035482025
Parallel import authorisation number: 337/25

This medicinal product is authorised in the European Economic Area (EEA) under the following names:
DE: Itami 140 mg Wirkstoffhaltiges Pflaster
PL: Itami, 140 mg, medicated patch