Itami

Patient Information Leaflet: User Information

Pain,140 mg, medicinal patch
For use in adults and adolescents over 16 years of age.
Diclofenac sodium

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• This medicine should always be used as described in the patient information leaflet or as directed by a doctor or pharmacist. Keep this leaflet, you may need to read it again.
• Ask your pharmacist if you need advice or more information.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet:

• 1. What is Itami and what is it 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 is Itami and what is it 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) and symptomatic treatment of pain in adults and adolescents over 16 years of age in case of acute strains, sprains or bruises of the limbs, resulting from blunt injuries, e.g. sports injuries.
If after 7 days there is no improvement or you feel worse, contact your doctor.

2. Important information before using Itami

When not to use Itami:

• if you are allergicto diclofenacor any of the other ingredientsof this medicine (listed in section 6);
• if you are allergicto any other non-steroidal anti-inflammatory drug(NSAID, e.g. acetylsalicylic acid or ibuprofen);
• if you have ever had an asthma attack, hives, swelling, and irritation of the nasal passagesafter taking acetylsalicylic acid or other NSAIDs;
• in patients with active stomach or duodenal ulcer disease;
• on injured skin(e.g. abrasions, cuts, burns), infected skin or with weeping eczema;
• in the last three months of pregnancy,
• if you are a child or adolescent under 16 years of age.

Warnings and precautions

Be careful when using Itami if:

• you have asthma or allergies; you may experience bronchospasm, which can make breathing difficult.
• a skin rash appears, which develops after applying the medicinal patch. If this happens, remove the patch immediately and stop treatment.
• you have kidney, heart, or liver problems, or if you have had stomach or duodenal ulcer disease, or inflammatory bowel disease, or have a tendency to bleed.

The occurrence of side effects can be reduced by using the smallest effective dose of the medicine for the shortest possible time.

IMPORTANT precautions

• The medicinal patch must not be used on or come into contact with the eyes or mucous membranes.
• In elderly patients, Itami should be used with caution, as they are more prone to side effects.

After removing the patch, avoid exposing the treated areas to sunlight and sunlamps to minimize the risk of photosensitivity.
Do not use other topical or oral medicines containing diclofenac, or any other non-steroidal anti-inflammatory drugs or anti-inflammatory medicines at the same time as Itami.

Other medicines and Itami

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about any medicines you plan to take.
Only a small amount of diclofenac is absorbed into the body if Itami is used correctly, so the likelihood of interactions described for oral diclofenac is low.

Pregnancy and breastfeeding

Pregnancy

Before using Itami, consult your doctor or pharmacist if you are pregnant or breastfeeding, or think you may be pregnant or plan to have a baby.
Itami should not be used during the first and second trimester of pregnancy and during planning of pregnancy unless clearly necessary and only after consulting a doctor. If use is necessary, the lowest dose should be used for the shortest possible time.
Itami should not be used during the last trimester of pregnancy.
After oral administration of diclofenac (e.g. tablets), complications for the mother and side effects in the child may occur (see "When not to use Itami"). It is not known if the same risk applies to Itami when used on the skin.

Breastfeeding

Small amounts of diclofenac pass into breast milk in nursing women.
Consult your doctor before using Itami during breastfeeding. Do not use Itami directly on the breast skin during breastfeeding.

Driving and using machines

Itami has no influence on the ability to drive and use machines.

3. How to use Itami

This medicine should always be used as described in the patient information leaflet or as directed by a doctor or pharmacist. If you are unsure, consult your doctor, pharmacist, or nurse.
The recommended dose is one medicinal patch twice a day.
Apply the medicinal patch to the painful area twice a day: in the morning and in the evening. The maximum dose is 2 medicinal patches per day, even if more than one area is to be treated. Only one painful area can be treated at a time.

Use in children and adolescents

Itami is contraindicated in children and adolescents under 16 years of age.
There is not enough data on the safety and efficacy of Itami 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 more than 7 days, or if symptoms worsen, it is recommended that the patient or their caregivers consult a doctor.

Method of use

For use on the skin (epidermis) only.
Instructions for use:

• 1. Tear the sachet along the perforated line and remove the medicinal patch.

Applying the patch:

• 2. Remove one of the two protective foils from the patch.

• 3. Apply to the area to be treated and remove the second protective foil.

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

Removing the patch:

• 5. Moisten the patch with water, peel off the edge of the patch, and gently remove the patch.

• 6. To remove any remaining medicine, wash the treated area with water, gently massaging with your fingers in a circular motion.

If necessary, the medicinal patch can be secured with a knitted bandage.
The medicinal patch can only be used on undamaged, healthy skin.
Do not use the medicinal patch with a non-permeable bandage (occlusive dressing).
Do not use during bathing or showering.
Do not divide the medicinal patch.

Duration of use

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

Using more than the recommended dose of Itami

In case of significant side effects due to improper use or accidental overdose (e.g. by children) of the medicine, contact your doctor. The doctor will decide on further action.

Missing a dose of Itami

Do not use a double dose to make up for a missed dose.
If you have any further questions about using 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.

If you experience any of the following symptoms, contact your doctor immediately and stop using the patch:

sudden itchy rash (hives); swelling of the hands, feet, ankles, face, lips, tongue, or throat, difficulty breathing; low blood pressure or weakness.
The following side effects may occur:
Common side effects (may affect up to 1 in 10 people):
local skin reactions, such as redness, burning, itching, red inflamed skin, rash, sometimes with pus-filled bumps or hives.
Uncommon side effects (may affect up to 1 in 100 people):
Dry skin
Rare side effects (may affect up to 1 in 1,000 people):
allergic reactions or local allergic reactions (contact dermatitis).
In patients using medicines from the same class as diclofenac, there are isolated reports of generalized skin rash, hypersensitivity reactions, such as skin and mucous membrane edema, and anaphylactic reactions with acute circulatory disorders and hypersensitivity to light.
Compared to the concentration of the active substance in the blood achieved after oral administration, diclofenac used on the skin is absorbed to a very small extent. Therefore, the likelihood of systemic side effects (such as gastrointestinal, liver, kidney problems, or breathing difficulties) is very low.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Itami

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachet after: EXP.
The expiry date refers to the last day of the month.
Do not store above 30°C.
Store in the original packaging to protect from light and moisture.
Do not use Itami if you notice damage.
Used patches should be folded in half, with the adhesive side inward.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Itami contains

• The active substance of Itami is diclofenac sodium. One medicinal patch contains 140 mg of diclofenac sodium.
• The other ingredients are: butyl methacrylate copolymer, basic acrylate copolymer, macrogol stearate, sorbitan oleate

Polyester backing layer
Paper-based monosiliconized protective layer

What Itami looks like and contents of the pack

Itami is a white, self-adhesive patch, 10x14 cm in size, with one side made of fabric and the other of paper.
Each pack of Itami contains 2, 5, or 10 medicinal patches. Each patch is enclosed in a separate sachet.
Not all pack sizes may be marketed.

Marketing authorization holder:

Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (Padova)
Italy

Manufacturer:

IBSA Farmaceutici Italia Srl,
Strada Statale n.11 Padana Superiore, km. 160
20051 Cassina de’ Pecchi (MI)
Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

DE: Itami 140 mg Wirkstoffhaltiges Pflaster
PL: Itami, 140 mg, plaster leczniczy

Date of last revision of the leaflet: 12/2024