ITAMI 140 mg Transdermal Patch

Зміст інструкції

1. Itami 140 mg medicated patch
   1. What is Itami and what is it used for?
   2. What you need to know 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

Itami 140 mg medicated patch

Diclofenac sodium
Generic medicine

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 want 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.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 14 days of treatment.

Contents of this leaflet:

• 1. What Itami is and what it is used for
• 2. What you need to know 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 contains the active ingredient diclofenac and belongs to a group of medicines called “non-steroidal anti-inflammatory drugs” (NSAIDs).
Itami is indicated for the local treatment of pain and inflammation of rheumatic origin or resulting from
trauma to joints, muscles, tendons and ligaments.
Consult your doctor if you do not feel better or if you feel worse after 14 days.

2. What you need to know before using Itami

Do not use Itami if:

• you are allergic to diclofenac or any of the other ingredients of this medicine listed in section 6;
• you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory medicines;
• following the intake of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) you have experienced allergic reactions that manifested with difficulty breathing (asthma attacks), inflammation of the nasal mucosa (rhinitis), sudden onset of itchy skin rash (urticaria);
• you have damaged skin due to: skin inflammation with blister formation (exudative dermatitis), eczema, infected lesion, burns or wounds;
• you are in the third trimester of pregnancy (see section “ Pregnancy, breastfeeding and fertility”);
• you have lesions in the stomach or intestine (active peptic ulcer).

Itami must not be used in children and adolescents under 16 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using Itami.

Stop using Itami immediately and consult your doctor if:

• you experience a skin rash after applying the patch.

Take special care:

• if you are taking other NSAIDs or other medicines containing diclofenac, including topical medicines;
• if you have kidney, heart, liver problems, have had a peptic ulcer, inflammatory bowel disease or a predisposition to develop bleeding;
• if you are elderly, as you are subject to an increased frequency of adverse effects;
• if you have had an allergic reaction in the past after taking NSAIDs or analgesic medicines, as asthmatic patients with chronic obstructive bronchial diseases, inflammation of the nasal mucosa (allergic rhinitis), nasal polyps are more likely than other patients to develop asthma attacks, local inflammation of the skin or mucous membranes (Quincke's edema) or urticaria;
• if you are planning to become pregnant, have fertility problems or need to undergo fertility investigations; treatment with Itami should be discontinued;
• if you use Itami on large areas of skin or for a prolonged period as it may develop the onset of adverse effects that affect the whole body (systemic);
• the patches must not come into contact with the eyes, mucous membranes and must not be ingested;
• if you need to be exposed to direct sunlight or sunlamps; wait at least one day after removing the patch to reduce the risk of light sensitivity.

The adverse effects of NSAIDs can be minimized by using the lowest effective dose and with a
duration of treatment that is as short as possible, in order to allow control of the symptoms.

Children and adolescents
Itami must not be used in children and adolescents under 16 years of age.

Other medicines and Itami
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Because the systemic absorption of diclofenac following the use of medicated patches is very low, the
risk of developing interactions with other medicines is negligible.
Do not use Itami at the same time as other medicines containing the same active ingredient diclofenac or other
NSAIDs (see section “ Adverse effects”).

Pregnancy and breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Oral forms (e.g. tablets) of diclofenac can cause adverse effects in the unborn child. It is not known whether
the same risk occurs with Itami when used on the skin.
Do not use Itami during the last three months of pregnancy as it may expose your baby to serious problems
to 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 medicine.
Do not use Itami 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 should be
used at the lowest dose for the shortest possible time.
Breastfeeding
Because diclofenac passes into breast milk in small amounts, if you are breastfeeding, consult your doctor
before using Itami.
Do not apply Itami to the breast or to large areas of skin for a prolonged period of time.

Driving and using machines
Itami does not impair the ability to drive vehicles and operate machinery.

3. How to use Itami

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults
The recommended dose is one patch twice a day (every 12 hours), in the morning and in the evening. Apply Itami to the area of skin to be treated for a period not exceeding 14 days. Do not exceed the recommended dose.
Use the patch only on intact and healthy skin and do not apply it before bathing or showering.
Do not use Itami with occlusive bandages that do not allow air to pass through.
The patch must be used whole.

Instructions for use

• 1. For applying the patch:
• 2. Remove one of the two protective sheets.

• 3. Apply the patch to the area to be treated and remove the remaining protective sheet.

• 4. Exert gentle pressure with the palm of your hand until complete adhesion to the skin.

To remove the patch:

• 5. Wet the patch with water and then lift a flap by gently pulling.

• 6. To remove any product residue, wash the affected area with water, making circular movements with your fingers.

Use in children and adolescents
Itami must not be used in children and adolescents under 16 years of age.
In children over 16 years of age, consult your doctor if symptoms do not improve or worsen after 7 days of treatment.

If you use more Itami than you should
No cases of overdose with medicated patches based on diclofenac have been reported.
In case of ingestion/accidental intake of Itami, immediately inform your doctor or go to the nearest hospital.

If you forget to use Itami
Do not use a double dose to make up for a missed dose.

If you stop using Itami
If you have any doubts 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.
The use of Itami at the same time as other medicines containing diclofenac may lead to serious skin diseases with blister formation, redness and peeling (Stevens-Johnson syndrome) or diseases
leading to skin necrosis (Lyell's syndrome).

Common side effects(may affect up to 1 in 10 people)

• skin rash, eczema, erythema, dermatitis (including allergic dermatitis and contact dermatitis), itching, reactions at the application site of the patch.

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

• bullous dermatitis;
• skin dryness.

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

• allergic reaction (hypersensitivity) including urticaria, anaphylactoid reaction, swelling of the face, hands and feet, lips, tongue, throat and/or larynx (angioedema);
• skin rash with blister formation;
• asthma;
• sensitivity to light (photosensitivity).

Side effects with unknown frequency

• burning sensation at the application site

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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the packaging after “ Exp.”. The expiry
date refers to the last day of that month. The expiry date indicated on the packaging refers to the
product in intact packaging, correctly stored.
Store at a temperature not exceeding 30 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Itami contains

• The active ingredient is diclofenac sodium. Each patch contains 140 mg of diclofenac sodium.
• The other ingredients are basic butyl methacrylate copolymer, acrylic acid copolymer, polyethylene glycol 12 stearate, sorbitan oleate, non-woven fabric, siliconized paper.

Description of the appearance of Itami and contents of the pack
Itami is presented in the form of a medicated, self-adhesive patch, measuring 10×14 cm, consisting of an
acrylic matrix containing the active ingredient, applied to an inert support of 100% polyester non-woven fabric; the matrix is protected by two single-layer strips of siliconized paper
The packs contain 5, 10 or 15 patches, each contained in a single sachet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

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