Itami

Patient Information Leaflet: Information for the User

Itami 140 mg Medicinal Patch

Sodium Diclofenac
Equivalent medicine
Please read all of this leaflet carefully before you start using this medicine because 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 to.

• Keep this leaflet. You may need to read it again.
• • If you need more information or advice, consult your pharmacist.
• • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement 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 Itami is and what it is used for

Itami contains the active substance diclofenac and belongs to a group of medicines known as "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 should know before using Itami

Do not use Itami if:

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

Itami must not be used in children and adolescents under 16 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using Itami.
Stop treatment with Itami immediately and consult your doctor if:

• you develop a skin rash after applying the patch.

Take particular care:

• if you are taking other NSAIDs or other medicines containing diclofenac, including topical medicines;
• if you have kidney, heart or liver problems, have had a peptic ulcer, inflammatory bowel disease, or are prone to bleeding;
• if you are elderly, as you may be more likely to experience adverse effects;
• if you have previously had an allergic reaction after taking NSAIDs or pain-relieving medicines, since asthmatic patients with chronic obstructive bronchial diseases, inflammation of the nasal mucosa (allergic rhinitis), or nasal polyps are more likely than other patients to develop asthma attacks, local skin or mucosal inflammation (Quincke's edema), or urticaria;
• if you are planning to become pregnant, have fertility problems, or are undergoing fertility investigations; treatment with Itami should be discontinued;
• if you use Itami over large areas of skin or for prolonged periods, as you may develop systemic adverse effects (affecting the whole body);
• the patches must not come into contact with the eyes or mucous membranes and must not be ingested;
• if you intend to expose yourself to direct sunlight or sunbed lamps; wait at least one day after removing the patch to reduce the risk of photosensitivity.

Adverse effects of NSAIDs can be minimized by using the lowest effective dose and the shortest duration of treatment necessary to control 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.
Since 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 simultaneously with other medicines containing the same active substance, diclofenac, or other NSAIDs (see section “Undesirable effects”).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Oral forms (e.g. tablets) of diclofenac may cause adverse effects in the unborn child. It is not known whether the same risk applies 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 heart, lung, and kidney problems. At the end of pregnancy, diclofenac may expose both mother and newborn to complications during delivery, such as inhibition of uterine contractions (delayed or prolonged labour), possible prolongation of bleeding time, and anti-aggregatory effects, which may occur even at very low doses of the medicine.
Do not use Itami during the first six months of pregnancy or if you are planning a pregnancy, unless strictly necessary and on medical advice. If treatment during this period is required, the lowest possible dose for the shortest possible time should be used.
Breastfeeding
Since diclofenac passes into breast milk in small amounts, consult your doctor before using Itami if you are breastfeeding.
Do not apply Itami to the breast or to large areas of skin for prolonged periods.
Driving and using machines
Itami does not impair the ability to drive or use machinery.

3. How to use Itami

Use this medicinal product exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults
The recommended dose is one patch twice daily (every 12 hours), in the morning and evening. Apply Itami to the area of skin to be treated for no longer than 14 days. Do not exceed the recommended dose.
Use the patch only on intact and healthy skin, and do not apply it before taking a bath or shower.
Do not use Itami with occlusive dressings that do not allow air passage.
The patch must be used whole.

Instructions for use
1.

For applying the patch:

2. Remove one of the two protective liners.
3. Apply the patch to the area to be treated and then remove the remaining protective liner.

4. Gently press with the palm of your hand until the patch is completely adhered to the skin.

For removing the patch:
5. Moisten the patch with water, lift one edge, and then gently peel it off.
6. To remove any residual product, wash the area with water, using circular motions 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 a 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 have been reported with medicated patches containing diclofenac.
In case of accidental ingestion/intake of Itami, inform your doctor immediately or go to the nearest hospital.

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

If you stop using Itami
If you have any doubts about using this medicinal product, 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 together with other medicines containing diclofenac may lead to serious skin diseases with blistering, redness and peeling (Stevens-Johnson syndrome) or diseases leading to skin necrosis (Lyell syndrome).

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

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

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

• bullous dermatitis;
• dry skin.

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 appearance of blisters;
• asthma;
• light sensitivity (photosensitivity).

Side effects not known

• burning sensation at the application site.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the packaging after "Exp.". The expiry date refers to the last day of that month. The expiry date indicated on the packaging applies to the product in its original, undamaged packaging, correctly stored.
Store below 30 °C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Itami contains

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

Description of the appearance of Itami and contents of the pack
Itami is a medicated, self-adhesive patch, 10×14 cm in size, consisting of an acrylic matrix containing the active substance applied onto an inert non-woven polyester mesh support (100% polyester); the matrix is protected by two single-layer silicone paper tabs.
Packs contain 5, 10 or 15 patches, each in an individual 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), Italy

Manufacturers
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