ITAMI 140 mg Plaster Leczniczy

Treść ulotki

1. Itami Unidie 140 mg medicated patch
   1. What is Itami Unidie and what is it used for?
   2. What you need to know before you use Itami Unidie
   3. How to use Itami Unidie
   4. Possible side effects
   5. How to store Itami Unidie
   6. Contents of the pack and other information

Itami Unidie 140 mg medicated patch

diclofenac sodico

Read this leaflet carefully before taking 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.
• See a doctor if you do not feel better or if your symptoms worsen after 7 days.

Contents of this leaflet

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

1. What is Itami Unidie and what is it used for?

Itami Unidie is a medicine that reduces pain. It belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Itami Unidie is used for the short-term local treatment (maximum 7 days) of pain
associated with muscle strains, sprains or bruises of arms and legs due to blunt trauma
in adolescents aged 16 years and older and in adults.

2. What you need to know before you use Itami Unidie

Do not use Itami Unidie

• if you are allergicto diclofenacor to 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, ibuprofen);
• if you have experienced asthma attacks, urticariaor swelling and irritation inside the noseafter taking acetylsalicylic acid or other NSAIDs;
• if you suffer from an active gastric or duodenal ulcer;
• on broken skin(e.g. skin abrasions, cuts, burns), infected or with inflammation(exudative dermatitis) or eczema;
• if you are in the last three months of pregnancy;
• in children and adolescents under the age of 16 years.

Warnings and precautions
Talk to your doctor or pharmacist before using Itami Unidie

• if you suffer from or have previously suffered from bronchial asthma or allergies, you may experience bronchospasm (bronchial constriction), which manifests with difficulty breathing;
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• if you notice a rashappearing after applying the medicated patch. If this happens, remove the medicated patch immediately and stop treatment.
• if you suffer from kidney, heartor liverdysfunction or have previously suffered from gastrointestinal ulcer, intestinal inflammationor a tendency to bleed.

Adverse effects can be reduced by using the lowest effective dose for the shortest possible time.

Important precautions

• The medicated patch must not come into contact with or be applied to eyes or mucous membranes.
• Elderly patients should use Itami Unidie with caution, as they may be more likely to develop adverse effects.

Avoid exposing the treated area to direct sunlight or solar lamps after removing the medicated patch, in order to reduce the risk of light sensitivity.
Do not use Itami Unidie simultaneously with any other medicine containing diclofenac or other non-steroidal anti-inflammatory and analgesic drugs, regardless of whether they are used externally or taken orally.

Children and adolescents
Taking diclofenac is contraindicated in children and adolescents under the age of 16 years.
There is not enough data available on efficacy and safety for children and adolescents under 16 years of age (see section Do not use Itami Unidie).

Other medicines and Itami Unidie
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If Itami Unidie is used correctly, only a very small amount of diclofenac is absorbed into the body, so interactions described for the oral use of medicines containing diclofenac are unlikely to occur.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
During the first six months of pregnancy or if you are planning a pregnancy, you should use Itami Unidie only after consulting your doctor.
During the last three months of pregnancy, you should not use Itami Unidie, as it is not possible to exclude an increased risk of complications for the mother and the baby (see “Do not use Itami

Unidie”).
Breastfeeding
Small amounts of diclofenac are excreted in breast milk.
Consult your doctor before using Itami Unidie during breastfeeding. In any case, Itami Unidie should not be applied directly to the area around the breast during breastfeeding.
Fertility
Systemic use of diclofenac may reduce female fertility. If you are planning a pregnancy, you should not use Itami Unidie as the risk associated with the use of topical preparations like Itami Unidie is unclear.

Driving and using machines

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Itami Unidie does not impair the ability to drive and operate machines.

Itami Unidie contains butylated hydroxyanisole (E320)
Butylated hydroxyanisole may cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

3. How to use Itami Unidie

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Adults and adolescents from 16 years of age
The recommended dose is one medicated patch per day.
Apply one medicated patch to the painful area. The maximum total daily dose is 1 medicated patch, even if more than one area needs to be treated. Treat only one painful area at a time.

Method of administration
Apply to the skin (cutaneous use).
Instructions for use:

• 1. Cut the sachet along the dotted line and remove the medicated patch.

To apply the patch:

• 2. Remove one of the two protective films.
• 3. Apply to the area to be treated and remove the remaining protective film.
• 4. Apply by exerting gentle pressure with the palm of your hand until the patch adheres completely to the skin.

To remove the patch:

• 5. Moisten the patch with water, lift one edge, and then gently peel off the skin.
• 6. To remove any product residue, rinse the affected area with water, gently rubbing with your fingers in a circular motion.

Use the medicated patch only on intact and healthy skin.
If necessary, the medicated patch can be held in place using an elastic net bandage.
Do not use the medicated patch together with an airtight (occlusive) bandage.
Do not wear the patch while bathing or showering.
Do not split the medicated patch.

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Duration of use
Do not use Itami Unidie for more than 7 days.
Consult a doctor if it is necessary to administer the medicine for more than 7 days to relieve pain or if symptoms worsen.

Use in children and adolescents
Itami Unidie should not be used in children and adolescents under 16 years of age.
For children and adolescents under 16 years of age, the available data on safety and efficacy are insufficient (see section 2).

If you use more Itami Unidie than you should
Inform your doctor if, after incorrect use of this medicine or occasional overdose (e.g. in children), intense undesirable effects appear. The doctor will know how to advise you on the measures to be taken.

If you forget to use Itami Unidie
Do not use a double dose to make up for a missed dose.
If you have any doubts 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 any of the following symptoms occur, inform your doctor immediately and stop using the
patch:
sudden itchy rash (urticaria); swelling of the hands, feet, ankles, face, lips,
mouth or throat; difficulty breathing; low blood pressure or weakness.
The following side effects may also occur:

Common (may affect up to 1 in 10 people):
rash, eczema, erythema, dermatitis (including allergic dermatitis and contact dermatitis),
itching, reactions at the site of patch application.

Rare (may affect up to 1 in 1,000 people):
Bullous dermatitis (e.g. bullous erythema), dry skin.

Very rare (may affect up to 1 in 10,000 people):
hypersensitivity (including urticaria), anaphylactoid reaction, sudden swelling of the face, hands and feet,
lips, tongue, throat and/or larynx (angioedema), rash
with the appearance of blisters, asthma, skin sensitivity to light (photosensitivity reaction).

Frequency not known:
Burning sensation at the application site.
In patients who used topical active ingredients belonging to the same class of medicines as
diclofenac, isolated cases of generalized skin rash, hypersensitivity reactions, such as swelling of the skin and mucous membranes and anaphylactic reactions with acute disturbances
of circulatory regulation and light sensitivity have been reported.
The absorption of diclofenac into the body through the skin is very low compared to
the concentration of active ingredient in the blood measured after oral administration of diclofenac. Therefore,

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the probability of occurrence of general side effects (such as, for example, gastrointestinal
or kidney disorders or difficulty breathing) is very low.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system 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 Unidie

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 pack and on the sachet after
“EXP”. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
Do not use Itami Unidie if you notice that the packaging is damaged.
Used patches must be folded in half with the adhesive side facing inwards.
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 Itami Unidie contains

• The active ingredient is diclofenac sodium. Each medicated patch contains 140 mg of diclofenac sodium.
• The other ingredients are: Supporting layer: Non-woven fabric polyester

Adhesive layer:
acrylic acid dispersion
tributyl citrate
butylated hydroxyanisole
Protective layer:
mono-siliconized paper

Description of the appearance of Itami Unidie and contents of the pack
Itami Unidie is a self-adhesive medicated patch, white in color, with dimensions of 10×14 cm,
consisting of a non-woven fabric layer and a paper layer.
Itami Unidie is available in packs of 2, 5, 7 and 10 medicated patches in sachets containing each
one patch.
Not all pack sizes may be marketed.

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Marketing Authorisation Holder and Manufacturer

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

Manufacturer
Fidia farmaceutici S.p.A.
Via Ampère, 29
20037 Paderno Dugnano (MI)
Italy

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Germany: Itamione 140 mg wirkstoffhaltiges Pflaster
Spain: Itami Diario 140 mg apósito adhesivo medicamentoso
Italy: Itami Unidie 140 mg cerotto medicato
Czech Republic: Itami
Slovakia: Itami

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