Itami Unidie

Patient Information Leaflet: Information for the User

Itami Unidie 140 mg medicated patch

diclofenac sodium
Please 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 instructed you.

• 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 improvement 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 Itami Unidie is and what it is 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 short-term local treatment (maximum 7 days) of pain associated with muscle strains, sprains or bruises of the arms and legs due to blunt trauma in adolescents from the age of 16 and in adults.

2. What you need to know before using Itami Unidie

Do not use Itami Unidie

• if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to any other non-steroidal anti-inflammatory drug (NSAID, e.g. acetylsalicylic acid, ibuprofen);
• if you have experienced asthma attacks, urticaria, or swelling and irritation inside the nose after taking acetylsalicylic acid or other NSAIDs;
• if you have active gastric or duodenal ulcer;
• on injured skin (e.g. skin abrasions, cuts, burns), infected skin, or skin with inflammation (exudative dermatitis) or eczema;
• during the last three months of pregnancy;
• in children and adolescents under 16 years of age.

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

• if you suffer or have previously suffered from bronchial asthma or allergies, as you may experience bronchial muscle spasm (bronchospasm), causing breathing difficulties;
• if you notice a skin rash appearing after applying the medicated patch. If this occurs, immediately remove the medicated patch and discontinue treatment;
• if you have renal, cardiac, or hepatic dysfunction, or have previously suffered from gastrointestinal ulcers, intestinal inflammations, or tendency to bleeding.

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration.
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 experience adverse effects.

Avoid exposing the treated area to direct sunlight or sunlamps after removing the medicated patch, in order to reduce the risk of photosensitivity.
Do not use Itami Unidie simultaneously with any other medicinal product containing diclofenac or other non-steroidal anti-inflammatory and analgesic drugs, regardless of whether they are used externally or taken orally.
Children and adolescents
The use of diclofenac is contraindicated in children and adolescents under 16 years of age.
There are insufficient data on efficacy and safety in children and adolescents under 16 years of age (see section Do not use Itami Unidie).
Other medicines and Itami Unidie
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
When Itami Unidie is used correctly, only a very small amount of diclofenac is absorbed into the body, making it unlikely that interactions described for oral diclofenac-containing medicines will occur.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
During the first six months of pregnancy or if you are planning a pregnancy, do not use Itami Unidie unless strictly necessary and only after consulting your doctor. If treatment is required during this period, the lowest possible dose for the shortest possible time should be used.
During the last three months of pregnancy, you must not use Itami Unidie.
Oral forms (e.g. tablets) of diclofenac can cause complications in the mother and adverse effects in the baby (see “Do not use Itami Unidie”).
It is not known whether the same risk applies with Itami Unidie when used on the skin.
Breastfeeding
Small amounts of diclofenac are excreted in breast milk.
Consult your doctor before using Itami Unidie during breastfeeding. In any case, Itami Unidie must 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 topical preparations such as Itami Unidie is unclear.
Driving and using machines
Itami Unidie does not affect the ability to drive or use machinery.
Itami Unidie contains butylated hydroxyanisole (E320)
Butylated hydroxyanisole may cause localized skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Itami Unidie

Use this medicine 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 and adolescents aged 16 years and older
The recommended dose is one medicated patch per day.
Apply one medicated patch to the painful area. The maximum total daily dose is one medicated patch, even if there are multiple areas 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. Press gently 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 a corner, and then gently peel it off the skin.
6. To remove any residue of the product, rinse the affected area with water, gently rubbing with your fingers using a circular motion.

Use the medicated patch only on intact and healthy skin.
If necessary, the medicated patch may be secured in place using an elastic mesh bandage.
Do not use the medicated patch together with an airtight (occlusive) dressing.
Do not wear the patch while bathing or showering.
Do not cut the medicated patch.
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 must not be used in children and adolescents under 16 years of age.
In children and adolescents under 16 years of age, available data on safety and efficacy are insufficient (see section 2).
If you use more Itami Unidie than you should
Inform your doctor if severe adverse effects occur after incorrect use of this medicine or accidental overdose (e.g. in children). Your doctor will advise you on the appropriate measures to take.
If you forget to use Itami Unidie
Do not use a double dose to make up for the missed dose.
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.
If any of the following symptoms occur, inform your doctor immediately and stop using the
patch:
sudden itchy rash (urticaria); swelling of hands, feet, ankles, face, lips, mouth or throat; breathing
difficulties; drop in 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 application site.
Rare (may affect up to 1 in 1,000 people):
bullous dermatitis (e.g. erythema multiforme), 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 (angioneurotic edema), skin rash with blistering, asthma, skin sensitivity to light (photosensitivity reaction).
Frequency not known:
Burning sensation at the application site.
In patients using topical active substances belonging to the same class of medicines as diclofenac, isolated cases of generalized skin exanthema, hypersensitivity reactions such as swelling of the skin and mucous membranes, anaphylactic-type reactions with acute disturbances in circulatory regulation, and light sensitivity have been reported.
Absorption of diclofenac into the body through the skin is very low compared to the active substance concentration in the blood measured after oral administration of diclofenac. Therefore, the likelihood of developing general side effects (such as, for example, gastrointestinal or renal disorders or breathing difficulties) is very low.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. You may 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 Unidie

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 should be folded in half with the adhesive side facing inwards.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Itami Unidie contains

• The active substance is sodium diclofenac. Each medicated patch contains 140 mg of sodium diclofenac.
• The other components are:
  Support layer: Non-woven polyester fabric

Adhesive layer:
polyacrylate dispersion
tributyl citrate
butylated hydroxyanisole
Protective layer:
siliconized paper

Description of the appearance of Itami Unidie and package contents
Itami Unidie is a white self-adhesive medicated patch measuring 10×14 cm, consisting of a non-woven fabric layer and a paper layer.
Itami Unidie is available in packages containing 2, 5, 7 and 10 medicated patches, each patch individually enclosed in a sachet.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 authorized in the Member States of the European Economic Area under the following names:
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
November 2024