ITAMI Medicated plaster Ref.[50023] Active ingredients: Diclofenac

Posology

Adults and adolescents from 16 years of age

One medicated plaster should be applied to the painful area twice daily, in the morning and in the evening. The maximum daily dose is 2 medicated plasters, even if there is more than one injured area to be treated. Therefore, only one painful area can be treated at a time.

Duration of use

Itami is for short-term treatment. The duration of use should not exceed 7 days. The therapeutic benefit of longer use has not been established.

Itami is to be used for the shortest duration necessary to control symptoms.

Elderly patients and patients with renal or hepatic impairment

This medicinal product should be used with caution in elderly patients who are more prone to adverse events (see also section 4.4).

In treatment of elderly and patients with renal or hepatic impairment see section 4.4.

Paediatric population

There are insufficient data on safety and efficacy for use in children and adolescents under 16 years of age (see also section 4.3).

In adolescents aged 16 years and over, if this medicinal product is required for more than 7 days for pain relief or if the symptoms worsen, the patient/parents of the adolescent is/are advised to consult a doctor.

Method of administration

Cutaneous use only.

The medicated plaster should be applied only to intact non-diseased skin and should not be worn when bathing or showering.

The medicated plaster should not be divided.

If necessary, the medicated plaster can be held in place using a net bandage.

The medicated plaster must not be used together with an occlusive dressing.

There is no experience with overdose of diclofenac medicated plaster. Should significant systemic undesirable effects occur following incorrect use or accidental overdose (e.g. in children), the precautions appropriate for poisoning with non-steroidal anti-inflammatory drugs should be taken.

3 years.

Do not store above 30°C.

Store in the original sachet in order to protect from light and moisture.

The medicated plasters are individually enclosed in sealed sachets made of paper/Al/copolymer ethylene-acrylic acid, provided with easy open and packed in a cardboard box.

Each pack contains 2, 5 or 10 medicated plasters.

Not all pack sizes may be marketed.

Used plasters should be folded in half, with the adhesive side inwards.

This medicinal product may pose a risk to the environment. (See section 5.3).

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.