NUROFEN DURANCE Medicated plaster Ref.[110138] Active ingredients: Ibuprofen

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Reckitt Benckiser Ireland Ltd, 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

4.1. Therapeutic indications

Nurofen Durance 200 mg medicated plaster is indicated for the short-term symptomatic treatment of local pain in acute muscular strains, or sprains in benign traumas close to the joint of the upper or lower limb in adults or adolescents aged 16 years and older.

4.2. Posology and method of administration

Posology

Adults or adolescents aged 16 years and over

One dose is equal to one medicated plaster. The maximum dose for a single 24 hour period is one medicated plaster. The plaster can be applied at any time during the day or night, but should be removed and a new plaster re-applied at the same time on the following day.

The medicated plaster should be used for the shortest duration necessary to control symptoms. The treatment duration should not exceed 5 days. The therapeutic benefit of treatment longer than 5 days has not been established.

If there is no improvement, during the recommended duration of treatment or a worsening of symptoms, a healthcare professional should be consulted.

Elderly patients

No special dose adjustment is necessary.

Paediatric population

The safety and efficacy of Nurofen Durance 200 mg medicated plaster in children and adolescents under 16 years of age has not yet been established.

Method of administration

For cutaneous use and short-term use only.

The medicated plaster should be used whole and not be cut.

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

It is recommended to carefully wash and dry the area to be treated before applying the medicated plaster.

Apply to intact skin only.

Tear or cut the sachet along the dotted line to remove a medicated plaster.

First remove the central portion of the release liner used to protect the adhesive surface and apply this surface to the painful area, once securely in place remove the remaining release liner at the edges of the plaster.

The medicated plaster is flexible and conformable, and if necessary can be applied on or near a joint and will allow for normal movement.

Avoid getting the medicated plaster wet.

4.9. Overdose

Accidental overdose with a medicated plaster is unlikely. However, possible signs of overdose may include nausea, vomiting, abdominal pain or more rarely, diarrhoea. Tinnitus, headache and gastrointestinal bleeding is also possible. The half-life of ibuprofen in ibuprofen overdose is 1.5-3 hours. In the event of overdose, management should be symptomatic and medical advice should be sought.

6.3. Shelf life

3 years (2 plasters per sachet).

2 years (4 plasters per sachet)

Shelf life after first opening of the sachet: 6 months.

6.4. Special precautions for storage

Do not store above 25ยบC (2 plasters per sachet).

Do not store above 30ยบC (4 plasters per sachet).

Store in the original package in order to protect from light.

6.5. Nature and contents of container

Each sachet is made of composite PET/LDPE/aluminium/LDPE film.

Each sachet contain 2 or 4 medicated plasters. Packs of 2, 4, 6, 8 or 10 medicated plasters.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of according to local requirements. Do not flush used plasters down the toilet.

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