4.1. Therapeutic indications

Nurofen Joint & Muscular Pain Relief 200mg 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 Joint & Muscular Pain Relief 200mg Medicated Plaster in children or 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.

4.3. Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

• In patients who have previously shown hypersensitivity reactions (e.g. asthma, bronchospasm, rhinitis, angioedema or urticaria) in response to ibuprofen, acetylsalicylic acid or other non-steriodal anti-inflammatory drugs (NSAIDs).

• Application on broken or damaged skin

• Third trimester of pregnancy.

• Use on the eyes, lips or the mucous membranes.

4.4. Special warnings and precautions for use

If symptoms persist for longer than 5 days or worsen, a healthcare professional should be consulted.

Undesirable effects can be reduced by reducing the duration of treatment.

Bronchospasm can occur in patients using ibuprofen who suffer or have previously suffered from bronchial asthma or allergies.

The treatment should be discontinued immediately if a skin rash develops after applying the medicated plaster.

Patients should be warned against exposure of the treated area to strong sources of natural and/or artificial light (e.g. tanning lamps) during treatment and for one day after removal of the medicated plaster, in order to reduce the risk of photosensitivity.

Although the systemic availability of topically applied ibuprofen is significantly less than for oral dosage forms, complications may occur in rare cases. For these reasons, patients with: an impaired renal, cardiac or hepatic function; active or a history of peptic ulcer, intestinal inflammation or haemorrhagic diathesis should seek medical advice before using this medicinal product.

Non-steroidal anti-inflammatory drugs should be used with caution in elderly patients, as they are more likely to experience undesirable effects.

Severe cutaneous adverse reactions (SCARs):

Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in association with the use of ibuprofen (see section 4.8). Most of these reactions occurred within the first month.

If signs and symptoms suggestive of these reactions appear ibuprofen should be withdrawn immediately and an alternative treatment considered (as appropriate).

4.5. Interaction with other medicinal products and other forms of interaction

Non-steroidal anti-inflammatory drugs may interact with antihypertensives, and may possibly enhance the effects of anticoagulants, however if the medicated plaster is used correctly, the rate of systemic transfer is low, so that the interactions reported in association with oral ibuprofen are unlikely to occur. Concurrent aspirin or other NSAIDs may result in an increased incidence of adverse reactions.

4.6. Fertility, pregnancy and lactation

Pregnancy:

There are no clinical data from the use of topical forms of Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster during pregnancy. Even if systemic exposure is lower compared with oral administration, it is not known if the systemic Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster exposure reached after topical administration can be harmful to an embryo/foetus. With reference to experience from treatment with systemically applied NSAIDs, the following is recommended:

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.

During the first and second trimester of pregnancy, Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster should not be given unless clearly necessary. If Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster is used during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);

- renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;

the mother and the neonate, at the end of pregnancy, to:

- possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.

- inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, ibuprofen is contraindicated during the third trimester of pregnancy (see Section 4.3).

Breast-feeding:

After systemic application, only small amounts of ibuprofen and its metabolites pass into the breast milk. As no harmful effects to infants are known to date, it is not usually necessary to interrupt breast-feeding during short-term treatment with this medicated plaster at the recommended dose.

However, as a precautionary measure, this medicated plaster should not be applied directly onto the breast area of women who are breast-feeding.

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

Systemic availability of topical ibuprofen is very low compared to orally administered NSAIDs. Adverse events, particularly those affecting the gastrointestinal tract, are less common with the use of topical ibuprofen.

The list of the following adverse events relates to those experienced with topical ibuprofen at OTC (dose maximum 500 mg per day), in short term use.

The following frequency conventions are used in the rating of undesirable effects: Very common (≥1/10); Common (≥1/100 to < 1/10); Uncommon (≥1/1,000 to < 1/100); Rare (≥1/10,000 to < 1/1,000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

System Organ Class

Frequency

Adverse Events

Immune System Disorders

Not known

Hypersensitivity 1

Gastrointestinal Disorders

Not known

Abdominal pain, dypepsia

Renal and Urinary Disorders

Not known

Renal impairment 2

General Disorders and Administration Site conditions

Not known

Application site reaction 3

Skin and subcutaneous tissue disorders

Very Rare

Not known

Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis)

Photosensitivity reactions

Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)

Acute generalised exanthematous pustulosis (AGEP)

Description of Selected Adverse Reactions

1 Hypersensitivity reactions have been reported following treatment with oral ibuprofen. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactions comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) skin reactions, including rashes of various types, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatoses (including toxic epidermal necrolysis, Stevens-Johnson Syndrome and erythema multiforme), and pruritus.

2 Renal impairment may occur following the use of topical ibuprofen, particularly in those with pre-existing renal dysfunction.

3 The most common undesirable effects are application site reactions

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in Google Play or Apple App store.

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.