4.1. Therapeutic indications

Movelat/Movelat Relief is a mild to moderate anti-inflammatory and analgesic topical preparation for the symptomatic relief of muscular pain and stiffness, sprains and strains and pain due to rheumatic and non-serious arthritic conditions.

4.2. Posology and method of administration

Adults, the elderly and children over 12 years of age:

Two to six inches (5 -15 cm) to be massaged to the affected area up to four times a day.

Children:

The use of Movelat/Movelat Relief is contra-indicated in children under 12 years of age.

4.3. Contraindications

Keep away from the eyes. Not to be used on large areas of skin, broken or sensitive skin, infected skin, eczema or on mucous membranes.

Not to be used on children under 12 years of age.

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

Hypersensitivity to aspirin or other non-steroidal anti-inflammatory drugs (including when taken by mouth) especially where associated with a history of asthma.

Not to be used on the breast area during lactation (see section 4.6).

4.4. Special warnings and precautions for use

For external use only. The stated dose should not be exceeded. If the condition persists or worsens, consult a doctor or pharmacist. Although systemic absorption of topical salicylate is much less than for oral dosage forms, the side effects of salicylates are theoretically possible.

Consult a doctor or pharmacist before use if pregnant, breast-feeding, asthmatic have pre-existing renal damage or on any prescribed medicines.

Some people may experience discomfort, particularly those with sensitive skin or if used in hot weather or after a bath. Wash hands immediately after use.

Discontinue use if excessive irritation or other unwanted effects occur.

Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Ingredients with specified warnings

This medicine contains cetostearyl alcohol and lanolin which may cause local skin reactions (e.g. contact dermatitis).

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

Although no adequately controlled interaction studies have been undertaken, it is possible that excessive use of topical salicylates may increase the effect of coumarin anticoagulants. It is therefore advisable that caution be exercised with patients who are taking coumarin anticoagulants.

Salicylic acid may increase skin permeability for other topically applied medications (see section 5.1).

4.6. Fertility, pregnancy and lactation

As with most medicines, patients must seek the doctor's or pharmacist's advice before using if they are pregnant or breast feeding.

Pregnancy

Do not use during the first trimester or during late pregnancy.

Breastfeeding

Not to be used on the breast area during lactation.

4.8. Undesirable effects

In this section, frequencies of undesirable effects are defined as follows: 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).

Skin and subcutaneous tissue disorders

Uncommon: Local skin reactions/irritations (e.g. redness, burning sensation or rashes).

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 the Google Play or Apple App Store

4.9. Overdose

Overdose associated with localised/topical application is unlikely.

Following accidental ingestion of Movelat/Movelat Relief, individuals may present with the symptoms of salicylate poisoning (hyperventilation, tinnitus, deafness, vasodilation, sweating). The stomach should be emptied and plasma salicylate, plasma pH and electrolytes should be monitored. Forced alkaline diuresis may be required if the plasma salicylate levels are in excess of 500 mg/litre (3.6 mmol/litre) in adults or 300 mg/litre (2.2 mmol/litre) in children.