4.1. Therapeutic indications

For adults and adolescents aged 14 years and over

For the short-term local, symptomatic treatment of mild to moderate pain in acute strains, sprains or contusions following blunt trauma.

4.2. Posology and method of administration

Posology

Adults and adolescents aged 14 years and over:

The occurrence of undesirable effects can be minimized by using the lowest possible dose for the shortest duration of treatment necessary to relieve symptoms.

Depending on the size of the affected site to be treated, a cherry to walnut-sized quantity, corresponding to 1 - 4 g of gel (11.6 - 46.4 mg diclofenac diethylamine, corresponding to 10 - 40 mg diclofenac sodium) should be applied 3-4 times daily. This is sufficient to treat of an area of 400 - 800 cm2.

The maximum daily dose is 16 g of gel corresponding to 185.6 mg of diclofenac, diethylamine salt (corresponding to 160 mg diclofenac sodium).

The duration of use depends on the symptoms and the underlying disease. Motusol should not be used longer than 1 week without medical advice.

If symptoms worsen or do not improve after 3 - 5 days, a doctor should be consulted.

Special patient groups

Elderly patients:

No special dose adjustment is required. Because of the potential undesirable- effect profile, elderly people should be carefully monitored.

Patient with renal impairment:

No dose reduction is required in patients with renal impairment

Patient with hepatic impairment:

No dose reduction is required in patients with hepatic impairment.

Children and adolescents (under 14 years):

There are insufficient data on efficacy and safety in children and adolescents under 14 years of age (see section 4.3). In children aged 14 years and over, if this 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

For cutaneous use.

The gel is applied to the affected parts of the body and gently rubbed into the skin. Afterwards, the hands should be wiped with a paper towel and then washed, unless the hands are the area to be treated.

If too much gel is accidentally applied, the excess gel should be wiped with a paper towel.

The paper towel should be disposed in the household waste to prevent unused product reaching the aquatic environment.

Before applying a bandage, the gel should be left to dry for a few minutes on the skin.

4.3. Contraindications

- hypersensitivity to the active substance or to any of the excipients listed in section 6.1

- patients with a history of hypersensitivity reactions, such as asthma, bronchospasmus, urticaria, acute rhinitis or angioedema in response to acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).

- on open injuries, inflammations or infections of the skin as well as on eczema or mucous membranes;

- in the third trimester of pregnancy (see section 4.6);

- in children and adolescents under 14 years of age is contraindicated.

4.4. Special warnings and precautions for use

The possibility of systemic undesirable effects from application of topical diclofenac cannot be excluded if the preparation is used on large areas of skin and over a prolonged period. The gel should therefore be used with caution by patients with reduced renal function, reduced heart function or reduced liver function as well as patients with active peptic ulcers in the stomach or duodenum.

Motusol must only be applied to intact, not diseased or injured skin. Eyes and mucous membranes must not come into contact with the medicinal product and it must not be taken orally.

Topical diclofenac may be used with a non-occlusive bandage but not with an airtight occlusive dressing (see section 5.2)

If symptoms worsen or do not improve after 3 – 5 days, a doctor should be consulted.

Patients suffering from asthma, hay fever, swelling of nasal mucous membranes (so- called nasal polyps) or chronic obstructive pulmonary disease, chronic respiratory infections (particularly associated with hay fever-like symptoms), and patients with hypersensitivity to painkillers and anti-rheumatic medicinal products of all kinds are rather at risk to asthma attacks (so called analgesic intolerance / analgesic asthma), to local skin or mucous membrane swelling (so-called quincke edema) or to urticaria - than other patients when treated with Motusol.

In these patients, Motusol may only be used under certain precautions (emergency preparedness) and direct medical supervision. The same applies for patients who are also allergic to other substances e.g. with skin reactions, itching or urticaria.

If a skin rash occurs during the treatment with Motusol, the treatment should be stopped.

Direct sunlight or artificial sun should be avoided during treatment and two weeks after treatment to avoid the risk of photosensitivity.

Preventive measures should be taken so that children do not contact the skin areas to which the gel has been applied.

This medicinal product contains fragrance with benzyl alcohol (0.15 mg/g, E1519), citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene and linalool which may cause allergic reactions.

In addition, benzyl alcohol may cause mild local irritation.

Instruct patients not to 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.

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

Since the systemic absorption of diclofenac is very low with topical application, interactions are very unlikely in use as intended. There are no known interactions with Motusol, but for a list of interactions known with oral diclofenac SPC for oral dosage forms should be consulted.

4.6. Fertility, pregnancy and lactation

Fertility

There are no data available on the use of topical formulations of diclofenac and its effects on fertility in humans.

Pregnancy

There is no clinical data from the use of diclofenac during pregnancy.

The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. Even if systemic exposure is lower compared with oral administration, it is not known if the systemic diclofenac exposure reached after topical administration can be harmful to an embryo/fetus. With reference to experience from treatment with NSAIDs with systemic uptake, the following is recommended:

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal 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 absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. 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-fetal 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, diclofenac should not be used unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or 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 fetus to:

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

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

• 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, diclofenac is contraindicated during the third trimester of pregnancy.

There are no clinical data from the use of this medicinal product during pregnancy. During the first and second trimester of pregnancy, this medicinal product should not be used unless clearly necessary. If used, the dose should be kept as low and duration of treatment as short as possible.

During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors including diclofenac may induce cardiopulmonary and renal toxicity in the foetus. At the end of the pregnancy prolonged bleeding time in both mother and child may occur, and labour can be delayed. Therefore, this medicinal product is contraindicated during the last trimester of pregnancy (see Section 4.3).

Breast-feeding

Diclofenac passes into breast milk in small amounts. However, at therapeutic doses of Motusol no effects on the breast-fed child are anticipated. Because of a lack of controlled studies in breast-feeding women, the medicinal product should only be used during breast-feeding under advice from a healthcare professional. Under this circumstance, Motusol should not be applied on the breasts of breast-feeding mothers, nor elsewhere on large areas of skin or for a prolonged period of time (see section 4.4).

4.7. Effects on ability to drive and use machines

The topical use of diclofenac has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: 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).

System organ class database

Adverse reactions and frequency

Infections and infestations

Very rare: Rash pustular

Immune system disorders

Very rare: Hypersensitivity (including urticaria), angioedema

Respiratory, thoracic and mediastinal disorders

Very rare: Asthma

Gastrointestinal disorders

Very rare: Gastrointestinal complaints

Skin and subcutaneous tissue disorders

Common: Dermatitis (including contact dermatitis), skin rash, erythema, eczema, pruritus

Uncommon: Scaling, dehydration of the skin, oedema

Rare: Dermatitis bullous

Very rare: Photosensitivity reaction

Not known: Burning sensation at the application site, dry skin, skin discolouration

When the gel is applied on large areas of skin and over a prolonged period, the possibility of systemic undesirable effects (e.g. renal, hepatic or gastrointestinal undesirable effects, systemic hypersensitivity reactions) - as they occur possibly after systemic administration of diclofenac-containing medicinal products cannot be excluded.

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 national reporting system listed in the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Signs and symptoms

Due to the low systemic absorption of diclofenac in limited topical use an overdose is unlikely.

Undesirable effects similar to those observed following an overdose of systemic diclofenac can occur if topical diclofenac is inadvertently ingested (1 tube of 100 g contains the equivalent of 1,160 diclofenac diethylamine corresponding to 1,000 mg diclofenac sodium).

Treatment

Management of overdosage with NSAIDs essentially consists of supportive and symptomatic measures. There is no typical clinical picture resulting from Voltarol overdosage. Supportive and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastro-intestinal irritation, and respiratory depression; specific therapies such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to their high rate of protein binding and extensive metabolism.

In the event of accidental ingestion, resulting in significant systemic adverse effects, general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory medicinal products should be used. Gastric lavage and the use of activated charcoal should be considered, especially within a short time (within one hour) of ingestion a toxic dose.

A specific antidote does not exist.