Voltarol 1.16% Emulgel, gel

For the local symptomatic relief of pain and inflammation in:

- trauma of the tendons, ligaments, muscles and joints, eg due to sprains, strains and bruises

- localised forms of soft tissue rheumatism

It is recommended that the treatment be reviewed after 14 days in these indications. For the treatment of osteoarthritis of superficial joints such as the knee. In the treatment of osteoarthritis, therapy should be reviewed after 4 weeks.

For cutaneous use only

Adults and children 14 years and over: Voltarol Emulgel should be rubbed gently into the skin. Depending on the size of the affected site to be treated 2- 4g (a circular shaped mass approximately 2.0-2.5cm in diameter) of gel should be applied 3 - 4 times a day.

After application, the hands should be washed unless they are the site being treated.

Use in the elderly: The usual adult dosage may be used.

Children and adolescents: There are insufficient data on efficacy and safety available for the children and adolescents below 14 years of age (see also contraindications 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.

Voltarol Emulgel is suitable for the transmission of ultrasound and may be used as a couplant in combination with ultrasound therapy. If large areas of the body are covered with gel, systemic absorption will be greater and the risk of side-effects increased, especially if the therapy is used frequently.

• Patients with or without chronic asthma in whom asthma, angioedema, urticaria or acute rhinitis are precipitated by acetylsalicylic acid (aspirin) or other non- steroidal anti-inflammatory drugs (NSAIDs).

• Hypersensitivity to diclofenac or any of the excipients

• Third trimester of pregnancy.

• The use in children and adolescents aged less than 14 years is contraindicated.

The possibility of experiencing systemic adverse events (those associated with the use of systemic forms of diclofenac) from application of Voltarol Emulgel cannot be excluded if the preparation is used at higher dosage/large amounts over large areas of skin and over a prolonged period (see the product information on systemic forms of diclofenac e.g. oral or injection for systemic adverse reactions).

Concomitant use of systemic NSAIDs should be cautioned since the possibility of an increase in incidence of untoward effects, particularly systemic side effects, cannot be ruled out.

Voltarol Emulgel contains propylene glycol and benzyl benzoate, which may cause mild, localised skin irritation in some people.

Like other drugs that inhibit prostaglandin synthetase activity, diclofenac and other NSAIDs can precipitate bronchospasm if administered to patients suffering from or with a previous history of, bronchial asthma.

Voltarol Emulgel should be applied only to intact, non-diseased skin and not to skin wounds or open injuries. It should not be allowed to come into contact with the eyes or mucous membranes, and should not be ingested.

Discontinue the treatment if a skin rash develops after applying the product.

Patients should be warned against excessive exposure to sunlight in order to reduce the incidence of photosensitivity.

Voltarol Emulgel can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.

Some possibility of gastro-intestinal bleeding in those with a significant history of this condition has been reported in isolated cases.

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.

Since systemic absorption of diclofenac from a topical application is very low such interactions are very unlikely. There are no known interactions with Voltarol Emulgel, but for a list of interactions known with oral diclofenac the data sheet for oral dosage forms should be consulted.

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 given 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 oligohydroamniosis;

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 (see section 4.3).

Lactation

Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of Voltarol Emulgel no effects on the suckling child are anticipated. Because of a lack of controlled studies in lactating women, the product should only be used during lactation under advice from a healthcare professional. Under this circumstance, Voltarol Emulgel should not be applied on the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time (see section 4.4).

Cutaneous application of Voltarol Emulgel has no influence on the ability to drive and use machines.

Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (> 1/10); common ≥ ( 1/100, <1/10); uncommon ≥ (1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (<1/10,000), not known: cannot be estimated from the available data.

Table 1

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.

Signs and symptoms

The low systemic absorption of Voltarol Emulgel renders overdose very unlikely. However, undesirable effects, similar to those observed following an overdose of diclofenac tablets, can be expected if Voltarol Emulgel is inadvertently ingested (e.g. 1 tube of 100g contains the equivalent of 1000mg of 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 medicines should be used. The use of activated charcoal should be considered, especially within a short time (within one hour) of ingestion of a toxic dose.

Pharmacotherapeutic group: Topical products for joint and muscular pain, anti- inflammatory preparations, non-steroids for topical use (ATC code M02A A15).

Diclofenac is a potent non-steroidal anti-inflammatory drug (NSAID) with effective analgesic, anti-inflammatory and antipyretic properties. Diclofenac exerts its therapeutic effects primarily through inhibition of prostaglandin synthesis by cyclo-oxygenase 2 (COX-2).

This medicine is an anti-inflammatory and analgesic preparation designed for topical application. In inflammation and pain of traumatic or rheumatic origin, relieves pain and decreases swelling.

Due to an aqueous-alcoholic base the gel exerts a soothing and cooling effect.

When Voltarol Emulgel is applied locally, the active substance is absorbed through the skin. In healthy volunteers approximately 6% of the dose applied is absorbed, as determined by urinary excretion of diclofenac and its hydroxylated metabolites. Findings in patients confirm that diclofenac penetrates inflamed areas following local application of Voltarol Emulgel. From the skin and underlying tissue, diclofenac preferentially distributes and persists in deep inflamed tissues (such as the joint), rather than in the bloodstream.

After topical administration of Voltarol Emulgel to hand and knee joints diclofenac can be measured in plasma, synovial tissue and synovial fluid. Maximum plasma concentrations of diclofenac are about 100 times lower than after oral administration of Voltarol.

None known.

Diethylamine, carbomers, cetomacrogol, cocoyl capryloccaprate, isopropyl alcohol, liquid paraffin, perfume creme 45 (containing benzyl benzoate), propylene glycol, purified water.

None known.

Three years.

Protect from heat (store below 25° C).

Voltarol Emulgel should be kept out of reach and sight of children.

Aluminium tubes with protective inner coating, available in packs of 10g, 20g and 100g. Not all pack sizes may be marketed.

Aluminium laminated tube [(low density polyethylene /aluminium/high density polyethylene (internal layer) or LDPE / aluminium / LLDPE, HDPE and Antiblock Masterbatch blend (internal layer)] fitted with a high density polyethylene shoulder and closed by a moulded seal. The tube is closed with a polypropylene screw cap, incorporating a moulded feature used to insert, twist and remove the seal before first use. This is available in packs of 10g, 20g and 100g. Not all pack sizes may be marketed.

None.