Voltarol Emulgel P or Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel

Diethylammonium-{-o-[2,6-dichlorophenyl)-amino]-phenyl}-acetate.

100g of this medicine contains 1.16g of the active substance diclofenac diethylammonium, which corresponds to 1g diclofenac sodium.

For excipients, see section 6.1

Gel for topical administration.

White to practically white, soft, homogeneous, cream-like

For the local symptomatic relief of pain and inflammation in:

- trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains and bruises

- localised forms of soft tissue rheumatism

For the relief of pain of non-serious arthritic conditions.

For cutaneous use only

Adults and children 14 years and over: The gel should be rubbed gently into the skin 3-4 times daily. 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. The maximum daily dose is 16g. Therefore the maximum weekly dose is 112g.

For arthritis pain it may be necessary to apply the gel for up to 7 days (to allow its effect to build up on the joint) before an improvement in pain is noticed. The gel can be used for up to 14 days under pharmacy supervision.

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

If symptoms do not improve by day 7, or if they worsen within the first 7 days, a consultation with a doctor is recommended. Consultation with a doctor is recommended if more than two major joints in the body are affected. Do not use for more than 14 days unless recommended by a doctor.

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.

• 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, acetylsalicylic acid other non-steroidal anti-inflammatory drugs 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 this medicine cannot be excluded if the preparation is used at higher dosage/large amounts over large areas of skin and/or over a prolonged period (see the product information of 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.

This medicine 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.

Patients with a history of, or active, peptic ulceration. Some possibility of gastro-intestinal bleeding in those with a significant history of this condition has been reported in isolated cases.

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.

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

This medicine can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.

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 SPCs 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

The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. 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 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, diclofenac is contraindicated during the third trimester of pregnancy.

Lactation

Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of this medicine 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, this medicine 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 this medicine has no or negligible 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 topical diclofenac renders overdose very unlikely. However, undesirable effects, similar to those observed following an overdose of diclofenac tablets, can be expected if this medicine 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 diclofenac 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.

ATC Code: M02AA15 (Anti-inflammatory preparations, non-steroids for topical use).

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

Synovial fluid and tissue levels of diclofenac are higher than those detected in plasma.

None known.

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

None stated.

Three years.

All presentations: Do not store above 30°C.

Pump dispenser presentation: The pump dispenser is a pressurised container. It should be protected from direct sunlight and must not be pierced or burned even when empty.

This medicine should be kept out of reach of children.

Sealed aluminium tubes with protective inner coating, closed with a polypropylene screw cap, available in packs of 10g, 30g, 50g and 100, 120g and 180g.

Aluminium laminated tube (low density polyethylene / aluminium / high density polyethylene (internal layer)) fitted with a high density polyethylene shoulder and closed by a moulded seal. The tube is closed with a polypropylene screw cap in white or blue, with two alternate shapes of cap and thread, incorporating a moulded feature used to insert, twist and remove the seal before first use. Available in packs of 30g, 50g, 100g, 120g,150g and 180g (not all packs may be marketed).

Pump dispenser with aluminium can, valve (high density polyethylene, reinforced with titanium dioxide) with multi-layer pouch (low density polyethylene), mounted with a protective cap. Available in packs of 75ml.

None

GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED

980 GREAT WEST ROAD

BRENTFORD

TW8 9GS

UNITED KINGDOM

PL 44673/0155

1 April 2000

1^st May 2020