This information is intended for use by health professionals

1. Name of the medicinal product

Voltarol Pain-eze Emulgel®

Voltarol Back and Muscle Pain Relief 1.16% Gel

2. Qualitative and quantitative composition

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.

3. Pharmaceutical form

Gel for topical administration.

4. Clinical particulars
4.1 Therapeutic indications

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

4.2 Posology and method of administration

Adults and children aged 14 years and over: this medicine 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) should be applied 3-4 times a day. After application, the hands should be washed unless they are the site being treated.

A period of at least 4 hours should be left between applications. The dose should not be applied more than 4 times in a 24 hour period.

If symptoms persist after 7 days or get worse at any time, medical advice should be sought.

Not to be used for more than 7 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.

4.3 Contraindications

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

• Hypersensitivity to diclofenac, acetylsalicylic acid or non-steroidal anti-inflammatory drugs or any of the excipients.

• Third trimester of pregnancy.

• Concomitant use of oral NSAID's.

• This medicine should not be co-administered with other products containing diclofenac.

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

4.4 Special warnings and precautions for use

• The possibility of systemic adverse events from application of this medicine cannot be excluded if the preparation is used on large areas of skin and over a prolonged period (see the product information on systemic forms of diclofenac). 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.

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

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 asthma or allergic disease.

Discontinue if a skin rash develops after applying the product.

This medicine contains propylene glycol 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.

4.5 Interaction with other medicinal products and other forms of interaction

Since systemic absorption of diclofenac from a topical application of this medicine is very low such interactions are very unlikely. There are no known interactions with this medicine but for a list of interactions known with oral diclofenac the Summary of Product Characteristics for oral dosage forms should be consulted.

Concurrent use of aspirin or other NSAIDs may result in an increased incidence of adverse reactions.

4.6 Fertility, pregnancy and lactation

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).

4.7 Effects on ability to drive and use machines

Cuetaneous application of topical diclofenac has no influence on the ability to drive and use machines.

4.8 Undesirable effects

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

Immune system disorder

Very rare

Hypersensitivity (including urticaria), angioneurotic oedema

Infections and infestations

Very rare

Rash pustular

Respiratory, thoracic and mediastinal disorders

Very rare

Asthma

Skin and subcutaneous tissue disorders

Common

Rash, eczema, erythema, dermatitis (including dermatitis contact), pruritus

Rare

Dermatitis bullous

Very rare

Photosensitivity reaction

General: Systemic absorption of this medicine is low compared with plasma levels obtained following administration of oral forms of Voltarol and the likelihood of systemic side-effects occurring with topical diclofenac is small compared with the frequency of side-effects associated with oral diclofenac. However, where this medicine is applied to a relatively large area of skin and over a prolonged period, the possibility of systemic side-effects cannot be completely excluded. If such usage is envisaged, the data sheet on Voltarol oral dosage forms should be consulted.

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.

4.9 Overdose

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 Topical diclofenac is inadvertently ingested (1 tube of 100 g contains the equivalent of 1000 mg diclofenac sodium).

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. Gastric decontamination and the use of activated charcoal should be considered, especially within a short time of ingestion.

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.

5. Pharmacological properties
5.1 Pharmacodynamic properties

This medicine is an anti-inflammatory and analgesic preparation designed for external application. Due to an aqueous-alcoholic base the gel exerts a soothing and cooling effect.

5.2 Pharmacokinetic properties

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 Voltarol Back and Muscle Pain Relief 1.16% Gel.

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

5.3 Preclinical safety data

None known.

6. Pharmaceutical particulars
6.1 List of excipients

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

6.2 Incompatibilities

None Stated

6.3 Shelf life

Three years

6.4 Special precautions for storage

Do not store above 30°C.

This medicine should be kept out of the sight and reach of children.

6.5 Nature and contents of container

Sealed aluminium tubes with protective inner coating, closed with a polypropylene screw cap.

Packaging available in packs of 10g, 30g, 40g and 50g.

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, incorporating a moulded feature used to insert, twist and remove the seal before first use or a push / pull cap applicator, which is designed to facilitate hand-free application of the product, available for 100g pack only

Packaging available in packs of 30g, 50g, 60g, 100g and 120g.

6.6 Special precautions for disposal and other handling

None

7. Marketing authorisation holder

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

8. Marketing authorisation number(s)

PL 44673/0156

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation:

22 November 2004

Date of latest renewal:

24 February 2011

10. Date of revision of the text

08th August 2018