VOLTAROL PAIN-EZE EMULGEL Gel for topical administration Ref.[6789] Active ingredients: Diclofenac

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.

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.

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).

Cuetaneous application of topical diclofenac 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:

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.

None stated.