SOLACUTAN Gel Ref.[27901] Active ingredients: Diclofenac

Due to the low systemic absorption of Solacutan gel, the likelihood of systemic adverse reactions following the external use of Solacutan gel is small compared to the frequency of adverse reactions with oral diclofenac. However, the possibility of systemic adverse events from application of topical diclofenac cannot be excluded if the preparation is used on large areas of skin and over a prolonged period of time (see medicinal product information for systemic formulations of diclofenac).

This medicinal product should be used with caution in patients with a history of active gastrointestinal ulceration and/or bleeding, or reduced heart, liver or kidney function because there have been isolated reports of systemic adverse reactions (such as kidney disorders) associated with externally used anti-inflammatory medicinal products.

Non-steroidal anti-inflammatory medicinal products are known to have anti-platelet activity. Therefore, although the likelihood of systemic adverse reactions is small, caution should be used in patients with intracranial haemorrhage and bleeding diathesis.

Exposure to direct sunlight and solarium use should be avoided during treatment. If hypersensitivity reactions of the skin occur, treatment must be stopped.

Topical diclofenac should be applied only to intact skin, and not to skin wounds, open injuries, infected skin areas or exfoliative dermatitis. The gel must not come into contact with the eyes or mucous membranes and should not be ingested.

Discontinue the treatment if a (generalised) skin rash develops after applying the medicinal product.

Topical diclofenac 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 formulation is very low, such interactions are very unlikely.

Pregnancy

The systemic concentration of diclofenac is lower after topical application compared to oral formulations.

With reference to experience from treatment with non-steroidal anti-inflammatory medicinal products (NSAIDs) with systemic uptake, the following is recommended:

• Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo-foetal 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 the dose and duration of therapy.
• Animal studies have shown reproductive toxicity. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal 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 trimesters of pregnancy, diclofenac should not be given unless clearly necessary. If diclofenac is used by a woman attempting to conceive or during the first or second trimester of pregnancy, the dose should be kept as low (<30% of the body surface) and duration of treatment as short as possible (not longer than 3 weeks).

During the second and third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to the following risks:

• renal dysfunction in the foetus. From the 12th week: oligohydramnios (usually reversible after the end of treatment) or anamnios (particularly with prolonged exposure). After birth: renal insufficiency may persist (particularly with late or prolonged exposure);
• cardiopulmonary toxicity in the foetus (pulmonary hypertension with premature closure of the ductus arteriosus). This risk exists from the beginning of the 6th month and increases if administration is close to the end of pregnancy.

At the end (during the third trimester) of pregnancy, all prostaglandin synthesis inhibitors may expose the mother and the neonate to the following risks:

• 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;
• increased risk of oedema formation in the mother.

Consequently, diclofenac is contraindicated during the third trimester of pregnancy (see section 4.3).

Breast-feeding

Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at the recommended therapeutic dosage of Solacutan gel no effects on the suckling child are anticipated.

Because of a lack of controlled studies in lactating women, the medicinal product should only be used during lactation under advice from a healthcare professional. Under these circumstances, Solacutan gel 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 use of topical diclofenac has no influence on the ability to drive and use machines.

Common adverse reactions: The most frequently reported adverse reactions are local skin reactions such as contact dermatitis, erythema and rash or application site reactions such as inflammation, skin irritation, pain and blistering.

In clinical studies to date there has appeared to be no age-related increase or age-specific pattern of reactions.

Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: 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)

Temporary hair discolouration at the application site has been reported. This is usually reversed on stopping treatment.

Skin tests in a previously treated patient population indicated a 2.18% probability of sensitisation to diclofenac, triggering allergic contact dermatitis (type IV). The clinical relevance is as yet unknown. Cross-reactions with other NSAIDs are unlikely.

Serum tests in more than 100 patients revealed no (type I) anti-diclofenac antibodies.

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 Website: www.mhra.gov.uk/yellowcard.

Not applicable.