Name
DICLOFENAC TEVA BV 10 MG/G GEL

Active ingredients
1 g of gel contains diclofenac in the form of 11.6 mg of diclofenac diethylammonium equivalent to 10 mg of diclofenac sodium. Excipient(s) with known effect : 1 g of gel contains 50 mg of propylene glycol (E1520) and 1 mg of perfume (contains 0.15 mg/g benzyl alcohol, citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene and linalool). For the full list of excipients, see section 6.1.

Therapeutic indications
Adults . For the local symptomatic treatment of pain: - associated with acute muscle strains, sprains or bruises following impact trauma; - of the soft tissues adjacent to the joint (e.g. bursae, tendons, tendon sheaths, ligaments, muscle inserts and joint capsules) in osteoarthritis of the knee joints and fingers; - in epicondylitis; - in acute muscle pain, e.g. in the back. Adolescents aged 14 years and over : For short-term treatment. For the local symptomatic treatment of pain associated with acute muscle strains, sprains or bruises following impact trauma.

Dosage
Dosage . Adults and adolescents aged 14 years and over : Depending on the size of the affected area to be treated, apply 3-4 times a day an amount ranging in size from a cherry to a walnut, equivalent to 1-4 g of gel (11.6-46.4 mg of diclofenac diethylammonium corresponding to 10-40 mg of diclofenac sodium). This dose is sufficient to treat an area of ​​400-800 cm². The maximum daily dose is 16 g of gel, corresponding to 185.6 mg of diclofenac, diethylammonium salt (corresponding to 160 mg of diclofenac sodium). The duration of use depends on the symptoms and the underlying disease. Diclofenac Teva BV should not be used for more than a week without consulting a doctor. If symptoms worsen or do not improve within 3-5 days, a doctor should be consulted. Special patient groups . Elderly patients : No special dose adjustments are required. Due to the potential adverse effect profile, elderly people should be carefully monitored. Patients with renal impairment : No dose reduction is required for patients with renal impairment. Patients with hepatic impairment: No dose reduction is required for patients with hepatic impairment. Children and adolescents (under 14 years) : There are insufficient data on efficacy and safety in children and adolescents under 14 years (see section 4.3). Method of administration : For cutaneous use. A thin layer of gel is applied to the affected body parts and gently rubbed into the skin. Hands should be washed unless they are the area to be treated. The gel should be allowed to dry on the skin for a few minutes before applying a bandage (see section 4.4).

Conservation
Store the medicine in the original tube in order to protect from light. This medicine does not require any special temperature storage conditions.

Pregnancy and breastfeeding
The systemic concentration of diclofenac, compared to oral formulations, is lower after topical administration. Based on experience with systemic NSAIDs, the following is recommended: Pregnancy : Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo-foetal development. Results of 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 of cardiovascular malformations 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-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has 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 taken 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 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 labor. Consequently, diclofenac is contraindicated during the third trimester of pregnancy. Breastfeeding : Diclofenac is secreted into breast milk in small amounts. However, at therapeutic doses of Diclofenac Teva BV no effects on the infant are anticipated. Due to the lack of controlled studies in breastfeeding women, the medicinal product should be used during breastfeeding only under the advice of a physician. In this circumstance, Diclofenac Teva BV should not be applied to the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period (see section 4.4).