Dosage and mode of use
Apply Leviogel Ge 3 or 4 times a day to the affected area, rubbing gently. The amount to be applied depends on the size of the affected part. For example, 4.2 g (quantitative variable size between a cherry and a walnut) is sufficient to treat an area of 400-800 cm ^ 2. After application, rinse your hands, otherwise it will be also treated with the gel. Adults over 18 years: attention only used for short periods of treatment
Adolescents aged 14 to 18 years: if this product and 'need for more' than 7 days for pain relief or if symptoms worsen, seek medical advice. Children under 14 years: There are insufficient data on efficacy and safety in children and adolescents under the age of 14. Therefore, the use and 'contra-indicated in children and adolescents under 14 years of age'. Elders may 'be used provided the usual dose for adults.
- Hypersensitivity 'to diclofenac or any of the excipients.
- Patients who have experienced asthma attacks, urticaria or acute rhinitis after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).
- Third trimester of pregnancy.
- Children and adolescents: Use in children and adolescents age 'under 14 years' contraindicated.
The possibility 'of systemic adverse events with the application of topical diclofenac can not' be excluded if the preparation is used on large areas and skin for an extended period (see the summary of product characteristics of the systemic forms of diclofenac). Topical diclofenac should only be applied to intact skin, not sick, not on skin wounds or open injuries. It should not be left to get in touch with the eyes or mucous membranes and should not be ingested. Discontinue treatment if skin rash develops after applying the product. Topical diclofenac can 'be used with non-occlusive bandages but should not be used with occlusive dressings that do not let air pass.
Pregnancy and breastfeeding
The systemic concentration of diclofenac, compared with oral formulations, and 'more' low following topical administration. Drawing on experience with NSAID treatment for systemic administration, the following is recommended: the inhibition of prostaglandin synthesis may 'adversely affect the pregnancy and / or the embryo / fetus. 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 for cardiovascular malformations increased from less than 1%, up to about 1.5%. E 'was found that the risk increases with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and mortality 'embryo-fetal. In addition, an increased incidence of various malformations, including cardiovascular, and 'been reported in animals which synthesis of prostaglandin inhibitors were administered during the organogenesis period.
During the first and second trimester of pregnancy, diclofenac should not be given unless clearly necessary. If diclofenac and 'used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept more' minimized and the duration of most 'shortest possible treatment. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: toxicity 'cardiopulmonary (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which can 'progress to renal failure with oligohydramnios; the mother and the neonate, at the end of pregnancy, to: possible prolongation of bleeding time, and antiplatelet effect which can 'occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, diclofenac and 'contra-indicated during the third trimester of pregnancy. Like other NSAIDs, diclofenac passes into breast milk in small quantities'. However, at therapeutic doses of the drug are not expected effects on the nursing infant.
Because of the lack of controlled studies in lactating women, the product should be used during breastfeeding only on the advice of a health professional. In this circumstance, the drug should not be applied to the breasts of nursing mothers, it 'elsewhere on large areas of skin or for an extended period of time.
Shelf life and storage
Check the expiration date on the package. The expiry date refers to the sealed container when stored.
Caution: Do not use the medicine after the expiration date on the package.
Leviogel Gel contains:
Active ingredient: Diclofenac Sodium 1g
Other ingredients: Purified water, 96% ethanol, isopropyl alcohol, carbomer, concentrated ammonia.