Leviogel 1% - pain relief gel for inflammation and muscle and joint pain 100g

Product Description

Gel

Leviogel Gel is used for the local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature of the joints, muscles, tendons, and ligaments.

Dosage and Directions for Use

Apply Leviogel Ge 3 or 4 times a day to the area to be treated, rubbing lightly. The amount to apply depends on the size of the affected area. For example, 2-4 g (an amount varying in size from a cherry to a walnut) is sufficient to treat an area of ​​400-800 cm^2. After application, rinse your hands, otherwise they will also be treated with the gel. Adults over 18 years: Caution: Use only for short periods of treatment.

Adolescents aged 14 to 18 years: If this product is needed for more than 7 days to relieve pain or if symptoms worsen, consult a doctor. Children under 14 years: There are insufficient data on efficacy and safety in children and adolescents under 14 years of age. Therefore, use is contraindicated in children and adolescents under 14 years of age. Elderly: The usual adult dosage can be used.

Contraindications

• Hypersensitivity to diclofenac or to any of the excipients.
• Patients who have experienced attacks of asthma, 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 under 14 years of age is contraindicated.

Special warnings

The possibility of systemic adverse events with the application of topical diclofenac cannot be excluded if the preparation is used on large areas of skin and for a prolonged period (see the summary of product characteristics for systemic forms of diclofenac). Topical diclofenac should only be applied to intact, non-diseased skin and not to skin wounds or open lesions. It should not be allowed to come into contact with eyes or mucous membranes and should not be ingested. Discontinue treatment if a skin rash develops after application of the product. Topical diclofenac can be used with non-occlusive dressings, but should not be used with an occlusive dressing that does not allow air to pass through.

Pregnancy and breastfeeding

• Pregnancy

The systemic concentration of diclofenac, compared to oral formulations, is lower after topical administration. Based on experience with treatment with systemically administered NSAIDs, the following is recommended: inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of miscarriage, cardiac malformation, and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period.

During the first and second trimesters of pregnancy, diclofenac should not be administered unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimesters of pregnancy, the dose should be kept as low as possible and the 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 oligohydramnios; the mother and newborn, at the end of pregnancy, to: possible prolongation of bleeding time; an antiplatelet effect that 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. Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of the drug, no effects on the infant are expected.

• Breastfeeding

Due to the lack of controlled studies in breastfeeding women, the product should be used during breastfeeding only under the advice of a healthcare professional. In this circumstance, the drug should not be applied to the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time.

Expiry and storage

Check the expiry date indicated on the package. The expiry date refers to the product in its intact packaging, correctly stored.

Caution:Do not use the medicine after the expiry date indicated on the package.

Composition

Leviogel Gel contains:
Active ingredient: Diclofenac Sodium 1g
Excipients: Purified water, ethanol 96%, isopropyl alcohol, carbomer, concentrated ammonia.

Format

100g tube.