Diclofenac zenitiva - pain treatment gel 50 g

Product Description

Local treatment of painful conditions

Indications

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

Composition

Active ingredients

100 g of gel contain: 1 g of diclofenac sodium.

Excipients

Purified water, 96% ethanol, isopropyl alcohol, carbomer, concentrated ammonia solution

Directions for use and Dosage

Adults over 18 years: Apply Diclofenac Zenitiva 3 or 4 times a day to the area to be treated, rubbing in lightly.
The amount to apply depends on the size of the affected area. For example, 2–4 g of Diclofenac Zenitiva (an amount between the size of a cherry and a walnut) is sufficient to treat an area of ​​400–800 cm².
After application, rinse your hands, otherwise they will also be treated with the gel.
Caution: use only for short periods of treatment. Adolescents aged 14 to 18 years:
Apply Diclofenac Zenitiva 3 or 4 times a day to the area to be treated, rubbing in lightly.
The amount to apply depends on the size of the affected area.
For example, 2–4 g of Diclofenac Zenitiva (an amount between the size of a cherry and a walnut) is sufficient to treat an area of ​​400–800 cm².
After application, wash your hands, otherwise they will also be treated with the gel.
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 (see also section 4.3 Contraindications).
Therefore, the use of Diclofenac Zenitiva is contraindicated in children under 14 years of age.
Elderly: It may be necessary to use this product in children under 14 years of age. The usual adult dosage should be used.

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 be applied only 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 may cause systemic side effects. Diclofenac may be used with non-occlusive dressings, but should not be used with an occlusive dressing that does not allow air to pass through.

Interactions

Since the systemic absorption of diclofenac following topical application is very low, such interactions are very unlikely.
Although bioavailability studies indicate this is unlikely, competition between absorbed diclofenac and other drugs that are highly bound to plasma proteins is theoretically possible.

Undesirable effects

Adverse reactions (Table 1) are listed by frequency, the most frequent first, using the following convention: 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.

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Overdose

The low systemic absorption of topical diclofenac makes overdose very unlikely. However, adverse effects similar to those observed after an overdose of diclofenac tablets may be expected if topical diclofenac is inadvertently ingested (1 50 g tube contains the equivalent of 500 mg of diclofenac sodium).
In case of accidental ingestion resulting in significant systemic adverse effects, general therapeutic measures normally adopted to treat poisoning with nonsteroidal anti-inflammatory drugs should be initiated.
Gastric decontamination and the use of activated charcoal should be considered, especially within a short time after ingestion.

Pregnancy and breastfeeding

Pregnancy: The systemic concentration of diclofenac is lower after topical administration compared to oral formulations. Based on experience with systemic NSAID treatment, 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 is 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 oligo-hydroamniosis; the mother and newborn, at the end of pregnancy, to: possible prolongation of bleeding time, and 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.
Breastfeeding: Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of Diclofenac Zenitiva, no effects on the infant are expected. 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, Diclofenac Zenitiva should not be applied to the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time (see Special warnings and precautions for use).

Storage

Store below 25°C.

Format

50 g tube.