Voltaren Emulgel Gel painkiller and anti-inflammatory For muscle and joint pain based on Diclofenac (1%). Voltaren Emulgel is a local treatment of painful and inflammatory states : of a rheumatic or traumatic nature of the joints, such as osteoarthritis and arthritis ; of the muscles, in case of contractures or injuries ; of tendons and ligaments, in the presence of tendinitis .
Dosage and method of use of Voltaren Emulgel Gel 60 Gr 1%
How to take Voltaren Emulgel Gel?
Adults over 18 years: Apply Voltaren Emulgel 1% gel 2 times a day on the area to be treated (preferably in the morning and in the evening), rubbing lightly. The quantity to be applied depends on the size of the affected part. For example, 2-4 g of Voltaren Emulgel 1% gel (quantity varying in size between a cherry and a walnut) are sufficient to treat an area of 400-800 cm².
Adolescents aged 14 to 18: Apply Voltaren Emulgel 1% gel 2 times a day on the area to be treated (preferably in the morning and evening), rubbing lightly. The quantity to be applied depends on the size of the affected part. For example, 2-4 g of Voltaren Emulgel 1% gel (quantity varying in size between a cherry and a walnut) are sufficient to treat an area of 400-800 cm².
Elderly (over 65 years): The usual dosage for adults can be used.
After application, clean your hands with absorbent paper and then wash them, unless they are the site to be treated. Paper towels should be disposed of in household waste after use. Patients should wait for Voltaren Emulgel 1% to dry before showering or bathing. The gel should not be used for more than 14 days without medical advice. Consult your doctor if symptoms persist or worsen after 7 days of treatment.
Active ingredients Voltaren Emulgel Gel 60 Gr 1%:
100 g of Voltaren Emulgel contain
Active ingredients : 2.32 g of diclofenac diethylammonium, equivalent to 2 g of sodium diclofenac. Excipients with known effects: propylene glycol (50 mg/g of gel) butylated hydroxytoluene (0.2 mg/g of gel) pungent eucalyptus perfume For the full list of excipients, see section 6.1.
Excipients : Butylated hydroxytoluene, carbomers, cocoyl caprylocaprate, diethylamine, isopropyl alcohol, liquid paraffin, macrogol cetostearyl ether, oleic alcohol, propylene glycol, pungent eucalyptus perfume, purified water.
Contraindications of Voltaren Emulgel Gel 60 Gr 1%
When can't Voltaren Emulgel Gel be used?
Contraindications/Side effects of Voltaren Emulgel Gel:
- Hypersensitivity to the active substance or to any of the excipients listed in the paragraph
- History of asthma, angioedema, urticaria or acute rhinitis following the intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)
- During the third trimester of pregnancy.
- Use in children and adolescents under 14 years of age is contraindicated.
Side effects of Voltaren Emulgel Gel 60 Gr 1%
The possibility of systemic adverse events with the application of Voltaren Emulgel 1% cannot be excluded if the preparation is used on large skin areas and for a prolonged period. Voltaren Emulgel 1% 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 the eyes or mucous membranes and should not be ingested. Discontinue treatment if skin rash develops after application of the product. Voltaren Emulgel 1% can be used with non-occlusive dressings, but must not be used with an occlusive dressing that does not allow air to pass through. Important information about some excipients Voltaren Emulgel 1% gel contains 200 mg of propylene glycol per dose (4 g) equivalent to 50 mg/g which may cause skin irritation. Voltaren Emulgel 1% gel contains butylated hydroxytoluene which may cause localized skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes. Voltaren Emulgel 1% gel contains pungent eucalyptus scent, an aroma which in turn contains benzyl alcohol, citronellol, coumarin, d-limonene, eugenol, geraniol, linalool which may cause allergic reactions.
Since the systemic absorption of diclofenac following topical application is very low, interactions are very unlikely.
Side effects include mild, transient skin reactions at the application site. In very rare cases, allergic reactions may occur. Side effects are listed below by organ, system/system:
- Infections and infestations: Very rare Rash with pustules.
- Immune system disorders: Very rare Hypersensitivity (including urticaria), angioedema.
- Respiratory, thoracic and mediastinal disorders: Very rare Asthma.
- Skin and subcutaneous tissue disorders: Common Dermatitis (including contact dermatitis), rash, erythema, eczema, pruritus. Rare Bullous dermatitis. Very rare Photosensitivity reaction, allergic reactions. Not known Burning sensation at the application site, dry skin.
Overdose Voltaren Emulgel Gel
The low systemic absorption of topical diclofenac makes overdose very unlikely; however, side effects similar to those seen after an overdose of diclofenac tablets can be expected if Voltaren Emulgel 1% is ingested (1 60 g tube contains the equivalent of 1.2 g of diclofenac sodium). In case of ingestion, which gives rise to significant systemic side effects, the general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory drugs should be undertaken. Further treatment modalities, within the short term of ingestion, should take into account clinical indications or the recommendation of the poison control center, where available.
Voltaren Emulgel Gel 60 Gr 1% during pregnancy and breastfeeding
Can I use Voltaren Emulgel Gel during pregnancy or breastfeeding?
The systemic concentration of diclofenac compared to oral formulations is lower after topical administration. Referring to experience with treatment with NSAIDs for systemic administration, the following is recommended: Inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increases from less than 1%, up to approximately 1.5%. The risk is believed to increase with the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality; furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals to which prostaglandin synthesis inhibitors had been administered during the organogenetic period. During the first and second trimester of pregnancy, diclofenac should not be administered unless strictly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester 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 inhibitors of prostaglandin synthesis can expose the fetus to: • cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); • renal dysfunction, which can progress to renal failure with oligo-hydramnios; the mother and the newborn, at the end of pregnancy, to: • possible prolongation of bleeding time, and anti-aggregating effect which can occur even at very low doses; • inhibition of uterine contractions resulting in delayed or prolonged labor. Diclofenac is contraindicated during the third trimester of pregnancy. Breastfeeding Like other NSAIDs, diclofenac passes into breast milk in small quantities. However, at therapeutic doses of Voltaren Emulgel 1% 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, Voltaren Emulgel 1% should not be applied to the breasts of breastfeeding mothers, nor elsewhere on large areas of skin or for a prolonged period of time.
Expiry and conservation of Voltaren Emulgel Gel 60 Gr 1%
How to store Voltaren Emulgel Gel?
Store below 30°C. The medicine can be used for 3 years after first opening.
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