Voltaren Emulgel Gel 100 Gr 2%

Voltaren Emulgel Pain-relieving and anti-inflammatory gel for muscle and joint pain based on Diclofenac (2%). Voltaren Emulgel is a local treatment for painful and phlogistic conditions : 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 tendonitis .

Posology and method of use of Voltaren Emulgel Gel 100 Gr 2%

How to take Voltaren Emulgel Gel?

Adults over 18 years: Apply Voltaren Emulgel 2% gel 2 times a day on the area to be treated (preferably in the morning and in the evening), rubbing lightly. The amount to be applied depends on the size of the affected part. For example 2-4 g of Voltaren Emulgel 2% gel (quantity ranging in size from a cherry to a walnut) are sufficient to treat an area of ​​400-800 cm².

Adolescents aged 14 to 18: Apply Voltaren Emulgel 2% gel 2 times a day on the area to be treated (preferably in the morning and in the evening), rubbing lightly. The amount to be applied depends on the size of the affected part. For example 2-4 g of Voltaren Emulgel 2% gel (quantity ranging in size from a cherry to a walnut) are sufficient to treat an area of ​​400-800 cm².

Elderly (over 65 years): The usual adult dosage 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 placed in household waste after use. Patients should wait for Voltaren Emulgel 2% 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 100 Gr 2%:

100 g of Voltaren Emulgel contain

Active ingredients : 2.32 g of diethylammonium diclofenac, equivalent to 2 g of sodium diclofenac. Excipients with known effects: propylene glycol (50 mg/g of gel) butylhydroxytoluene (0.2 mg/g of gel) pungent eucalyptus perfume For the full list of excipients, see section 6.1.

Excipients : Butylhydroxytoluene, 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 100 Gr 2%

When should Voltaren Emulgel Gel not be used?

Contraindications/undesirable effects of Voltaren Emulgel Gel:

1. Hypersensitivity to the active substance or to any of the excipients listed in the paragraph
   
   
2. History of asthma, angioedema, urticaria or acute rhinitis after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)
   
   
3. During the third trimester of pregnancy.
   
   
4. Use in children and adolescents under 14 years of age is contraindicated.

Side effects of Voltaren Emulgel Gel 100 Gr 2%

The possibility of systemic adverse events with the application of Voltaren Emulgel 2% cannot be excluded if the preparation is used on large skin areas and for a prolonged period. Voltaren Emulgel 2% must 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 skin rash develops after application of the product. Voltaren Emulgel 2% can be used with non-occlusive dressings, but should not be used with an air-tight occlusive dressing. Important information about some of the excipients Voltaren Emulgel 2% gel contains 200 mg of propylene glycol per dose (4 g) equivalent to 50 mg/g which may cause skin irritation. Voltaren Emulgel 2% gel contains butylhydroxytoluene which can cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes. Voltaren Emulgel 2% gel contains pungent eucalyptus perfume, an aroma in turn containing benzyl alcohol, citronellol, coumarin, d-limonene, eugenol, geraniol, linalool which can cause allergic reactions.

Interactions

Since the systemic absorption of diclofenac following topical application is very low, interactions are very unlikely.

Side effects

Side effects include mild and transient skin reactions at the application site. In very rare cases, allergic reactions can occur. Undesirable 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 an overdose very unlikely; however undesirable effects similar to those observed after an overdose of diclofenac tablets can be expected if Voltaren Emulgel 2% is ingested (1 tube of 60 g contains the equivalent of 1.2 g of diclofenac sodium). In case of ingestion, which gives rise to significant systemic undesirable effects, the general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory drugs must be undertaken. Additional treatment modalities, within the short term of ingestion, should take into consideration clinical indications or poison center recommendation, where available.

Voltaren Emulgel Gel 100 Gr 2% in pregnancy and lactation

Can I use Voltaren Emulgel Gel when pregnant or breastfeeding?

The systemic concentration of diclofenac compared with oral formulations is lower after topical administration. Referring to the experience with treatment with NSAIDs for systemic administration, the following is recommended: Inhibition of prostaglandin synthesis can negatively affect pregnancy and/or embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increases from less than 1% to about 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 cause increased pre- and post-implantation loss and embryofetal mortality; in addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given prostaglandin synthesis inhibitors 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 prostaglandin synthesis inhibitors may 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 oligohydramnios; the mother and the newborn, at the end of pregnancy, to: • possible prolongation of bleeding time, and antiplatelet effect which may occur even at very low doses; • inhibition of uterine contractions resulting in delayed or prolonged labour. Diclofenac is contraindicated during the third trimester of pregnancy. Breast-feeding Like other NSAIDs, diclofenac passes into breast milk in small quantities. However, at therapeutic doses of Voltaren Emulgel 2%, no effects on the infant are expected. Due to the lack of controlled studies in lactating women, the product should only be used during lactation under the advice of a healthcare professional. In this circumstance, Voltaren Emulgel 2% should not be applied to the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time.

Expiration and conservation of Voltaren Emulgel Gel 100 Gr 2%

How to store Voltaren Emulgel Gel?

Store below 30°C. The medicine can be used for 3 years after first opening.