NOVARTIS FARMA SpA
Voltaren Emulgel Gel 60 Gr 2%
Voltaren Emulgel Gel 60 Gr 2%

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PRODUCT NET WEIGHT
PRODUCT NET WEIGHT
60g
EAN
EAN
034548065
MINSAN
MINSAN
034548065
Voltaren Emulgel Gel pain reliever and anti-inflammatory For muscle and joint pain based on Diclofenac (2%). Voltaren Emulgel is a local treatment of painful and inflammatory 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 .
ACTIVE INGREDIENTS
Active ingredients contained in Voltaren Emulgel Gel 60 Gr 2% - What is the active ingredient in Voltaren Emulgel Gel 60 Gr 2%?
100 g of Voltaren Emulgel contain 2.32 g of diclofenac diethylammonium, equivalent to 2 g of diclofenac sodium. Excipients with known effect: 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
Composition of Voltaren Emulgel Gel 60 Gr 2% - What does Voltaren Emulgel Gel 60 Gr 2% contain?
Butylated hydroxytoluene, carbomers, cocoyl caprylocaprate, diethylamine, isopropyl alcohol, liquid paraffin, macrogol cetostearyl ether, oleic alcohol, propylene glycol, pungent eucalyptus perfume, purified water.
DIRECTIONS
Therapeutic indications Voltaren Emulgel Gel 60 Gr 2% - Why is Voltaren Emulgel Gel 60 Gr 2% used? What is it used for?
Local treatment of painful and inflammatory conditions of rheumatic or traumatic nature of the joints (such as osteoarthritis and arthritis), muscles (such as contractures or injuries), tendons and ligaments (such as tendinitis).
CONTRAINDICATIONS SIDE EFFECTS
Contraindications Voltaren Emulgel Gel 60 Gr 2% - When should Voltaren Emulgel Gel 60 Gr 2% not be used?
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; history of asthma, angioedema, urticaria or acute rhinitis following the intake of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs); during the third trimester of pregnancy; use in children and adolescents under 14 years of age is contraindicated.
DOSAGE
Quantity and method of taking Voltaren Emulgel Gel 60 Gr 2% - How is Voltaren Emulgel Gel 60 Gr 2% taken?
For cutaneous use. Adults over 18 years, Voltaren Emulgel 2% gel provides pain relief for up to 12 hours: apply Voltaren Emulgel 2% gel 2 times a day to the area to be treated (preferably in the morning and evening), rubbing in lightly. The amount to be applied depends on the size of the affected area. For example, 2-4 g of Voltaren Emulgel 2% gel (an amount between the size of a cherry and a walnut) is sufficient to treat an area of 400-800 cm^2. After application, clean your hands with absorbent paper and then wash them, unless they are the site to be treated. Absorbent paper should be disposed of in household waste after use. Patients should wait for Voltaren Emulgel 2% to dry before showering or bathing. Caution: Use only for short periods of treatment. The duration of treatment depends on the indication for use and the clinical response. 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. Adolescents aged 14 to 18 years: apply Voltaren Emulgel 2% gel 2 times a day to the area to be treated (preferably in the morning and evening), rubbing in lightly. The amount to be applied depends on the size of the affected area. For example, 2-4 g of Voltaren Emulgel 2% gel (an amount between the size of a cherry and a walnut) is sufficient to treat an area of 400-800 cm^2. After application, clean your hands with absorbent paper and then wash them, unless they are the site to be treated. Absorbent paper should be disposed of in household waste after use. Patients should wait for Voltaren Emulgel 2% to dry before showering or bathing. If this product is needed for more than 7 days to relieve pain or if symptoms worsen, consult a doctor. Children under 14 years: insufficient data are available on the efficacy and safety in children and adolescents under 14 years of age (see section 4.3 Contraindications). Therefore, the use of Voltaren Emulgel 2% gel is contraindicated in children under 14 years of age. Elderly (over 65 years): the usual adult dosage may be used.
CONSERVATION
Storage Voltaren Emulgel Gel 60 Gr 2% - How is Voltaren Emulgel Gel 60 Gr 2% stored?
This medicinal product does not require any special storage conditions.
WARNINGS
Warnings Voltaren Emulgel Gel 60 Gr 2% - On Voltaren Emulgel Gel 60 Gr 2% it is important to know that:
The possibility of systemic adverse events with the application of Voltaren Emulgel 2% cannot be excluded if the preparation is used on large areas of skin and for a prolonged period. Voltaren Emulgel 2% must be applied only to intact, non-diseased skin and not to skin wounds or open lesions. It must not be allowed to come into contact with the eyes or mucous membranes and must not be ingested. Discontinue treatment if a skin rash develops after application of the product. Voltaren Emulgel 2% 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 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 may cause localised skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes. Voltaren Emulgel 2% gel contains pungent eucalyptus perfume, a flavouring containing benzyl alcohol, citronellol, coumarin, d-limonene, eugenol, geraniol, linalool which may cause allergic reactions.
INTERACTIONS
Interactions Voltaren Emulgel Gel 60 Gr 2% - Which medicines or foods can modify the effect of Voltaren Emulgel Gel 60 Gr 2%?'
Since systemic absorption of diclofenac following topical application is very low, interactions are very unlikely.
SIDE EFFECTS
Like all medicines, Voltaren Emulgel Gel 60 Gr 2% can cause side effects - What are the side effects of Voltaren Emulgel Gel 60 Gr 2%?
Undesirable effects include mild and transient skin reactions at the application site. In very rare cases, allergic reactions may occur. Undesirable effects are listed below by system organ class and MedDRA frequency. Frequencies are defined as: very common (>= 1/10); common (>= 1/100 to <1/10); uncommon (>= 1/1,000 to < 1/100); rare (>= 1/10,000 to < 1/1,000); very rare (< 1/10,000) not known (frequency cannot be estimated from the available data). 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. 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
PREGNANCY AND BREASTFEEDING
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Voltaren Emulgel Gel 60 Gr 2%
Pregnancy: The systemic concentration of diclofenac compared to oral formulations is lower after topical administration. Based on experience with treatment with systemic NSAIDs, the following is recommended: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/fetal development. 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 of cardiac malformations increases from less than 1%, up 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 cause increased pre- and post-implantation loss and embryo/fetal mortality; In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, diclofenac should not be given unless clearly 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 and 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 neonate, at the end of pregnancy, to: possible prolongation of bleeding time, and an anti-aggregating effect which may 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 2% no effects on the infant are anticipated. 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 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 (see section 4.4 Special warnings and precautions for use).
