Voltaren Emulgel Gel Derm 120g 1%

NAME
VOLTAREN EMULGEL 1% GEL

PHARMACOTHERAPEUTIC CATEGORY
Topical medications for joint and muscle pain.

ACTIVE PRINCIPLES
Diclofenac sodium.

EXCIPIENTS
Diethylamine, carbomers, macrogol cetostearyl ether, cocoyl caprylocaprate, isopropyl alcohol, liquid paraffin, Cream 45 perfume (contains benzyl benzoate), propylene glycol, purified water.

INDICATIONS
Local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature of the joints (such as osteoarthritis and arthritis), of the muscles (such as contractures or injuries), of the tendinies of the ligaments (such as tendinitis).

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the listed excipients; patients who have experienced asthma attacks, hives or acute rhinitis after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs); third trimester of pregnancy; children and adolescents: use in children and adolescents under the age of 14 years is contraindicated.

DOSAGE
Adults over 18 years: apply the gel 3 or 4 times a day on the area to be treated, rubbing lightly. The amount to be applied depends on the size of the affected part. For example, 2-4 g of gel (quantity varying in size between a cherry and a walnut) are sufficient to treat an area of 400-800 cm ^ 2. After application, wash your hands, otherwise they will also be treated with the gel. Attention use only for short periods of treatment. Teenagers from 14 to 18 years: apply the gel 3 or 4 times a day on the area to be treated, rubbing lightly. The amount to apply depends on the size of the affected part. For example 2-4 g of gel (quantity varying in size between a cherry and a walnut) are sufficient to treat an area of 400-800 cm ^ 2. After application, wash your hands, otherwise they will also be treated with gel. If this product is needed for more than 7 days to relieve pain or if symptoms worsen, consult a physician. Children below 14 years: There are insufficient data on efficacy and safety in children and adolescents below 14 years. Therefore, the use of the gel is contraindicated in children under six 14 years of age. Elderly (over 65 years): the usual dosage for adults can be used.

STORAGE
60 g, 100 g, 120 g and 150 g gel tube: keep at a temperature below 30 degrees C. 50 g pressurized container: keep at a temperature below 30 degrees C. Warning: the container is under pressure: keep sheltered direct sunlight, do not pierce or burn the container even after use.

WARNINGS
The possibility of systemic adverse events with the application of topical diclofenac cannot be excluded if the preparation is used on large skin areas and for a prolonged period. 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 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. The drug contains propylene glycol and benzyl benzoate which can cause skin irritation.

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

SIDE EFFECTS
Adverse reactions are listed by frequency, most frequent first, using the following convention: very common (> = 1/10), 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. Disorders of the immune system. Very rare: hypersensitivity '(including urticaria), angioneurotic edema. Infections and infestations. Very rare: rash with pustules. Respiratory, thoracic and mediastinal disorders. Very rare: asthma. Skin and subcutaneous tissue disorders. Common: rash, eczema, erythema, dermatitis (including contact dermatitis), pruritus; rare: bullous dermatitis; very rare: photosensitivity reaction, allergic reactions. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND 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 / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk was believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in 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 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 can expose the fetus to: cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); renal dysfunction, which can 'progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to: possible prolongation of the bleeding time, and antiplatelet effect which can 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, no effects on the infant are anticipated at therapeutic doses of the medicinal product. Due to the lack of controlled studies in breastfeeding women, the product should only be used during breastfeeding under the advice of a healthcare professional. In this circumstance, the gel should not be applied to the breast of lactating mothers, nor elsewhere on large areas of skin or for an extended period of time.