Tinset*gel 30g 5%

NAME
TINSET 5% GEL

PHARMACOTHERAPEUTIC CATEGORY
Antihistamines for systemic and topical use.

ACTIVE PRINCIPLES
100 g of gel contain: oxatomide hydrate 5.21 g (equal to 5 g of oxatomide).

EXCIPIENTS
5% gel: macrogol 300, triethanolamine, carboxypolymethylene, phenoxyethanol, purified water.

INDICATIONS
Local symptomatic treatment of itchy dermatitis, sunburn, insect bites.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance, or to any of the excipients, liver failure.

DOSAGE
Apply the gel 2-3 times a day only on limited areas. Do not use with occlusive dressings.

STORAGE
This medicine does not require any special storage conditions.

WARNINGS
The use, especially if prolonged, of medicines for cutaneous use can give rise to sensitization phenomena, where this occurs it is necessary to interrupt the treatment. To avoid systemic absorption of the medicine, avoid application on extensive lesions, as well as on areas of skin with blisters, on living sores and exuding surfaces. Avoid contact with eyes or mucous membranes. In the case of sunburn, do not expose the skin to the sun afterwards. In cases of systemic absorption of the drug, there have been reports of hepatitis, liver damage, jaundice and changes in liver function (moderate to large increase in liver enzymes), including very rare cases of fatal liver failure. Patients should be carefully observed for hepatic side effects. In case of abnormal liver values, appropriate measures should be taken such as discontinuation of treatment and drug therapy should not be resumed. Dyskinesia and extrapyramidal symptoms have been observed in both adults and children. Extrapyramidal symptoms were more frequent in children. Children are probably more susceptible to central nervous system effects due to immaturity of the blood-brain barrier. Therefore caution should be recommended in children between 1 and 6 years of age and particularly in those between 12 and 24 months.

INTERACTIONS
Following the cutaneous use of the drug, no interactions were noted. Patients should be advised that after systemic administration of the drug there may be an increase in the sedative effect of central nervous system depressants, including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives, anxiolytics and antipsychotics. Undesirable effects of anticholinergic drugs may be increased by concomitant administration of the drug. The concomitant use of MAO inhibitors and the product is not recommended. Oxatomide, like other antihistamines, can interfere with skin allergen tests and therefore treatment should be stopped for at least 3 days before skin testing.

SIDE EFFECTS
Frequencies of adverse reactions: 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. Skin and subcutaneous tissue disorders. Rare: mild and transient reddening reaction; not known: skin burning sensation, contact dermatitis. Report any suspected adverse reactions via the national reporting system.

PREGNANCY AND BREASTFEEDING
No direct embryotoxic, peri and postnatal toxic effects were noted in animals. There were no direct adverse effects on fertility ', while secondary effects were recorded only at doses toxic to the mothers. Animal test data demonstrate limited passage of oxatomide across the placental barrier, but safety in pregnant women has not been established. Although pharmacokinetic data indicate poor systemic absorption of the drug, in case it is necessary to administer the drug during pregnancy, the potential risks must be carefully weighed against the expected therapeutic benefits. There is insufficient information on oxatomide excretion in human milk. Although pharmacokinetic data indicate poor systemic absorption of the medicinal product, in case of treatment with the product, the potential risks must be carefully weighed against the expected therapeutic benefits.