Antihistamine gel for topical use.
Indications
Tinset Gel is used for the local symptomatic treatment of urticaria, itchy dermatitis, mild sunburn, and insect bites.
Composition
Tinset 5% Gel contains:
- Active ingredient: Oxatomide hydrate 5.21 g (equivalent to 5 g of oxatomide).
- Excipients: macrogol 300, triethanolamine, carboxypolymethylene glycol, phenoxyethanol, purified water.
Tinset Dosage
Tinset antihistamine gel is applied 2-3 times a day, exclusively to small areas. Do not use with occlusive dressings. If symptoms do not improve within a few days, it is advisable to consult a doctor.
Contraindications
Hypersensitivity to the active ingredient, cinnarizine, or any of the excipients. Contraindicated for use in children under 1 year of age.
Special warnings
Tinset Gel is not indicated for the acute treatment of allergic conditions such as asthma attacks. When the drug is prescribed to asthmatic patients, ongoing drug treatment should not be stopped abruptly, but rather gradually reduced. This This is especially true for patients receiving corticosteroids. Cases of hepatitis, liver damage, jaundice, and changes in liver function (moderate to severe elevations of liver enzymes) have been reported, including very rare cases of fatal liver failure.
If abnormal liver values are detected, appropriate measures, such as discontinuation of treatment, should be taken. Due to its hepatic elimination, caution should be exercised when prescribing oxatomide to patients with known liver disorders. If necessary, treatment of these patients should preferably begin with half the usual dose. The dosing interval can be maintained unchanged. Dyskinesia and extrapyramidal symptoms have been observed in both adults and children. Extrapyramidal symptoms were more common in children. Children are likely more susceptible to central nervous system effects due to the immaturity of the blood-brain barrier. Therefore, caution is recommended in children under 6 years of age, particularly those under 24 months. Use in children under 1 year of age is contraindicated.
In the geriatric population, age-related physiological changes (e.g., increased blood-brain barrier permeability and decreased hepatic metabolism) may influence the activity of H1-receptor antagonists. Oxatomide, like other antihistamines, may interfere with skin allergy tests; therefore, treatment should be discontinued for at least 3 days before the skin test.
Especially in children, overdosage of antihistamines can produce sometimes serious effects. Use, especially if prolonged, may give rise to sensitization phenomena; if this occurs, the patient should be monitored closely. If this occurs, treatment should be discontinued. To avoid systemic absorption of the product, avoid application to large lesions, blistered skin areas, open wounds, and exuding surfaces. Avoid contact with eyes or mucous membranes. In case of sunburn, do not subsequently expose the skin to the sun.
Pregnancy and breastfeeding
- Pregnancy:No direct toxic effects, whether embryotoxic or peri- or postnatal, have been observed in animals. There were no direct adverse effects on fertility, while secondary effects were recorded only at doses toxic to the mothers. Animal data demonstrate limited passage of oxatomide across the placental barrier, but the safety of the drug in pregnant women has not been established. If the drug must be administered during pregnancy, the potential risks must be carefully weighed against the expected therapeutic benefits.
- Breastfeeding: There is insufficient information on the excretion of oxatomide in human milk. Therefore, breastfeeding should be discontinued if treatment is initiated.
Expiry and storage
Check the expiry date on the packaging. The expiry date indicated on the packaging refers to the product in its intact packaging, stored correctly. Do not use the medicine after the expiry date indicated on the packaging.
Format
30-gram tube.
Product Code:FRCM046569
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