XAMAMINA * 6CPS 50MG

XAMAMINA * 6CPS 50MG

Therapeutic indications

Sea, plane, car and train sickness.

Dosage and method of use

XAMAMINE 50 mg soft capsulesIn adults 1 soft capsule half an hour before travel; if necessary repeat the dose after 3-4 hours, up to a maximum of 4 soft capsules in 24 hours.XAMAMINE Children 25 mg soft capsulesIn children aged 2-6 years 1 soft capsule of Xamamina Children half an hour before travel up to a maximum of 3 times in 24 hours. In children aged 7-12 years 1-2 soft capsules of Xamamina Children half an hour before travel, up to a maximum of 2-3 times in 24 hours. Do not exceed the recommended dose.

Contraindications

Hypersensitivity to the active substance, to other antihistamines or to any of the excipients. Contraindicated in children under 2 years of age. Contraindicated during pregnancy and lactation.

Side effects

The following side effects have been reported following treatment with Xamamina:

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

The product should be administered with caution in subjects suffering from narrow-angle glaucoma, prostatic hypertrophy, urinary retention, slowing of intestinal transit, bronchial asthma, epilepsy, porphyria. The product may mask the symptoms of ototoxicity and therefore should be administered with caution in patients receiving ototoxic drugs. Soft capsules containsorbitol: Patients with rare hereditary problems of fructose intolerance should not take this medicine. Soft capsules containparabenswhich can cause allergic reactions (including delayed).

Pregnancy and breastfeeding

Pregnancy. In reproductive studies in rats and rabbits, doses 20-25 times higher than those normally used in therapy in humans did not show teratogenic effects or impaired fertility. However, no data are available on the use of the product in pregnant women. Therefore, although the teratogenicity of the product appears unlikely, the use of dimenhydrinate in pregnancy is contraindicated.Feeding time. Small amounts of dimenhydrinate pass into breast milk. Given the possible adverse events of the product in infants, the use of dimenhydrinate during lactation is contraindicated.

Expiry and retention

Store at a temperature not exceeding 25 ° C

Interactions with other drugs

The product may enhance the effects of other CNS depressants, such as alcohol, barbiturates, other hypnotics, sedatives or tranquilizers. In case of concomitant intake of these substances, attention must be paid in order to avoid additive phenomena of sedation. The product may potentiate the effects of other anticholinergic drugs, including antidepressants. If administered concomitantly with aminoglycoside antibiotics or other ototoxic drugs, dimenhydrinate can mask the first symptoms of ototoxicity, which can only be detected when the damage is irreversible (see also section 4.4).

Overdose

In case of overdose consult your doctor immediately. Sleepiness is the most usual symptom of overdosing. Toxic doses can produce: convulsion, coma and respiratory depression. If necessary, implement symptomatic therapy. When needed, respiratory assistance.

Active principles

XAMAMINE 50 mg soft capsulesOne soft capsule contains: active ingredient: dimenhydrinate 50 mg Excipients: sorbitol, parabensXAMAMINE Children 25 mg soft capsulesOne soft capsule contains: active substance: dimenhydrinate 25 mg Excipients: sorbitol, parabens For a full list of excipients, see section 6.1

Excipients

XAMAMINE 50 mg soft capsules and XAMAMINE Children 25 mg soft capsulesmacrogol 400. Shell: gelatin;partially dehydrated liquid sorbitol; ethyl sodium-parahydroxybenzoate (E215); propyl sodium parahydroxybenzoate (E 217).