Xamamine Children 25 mg Antiemetic 6 Soft Capsules

XAMAMINA TRAVEL SICK

Therapeutic indications

Seasickness, plane sickness, car sickness and train sickness.

Dosage and method of use

XAMAMINA TRAVEL SICKNESS 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.XAMAMINA TRAVEL SICKNESS Children 25 mg soft capsulesIn children aged between 2-6 years 1 soft capsule of Xamamine Travel Sickness Children half an hour before travel up to a maximum of 3 times in 24 hours. In children aged between 7-12 years 1-2 soft capsules of Xamamine Travel Sickness 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 breastfeeding.

Side effects

The following side effects have been reported following treatment with Xamamine Travel Mal:

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

Pregnancy and breastfeeding

Pregnancy. In reproduction studies in rats and rabbits, doses 20-25 times higher than those normally used in human therapy did not show any teratogenic effects or reduction in 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 during pregnancy is contraindicated.Feeding time. Small amounts of dimenhydrinate pass into breast milk. Given the possible adverse effects of the product in newborns, the use of dimenhydrinate during breastfeeding is contraindicated.

Expiration and conservation

Store at a temperature not exceeding 25°C

Interactions with other drugs

The product may increase the effects of other Central Nervous System depressants, such as alcohol, barbiturates, other hypnotics, sedatives or tranquilizers. In case of concomitant intake of these substances, care must be taken to avoid additive sedation phenomena. The product may enhance 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 par. 4.4).

Overdose

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

Active principles

XAMAMINA TRAVEL SICKNESS 50 mg soft capsulesOne soft capsule contains: active ingredient: dimenhydrinate 50 mg Excipients: sorbitol, parabensXAMAMINA TRAVEL SICKNESS Children 25 mg soft capsulesOne soft capsule contains: active ingredient: dimenhydrinate 25 mg Excipients: sorbitol, parabens For the full list of excipients, see section 6.1

Excipients

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