Xamamina Travel Sickness 50mg 6 softgels

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Seasickness, plane sickness, car sickness and train sickness.

ACTIVE INGREDIENTS

XAMAMINA TRAVEL SICKNESS 50 mg soft capsules One soft capsule contains: active ingredient: dimenhydrinate 50 mg Excipients: sorbitol, parabens XAMAMINA TRAVEL SICKNESS Children 25 mg soft capsules One soft capsule contains: active substance: dimenhydrinate 25 mg Excipients: sorbitol, parabens For the complete list of excipients, see section 6.1

EXCIPIENTS

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

CONTRAINDICATIONS AND SIDE EFFECTS

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.

DOSAGE

XAMAMINA TRAVEL SICKNESS 50 mg soft capsules In 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 capsules In 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 doses.

CONSERVATION

Store at a temperature not exceeding 25°C

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 contain sorbitol: Patients suffering from rare hereditary problems of fructose intolerance should not take this medicine. The soft capsules contain parabens which can cause allergic reactions (even delayed).

INTERACTIONS

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).

SIDE EFFECTS

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

Metabolism and nutrition disorders - Frequent side effects: Anorexia.

Psychiatric disorders - Less frequent side effects: Insomnia (especially in children) Euphoria.

Nervous system disorders - Most frequent side effects: Sedation Drowsiness. Frequent side effects: Headache. Less frequent side effects: Dizziness Tremors Convulsions (especially in children).

Vision disorders - Frequent side effects: Accommodation disorders.

Cardiac disorders - Less frequent side effects: Tachycardia.

Vascular disorders - Less frequent side effects: Hypotension.

Gastrointestinal disorders - Frequent side effects: Dry mouth Nausea.

Skin and subcutaneous tissue disorders - Frequent side effects: Photosensitivity Allergic skin reaction.

Kidney and urinary disorders - Frequent side effects: Micturition disorders.

General disorders and administration site conditions - Less frequent side effects: Asthenia.

"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.

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.

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. Breastfeeding. Small amounts of dimenhydrinate pass into breast milk. Given the possible adverse events of the product in newborns, the use of dimenhydrinate during breastfeeding is contraindicated.

EFFECTS ON DRIVING ABILITY

Since the most frequent side effect of antihistamines is sedation which can manifest itself as drowsiness, this must be taken into account by those who carry out operations requiring an intact level of vigilance (driving motor vehicles, operating machinery).