
In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219
INDICATIONS
Seasickness, plane sickness, car sickness and train sickness.
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.
WARNINGS AND PRECAUTIONS FOR USE
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
Following treatment with Xamamine Travel Mal, the following side effects have been reported:
Systemic organ class | More frequent side effects | Frequent side effects | Less frequent side effects
Metabolism and nutrition disorders | Frequent side effects: Anorexia
Psychiatric disorders | Less frequent side effects: Insomnia (especially in children) Euphoria
Nervous system disorders | More frequent side effects: Sedation Drowsiness | Frequent side effects: Headache | Less frequent side effects: Vertigo Tremors Seizures (especially in children)
Vision disorders | Frequent side effects: Accommodation disorders
Heart disorders | Less frequent side effects: Tachycardia
Vascular disorders | Less frequent side effects: Hypotension
Gastrointestinal disorders | Frequent side effects: Dry mouth Nausea
Disorders of the skin and subcutaneous tissue | Frequent side effects: Photosensitivity Allergic skin reaction
Kidney and urinary disorders | Frequent side effects: Urination 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.








