XAMAMINA BB 6CPS 25MG

XAMAMINA CAPSULE MOLLS

active ingredients

XAMAMINA 50 mg soft capsules A soft capsule contains: active ingredient: dimenhydrate 50 mg Excipients: sorbitol, parabens XAMAMINA Children 25 mg soft capsules A soft capsule contains: active ingredient: dimenhydrate 25 mg Eccipients: sorbitol, parabens For the full list of excipients, see paragraph 6.1

Excellent

XAMAMINA 50 mg soft capsules XAMAMINA Children 25 mg soft capsules macrogol 400. Wrap: gelatin; liquid sorbitol partially dehydrated; sodium-parahydroxybenzoate of ethyl (E215); sodioparahydroxybenzoate propile (E 217).

Therapeutic indications

Sea, plane, car and train.

Contraindications

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

Population

XAMAMINA 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 Children 25 mg soft capsules In children aged 2-6 years 1 soft capsule of Xamamina Children half an hour before travelling 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 travelling, 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 should be administered with caution in subjects suffering from closed angle glaucoma, prostate hypertrophy, urinary retention, slowing intestinal transit, bronchial asthma, epilepsy, porphyria. The product can mask the symptoms of ototoxicity and therefore should be given with caution in patients in ototoxic drugs therapy. Soft capsules contain sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine. Soft capsules contain parabens which can cause allergic reactions (also delayed).

Interactions

The product can increase the effects of other depressive agents of the Central Nervous System, such as alcohol, barbiturates, other hypnotics, sedatives or tranquilizers. In the event of concurrent intake of such substances, attention must be paid to the purpose of avoiding additional phenomena of sedation. The product can enhance the effects of other anticholinergic drugs, including antidepressants. If administered in conjunction with aminoglycosidic antibiotics or other ototoxic drugs, dimenhydrate may mask the first symptoms of ototoxicity, which can only be detected when the damage is irreversible (see also paragraph 4.4).

Effects

Following Xamamina treatment, the following side effects were reported:

Systemic organ class	Most common side effects	Frequently unwanted effects	Less frequent side effects
Disorders of metabolism and nutrition		Anorexia
Psychiatric disorders			Insomnia (especially in children), Euphora
Disorders of the nervous system	Sedazione, Sonnolenza	Cefa	Vertigo, Tremori, Convulsions (especially in children)
Disorders of sight		Disorders of acceptance
Heart disorders			Tachycardia
Vascular disorders			Hypotension
Gastrointestinal disorders		Dryness of the bundles, Nausea
Disorders of skin and subcutaneous tissue		Sensitivity, Skin reaction on an allergic basis
Renal and urinary disorders		Disorders of urination
General disorders and conditions of the administration site			Austria

Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

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

Pregnancy

. In studies on reproduction in rats and conigli doses greater than 20-25 times than those normally used in human therapy have not evidenced teratogenic effects or fertility reduction. However, data on the use of the product in pregnant women are not available. Therefore, although the teratogenicity of the product appears unlikely, the use of dimenhydrate in pregnancy is contraindicated.

Food

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

Source: Farmadati