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XAMAMINA * BB 6CPS 25MG

002955108
12 Items
Features:


Suitable for children from 2 years.


Indicated in case of seasickness, car and train sickness.


Deductible over-the-counter drug.


Antihistamine and anticholinergic action.


















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002955108
12 Items

XAMAMINA * BB 6CPS 25MG

Therapeutic indications

Sea, plane, car and train sickness.

Dosage and method of use

XAMAMINE 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. XAMAMINE Children 25 mg soft capsules In 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. XAMAMINE 25 mg medicated chewing gum In adults 1 medicated chewing gum at the first symptoms of nausea; the effect lasts about 4 hours. If necessary, repeat the dose after 3–4 hours, up to a maximum of 4 medicated chewing gums in 24 hours. In children 4 to 12 years of age 1 medicated chewing gum half an hour before travel or at the first symptoms of nausea and vomiting and if necessary repeat the dose after 6-8 hours, up to a maximum of 2 gum chew medicated within 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:

System organ class More frequent side effects Frequent side effects Less frequent side effects
Disorders of metabolism and nutrition Anorexia
Psychiatric disorders Insomnia (especially in children), Euphoria
Disorders of the nervous system Sedation, Somnolence Headache Vertigo, Tremors, Convulsions (especially in children)
Disorders of vision Disorders of accommodation
Cardiac disorders Tachycardia
Vascular disorders Hypotension
Gastrointestinal disorders Dry mouth, Nausea
Disorders of the skin and subcutaneous tissue Photosensitivity, Skin reaction on an allergic basis
Renal and urinary disorders Disorders of urination
General Disorders and Administration Site Conditions Asthenia
"Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows for continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili ".

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 to patients receiving ototoxic drugs. Soft capsules and medicated chewing gums contain sorbitol: Patients with rare hereditary problems of fructose intolerance should not take this medicine. Soft capsules contain parabens which can cause allergic reactions (even delayed). Medicated chewing gums contain aspartame, a source of phenylalanine. It can be harmful to you if you have phenylketonuria.

Pregnancy and breastfeeding

Pregnancy. In reproductive studies in rats and rabbits, doses 20-25 times higher than those normally used in human therapy 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.

Expiration and retention

None Xamamina soft capsules: store at a temperature not exceeding 25 ° C

Interactions with other drugs

The product may enhance 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, 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 capsules One soft capsule contains: active ingredient: dimenhydrinate 50 mg Excipients: sorbitol, parabens XAMAMINE Children 25 mg soft capsules One soft capsule contains: active ingredient: dimenhydrinate 25 mg Excipients: sorbitol, parabens XAMAMINE 25 mg medicated chewing gum One medicated chewing gum contains: active substance: dimenhydrinate 25 mg Excipients: aspartame, sorbitol For a full list of excipients, see section 6.1

Excipients

XAMAMINE 50 mg soft capsule and XAMAMINE Children 25 mg soft capsule macrogol 400. Shell: gelatin; partially dehydrated liquid sorbitol; sodium – ethyl parahydroxybenzoate (E215); propyl sodium parahydroxybenzoate (E 217). XAMAMINE 25 mg medicated chewing gum Nucleus: copolymer of methacrylic acid Type A, sorbitol, mint flavor, magnesium stearate, gum base, levomenthol, aspartame, talc, colloidal silica, anhydrous tricalcium phosphate; Coating: hypromellose, macrogol 6000, titanium dioxide, quinoline yellow (E104), patent blue V (E131).

002955108
12 Items

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