Xamamina Children 25 mg Antiemetic Dimenhydrate 6 Soft Capsules

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 can mask the symptoms of ototoxicity and therefore should be administered with caution in 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. The soft capsules contain parabens which can cause allergic reactions (including delayed ones). Medicated chewing gums contain aspartame, a source of phenylalanine. It can be harmful to you if you have phenylketonuria.
PHARMACOTHERAPEUTIC CATEGORY
Antiemetics and antinauseants.
STORAGE
Soft capsules: store at a temperature not exceeding 25 degrees C.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance, to other antihistamines or to any of the excipients. Contraindicated in children younger 'less than 2 years. Contraindicated during pregnancy and lactation.
NAME
XAMAMINA
EXCIPIENTS
50 mg soft capsules and Children 25 mg soft capsules: macrogol 400. Shell: gelatin; partially dehydrated liquid sorbitol; ethyl sodium-parahydroxybenzoate (E215); propyl sodium parahydroxybenzoate (E217). 25 mg medicated chewing gum. Core: Type A methacrylic acid copolymer, sorbitol, mint flavor, magnesium stearate, gumabase, levomentol, aspartame, talc, colloidal silica, anhydrous tricalcium phosphate; Coating: hypromellose, macrogol 6000, titanium dioxide, quinoline yellow (E104), patent blue V (E131).
SIDE EFFECTS
Disorders of metabolism and nutrition. Frequent: anorexia. Psychiatric disorders. Less frequent: insomnia, euphoria. Disorders of the nervous system. More frequent: sedation, drowsiness; frequent: headache; less frequent: dizziness, tremors, convulsions. Disorders of life. Frequent: accommodation disturbances. Cardiac disorders. Less frequent: tachycardia. Vascular disorders. Less frequent: hypotension. Gastrointestinal disorders. Frequent: dry mouth, nausea. Disorders of the skin and subcutaneous tissue. frequent: photosensitivity ', skin reaction on allergic basis. Heurinary kidney disorders. Frequent: disturbances in urination. General Disorders and Administration Site Conditions. Less frequent: asthenia. Report any suspected adverse reactions via the national reporting system.
PREGNANCY AND BREASTFEEDING
In reproduction studies in rats and rabbits, doses 20-25 times higher than those normally used in therapy in humans did not show teratogenic effects or reduced 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. Small amounts of dimenhydrinate pass into breast milk. Given the possible adverse events of the product in newborns, the use of dimenhydrinate during lactation and 'contraindicated.
INDICATIONS
Sea, plane, car and train sickness.
INTERACTIONS
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. When 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.
DOSAGE
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. Children 25 mg soft capsules. In children aged 2-6 years: 1 soft capsule 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 half an hour before the trip, up to a maximum of 2-3 times in 24 hours. 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 aged between 4 and 12 years 1 medicated chewing gum half an hour before the trip 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 medicated chewing gums within 24 hours. Do not exceed the recommended dose.
ACTIVE PRINCIPLES
50 mg soft capsules: dimenhydrinate 50 mg. Children 25 mg soft capsules: dimenhydrinate 25 mg. 25 mg medicated chewing gum: dimenhydrinate 25 mg.