VALONTAN ADULTS 100 MG COATED TABLETS
Prevention and treatment of nausea, vomiting and dizziness, typical of nausea (seasickness, car sickness, train sickness, plane sickness).
Dosage and method of use
AdultsIn case of naupathy (seasickness, car sickness, train sickness, plane sickness), nausea and vomiting can be controlled with a single dose of half a tablet of VALONTAN Adults (50 mg), the effect of which lasts approximately 4 hours ; this dose, if necessary, can be repeated, for prevention purposes, every 4 hours (3 tablets in 24 hours). Do not exceed the recommended dose. Do not use for prolonged treatments.
Hypersensitivity to the active ingredient, to other antihistamines, or to any of the excipients. Contraindicated in children and adolescents. Contraindicated during pregnancy and breastfeeding.
The following side effects have been reported following treatment with VALONTAN Adults:
|Systemic organ classification according to MedDRA
|More frequent side effects
|Frequent side effects
|Less frequent side effects
|Metabolism and nutrition disorders
|Nervous system disorders
|Dizziness, Tremors, Convulsions
|Dry mouth, Nausea
|Pathologies of the skin and subcutaneous tissue
|Photosensitivity, Allergic skin reaction
|Renal and urinary disorders
|General disorders and administration site conditions
Reporting of suspected adverse reactionsReporting 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 athttps://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
The use of antihistamines simultaneously with certain antibiotics or other ototoxic drugs can mask the first signs of ototoxicity, which may only reveal itself when the damage is irreversible. Use with caution in subjects suffering from glaucoma, prostatic hypertrophy, other urinary retention syndromes, intestinal obstruction, arterial hypertension, cardiovascular diseases, bronchial asthma, chronic bronchitis or emphysema, hyperthyroidism. The medicine may exacerbate seizure disorders. It should therefore be used with great caution in subjects suffering from epilepsy.VALONTAN Adults contains sucrose. Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine.
Pregnancy and breastfeeding
VALONTAN Adults is contraindicated during pregnancy and breastfeeding (see section 4.3). In breastfeeding patients, it is necessary to decide whether to give up breastfeeding the baby and start treatment or, vice versa, continue breastfeeding and avoid administration of the product.
Expiration and conservation
Interactions with other drugs
During treatment, avoid the simultaneous use of alcoholic beverages and antidepressant, hypnotic, sedative or tranquilizer drugs, in order to prevent any additive phenomena of sedation (see also section 4.7).
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.
Each coated tablet contains:Active principleDimenhydrinate 100 mg Excipient with known effects: each coated tablet contains 16 mg of sucrose. For the full list of excipients, see section 6.1.
Sucrose, colloidal silica, magnesium stearate, corn starch.Cladding components: acrylic resin (Eudragit), talc.