VALONTAN * 4CPR RIV 100MG
Therapeutic indications
Prevention and treatment of nausea, vomiting and vertigo, typical of naupathias (seasickness, car, train, plane sickness).
Dosage and method of use
AdultsIn naupathy (seasickness, car, train, plane sickness), nausea and vomiting can be controlled with a single dose of half a tablet of VALONTAN Adult (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.
Contraindications
Hypersensitivity to the active substance, to other antihistamines, or to any of the excipients. Contraindicated in children and adolescents. Contraindicated during pregnancy and lactation.
Side effects
The following undesirable effects have been reported following treatment with VALONTAN Adults:
System organic classification according to MedDRA | More frequent side effects | Frequent side effects | Less frequent side effects |
Metabolism and nutrition disorders | | Anorexia | |
Psychiatric disorders | | | Insomnia, Euphoria |
Nervous system disorders | Sedation, Somnolence | Headache | Vertigo, Tremors, Convulsions |
Eye disorders | | Disorders of accommodation | |
Cardiac pathologies | | | Tachycardia |
Vascular pathologies | | | Hypotension |
Gastrointestinal disorders | | Dry mouth, Nausea | |
Skin and subcutaneous tissue disorders | | Photosensitivity, Skin reaction on allergic basis | |
Renal and urinary disorders | | Disorders of urination | |
General disorders and administration site conditions | | | Asthenia |
Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting systemhttps://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Special warnings
Using antihistamines at the same time as certain antibiotics or other ototoxic drugs can mask the early signs of ototoxicity, which can 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 disease, bronchial asthma, chronic bronchitis or emphysema, hyperthyroidism. The medicine can exacerbate seizure disorders. It should therefore be used with great caution in subjects suffering from epilepsy.VALONTAN Adult contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine.
Pregnancy and breastfeeding
VALONTAN Adult is contraindicated during pregnancy and lactation (see section 4.3). In breastfeeding patients it is necessary to decide whether to give up breastfeeding the baby and start the treatment or, vice versa, continue breastfeeding avoiding the administration of the product.
Expiry and retention
None.
Interactions with other drugs
During treatment, avoid the simultaneous use of alcoholic beverages and antidepressant, hypnotic, sedative or tranquilizing drugs, in order to prevent any additive sedation phenomena (see also section 4.7).
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
Each coated tablet contains:Active principleDimenhydrinate 100 mg Excipient with known effect: each coated tablet contains 16 mg of sucrose. For the full list of excipients, see section 6.1.
Excipients
Sucrose, colloidal silica, magnesium stearate, corn starch.Coating components: acrylic resin (Eudragit), talc.