VALENTAN CHILDREN
Therapeutic indications
Prevention and treatment of nausea, vomiting and dizziness, typical of nausea (seasickness, car sickness, train sickness, plane sickness).
Dosage and method of use
In children aged between 2-6 years: 1 tablet or 1 suppository of VALONTAN children up to a maximum of 3 times a day, as needed. In children aged between 7-12 years: 1-2 tablets or suppositories of VALONTAN children 2-3 times a day. It is recommended to take it approximately 30 minutes before obtaining the desired effect. Do not administer to children under 2 years of age (see 4.3). Do not exceed the recommended doses. Do not use for prolonged treatments.
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Contraindicated in children under 2 years of age. Generally contraindicated during pregnancy and breastfeeding.
Side effects
The most frequent side effect of antihistamines is sedation which can manifest as drowsiness. With the use of antihistamines, dry mouth, photosensitivity, accommodation disorders, urination disorders, headache, anorexia, nausea, allergic skin reactions may occur. Less frequently dizziness, asthenia, insomnia (especially in children), euphoria, tremors, hypotension, tachycardia and, at high doses, especially in children, convulsions.
Special warnings
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. The tablets contain sucrose and are therefore not suitable for individuals with hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.
Pregnancy and breastfeeding
Its use is not recommended during pregnancy. 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
None.
Interactions with other drugs
During treatment, in order to prevent additive sedation phenomena, the child should be prevented from being administered drugs that act on the Central Nervous System.
Overdose
Drowsiness is the most usual symptom of overdose. Toxic doses can produce: convulsions, coma and respiratory depression. If necessary, implement symptomatic therapy; when necessary, respiratory assistance.
Active principles
Coated tablets : Each coated tablet contains: Active ingredient Dimenhydrinate 25 mg Suppositories : Each suppository contains : Active ingredient Dimenhydrinate 25 mg For excipients: see 6.1
Excipients
Coated tablets : Each coated tablet contains: Excipients: Sucrose 15.0 mg, polyvinylpyrrolidone 2.0 mg, precipitated silica 1.5 mg, magnesium stearate 1.5 mg, corn starch 45.0 mg, hydroxypropyl methylcellulose 1.875 mg, polyethylene glycol 400 0.1875 mg, titanium dioxide 0.9375 mg. Suppositories : Each suppository contains: Excipients: Precipitated silica 10 mg, semi-synthetic glycerides 1500 mg.