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Valontan Adults 100 mg Coated tablets

  • Recordati Industria Chimica e Farmaceutica S.p.A.
  • 003452024
Features:



Indicated in case of nausea and vomiting.



Indicated in case of seasickness, motion sickness and train sickness.



Deductible over-the-counter drug.



Indicated from 12 years of age.



















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VALONTAN ADULTS 100 MG COATED TABLETS

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

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.

Contraindications

Hypersensitivity to the active ingredient, to other antihistamines, or to any of the excipients. Contraindicated in children and adolescents. Contraindicated during pregnancy and breastfeeding.

Side effects

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   Anorexia  
Psychiatric disorders     Insomnia, Euphoria
Nervous system disorders Sedation, Drowsiness Headache Dizziness, Tremors, Convulsions
Eye pathologies   Accommodation disorders  
Cardiac diseases     Tachycardia
Vascular pathologies     Hypotension
Gastrointestinal disorders   Dry mouth, Nausea  
Pathologies of the skin and subcutaneous tissue   Photosensitivity, Allergic skin reaction  
Renal and urinary disorders   Urination disorders  
General disorders and administration site conditions     Asthenia

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.

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.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

None.

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).

Overdose

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.

Active principles

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.

Excipients

Sucrose, colloidal silica, magnesium stearate, corn starch.Cladding components: acrylic resin (Eudragit), talc.

Data sheet

Packaging
100 mg 10 tablets
Product Type
HUMAN DRUG
ATC code
R06AA11
ATC description
Dimenhydrinate (ATC R06AA02 cleaves: products containing dimenhydrinate / diphenhydramine theoclate go into the new ATC. Products containing diphenhydramine chloride remain in R06AA02.
Dimenidrinato (l'ATC R06AA02 si scinde: i prodotti contenenti dimenidrinato /difenidramina teoclato vanno nel nuovo ATC. I prodotti che contengono difenidramina cloruro rimangono in R06AA02).
Therapeutic Group
Antiemetics
Active principle
dimenhydrinate (DC.IT) (FU)
Class
C.
Pharmaceutical form
coated tablet
coated tablets
Type of Administration
oral
Container
blister
Quantity
10 coated tablets
Capacity
100 milligrams
Quantity of the Active Ingredient
100MG
Recipe required
OTC - self-medication medicine
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