Directions for use Nausicalm Adults 50 mg 14 capsules
FOR ADULTS ONLY (from 15 years old).
- 1 to 2 capsules every 6 to 8 hours. Maximum dosage: 400 mg/24 h, i.e. 8 capsules/24 h.
- In the treatment of motion sickness: the first dose should be taken half an hour before departure. The intake can possibly be renewed during the journey.
- In the symptomatic treatment of nausea and vomiting not accompanied by fever: the duration of treatment without medical advice should not exceed 2 days.
Precaution of use
CONTRA-INDICATED:
- This drug is CONTRAINDICATED in the following situations:
. Hypersensitivity to antihistamines.
. Risk of glaucoma by angle closure.
. Risk of urinary retention due to urethroprostatic disorders.
- Due to the presence of sucrose, this medication is contraindicated in cases of fructose intolerance, glucose and galactose malabsorption syndrome, or sucrase-isomaltase deficiency.
NOT RECOMMENDED:
This medication MUST NOT BE USED if you are breastfeeding (dimenhydrinate passes into breast milk).
- As a precaution, do not use this medication in case of bronchial asthma.
- The use of alcoholic beverages and medicines containing alcohol (see chapter on interactions) during treatment is strongly discouraged.
Special warnings
This drug contains sucrose. Its use is not recommended in patients with sucrose intolerance.
Precautions for use
As a precaution, do not use this medication in cases of bronchial asthma. Dimenhydrinate should be used with caution: - in elderly patients with
o a greater sensitivity to orthostatic hypotension, dizziness and sedation,
o chronic constipation (risk of paralytic ileus)
o possible prostatic hypertrophy;
- in severe hepatic and/or renal insufficiency, because of the risk of accumulation.
Precautions must be taken in case of association with certain ototoxic antibiotics, as dimenhydrinate may mask the symptoms of ototoxicity.
The use of alcoholic beverages and alcohol-containing drugs (see Interactions with other drugs and other forms of interaction) during treatment is strongly discouraged.
The risk of abuse and drug dependence is low. However, cases of abuse and dependence have been reported mainly in adolescents or young adults for recreational purposes and/or in patients with psychotic disorders or a history of abuse and/or dependence. The occurrence of signs or symptoms suggestive of dimenhydrinate abuse should be carefully monitored.
Pregnancy and Nursing :
Pregnancy: Animal studies have not demonstrated a teratogenic effect. In the absence of teratogenic effect in animals, a malformative effect in humans is not expected. Indeed, to date, substances responsible for malformations in humans have been shown to be teratogenic in animals in well-conducted studies in two species. Clinically, the use of dimenhydrinate in a limited number of pregnancies has apparently not revealed any particular malformative or fetotoxic effects to date. However, further studies are needed to assess the consequences of exposure during pregnancy. In neonates of mothers treated long-term with high doses of an anticholinergic antihistamine, digestive signs related to the atropine properties have been rarely described (abdominal distension, meconium ileus, delayed meconium release, difficulty in initiating feeding, tachycardia, neurological disorders...). Consequently, the use of this drug should be considered during pregnancy only if necessary. If the administration of this drug took place at the end of pregnancy, it seems justified to observe a period of monitoring of neurological and digestive functions of the newborn.
Breastfeeding: The use of this drug is not recommended during breastfeeding (dimenhydrinate passes into breast milk).
Effects on ability to drive and use machines:
- The attention is drawn, in particular in the drivers of vehicles and the users of machines, on the risks of drowsiness attached to the use of this drug.
- This phenomenon is accentuated by taking alcoholic beverages or medicines containing alcohol.
Composition Nausicalm Adults 50 mg 14 capsules
capsule : Dimenhydrinate 50 mg.
Excipients: Neutral granules size 30 (1), (Sucrose, Starch), Shellac, Polyvidone excipient, Talc, qsp 1 capsule.
Excipient(s) with notorious effect : saccharose. (1) Neutral granules size 30 : saccharose 75 per cent, starch 25 per cent.
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