Maalox nausea 20 effervescent tablets

Product Description

Prevention of nausea.

Indications

Maalox Nausea is indicated in adults for the symptomatic treatment of nausea.

Composition

Active ingredients

Metoclopramide hydrochloride 5 mg

Excipients

monosodium citrate anhydrous, potassium bicarbonate, citric acid anhydrous, potassium carbonate, sorbitol, macrogol 6000, leucine, sodium saccharin, lemon flavoring.

Directions for use and Dosage

The use of the product is limited to adult patients. Use in children under 16 years of age is contraindicated (see Contraindications).
Use is not recommended in the 16–18 age group. One sachet of effervescent granules or one effervescent tablet before meals or when symptoms arise, in half a glass of water, 2–3 times a day.
The maximum recommended duration of treatment is 5 days.
The maximum recommended daily dose is 30 mg. Do not exceed the recommended doses.
A minimum interval of 6 hours must be respected between two administrations, even in case of vomiting or rejection of the dose.

Warnings

Neurological disorders Extrapyramidal disorders may occur, particularly in children and young adults and/or with the use of high doses.
Methaemoglobinaemia Methaemoglobinaemia possibly related to NADH cytochrome b5 reductase deficiency has been reported. In such cases, metoclopramide must be discontinued immediately and permanently and appropriate measures (such as treatment with methylene blue) must be taken. Cardiac disorders Metoclopramide may induce torsade de pointes, therefore particular caution should be exercised when administering the drug to patients with a known risk factor for QT interval prolongation such as: ,Altered electrolyte balance (e.g. hypokalaemia, hypomagnesemia); ,Congenital long QT syndrome; ,Bradycardia. Concomitant use of drugs known to prolong the QT interval such as class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics.
Renal and hepatic impairment: In patients with renal impairment or severe hepatic impairment, a reduction in dosage is recommended.
Sorbitol: Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Interactions

Contraindicated combinations Levodopa or dopamine agonists and metoclopramide antagonize each other.
Combinations to avoid Alcohol enhances the sedative effect of metoclopramide.
Combinations to take into account Due to the prokinetic effect of metoclopramide, the absorption of some drugs may be altered. Anticholinergics and morphine derivatives Anticholinergics and morphine derivatives could both have an antagonistic effect on metoclopramide on the motility of the digestive tract. CNS depressants (morphine derivatives, anxiolytics, sedative H1 antihistamines, sedative antidepressants, barbiturates, clonidine and related drugs)
The sedative effects of central nervous system depressants and metoclopramide are enhanced.
Neuroleptics Metoclopramide may have an additive effect with other neuroleptics (phenothiazines, butyrophenones, thioxanthenes, etc.) in the case of extrapyramidal disorders. Serotonergic drugs The use of metoclopramide with serotonergic drugs such as SSRIs may increase the risk of serotonin syndrome.
Digoxin Metoclopramide may reduce the bioavailability of digoxin.
Careful monitoring of digoxin plasma concentrations is required.
Cyclosporin Metoclopramide increases the bioavailability of ciclosporin (Cmax by 46% and exposure by 22%).
Careful monitoring of ciclosporin plasma concentrations is required.
The clinical consequences are uncertain.
Mivacurium and suxamethonium Metoclopramide injection may increase the risk of serotonin syndrome. prolong the duration of neuromuscular blockade (by inhibiting plasma cholinesterase).
Cisplatin Some observations report, with metoclopramide, an increase in the renal toxicity of cisplatin.
Insulin By reducing the intestinal transit of food, treatment with metoclopramide may require an adjustment of the insulin dosage in diabetes.
Strong CYP2D6 inhibitors Metoclopramide exposure levels increase when administered concomitantly with strong CYP2D6 inhibitors such as fluoxetine and paroxetine.
Although the clinical significance is uncertain, patients should be monitored for adverse reactions.
Metoclopramide also reduces the effects of apomorphine on the CNS.

Pregnancy and breastfeeding

Pregnancy Use of the product during the first trimester of pregnancy is contraindicated.
A large amount of data on pregnant women (more than 1,000 exposed outcomes) indicates no malformative toxicity or fetotoxicity.
If clinically necessary, metoclopramide can be used during pregnancy.
Due to its pharmacological properties (as with other neuroleptics), extrapyramidal syndrome in the newborn cannot be ruled out if metoclopramide is administered at the end of pregnancy. Metoclopramide should be avoided at the end of pregnancy.
If metoclopramide is used, neonatal monitoring should be instituted.
Breastfeeding Metoclopramide is excreted in breast milk at low levels.
Adverse reactions in the breast-fed child cannot be ruled out. Therefore, metoclopramide is not recommended during breastfeeding.
Consideration should be given to discontinuing metoclopramide in breastfeeding women. Alternatively, bottle-feeding should be used.

Storage

Store below 30°C in the original container.

Format

20 effervescent tablets.