Moxydar

Moxydar

Nhà sản xuất:

Grimberg

Nhà phân phối:

Nafarma
Thông tin kê toa chi tiết tiếng Anh
Contents
Hydrated aluminium oxide, Magnesium hydroxide, Hydrated aluminium phosphate, Coated guar gum.
Description
Active ingredients: Hydrated aluminium oxide 500.0 mg, Magnesium hydroxide 500.0 mg, Hydrated aluminium phosphate 300.0 mg, Coated guar gum 200.0 mg Quantity equivalent to guar gum 198.0 mg For a tablet weighing 1.565 g.
Excipients/Inactive Ingredients: Sodium cyclamate, sodium saccharin, magnesium stearate, mint flavour*, simethicone, sorbitan oleate, polysorbate 80.
*Composition of the mint flavour: essential oils of mint deterpenized and essential oils of mint atomised on an acacia gum backing.
Action
Pharmacotherapeutic Group: ANTACID. ATC Code: A02AD01 (A: digestive system and metabolism).
Pharmacology: Pharmacodynamics: In-vitro study (using the Vatier method): total antacid capacity (titration at pH 1) = 46.82 mmoles acid/dose; mechanism of action: neutralising capacity (rise in pH) = 20%, buffering potential (pH maintained around a fixed value) = 80% at pH 3.0 – 2.0; theoretical protective capacity: from pH 1 to pH 3 = 31.57 mmoles of acid/dose.
Pharmacokinetics: Hydroxides of magnesium and aluminium are considered as local antiacids, non-systematic, whose absorption is negligible under normal conditions of use.
Toxicology: Preclinical safety data: Not specified.
Indications/Uses
Symptomatic treatment for pain linked to oesophago-gastro-duodenal disorders.
Symptomatic treatment of gastro-oesophageal reflux.
Dosage/Direction for Use
Oral route.
Put the tablet in a glass of water. After complete disintegration of the tablet, shake the suspension a few moments then ingest the obtained suspension. Rinse possibly the glass with a little water and ingest again.
Symptomatic treatment for pain linked to oesophago-gastro-duodenal disorders: One tablet if painful attacks occur, without exceeding 4 doses per day.
Symptomatic treatment of gastro-oesophageal reflux: During the loading period: 1 tablet 1 hour after each of the 3 meals and 1 additional tablet if pain occurs, for 4 to 6 weeks; For maintenance treatment: 1 tablet if pain occurs.
Overdosage
High doses of aluminium may increase the risk of occurrence of phosphorous depletion, constipation or bowel obstruction.
Patients with renal failure may be at risk of hypermagnesemia.
Contraindications
Related to magnesium: severe renal failure.
Hypersensitivity to the active substances or to any of the excipients mentioned in Description.
Special Precautions
In renal failure patients and chronic dialysis patients, take into account the aluminium content (risk of encephalopathy).
Effects on the ability to drive and use machines: Moxydar has no effect or an insignificant effect on the ability to drive and use machines.
Use In Pregnancy & Lactation
There are no reliable teratogenicity data in animals.
In clinical use, there are to date insufficient pertinent data to assess the possible malformative or foetotoxic effect of aluminium or magnesium hydroxides when they are administered during pregnancy.
Taking into account its poor absorption, this medicinal product is only to be used during pregnancy if necessary.
Take into account the presence of aluminium and magnesium ions likely to have an impact on transit: aluminium salts cause constipation, which may be additional to that classically experienced during pregnancy; magnesium salts may induce diarrhoea.
Try to restrict the daily dose and, if possible, and the duration of intake of this medicinal product
Adverse Reactions
Transit disorders (diarrhoea and constipation).
Related to aluminium: phosphorous depletion in the event of prolonged use or high doses.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued 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.
Drug Interactions
An interval of 2 hours must be observed between the intake of this medicine and administration of other medicines such as: salicylic acid, H2 antihistaminic, lansoprazole, bisphosphonates, cation resins, some antibiotics (fluoroquinolones, cyclins, lincosanides), digitalis, glucocorticoids, thyroid hormones, thiazides' diuretics and related drugs, phenothiazine's neuroleptics, sulpiride, some beta-blockers, penicillamine, ions (iron, phosphor, fluorine), zinc, strontium, chloroquine, dolutegravir, elviteravir, fexofenadine, ledipasvir, rosuvastatine, teriflunomide, ulipristal, estramustine.
Caution For Usage
Incompatibilities: Not applicable.
Instructions for use and handling: Any unused product or waste material should be disposed of in accordance with local requirements.
Storage
This medicine does not require any special storage conditions.
Shelf life: 3 years.
ATC Classification
A02AX - Antacids, other combinations ; Used in the treatment of acid-related disorders.
Presentation/Packing
Tab for oral susp (white, 20 mm in diameter) 30's, 60's.
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