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GastroRelief

GastroRelief

Manufacturer:

Winwa Medical

Distributor:

Winwa Medical
Full Prescribing Info
Contents
Aluminum hydroxide, magnesium hydroxide, simethicone.
Description
Active Ingredients: Chewable tab: Each tablet contains Dried Aluminium Hydroxide 200 mg, Magnesium Hydroxide 200 mg, Simethicone 20 mg.
Source of lactose is bovine.
Oral susp: Each 10 ml contains Dried Aluminium Hydroxide 400 mg, Magnesium Hydroxide 400 mg, Simethicone 60 mg.
Excipients/Inactive Ingredients: Oral susp: Preservative: Chloroform 0.15% v/v.
Action
Pharmacology: GastroRelief Antacid Tablet when taken by mouth is nonsystemic. Aluminium Hydroxide and Magnesium Hydroxide react with hydrochloric acid and convert to their respective chloride salts in the stomach. They reduce gastric acidity by neutralizing secreted gastric acid. The increased gastric pH and decreased pepsin production help in the healing of peptic ulcers. The clinical use of Simethicone is based on its antifoam properties. Silicone antifoams spread on the surface of aqueous liquids, forming a film of low surface tension and thus causing collapse of foam bubbles. Simethicone reportedly allows mucus-surrounded gas bubbles in the gastrointestinal (GI) tract to coalesce and be expelled.
Aluminium Hydroxide reacts with Hydrochloric Acid in the stomach to form Aluminium Chloride. Absorbed Aluminium is eliminated in the urine. The majority of Aluminium remains in the GI tract and forms insoluble poorly absorbed Aluminium salts including hydroxide, phosphate, carbonate and fatty acid derivatives, which are excreted in the faeces. Magnesium Hydroxide reacts with hydrochloric acid in the stomach to produce Magnesium Chloride and water. About 30% of the Magnesium salts are absorbed from the small intestine and excreted in the urine (absorbed fraction) and the faeces (unabsorbed fraction). Simethicone is physiologically inert; it does not appear to be absorbed from the GI tract or to interfere with gastric secretion or absorption of nutrients. Following oral administration, the drug is excreted uncharged in faeces.
Indications/Uses
For the relief of gastric pain and discomforts of peptic ulcer, heartburn, dyspepsia (indigestion) and acid reflux. It also helps to relieve gastrointestinal conditions caused by excessive gas (flatulence).
Dosage/Direction for Use
Chewable tab: Adults and children above 12 years: Chew 2 to 4 tablets 4 times a day.
Children 6 to 12 years: Chew 1 to 2 tablets 4 times a day.
Chew well before swallowing, preferably ½ hour before meals or 2 hours after meals and at bedtime or as directed by a doctor.
Oral susp: For oral use only.
Adults and children above 12 years: Take 10 ml to 20 ml 4 times a day.
Preferably 20 minutes to 1 hour after meals and at bedtime or as directed by a doctor.
Shake well before use.
Overdosage
Symptoms of overdose may include gastrointestinal irritation, diarrhoea and constipation. Severe poisoning may produce hypermagnesaemia.
Treatment consists of the intravenous administration of Calcium Gluconate injection 10% in a dose of 10 to 20 ml to counteract respiratory depression or heart block. If renal function is normal, adequate fluids should be given to assist the removal of Magnesium from the body. Dialysis may be necessary for patients with renal impairment or severe hypermagnesaemia. Treatments should be symptomatic and supportive.
Contraindications
Contraindicated in patients with known hypersensitivity to Aluminium Hydroxide, Magnesium Hydroxide, Simethicone or any other ingredients in this product.
Should not be used in patients who are severely debilitated or suffering from kidney failure.
Special Precautions
It should be used with caution in patients with renal insufficiency.
If symptoms persist, consult a doctor.
Chewable tab: Unsuitable for phenylketonurics.
Use In Pregnancy & Lactation
Antacids are generally regarded as safe. No data is available to suggest any harmful effects of Aluminium Hydroxide and Magnesium Hydroxide associated with Simethicone in pregnant women. A small amount of Aluminium Hydroxide and Magnesium Hydroxide may be secreted in breastmilk and the concentration is too small to be harmful. Secretion of Simethicone in the breast milk of nursing mothers has not been established.
Adverse Reactions
Antacids may occasionally cause constipation, diarrhoea, nausea and vomiting.
Drug Interactions
May interfere with or reduce the absorption of anticholinergic agents, Barbiturates, Digoxin, Quinidine and Vitamins.
Antacids can interfere with the absorption of iron preparations, Tetracyclines or other antibiotics. Hence, antacids should not be taken within 2 hours of other medications because the effectiveness of the other medications may be affected.
Storage
Store below 30°C. Protect from light.
Shelf Life: 3 years from the date of manufacture.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
ATC Classification
A02AF02 - ordinary salt combinations and antiflatulents ; Belongs to the class of antacids with antiflatulents.
Presentation/Packing
Form
GastroRelief chewable tab
Packing/Price
(blackcurrant flavour) 2 × 8's; (freshmint flavour) 2 × 12's
Form
GastroRelief oral susp
Packing/Price
(blackcurrant/peppermint flavour) 100 mL x 1's
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