Simeco

Simeco

Manufacturer:

Interphil

Distributor:

GSK Consumer Healthcare
Full Prescribing Info
Contents
Hydrotalcite, magnesium hydroxide, dimethicone.
Description
Each tablet contains: Hydrotalcite 282 mg, Magnesium Hydroxide 85 mg and Dimethicone 25 mg.
This product is an antacid and antiflatulent drug that helps relieve hyperacidity and flatulence. The active ingredients in Simeco tablets area combination of antacid compounds: Hydrotalcite (Aluminum Hydroxide, and Magnesium Carbonate), Magnesium Hydroxide and Dimethicone (Polydimethylsiloxane). This also contains Mannitol (66 mg), Confectioner's Sugar (63.5 mg), FD&C Color Yellow #5 (1.5 mcg) and Alcohol subcomponents.
Indications/Uses
This medicine is indicated for the symptomatic relief of hyperacidity and flatulence associated with the diagnosis of peptic ulcer, gastritis, gastroesophageal reflux esophagitis, hyperacidity, and hiatal hernia and dyspeptic complaints.
Dosage/Direction for Use
Adults: 2-4 chewable tablets taken 1-2 hours after meals and at bedtime or as directed by a physician. Tablets should be chewed.
Missed Dose: If the doctor has told the patient to take the medication regularly, take the missed dose as soon as the patient remembers it. However, if it is almost time for the next dose, skip the missed dose and continue the regular dosing schedule. Do not take double dose to make up for the missed one.
Overdosage
Signs and symptoms include nausea and vomiting and muscle weakness. Severe toxicity occurs after chronic excessive oral doses, often in patients with renal insufficiency. Early manifestations are lethargy, hyporeflexia (decrease reflexes) followed by weakness, paralysis, hypotension, ECG changes (prolonged PR and QRS intervals), CNS depression, seizures and respiratory depression.
In case of accidental overdose or at the first sign of any adverse reaction, discontinue use and seek professional assistance immediately.
Contraindications
This product is contraindicated for use in patients with: Known hypersensitivity to the active ingredients or any other components listed in Description.
Severe renal impairment and abdominal pain.
Special Precautions
The recommended dose should not be exceeded without medical advice.
In renal failure and long term use in particular, there is an increased risk of phosphate depletion syndrome with hypercalciuria and osteomalacia or aluminum ion-induced deterioration in dementia syndrome in patients receiving chronic renal dialysis.
Caution is also required in individuals with severe constipation, especially elderly ones, or following a low-sodium diet.
When there is a need for other medicines, these may be taken at two-hour intervals.
Use in Pregnancy: There are no adequate clinical studies in pregnant women. However, aluminum and magnesium-containing antacids are generally considered safe for use during the last two trimesters of pregnancy as long as chronic high doses are avoided. Problems with Dimethicone use have not been documented during all three trimesters of pregnancy.
Use in Lactation: There is no evidence to suggest that Dimethicone, aluminum and magnesium-containing antacids should not be given to breast feeding mothers.
Consult the Doctor: If the patient notices other side effects that the he/she thinks are caused by this medicine, tell the doctor.
Use In Pregnancy & Lactation
Use in Pregnancy: There are no adequate clinical studies in pregnant women. However, aluminum and magnesium-containing antacids are generally considered safe for use during the last two trimesters of pregnancy as long as chronic high doses are avoided. Problems with Dimethicone use have not been documented during all three trimesters of pregnancy.
Use in Lactation: There is no evidence to suggest that Dimethicone or aluminum and magnesium-containing antacids should not be given to breastfeeding mothers.
Adverse Reactions
Magnesium-containing and Aluminum containing antacids usually do not cause constipation or diarrhea. This medication may rarely cause nausea or vomiting and very rarely, during long-term use, development of phosphate depletion syndrome or formation of fecaliths in elderly patients with severe constipation.
Drug Interactions
The concurrent use of the product with tetracyclines may inhibit their absorption (except for Doxycycline and possibly minocycline). The absorption of other medicines (anticholinergics, cimetidine, isoniazid, triazole antifungals iron salts, carbenoxolone, digitoxin, quinidine, phenobarbital) may also be delayed or reduced, or warfarin and phenindione absorption may be impaired.
The concurrent use of this product with the following agents decreases their effect: Benzodiazepines, captopril, corticosteroids, fluoroquinolones, H2 histamine receptor antagonists, hydantoins, ketoconazole, penicillamine, phenothiazines, salicylates and ticlopidine.
On the contrary, the concurrent use of this product with the following agents increases their effect: Levodopa, sulfonylureas and sodium valproate.
Acetate salts increase the adsorption and hence the toxicity of aluminum ions. With the ion-exchange resin, sodium polystyrene sulfonate, it may cause metabolic alkalosis in patients with renal failure. Antacids should not be administered in combination with the above products. These other medical products should be taken at least 1 to 2 hours before the antacids.
Storage
Store at temperatures below 30°C.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
ATC Classification
A02AF - Antacids with antiflatulents ; Used in the treatment of acid-related disorders.
Presentation/Packing
Form
Simeco tab
Packing/Price
100's (P6/tab, P600/box)
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