Antacids
Simethicone 40 mg / 1ml
15ml - 30 ml
OD-02
145/1999
31/7/1999
Mechanism Of Action | Physiologically simeticone is extremely inert, and therefore it will not be pharmacologically active. It works by altering the elasticity of interfaces of bubbles in the gastrointestinal tract. The gas bubbles are thus broken down or coalesced and in this form gas is more easily eliminated through eructation or passing flatus |
INDICATIONS | Antiflatulent agent for the symptomatic relief of flatulence, wind pains, bloating, abdominal distension and other symptoms associated with gastrointestinal gas |
CONTRAINDICATIONS | Simeticone is contraindicated in patients with a previous history of hypersensitivity to simeticone or excipients. |
Side EFFECTS | Minor adverse effects: nausea and constipation. Rarely hypersensitivity reactions: such as rash, pruritus, facial oedema, tongue oedema, respiratory difficulty. Frequency not defined: Loose stools |
WARNINGS | • If symptoms persist for more than 14 days, or if symptoms worsen, medical advice must be sought. • The chew tab contains sorbitol; Patients with rare hereditary problems of fructose intolerance should not take this medicine. • The Oral suspension (drops) contains sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates |
DRUG INTERACTIONS | Although no studies have been presented, the concomitant use of this drug and mineral oil (paraffin) based laxatives is not recommended since mixing of these two will diminish the efficacy. Levothyroxine may bind to simeticone. Absorption of levothyroxine may be impaired if this drug is taken concurrently to treatment for thyroid disorders. |
Pregnancy And lactations | Medical advice should be sought prior to taking this product if pregnant. Studies in animals have revealed adverse effects on the foetus and there are no controlled studies in women. Drugs should be given only if the potential benefit justifies the potential risk to the foetus. |
Dosage And Administration | Chewable tablet: Chew thoroughly and swallow Oral suspension (drops): Shake well before using; may mix with 30 mL water, infant formula, or other liquids. For 125 mg Chewable Tab: Adults, elderly and children over 12 years: One tablet to be taken three or four times daily or as required, after meals and upon retiring. Maximum daily dose: Four tablets (500mg) in any 24 hours. Do not exceed the stated dose. Not to be taken by children under 12 years. For 40 mg and 80 mg chew tab: Children and adults >12 yr: 40 to 80 mg Children 2-12 yr: 40 mg 4 times daily after meals and at bedtime, as needed (maximum: 500 mg/day) |
OVERDOSE | In the event of deliberate or accidental overdosage, treat symptoms on appearance. There are no special procedures recommended. |
Storage Conditions | Maintains temperature below 20 To accommodate a large space for children |