Saccheroi Syrup 135 mg Syrup

SACCHEROI SYRUP is indicated for use as an antacid in infants and children up to 10 years.

Posology
SHAKE THE BOTTLE BEFORE USE.
Take three to four times a day with water.
Children:
0 u2013 6 months: 7,5 ml (1u00bd medicine measuresful)
6 months u2013 1 year: 10 ml (2 medicine measuresful)
1 u2013 2 years: 15 ml (3 medicine measuresful)
3 u2013 5 years: 20 ml (4 medicine measuresful)
6 u2013 10 years: 30 u2013 35 ml (6 u2013 7 medicine measuresful)
Do not give more than three to four times per 24 hour period.
Do not give this medicine to babies with a body mass less than 2,5 kg (see section 4.3).
IF YOU MISS GIVING A DOSE, SKIP THE MISSED DOSE. DO NOT DOUBLE THE DOSES.
Do not use the maximum dosage of this product for more than two weeks, except under the advice and supervision of a doctor (see section 4.4).

Method of administration
For oral use only.

SACCHEROI SYRUP is contraindicated in:
u2022 patients with metabolic or respiratory alkalosis, hypocalcaemia or hypochlorhydria;
u2022 babies with a body mass less than 2,5 kg;
u2022 patients who are hypersensitive to sodium bicarbonate or to any of the excipients listed in section 6.1.

Do not use the maximum dosage of this product for more than two weeks, except under the advice and supervision of a doctor.
SACCHEROI SYRUP should be administered extremely cautiously to patients with congestive heart failure, oedema, renal impairment, cirrhosis of the liver or hypertension, aldosteronism, and to patients receiving corticosteroids.
Methyl paraben and propyl paraben may cause allergic reactions (possibly delayed).
This medicine contains 0,30824 ml of alcohol (ethanol 96 %) in each 5 ml. The small amount of alcohol in this medicine will not have any noticeable effects.
Contains sucrose. Patients with rare hereditary conditions such as fructose intolerance, glucose-galactose mal-absorption or sucrase-isomaltase insufficiency should not take SACCHEROI SYRUP.

Sodium bicarbonate may increase or decrease the effects of a number of medicines due to raising gastric pH and the alkalinisation of the urine.
Alkalinisation of the urine by sodium bicarbonate leads to increased renal clearance of acidic medicines such as salicylates, tetracyclines, barbiturates.
Alkalisation of the urine may also affect the elimination of sympathomimetics, anticholinergics, tricyclic antidepressants, H2-blockers, captopril and quinidine.
Lithium excretion is enhanced.
Most interactions can be avoided by taking antacids 2 hours before or after ingestion of other medicines.

Pregnancy
There is no data available on the effects of SACCHEROI SYRUP on pregnancy as this product is not intended for use during pregnancy.
Breastfeeding
There is no data available on the effects of SACCHEROI SYRUP on breastfeeding as this product is not intended for use during breastfeeding.
Fertility
There is no data available on the effects of SACCHEROI SYRUP on fertility.

Gastrointestinal disorders
Frequency unknown: Stomach cramps, flatulence and belching.
Reporting of suspected adverse reactions
Reporting of 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 providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

Excessive administration may lead to metabolic alkalosis, especially in patients with impaired renal function. Symptoms may include shortness of breath, muscle weakness, restlessness, convulsions and coma. Hyperkalaemia may occur in patients with renal failure. Muscle hypertonicity, twitching, and tetany may develop especially in hypocalcaemic patients. Treatment of metabolic alkalosis and hypernatraemia associated with sodium bicarbonate overdose consists mainly of appropriate correction of fluid and electrolyte balance. Replacement of calcium, chloride and potassium ions may be of particular importance. Excessive doses of sodium salts may also lead to sodium overloading and hyperosmolality.