Quatro-Soda Cranberry 4g Granules

QUATRO-SODA CRANBERRY is indicated:

• As a gastric antacid.
• As a urinary alkaliniser: to alleviate symptoms associated with inflammatory conditions of the bladder.
• To prevent crystalluria during sulphonamide treatment.

Posology

Adults: One to two 5 ml medicine measures (4 g to 8 g) in half a glass of cold water 3 to 4 times daily, taken on an empty stomach and followed with additional water. Drink after effervescence.

Long-term therapy: One 5 ml medicine measure (4 g) daily (see section 4.8).

Special populations

Paediatric population

Children (6 to 12 years of age): One 5 ml medicine measure (4 g) in half a glass of cold water, 2 to 3 times daily, taken on an empty stomach and followed with additional water. Drink after effervescence.

Method of administration

Oral use.

QUATRO-SODA CRANBERRY is contraindicated in:

• Patients with hypersensitivity to sodium bicarbonate, tartaric acid, citric acid, sodium citrate or to any of the excipients in QUATRO-SODA CRANBERRY (see section 6.1).
• Patients with metabolic disturbances with alkalosis, hypocalcaemia or hypochlorhydria.
• Patients taking urinary antiseptics which require an acid urine, such as methenamine mandelate, methenamine hippurate, hexamine mandelate or hexamine hippurate (see section 4.5).
• Patients with severe renal disease, renal failure or hypernatraemia.
• Patients with overt and occult cardiac failure.

Metabolic alkalosis

Caution should be used in patients with peptic ulceration and patients with renal abnormalities, to avoid the condition of metabolic alkalosis. Patients with renal disease should have periodic determinations of serum electrolytes and acid-base balance to ensure that acid-base balance is maintained.

General

Caution should be observed in patients with cirrhosis of the liver, impaired renal function, congestive heart failure or hypertension, peripheral and pulmonary oedema and pre-eclampsia (see section 4.3)

Bacteriuria

Alkalinising medicines, such as QUATRO-SODA CRANBERRY, do not eradicate bacteriuria although they may temporarily relieve lower urinary tract symptoms.

Excipients

QUATRO-SODA CRANBERRY contains sucrose and glucose which may have an effect on the glycaemic control of patients with diabetes mellitus. Patients with the rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take QUATRO-SODA CRANBERRY.

QUATRO-SODA CRANBERRY contains 613, 5 mg of sodium per 4 g, equivalent to 30 % of the WHO recommended daily intake of 2 g sodium for and adult.

Quinolones

Citrates, as in QUATRO-SODA CRANBERRY, may reduce the solubility of ciprofloxacin, norfloxacin or ofloxacin in the urine. Patients should be observed for signs of crystalluria and nephrotoxicity (see section 4.3).

Methenamine

Alkalinisation of the urine caused by sodium bicarbonate and citrates, as in QUATRO-SODA CRANBERRY, may reduce the effectiveness of methenamine by inhibiting its conversion to formaldehyde. Concurrent use with QUATRO-SODA CRANBERRY is contraindicated (see section 4.3).

Antacids

• Concurrent use of antacids with citrates, as in QUATRO-SODA CRANBERRY may result in systemic alkalosis.
• Concomitant administration of antacids with sodium citrate and sodium bicarbonate, as in QUATRO-SODA CRANBERRY, may promote the development of calcium stones in patients with uric acid stones and may also cause hypernatraemia.
• Concurrent use of aluminium-containing antacids with citrate salts, as in QUATRO-SODA CRANBERRY, can increase aluminium absorption, possibly resulting in acute aluminium toxicity, especially in patients with renal insufficiency.

Salicylates

Concurrent use of salicylates with citrates, as in QUATRO-SODA CRANBERRY, may increase the urinary excretion and decrease the therapeutic effects of salicylates due to alkalinisation of the urine.

Tetracyclines

Tetracycline absorption may be decreased when it is used concurrently with sodium bicarbonate, as in QUATRO-SODA CRANBERRY, because of the increase in intragastric pH. QUATRO-SODA CRANBERRY should not be taken within 1 to 2 hours of tetracyclines. Alkalisation of the urine by QUATRO-SODA CRANBERRY may therefore result in a decreased therapeutic effect of tetracyclines.

Ketoconazole

Sodium bicarbonate, as in QUATRO-SODA CRANBERRY, may cause increased gastrointestinal pH; concurrent administration with QUATRO-SODA CRANBERRY, may result in a marked reduction in absorption of ketoconazole. Patients should take QUATRO-SODA CRANBERRY at least 2 hours after ketoconazole.

Lithium

Alkalisation of the urine by QUATRO-SODA CRANBERRY may result in a decreased therapeutic effect of lithium.

Amphetamines/ephedrine/pseudoephedrine

Alkalinisation of the urine due to the use of QUATRO-SODA CRANBERRY may result in an increased effect of amphetamines and ephedrine/pseudoephedrine.

Chlorpropamide

Alkalisation of the urine by QUATRO-SODA CRANBERRY may result in a decreased therapeutic effect of chlorpropamide.

Laxatives

Concurrent administration of citrates, as in QUATRO-SODA CRANBERRY, with laxatives may have an additive effect.

Safety of QUATRO-SODA CRANBERRY in pregnancy and lactation has not been established.

Pregnancy

Studies regarding the effect of citrates, as in QUATRO-SODA CRANBERRY have not been done.

Breastfeeding

Caution should be exercised when administered to a nursing mother.

Fertility

No data available.

QUATRO-SODA CRANBERRY has negligible effect on the ability to drive or to use machines. However, patients should be alerted to the risk of metabolic alkalosis which could cause mental disturbances and hypernatraemia, which could cause dizziness. Patients should therefore not drive, use machinery or perform any tasks that require concentration, until they are certain that QUATRO-SODA CRANBERRY does not adversely affect their ability to do so (see section 4.8).

a) Tabulated list of adverse reactions

System organ class

Less frequent

Frequency unknown

Metabolism and nutrition disorders

Increased thirst, hypernatraemia (dizziness, fast heartbeat, high blood pressure, irritability, muscle twitching, restlessness, seizures, swelling of feet or lower legs, weakness)

Metabolic alkalosis (shortness of breath, muscle weakness and mental disturbances such as restlessness, convulsions and coma) especially in patients with renal dysfunction. Excessive doses may lead to sodium overloading, hyperosmolality

Gastrointestinal disorders

Stomach cramps, laxative effect (diarrhoea or loose bowel movements). Abdominal distension, flatulence, belching, nausea (may occur if the QUATRO-SODA CRANBERRY is taken before effervescence is complete see section 4.2);

Musculoskeletal and connective tissue disorders

Muscle hypertonicity, twitching, tetany (especially in hypocalcaemic patients).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to: SAHPRA: https://www.sahpra.org.za/health-products-vigilance/ Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088

Symptoms

Overdose may result in metabolic alkalosis and hypernatraemia (see section 4.8).

Treatment

Symptomatic and supportive treatment should be instituted to correct fluid and electrolyte balance with complete withdrawal of QUATRO-SODA CRANBERRY. In these cases, regular electrolyte estimations should be taken, and the necessary therapy instituted.