Citrogran 4 g Effervescent granules

CITROGRAN is indicated as a gastric antacid and urinary alkalinising agent. As a urinary alkaliniser, CITROGRAN can be used to alleviate symptoms associated with inflammatory conditions of the bladder. CITROGRAN can be used to prevent crystalluria during sulphonamide treatment.

Posology
Adults: One to two 5 mL medicine measures (4 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 (see section 4.8).
Long-term therapy: One 5 mL (4 g) medicine measure daily.
Paediatric population
Children (6 - 12 years): One 5 mL medicine measure (4 g) in half a glass of cold water, 2 or 3 times daily, taken on an empty stomach and followed with additional water. Drink after effervescence (see section 4.8).
Method of administration
Take on an empty stomach, followed with additional water. Drink after effervescence.

CITROGRAN is contraindicated in:
u2022 Patients with known hypersensitivity to sodium bicarbonate, citric acid, sodium citrate, tartaric acid or to any of the excipients used in the formulation of CITROGRAN (see section 6.1).
u2022 In patients with severe renal disease and metabolic disturbances with alkalosis, hypocalcaemia or hypochlorhydria.
u2022 When co-administered with urinary tract antiseptics which require acid urine, such as methenamine mandelate and methenamine hippurate. (see section 4.5).

In patients suffering from renal insufficiency, CITROGRAN effervescent granules should be used with caution. Alkalinising agents may temporarily relieve lower urinary tract symptoms but they do not eliminate bacteriuria. In patients with compromised renal function, concurrent use of CITROGRAN effervescent granules with an antacid may result in the absorption of dangerously high amounts of aluminium (see section 4.5). Patients that suffer from hypertension and congestive cardiac failure should not use CITROGRAN effervescent granules, except under the advice and supervision of a doctor. To avoid the condition of metabolic alkalosis, patients with renal abnormalities and patients with peptic ulceration should use CITROGRAN with caution. To ensure that acid-base balance is maintained, patients with renal disease should have periodic determinations of serum electrolytes. Patients on a sodium-restricted diet should not take CITROGRAN. In patients with cirrhosis of the liver, pre-eclampsia, peripheral and pulmonary oedema caution should also be taken.
Liquid Glucose CITROGRAN contains liquid glucose. Patients with rare glucose-galactose malabsorption should not take this medicine.

CITROGRAN effervescent granules should not be administered with urinary tract antiseptics which require acid urine, such as methenamine hippurate and methenamine mandelate (see section 4.3).
Antacids: Systemic alkalosis may occur with concurrent use of antacids and citrates. In patients with uric acid stones, simultaneous administration of antacids with sodium bicarbonate and sodium citrate may promote the development of calcium stones and may also cause hypernatraemia.
Concomitant use of citrate salts in CITROGRAN effervescent granules with aluminium-containing antacids, especially by patients with compromised renal function, may result in the absorption of dangerously high amounts of aluminium (see section 4.4).
Quinolones: The solubility of ciprofloxacin, norfloxacin, or ofloxacin in the urine may be reduced by citrates. Patients should be monitored for signs of nephrotoxicity and crystaluria.
Salicylates: Simultaneous use of salicylates with citrates may decrease the therapeutic effects of salicylates by increasing the urinary excretion of salicylates due to urine alkalinisation.
Tetracyclines: Due to the increase in intragastric pH, a decrease in tetracycline absorption may occur when it is used simultaneously with sodium bicarbonate. CITROGRAN should not be taken within 1 to 2 hours of tetracyclines.
Ketoconazole: Simultaneous use with sodium bicarbonate may result in a marked reduction in absorption of ketoconazole due to the increased gastrointestinal pH caused by sodium bicarbonate. Patients should take CITROGRAN at least 2 hours after ketoconazole.
Methenamine: Sodium bicarbonate and citrates alkalinises the urine, which may inhibit the conversion of methenamine to formaldehyde, resulting in a reduction of efficacy; simultaneous use with CITROGRAN is therefore not recommended.

Pregnancy: Safety of citrates, and therefore CITROGRAN in pregnancy has not been established.
Breastfeeding: Caution should be exercised when administered to a breastfeeding mother.

None known.

Summary of adverse reactions
The following adverse reactions have been classified according to the following categories, frequent, less frequent and frequency unknown.
Metabolism and nutrition disorders:
Less frequent: Increased thirst. Hypernatraemia (fast heartbeat, dizziness, high blood pressure, muscle twitching, irritability, seizures, restlessness, swelling of feet or lower legs, weakness) may occur.
Frequency unknown: Metabolic alkalosis (muscle weakness, shortness of breath and mental disturbances such as restlessness, convulsions and coma) may occur especially in patients with renal impairment. Excessive doses may lead to sodium overloading and hyperosmolality.
Gastrointestinal disorders:
Less frequent: Stomach cramps and laxative effect (loose bowel movements or diarrhoea) may occur.
Frequency unknown: Abdominal distension, belching, flatulence and nausea may occur if CITROGRAN is taken before effervescence is complete.
Musculoskeletal, connective tissue and bone disorders:
Frequency unknown: Muscle hypertonicity, twitching and tetany may develop, 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. Health care 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 and to Cipla Medpro (Pty) Ltd at [email protected] or telephone 080 222 6662 (toll free).

Overdosage may result in hypernatraemia and metabolic alkalosis (see section 4.8). Treatment is symptomatic and supportive and consists mainly of correction of fluid and electrolyte balance with complete withdrawal of the preparation. A doctor should be consulted in known cases of overdosage. Electrolyte estimations should be taken regularly and the necessary treatment provided.