Alkafizz Lemon Granules

ALKAFIZZ LEMON is indicated as a gastric antacid and urinary alkalinising agent. As a urinary alkaliniser, ALKAFIZZ LEMON can be used to alleviate symptoms associated with inflammatory conditions of the bladder. ALKAFIZZ LEMON can be used 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 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 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.

ALKAFIZZ LEMON is contraindicated in:

• Patients with known hypersensitivity to sodium bicarbonate, citric acid, sodium citrate, tartaric acid or to any of the excipients used in the formulation of ALKAFIZZ LEMON (see section 6.1)
• Patients with severe renal disease and metabolic disturbances with alkalosis, hypocalcaemia or hypochlorhydria.
• ALKAFIZZ LEMON should not be given with urinary tract antiseptics which require an acid urine, such as methanamine mandelate and methanamine hippurate.(see section 4.5).

ALKAFIZZ LEMON should be used with care in patients suffering from renal insufficiency. Alkalinising agents do not eradicate bacteriuria although they may temporarily relieve lower urinary tract symptoms. Concomitant use of ALKAFIZZ LEMON with an antacid by patients with compromised renal function may result in the absorption of dangerously high amounts of aluminium (see section 4.5). Patients suffering from congestive cardiac failure and hypertension should not use ALKAFIZZ LEMON except under the advice and supervision of a doctor. 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 to ensure that acid-base balance is maintained. Should not be taken by patients on a sodium-restricted diet. Caution should also be observed in patients with cirrhosis of the liver, congestive heart failure or hypertension, peripheral and pulmonary oedema and pre-eclampsia. Liquid Glucose ALKAFIZZ LEMON contains liquid glucose. Patients with rare glucose-galactose malabsorption should not take this medicine.

Antacids: Concurrent use of antacids with citrates may result in systemic alkalosis. Concomitant administration of antacids with sodium citrate and sodium bicarbonate 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 can increase aluminium absorption, possibly resulting in acute aluminium toxicity, especially in patients with renal insufficiency (see section 4.4).

Quinolones: Citrates may reduce the solubility of ciprofloxacin, norfloxacin, or ofloxacin in the urine. Patients should be observed for signs of crystalluria and nephrotoxicity.

Salicylates: Concurrent use of salicylates with citrates may increase the urinary excretion and decrease the therapeutic effects of salicylates due to alkalinization of the urine.

Tetracyclines: Tetracycline absorption may be decreased when it is used concurrently with sodium bicarbonate because of the increase in intragastric pH. ALKAFIZZ LEMON should not be taken within 1 to 2 hours of tetracyclines.

Ketoconazole: Sodium bicarbonate may cause increased gastrointestinal pH; concurrent administration with sodium bicarbonate may result in a marked reduction in absorption of ketoconazole; patients should take ALKAFIZZ LEMON at least 2 hours after ketoconazole.

Methenamine: Alkalinisation of the urine caused by sodium bicarbonate and citrates may reduce the effectiveness of methenamine by inhibiting its conversion to formaldehyde; concurrent use with ALKAFIZZ LEMON is not recommended.

Pregnancy Safety of citrates, and therefore ALKAFIZZ LEMON in pregnancy has not been established.

Breastfeeding: Caution should be exercised when administered to a breastfeeding mother.

None known.

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 dysfunction. Excessive doses may lead to sodium overloading and hyperosmolality with resulting oedema and possible effect on the cerebral, pulmonary or peripheral circulations.

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 ALKAFIZZ LEMON 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 metabolic alkalosis and hypernatraemia (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. In these cases, regular electrolyte estimations should be taken and the necessary therapy instituted.