Citro-Soda Cranberry 4 g Granules.

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

Posology
Do not exceed the prescribed dose
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.
Long-term therapy: One 5 ml (4 g) medicine measure daily.
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.

Method of administration
Oral. Drink after effervescence.

• Hypersensitivity to sodium bicarbonate, tartaric acid, citric acid, sodium citrate or any of the ingredients in the preparations listed in section 6.1.
• Patients with severe renal disease, metabolic disturbances with alkalosis, hypocalcaemia or hypochlorhydria.
• CITRO-SODA CRANBERRY should not be given with urinary antiseptics which require acidic urine, such as methenamine mandelate and methenamine hippurate (see u2018 section 4.5).

CITRO-SODA CRANBERRY

• Phenylketonurics: CITRO-SODA Cranberry contain phenylalanine.
• Use with care in patients suffering from renal insufficiency.
• Do not use this product if you are suffering from congestive cardiac failure or hypertension except under the advice and supervision of a doctor (see section 4.8).
• Alkalinising agents do not eradicate bacteriuria although they may temporarily relieve lower urinary tract symptoms.

Citric Acid:

• Citric acid ingested frequently or in large quantities may cause erosion of the teeth and have a local irritant action.

Sodium bicarbonate:

• Bicarbonate or bicarbonate-forming compounds should not be given to patients with respiratory alkalosis, hypocalcaemia, or hypochlorhydria.
• Caution should be used in patients with peptic ulceration and patients with renal abnormalities, to avoid the condition of metabolic alkalosis.
• Sodium-containing salts should be given with extreme caution to patients with heart failure, oedema, renal impairment, hypertension, eclampsia, or aldosteronism.
• 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.
• CITRO-SODA CRANBERRY contains liquid glucose which may have an effect on the glycaemic control of patients with diabetes mellitus.
• CITRO-SODA CRANBERRY contains Aspartame. Aspartame is hydrolysed in the gastrointestinal tract when orally ingested. One of the major hydrolysis products is phenylalanine.

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.

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. CITRO-SODA CRANBERRY 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 CITRO-SODA CRANBERRY 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 CITRO-SODA CRANBERRY is not recommended.

Barbiturates
Alkalinisation of the urine leads to increased renal clearance of acidic medicines such as barbiturates.

Lithium
Sodium bicarbonate enhances lithium excretion.

Pregnancy
The safety of CITRO SODA CRANBERRY in pregnancy and lactation has not been established.

Breastfeeding
Caution should be exercised when administered to a nursing mother.

Fertility
The effects of CITRO SODA CRANBERRY in the fertility of males and females has not yet been established.

None known.

Frequency
System organ class
Undesirable effects

• Less Frequent
• Gastrointestinal disorders
  • Stomach cramps and laxative effect (diarrhoea or loose bowel movements).
• 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).
• Gastrointestinal disorders
  • Abdominal distension, flatulence, belching and nausea may occur if the product is taken before effervescence is complete.
  • Violent vomiting, diarrhoea and abdominal pain may occur if product is ingested undiluted.

Frequency Unknown
Metabolism and nutrition disorders

• Metabolic alkalosis (shortness of breath, muscle weakness and mental disturbances such as restlessness, convulsions and coma) may occur especially in patients with renal dysfunction.
• Alkalosis may precipitate seizures.
• Hypokalaemia (mood changes, tiredness, slow breathing, muscle weakness, and irregular heartbeat).
• Excessive doses may lead to sodium overloading.

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 Med safety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRAu2019s website. Adverse Drug Reactions may also be reported to Adcock Ingram Limited using the following email: [email protected]

Overdosage may result in metabolic alkalosis and hypernatraemia. Alkalosis may precipitate seizures. Excessive use of bicarbonate or bicarbonate-forming compounds may lead to hypokalaemia. Symptoms include mood changes, tiredness, slow breathing, muscle weakness, and irregular heartbeat.

Excessive use of Tartaric acid: Strong solutions of tartaric acid are mildly irritant and if ingested undiluted may cause violent vomiting and diarrhoea, abdominal pain, and thirst. Cardiovascular collapse or acute renal failure may follow (see section 4.8). Symptomatic and supportive treatment should be instituted to correct fluid and electrolyte balance with complete withdrawal of the preparation. In these cases, regular electrolyte estimations should be taken and the necessary therapy instituted. During treatment of acidosis, frequent monitoring of serum-electrolyte concentrations and acid u2013 base status is essential.