INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CITRO-SODA Granules
CITRO-SODA ORANGE Granules
CITRO-SODA ORANGE TABLETS Effervescent Tablets

SCHEDULING STATUS:
S0

PROPRIETARY NAME:
(and dosage form):

CITRO-SODA Granules
CITRO-SODA ORANGE Granules
CITRO-SODA ORANGE TABLETS Effervescent Tablets

COMPOSITION:
CITRO-SODA
Granules and CITRO-SODA ORANGE Granules:
Each 4 g contains:
Sodium bicarbonate         1716 mg
Tartaric acid         858 mg
Citric acid         702 mg
Sodium citrate         613 mg
Contains sugar.        

CITRO-SODA ORANGE TABLETS Effervescent Tablets:
Each tablet contains:
Sodium bicarbonate                1690 mg
Tartaric acid         856 mg
Citric acid         700 mg
Sodium citrate         612 mg
Contains sodium benzoate 1,55% m/m
Contains sugar. 

PHARMACOLOGICAL CLASSIFICATION:
A 18.3. Ion-exchange preparations

INDICATIONS:
CITRO-SODA
is a gastric antacid and urinary alkalinising agent.

CONTRA-INDICATIONS:
Patients with severe renal disease, metabolic disturbances with alkalosis, hypocalcaemia or hypochlorhydria.
CITRO-SODA should not be given with urinary antiseptics which require an acid urine, such as methenamine mandelate and methenamine hippurate.

WARNINGS:
PHENYLKETONURICS: CITRO-SODA ORANGE Granules AND CITRO-SODA ORANGE TABLETS Effervescent Tablets CONTAIN PHENYLALANINE.

INTERACTIONS:
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.

PREGNANCY AND LACTATION:
Pregnancy
Studies regarding the effect of citrates on pregnancy have not been done.
Nursing Mothers
Caution should be exercised when administered to a nursing mother.

DOSAGE AND DIRECTIONS FOR USE:
CITRO-SODA
Granules and CITRO-SODA ORANGE Granules:
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 (4 g) medicine measures daily.
Children (6 to 12 years of age):
One 5 mL medicine measures (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.

CITRO-SODA ORANGE TABLETS Effervescent Tablets:
Adults:
One or two effervescent tablets 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 tablet daily.
Children (6 to 12 years of age):
One effervescent tablet 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.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Abdominal distension, flatulence, belching and nausea may occur if the product is taken before effervescence is complete. Metabolic alkalosis may occur in patients with renal dysfunction. Hypernatraemia and laxative effect (diarrhoea or loose bowel movements) may occur.
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.
Alkalising agents do not eradicate bacteriuria although they may temporarily relieve lower urinary tract symptoms.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage may result in metabolic alkalosis. Symptomatic treatment should be instituted with complete withdrawal of the preparation.
In these cases, regular electrolyte estimations should be taken and the necessary therapy instituted.

IDENTIFICATION:
CITRO-SODA
Granules consist of sweetened lemon flavoured granules. When added to water it effervesces and dissolves to form a clear alkaline solution which is lemon flavoured.
CITRO-SODA ORANGE Granules consists of sweetened orange flavoured granules. When added to water it effervesces and dissolves to form an orange coloured alkaline solution which is orange flavoured.
CITRO-SODA ORANGE Tablets Effervescent Tablets are round, flat, bevel-edged, speckled orange tablets with no markings.

PRESENTATION:
CITRO-SODA
Granules:
Screw-top glass bottles containing 60 g, 100 g or 120 g and sachets containing 4 g.
CITRO-SODA ORANGE Granules:
Screw-top glass bottles containing 60 g, 100 g or 120 g and sachets containing 4 g.
CITRO-SODA ORANGE TABLETS Effervescent Tablets:
Tubes containing 10 tablets.

STORAGE INSTRUCTIONS:
Store in a cool (below 25°C), dry place.
Keep out of reach of children.

REGISTRATION NUMBER:
CITRO-SODA Granules                        E1031 (Act 101/1965)
CITRO-SODA ORANGE Granules         28/18.3/0372
CITRO-SODA ORANGE TABLETS Effervescent Tablets         28/18.3/0257

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext. 77
Private Bag x69,
Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
17 February 1998

New addition to this site: April 2004
Source: Pharmaceutical Industry

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