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

Logo ALKAFIZZ Effervescent Granules

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

ALKAFIZZ Effervescent Granules

COMPOSITION:
Each 4 g contains
Sodium citrate         0,613 g
Sodium bicarbonate         1,716 g
Citric acid anhydrous         0,702 g
Tartaric acid         0,858 g

PHARMACOLOGICAL CLASSIFICATION:
A 18.3 Medicines acting on genito-urinary system - Ion exchange preparations.

PHARMACOLOGICAL ACTION:
ALKAFIZZ
has gastric antacid as well as urinary alkalinising properties.

INDICATIONS:
ALKAFIZZ is a gastric antacid and urinary alkalinising agent.

CONTRA-INDICATIONS:
ALKAFIZZ
should not be administered to patients with severe renal disease and metabolic disturbances with alkalosis, hypocalcaemia or hypochlorhydria.
ALKAFIZZ should not be administered with urinary tract antiseptics which require an acid urine, such as methanamine mandelate and methanamine hippurate.

WARNINGS:
ALKAFIZZ 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 with an antacid by patients with compromised renal function may result in the absorption of dangerously high amounts of aluminium.
Patients suffering from congestive cardiac failure and hypertension should not use ALKAFIZZ except under the advice and supervision of a doctor.

DOSAGE AND DIRECTIONS FOR USE:
60 g, 100 g & 120 g bottles
ADULTS:
One to two medicine measurefuls (4 to 8 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.
CHILDREN: (6 - 12 years)
One medicine measureful (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.

30 x 4 g sachets
ADULTS:
One to two sachets in half a glass of water, 2 or 3 times daily, taken on an empty stomach and followed with additional water. Drink after effervescence.
CHILDREN: (6 - 12 years)
One sachet in half a glass of water, 2 or 3 times daily, taken on an empty stomach and followed with additional water. Drink after effervescence.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Abdominal distention, flatulence, belching and nausea may occur if ALKAFIZZ is taken before effervescence is complete.
Excessive administration of ALKAFIZZ may lead to metabolic alkalosis in patients with impaired renal function. Symptoms may include shortness of breath, muscle weakness and mental disturbances such as restlessness, convulsions and coma.
Muscle hypertonicity, twitching and tetany may develop especially in hypocalcaemic patients. Excessive doses may lead to sodium overloading and hyperosmolality with resulting oedema and possible effect on the cerebral, pulmonary or peripheral circulations. Stomach cramps may occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Refer to "SIDE EFFECTS AND SPECIAL PRECAUTIONS".
Treatment is symptomatic and supportive and consists mainly of correction of fluid and electrolyte balance. Consult a doctor in known cases of overdosage.

IDENTIFICATION:
White granules with a lemon odour and a sweet/sour slightly lemon taste. After reconstitution with water a clear colourless solution with a slight lemon odour is obtained.

PRESENTATION:
ALKAFIZZ
Effervescent Granules is available in clear glass bottles with screw cap, and dosage measure, each bottle containing 60 g, 100 g or 120 g of effervescent granules and ALKAFIZZ Effervescent Granules is available in a carton containing 30 x 4 g sachets.

STORAGE INSTRUCTIONS:
Store in a cool (below 25°C), dry place.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
29/18.3/0378

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Xeragen Laboratories (Pty) Ltd.
8-11 Glen Park Industrial
Highdale Road
GLEN ANIL
4051

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
17 December 1996

Updated on this site: May 2004
Source: Pharmaceutical Industry

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