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

Logo EFFERSOL® GRANULES

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

EFFERSOL® GRANULES

COMPOSITION:
Each 5 g contains:
  Sodium bicarbonate 2,550 g
  Citric acid 0,823 g

PHARMACOLOGICAL CLASSIFICATION:
A 18.3 Medicines acting on the genitourinary system. Ion-exchange preparations.

PHARMACOLOGICAL ACTION:
Effersol, renders the urine less acid.

INDICATIONS:
As a urinary alkaliniser. This is indicated when there is an excessively high concentration of acid in the urine.

CONTRA-INDICATIONS:
Should not be given with urinary antiseptics which require an acid urine, such as methenamine mandelate and methenamine hippurate.

WARNINGS:
Effersol is contra-indicated where sodium (salt) intake has been limited under medical advice.
Use with care in patients suffering from renal insufficiency. Alkalinizing agents do not eradicate bacteriuria although they may temporarily relieve lower urinary tract symptoms.
Concomitant use of Effersol with an antacid in patients with compromised renal function may result in the absorbtion of dangerously high amounts of aluminium.
Sodium bicarbonate should be administered extremely cautiously to patients with congestive heart failure, cirrhosis of the liver, or hypertension, and to patients receiving corticosteroids.

DOSAGE AND DIRECTIONS FOR USE:
Adults One to two medicine measures in half a glass of cold water after meals three times daily followed by aditional water. Drink after effervescence..
Children 6 - 12 years One medicine measure as above, three times daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Large doses may give rise to nausea, vomiting, diarrhoea and alkalosis.
Should symptoms persist, please consult a doctor.
Citric acid may cause erosion of the teeth and have a local irritant action.
Sodium bicarbonate may cause stomach cramps and flatulence.
It is recommended that sodium bicarbonate should not be administered to patients with metabolic or respiratory alkalosis, hypocalcaemia or hypochlorhydria.
Large doses of sodium bicarbonate may lead to metabolic alkalosis, especially 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 due to increased protein binding and renal reabsorption of calcium. Excessive doses may lead to sodium overloading and hyperosmolality.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side effects and special precautions.
Treatment is symptomatic and supportive and consists mainly of correction to fluid and electrolyte balance.
Consult a doctor in known cases of overdose.

IDENTIFICATION:
White granules.

PRESENTATION:
100 mL and 200 mL clear glass bottles containing 60 g and 120 g respectively.

STORAGE INSTRUCTIONS:
Store below 25°C. Keep container tightly closed to prevent absorption of moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
H/18.3/1629

NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
24


/08/1994
        G650B
        KOHLER C&P P.E.

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