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

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

LENOLAX ENEMA

COMPOSITION:
Each 1 mL contains:

Sodium Phosphate Dodecahydrate equivalent to
Sodium Phosphate Heptahydrate	60,0 mg
Sodium Acid Phosphate Dihydrate equivalent to
Sodium Acid Phosphate Monohydrate	160,0 mg
Preservatives:
Methyl Hydroxybenzoate	0,048 % m/v
Sodium Benzoate	0,100 % m/v

This product contains 217,3 millimoles of sodium per 135 mL dose.

PHARMACOLOGICAL CLASSIFICATION:
A 11.5 Medicines acting on the gastro-intestinal tract: Laxatives

PHARMACOLOGICAL ACTION:
Agents which act by their osmotic properties, thus increasing stimulation of fluid secretion, thereby promoting bowel movements.

INDICATIONS:
Relief of occasional constipation, Pre-operative emptying of the bowel.

CONTRA-INDICATIONS:
Sensitivity to the ingredients.
Should not be administered to patients with severely impaired renal function or hyperphosphataemia.
Do not use in patients with megacolon, as hypernatremic dehydration may occur.

WARNINGS:
Do not use when nausea, vomiting or abdominal pain is present.
Frequent or prolonged use of this preparation may result in dependence on laxatives and loss of normal bowel function.
No laxative should be used for longer than one week except on the advice of a doctor.
If you have noticed a sudden change in bowel habits that has persisted for a period greater than 2 weeks, consult a doctor before using the laxative.
Rectal bleeding or failure to have a bowel movement after use of a laxative may indicate a serious condition. Discontinue use and consult a doctor.
Do not use this product unless directed by a doctor.
This product contains 217,3 millimoles of sodium per 135 mL dose. If you are on a low salt diet, have a kidney disease, or suffer from high blood pressure, do not use this product except under the supervision of a doctor.

DOSAGE AND DIRECTIONS FOR USE:
This product generally produces bowel movement in 2 to 15 minutes.
Do not administer to children under 2 years of age unless directed by a doctor.

Adults and children 12 years of age and over:	The contents of one (adult) bottle (135 mL).
Children 2 to under 12 years of age:	The contents of one (paediatric) bottle (64 mL).

May be used at room temperature or as directed by the physician. For best results place the patient on left side with knees bent, or in knee-chest position. Remove cover from rectal tube by holding bottle at neck and lifting off. Lubricate tip of tube with suitable lubricant (vaseline or other suitable substance). Insert tube in the rectum. Squeeze bottle gently until desired quantity has been given. The patient should remain in this position until urge to evacuate is strong - usually within 2 - 5 minutes.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Excessive use may cause hyperphosphataemia, which may lead to the development of hypocalcaemia, and atopic calcification - due to precipitation of calcium phosphate.
Nausea, vomiting, diarrhoea and abdominal pain have been reported.
Hyperphosphataemia and hypocalcaemia has occurred in children after the use of phosphate enemas.
Sodium salts should be used cautiously in patients with cardiac failure, hypertension, impaired renal function, peripheral and pulmonary oedema and in toxaemia of pregnancy.
Sodium "excess" may take two forms. The first is a rise in extracellular concentration (hypernatraemia) and the second form is too much sodium and water in the body without change in extracellular concentration. Symptoms of hypernatraemia may include restlessness, weakness, thirst, reduced salivation and lachrymation, swollen tongue, flushing of the skin, pyrexia, dizziness, headache, oliguria, hypotension, tachycardia, delirium, hyperpnoea and respiratory arrest.
Retention of sodium and water leads to the accumulation of extracellular fluid (oedema). This may effect the cerebral, pulmonary, or peripheral circulations. It is the consequence of heart failure, renal failure, increased adrenocortical activity, the administration of corticosteroids, or excessive administration of sodium after operation or injury (when there is a renal restriction on sodium excretion).

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions".
Treatment is symptomatic and supportive.

IDENTIFICATION:
A clear, colourless aqueous solution, free of particulate matter.

PRESENTATION:
Adult (135 mL) and Paediatric (64 mL) in disposable plastic bottles.

STORAGE INSTRUCTIONS:
Store below 25°C. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
E/11.5/819

NAME AND ADDRESS OF APPLICANT:
Pharmacare Limited, 7 Fairclough Road, Korsten, PORT ELIZABETH 6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
8 December 1995

        G546
        KOHLER C&P P.E

Updated on this site: April 2005
Source: Hospital Pharmacy
SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2005