Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191
PHARMAPRESS CO is indicated for the treatment of hypertension in patients where fixed combination therapy is considered more appropriate than monotherapy.
The usual dose is one tablet, administered once daily. The dosage may be increased to a maximum of two tablets, administered once daily, if appropriate.
For patients with renal impairment, thiazides, including hydrochlorothiazide, as in PHARMAPRESS CO, may not be the appropriate diuretic for use and are ineffective at creatinine clearance values of 30 mL/min or below (i.e. moderate or severe renal insufficiency).
In any patient with renal insufficiency, PHARMAPRESS CO must not be used as initial therapy. PHARMAPRESS CO may be used in patients with creatinine clearance of >30 mL/min and <80 mL/min, but only after titration of the individual components (see section 4.3).
No data are available.
PHARMAPRESS CO is taken orally.
On the treatment of overdosage with PHARMAPRESS CO, no specific information is available. Treatment is symptomatic and supportive.
Therapy with PHARMAPRESS CO should be discontinued and the patient observed closely. Suggestive measures include induction of emesis, administration of activated charcoal, administration of a laxative if the ingestion is recent and/or gastric lavage, and correction of electrolyte imbalance, hypotension and dehydration, by established procedures introduced within 2 hours after ingestion.
Hypotension is the most prominent feature of overdosage, beginning some six hours after ingestion of tablets, concomitant with blockade of the renin-angiotensin system and stupor. Symptoms associated with overdosage of ACE inhibitors such as enalapril, as in PHARMAPRESS CO, may include circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough.
The recommended treatment of overdosage is intravenous infusion of normal saline solution. If hypotension occurs, the patient should be placed in the shock position. If available, treatment with angiotensin II infusion and/or intravenous catecholamines may also be considered. If ingestion is recent, take measures aimed at eliminating enalapril maleate, as in PHARMAPRESS CO (e.g. emesis, gastric lavage, administration of absorbents, and sodium sulphate). Haemodialysis may be used to remove enalapril, as in PHARMAPRESS CO from the general circulation.
Pacemaker therapy is indicated for therapy-resistant bradycardia. Vital signs, serum electrolytes and creatinine concentrations should be monitored continuously.
The most common signs and symptoms observed are those caused by electrolyte depletion (hypochloraemia, hypokalaemia, hyponatraemia) and from excessive diuresis, dehydration will result.
Cardiac dysrhythmias may be accentuated by hypokalaemia, if digoxin has also been administered.
24 Months.
Store at or below 25°C.
Protect from light.
Store in a dry place.
Keep the blisters in the carton until required for use.
28 or 30 tablets are packed in a matt silver polyamide, aluminium and polyvinylchloride film sealed with an aluminium foil backing. The blister strip is packed into an outer cardboard carton.
No special requirements.
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