Laceran tablets are prescribed for the following indications:
Treatment of arterial hypertension. Prevention of cardiovascular diseases. Treatment of kidney disease. Treatment of symptomatic heart failure. Secondary prevention after acute myocardial infarction.
Composition
Active ingredient: ramipril;
1 tablet contains 2.5 mg, 5 mg or 10 mg of ramipril;
Excipients: lactose, corn starch, croscarmellose sodium, sodium bicarbonate, sodium stearyl fumarate; 2.5 mg tablets - iron oxide yellow (E172) 5 mg tablets - iron oxide red (E172), iron oxide yellow (E172).
Contraindication
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to other ACE inhibitors. History of angioedema (hereditary, idiopathic or previously treated with ACE inhibitors or angiotensin II receptor antagonists). Significant bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. Pregnant women and women planning to become pregnant. Arterial hypotension or haemodynamically unstable conditions. Concomitant use of Laceran with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal dysfunction (GFR less than 60 ml/min/1.73 m2). Concomitant use with sacubitril/valsartan. Treatment with Laceran should not be started until 36 hours after the last dose of sacubitril/valsartan. The concomitant use of ACE inhibitors and extracorporeal treatments that result in blood contact with negatively charged surfaces should be avoided.
Method of application
Drug for oral use.
It is recommended to take Laceran at the same time every day. The drug can be taken before, during, and after meals, as food does not affect the bioavailability of the drug. Laceran tablets should be swallowed whole with water. They should not be chewed or crushed.
If it is impossible to use the prescribed dose, ramipril should be used in the appropriate dosage.
Application features
Pregnant women
Contraindicated.
Children
Not recommended for use.
Drivers
With caution.
Overdose
Symptoms associated with an overdose of the drug may include: excessive peripheral vasodilation (with pronounced hypotension, shock), bradycardia, electrolyte imbalance and renal failure. The patient's condition should be carefully monitored and symptomatic and supportive therapy should be administered. The proposed therapeutic measures include primary detoxification (gastric lavage, administration of adsorbents), as well as measures aimed at restoring stable hemodynamics, including the administration of alpha-1 adrenoceptor agonists or angiotensin II (angiotensinamide). Ramiprilat, the active metabolite of ramipril, is poorly removed from the systemic circulation by hemodialysis.
Side effects
The safety profile of Laceran includes persistent cough and hypotension-related reactions. Serious adverse reactions include angioedema, hyperkalemia, hepatic or renal impairment, pancreatitis, severe skin reactions, and neutropenia/agranulocytosis.
Interaction
Concomitant use of Laceran with drugs containing aliskiren is contraindicated in patients with diabetes mellitus or renal dysfunction (GFR less than 60 ml/min/1.73 m2).
Concomitant use with sacubitril/valsartan is contraindicated. Treatment with Laceran should only be started 36 hours after the last dose of sacubitril/valsartan.
The concomitant use of ACE inhibitors and extracorporeal treatments that result in blood contact with negatively charged surfaces should be avoided.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Store in original packaging to protect from moisture.
Shelf life - 2 years.
