Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes Cedex, France
Lipercosyl is indicated as substitution therapy as part of cardiovascular risk management (see section 5.1), in adult patients adequately controlled with atorvastatin and perindopril given concurrently at the same dose level but as separate products.
The usual posology is one capsule once daily.
The fixed dose combination is not suitable for initial therapy.
If a change of posology is required, titration should be done with the individual components.
The patients should continue a standard cholesterol-lowering diet during treatment with Lipercosyl.
In patients taking tipranavir, ritonavir, telaprevir or ciclosporine concomitantly with Lipercosyl, the dose of atorvastatin in Lipercosyl should not exceed 10 mg/day (see sections 4.4 and 4.5).
In patients taking hepatitis C antiviral agents containing boceprevir, elbasvir/grazoprevir or letermovir for cytomegalovirus infection prophylaxis concomitantly with Lipercosyl, the dose of atorvastatin in Lipercosyl should not exceed 20 mg/day (see sections 4.4 and 4.5). Use of Lipercosyl is not recommended in patients taking letermovir co-administered with ciclosporin (see sections 4.4 and 4.5).
Lipercosyl can be administered in patients with creatinine clearance >60 mL/min, and is not suitable for patients with creatinine clearance <60 mL/min. In these patients, an individual dose titration with the monocomponents is recommended (see section 4.4).
Older people can be treated with Lipercosyl according to the renal function (see sections 4.4 and 5.2).
Lipercosyl should be used with caution in patients with hepatic impairment. Lipercosyl is contraindicated in patients with active liver disease (see sections 4.3, 4.4 and 5.2).
The safety and efficacy of Lipercosyl in children and adolescents have not been established. No data are available. Therefore, use in children and adolescents is not recommended.
Oral use.
Lipercosyl should be taken as a single dose once daily in the morning before a meal.
The capsules must not be chewed or broken.
There is no information on overdose with Lipercosyl in humans.
Specific treatment is not available for atorvastatin overdose. Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required. Liver function tests should be performed and serum CK levels should be monitored. Due to extensive atorvastatin binding to plasma proteins, haemodialysis is not expected to significantly enhance atorvastatin clearance.
Symptoms associated with overdosage of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough.
The recommended treatment of overdosage is intravenous infusion of sodium chloride 9 mg/mL (0.9%) 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. Perindopril may be removed from the general circulation by haemodialysis (see section 4.4). Pacemaker therapy is indicated for therapy-resistant bradycardia. Vital signs, serum electrolytes and creatinine concentrations should be monitored continuously
2 years.
Store in the original container in order to protect from moisture.
This medicinal product does not require any special temperature storage conditions.
30 hard capsules in a PP container closed with a LDPE stopper.
90 (3x30) hard capsules in 3 PP containers closed with a LDPE stopper.
100 hard capsules in a HDPE bottle closed with a PP stopper.
Not all pack sizes may be marketed.
No special requirements for disposal.
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