TRIVERAM Film-coated tablet Ref.[107808] Active ingredients: Amlodipine Atorvastatin Atorvastatin, Amlodipine and Perindopril Perindopril

Posology

The usual posology is one tablet 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.

Co-administration with other medicines (see sections 4.4 and 4.5)

In patients taking hepatitis C antiviral agents elbasvir/grazoprevir or letermovir for cytomegalovirus infection prophylaxis concomitantly with Triveram the dose of atorvastatin in Triveram should not exceed 20 mg/day.

Use of Triveram is not recommended in patients taking letermovir coadministered with ciclosporin.

Renal impairment (see section 4.4)

Triveram can be administered in patients with creatinine clearance 60mL/min, and is not suitable for patients with creatinine clearance <60mL/min. In these patients, an individual dose titration with the monocomponents is recommended.

Elderly (see sections 4.4 and 5.2)

Elderly can be treated with Triveram according to the renal function.

Hepatic impairment (see sections 4.3, 4.4 and 5.2)

Triveram should be used with caution in patients with hepatic impairment. Triveram is contraindicated in patients with active liver disease.

Paediatric population

The safety and efficacy of Triveram in children and adolescents have not been established. No data are available. Therefore, use in children and adolescents is not recommended.

Method of administration

Oral use.

Triveram tablet should be taken as a single dose once daily in the morning before a meal.

There is no information on overdose with Triveram in humans.

Atorvastatin

Symptoms and Management

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.

Perindopril

Symptoms

Symptoms associated with overdosage of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough.

Management

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.

Amlodipine

In humans experience with intentional overdose is limited.

Symptoms

Available data suggest that gross overdosage could result in excessive peripheral vasodilatation and possibly reflex tachycardia. Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported.

Non-cardiogenic pulmonary oedema has rarely been reported as a consequence of amlodipine overdose that may manifest with a delayed onset (24-48 hours post-ingestion) and require ventilatory support. Early resuscitative measures(including fluid overload) to maintain perfusion and cardiac output may be precipitating factors.

Management

Clinically significant hypotension due to amlodipine overdosage calls for active cardiovascular support including frequent monitoring of cardiac and respiratory function, elevation of extremities and attention to circulating fluid volume and urine output. A vasoconstrictor may be helpful in restoring vascular tone and blood pressure, provided that there is no contraindication to its use. Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade. Gastric lavage may be worthwhile in some cases. In healthy volunteers the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of amlodipine. Since amlodipine is highly protein-bound, dialysis is not likely to be of benefit.

2 years.

Tablets are stable 30 days after opening in the 30-tablet polypropylene container.

PP Container: Store below 30°C.

Keep the container tightly closed in order to protect from moisture.

30 film-coated tablets in polypropylene tablet container closed with a LDPE stopper. The stopper contains a desiccant. 10/5/5 mg tablet container contains a LDPE flow reducer.

Box of 30 film-coated tablets.

No special requirements for disposal.