TRINOMIA HARD CAPSULES 100MG/ 20MG/ 5MG [SIN15648P]

Product Info

TRINOMIA HARD CAPSULES 100MG/ 20MG/ 5MG

[SIN15648P]

V. Indications

Trinomia is indicated for the secondary prevention of cardiovascular events as substitution therapy in adult patients adequately controlled with the monocomponents given concomitantly at equivalent therapeutical doses.

VI Recommended Dosage

Adults

Patients who are currently controlled with equivalent therapeutical doses of acetylsalicylic acid, atorvastatin and ramipril can be directly switched to Trinomia capsules.

The initiation of treatment should take place under medical supervision.

For cardiovascular prevention, the target maintenance dose of Ramipril is 10 mg once daily.

Paediatric population

Trinomia is contraindicated in children and adolescents below 18 years of age.

Special populations

• Patients with renal impairment: Daily dose in patients with renal impairment should be based on creatinine clearance:
  

  • if creatinine clearance is ≥ 60 ml/min, the maximal daily dose of ramipril is 10 mg;

  • if creatinine clearance is between 30–60 ml/min, the maximal daily dose of ramipril is 5 mg;

  In patients in hemodialysis and/or with severe renal impairment (creatinine clearance < 30 ml/min) Trinomia is contraindicated.

• Patients with hepatic impairment: Trinomia should be administered with caution in case of hepatic impairment. Liver function tests should be performed before the initiation of treatment and periodically thereafter. Patients who develop any signs or symptoms suggestive of liver injury should have liver function tests performed. Patients who develop increased transaminase levels should be monitored until the abnormality(ies) resolve. Should an increase in transaminases of greater than 3 times the upper limit of normal (ULN) persist, withdrawal of Trinomia is recommended.

  In addition, the maximum daily dose of ramipril in this patients is 2.5 mg.

  In patients with severe or active hepatic impairment Trinomia is contraindicated.

• Elderly:
  In very old and frail patients, treatment should be started with caution because of greater chance of undesirable effects.

Co-adminstration with other medicines
In patients taking hepatitis C antiviral agents elbasvir/grazoprevir concomitantly with atorvastatin, the dose of atorvastatin should not exceed 20mg/day.

VIII Contraindications

• Hypersensitivity to the active substances, to any of the excipients, to other salicylates, to nonsteroidal anti-inflammatory drugs (NSAIDs), to any other ACE (Angiotensin Converting Enzyme) inhibitors or to tartrazine.

• Hypersensitivity to soya or peanut.

• In case of history of previous asthma attacks or other allergic reactions to salicylic acid or other nonsteroidal analgesics / anti-inflammatories.

• Acute gastric and enteric ulcers.

• Haemophilia and other bleeding disorders.

• Severe kidney and liver impairment.

• Patients in hemodialysis.

• Severe heart failure.

• Concomitant treatment with methotrexate at a dosage of 15 mg or more per week.

• Patients with nasal polyps associated to asthma induced or exacerbated by acetylsalicylic acid.

• Active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal.

• During pregnancy, lactation and in women of child-bearing potential not using appropriate contraceptive measures.

• Due to the risk of rhabdomyolysis, concomitant treatment with tipranavir or ritonavir.

• Due to the risk of rhabdomyolysis, concomitant treatment with ciclosporin.

• History of angioedema (hereditary, idiopathic or due to previous angioedema with ACE inhibitors or Angiotensin II receptor antagonists (AIIRAs).

• Extracorporeal treatments leading to contact of blood with negatively charged surfaces.

• Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney.

• Ramipril must not be used in patients with hypotensive or haemodynamically unstable states.

• Children and adolescents below 18 years of age. Risk of Reye syndrome exists in case of children under 16 years with fever, flu or chicken pox.

• Concomitant use of Trinomia with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²).

• In patients who are concomitantly treated with glecaprevir/pibrentasvir.