TRINOMIA HARD CAPSULES 100mg/ 20mg/ 10mg

DCH AURIGA SINGAPORE

DCH AURIGA SINGAPORE

Therapeutic

Prescription Only

CAPSULE

**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. **VII Mode/Route of administration** Trinomia hard capsules are for oral use. Trinomia should be taken orally as a single capsule per day, preferably after a meal. Trinomia has to be swallowed with liquid. It must not be chewed nor crushed before swallowing. The capsule must not be opened. The closure system guarantees the pharmacological properties of the active drugs. Avoid grapefruit juice when taking Trinomia.