Tritace Comp 5 mg/25 mg 14 tablets

Tritace Comp 5 mg/25 mg 14 tablets

Composition:

Ramipril 5 mg

Hydrochlorothiazide 25 mg

Inactive ingredients:

Hypromellose 

Pregelatinized maize starch

Microcrystalline cellulose

Sodium stearyl fumarate

Properties:

Pharmacotherapeutic group: ACE inhibitors and diuretics, ramipril and diuretics, ATC code C09BA05.

-Ramipril is an angiotensin-converting enzyme (ACE) inhibitor. It works by blocking a substance in the body that causes blood vessels to tighten. As a result, ramipril relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

-Hydrochlorothiazide is in a class of medications called diuretics (‘water pills’). It works by causing the kidneys to get rid of unneeded water and salt from the body into the urine.

Indications:

Treatment of essential hypertension.

This fixed dose combination is indicated in patients whose blood pressure is adequately controlled with ramipril and hydrochlorothiazide given at the same dose.

Dosage and administration:

-It is recommended that Tritace Comp is taken once daily, at the same time of the day, usually in the morning. 

-Tritace Comp can be taken before, with or after meals, because food intake does not modify its bioavailability

-Tritace Comp has to be swallowed with liquid. It must not be chewed or crushed.

-Adults:

The dose should be individualized according to the patient profile  and blood pressure control.

Tritace Comp 5 mg/ 25 mg tablets should be administered as one tablet once daily. The maximum permitted doses are 10 mg of ramipril and 25 mg of hydrochlorothiazide daily.

-Diuretic-treated patients:

In patients concurrently treated with diuretics, as hypotension may occur following initiation of the treatment, caution is recommended. Consideration must be given to reducing the diuretic dose or discontinuing the diuretic before starting treatment with Tritace.

-Severe Renal Impairment:

Tritace is contraindicated in severe renal impairment due to the hydrochlorothiazide component 

-Moderate Renal Impairment:

Patients with creatinine clearance levels between 30 and 60 ml/min should only be treated with the lowest fixed dose combination of ramipril and hydrochlorothiazide after administration of ramipril alone. The maximum permitted doses are 5 mg of ramipril and 25 mg of hydrochlorothiazide daily: therefore, Tritace tablets must not be used in patients with moderate renal impairment.

-Patients with Hepatic Impairment:

Mild or Moderate Hepatic Impairment:

In patients with mild to moderate hepatic impairment, treatment with ramipril and hydrochlorothiazide must be initiated only under close medical supervision and the maximum daily doses are 2.5 mg/25 and 12.5 mg of hydrochlorothiazide.

-Older people:

Initial doses should be lower and subsequent dose titration should be more gradual because of greater chance of undesirable effects especially in very old and frail patients.

-Pediatric population:

Tritace is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.

Side effects: 

-Serious:  angioedema or anaphylaxis

reaction, renal or hepatic impairment, pancreatitis, severe skin reactions and

neutropenia agranulocytosis;

-Syndrome of inappropriate antidiuretic hormone;

-Diabetes mellitus, Anorexia, Blood potassium decreased, Glycosuria,

glucose tolerance potassium decreased. increased metabolic alkalosis, decreased, blood thirst due to hydro-due to hypochloremia, glucose increased chlorothiazide ramipril hypomagnesaemia, blood uric acid Hypercalcaemia, increased, gout dehydration due to aggravated, blood hydrochlorothiazide cholesterol and/or triglycerides increased due to psychiatric disorders, Depressed mood, Confusional state, apathy, anxiety, restlessness, nervousness, disturbance, sleep disorders, Headache, Somnolence, Cerebral ischemia, dizziness, Vertigo, paraesthesia.

disorders tremor, balance including ischaemic disorder, burning stroke and transient sensation, dysgeusia ischaemic attack, ageusia psychomotor skills paired, parasomnia, Myocardial including angina pectoris, tachycardia, arrhythmia, palpitations, oedema, peripheral, Vascular disorders, Non-productive tickling cough, Sinusitis, dyspnoea, Bronchospasm, thoracic and nasal congestion including asthma, bronchitis, Pancreatitis, dyspepsia, gastritis, diarrhea, inhibitors, pancreatic nausea, constipation abdominal enzymes increased

Common: hepatic enzyme and /or bilirubin conjugated increase, cholecystitis due to hydrochlorothiazide, Stevens-Johnson syndrome, psoriasis, exanthema or enanthem, urticaria, Systemic lupus, erythematosus, Arthralgia, muscle and connective spasms, Muscular weakness, skeletal musculoskeletal stiffness, Fatigue, Chest pain, pyrexia

Contraindications:

-Hypersensitivity to the active substance or to any other ACE (Angiotensin Converting Enzyme) inhibitor, hydrochlorothiazide, other thiazide diuretics, sulfonamides;

-History of angioedema;

-Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney;

-During pregnancy; 

-Lactation; 

-Severe impairment of renal function; -Clinically relevant electrolyte disturbances;

-Severe impairment of liver function;

-Hepatic encephalopathy;

-The concomitant use of Tritace Comp with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment.

Warnings and precautions:

• Pregnancy:

Ramipril should not be used during pregnancy. Patients planning pregnancy should be changed to alternative antihypertensive treatments.

– Patients at risk of cardiac or cerebral ischemia in case of acute hypotension

The initial phase of treatment requires special medical supervision.

• Patients with liver disease:

Electrolyte disturbances due to diuretic therapy including hydrochlorothiazide may cause hepatic encephalopathy in patients with liver disease.

• Surgery:

It is recommended that treatment with ramipril should be discontinued where possible one day before surgery.

• Athletes:

Hydrochlorothiazide may produce a positive analytic result in the anti-doping test.

• Caution must be taken when concomitant use with such medicines:

-Antihypertensive agents 

-Vasopressor sympathomimetics 

-Allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics -Lithium salts

-Antidiabetic agents inducing insulin

-Nonsteroidal anti-inflammatory drugs and acetylsalicylic acid

-Oral anticoagulants

-Corticosteroids, ACTH

-Methyldopa

-Curare-type muscle relaxants

-Calcium salts and plasma calcium increasing medicine prodụcts

-Carbamazepine

-Penicillin

-Quinine

-Heparin

-Racecadotril

• Pregnancy:

Tntace is not recommended during the first trimester of pregnancy and contraindicated during the second and third trimesters of pregnancy.

When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately.

• Breastfeeding:

Tritace is contraindicated during breast-feeding. 

• Effects on ability to drive and use machines:

After the first dose or subsequent increases in dose it is not advisable to drive or operate machinery for several hours.

Storage:

Store at a temperature not exceeding 30°C

Package:

Carton box holds a blister pack of 14 tablets and an insert leaflet.