TRITACE Tablet (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Tritace 1.25 mg Tablets or Ramipril 1.25mg Tablets

2. Qualitative and quantitative composition

Tablets. Each tablet contains ramipril 1.25 mg. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Tablets 1.25mg. White to almost white oblong tablet with dimensions of 8 4 mm with score-line. Upper stamp: 1.25 & logo ( ) Lower stamp: HMN & 1.25 The score-line is only to facilitate breaking for ease ...

4.1. Therapeutic indications

Treatment of hypertension. Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease ...

4.2. Posology and method of administration

Posology It is recommended that TRITACE is taken each day at the same time of the day. TRITACE can be taken before, with or after meals, because food intake does not modify its bioavailability (see section ...

4.3. Contraindications

Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or any other ACE (Angiotensin Converting Enzyme) inhibitors. History of angioedema (hereditary, idiopathic or due ...

4.4. Special warnings and precautions for use

Special populations Pregnancy ACE inhibitors such as ramipril or Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. Unless continued ACE inhibitor/AIIRAs therapy is ...

4.5. Interaction with other medicinal products and other forms of interaction

Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated ...

4.6. Pregnancy and lactation

Pregnancy TRITACE is not recommended during the first trimester of pregnancy (see section 4.4) and is contraindicated during the second and third trimesters of pregnancy (see section 4.3). Epidemiological ...

4.7. Effects on ability to drive and use machines

Some adverse effects (e.g. symptoms of a reduction in blood pressure such as dizziness) may impair the patients ability to concentrate and react and, therefore, constitute a risk in situations where these ...

4.8. Undesirable effects

Summary of safety profile The safety profile of ramipril includes persistent dry cough and reactions due to hypotension. Serious adverse reactions include angioedema, hyperkalaemia, renal or hepatic impairment, ...

4.9. Overdose

Symptoms Symptoms associated with overdose of ACE inhibitors may include excessive peripheral vasodilation (with marked hypotension, shock), brady cardia, electrolyte disturbances and renal failure. Management ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: ACE Inhibitors, plain ATC code: C09AA05 Mechanism of action Ramiprilat, the active metabolite of the prodrug ramipril, inhibits the enzyme dipeptidylcarboxypeptidase ...

5.2. Pharmacokinetic properties

Absorption Following oral administration ramipril is rapidly absorbed from the gastrointestinal tract: peak plasma concentrations of ramipril are reached within one hour. Based on urinary recovery, the ...

5.3. Preclinical safety data

Oral administration of ramipril has been found to be devoid of acute toxicity in rodents and dogs. Studies involving chronic oral administration have been conducted in rats, dogs and monkeys. Indications ...

6.1. List of excipients

Hypromellose Pregelatinised maize starch Microcrystalline cellulose Sodium stearyl fumarate

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Packs of 14, 15, 20, 28, 30, 50, 90, 98, 100 tablets in PVC/Alu blisters. 500 tablets in brown type III (Ph. Eur.) glass bottle with HDPE screw cap. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Aventis Pharma Ltd., 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Or trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

8. Marketing authorization number(s)

PL 04425/0356

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 30th September 2003 Date of latest renewal: 31st March 2012

10. Date of revision of the text

04 June 2021

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