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ZESTRIL Tablet (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Zestril 5 mg, 10 mg, and 20 mg tablets.

Qualitative and quantitative composition

Each tablet contains lisinopril dihydrate equivalent to 5 mg, 10 mg, or 20 mg anhydrous lisinopril. For the full list of excipients, see section 6.1.

Pharmaceutical form

5 mg tablets: round, pink, uncoated, biconvex tablet with ♥ 5 on one side and bisected on the other side. Diameter 6 mm. The tablet can be divided into equal doses. 10 mg tablets: round, pink, uncoated, ...

Therapeutic indications

Hypertension: Treatment of hypertension. Heart failure: Treatment of symptomatic heart failure. Acute myocardial infarction: Short-term (6 weeks) treatment of haemodynamically stable patients within 24 ...

Posology and method of administration

Zestril should be administered orally in a single daily dose. As with all other medication taken once daily, Zestril should be taken at approximately the same time each day. The absorption of Zestril tablets ...

Contraindications

Hypersensitivity to Zestril, to any of the excipients listed in section 6.1 or any other angiotensin converting enzyme (ACE) inhibitor. History of angioedema associated with previous ACE inhibitor therapy. ...

Special warnings and precautions for use

Symptomatic hypotension Symptomatic hypotension is seen rarely in uncomplicated hypertensive patients. In hypertensive patients receiving Zestril, hypotension is more likely to occur if the patient has ...

Interaction with other medicinal products and other forms of interaction

Antihypertensive agents When Zestril is combined with other antihypertensive agents (e.g. glyceryl trinitrate and other nitrates, or other vasodilators), additive falls in blood pressure may occur. Clinical ...

Pregnancy and lactation

Pregnancy The use of ACE inhibitors is not recommended during the first trimester of pregnancy (see section 4.4). The use of ACE inhibitors is contra-indicated during the second and third trimester of ...

Effects on ability to drive and use machines

When driving vehicles or operating machines it should be taken into account that occasionally dizziness or tiredness may occur.

Undesirable effects

The following undesirable effects have been observed and reported during treatment with Zestril and other ACE inhibitors with the following frequencies: Very common (≥1/10), common (≥1/100 to <1/10), uncommon ...

Overdose

Limited data are available for overdose in humans. Symptoms associated with overdosage of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Angiotensin-converting enzyme inhibitors ATC code: C09AA03 Mechanism of Action Zestril is a peptidyl dipeptidase inhibitor. It inhibits the angiotensin-converting enzyme (ACE) ...

Pharmacokinetic properties

Lisinopril is an orally active non-sulphydryl-containing ACE inhibitor. Absorption Following oral administration of lisinopril, peak serum concentrations occur within about 7 hours, although there was ...

Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of general pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential. Angiotensin-converting enzyme ...

List of excipients

Mannitol Calcium hydrogen phosphate dihydrate Red iron oxide (E172) Maize starch Pregelatinised starch Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

4 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

<u>5 mg Tablets:</u> Aluminium/PVC-PVDC or Aluminium/PVC foil blister packs of 14, 20, 28, 28x1, 30, 42, 50, 56, 60, 84, 98, 100, 400 and 500 tablets. Aluminium/PVC-PVDC or Aluminium/PVC foil blister calendar ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK

Marketing authorization number(s)

5 mg: PL 17901/0061 10 mg: PL 17901/0062 20 mg: PL 17901/0063

Date of first authorization / renewal of the authorization

Date of first authorisation: 8 June 2000 Date of first renewal: 1 August 2010

Date of revision of the text

5<sup>th</sup> October 2017

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