ZESTRIL Tablet (2021)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
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
<u>5 mg tablets:</u> 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. <u>10 mg tablets:</u> round, ...
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 hours ...
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
<b>Pharmacotherapeutic group:</b> Angiotensin-converting enzyme inhibitors <b>ATC code:</b> C09AA03 Mechanism of Action Zestril is a peptidyl dipeptidase inhibitor. It inhibits the angiotensin-converting ...
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
Atnahs Pharma UK Limited, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom
Marketing authorization number(s)
5 mg: PL 43252/0031 10 mg: PL 43252/0032 20 mg: PL 43252/0033
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
01/09/2021
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
