Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Πρόγραμμα συνδρομητών Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του galinos.gr από το 2011 μέχρι σήμερα
 

SPC, UK: ACCUPRO Film-coated tablets (2018)

Αναφορές

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

Περιεχόμενα

Name of the medicinal product

Accupro 10 mg film-coated tablets.

Qualitative and quantitative composition

10 mg quinapril (as 10.832 mg quinapril hydrochloride). Excipient(s) with known effect: Lactose, 72 mg per tablet. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. Reddish-brown, triangular, film-coated tablets, scored on both sides and 10 debossed on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide ...

Therapeutic indications

For the treatment of all grades of essential hypertension. Accupro is effective as monotherapy or concomitantly with diuretics in patients with hypertension (see sections 4.3, 4.4, 4.5 and 5.1). For the ...

Posology and method of administration

Posology Adults Hypertension Monotherapy: The recommended initial dosage is 10 mg once daily in uncomplicated hypertension. Depending upon clinical response, patients dosage may be titrated (by doubling ...

Contraindications

Accupro is contraindicated: In patients with hypersensitivity to the active substance or to any of the excipients listed in section 6.1. In the second and third trimesters of pregnancy (see sections 4.4 ...

Special warnings and precautions for use

Aortic Stenosis Quinapril should be used in caution in selected patients with aortic stenosis. Sensitivity Reactions Sensitivity reactions may occur in patients with or without a history of allergy or ...

Interaction with other medicinal products and other forms of interaction

Tetracycline and Other Drugs That Interact with Magnesium Because of the presence of magnesium carbonate in the formulation, Accupro has been shown in healthy volunteers to reduce the absorption of tetracycline ...

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 contraindicated during the 2<sup>nd</sup> and 3rd trimester ...

Effects on ability to drive and use machines

There are no studies on the effect of this medicine on the ability to drive. When driving vehicles or operating machines it should be taken into account that occasionally dizziness or weariness may occur. ...

Undesirable effects

The following undesirable effects have been observed and reported during treatment with quinapril with the following frequencies: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); ...

Overdose

The oral LD<sub>50</sub> of quinapril in mice and rats ranges from 1440 to 4280 mg/kg. No data are available with respect to overdosage in humans. The most likely clinical manifestation would be symptoms ...

Pharmacodynamic properties

Pharmacotherapeutic group: Angiotensin-converting enzyme (ACE) inhibitor, plain ATC code: CO9AAO6 Quinapril is rapidly de-esterified to quinaprilat (quinapril diacid, the principal metabolite) which is ...

Pharmacokinetic properties

Peak plasma Accupro concentrations are observed within 1 hour of oral administration. The extent of absorption is approximately 60%, and is not influenced by food. Following absorption, Accupro is de-esterified ...

Preclinical safety data

The results of the preclinical tests do not add anything of further significance to the prescriber.

List of excipients

Magnesium carbonate Lactose Gelatin Crospovidone Magnesium stearate Candelilla wax Colourings: Opadry Y-5-9020 (containing hydroxypropyl methylcellulose, hydroxypropyl cellulose, Macrogol 400, red iron ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from moisture.

Nature and contents of container

Tampertainers with desiccant containing 56 or 100 tablets. Polyamide/aluminium/PVC blister strip containing 7, 28, 56 or 100 tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Marketing authorization number(s)

PL 00057/0515

Date of first authorization / renewal of the authorization

Date of first authorisation: 01 August 2003 Date of latest renewal: 14 February 2006

Date of revision of the text

04/2018

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

File
application/pdf - 127,4 KB