ACCUPRO Film-coated tablet (2018)
Βιβλιογραφική αναφορά
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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
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
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