PLENDIL Prolonged-release tablet (2023)
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Περιεχόμενα
Name of the medicinal product
Plendil 2.5 mg prolonged-release tablets.
Qualitative and quantitative composition
Each tablet contains 2.5 mg felodipine. <u>Excipients with known effect:</u> Each tablet contains 28 mg lactose and 2.5 mg macrogolglycerol hydroxystearate. For the full list of excipients, see section ...
Pharmaceutical form
Prolonged-release tablet. <u>Plendil 2.5 mg:</u> The tablet is yellow, circular, biconvex, engraved A/FL on one side and 2.5 on the other side, with a diameter of 8.5 mm.
Therapeutic indications
Hypertension. Stable angina pectoris.
Posology and method of administration
Posology Hypertension The dose should be adjusted individually. Treatment can be started with 5 mg once daily. Depending on the patients response, the dosage can, where applicable, be decreased to 2.5 ...
Contraindications
Pregnancy Hypersensitivity to felodipine or any of the excipients listed in section 6.1. Decompensated heart failure. Acute myocardial infarction. Unstable angina pectoris. Haemodynamically significant ...
Special warnings and precautions for use
The efficacy and safety of felodipine in the treatment of hypertensive emergencies has not been studied. Felodipine may cause significant hypotension with subsequent tachycardia. This may lead to myocardial ...
Interaction with other medicinal products and other forms of interaction
Felodipine is metabolised in the liver by cytochrome P450 3A4 (CYP3A4). Concomitant administration of substances which interfere with CYP3A4 enzyme system may affect plasma concentrations of felodipine. ...
Fertility, pregnancy and lactation
Pregnancy Felodipine should not be given during pregnancy. In non-clinical reproductive toxicity studies there were foetal developmental effects, which are considered to be due to the pharmacological action ...
Effects on ability to drive and use machines
Felodipine has minor or moderate influence on the ability to drive and use machines. If patients taking felodipine suffer from headache, nausea, dizziness or fatigue and ability to react may be impaired. ...
Undesirable effects
Summary of the safety profile Felodipine can cause flushing, headache, palpitations, dizziness and fatigue. Most of these adverse reactions are dose-dependent and appear at the start of treatment or after ...
Overdose
Symptoms Overdosage may cause excessive peripheral vasodilatation with marked hypotension and sometimes bradycardia. Management If justified: activated charcoal, gastric lavage if performed within one ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> calcium channel blockers, dihydropyridine derivatives <b>ATC code:</b> C08CA02 Mechanism of action Felodipine is a vascular selective calcium antagonist, which lowers ...
Pharmacokinetic properties
Absorption Felodipine is administered as extended-release tablets, from which it is completely absorbed in the gastrointestinal tract. The systemic availability of felodipine is approximately 15% and is ...
Preclinical safety data
Reproduction toxicity In a study on fertility and general reproductive performance in rats treated with felodipine, a prolongation of parturition resulting in difficult labour/increased foetal deaths and ...
List of excipients
<u>Tablet core:</u> Hydroxypropylcellulose Hypromellose 50 mPa·s Hypromellose 10000 mPa·s Lactose anhydrous Macrogolglycerol hydroxystearate Microcrystalline cellulose Propyl gallate Sodium aluminium silicate ...
Incompatibilities
Not applicable.
Shelf life
Prolonged-release tablets 2.5 mg (blister): 2 years. Prolonged-release tablets 2.5 mg (bottle): 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
High-density polyethylene bottle with a standard cap of polypropylene. PVC/PVDC/Aluminium blister. <u>Blister pack:</u> 20 tablets (blister pack) 28 tablets (calendar blister pack) 30 tablets (blister ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Glenwood GmbH, Pharmazeutische Erzeugnisse, Arabellastrasse 17, 81925 Munich, Germany
Marketing authorization number(s)
PA2256/005/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 19 May 1997 Date of last renewal: 18 May 2007
Date of revision of the text
August 2023
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