LACIDIPINE Film-coated tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Lacidipine 2 mg Film-Coated Tablets. Pezius 2 mg Film-Coated Tablets.
Qualitative and quantitative composition
Each tablet contains 2 mg lacidipine. Excipient with known effect: Each tablet contains 118 mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. White coloured, round shaped, film-coated tablet debossed with on one side and 225 on the other side.
Therapeutic indications
Lacidipine is indicated in adults for the treatment of hypertension either alone or in combination with other antihypertensive agents, including β-adrenoceptor antagonists, diuretics, and ACE-inhibitors. ...
Posology and method of administration
Posology Adults The treatment of hypertension should be adapted to the severity of the condition, and according to the individual response. The recommended initial dose is 2 mg once daily. The dose may ...
Contraindications
Lacidipine tablets are contraindicated in patients with known hypersensitivity to any ingredient of the preparation. Lacidipine should only be used with great care in patients with a previous allergic ...
Special warnings and precautions for use
In specialised studies lacidipine has been shown not to affect the spontaneous function of the SA node or to cause prolonged conduction within the AV node. However, the theoretical potential for a calcium ...
Interaction with other medicinal products and other forms of interaction
Co-administration of lacidipine with other agents recognised to have a hypotensive effect, including anti-hypertensive agents, (e.g. diuretics, beta-blockers or ACE-inhibitors), may have an additive hypotensive ...
Pregnancy and lactation
Pregnancy Although some dihydropyridine compounds have been found to be teratogenic in animals, data in the rat and rabbit for lacidipine provide no evidence of a teratogenic effect. Using doses far above ...
Effects on ability to drive and use machines
Lacidipine may cause dizziness. Patients should be warned not to drive or operate machinery if they experience dizziness or related symptoms.
Undesirable effects
Lacidipine is generally well tolerated. Some individuals may experience minor side effects which are related to its known pharmacological action of peripheral vasodilation. Such effects, indicated by a ...
Overdose
Symptoms There have been no recorded cases of Lacidipine overdosage. The expected symptoms could comprise prolonged peripheral vasodilation associated with hypotension and tachycardia. Bradycardia or prolonged ...
Pharmacodynamic properties
Pharmacotherapeutic group: Calcium channel blockers, Dihydropyridine derivatives ATC code: C08CA09 Lacidipine is a specific and potent calcium antagonist with a predominant selectivity for calcium channels ...
Pharmacokinetic properties
Lacidipine is a highly lipophilic compound; it is rapidly absorbed from the gastrointestinal tract following oral dosing. Absolute bioavailability averages about 10% due to extensive first-pass metabolism ...
Preclinical safety data
In acute toxicity studies, Lacidipine has shown a wide safety margin. In repeated dose toxicological studies, findings in animals, related to the safety profile of Lacidipine in man, were reversible and ...
List of excipients
<u>Tablet core:</u> Lactose monohydrate Povidone (K-30) Crospovidone Magnesium stearate <u>Film-coating:</u> Hypromellose 5cP (E464) Titanium dioxide (E171) Macrogol/PEG 400
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.
Nature and contents of container
Alu/Alu blisters (OPA/Alu/PVC-Alu). Pack sizes: 28 Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Dr. Reddys Laboratories (UK) Ltd., 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD, United Kingdom
Marketing authorization number(s)
PL 08553/0502
Date of first authorization / renewal of the authorization
20/08/2014
Date of revision of the text
04/03/2019
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