LERCANIDIPINE HYDROCHLORIDE Film-coated tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Lercanidipine hydrochloride 10 mg film-coated tablet.
Qualitative and quantitative composition
One film-coated tablet contains 10 mg lercanidipine hydrochloride, equivalent to 9.4mg lercanidipine. Excipient with known effect: Lercanidipine hydrochloride 10 mg film-coated tablet: Lactose monohydrate ...
Pharmaceutical form
Film-coated tablet. <u>Lercanidipine hydrochloride 10 mg film-coated tablet:</u> Yellow, round, biconvex 6.5 mm film-coated tablets, scored on one side, marked L on the other side. The score line is only ...
Therapeutic indications
Lercanidipine hydrochloride is indicated for the treatment of mild to moderate essential hypertension.
Posology and method of administration
Posology Route of administration: For oral use. The recommended dosage is 10 mg orally once a day at least 15 minutes before meals; the dose may be increased to 20 mg depending on the individual patient ...
Contraindications
Hypersensitivity to the active substance, to any dihydropyridine or to any of the excipients listed in section 6.1. Left ventricular outflow tract obstruction. Untreated congestive cardiac failure. Unstable ...
Special warnings and precautions for use
Sick sinus syndrome Special care should be exercised when lercanidipine is used in patients with sick sinus syndrome (if a pacemaker is not in situ). Although hemodynamic controlled studies revealed no ...
Interaction with other medicinal products and other forms of interaction
Metabolic interactions Lercanidipine is known to be metabolised by the CYP3A4 enzyme and, therefore, inhibitors and inducers of CYP3A4 administered concurrently may interact with the metabolism and elimination ...
Pregnancy and lactation
Pregnancy There are no adequate data from the use of lercanidipine in pregnant women. Non-clinical data provide no evidence of a teratogenic effect in the rat and the rabbit and reproductive performance ...
Effects on ability to drive and use machines
Lercanidipine has no or negligible influence on the ability to drive and use machines. However, caution should be exercised because dizziness, asthenia, fatigue and rarely somnolence may occur.
Undesirable effects
The following undesirable effects have been reported in clinical studies and in the post-marketing phase: Assessment of frequencies: Very common: ≥1/10, Common: ≥1/100 to <1/10, Uncommon: ≥1/1,000, to ...
Overdose
In the post-marketing experience, three cases of overdose were reported (150 mg, 280 mg and 800 mg of lercanidipine, respectively, ingested in an attempt to commit suicide). Dose level Signs/Symptoms ...
Pharmacodynamic properties
Pharmacotherapeutic group: Selective calcium channel blockers with mainly vascular effects ATC Code: C08CA13 Lercanidipine is a calcium antagonist of the dihydropyridine group and inhibits the transmembrane ...
Pharmacokinetic properties
Absorption Lercanidipine is completely absorbed after 10-20 mg oral administration and peak plasma levels, 3.30 ng/ml ± 2.09 s.d. and 7.66 ng/ml ± 5.90 s.d. respectively, occur about 1.5-3 hours after ...
Preclinical safety data
Safety pharmacological studies in animals have shown no effects on the autonomic nervous system, the central nervous system or on gastrointestinal function at antihypertensive doses. The relevant effects ...
List of excipients
<u>Tablet core:</u> Magnesium stearate Povidone Sodium starch glycolate Type A Lactose monohydrate Cellulose, microcrystalline <u>Film-coating:</u> Lercanidipine 10 mg film-coated tablets: Macrogol Polyvinyl ...
Incompatibilities
Not applicable.
Shelf life
<u>Blister pack:</u> 2 years. <u>Tablet container:</u> 3 years.
Special precautions for storage
AL/PVC/PVDC blister: Do not store above 30°C. Store in the original package in order to protect from moisture. HDPE containers: Store in the original packaging. Keep the container tightly closed in order ...
Nature and contents of container
Blister pack (Aluminium/PVC/PVDC) with push-through foil. Tablet container (HDPE), closed with a sealed LDPE-cap. Pack sizes <u>Blister (AL/PVC/PVDC):</u> Lercanidipine hydrochloride 10 mg film-coated ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörõur, Iceland
Marketing authorization number(s)
PL30306/0136
Date of first authorization / renewal of the authorization
19.06.2009/24.09.2014
Date of revision of the text
16.03.2018
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