RANEXA Prolonged-release tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Ranexa 375 mg prolonged-release tablets.
Qualitative and quantitative composition
Each tablet contains 375 mg of ranolazine. For the full list of excipients see section 6.1.
Pharmaceutical form
Prolonged-release tablet. Pale blue oval-shaped tablet engraved with 375 on one side.
Therapeutic indications
Ranexa is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such ...
Posology and method of administration
Posology Ranexa is available as 375 mg, 500 mg, and 750 mg prolonged-release tablets. Adults The recommended initial dose of Ranexa is 375 mg twice daily. After 2–4 weeks, the dose should be titrated to ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe renal impairment (creatinine clearance <30 ml/min) (see sections 4.2 and 5.2). Moderate or severe hepatic ...
Special warnings and precautions for use
Caution should be exercised when prescribing or uptitrating ranolazine to patients in whom an increased exposure is expected: Concomitant administration of moderate CYP3A4 inhibitors (see sections 4.2 ...
Interaction with other medicinal products and other forms of interaction
Effects of other medicinal products on ranolazine CYP3A4 or P-gp inhibitors Ranolazine is a substrate of cytochrome CYP3A4. Inhibitors of CYP3A4 increase plasma concentrations of ranolazine. The potential ...
Fertility, pregnancy and lactation
Pregnancy There are limited amount of data from the use of ranolazine in pregnant women. Studies in animals showed embryo toxicity (see Section 5.3). The potential risk for humans is unknown. Ranexa should ...
Effects on ability to drive and use machines
No studies on the effects of Ranexa on the ability to drive and use machines have been performed. Ranexa may cause dizziness, blurred vision, diplopia, confusional state, coordination abnormal, hallucination ...
Undesirable effects
Undesirable effects in patients receiving Ranexa are generally mild to moderate in severity and often develop within the first 2 weeks of treatment. These were reported during the Phase 3 clinical development ...
Overdose
In an oral high-dose tolerability study in angina patients, the incidence of dizziness, nausea, and vomiting increased in a dose-dependent manner. In addition to these adverse events, diplopia, lethargy, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other cardiac preparations ATC code: C01EB18 Mechanism of action The mechanism of action of ranolazine is largely unknown. Ranolazine may have some antianginal effects by inhibition ...
Pharmacokinetic properties
After oral administration of Ranexa, peak plasma concentrations (C<sub>max</sub>) are typically observed between 2 and 6 hours. Steady state is generally achieved within 3 days of twice-daily dosing. ...
Preclinical safety data
Adverse reactions not observed in clinical studies, but seen in animals at levels similar to clinical exposure, were as follows: Ranolazine was associated with convulsions and increased mortality in rats ...
List of excipients
Excipients for all ranolazine prolonged-release tablets: Carnauba wax Hypromellose Magnesium stearate Methacrylic acid-ethyl acrylate copolymer (1:1) Microcrystalline cellulose Sodium hydroxide Titanium ...
Incompatibilities
Not applicable.
Shelf life
Shelf life Blister pack: 5 years. Bottle pack: 4 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PVC/PVDC/Aluminium blisters of 15 or 20 tablets per blister card. Each carton contains 2, 3, or 5 blister cards (30, 60, or 100 tablets) or one HDPE bottle containing 60 tablets. Not all pack-sizes may ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
Marketing authorization number(s)
60 tablets in blister pack: EU/1/08/462/001 60 tablets in bottle: EU/1/08/462/002 30 tablets in blister pack: EU/1/08/462/007 100 tablets in blister pack: EU/1/08/462/008
Date of first authorization / renewal of the authorization
Date of first authorisation: 09 July 2008 Date of last renewal: 06 March 2013
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