RELPAX Film-coated tablet (2021)
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Περιεχόμενα
Name of the medicinal product
RELPAX 20 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 20 mg eletriptan (as hydrobromide). Excipients with known effect: Each film-coated tablet contains 23 mg lactose and 0.036 mg Sunset yellow. For the full list of excipients, ...
Pharmaceutical form
Film-coated tablet. Round, convex orange tablets debossed with REP 20 on one side and Pfizer on the other.
Therapeutic indications
RELPAX is indicated in adults for the acute treatment of the headache phase of migraine attacks, with or without aura.
Posology and method of administration
Posology RELPAX tablets should be taken as early as possible after the onset of migraine headache but they are also effective if taken at a later stage during a migraine attack. RELPAX, if taken during ...
Contraindications
RELPAX is contraindicated in patients with: hypersensitivity to eletriptan hydrobromide or to any of the excipients listed in 6.1. severe hepatic or severe renal impairment. moderately severe or severe ...
Special warnings and precautions for use
RELPAX should not be used together with potent CYP3A4 inhibitors e.g., ketoconazole, itraconazole, erythromycin, clarithromycin, josamycin and protease inhibitors (ritonavir, indinavir and nelfinavir). ...
Interaction with other medicinal products and other forms of interaction
Effect of other medicinal products on eletriptan In the pivotal clinical trials of eletriptan no evidence of interaction with beta-blockers, tricyclic antidepressants, selective serotonin reuptake inhibitors ...
Fertility, pregnancy and lactation
Pregnancy For RELPAX no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition ...
Effects on ability to drive and use machines
RELPAX has moderate influence on the ability to drive and use machines. Migraine or treatment with RELPAX may cause drowsiness or dizziness in some patients. Patients should be advised to evaluate their ...
Undesirable effects
Summary of the safety profile RELPAX has been administered in clinical trials to over 5000 subjects, taking one or two doses of RELPAX 20 or 40 or 80 mg. The most common adverse reactions noted were asthenia, ...
Overdose
Subjects have received single doses of 120 mg without significant adverse effects. However based on the pharmacology of this class, hypertension or other more serious cardiovascular symptoms could occur ...
Pharmacodynamic properties
Pharmacotherapeutic group: Selective Serotonin (5HT<sub>1</sub>) receptor agonists ATC code: N02CC06 Mechanism of action Eletriptan is a selective agonist at the vascular 5-HT<sub>1B</sub> and neuronal ...
Pharmacokinetic properties
Absorption Eletriptan is rapidly and well absorbed across the gastro-intestinal tract (at least 81%) after oral administration. Absolute oral bioavailability across males and females is approximately 50%. ...
Preclinical safety data
Preclinical data, revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity and toxicity to reproduction.
List of excipients
<u>Core Tablet:</u> Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Magnesium stearate <u>Film Coat:</u> Titanium dioxide (E171) Hypromellose Lactose monohydrate Glycerol triacetate ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
<u>Opaque PVC/Aclar/Aluminium blister:</u> this medicinal product does not require any special storage conditions. <u>HDPE bottles:</u> keep the container tightly closed, in order to protect from moisture. ...
Nature and contents of container
Opaque PVC/Aclar/Aluminium blister packs containing 2, 3, 4, 5, 6, 10, 18, 30 and 100 tablets. HDPE bottles with child-resistant HDPE/PP closures containing 30 and 100 tablets. Not all pack sizes may be ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Upjohn UK Limited, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 50622/0053
Date of first authorization / renewal of the authorization
Date of First Authorisation: 12 February 2001 Date of Last Renewal: 12 February 2011
Date of revision of the text
01/2021
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