OXCARBAZEPINE MYLAN Film-coated tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Oxcarbazepine Mylan 150 mg Film-coated Tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 150 mg oxcarbazepine. Excipient with known effect: Each 150 mg tablet contains 1.23 mg lactose monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. Buff, oblong, normal convex film-coated tablet debossed OX|150 on one side and G|G on the other side. The tablet has a score line to facilitate breaking for ease of swallowing and not ...
Therapeutic indications
Oxcarbazepine Mylan is indicated for the treatment of partial seizures with or without secondarily generalised tonic-clonic seizures. Oxcarbazepine Mylan is indicated for use as monotherapy or adjunctive ...
Posology and method of administration
Posology In mono- and adjunctive therapy, treatment with Oxcarbazepine Mylan is initiated with a clinically effective dose given in two divided doses. The dose may be increased depending on the clinical ...
Contraindications
Hypersensitivity to the active substance, eslicarbazepine or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Hypersensitivity Class I (immediate) hypersensitivity reactions including rash, pruritus, urticaria, angioedema and reports of anaphylaxis have been received in the post-marketing period. Cases of anaphylaxis ...
Interaction with other medicinal products and other forms of interaction
Enzyme induction Oxcarbazepine and its pharmacologically active metabolite (the monohydroxy derivative, MHD) are weak inducers in vitro and in vivo of the cytochrome P450 enzymes CYP3A4 and CYP3A5 responsible ...
Fertility, pregnancy and lactation
Women of child-bearing potential and contraceptive measures Oxcarbazepine may result in a failure of the therapeutic effect of oral contraceptive medicinal products containing ethinylestradiol (EE) and ...
Effects on ability to drive and use machines
Adverse reactions such as dizziness, somnolence, ataxia, diplopia, blurred vision, visual disturbances, hyponatraemia and depressed level of consciousness were reported with oxcarbazepine (for complete ...
Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions are somnolence, headache, dizziness, diplopia, nausea, vomiting and fatigue occurring in more than 10% of patients. The safety ...
Overdose
Isolated cases of overdose have been reported. The maximum dose taken was approximately 48,000 mg. Signs and symptoms Electrolyte and fluid balance conditions: hyponatraemia Eye disorders: diplopia, miosis, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antiepileptics, Carboxamide derivatives ATC code: N03AF02 Mechanism of action The pharmacological activity of oxcarbazepine is primarily exerted through the metabolite (MHD) ...
Pharmacokinetic properties
Absorption Following oral administration of oxcarbazepine, oxcarbazepine is completely absorbed and extensively metabolised to its pharmacologically active metabolite (MHD). After a single dose administration ...
Preclinical safety data
Preclinical data indicated no special hazard for humans based on safety pharmacology and genotoxicity studies with oxcarbazepine and the pharmacologically active metabolite, monohydroxy derivative (MHD). ...
List of excipients
Tablet core: Crospovidone Hypromellose Cellulose, microcrystalline Silica, colloidal anhydrous Magnesium stearate Tablet coating: Black iron oxide (E172) Hypromellose Lactose monohydrate Macrogol 4000 ...
Incompatibilities
Not applicable.
Shelf life
30 months.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Clear PVC-PVdC/aluminium blisters. Pack sizes: 10, 20, 30, 50, 60, 100, 200 film-coated tablets. Polypropylene tablet containers with tamper evident polyethylene caps and optional polyethylene ullage filler. ...
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts. EN6 1TL, United Kingdom
Marketing authorization number(s)
PL 04569/0779
Date of first authorization / renewal of the authorization
30/04/2011
Date of revision of the text
23/01/2019
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