VIMPAT Film-coated tablet (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Vimpat 50 mg film-coated tablets. Vimpat 100 mg film-coated tablets. Vimpat 150 mg film-coated tablets. Vimpat 200 mg film-coated tablets.
Qualitative and quantitative composition
<u>Vimpat 50 mg film-coated tablets:</u> Each film-coated tablet contains 50 mg lacosamide. <u>Vimpat 100 mg film-coated tablets:</u> Each film-coated tablet contains 100 mg lacosamide. <u>Vimpat 150 mg ...
Pharmaceutical form
Film-coated tablet. <u>Vimpat 50 mg film-coated tablets:</u> Pinkish, oval film-coated tablets with approximate dimensions of 10.4 mm x 4.9 mm, and debossed with SP on one side and 50 on the other side. ...
Therapeutic indications
Vimpat is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. Vimpat is indicated ...
Posology and method of administration
Posology The physician should prescribe the most appropriate formulation and strength according to weight and dose. The recommended posology for adults, adolescents and children from 2 years of age is ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Known second- or third-degree atrioventricular (AV) block.
Special warnings and precautions for use
Suicidal ideation and behaviour Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal products in several indications. A meta-analysis of randomised placebo-controlled ...
Interaction with other medicinal products and other forms of interaction
Lacosamide should be used with caution in patients treated with medicinal products known to be associated with PR prolongation (including sodium channel blocking antiepileptic medicinal products) and in ...
Fertility, pregnancy and lactation
Women of childbearing potential Physicians should discuss family planning and contraception with women of childbearing potential taking lacosamide (see Pregnancy). If a woman decides to become pregnant, ...
Effects on ability to drive and use machines
Lacosamide has minor to moderate influence on the ability to drive and use machines. Lacosamide treatment has been associated with dizziness or blurred vision. Accordingly, patients should be advised not ...
Undesirable effects
Summary of safety profile Based on the analysis of pooled placebo-controlled clinical trials in adjunctive therapy in 1,308 patients with partial-onset seizures, a total of 61.9% of patients randomised ...
Overdose
Symptoms Symptoms observed after an accidental or intentional overdose of lacosamide are primarily associated with CNS and gastrointestinal system. The types of adverse reactions experienced by patients ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> antiepileptics, other antiepileptics <b>ATC code:</b> N03AX18 Mechanism of action The active substance, lacosamide (R-2-acetamido-N-benzyl-3-methoxypropionamide) is a ...
Pharmacokinetic properties
Absorption Lacosamide is rapidly and completely absorbed after oral administration. The oral bioavailability of lacosamide tablets is approximately 100%. Following oral administration, the plasma concentration ...
Preclinical safety data
In the toxicity studies, the plasma concentrations of lacosamide obtained were similar or only marginally higher than those observed in patients, which leaves low or non-existing margins to human exposure. ...
List of excipients
<u>Tablet core:</u> Microcrystalline cellulose Hydroxypropylcellulose Hydroxypropylcellulose (low substituted) Silica, colloidal, anhydrous Crospovidone (polyplasdone XL-10 Pharmaceutical Grade) Magnesium ...
Incompatibilities
Not applicable.
Shelf life
5 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
<u>Vimpat 50 mg film-coated tablets:</u> Packs of 14, 28, 56 and 168 film-coated tablets in PVC/PVDC blister sealed with an aluminium foil. Packs of 14 1 and 56 1 film-coated tablets in PVC/PVDC perforated ...
Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium
Marketing authorization number(s)
EU/1/08/470/001 EU/1/08/470/002 EU/1/08/470/003 EU/1/08/470/004 EU/1/08/470/005 EU/1/08/470/006 EU/1/08/470/007 EU/1/08/470/008 EU/1/08/470/009 EU/1/08/470/010 EU/1/08/470/011 EU/1/08/470/012 EU/1/08/470/020 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 29 August 2008 Date of latest renewal: 31 July 2013
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