País: Holanda
Língua: holandês
Origem: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LACOSAMIDE 150 mg/stuk
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
N03AX18
LACOSAMIDE 150 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463a) ; HYPROLOSE (E 463) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL (E 1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROLOSE (E 463) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Lacosamide
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); HYPROLOSE (E 463); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); INDIGOKARMIJN ALUMINIUMLAK (E 132); MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
1900-01-01
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LACOSAMIDE STADA 50 MG, FILMOMHULDE TABLETTEN LACOSAMIDE STADA 100 MG, FILMOMHULDE TABLETTEN LACOSAMIDE STADA 150 MG, FILMOMHULDE TABLETTEN LACOSAMIDE STADA 200 MG, FILMOMHULDE TABLETTEN lacosamide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What [Product Name] is and what it is used for 2. What you need to know before you take [Product Name] 3. How to take [Product Name] 4. Possible side effects 5. How to store [Product Name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR WHAT [PRODUCT NAME] IS [Product Name] contains lacosamide. This belongs to a group of medicines called “antiepileptic medicines”. These medicines are used to treat epilepsy. • You have been given this medicine to lower the number of fits (seizures) you have. WHAT [PRODUCT NAME] IS USED FOR • [Product Name] is used − on its own and in association with other antiepileptic medicines in adults, adolescents and children aged 2 years and older to treat a certain type of epilepsy characterised by the occurrence of partial-onset seizure with or without secondary generalisation. In this type of epilepsy, fits first affect only one side of your brain. However, these may then spread to larger areas on both sides of your brain. − in association with other antiepileptic medicines in adults, adolescents and children aged 4 years and older to treat primary generalised tonic- clonic seizures (major fits, including loss of consciousness) in Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lacosamide STADA 50 mg, filmomhulde tabletten Lacosamide STADA 100 mg, filmomhulde tabletten Lacosamide STADA 150 mg, filmomhulde tabletten Lacosamide STADA 200 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [Product Name] 50 mg film-coated tablets: Each film-coated tablet contains 50 mg lacosamide. [Product Name] 100 mg film-coated tablets: Each film-coated tablet contains 100 mg lacosamide. [Product Name] 150 mg film-coated tablets: Each film-coated tablet contains 150 mg lacosamide. [Product Name] 200 mg film-coated tablets: Each film-coated tablet contains 200 mg lacosamide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet [Product Name] 50 mg are pink, film coated oblong biconvex tablets, embossed with “50” on one side, plain on the other with 10.3 mm length and 4.8 mm width approximately. [Product Name] 100 mg are yellow, film coated oblong biconvex tablets, embossed with “100” on one side, plain on the other with 13.1 mm length and 6.1 mm width approximately. [Product Name] 150 mg are beige, film coated oblong biconvex tablets, embossed with “150” on one side, plain on the other with 15.2 mm length and 7.1 mm width approximately. [Product Name] 200 mg are blue, film coated oblong biconvex tablets, embossed with “200” on one side, plain on the other with 16.6 mm length and 7.7 mm width approximately. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Product name] 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. [Product name] is indicated as adjunctive therapy • in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. • in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 ye Leia o documento completo