Country: Cyprus
Language: Greek
Source: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
LAMOTRIGINE
DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629
N03AX09
LAMOTRIGINE
25MG
TABLETS
LAMOTRIGINE (0084057841) 25MG
ORAL USE
Εθνική Διαδικασία
LAMOTRIGINE
Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 TABS IN BLISTER(S) (340000308) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται
COMPARATIVE TABLE ENGLISH VS GREEK PIL PACKAGE LEAFLET: INFORMATION FOR THE USER SEIZAL 25 MG TABLETS SEIZAL 50 MG TABLETS SEIZAL 100 MG TABLETS SEIZAL 200 MG TABLETS lamotrigine 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 Seizal is and what it is used for 2. What you need to know before you take Seizal 3. How to take Seizal 4. Possible side effects 5. How to store Seizal 6. Contents of the pack and other information 1. WHAT SEIZAL IS AND WHAT IT IS USED FOR Seizal belongs to a group of medicines called _anti-epileptics_. It is used to treat two conditions – EPILEPSY and BIPOLAR DISORDER. ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ: ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ ΤΟΝ ΧΡΉΣΤΗ SEIZAL 25 MG ΔΙΣΚΊΑ SEIZAL 50 MG ΔΙΣΚΊΑ SEIZAL 100 MG ΔΙΣΚΊΑ SEIZAL 200 MG ΔΙΣΚΊΑ λαμοτριγίνη ΔΙΑΒΆΣΤΕ ΠΡΟΣΕΚΤΙΚΆ ΟΛΌΚΛΗΡΟ ΤΟ ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ ΠΡΙΝ ΑΡΧΊΣΕΤΕ ΝΑ ΠΑΊΡΝΕΤΕ ΑΥΤΌ ΤΟ ΦΆΡΜΑΚΟ, ΔΙΌΤΙ ΠΕΡΙΛΑΜΒΆΝΕΙ ΣΗΜΑΝΤΙΚΈΣ ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ ΣΑΣ. Φυλάξτε αυτό το φύλλο οδηγιών χρήσης. Ίσως χρειαστεί να το διαβάσετε ξανά. Εάν έχετε περαιτέρω απορίες, ρωτήστε τον γιατρό ή τον φαρµακοποιό σας. Η συνταγή για αυτό το φάρµακο χορηγήθηκε αποκλειστικά για σας. ∆εν πρέπει να Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Seizal 25 mg Τablets Seizal 50 mg Τablets Seizal 100 mg Τablets Seizal 200 mg Τablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg of lamotrigine. Excipient (s) with known effect : Each tablet contains 4.0 mg lactose monohydrate. Each tablet contains 50 mg of lamotrigine. Excipient (s) with known effect : Each tablet contains 8.0 mg lactose monohydrate. Each tablet contains 100 mg of lamotrigine. Excipient (s) with known effect : Each tablet contains 16.0 mg lactose monohydrate. Each tablet contains 200 mg of lamotrigine. Excipient (s) with known effect : Each tablet contains 32.0 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. For 25 mg, 50 mg, 100 mg, 200 mg tablets strength: White to off-white, round, flat face, bevelled edge tablet, plain on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epilepsy _Adults and adolescents aged 13 years and above_ Adjunctive or monotherapy treatment of partial seizures and generalised seizures, including tonic-clonic seizures. Seizures associated with Lennox-Gastaut syndrome. Seizal is given as adjunctive therapy but may be the initial antiepileptic drug (AED) to start with in Lennox-Gastaut syndrome. 1 SUMMARY OF PRODUCT CHARACTERISTICS _Children and adolescents aged 2 to 12 years_ Adjunctive treatment of partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut syndrome. Monotherapy of typical absence seizures. Bipolar disorder _Adults aged 18 years and above_ Prevention of depressive episodes in patients with bipolar I disorder who experience predominantly depressive episodes (see section 5.1). Seizal is not indicated for the acute treatment of manic or depressive episodes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Seizal tablets should be swallowed whole, and should not be chewed or crushed. If the calculated dose of lamot Read the complete document