Country: Նիդերլանդեր
language: հոլանդերեն
source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
EBASTINE
Substipharm développement
R06AX22
EBASTINE
Orodispergeerbare tablet
ARABISCHE GOM (E 414) ; BUTYLHYDROXYANISOL (E 320) ; CARMELLOSE CALCIUM (E 466) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; GELATINE (E 441) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; NATRIUMBENZOAAT (E 211) ; NEOTAAM ; POLOXAMEER 188 ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; TRUSIL PEPERMUNT SPECIAL SMAAKSTOF,
Oraal gebruik
Ebastine
Hulpstoffen: ARABISCHE GOM (E 414); BUTYLHYDROXYANISOL (E 320); CARMELLOSE CALCIUM (E 466); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); CROSPOVIDON (E 1202); GELATINE (E 441); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MAGNESIUMSTEARAAT (E 470b); MALTODEXTRINE; MANNITOL (D-) (E 421); NATRIUMBENZOAAT (E 211); NEOTAAM; POLOXAMEER 188; POVIDON K 30 (E 1201); SILICIUMDIOXIDE, GEHYDRATEERD (E 551); TRUSIL PEPERMUNT SPECIAL SMAAKSTOF;
2015-10-09
C O N F I D E N T I A L MODULE 1.3.1.4 PACKAGE LEAFLET – ENGLISH VERSION June 2015 – D210 Mod 1.3.1.4 page 1 PACKAGE LEAFLET: INFORMATION FOR THE USER Lacinet 10 mg, orodispergeerbare tabletten Lacinet 20 mg, orodispergeerbare tabletten Ebastine 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 or nurse. - 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 or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET : 1. What LACINET is and what it is used for 2. What you need to know before you take LACINET 3. How to take LACINET 4. Possible side effects 5. How to store LACINET 6. Content of the pack and other information 1. WHAT LACINET IS AND WHAT IT IS USED FOR LACINET 10 mg 20 mg is a medicine that is used for the treatment of allergies (antihistaminicum). It helps you to control the symptoms of an allergic reaction . It is indicated in adults and children aged 12 years and older for the treatment of seasonal and persistent allergic rhinitis (runny nose), with or without allergic conjunctivitis (inflammation of the eye), and for the treatment of urticaria (hives) in adults over the age of 18 years. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LACINET DO NOT TAKE LACINET - if you are allergic to ebastine or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking LACINET: - if you have a certain abnormal pattern to your heart beat (known prolongation of the QTc interval on the ECG) which can occur in some forms of heart disease - if you have low potassium levels in your blood. -if you are already taking certain antibiotics or m read_full_document
C O N F I D E N T I A L MODULE 1.3.1.1 SUMMARY OF PRODUCT CHARACTERISTICS – ENGLISH VERSION June 2015 – D210 Mod 1.3.1.1 page 1 1. NAME OF THE MEDICINAL PRODUCT Lacinet 10 mg, orodispergeerbare tabletten Lacinet 20 mg, orodispergeerbare tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 10 mg ebastine. Each orodispersible tablet contains 20 mg ebastine. For a full list of excipients, see Section 6.1 3. PHARMACEUTICAL FORM Orodispersible tablets. [PRODUCT NAME] 10 mg are white to off white, round shaped, flat faced bevel edged orodispersible tablets approximately 8.50 mm in diameter and 2.20 mm thickness debossed with ’10’ on one side and plain on the other side. [PRODUCT NAME] 20 mg are white to off white, round shaped, flat faced bevel edged orodispersible tablets approximately 11 mm in diameter and 2.70 mm thickness debossed with ’20’ on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS [PRODUCT NAME] 10 mg Symptomatic treatment of seasonal and perennial allergic rhinitis, in conjunction with or without allergic conjunctivitis in adults and adolescents aged 12 years and older. Treatment of urticaria in adults aged 18 years and older. [PRODUCT NAME] 20 mg Symptomatic treatment of seasonal and perennial allergic rhinitis, in conjunction with or without allergic conjunctivitis in adults and adolescents aged 12 years and older. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For oral use. POSOLOGY Allergic rhinitis with or without allergic conjunctivitis For adolescents aged 12 years and older and adults the following dosage recommendations apply: C O N F I D E N T I A L MODULE 1.3.1.1 SUMMARY OF PRODUCT CHARACTERISTICS – ENGLISH VERSION June 2015 – D210 Mod 1.3.1.1 page 2 - 10 mg ebastine (1 [PRODUCT NAME] 10 mg orodispersible tablet) once daily. In cases of severe symptoms the dose may be increased to 20 mg ebastine (2 [PRODUCT NAME] 10 mg orodispersible tablets) once daily. - 10 mg ebastine (1 [PRODUCT NAME] 10 mg orodispe read_full_document