Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
MOXONIDINE 0,3 mg/stuk
Teva Pharma B.V. Swensweg 5 2031 GA HAARLEM
C02AC05
MOXONIDINE 0,3 mg/stuk
Filmomhulde tablet
CROSPOVIDON (E 1202) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 25 (E 1201) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Moxonidine
Hulpstoffen: CROSPOVIDON (E 1202); HYPROMELLOSE (E 464); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); POVIDON K 25 (E 1201); TITAANDIOXIDE (E 171);
1900-01-01
NL/H/0399/01-03 NL/H/0405/01-03 Moxonidine 0.2_0.3_0.4 mg film-coated tablets PIL, 16.05.13 1 PACKAGE LEAFLET: Information for the user _MOXAMAR 0,2 MG, FILMOMHULDE TABLETTEN _ _MOXAMAR 0,3 MG, FILMOMHULDE TABLETTEN _ _MOXAMAR 0,4 MG, FILMOMHULDE TABLETTEN _ _ _ Active substance: moxonidine 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 /…/ is and what it is used for 2. What you need to know before you take /…/ 3. How to take /…/ 4. Possible side effects 5. How to store /…/ 6. Contents of the pack and other information 1. WHAT /.../ IS AND WHAT IT IS USED FOR _/.../ _ is a centrally acting agent used to lower high blood pressure. _/.../_ is used - in the treatment of high blood pressure (primary or essential hypertension). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE _/.../_ DO NOT TAKE _/.../_ - if you are allergic to moxonidine or any of the other ingredients of this medicine (listed in section 6). - if you have sick sinus syndrome (a kind of heart rhythm disorder) or sinoatrial block (a disturbance in the conduction [flow] of electrical impulses through the heart as they pass between the sinus node and the heart’s upper chamber) - if your heart rate is extremely slow (below 50 beats per minute at rest) - if you have second or third-degree AV block (severe disturbances in the conduction [flow] of electrical impulses passing from the upper to the lower chambers of the heart) - if you suffer from heart muscle weakness WARNINGS AND PRECAUTIONS_ _ Talk to your doctor or pharmacist before t Lees het volledige document
NL/H/0399/01-03 NL/H/0405/01-03 Moxonidine 0.2_0.3_0.4 mg film-coated tablets SPC, 16.05.13 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Moxamar 0,2 mg, filmomhulde tabletten Moxamar 0,3 mg, filmomhulde tabletten Moxamar 0,4 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.2 mg moxonidine. Each tablet contains 0.3 mg moxonidine. Each tablet contains 0.4 mg moxonidine. Excipient with known effect: lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Appearance: All tablets are round, approximately 6 mm in diameter. The 0.2 mg tablet is light pink, the 0.3 mg tablet is pink and the 0.4 mg tablet is dark pink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mild to moderate essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ Treatment must be instituted with the lowest dosage of Moxonidine. This means a daily dose of 0.2 mg moxonidine in the morning. If the therapeutic effect is insufficient, the dose can be increased after three weeks to 0.4 mg. This dose can be given as a single dose (to be taken in the morning) or as a divided daily dose (morning and evening). If the results are still insufficient after a further three weeks, the dosage can be increased further to a maximum of 0.6 mg given divided in the morning and evening. A single dose of 0.4 mg Moxonidine and a daily dose of 0.6 mg Moxonidine should not be exceeded. _Paediatric population _ NL/H/0399/01-03 NL/H/0405/01-03 Moxonidine 0.2_0.3_0.4 mg film-coated tablets SPC, 16.05.13 2 Moxonidine should not be given to children and adolescents under 16 years of age as insufficient therapeutic data are available for this. _Elderly _ Provided that renal function is not impaired, dosage recommendation is the same as for adults. The treatment should not be stopped abruptly, but withdrawn over a period of two weeks (see also section 4.4). Method of administration As concomitant ingestion of food does not Lees het volledige document