Isosorbidemononitraat Sandoz 20, tabletten 20 mg

Страна: Нідерланди

мова: голландська

Джерело: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Активний інгредієнт:

ISOSORBIDEMONONITRAAT

Доступна з:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Код атс:

C01DA14

ІПН (Міжнародна Ім'я):

ISOSORBIDEMONONITRAAT

Фармацевтична форма:

Tablet

Склад:

CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B), CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B),

Адміністрація маршрут:

Oraal gebruik

Терапевтична области:

Isosorbide Mononitrate

Огляд продуктів:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); SILICIUMDIOXIDE (E 551); TALK (E 553 B);

Дата Авторизація:

1988-08-17

інформаційний буклет

Sandoz B.V.
Page 1/9
Isosorbidemononitraat Sandoz
®
20/40, tabletten 20/40 mg; RVG
13418; RVG 13419
1313-v15
1.3.1.3 Bijsluiter
April 2019
Sandoz B.V.
Page 1/9
Isosorbidemononitraat Sandoz
®
20/40, tabletten 20/40 mg; RVG
13418; RVG 13419
V16
1.3.1.3 Bijsluiter
April 2020
DMA
Isosorbidemononitrate
20 mg / 40 mg tablets
1.3.1.3 PACKAGE LEAFLET
NL/H/0179/001-002
Property of Sandoz GmbH
Sandoz B.V.
Page 2/9
Isosorbidemononitraat Sandoz
®
20/40, tabletten 20/40 mg; RVG
13418; RVG 13419
1313-v15
1.3.1.3 Bijsluiter
April 2019
Sandoz B.V.
Page 2/9
Isosorbidemononitraat Sandoz
®
20/40, tabletten 20/40 mg; RVG
13418; RVG 13419
V16
1.3.1.3 Bijsluiter
April 2020
Confidential
May not be used, divulged or otherwise disclosed
without the consent of Sandoz GmbH
Sandoz B.V.
Page 3/9
Isosorbidemononitraat Sandoz
®
20/40, tabletten 20/40 mg; RVG
13418; RVG 13419
1313-v15
1.3.1.3 Bijsluiter
April 2019
Sandoz B.V.
Page 3/9
Isosorbidemononitraat Sandoz
®
20/40, tabletten 20/40 mg; RVG
13418; RVG 13419
V16
1.3.1.3 Bijsluiter
April 2020
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
ISOSORBIDEMONONITRAAT SANDOZ 20, TABLETTEN 20 MG
ISOSORBIDEMONONITRAAT SANDOZ 40, TABLETTEN 40 MG
Isosorbidemononitraat
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
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
WHAT IS IN THIS LEAFLET:
1. What [nationally completed name] is and what it is used for
2. What you need to know before you take [nationally completed name]
3. How to take [nationally completed name]
4. Possible side effects
5. How to store [nationally completed name]
6. Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT

Характеристики продукта

Sandoz B.V.
Page 1/9
Isosorbidemononitraat Sandoz
®
20, tabletten 20 mg
Isosorbidemononitraat Sandoz
®
40, tabletten 40 mg
RVG 13418; RVG 13419
V09
1.3.1.1 Samenvatting van de Productkenmerken
April 2020
1.
NAAM VAN HET GENEESMIDDEL
Isosorbidemononitraat Sandoz 20, tabletten 20 mg
Isosorbidemononitraat Sandoz 40, tabletten 40 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One table of [Nationally completed name] contains 20 mg
isosorbidemononitrate.
One table of [Nationally completed name] contains 40 mg
isosorbidemononitrate.
Excipients with known effect:
Each 20mg tablet contains lactose (as lactose monohydrate 176 mg)
Each 40mg tablet contains lactose (as lactose monohydrate 156 mg)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
20 mg Tablet:
White, biplanar round tablet with bevelled edges, scored on one side,
inscription on reverse
side ‘20’
The tablets can be divided into equal halves
40 mg Tablet:
White, biplanar round tablet with bevelled edges, scored on one side,
inscription on reverse
side ‘40’
The tablets can be divided into equal halves
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis and maintenance treatment of angina pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The usual daily dosage for adults is 40-80 mg isosorbidemononitrate
divided in 2-3 gifts. In
order to avoid possible, initial adverse effects, it is recommended to
start treatment with 10
Sandoz B.V.
Page 2/9
Isosorbidemononitraat Sandoz
®
20, tabletten 20 mg
Isosorbidemononitraat Sandoz
®
40, tabletten 40 mg
RVG 13418; RVG 13419
V09
1.3.1.1 Samenvatting van de Productkenmerken
April 2020
mg, 2 to 3 times daily. Patients who are already under treatment with
nitrate derivates can be
directly transferred to therapeutic doses of isosorbidemononitrate.
If the response obtained is not enough, the dosage can be incremented
to 40 mg 2 to 3 times
daily. During maintenance treatment with isosorbidemononitrate
tolerance (decrease in effect)
may occur. This occurs mainly at high and