Dipyridamol/Acetylsalicylzuur Sandoz 200/25 mg, capsules met gereguleerde afgifte, hard
国家: 荷兰
语言: 荷兰文
来源: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
资料单张 有效成分:
ACETYLSALICYLZUUR 25 mg/stuk ; DIPYRIDAMOL 200 mg/stuk
可用日期:
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
ATC代码:
B01AC30
INN（国际名称）:
ACETYLSALICYLZUUR 25 mg/stuk ; DIPYRIDAMOL 200 mg/stuk
药物剂型:
Capsule met gereguleerde afgifte, hard
组成:
ARABISCHE GOM (E 414) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CHINOLINEGEEL (E 104) ; CHINOLINEGEEL ALUMINIUMLAK (E 104) ; COPOLYMEER VAN METHACRYLZUUR-METHYLMETHACRYLAAT (1:2)(E 1207) ; DIMETICON (E 900) ; GELATINE (E 441) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; HYPROMELLOSEFTALAAT ; LACTOSE 0-WATER ; LECITHINE, SOYA (E 322) ; METHYLPARAHYDROXYBENZOAAT (E 218) ; PATENTBLAUW V (E 131) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; PONCEAU 4R (E 124) ; POVIDON K 30 (E 1201) ; PROPYLPARAHYDROXYBENZOAAT ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; WATER, GEZUIVERD ; WIJNSTEENZUUR (D-,L-) (E 334) ; XANTHAANGOM (E 415) ; ZETMEEL, GEPREGELATINEERD ; ZONNEGEEL FCF (E 110) ; ZWARTE INKT, ARABISCHE GOM (E 414) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CHINOLINEGEEL (E 104) ; CHINOLINEGEEL ALUMINIUMLAK (E 104) ; COPOLYMEER VAN METHACRYLZUUR-METHYLMETHACRYLAAT (1:2) ; DIMETICON (E 900) ; GELATINE (E 441) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; HYPROMELLOSEFTALAAT ; LACTOSE 0-WATER ; LECITHINE, SOYA (E 322) ; METHYLPARAHYDROXYBENZOAAT (E 218) ; PATENTBLAUW V (E131) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; PONCEAU 4R (E 124) ; POVIDON K 30 (E 1201) ; PROPYLPARAHYDROXYBENZOAAT ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; WATER, GEZUIVERD ; WIJNSTEENZUUR (D-,L-) ; XANTHAANGOM (E 415) ; ZETMEEL, GEPREGELATINEERD ; ZONNEGEEL FCF (E 110) ; ZWARTE INKT, ARABISCHE GOM (E 414) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CHINOLINEGEEL (E 104) ; CHINOLINEGEEL ALUMINIUMLAK (E 104) ; COPOLYMEER VAN METHACRYLZUUR-METHYLMETHACRYLAAT (1:2) ; DIMETICON (E 900) ; GELATINE (E 441) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; HYPROMELLOSEFTALAAT ; LACTOSE 0-WATER ; LECITHINE, SOYA (E 322) ; METHYLPARAHYDROXYBENZOAAT (E 218) ; PATENTBLAUW V (E131) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; PONCEAU 4R (E 124) ; POVIDON K 30 (E 1201) ; PROPYLPARAHYDROXYBENZOAAT (E 2
给药途径:
Oraal gebruik
治疗领域:
Combinations
產品總結:
Hulpstoffen: ARABISCHE GOM (E 414); CELLULOSE, MICROKRISTALLIJN (E 460); CHINOLINEGEEL ALUMINIUMLAK (E 104); CHINOLINEGEEL (E 104); COPOLYMEER VAN METHACRYLZUUR-METHYLMETHACRYLAAT (1:2); DIMETICON (E 900); GELATINE (E 441); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE (E 464); HYPROMELLOSEFTALAAT; LACTOSE 0-WATER; LECITHINE, SOYA (E 322); METHYLPARAHYDROXYBENZOAAT (E 218); PATENTBLAUW V (E131); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); PONCEAU 4R (E 124); POVIDON K 30 (E 1201); PROPYLPARAHYDROXYBENZOAAT (E 216); SILICIUMDIOXIDE (E 551); STEARINEZUUR (E 570); TALK (E 553 B); TITAANDIOXIDE (E 171); WIJNSTEENZUUR (D-,L-); XANTHAANGOM (E 415); ZETMEEL, GEPREGELATINEERD; ZONNEGEEL FCF (E 110); ZWARTE INKT;
授权日期:
2012-09-19
资料单张
Sandoz B.V.
Page 1/7
Dipyridamol/Acetylsalicylzuur Sandoz 200/25 mg
RVG 109873
V9
1.3.1.3 Bijsluiter
September 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DIPYRIDAMOL/ACETYLSALICYLZUUR SANDOZ
® 200/25 MG, CAPSULES MET GEREGULEERDE AFGIFTE, HARD
dipyridamole and acetylsalicylic acid
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 [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 IS USED FOR
The name of your medicine is [Nationally completed name]. It contains
two different medicines called
dipyridamole and acetylsalicylic acid*. Both belong to a group of
medicines called ‘anti-thrombotic
medicines’. Acetylsalicylic acid* is also a type of medicine called
a ‘Non-Steroidal Anti-inflammatory
Drug’ (NSAID).
[Nationally completed name] belongs to a group of medicines called
‘anti-thrombotic agents’. They
are used to stop blood clots forming. [Nationally completed name] is
used for people who have had a
•
Stroke
•
Transient Ischaemic Attack (TIA)
which are caused by a clot in the brain. This medicine reduces the
risk of them happening again.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME] IF YOU:
•
are ALLERGIC
to
DIPYRIDAMOLE, ACETYLSALICY
阅读完整的文件
产品特点
Sandoz B.V.
Page 1/17
Dipyridamol/Acetylsalicylzuur Sandoz 200/25 mg
RVG 109873
V7
1.3.1.1 Samenvatting van de Productkenmerken
Augustus 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dipyridamol/Acetylsalicylzuur Sandoz 200/25 mg, capsules met
gereguleerde afgifte, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 200 mg of dipyridamole and 25 mg of
acetylsalicylic acid.
Excipients with known effect
Each capsule contains 29.2 mg of lactose, 0.872 mg of methyl
parahydroxybenzoate (E 218), 0.218
mg of propyl parahydroxybenzoate (E 216), 0.04 mg of soya lecithin (E
322), 0.0029 mg of azo
colouring agent ponceau 4R (E 124) and 0.0264 mg of azo colouring
agent sunset yellow (E 110).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified-release capsule, hard.
Capsule containing acetylsalicylic acid in standard release form and
dipyridamole in modified-release
form.
Capsule with orange coloured cap and white to off-white coloured body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Secondary prevention of ischaemic stroke and transient ischaemic
attacks.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, including the elderly _
The recommended dose is one capsule twice daily, usually one in the
morning and one in the evening.
_Paediatric population _
[Nationally completed name] is not indicated for use in children due
to safety concerns (see section
4.4)
_Alternative regimen in case of intolerable headaches _
In the event of intolerable headaches during treatment initiation,
switch to one capsule at bedtime and
low-dose acetylsalicylic acid in the morning. Because there are no
outcome data with this regimen and
headaches become less of a problem as treatment continues, patients
should return to the usual
regimen as soon as possible, usually within one week.
_Renal impairment _
Sandoz B.V.
Page 2/17
Dipyridamol/Acetylsalicylzuur Sandoz 200/25 mg
RVG 109873
V7
1.3.1.1 Samenvatting van de Productkenmerken
Augustus 2020
Due to the acet
阅读完整的文件
