Sumatriptan 100 mg, tabletten

Ülke: Hollanda

Dil: Hollandaca

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

Aktif bileşen:

SUMATRIPTANSUCCINAAT SAMENSTELLING overeenkomend met ; ; SUMATRIPTAN 100 mg/stuk

Mevcut itibaren:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC kodu:

N02CC01

INN (International Adı):

SUMATRIPTANSUCCINAAT SAMENSTELLING overeenkomend met ; ; SUMATRIPTAN 100 mg/stuk

Farmasötik formu:

Tablet

Kompozisyon:

AMMONIOMETHACRYLAATCOPOLYMEER TYPE A ; ARABISCHE GOM (E 414) ; CARMELLOSE NATRIUM (E 466) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GRAPEFRUIT FLAVOUR 11473-71 (RI) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE, AMMONIOMETHACRYLAATCOPOLYMEER TYPE A ; ARABISCHE GOM (E 414) ; CARMELLOSE NATRIUM (E 466) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GRAPEFRUIT FLAVOUR 11473-71 (RI) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE,

Uygulama yolu:

Oraal gebruik

Terapötik alanı:

Sumatriptan

Ürün özeti:

Hulpstoffen: AMMONIOMETHACRYLAATCOPOLYMEER TYPE A; ARABISCHE GOM (E 414); CARMELLOSE NATRIUM (E 466); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); GRAPEFRUIT FLAVOUR 11473-71 (RI); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MALTODEXTRINE;

Yetkilendirme tarihi:

2004-12-01

Bilgilendirme broşürü

Sandoz B.V.
Page 1/7
Sumatriptan 50/100 mg, tabletten
RVG 29126-7
1313-V11
1.3.1.3 Leaflet
Maart 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SUMATRIPTAN 50 MG, TABLETTEN
SUMATRIPTAN 100 MG, TABLETTEN
sumatriptan (as succinate)
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
Sumatriptan, the active substance in [NATIONALLY COMPLETED NAME],
belongs to a group of medicines called
triptanes, which are used to treat migraine headache.
Migraine symptoms may be caused by the temporary widening of blood
vessels in the head. Sumatriptan is
believed to reduce the widening of these blood vessels. This in turn
helps to take away the headache and
relieve other symptoms of a migraine attack, such as feeling or being
sick (nausea or vomiting) and
sensitivity to light and sound.
[NATIONALLY COMPLETED NAME]
works only when a migraine attack has started. It will not stop you
from
getting an attack.
You must not use
[NATIONALLY COMPLETED NAME]
to prevent a migraine attack.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]
•
if you are allergic to sumatriptan or any of the other ingredients of
this

Ürün özellikleri

Sandoz B.V.
Page 1/10
Sumatriptan 50/100 mg, tabletten
RVG 29126-7
1311-V10
1.3.1.1 Summary of Product Characteristics
Augustus 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sumatriptan 50 mg, tabletten
Sumatriptan 100 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg sumatriptan (as succinate).
Excipients with known effect
Each tablet contains 176.20 mg lactose (as monohydrate) and up to 0.15
micrograms of sulphites per
tablet.
Each tablet contains 100 mg sumatriptan (as succinate).
Excipients with known effect
Each tablet contains 110.39 mg lactose (as monohydrate) and up to 0.3
micrograms of sulphites per
tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
_50 mg tablets:_
Pink, oblong tablet with a break notch on both sides.
The tablet can be divided into equal doses.
_100 mg tablets: _
White to slightly yellow, oblong tablet with a break notch on both
sides.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
{Nationally completed name} is indicated for the acute treatment of
migraine attacks with or without
aura.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
General recommendations with regard to use and administration:
Sumatriptan should not be used prophylactically.
Sandoz B.V.
Page 2/10
Sumatriptan 50/100 mg, tabletten
RVG 29126-7
1311-V10
1.3.1.1 Summary of Product Characteristics
Augustus 2020
Sumatriptan is recommended as monotherapy for the acute treatment of a
migraine attack and should
not be given concomitantly with ergotamine or derivatives of
ergotamine (including methysergide)
(see section 4.3).
It is advisable that sumatriptan be given as early as possible after
the onset of a migraine headache. It
is equally effective at whatever stage of the attack it is
administered.
Posology
The following recommended doses of sumatriptan should not be exceeded.
_Adults _
The recommended dose for adults is 50 mg sumatriptan. Some patients
may require 100 mg
sumatriptan.