Zolmitriptan Sandoz smelttablet 5 mg, orodispergeerbare tabletten

Land: Holland

Sprog: hollandsk

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

Aktiv bestanddel:

ZOLMITRIPTAN 5 mg/stuk

Tilgængelig fra:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-kode:

N02CC03

INN (International Name):

ZOLMITRIPTAN 5 mg/stuk

Lægemiddelform:

Orodispergeerbare tablet

Sammensætning:

ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CITROENZUUR 0-WATER (E 330) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; SILICIUMDIOXIDE (E 551) ; SINAASAPPELSMAAKSTOF type Sweet Permaseal PHS-132960, ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CITROENZUUR 0-WATER (E 330) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; SILICIUMDIOXIDE (E 551) ; SINAASAPPELSMAAKSTOF type Sweet Permaseal PHS-132960,

Indgivelsesvej:

Oraal gebruik

Terapeutisk område:

Zolmitriptan

Produkt oversigt:

Hulpstoffen: ASPARTAAM (E 951); CELLULOSE, MICROKRISTALLIJN (E 460); CITROENZUUR 0-WATER (E 330); CROSPOVIDON (E 1202); MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); NATRIUMWATERSTOFCARBONAAT (E 500 (II)); SILICIUMDIOXIDE (E 551); SINAASAPPELSMAAKSTOF type Sweet Permaseal PHS-132960;

Autorisation dato:

1900-01-01

Indlægsseddel

Sandoz B.V.
Page 1/8
Zolmitriptan Sandoz
®
smelttablet 2,5/5 mg,
orodispergeerbare tabletten
RVG 106564+106565
1313-V4
1.3.1.3 Bijsluiter
Juni 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZOLMITRIPTAN SANDOZ
® SMELTTABLET, 2,5 MG, ORODISPERGEERBARE TABLETTEN
ZOLMITRIPTAN SANDOZ
® SMELTTABLET, 5 MG, ORODISPERGEERBARE TABLETTEN
zolmitriptan
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
[Nationally completed name] contains zolmitriptan and belongs to a
group of medicines called triptans.
[NATIONALLY COMPLETED NAME] IS USED TO TREAT MIGRAINE HEADACHE
IN ADULTS AGED 18 YEARS AND OLDER
.
•
Migraine symptoms may be caused by the widening of blood vessels in
the head. [Nationally
completed name] is thought to reduce the widening of these blood
vessels. This helps to take away the
headache and other symptoms of a migraine attack, such as feeling or
being sick (nausea or vomiting)
and being sensitive to light and sound.
•
[Nationally completed name] works only when a migraine attack has
started. It will not stop you from
getting an attack.
Sandoz B.V.
Page 2/8
Zolmitriptan Sandoz
®
smelttablet 2,5/5 mg,
orodispergeerbare tabletten
RVG 106564+106565
131

Produktets egenskaber

Sandoz B.V.
Page 1/11
Zolmitriptan Sandoz smelttablet, 2,5/5 mg,
orodispergeerbare tabletten
RVG 106564-106565
1311-V4
1.3.1.1 Samenvatting van de Productkenmerken
Juni 2021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zolmitriptan Sandoz smelttablet, 2,5 mg, orodispergeerbare tabletten
Zolmitriptan Sandoz smelttablet, 5 mg, orodispergeerbare tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_[2.5 mg] _
Each orodispersible tablet contains 2.5 mg of zolmitriptan.
Excipients with known effect
Each orodispersible tablet contains up to 25 ng of sulphites and 2.5
mg of aspartame.
_[5 mg] _
Each orodispersible tablet contains 5 mg of zolmitriptan.
Excipients with known effect
Each orodispersible tablet contains up to 50 ng of sulphites and 5 mg
of aspartame.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet.
_[2.5 mg] _
White, round, flat orodispersible tablets with ‘ZMT 2.5’ debossed
on one side.
_[5 mg]_
White, round, flat orodispersible tablets with ‘ZMT 5’ debossed on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] is indicated in adults aged 18 years and
older for acute treatment of
migraine headache with or without aura.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of
[
Nationally completed name] orodispersible tablets to treat a migraine
attack is 2.5 mg. It is advisable that [Nationally completed name] is
taken as early as possible after the
onset of migraine headache but it is also effective if taken at a
later stage.
If symptoms of migraine should recur within 24 hours following an
initial response, a second dose
may be taken. If a second dose is required, it should not be taken
within 2 hours of the initial dose. If a
Sandoz B.V.
Page 2/11
Zolmitriptan Sandoz smelttablet, 2,5/5 mg,
orodispergeerbare tabletten
RVG 106564-106565
1311-V4
1.3.1.1 Samenvatting van de Productkenmerken
Juni 2021
patient does not respond to the first dose, it is unlikely that a
second d