Zomig 2,5 mg Filmdragerad tablett

Ülke: İsveç

Dil: İsveççe

Kaynak: Läkemedelsverket (Medical Products Agency)

Aktif bileşen:

zolmitriptan

Mevcut itibaren:

Paranova Läkemedel AB

ATC kodu:

N02CC03

INN (International Adı):

zolmitriptan

Doz:

2,5 mg

Farmasötik formu:

Filmdragerad tablett

Kompozisyon:

laktos (vattenfri) Hjälpämne; zolmitriptan 2,5 mg Aktiv substans

Reçete türü:

Receptbelagt

Terapötik alanı:

Zolmitriptan

Yetkilendirme durumu:

Avregistrerad

Yetkilendirme tarihi:

2003-03-26

Ürün özellikleri

1.
NAME OF THE MEDICINAL PRODUCT
Zomig 2.5 mg film-coated tablets
Zomig 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 mg film-coated tablet contains 2.5 mg zolmitriptan.
Each 5 mg film-coated tablet contains 5 mg zolmitriptan.
Excipients with known effect
Each 2.5 mg film-coated tablet contains 100 mg lactose.
Each 5 mg film-coated tablet contains 200 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Round, biconvex, yellow or pink film-coated tablets containing 2.5 mg
and 5 mg of zolmitriptan
respectively. The tablets are intagliated with the letter ‘Z’ on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zomig 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 Zomig tablets to treat a migraine attack is
2.5 mg. It is advisable that
Zomig tablets are taken as early as possible after the onset of
migraine headache but they are 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
patient does not respond to the first dose, it is unlikely that a
second dose will be of benefit in the same
attack.
If a patient does not achieve satisfactory relief with 2.5 mg doses,
for subsequent attacks 5 mg doses of
Zomig could be considered.
The total daily intake should not exceed 10 mg. Not more than 2 doses
of Zomig should be taken in
any 24-hour period.
Zomig is not indicated for prophylaxis of migraine.
Zolmitriptan 2,5 mg; 5 mg
Film-coated tablet
_Paediatric population_
_Use in Children (under 12 years of age) _
The safety and efficacy of zolmitriptan tablets in children aged birth
to <
12 years have not been
established. No data are available. Use of Zomig in children is
therefore not recommended.
_Ad