ZOMIG RAPIMELT

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

ZOLMITRIPTAN

Dostupné z:

ASTRA ZENECA (ISRAEL) LTD

ATC kód:

N02CC03

Forma lieku:

TABLETS SOLUBLE IN MOUTH

Zloženie:

ZOLMITRIPTAN 2.5 MG

Spôsob podávania:

PER OS

Typ predpisu:

Required

Výrobca:

ASTRA ZENECA UK LIMITED

Terapeutické skupiny:

ZOLMITRIPTAN

Terapeutické oblasti:

ZOLMITRIPTAN

Terapeutické indikácie:

Acute treatment of migraine with or without aura.

Dátum Autorizácia:

2012-05-31

Súhrn charakteristických

ZOMIG RAPIMELT approved 0509
Page of 10
1
“This leaflet format has been determined by the Ministry of Health
and the content thereof has been checked and
approved 01.2012.”
SUMMARY OF PRODUCT CHARACTERISTICS ZOMIG 2.5 MG SOLUBLE IN MOUTH
1.
TRADENAME OF THE MEDICINAL PRODUCT
‘Zomig Rapimelt’ 2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets soluble in mouth containing 2.5 mg of zolmitriptan.
For excipients: see Section 6.1
3.
PHARMACEUTICAL FORM
Tablets soluble in mouth.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
‘Zomig Rapimelt’ is indicated for the acute treatment of migraine
with or without
aura.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose of ‘Zomig Rapimelt’ to treat a migraine
attack is 2.5 mg.
‘Zomig Rapimelt’ rapidly dissolves when placed on the tongue and
is swallowed
with the patient’s saliva. A drink of water is not required when
taking ‘Zomig
Rapimelt’. ‘Zomig Rapimelt’ can be taken when water is not
available thus
allowing early administration of treatment for a migraine attack. This
formulation
may also be beneficial for patients who suffer from nausea and are
unable to drink
during a migraine attack, or for patients who do not like swallowing
conventional
tablets.
If symptoms persist or return within 24 hours, a second dose of
zolmitriptan has
been shown to be effective. If a second dose is required, it should
not be taken
within 2 hours of the initial dose.
If a patient does not achieve satisfactory relief with 2.5 mg doses,
subsequent
attacks can be treated with 5 mg doses of ‘Zomig Rapimelt’. In
those patients who
respond, significant efficacy is apparent within 1 hour of dosing with
zolmitriptan.
Zolmitriptan is equally effective whenever the tablets are taken
during a migraine
attack; although it is advisable that ‘Zomig Rapimelt’ is taken as
early as possible
after the onset of migraine headache.
ZOMIG RAPIMELT approved 0509
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2
In the event of recurrent attacks, it is recommended that the total
intake of ‘Zomig
Rap