ZOMIG 2.5 MG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

ZOLMITRIPTAN

Tilgængelig fra:

ASTRAZENECA (ISRAEL) LTD

ATC-kode:

N02CC03

Lægemiddelform:

FILM COATED TABLETS

Sammensætning:

ZOLMITRIPTAN 2.5 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

ASTRA ZENECA UK LIMITED

Terapeutisk gruppe:

ZOLMITRIPTAN

Terapeutisk område:

ZOLMITRIPTAN

Terapeutiske indikationer:

Acute treatment of migraine with or without aura.

Autorisation dato:

2022-12-31

Indlægsseddel

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
Zomig
®
2.5 mg
Film-coated Tablets
Composition:
Each film-coated tablet contains:
Zolmitriptan 2.5 mg
For inactive ingredients, please see section 6 - "Further
Information".
Please also see section 2 – "Important information about some of the
ingredients of
the medicine
".
Read this leaflet carefully in its entirety before using the medicine.
This leaflet contains concise information about the medicine. If you
have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar.
This medicine is not recommended for children and adolescents under 18
years of
age and for adults over 65 years of age.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Treatment of migraine with or without aura.
Therapeutic group:
Triptans, selective serotonergic 5HT
1
agonist (5HT
1
agonists).
Migraine symptoms may be caused by swollen blood vessels in the head.
Zomig is
reducing the widening of these blood vessels. This helps to reduce the
headache and
other symptoms of a migraine attack, such as nausea or vomiting and
being sensitive
to light and sound.
Zomig works only when a migraine attack has started. It will not stop
you from getting
an attack.
2.
BEFORE USING THE MEDICINE
X Do not use the medicine if:
•
you are sensitive (allergic) to the active ingredient Zolmitriptan or
to any of the other
ingredients contained in the medicine (please see section 6).
•
you suffer from high blood pressure.
•
you suffer or have suffered in the past from heart problems, including
myocardial infarction
(heart attack), angina pectoris (chest pain caused by exercise or
effort), Prinzmetal's angina
(chest pain which happens at rest) or you have experienced
heart-related symptoms such as
shortness of breath or pressure over the chest.
•
you suffer from a

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zomig 2.5 mg Film Coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of zolmitriptan.
Excipient(s) with known effect
Each tablet contains 100 mg lactose anhydrous.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Film Coated Tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
‘Zomig’ is indicated for the acute treatment of migraine with or
without aura.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Zomig to treat a migraine attack is 2.5 mg.
If symptoms persist or return within 24 hours, a second dose 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.
In those patients who respond, significant efficacy is apparent within
1 hour of
dosing.
Zomig is equally effective whenever the tablets are taken during a
migraine attack;
although it is advisable that Zomig is taken as early as possible
after the onset of
migraine headache.
In the event of recurrent attacks, it is recommended that the total
intake of Zomig in a
24 hour period should not exceed 10 mg.
Zomig is not indicated for prophylaxis of migraine.
_Paediatric population (under 12 years of age) _
The safety and efficacy of Zomig tablets in children aged 0-12 years
has not yet been
established. No data are available. Use of Zomig in children is
therefore not
recommended.
_Adolescents (12 - 17 years of age)_
_ _
The efficacy of Zomig tablets was not demonstrated in a placebo
controlled clinical
trial for patients aged 12 to 17 years. Use of Zomig tablets in
adolescents is therefore
not recommended.
_Elderly _
Safety and efficacy of Zomig in individuals aged over 65 years have
not been
systematically evaluated.
_Hepatic impairment _
Metabolism is reduced in patients with hepatic impairment (see Section
5.2