IMITREX TABLETS 50 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SUMATRIPTAN AS SUCCINATE

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

N02CC01

Pharmaceutical form:

FILM COATED TABLETS

Composition:

SUMATRIPTAN AS SUCCINATE 50 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

GLAXO SMITH KLINE PHARMACEUTICALS S.A., POLAND

Therapeutic group:

SUMATRIPTAN

Therapeutic area:

SUMATRIPTAN

Therapeutic indications:

Imitrex tablets are indicated for the acute relief of migraine attacks, with or without aura. Imitrex should only be used where there is a clear diagnosis of migraine.

Authorization date:

2021-10-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH
THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed according to a physician's prescription only
IMITREX TABLETS 50 MG
FILM-COATED TABLETS
Each tablet contains:
SUMATRIPTAN (AS SUCCINATE) 50 MG
IMITREX TABLETS 100 MG
FILM-COATED TABLETS
Each tablet contains:
SUMATRIPTAN (AS SUCCINATE) 100 MG
For the list of inactive and allergenic ingredients in the
preparation, see
section 2 – “Important information about some of the ingredients
of the
medicine” and section 6 – “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet
contains concise information about the medicine. If you have any other
questions, refer to the physician or the 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.
1. WHAT IS THE MEDICINE INTENDED FOR?
Imitrex Tablets is indicated for the acute relief of migraine attacks,
with or
without aura.
Imitrex Tablets should only be used where there is a clear diagnosis
of
migraine.
Migraine symptoms may be caused by the temporary widening of blood
vessels in the head. Imitrex Tablets 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 nausea or vomiting and
sensitivity to light and sound.
THERAPEUTIC GROUP
Analgesics: triptans - selective 5-HT
1
receptor agonists.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE:
• IF YOU ARE SENSITIVE (ALLERGIC) to sumatriptan or to any of the
additional
ingredients contained in the medicine (listed in section 6).
• IF
YOU
HAVE
A
HEART
PROBLEM
such
as
narrowing
of
the
arteries
(
ischaemic heart disease
) or chest pains (
angina
), or have already had a
heart attack.
• IF YOU HAVE CIRCULATION PROBLEMS IN YOUR LEGS that cause cramp-like
pains when you walk (
peripheral vascular disease
).
• IF YOU HAVE HAD A STROKE or a mini-stro

Summary of Product characteristics

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1
of
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IMITREX TABLETS 50
MG IMITREX TABLETS 100 MG
PRODUCT SUMMARY
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Imitrex Tablets 50 mg
Imitrex Tablets 100 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION IMITREX TABLETS 50 MG:
50 mg sumatriptan base as the succinate salt.
Excipient with known effect:
70 mg lactose monohydrate/tablet.
140 mg lactose anhydrous/tablet. IMITREX TABLETS 100 MG:
100 mg sumatriptan base as the succinate salt.
Excipient with known effect:
140 mg lactose monohydrate/tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablets
_50 mg tablet: _
Pink, film-coated, capsule-shaped, biconvex tablet, engraved '50'
on one face and plain on the other face.
_100 mg tablet: _
White or off-white, film-coated, capsule-shaped, biconvex
tablet engraved '100' on one face and plain on the other face.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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Imitrex tablets are indicated for the acute relief of migraine
attacks, with or
without aura
.
Imitrex should only be used where there is a clear diagnosis of
migraine.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
Imitrex is indicated for the acute intermittent treatment of migraine.
It should
not be used prophylactically. The recommended dose of Imitrex should
not be
exceeded.
It is advisable that Imitrex be given as early as possible after the
onset of
migraine
attack but it is equally effective at whatever stage of the attack it
is
administered.
The recommended dose of oral Imitrex is a 50mg tablet. Some patients
may
require 100mg.
If the patient has responded to the first dose but the symptoms recur
a second
dose may be given provided that there is a minimum interval of two
hours
between the two doses. No more than 300mg should be taken in any 24
hour
period.
Patients who do not respond to the prescribed dose of Imitrex should
not take
a second dose for the same attack. In these cases the attack can be
treated with
paracetamol, acetylsalicylic acid, or non-steroidal anti-inflammatory
drugs.
Imitrex may