Imigran 50mg tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Sumatriptan succinate

Sẵn có từ:

GlaxoSmithKline UK Ltd

Mã ATC:

N02CC01

INN (Tên quốc tế):

Sumatriptan succinate

Liều dùng:

50mg

Dạng dược phẩm:

Oral tablet

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 04070401; GTIN: 5000123108053 5000123108107

Tờ rơi thông tin

PACKAGE LEAFLET: INFORMATION FOR THE USER
IMIGRAN
® 50 MG TABLETS
(sumatriptan succinate)
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.
The name of your medicine is Imigran 50 mg Tablets, but will be
referred to as Imigran throughout the remainder of the leaflet.
Your medicine is also available in a 100 mg strength.
WHAT IS IN THIS LEAFLET
1.
WHAT IMIGRAN IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE IMIGRAN
3.
HOW TO USE IMIGRAN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE IMIGRAN
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT IMIGRAN IS AND WHAT IT IS USED FOR
EACH IMIGRAN TABLET CONTAINS A SINGLE DOSE of sumatriptan, which
belongs to a group of medicines called triptans _(also known as 5-HT_
_1_
_ _
_receptor agonists)_.
IMIGRAN IS USED TO TREAT MIGRAINE HEADACHE.
Migraine symptoms may be caused by the temporary widening of
blood vessels in the head. Imigran 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
feeling or being sick (nausea or vomiting) and sensitivity to light
and
sound.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE IMIGRAN
DON’T USE IMIGRAN:
•
IF YOU’RE ALLERGIC to sumatriptan, or any of the other ingredients
of
this 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 cram

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Imigran Tablets 50mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
50mg sumatriptan base as the succinate salt.
Excipient with known effect:
70 mg lactose monohydrate/tablet.
140 mg lactose/tablet.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
_50 mg tablet: _Pink, film-coated, capsule-shaped, biconvex tablet (of
nominal
dimensions: 12 mm x 6.5 mm), engraved “50” on one face and plain
on the
other face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imigran tablets are indicated for the acute relief of migraine
attacks, with or without
aura. Imigran should only be used where there is a clear diagnosis of
migraine.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
Imigran is indicated for the acute intermittent treatment of migraine.
It should not be
used prophylactically. The recommended dose of Imigran should not be
exceeded.
It is advisable that Imigran 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 Imigran 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 Imigran 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. Imigran
may be taken for subsequent attacks.
Imigran is recommended as monotherapy for the acute treatment of
migraine and
should not be given concomitantly with ergotamine or derivatives of
ergotamine
(including methysergide) (see section 4.3).
The tablets should be swallowed whole with water.
_Paediatric population _
The efficacy and safety of Imigran in children aged l