Migril tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Ergotamine tartrate; Cyclizine hydrochloride; Caffeine hydrate

Saadav alates:

Wockhardt UK Ltd

ATC kood:

N02CA52

INN (Rahvusvaheline Nimetus):

Ergotamine tartrate; Cyclizine hydrochloride; Caffeine hydrate

Annus:

2mg ; 50mg ; 100mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Never Valid To Prescribe As A VMP

Toote kokkuvõte:

BNF: 04070401; GTIN: 5012727903545

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
MIGRIL® TABLETS
Ergotamine Tartrate 2mg, Cyclizine Hydrochloride 50mg and Caffeine
Hydrate 100mg
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.
WHAT IS IN THIS LEAFLET:
1. What Migril® Tablets are and what they are used for
2. What you need to know before you take Migril® Tablets
3. How to use Migril® Tablets
4. Possible side effects
5. How to store Migril® Tablets
6. Contents of the pack and other information
_ARE AND WHAT THEY ARE USED F_
1. WHAT MIGRIL®
TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Migril® Tablets. Migril® Tablets
contain the active substances ergotamine
tartrate, cyclizine hydrochloride and caffeine hydrate. These tablets
belong to a group of medicines called
vasoconstrictors and anti-emetics. Vasoconstrictors cause narrowing of
the blood vessels and anti-emetics
stop you feeling and being sick.
Migril® Tablets are used in the treatment of migraines to relieve the
symptoms and to stop the attack getting
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIGRIL® TABLETS
DO NOT TAKE MIGRIL® TABLETS IF:
• you are allergic (hypersensitive) to ergotamine tartrate,
cyclizine hydrochloride, caffeine hydrate or to any of
the other ingredients in this medicine (see section 6, Contents of the
pack and other information)
• you are suffering from kidney or liver disease
• you are suffering from angina, coronary heart disease or high
blood pressure
• you are suffering from temporal arteritis
• you are suffering from a condition called por

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Migril Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ergotamine tartrate 2.0mg, cyclizine hydrochloride 50.0mg and caffeine
equivalent
to caffeine hydrate 100mg.
For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, round, biconvex compression-coated tablets with a pink core,
scored and
impressed ‘CP A4A’.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Migril is indicated for the relief of acute migraine attack
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults: _Migril should be taken as soon as possible after the first
warning of an attack
of migraine and repeated if necessary at the prescribed intervals.
The usual initial dose is one tablet.
Additional doses of a half to one tablet may then be required at
half-hourly intervals.
No more than 3 tablets (6 mg ergotamine) should be taken in any 24
hours or 4 tablets
(8mg ergotamine) during any one attack.
The recommended minimum interval between successive courses is 4 days.
No more than 6 tablets (12 mg ergotamine) should be given in any one
week.
No more than two courses of treatment should be administered in a
month.
Use the minimum effective dosage of Migril necessary, since individual
sensitivity to
the arterial effects of ergotamine varies considerably.
_Children_: The use of Migril in children is not recommended.
_Use in the elderly: _There are no absolute contra-indications to the
use of Migril in the
elderly, but see Section 4.3 _'Contra-indications' _and Section 4.4
_'Precautions'._
4.3
CONTRAINDICATIONS
Co-administration of ergotamine with potent CYP3A4 inhibitors
(ritonavir,
nelfinavir, indinavir, amprenavir, azithromycin, erythromycin,
clarithromycin) has
been associated with acute ergot toxicity (ergotism) characterised by
vasospasm and
ischaemia of the extremities, with some cases resulting in amputation.
There have
been rare reports of cerebral ischaemia in patients on protease
inhibitor therapy when
ergotamine was co-administered, at least one resulting in death.