MIGRIL TABLETS
Active substance(s): CAFFEINE / CYCLIZINE HYDROCHLORIDE / ERGOTAMINE TARTRATE
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(26.25cms)
Neutral code not required on the leaflet artworks.
4th fold
(26.25cms)
3rd fold
(26.25cms)
2nd fold
(26.25cms)
1st fold
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 to take this
medicine.
- Keep this leaflet. You may need to
read it again while you are receiving
your treatment.
- If you have any further questions,
please ask your doctor or
pharmacist.
- This medicine has been prescribed
for you. Do not pass it on to others.
It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Migril® Tablets are and what they are used for
2. Before you take Migril® Tablets
3. How to use Migril® Tablets
4. Possible side effects
5. How to store Migril® Tablets
6. Further information
1. What Migril® Tablets are and what they are used for
8th fold
(26.25cms)
7th fold
(26.25cms)
6th fold
(26.25cms)
5th fold
(26.25cms)
The name of your medicine is Migril® Tablets; 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. Before you take Migril® Tablets
You should 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, Further 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 porphyria which affects the
liver, skin or blood
• you have trouble with your circulation or cramp like pains in the leg
caused by bad circulation
• you have an overactive thyroid (hyperthyroidism)
• you are taking medicines used to treat bacterial infections (e.g.
quinupristin, dalfopristim, azithromycin, erythromycin or clarithromycin)
• you are taking medicines used to treat viral infections (protease
inhibitors e.g. amprenavir, ritonavir, nelfinavir or indinavir)
• you are taking medicines used to treat fungal infections (e.g.
ketoconazole or itraconazole)
• you are taking medicines used to treat ulcers (e.g. cimetidine)
• you are pregnant, wish to become pregnant or are breast-feeding.
Migril® Tablets are not recommended for children.
Talk to your doctor or pharmacist if:
• you have hepatitis
•
•
•
•
•
•
•
you have anaemia
you have problems with your heart
you have a blockage of the gut
you have a swollen prostate gland
you are suffering from glaucoma (high pressure in the eyeball)
you are having problems passing water
you are elderly.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
The following medicines can affect or be affected by treatment with
Migril® Tablets:
• beta-blockers: medicines used to treat high blood pressure, heart failure
or angina and may have been prescribed for treatment of migraines
• other medicines used to treat migraines (e.g. zolmitriptan,
almotriptan, sumatriptan, rizatriptan. frovatriptan). It is important not
to take these medicines for 24 hours after taking Migril® Tablets and
do not take Migril® Tablets for 6 hours after taking any of these
medicines
• eletriptan (used to treat migraines). It is important not to take this
medicine for 24 hours after taking Migril® Tablets and do not take
Migril® Tablets for 24 hours after taking eletriptan
• saquinavir (used in the treatment of HIV and other viral infections)
• metronidazole (used to treat certain types of infection)
• mexiletine (used to treat heart irregularities)
• disulfiram (used to treat alcohol dependence)
• lithium (used to treat manic depressive illness)
• clotrimazole and fluconazole (used to treat fungal infections)
• phenytoin (used in the treatment of epilepsy)
• glyceryl trinitrate (used to relieve angina)
• diazepam (used to treat anxiety or insomnia)
• atropine (used to treat gut spasm or as premedication before an
anaesthetic)
• oral contraceptive (The Pill), hormone injections or hormone
replacement treatment (HRT)
• medicines used to treat wheezing (e.g. theophylline) and
decongestants (e.g. phenylephrine or pseudoephedrine)
• medicines used to treat depression (e.g. nefazodone, fluoxetine and
fluvoxamine), tricyclic antidepressants (e.g. dothiepin, amitriptyline)
and monoamine oxidase inhibitors (MAOIs e.g. phenelzine)
• other medicines used to treat bacterial infections such as quinolones
(e.g. ciprofloxacin) or tetracyclines.
Taking Migril® Tablets with food and drink
• Grapefruit juice should be avoided while taking these tablets as it can
increase the risk of side effects
• Do not smoke or drink alcohol while taking this medicine.
Pregnancy and breast-feeding
You should not take Migril® Tablets if you are pregnant, wish to
become pregnant or are breast-feeding.
Driving and using machinery
It is possible that these tablets may make you feel drowsy. Do not drive
or operate machinery if affected.
Important information about some of the ingredients in Migril® Tablets
This medicine contains lactose and glucose. If you have been told by
your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicinal product).
103819/4
ART WORK CHECK BOX
PRODUCT :
CUSTOMER :
FP CODE:
PLANT LOCATION :
DIMENSIONS :
PHARMACODE No. :
SAP CODE No. :
TEXT FONT SIZE :
FILE NAME :
SOFTWARE :
TYPEFACES :
ARTWORK (DETAILS)
RECEIVED ON :
PROOF REVISION :
Black
Migril Tablets - 100 Tablets
Wockhardt UK
FP2128
Daman (Kadaiya)
(w) 177 x (h) 210mm
2587
222744
7 pt.
Migril Tablets_Leaflet_103819-3.ai
Adobe Illustrator CS5
Arial Regular / Bold
25th July & 3rd August, 2017
R 1st PDF sent on - 3RD AUG. 2017
R 2nd PDF sent on - 8TH AUG. 2017
CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Non-Regulatory
Changes in detail: • Text amend (’metabisulphate’ to ‘metabisulfate’;
‘sulphosuccinate’ to ‘sulfosuccinate’ & removed extra
word ‘take’ from point no.6)
You should also seek medical help immediately if:
• if you develop blueness, coldness, numbness or tingling in your
hands or feet
• if you have a headache most days and it is only relieved by taking
more of this medicine.
You should tell your doctor or pharmacist if you have any of the
following side effects:
• headaches, nausea, vomiting, dry mouth
• constipation, stomach pains, diarrhoea
• drowsiness, dizziness, (including vertigo)
• confusion, anxiousness or depression
• experiencing hallucinations
• sleep disturbances including insomnia
• difficulty in passing water
• muscle cramps, joint pains or pain in the legs
• pain in abdomen and swelling in one leg
• swelling of the skin or itching
• coldness and whiteness of the hands and feet or pins and needles
• a prickling feeling over your skin or numbness
• yellowing of the skin and general weak feeling
• blurred vision or any other visual disturbances (that you don’t think
are connected to your migraine).
Other side effects that have been reported include:
• an increase or decrease in blood pressure, fainting
• rapid and weak pulse, slow or irregular heart beat, or heightened
sense of your heart beating
1st fold
(26.25cms)
2nd fold
(26.25cms)
3rd fold
(26.25cms)
4th fold
(26.25cms)
6. Further information
What Migril® Tablets look like and the contents of the pack
Each white round tablet is marked with a score line, CP and ‘A4A’ on
the same side. These are available in bottles of 100 tablets.
Other formats
To listen to or request a copy of this information in Braille, large print or
audio please call, free charge: 0800 198 5000 (UK only)
5th fold
What Migril® Tablets contain
The active ingredients are: ergotamine tartrate 2mg, cyclizine
hydrochloride 50mg and caffeine hydrate 100mg.
The other ingredients are: lactose, maize starch, liquid glucose and
glucose, amaranth, dioctyl sodium sulfosuccinate, gelatin, sodium
metabisulfate and magnesium stearate.
(26.25cms)
As can happen with any medicine, a few people may develop an
allergic reaction. If you experience any of the following, seek medical
help immediately:
• rash, itching, difficulty breathing.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help protect the environment.
6th fold
Like all medicines, Migril® Tablets can cause side effects, although not
everybody gets them. Do not exceed the maximum dose or take the
tablets more often than as stated in this leaflet, this could lead to
dependence on this medicine as well as other serious side effects.
Keep out the reach and sight of children.
• Do not store above 25°C. Store in the original container do not
transfer your tablets to another container.
• Do not take this medicine after the expiry date on the label or if they
show signs of deterioration such as discolouration. The expiry date
refers to the last day of the month.
(26.25cms)
4. Possible side effects
5. How to store Migril® Tablets
Please be ready to give the following information:
Product name
Reference number
Migril Tablets
29831/0090
This is a service provided by the Royal National Institute for Blind People.
Marketing Authorisation Holder:
Wockhardt UK Ltd., Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer:
CP Pharmaceuticals Ltd., Ash Road North, Wrexham, LL13 9UF, UK.
7th fold
If you forget to take Migril® Tablets
If you forget a dose, take another as soon as you remember. If it is
almost time for your next dose, then do not take the missed dose at all.
NEVER take a double dose to make up for the one missed.
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. You can also report
side effects directly via the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
(26.25cms)
If you have taken more Migril® Tablets than you should
If you (anybody else or a child), takes more tablets than you should
contact your nearest hospital casualty department or your doctor
immediately. Always take the container with you even if empty.
angle-closure glaucoma
reduced blood supply or clotting in the arteries of the body or the brain
blockage of the arteries in the heart
pain in your chest or shortness of breath
thickening of the tissues in the lungs
tremors and convulsions
gangrene
blueness of the skin
fever
changes in the blood causing a
tendency to bleed or bruise easily.
Product License Number: PL 29831/0090
This leaflet was last revised in 08/2015.
Migril® is a trademark of CP Pharmaceuticals Limited ©1998
103819/4
222744
8th fold
Always take Migril® Tablets as your doctor has told you. Your doctor
will decide the right dose for you; this will be on the pharmacist’s label.
Check this carefully, it will tell you how many tablets to take and how
often to take them.
It is important that you do not take more than the dose agreed with
your doctor.
• The usual dosage for adults is one tablet as soon as possible after
the first signs of a migraine.
• Extra doses of a half to one tablet at half-hourly intervals, may be
required in some cases.
• Do not take more than 4 tablets during any one attack and no more
than 3 tablets in a 24-hour period, you must leave a gap of at least 4
days before taking any more tablets.
• Do not take more than 6 tablets in a week.
• Do not take more than two courses of Migril® Tablets in a month.
Do not take Migril® Tablets on a regular basis or to prevent a migraine
attack. Regular use can lead to dependence and ‘rebound headaches’
which in turn may lead you to take tablets more often.
•
•
•
•
•
•
•
•
•
•
(26.25cms)
3. How to use Migril® Tablets
Neutral code not required on the leaflet artworks.
4th fold
(26.25cms)
3rd fold
(26.25cms)
2nd fold
(26.25cms)
1st fold
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 to take this
medicine.
- Keep this leaflet. You may need to
read it again while you are receiving
your treatment.
- If you have any further questions,
please ask your doctor or
pharmacist.
- This medicine has been prescribed
for you. Do not pass it on to others.
It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Migril® Tablets are and what they are used for
2. Before you take Migril® Tablets
3. How to use Migril® Tablets
4. Possible side effects
5. How to store Migril® Tablets
6. Further information
1. What Migril® Tablets are and what they are used for
8th fold
(26.25cms)
7th fold
(26.25cms)
6th fold
(26.25cms)
5th fold
(26.25cms)
The name of your medicine is Migril® Tablets; 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. Before you take Migril® Tablets
You should 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, Further 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 porphyria which affects the
liver, skin or blood
• you have trouble with your circulation or cramp like pains in the leg
caused by bad circulation
• you have an overactive thyroid (hyperthyroidism)
• you are taking medicines used to treat bacterial infections (e.g.
quinupristin, dalfopristim, azithromycin, erythromycin or clarithromycin)
• you are taking medicines used to treat viral infections (protease
inhibitors e.g. amprenavir, ritonavir, nelfinavir or indinavir)
• you are taking medicines used to treat fungal infections (e.g.
ketoconazole or itraconazole)
• you are taking medicines used to treat ulcers (e.g. cimetidine)
• you are pregnant, wish to become pregnant or are breast-feeding.
Migril® Tablets are not recommended for children.
Talk to your doctor or pharmacist if:
• you have hepatitis
•
•
•
•
•
•
•
you have anaemia
you have problems with your heart
you have a blockage of the gut
you have a swollen prostate gland
you are suffering from glaucoma (high pressure in the eyeball)
you are having problems passing water
you are elderly.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
The following medicines can affect or be affected by treatment with
Migril® Tablets:
• beta-blockers: medicines used to treat high blood pressure, heart failure
or angina and may have been prescribed for treatment of migraines
• other medicines used to treat migraines (e.g. zolmitriptan,
almotriptan, sumatriptan, rizatriptan. frovatriptan). It is important not
to take these medicines for 24 hours after taking Migril® Tablets and
do not take Migril® Tablets for 6 hours after taking any of these
medicines
• eletriptan (used to treat migraines). It is important not to take this
medicine for 24 hours after taking Migril® Tablets and do not take
Migril® Tablets for 24 hours after taking eletriptan
• saquinavir (used in the treatment of HIV and other viral infections)
• metronidazole (used to treat certain types of infection)
• mexiletine (used to treat heart irregularities)
• disulfiram (used to treat alcohol dependence)
• lithium (used to treat manic depressive illness)
• clotrimazole and fluconazole (used to treat fungal infections)
• phenytoin (used in the treatment of epilepsy)
• glyceryl trinitrate (used to relieve angina)
• diazepam (used to treat anxiety or insomnia)
• atropine (used to treat gut spasm or as premedication before an
anaesthetic)
• oral contraceptive (The Pill), hormone injections or hormone
replacement treatment (HRT)
• medicines used to treat wheezing (e.g. theophylline) and
decongestants (e.g. phenylephrine or pseudoephedrine)
• medicines used to treat depression (e.g. nefazodone, fluoxetine and
fluvoxamine), tricyclic antidepressants (e.g. dothiepin, amitriptyline)
and monoamine oxidase inhibitors (MAOIs e.g. phenelzine)
• other medicines used to treat bacterial infections such as quinolones
(e.g. ciprofloxacin) or tetracyclines.
Taking Migril® Tablets with food and drink
• Grapefruit juice should be avoided while taking these tablets as it can
increase the risk of side effects
• Do not smoke or drink alcohol while taking this medicine.
Pregnancy and breast-feeding
You should not take Migril® Tablets if you are pregnant, wish to
become pregnant or are breast-feeding.
Driving and using machinery
It is possible that these tablets may make you feel drowsy. Do not drive
or operate machinery if affected.
Important information about some of the ingredients in Migril® Tablets
This medicine contains lactose and glucose. If you have been told by
your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicinal product).
103819/4
ART WORK CHECK BOX
PRODUCT :
CUSTOMER :
FP CODE:
PLANT LOCATION :
DIMENSIONS :
PHARMACODE No. :
SAP CODE No. :
TEXT FONT SIZE :
FILE NAME :
SOFTWARE :
TYPEFACES :
ARTWORK (DETAILS)
RECEIVED ON :
PROOF REVISION :
Black
Migril Tablets - 100 Tablets
Wockhardt UK
FP2128
Daman (Kadaiya)
(w) 177 x (h) 210mm
2587
222744
7 pt.
Migril Tablets_Leaflet_103819-3.ai
Adobe Illustrator CS5
Arial Regular / Bold
25th July & 3rd August, 2017
R 1st PDF sent on - 3RD AUG. 2017
R 2nd PDF sent on - 8TH AUG. 2017
CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Non-Regulatory
Changes in detail: • Text amend (’metabisulphate’ to ‘metabisulfate’;
‘sulphosuccinate’ to ‘sulfosuccinate’ & removed extra
word ‘take’ from point no.6)
You should also seek medical help immediately if:
• if you develop blueness, coldness, numbness or tingling in your
hands or feet
• if you have a headache most days and it is only relieved by taking
more of this medicine.
You should tell your doctor or pharmacist if you have any of the
following side effects:
• headaches, nausea, vomiting, dry mouth
• constipation, stomach pains, diarrhoea
• drowsiness, dizziness, (including vertigo)
• confusion, anxiousness or depression
• experiencing hallucinations
• sleep disturbances including insomnia
• difficulty in passing water
• muscle cramps, joint pains or pain in the legs
• pain in abdomen and swelling in one leg
• swelling of the skin or itching
• coldness and whiteness of the hands and feet or pins and needles
• a prickling feeling over your skin or numbness
• yellowing of the skin and general weak feeling
• blurred vision or any other visual disturbances (that you don’t think
are connected to your migraine).
Other side effects that have been reported include:
• an increase or decrease in blood pressure, fainting
• rapid and weak pulse, slow or irregular heart beat, or heightened
sense of your heart beating
1st fold
(26.25cms)
2nd fold
(26.25cms)
3rd fold
(26.25cms)
4th fold
(26.25cms)
6. Further information
What Migril® Tablets look like and the contents of the pack
Each white round tablet is marked with a score line, CP and ‘A4A’ on
the same side. These are available in bottles of 100 tablets.
Other formats
To listen to or request a copy of this information in Braille, large print or
audio please call, free charge: 0800 198 5000 (UK only)
5th fold
What Migril® Tablets contain
The active ingredients are: ergotamine tartrate 2mg, cyclizine
hydrochloride 50mg and caffeine hydrate 100mg.
The other ingredients are: lactose, maize starch, liquid glucose and
glucose, amaranth, dioctyl sodium sulfosuccinate, gelatin, sodium
metabisulfate and magnesium stearate.
(26.25cms)
As can happen with any medicine, a few people may develop an
allergic reaction. If you experience any of the following, seek medical
help immediately:
• rash, itching, difficulty breathing.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help protect the environment.
6th fold
Like all medicines, Migril® Tablets can cause side effects, although not
everybody gets them. Do not exceed the maximum dose or take the
tablets more often than as stated in this leaflet, this could lead to
dependence on this medicine as well as other serious side effects.
Keep out the reach and sight of children.
• Do not store above 25°C. Store in the original container do not
transfer your tablets to another container.
• Do not take this medicine after the expiry date on the label or if they
show signs of deterioration such as discolouration. The expiry date
refers to the last day of the month.
(26.25cms)
4. Possible side effects
5. How to store Migril® Tablets
Please be ready to give the following information:
Product name
Reference number
Migril Tablets
29831/0090
This is a service provided by the Royal National Institute for Blind People.
Marketing Authorisation Holder:
Wockhardt UK Ltd., Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer:
CP Pharmaceuticals Ltd., Ash Road North, Wrexham, LL13 9UF, UK.
7th fold
If you forget to take Migril® Tablets
If you forget a dose, take another as soon as you remember. If it is
almost time for your next dose, then do not take the missed dose at all.
NEVER take a double dose to make up for the one missed.
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. You can also report
side effects directly via the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
(26.25cms)
If you have taken more Migril® Tablets than you should
If you (anybody else or a child), takes more tablets than you should
contact your nearest hospital casualty department or your doctor
immediately. Always take the container with you even if empty.
angle-closure glaucoma
reduced blood supply or clotting in the arteries of the body or the brain
blockage of the arteries in the heart
pain in your chest or shortness of breath
thickening of the tissues in the lungs
tremors and convulsions
gangrene
blueness of the skin
fever
changes in the blood causing a
tendency to bleed or bruise easily.
Product License Number: PL 29831/0090
This leaflet was last revised in 08/2015.
Migril® is a trademark of CP Pharmaceuticals Limited ©1998
103819/4
222744
8th fold
Always take Migril® Tablets as your doctor has told you. Your doctor
will decide the right dose for you; this will be on the pharmacist’s label.
Check this carefully, it will tell you how many tablets to take and how
often to take them.
It is important that you do not take more than the dose agreed with
your doctor.
• The usual dosage for adults is one tablet as soon as possible after
the first signs of a migraine.
• Extra doses of a half to one tablet at half-hourly intervals, may be
required in some cases.
• Do not take more than 4 tablets during any one attack and no more
than 3 tablets in a 24-hour period, you must leave a gap of at least 4
days before taking any more tablets.
• Do not take more than 6 tablets in a week.
• Do not take more than two courses of Migril® Tablets in a month.
Do not take Migril® Tablets on a regular basis or to prevent a migraine
attack. Regular use can lead to dependence and ‘rebound headaches’
which in turn may lead you to take tablets more often.
•
•
•
•
•
•
•
•
•
•
(26.25cms)
3. How to use Migril® Tablets
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
