MIGRALEVE

Active substance: PARACETAMOL DC 96%

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2 Before taking this medicine

Mig",'eve
Paracetamol, Codeine & Bucllzlne
• Fer the short tenn treatment of acute moderate pain which Is nat relieved
by panDllamol, ibuprofen or aspiril alone Sl£h as migraine atIacks,
inclllling the symptoms 01 mi,aine headache, reusee nI Wlmiting.
• '1tiu should only take this product for a maximum of three days at a time.

If you need 'Ill 'lake it for longer tIltn three days you should 888 your
doctor or pharmacist for advice.
• This medicina contains codeine which can C8lBII addiction if you takB iI
continuously fur moru than three days. This can give you withdrawal
symptoms from the medicine when you _laking it
• nyou lake this medicine for headaches for more than three days ncan
make them worse.
• This medicine Is for use by adulls and children aged 12 years and over.

• tfyou have ...... cIIeae.
• tfyou drink IIrge IlIIIIIInil oIllcohoI, you may be more open to
the side effects of paracetamol.
nyou are oot sure about the medicine you Bre taking, show the battle

or pack 10 your pharmacist.

n any of these bul~ points apply to you now or in IhII past, talk to •
directed by your doctor.
A docIor or pharrnlclll:.
This IIlIIdlclne Is sullable lor most people but a few people shoukl lilt use .... WBmilgs and pracaulions
It. n you are In any doobt, talk to your dOClDr or phannaclst.
Codeine Is transformed to morphine In the liver by an enzyme.
r'J
Morphine Is the substance that produces pain relief. Some people
[;,,] Do not use Ihls medicine...
have a variation of this enzyme and this can affect people In different


tf~..:m~~r8ecnb9d Ulis product do not 'lake it for lOnger than

• Unless your migraines have been cIagIaed by • doclDr.
• n you have taken any other painkillers In the last IotJr hours.

ways. In some P8Dple, morphine Is nat produced or produced In very
small quantitiss, and itwill nat pl'lN'ideenough pain relief. Other
people are mOl'llikely to get serious sidellffects because avery high
amount of morphine is produced. n you notice any of the following
Sida effects, you must stop taking this madicine and I!I8EIk immediate
medical advice: slow or shallow breathing, confusion, aleepinllll8,
small pupils, feeling or being sick, constipation, lack of appetite.

• nyou have ever had abad ........ 10 Mlgraleve or any of lis
Ingredients. .

..

..

• nYl!.u are taki~g other madlClnes contaimng paracdlmaI.
• n illS!or a ~hl.1d u~dIr 12 yean of III·

• For pain relief !n chll!:lren and ~Iescents (0-18 Y8:8'"S of ags) after A
re":~ their tenliis or adenOids due 10 obstructive sleep apnoea .... Children and

. . .......... whOIIllIfIIt CII1fuIIJ bIIon yau _Ihl.lftldlclna.
Keep the 1eHfIst: you might need it again.

n

adolescents

lIII ~ cIIIldl'lll_lIIIDIIIcInIIlfIiIr ....ry
Codeine lIhould not be lI88d for pain relief in children and adollllC8llls
after remaval 01 their 'IIlnsils or adenoids dUll to ObslructiY8 Sleap
Ajmea Syndrome.

• &u know that you rneIaboli911 wry rapidly codeine into morphine
• nyou are breutfeeding
any of these apply 1D you,
from • daclar II" phumllllll:
wiIhDut: _III Mi.........

1 What the medicine is for
For the short term treatment of acute moderate pain which Is not relieved
by paracetamol, Ibuprofen or aspirin alone such as migraine attacks,
Including the symptoms 01 migraine headache, nausea and vommng.
There are two types of Migraleve tablet available:
• MllrWIi ~k tablets
• MlgrWn"Mow tabiD
They are available aeparately or together in one pack.
Migral... Pink 1abI8Is oontai1 paracelamol and codeine which III8SII8 pain
and budizine which helps relieve nausea and Wlmiling.1he Pink tablets
theralore treat all the symptoms rI migraine. n taken at the fi'sI sign of a
migraine, Mil18leve Pink 1abletl!l can prevent an attack from develOpilg.
Migral... .,.llow tablets colTlaln paracetamol and codeine for the
treatment 01 pain and relief 01 conIInulng migraine symlJtDms. They should
always be taken i!l'ter the IIrst dose 01 MlgraJeve Pink tablels.
Codeine can be used In children over 12 years 01 age for the short-term
relief of moderate pain that Is not relieved by other palnldllers such as
paracetamol or Ibuprofen alone.
This product contaillll codeine. Codeine belongs 1:1 a grtql of medicines
called opioid analgesics which m:t to relilMl pain. It can be lIIed on ill own
or in combination with other pain killn such as paracetarnol.

" you """ .........._ _ (u."ary ....nHon).

_ 1111s medicine contains codeine which can cause addlctloo If you take
n continuously for more than three days. 111ls can give you wllhdrawal
symptoms frol!' '11:111 medicine when you stop taking i t .
• If you 'lake II pamkiller for headaches for more than three days it can

am __

A Talk to JOur doctororo:.e:nnacist...
• nyou
.......

"" ....." ... - ......,...CodIIIIlIIs not recommendad In children with brelllhing problems,

IIUfI8r fnIn . . .

• nyou IIUfI8r fnIn .1I:ahaIc II..- . . . . or .1I:ahaIc IIIIpIndInw.
since the symptoms of morphine toxicity may be worse in these
• nyou are IBkIng any other pnalbid mlldlclna
A children.
• nyou lire IIIkIng, or have taken ~ the last bwI weeks, . . tar
.... HyOU are pregnant or breastreedlna
depreakln known as Monoamine OxIdase Inhlblin (MA01s).
AiM. your doctDr or pharmacist for advice before liking this medicine If
• nyou have '*-lingle gllllxln. Oncreued presue In the eye).
you are pregnant
• nyou are IBkIng any other meclclnes Inclllllng:
Do not take codeine while you are breastfeedlng. Codeine and
• metJckJpnMrJldeor dompetIdone (used to treat _ _ and

...,"""_Q

'lDll'l1Ing)

• _ ( u s e d ..
• ~ (drugs thaI'IIIIn . . blDad, such as warfarin)
• aJtimusciriIic tttclS 8.(1.:
- ~ (drug IJSlId _ _ ' " condili_ and
_
kltnlal: some
- tric)dc ant~:lIra.rta (drugs 1:1 Ir8aI mood dilordn)
• CNIfci8ptrJ86tIntJ ag.:
- hypnoIicB (1IIepI11II tullll in::ludq barbiillalBs)
- 8f1dtltiwIs (drugs UIIBd 1:1 prudIIce CII.- or 10 hIIp yau
"",".lO'~

.....)

=~~= .:oo~re~=:eg~~
'Iran1aOOI, ITIIIJIhlne)

epot " 12 x 2 centered In
the margin of 14 mm

....
A

morphine passes into breast milk.

Special warnings about drowsl....
11IBse tabiD may caulll drowsinB8B. If affected do not operaIB
machinery.
This medicine can affect , - abilih. to drive.
IIn"r
.,
Do not drive whilst taking this medicine until you know how this
medicine IfIecIs you.
n may be an offence 1:1 drive when taking this medicine if your ability
to drive Iltfaly ie affacI8d. Talk 10 your doctor or phannaciSl if you are
nat sure whether iI is safu for you to drive while taking this medicine.
There Is further Infonnatlon for patients who are Intending 10 drive In
the UK - go to htIps:llwww.gov.ukldrug-drtvlng-law.
Avoid alcoholic drink.
turn over ....

Distance between cutted linelmiddel of the spot '" 83.1 mm

Barcodes placed at 14 mm
Hight for bars : 10 mm

,.

reading way

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3 How to take this medicine

Check the 1lIbies _
1lIk8.

to see how ..,00 medicine to

• For oral UM only. Swallow the tablets with a glass of water.
• Do not take less than IotJr hours after taking other painkillers.
• Nwfr{s start with Migraleve Pink tabiD.
• Do not take more than the stated do9II shown below.
• Thill medicine should nat be 'laken for more than 3 days. If the pain
does not Improve after 3 days, talk to your docIDr fur advice.

. , Chlkhn under 12

r.::

This medicine should not e taken by children below the age of 12
years, due 10 the risk 01 severe brelllhing problems.

..... -

. , ChikhnI2-14y&1118
Ago

Chldren
12-14

,...

Swallow 1 IIlgrallM Pink tablet at the first
sl!1l of a migraine atlack.lfthe migraine persists,
then take 1 M...., VIIlaw' tablet 4 hours
aIIer the Pink dose and then every 4 hours.

• Da nat 'lake mll8 than 4 tablets (1 pink and 3 yellow) in a
24 hour period.
• If symptoms persist for mll"e than 3 days, talk to your docIDr.

. , Adulis and Chlllhn15 yean; and over
Ago

_ron
,
........

Adulll ....

Swallow 2111gralIM Pink tablets at the 1Irst
sl!1l of a migraine atlack.lfthe migraine persists,
then take 2 MI!JUve YelIaW' tablets 4 hours
aIIer the Pink dose and then every 4 hours.

• Da nat take more than 8 tablets (2 pink and 6 yellow) In a
24 hour period.
• If symptoms persist for mOl'l than 3 days, talk to your docIDr.

A II =. has too much
1m

A.

ale meclcal advice should be sought In the event rllIl

DWI1Iose, even If you feel well, because 01 the risk of delayed, serious
liver damage. Thke tID leaIIet l1li any remaining 1ablels \YIIh you.

II JOU forget to 1lI1ce the medicine

'mu should only"lake this medicine as required following the dosage
Instructions above carefully. If you forget 10 take a dose, take the
next dose when ll8eded provided that the last dose was taken at
least 4 hDln ago. Do nDI take a double dose. Rlmlllllllr IhIt yau
Cln onlJ takI Gill Migral. . Pink ..... In any 24 .....r PII'Iad.

A !!P&Cial warnings about addictioo
can

ThIS mediCine contains codeine and
cauee addiction if you take
it continuDllllyfor more than three days. When you stop taking iI
you may gut withdrawal sympltrns. You should talk 1:1 your doctor
or pharmacist if you think you are suffering from withdrawal
symptoms.

4 Possible side-effects
Some I*lple may have slde-effects when taking this medicine. If you have
any unwanl8d slde-1fIIICIs you should SIlk. advice from your doctDr or
other heaJthcare professional.
Also you can help 10 make sure that medicines remain as safe as possible
by
.ny UllWlnlld Ild.1fIeI:tI vi. . . ~II:
• _.'IIIIDWCII'd.JlDV.Uk; alternatively you can call ~GIII
"'100 33152 (available between 1C1am-2pm Monday - Friday) or
III in • PlPII" form available from your local pharmacy.
Migralave can have aidHffeCl8, like all medicines, although these don't
affect B\I8I)'OOB and are usually mild.

rIPG_

nyou axperience any of Iha followmg, stop u"g
Iha medicine and tall your doctor.

• Allergic r88CIions includi~ swelling of the face, tongue or throat,
difficulty swallowing, unexplained wheezi~, IIhortnB8B of Inath which
may be accompanied by skin rBIIh or hives.
• 8ecomlng unusually1lred, unexpected bruising or bleeding and getang
mll"e Infections (such as colds) than usual. These lire very rare and nat
necessarily related to paracetamol.

0Ihar afIacIB which may occur include:











Constiplrtion.
Itching.
SW8lIting.
Dry Mouth.
DrowsIness (although the desire 'Ill sleep can be a symptom 01 migraine),
nausea (feeling sick or queasy) nI vommng (beIng siCk).
IndlgesHon, pain or discomfort In the abdomen.
Acute Inflammation of the pancreas In patients who have had a
cholecystectomy (gallbladder removal).
Dlfllcully In passing urine.
Headache, dizziness, problems with movements and coordination, upset
stomach, thickened mucus and blurred vision.
Takilg a pailkilllr for hIDd1es kID DfIIIII orforlDD IDI1I can makalhllm MnII.

How do I know nI am addlcled?

If you take the medicine according 'Ill the Instructloos on the pack It Is
unlikely that you will become addicted to the medicine. However, n the
following apply to you It Is Important that you talk to your doctDr.
• 'ttJu need 'Ill take the medicine for longer periods 01 time.
• 'ttJu need 'Ill take more than the recommended dose.
• Whln you stop taking the medicine you feel unwell but you feel bl1lllr
when you start taking the medicine again.

5 Storing this medicine
Thll'e are 00 special storage Instrudlons for tIE medicine. Keep the JI(lduct out
01 the reach and ~ rI chldren.Do nat use afIII" the end of the month shown
as an expiry dale on the packaging. Medicines should nat be disposed 01 via
waslNater or household waste. Ask your phannaclst how 'Ill dispose 01
medlcllllBlID kqjll"~ lhIIIIIIlllIIIIIlIIIIlwi ~1D IIDIIICtthelll"lllttnnlnt.

6 Further infonnation
What's in this medicine?

.... actM i......... in 11th Mig..... Pink ..bIII ....: ParaceIamoI DC
96% 520 mg ~ivaII!Int 1:1 Para::elamol500 mg, Codeine phosphate 8 mg
and EU::lizine hydrochlorkle 6.25 mg.
OIh.r IlIIredllllll
magnB8ium sIBanrte, colloidal anhydrousailica,
stearic acid, pregelaliniaad maize stan:h, gelatin, hyprornellose, macrogol,
E127 (erythrosine), aluminium oxide and E171 (titanium dioxide).
1111 1CIwI_1'IIIIInII In IICh Mig....... 'ftIIaw"lllllllt ....: Plec8la"nol DC
!16% 520 mg equlvalent'lll PIm:eIamoI500 mg and CodeIne phosJhrte 8 mg.
DI.- I....... III: rnapskJm sIaIaIe, coikilalllli1yltoos silica, sIIBIc 1Gd,
pregeIaIInlsed maize starch, gel~, hyprornellose, macrogol, El 04 (qumllne
yellow), alllninium axlde, EI71 (tIIBnIum dk»dde) and EI72 (ton oxide yellow).

.re:

What the medicine I"'*" like

There are two types 01 MlgraJeve table1s available: Mlgraleve Pink and
Mlgraleve ""low. These lire film coated tablets which are available
separately or together In ooe pack.

Packs on sale in your Phannacy
M~"'Ieve: 12 tablet pack containin~
8 ig...1eve Pink and 4 Migral.. ellow tablets
Mi,.leve: 24 tablet pack containing
Pink and 8 Mig...len Yellow tablets
18
Migra
Pink: ~~ of 12 and 24 tablets
Migraleve Yellow: acks of 24

:'Ieve

Packs available only on prescrtptlon from your Doctor
Mlg...leve: 48 tablet pack containing
32 Mig...1eve Pink and 16 Migl"llien Yellow tablets
Migraleve Pink: packs of 48 tablets
Please Note: Because Migraleve packs contain txrth
Migraleva Pink and Migraleve Yellow tablets, a double
prescription charge must be made.
Praduct UctnCl hOldII': McNeil Products Ltd, Maidenhead, Berkshire,
SL6 3UG, UK.
M..r.:Iurw: Janflllll-Cilag, Domaine de Maigremont. 27100 Val de Reuil,

......

11111II1II11 . . mIIId April 2014ta:NelI Producls lid Is the licensee 01 the reglslered lnIIe mark. MIGIW..EYE.

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365002F
14-0051

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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