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File title:

9737_LF03520D–11017637_Solpadeine Migraine_24s_PIL_UK_v3

Item No.:


OPI No.:


Last edit:

14th October 2015




Migraine Tabs 24

Component: Leaflet


Dimensions: 140 x 305mm

• If you are pregnant.
• For pain relief in children and adolescents
(0-18 years of age) after removal of their
tonsils or adenoids due to obstructive sleep
apnoea syndrome
• If you know that you metabolise very rapidly
codeine into morphine
•If you are breastfeeding.
Take special care with Solpadeine Migraine

• This medicine is for the short term
treatment of acute moderate pain
when other painkillers have not
• You should only take this medicine for
a maximum of 3 days at a time. If you
need to take it for longer than 3 days
you should see your doctor or
pharmacist for advice.
• This medicine contains codeine which
can cause addiction if you take it
continuously for more than 3 days. This
can give you withdrawal symptoms
from the medicine when you stop
taking it.
• If you take this medicine for headaches
for more than 3 days it can make them
Please read right through this leaflet before
you start using this medicine. This medicine is
available without prescription, but you still
need to use Solpadeine Migraine Tablets
carefully to get the best results from them.
• Keep this leaflet you may need to read it
• If you have any further questions, ask your
In this leaflet:
1. What Solpadeine Migraine Does
2. Check before you take Solpadeine Migraine
3. How to take Solpadeine Migraine
4. Possible side effects
5. How to store Solpadeine Migraine
6. Further information
1. What Solpadeine Migraine Does
Solpadeine Migraine can be used in patients
over 12 years of age for the short-term relief
of moderate pain that is not relieved by other
painkillers such as paracetamol or ibuprofen
It can be used for migraine, headaches, period
and dental pain, muscle and joint pain,
backache, fibrositis, tennis elbow, sports
injuries (e.g. sprains, strains) and for pain due
to non-serious arthritis.
The active ingredients are ibuprofen and
codeine, which are both painkillers. By working
on your body in different ways, ibuprofen and
codeine combine to relieve pain and ease
stiffness. Ibuprofen belongs to a family of
medicines called non-steroidal
anti-inflammatory drugs (NSAIDs) which relieve
pain and reduce inflammation.
Codeine belongs to a group of medicines called
opioid analgesics which act to relieve pain. It
can be used on its own or in combination with
other pain killers.
2. Check before you take Solpadeine
• This medicine contains codeine which can
cause addiction if you take it continuously
for more than 3 days. This can give you
withdrawal symptoms from the medicine
when you stop taking it.
• If you take a painkiller for headaches for
more than 3 days it can make them worse.
Do not take Solpadeine Migraine:
• If you have ever had an allergic reaction to
codeine, ibuprofen, aspirin or any other NSAID
or to any of the other ingredients (listed in
Section 6)
• If you have ever had a stomach ulcer,
perforation or bleeding of the stomach
• If you are taking aspirin at doses above 75
mg daily
• If you are taking other products containing
ibuprofen or other NSAID painkillers
• If you suffer from severe heart or liver
problems, or kidney problems

• Medicines such as Solpadeine Migraine may
be associated with a small increased risk of
heart attack (myocardial infarction) or stroke.
Any risk is more likely with high doses and
prolonged treatment.
Ask your doctor or pharmacist before
you take this medicine:
• If you suffer or have suffered from asthma or
allergic disease
• If you are elderly
• If you suffer from digestive disease, high blood
pressure or autoimmune diseases such as Lupus
• If you have heart problems, previous stroke or
think that you might be at risk of these
conditions (for example if you have high blood
pressure, high cholesterol or are a smoker)
• If you are taking aspirin at doses below 75 mg
• If you are trying to become pregnant
• If you have had an operation to remove your
gall bladder or recent stomach surgery
• If you are taking medicines which make you
drowsy or sleepy including sleeping tablets,
sedatives, tricyclic antidepressants,
tranquillizers e.g. phenothiazine or alcohol
• If you have been told by your doctor that you
have an intolerance to some sugars.
If you are taking other medicines
Talk to your doctor or pharmacist before
taking these tablets if you are taking any other
medicines; particularly drugs to prevent blood
clotting (antiplatelet drugs e.g. aspirin); water
tablets (diuretics), MAOIs or lithium
(to treat depression), methotrexate, zidovudine,
sulfonylureas (hypoglycaemic agents), antibiotics
(e.g. ciprofloxacin and aminoglycosides such as
gentamycin), mifepristone, domperidone,
metoclopramide (to treat nausea and vomiting),
opiate painkillers, drugs for high blood pressure
(e.g. captopril, atenolol or losartan) or
corticosteroids (to treat allergic or inflammatory
disorders). If you take blood thinning drugs
(anticoagulants e.g. warfarin) and you need to
take a pain reliever on a daily basis, talk to
your doctor because of the risk of bleeding.
But you can still take occasional doses of
Solpadeine Migraine at the same time as
Warnings and Precautions
Codeine is transformed to morphine in the
liver by an enzyme. Morphine is the substance
that produces pain relief. Some people have a
variation of this enzyme and this can affect
people in different ways. In some people,
morphine is not produced or produced in very
small quantities, and it will not provide enough
pain relief. Other people are more likely to get
serious side effects because a very high amount
of morphine is produced. If you notice any of
the following side effects, you must stop
taking this medicine and seek immediate
medical advice: slow or shallow breathing,
confusion, sleepiness, small pupils, feeling or
being sick, constipation, lack of appetite.
Children and adolescents
Use in children and adolescents after surgery:
Codeine should not be used for pain relief in
children and adolescents after removal of their
tonsils or adenoids due to Obstructive Sleep
Apnoea Syndrome.
Use in children with breathing problems:
Codeine is not recommended in children with
breathing problems, since the symptoms of
morphine toxicity may be worse in these
Pregnancy and breast feeding
This medicine belongs to a of medicines which
may impair fertility in women. This effect goes
away when the medicine is stopped. It is
unlikely that this medicine, used occasionally,
will affect your chances of

becoming pregnant; however tell your doctor
before taking this medicine if you have
problems becoming pregnant.
Do not take Solpadeine Migraine if you are
Do not take Solpadeine Migraine while you are
breastfeeding. Codeine and morphine passes
into breast milk.
Driving and using machines
This medicine can affect your ability to drive as
it may make you sleepy or dizzy.
Do not drive while taking this medicine until
you know how it affects you. It is an offence
to drive if this medicine affects your ability to
However, you would not be committing an
offence if:
• The medicine has been taken to treat a
medical or dental problem and
• You have taken it according to the
information provided with the medicine and
• It was not affecting your ability to drive
Talk to your doctor or pharmacist if you are not
sure whether it is safe for you to drive while
taking this medicine.
Details regarding a new driving offence
concerning driving after drugs have been
taken in the UK may be found here:
3. How to take Solpadeine Migraine
This product is intended for short term use
only. You should take the lowest effective dose
for the shortest time necessary to relieve your
Adults and children aged 12 years and
Swallow 1 or 2 tablets with water, every
4 to 6 hours as needed.
• Leave at least 4 hours between doses.
• Do not take more than 6 tablets in 24
• Do not take more than the
recommended dose.
• This medicine should not be taken for
more than 3 days. If the pain does not
improve after 3 days, talk to your
doctor for advice.
• Solpadeine Migraine should not be
taken by children below the age of 12
years, due to the risk of severe
breathing problems.
Possible withdrawal effects
This medicine contains codeine and can cause
addiction if you take it continuously for more
than 3 days. When you stop taking it you may
get withdrawal symptoms. You should talk to
your doctor or pharmacist if you think you are
suffering from withdrawal symptoms.
If you take too many tablets contact your
doctor or casualty department. If your
symptoms continue or your headache becomes
persistent, see your doctor.
4. Possible side effects
Some people may have side effects when using
this medicine. If you have any unwanted side
effects you should seek advice from your
doctor, pharmacist or other healthcare
If you suffer from any of the following at any
time during treatment stop taking the
medicine and seek immediate medical help:
• Passing blood in your stools
• Passing black tarry stools
• Vomiting any blood or dark particles that
look like coffee grounds.
Stop taking the medicine and tell your doctor
if you experience:
• Allergic reactions, which can include; bruising
or facial swelling, swelling of the lips, throat
and tongue causing difficulty swallowing or
breathing; breathing problems e.g.
unexplained wheezing, shortness of breath,
asthma or worsening asthma; skin reactions
e.g. skin rashes, itching, urticaria (hives) which
can be severe with blistering and peeling of
the skin; rapid heart rate/palpitations,
collapsing or low blood pressure.

• Severe abdominal pain, nausea and vomiting
if you have recently had your gall bladder
• Unexplained bruising or bleeding, sore
throat, mouth ulcers, fever, extreme paleness,
weakness or exhaustion. These can be signs
of blood disorders such as anaemia, low
white blood cells, low platelet count,
suppressed bone marrow function or
reduction in agranulocytes (a type of white
blood cell).
The following side effects may occur.
Tell your doctor if you get them.




Uncoated paper, white, 60g/m2

Cutter guide: CG124_OTC.LT.012
TSS file:
Reel Unwind: No. 5 inside No. 1 outside (if orientation changes, then this changes too)
EAN Code:


PharmaCode: 10930
Replacement number: 11016705
Manufacturing Site: Aenova
No. of colour: 1

In 1 in 10 to 1 in 100 people:
• Headaches, drowsiness, dizziness, vertigo or
ringing in the ears.

81 Rivington Street
London EC2A 3AY
United Kingdom

In 1 in 100 to 1 in 1000 people:
• Stomach pains, nausea and digestive

awk contact:
Phil Hinckley
+44 (0)7710 521027
+44 (0)203 008 6041

In 1 in 1000 to 1 in 10,000 people:
• Diarrhoea, constipation, flatulence or
In less than 1 in 10,000 people:
• Worsening of existing bowel disease
(ulcerative colitis or Crohn's disease)
• Aseptic meningitis with symptoms such as
headache, stiff neck, disorientation, fever
and eye sensitivity to light, particularly in
patients with existing autoimmune disorders
such as lupus.
• Blood in the urine, cloudy urine, you pass
more or less urine than normal or you
experience pain in the back and/or swelling
(particularly in the legs).
• liver problems such as hepatitis or jaundice
(yellowing of the skin).
• Breathlessness and/or swelling of the legs or
Medicines such as Solpadeine Migraine may be
associated with a small increased risk of heart
attack (myocardial infarction) or stroke.
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
By reporting side effects you can help provide
more information on the safety of this
How do I know if I am addicted?
If you take this medicine according to the
instructions on the pack, it is unlikely you will
become addicted to the medicine. However, if
the following apply to you it is important that
you talk to your doctor:
• You need to take the medicine for longer
periods of time.
• You need to take more than the
recommended dose.
• When you stop taking the medicine you feel
very unwell but you feel better if you start
taking the medicine again.

Marketing Approval:

Name (please print):....................................................................................................

Contact email:................................................................................................................

Regulatory Approval:

Contact email:................................................................................................................

Page 1 of 1

6. Further information
Active ingredients Each tablet contains
Ibuprofen 200 mg and Codeine Phosphate
Hemihydrate 12.8 mg.
Other ingredients Microcrystalline cellulose,
hydrogenated vegetable oil, sodium starch
glycollate, colloidal silicon dioxide, lactose,
hypromellose, polyethylene glycol.
This pack contains 24 tablets embossed with
MIGRAINE or plain on both sides.
The marketing authorisation holder is Omega
Pharma Ltd, 32 Vauxhall Bridge Road, London,
SW1V 2SA, United Kingdom and all enquiries
should be sent to this address.
The manufacturer is GlaxoSmithKline
Dungarvan Ltd., Co. Waterford, Ireland or
Swiss Caps GmbH Grassingerstraβe 9, 83043
Bad Aibling, Germany (Aenova Group).




Name (please print):....................................................................................................

5. How to store Solpadeine Migraine
Keep out of the reach and sight of children.
Do not use this medicine after the 'EXP' date
shown on the pack.

This leaflet was last revised in
October 2015.


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