SOLPADOL CAPLETS

Active substance: PARACETAMOL

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Talk to your doctor straight away if you
notice the following serious side effect:
• Severe stomach pain, which may reach
through to your back. This could be a sign
of inflammation of the pancreas
(pancreatitis). This is a very rare side effect
Tell your doctor or pharmacist if any of the
following side effects gets serious or lasts
longer than a few days:
• Constipation
• Feeling sick (nausea), being sick
(vomiting)
• Dizziness, light-headedness, drowsiness,
confusion
• Difficulty in passing water (urine)
• Becoming dependent on codeine
• You get infections or bruise more easily
than usual. This could be because of a
blood problem (such as agranulocytosis,
neutropenia or thrombocytopenia)
• Redness of the skin (erythema), Itchy
lumpy rash (urticaria)
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 (see details below). By reporting side
effects you can help provide more
information on the safety of this medicine.
United Kingdom
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
Malta
ADR Reporting, The Medicines Authority,
Post-Licensing Directorate, 203 Level 3,
Rue D'Argens, GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail:
postlicensing.medicinesauthority@gov.mt

Do not store above 25°C.

PATIENT INFORMATION LEAFLET

2. Before you take Solpadol

Ask your pharmacist how to dispose of
medicines no longer required. Do not
dispose of medicines by flushing down a
toilet or sink or by throwing out with your
normal household rubbish. This will help
protect the environment.

SOLPADOL 30mg/500mg
CAPLETS

Important things you should know about
Solpadol
• Do not take for longer than your doctor tells
you to
• Taking codeine regularly for a long time can
lead to addiction, which might cause you to
feel restless and irritable when you stop the
caplets
• Taking a painkiller for headaches too often or
for too long can make them worse

Codeine Phosphate and
Paracetamol

6. Further information
What Solpadol 30mg/500mg Caplets
contain
• The active substances of Solpadol
30mg/500mg Caplets are codeine
phosphate and paracetamol. Each caplet
contains 30mg of codeine phosphate and
500mg of paracetamol
• The other ingredients are pregelatinised
starch, maize starch, potassium sorbate,
microcrystalline cellulose, stearic acid,
talc, magnesium stearate, povidone and
croscarmellose sodium (type A)
What Solpadol 30mg/500mg Caplets look
like and contents of pack
Solpadol 30mg/500mg Caplets are white,
capsule shaped tablets (caplets), marked
with the word ‘SOLPADOL’ on one face.
They come in cartons of 4, 10, 24, 30, 60
and 100 caplets. Not all pack sizes may be
sold.
The Marketing Authorisation Holder is
Sanofi, One Onslow Street, Guildford, Surrey,
GU1 4YS, UK.
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
The Manufacturer is
Fawdon Manufacturing Centre,
Edgefield Avenue, Fawdon,
Newcastle upon Tyne, NE3 3TT, UK.
This leaflet was last updated in March 2014
© Sanofi 1989-2014

5. How to store Solpadol
Keep this medicine in a safe place out of the
reach and sight of children.
Do not use this medicine after the expiry
date shown on the pack.
Store your medicine in the original
packaging in order to protect from
moisture.

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Is this leaflet hard to
see or read?
Phone 0845 372 7101
for help
Read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may need to read it
again
• If you have 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 gets serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist
In this leaflet:
1. What Solpadol is and what it is used for
2. Before you take Solpadol
3. How to take Solpadol
4. Possible side effects
5. How to store Solpadol
6. Further information
1. What Solpadol is and what
it is used for
The name of your medicine is Solpadol
30mg/500mg Caplets (called Solpadol
throughout this leaflet). Solpadol contains
two different medicines called codeine
phosphate and paracetamol.
Codeine belongs to a group of medicines
called opioid analgesics which act to relieve
pain. Solpadol is used to treat severe pain.
Codeine can be used in children 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 alone.

Do not take Solpadol and tell your
doctor if:
× You are allergic (hypersensitive) to codeine,
paracetamol or any of the other ingredients
in your medicine (listed in Section 6:
Further information). Signs of an allergic
reaction include a rash and breathing
problems. There can also be swelling of the
legs, arms, face, throat or tongue
× You have severe asthma attacks or severe
breathing problems
× You have recently had a head injury
× You have been told by your doctor that
you have increased pressure in your head.
Signs of this include: headaches, being
sick (vomiting) and blurred eyesight
× You have recently had an operation on your
liver, gallbladder or bile duct (biliary tract)
× You are taking medicine to treat depression
called MAOIs (monoamine oxidase
inhibitors) or have taken them in the last
2 weeks. MAOIs are medicines such as
moclobemide, phenelzine or
tranylcypramine (see ‘Taking other
medicines’)
× You are an alcoholic
× The person going to take the caplets is
under 12 years of age.
× You are under 18 years of age and have had
your tonsils or adenoids removed due to
obstructive sleep apnoea syndrome
× If you know that you metabolise very
rapidly codeine into morphine
× If you are breastfeeding
Do not take Solpadol if any of the above
apply to you.
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Warnings and precautions
Take special care and check with
your doctor before taking Solpadol if:
▲ You have severe kidney or liver problems
▲ You have problems passing water or
prostate problems
▲ You have a bowel problem such as colitis
or Crohn’s disease or a blockage of your
bowel
▲ You are elderly
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.
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before taking this medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines. This includes medicines obtained
without a prescription, including herbal
medicines. This is because Solpadol can affect
the way some other medicines work. Also,
some other medicines can affect the way
Solpadol works.
While taking Solpadol you should not
take any other medicines which
contain paracetamol.
This includes some painkillers, cough and
cold remedies. It also includes a wide
range of other medicines available from
your doctor and more widely in shops.
Do not take this medicine, and tell
your doctor, if you are taking
• Medicines to treat depression called
MAOIs (monoamine oxidase
inhibitors) or have taken them in the
last 2 weeks. MAOIs are medicines
such as moclobemide, phenelzine,
tranylcypramine

Tell your doctor if you are taking any
of the following medicines:
• Medicines which make you drowsy or
sleepy (CNS depressants)
• Medicines used to thin the blood
such as warfarin
• Chloramphenicol - an antibiotic used
for infections
• Metoclopramide or domperidone
- used to stop you feeling sick (nausea)
or being sick (vomiting)
• Colestyramine - for lowering blood
cholesterol levels
• The oral contraceptive pill
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before taking Solpadol.
Taking Solpadol with food and drink
You should not drink alcohol while you are
taking these caplets. This is because
Solpadol can change the way alcohol affects
you.
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 children.
Pregnancy and breast-feeding
Talk to your doctor before taking these
caplets if:
• You are pregnant, think you may be
pregnant or plan to get pregnant
Do not take Solpadol and speak to your
doctor if:
• You are in the last three months of
pregnancy
• In labor
Do not take codeine while you are
breastfeeding. Codeine and morphine
passes into breast milk.

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Driving and using machines
Solpadol 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 drive.
• However, you would not be committing
an offence if:
- The medicine has been prescribed to
treat a medical or dental problem and
- You have taken it according to the
instructions given by the prescriber or
in the information provided with the
medicine and
- It was not affecting your ability to
drive safely
Talk to your doctor or pharmacist if you are
not sure whether it is safe for you to drive
while taking this medicine.
Changing or stopping treatment
Long term usage of Solpadol may lead to
tolerance and dependence. If you have taken
regular daily doses of Solpadol for a long
time, do not increase the dose or suddenly
stop treatment without discussing this with
your doctor.
3. How to take Solpadol
Always take Solpadol exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
• Do not take more than the
recommended dose
• Do not take for longer than your doctor
tells you to
Adults and children over 12
• Take this medicine by mouth
• Swallow the caplets whole with a drink of
water
• The usual dose of Solpadol is
2 caplets, taken together
• Adults should wait at least 4 hours before
taking another dose
• Children aged 12 years and over should
wait at least 6 hours before taking
another dose.
• Do not take more than 8 caplets in any
24-hour period
• This medicine should not be taken for
more than 3 days. If pain does not
improve after 3 days, talk to your doctor
for advice

• Elderly people may be prescribed a lower
dose
Children
Solpadol should not be given to children
below the age of 12 years, due to the risk of
severe breathing problems.
If you take more Solpadol than you
should
• Tell your doctor or go to your nearest
hospital casualty department straight
away - even if you feel well. This is
because of the risk of delayed, serious
liver damage
• Remember to take any remaining caplets
and the pack with you. This is so the doctor
knows what you have taken

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If you have forgotten to take Solpadol
If you forget to take a dose at the right time,
take it as soon as you remember. However,
if it is almost time for your next dose, skip
the missed dose. Do not take two doses at or
near the same time. Remember to leave
at least 4 hours between doses.

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4. Possible side effects
As with all medicines, Solpadol can cause
side effects, although not everybody gets
them. The following side effects may
happen with this medicine:

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Important side-effects you should know
about Solpadol
• Taking a painkiller for headaches too often
or for too long can make them worse.
• Taking codeine regularly for a long time
can lead to addiction, which might cause
you to feel restless and irritable when you
stop the caplets
Stop taking Solpadol and see a doctor or
go to a hospital straight away if:
• You have difficulty in breathing or you
feel dizzy
• You get swelling of the hands, feet, ankles,
face, lips or throat which may cause
difficulty in swallowing or breathing. You
could also notice an itchy, lumpy rash
(hives) or nettle rash (urticaria)
This may mean you are having an
allergic reaction to Solpadol
• You get serious skin reactions. Very rare
cases have been reported.
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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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