CO-CODAMOL 30MG/500MG CAPSULES

Active substance: PARACETAMOL

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PATIENT INFORMATION LEAFLET

Solpadol 30mg/
500mg Capsules

Codeine Phosphate and
Paracetamol
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
Capsules (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.

2. Before you take Solpadol
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 capsules
• Taking a painkiller for headaches too often or for
too long can make them worse
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 capsules is under 12
years of age. Solpadol must not be given to
children 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. If you are not sure, talk to
your doctor or pharmacist before taking
-1Solpadol.
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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 capsules. 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 capsules 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. -211504550-05

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.

• 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 capsules 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.

Important information about some of the
ingredients of your Solpadol capsules
Azorubine: This may cause allergic reactions.

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 capsules and
the pack with you. This is so the doctor knows
what you have taken

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.

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.

3. How to take Solpadol

4. Possible side effects

Always take Solpadol exactly as your doctor has told
you. You should check with your doctor or
pharmacist if you are not sure.

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

• Do not take more than the recommended dose
• Do not take for longer than your doctor tells
you to

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
-3irritable when you stop the capsules

Adults and children over 12
• Take this medicine by mouth
• Swallow the capsules whole with a drink of water
• The usual dose of Solpadol is 2 capsules, taken
together

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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
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 bloodproblem
(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 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.

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.
Do not store above 25°C.
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.
6. Further Information
What Solpadol 30mg/500mg Capsules contain
• The active substances of Solpadol 30/500 Capsules
are codeine phosphate and paracetamol.
Each capsule contains 30mg of codeine
phosphate and 500mg of paracetamol
• The other ingredients are, maize starch, indigotine
(E132), azorubine (E122), titanium dioxide (E171),
gelatin, black iron oxide (E172), shellac, propylene
glycol, talc and magnesium stearate
What Solpadol 30mg/500mg Capsules look like
and contents of pack
Solpadol 30mg/500mg Capsules are grey and purple
printed with the word ‘SOLPADOL’ in black ink.
They come in cartons of 4, 10, 12, 24, 30, 60 and
100 capsules. 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
FAMAR HEALTH CARE SERVICES MADRID, S.A.U.
Avda. Leganés, 62,
Alcorcón 28923 (Madrid) Spain
This leaflet was last updated in March 2014
© Sanofi 1994-2014

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Artworks Department. Madrid. Spain
Product Description: Solpadol 100 capsulas
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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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