SOLPADOL 30MG/500MG CAPSULES
Active substance(s): CODEINE PHOSPHATE / PARACETAMOL
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PATIENT INFORMATION LEAFLET
2. Before you take Solpadol
Solpadol 30mg/
500mg Capsules
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
Codeine Phosphate and
Paracetamol
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
tranylcypromine (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
Solpadol.
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.
-1-
11504550-07
Warnings and precautions
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, tranylcypromine
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
• You are sensitive to aspirin or other medicines
used for the treatment of inflammation (Non
Steroidal Antiinflammatory Drugs) such as Ibuprofen
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.
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.
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.
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 labour
Do not take codeine while you are breastfeeding.
Codeine and morphine passes into breast milk.
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.
-2-
11504550-07
Children aged 16 to 18 years: 1-2 capsules every
6 hours when necessary up to a maximum of
8 capsules in 24 hours.
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.
Children aged 12 to 15 years: 1 capsule every
6 hours when necessary up to a maximum of
4 capsules in 24 hours.
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
Children under 12 years: 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 capsules and
the pack with you. This is so the doctor knows
what you have taken
Important information about some of the
ingredients of your Solpadol capsules
Azorubine: This may cause allergic reactions.
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.
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.
4. Possible side effects
3. How to take Solpadol
As with all medicines, Solpadol can cause side effects,
although not everybody gets them. The following
side effects may happen with this medicine:
Always take Solpadol exactly as your doctor has told
you. You should check with your doctor or
pharmacist if you are not sure.
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 capsules
• Do not take more than the recommended dose
• Do not take for longer than your doctor tells
you to
• Take this medicine by mouth
• Swallow the capsules whole with a drink of water
Adults: 2 capsules every 4 hours up to a maximum
of 8 capsules in 24 hours. Elderly people may be
prescribed a lower dose.
-3-
11504550-07
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
5. How to store Solpadol
Keep this medicine in a safe place out of the sight
and reach 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.
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
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
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)
• Difficulty breathing, wheezing, tightness in the
chest (bronchospasm)
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
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.
The Manufacturer is
FAMAR HEALTH CARE SERVICES MADRID, S.A.U.
Avda. Leganés, 62,
Alcorcón 28923 (Madrid) Spain
This leaflet was last updated in October 2016
© Sanofi 1994-2016
-4-
11504550-07
Artworks Department. Madrid. Spain
Product Description: Solpadol 100 cap.
SAP-/ID number:
Replace:
Version number:
Date:
Country:
Designer:
11504550-07
11504550-06
01
27.10.2016
UK
M. Luz Peirotén
COLOURS
P. Reflex blue
Technical drawing St:
Zt:
Dimensions:
Laetus number:
Folder nº:
Minimum point size:
570
570-1
180x210 (x2)
194
2497213
10
2. Before you take Solpadol
Solpadol 30mg/
500mg Capsules
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
Codeine Phosphate and
Paracetamol
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
tranylcypromine (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
Solpadol.
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.
-1-
11504550-07
Warnings and precautions
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, tranylcypromine
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
• You are sensitive to aspirin or other medicines
used for the treatment of inflammation (Non
Steroidal Antiinflammatory Drugs) such as Ibuprofen
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.
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.
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.
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 labour
Do not take codeine while you are breastfeeding.
Codeine and morphine passes into breast milk.
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.
-2-
11504550-07
Children aged 16 to 18 years: 1-2 capsules every
6 hours when necessary up to a maximum of
8 capsules in 24 hours.
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.
Children aged 12 to 15 years: 1 capsule every
6 hours when necessary up to a maximum of
4 capsules in 24 hours.
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
Children under 12 years: 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 capsules and
the pack with you. This is so the doctor knows
what you have taken
Important information about some of the
ingredients of your Solpadol capsules
Azorubine: This may cause allergic reactions.
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.
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.
4. Possible side effects
3. How to take Solpadol
As with all medicines, Solpadol can cause side effects,
although not everybody gets them. The following
side effects may happen with this medicine:
Always take Solpadol exactly as your doctor has told
you. You should check with your doctor or
pharmacist if you are not sure.
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 capsules
• Do not take more than the recommended dose
• Do not take for longer than your doctor tells
you to
• Take this medicine by mouth
• Swallow the capsules whole with a drink of water
Adults: 2 capsules every 4 hours up to a maximum
of 8 capsules in 24 hours. Elderly people may be
prescribed a lower dose.
-3-
11504550-07
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
5. How to store Solpadol
Keep this medicine in a safe place out of the sight
and reach 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.
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
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
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)
• Difficulty breathing, wheezing, tightness in the
chest (bronchospasm)
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
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.
The Manufacturer is
FAMAR HEALTH CARE SERVICES MADRID, S.A.U.
Avda. Leganés, 62,
Alcorcón 28923 (Madrid) Spain
This leaflet was last updated in October 2016
© Sanofi 1994-2016
-4-
11504550-07
Artworks Department. Madrid. Spain
Product Description: Solpadol 100 cap.
SAP-/ID number:
Replace:
Version number:
Date:
Country:
Designer:
11504550-07
11504550-06
01
27.10.2016
UK
M. Luz Peirotén
COLOURS
P. Reflex blue
Technical drawing St:
Zt:
Dimensions:
Laetus number:
Folder nº:
Minimum point size:
570
570-1
180x210 (x2)
194
2497213
10
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
