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SOLPADOL 30MG/500MG EFFERVESCENT TABLETS

Active substance(s): CODEINE PHOSPHATE / PARACETAMOL / CODEINE PHOSPHATE / PARACETAMOL

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419371 (alt 417842) GMID 657786 PB Solpadol 500/30mg GB Operator A.Schmitz 148 x 210 DC
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.
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 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.
Important information about some of the
ingredients of your Solpadol tablets
• Sodium: There is 387.97 mg of sodium per
effervescent tablet. This may be harmful to
people on a low sodium or low salt diet
• Sorbitol: This is a type of sugar. If you have
been told by your doctor that you cannot
tolerate some sugars, talk to your doctor
before 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

419371 PB Solpadol 50030mg GB.indd 2-3

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• Dissolve the effervescent tablets in a glass
of water before taking
Adults: 2 tablets every 4 hours when
necessary up to a maximum of 8 tablets in 24
hours.
Children aged 16 to 18 years: 1 to 2 tablets
every 6 hours when necessary up to a
maximum of four doses in 24 hours.
Children aged 12 to 15 years: 1 tablet every
6 hours when necessary to a maximum of four
doses in 24 hours.
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.
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 tablets
and the pack with you. This is so the doctor
knows what you have taken
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.
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:
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
tablets
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black min. 9pt Ocean San pro san - Version 2

PACKAGE INFORMATION LEAFLET

SOLPADOL 30mg/500mg
EFFERVESCENT TABLETS
Codeine Phosphate and
Paracetamol

Is this leafl­et hard to
see or read?
Phone 08453727101
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 effect 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 30/500
Effervescent Tablets (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
tablets
• 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 tranylcypromine (see ‘Taking
other medicines’)
You are an alcoholic
The person going to take the tablets 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
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.
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,
tranylcypromine
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 tablets. This is because Solpadol
can change the way alcohol affect 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 tablets
if:
• You are pregnant, think you may be
pregnant or plan to get pregnant

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
blood problem (such as agranulocytosis,
neutropenia or thrombocytopenia)
• Difficulty breathing, wheezing, tightness in
the chest (bronchospasm)
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

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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 Effervescent
Tablets contain
• The active substances of Solpadol
30mg/500mg Effervescent Tablets are
codeine phosphate and paracetamol. Each
tablet contains 30mg of codeine phosphate
and 500mg of paracetamol
• The other ingredients are sodium
bicarbonate, anhydrous citric aid,
anhydrous sodium carbonate, sorbitol
powder, saccharin sodium, povidone,
dimeticone and sodium lauryl sulphate
What Solpadol 30mg/500mg Effervescent
Tablets look like and contents of pack
Solpadol 30mg/500mg Effervescent Tablets
are white, bevelled edge tablets scored on one
face.
They come in cartons of 4, 12, 30, 32, 60 and
100 tablets.
Not all pack sizes may be marketed.
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
A. Nattermann & Cie. GmbH
Nattermannallee 1
50829 Cologne, Germany
This leaflet was last updated in December 2016
© Sanofi 1989 - 2016

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.
2

419371 PB Solpadol 50030mg GB.indd 4-5

Store your medicine in the original packaging
in order to protect from moisture.

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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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