SOLPADOL CAPLETS

Active substance: PARACETAMOL

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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)
If any of the side effects gets serious,
lasts longer than a few days or you
notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
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 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)

PATIENT INFORMATION LEAFLET

SOLPADOL 30mg/500mg
CAPLETS
Codeine Phosphate and
Paracetamol

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.

Is this leaflet hard to
see or read?
Phone 01483 505515
for help

The Marketing Authorisation Holder is
Sanofi-Aventis, One Onslow Street,
Guildford, Surrey, GU1 4YS, UK.
Tel: 01483 505515
Fax: 01483 535432
email:
uk-medicalinformation@sanofi-aventis.com
The Manufacturer is
Fawdon Manufacturing Centre,
Edgefield Avenue, Fawdon,
Newcastle upon Tyne, NE3 3TT, UK.

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

This leaflet was last updated in
December 2010
© Sanofi-aventis 1989-2010

31962202

4

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.
It belongs to a group of medicines
called analgesics (painkillers) and is
used to treat severe pain.

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 caplets
• 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 caplets is
under 12 years of age.
Do not take Solpadol if any of the above
apply to you.
Turn
Over
1

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
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.
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
• You are breast-feeding or planning to
breast-feed
Usually it is safe to take Solpadol while
breast feeding as the levels of the active
ingredients of this medicine in breast
milk are too low to cause your baby any
problems. However, some women who
are at increased risk of developing side
effects at any dose may have higher
levels in their breast milk. If any of the
following side effects develop in you or
your baby, stop taking this medicine
and seek immediate medical advice;
feeling sick, vomiting, constipation,
decreased or lack of appetite, feeling
tired or sleeping for longer than normal,
and shallow or slow breathing.
2

Driving and using machines
You may feel dizzy or sleepy while
taking Solpadol. If this happens, do not
drive or use any tools or machines.
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
• Wait at least 4 hours before taking
another dose
• Do not take more than 8 caplets in
any 24-hour period
• Elderly people may be prescribed a
lower dose
Children
Solpadol should not be given to
children under 12 years of age.
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
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 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
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 Turn
Over
side effect
3

Brand:

LLET RFED SOLPADOL CAPLETS UK

Category:
LEAFLET
Argus Code: 820
Spec No:
31962202
Supersedes: 31962201
Core Spec No: 60101300
Ticket No:
Date:
Issue No:
Operator:
Page:

283582
09.12.10
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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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