SOLPADOL 30MG/500MG CAPSULES

Active substance: PARACETAMOL

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PATIENT INFORMATION LEAFLET
Solpadol 30mg/500mg Capsules
Codeine Phosphate and Paracetamol
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’)

Reference: 89196 1.3.1.3 - Leaflet Text - PIL - 30mg, 500mg - 2013-10-10 - Codeine Art 31 0.5

• 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.
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,
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)

Reference: 89196 1.3.1.3 - Leaflet Text - PIL - 30mg, 500mg - 2013-10-10 - Codeine Art 31 0.5

• 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 codeine while you are breastfeeding. Codeine and morphine passes into breast
milk.
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.
Important information about some of the ingredients of your Solpadol capsules
Azorubine: This may cause allergic reactions.
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 capsules whole with a drink of water
• The usual dose of Solpadol is 2 capsules, 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 capsules in any 24-hour period

Reference: 89196 1.3.1.3 - Leaflet Text - PIL - 30mg, 500mg - 2013-10-10 - Codeine Art 31 0.5

• 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 capsules 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 capsules
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 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)
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.

Reference: 89196 1.3.1.3 - Leaflet Text - PIL - 30mg, 500mg - 2013-10-10 - Codeine Art 31 0.5

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 tablet 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 and100 capsules. Not all pack sizes may be
sold.
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
FAMAR HEALTH CARE SERVICES MADRID, S.A.U.
Avda. Leganés, 62,
Alcorcón 28923 (Madrid) Spain

This leaflet was last revised in October 2013
© Sanofi-aventis 1994-2013

Reference: 89196 1.3.1.3 - Leaflet Text - PIL - 30mg, 500mg - 2013-10-10 - Codeine Art 31 0.5

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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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