Co-Codamol 30mg/500mg Capsules
PACKAGE LEAFLET - INFORMATION FOR THE USER
Co-codamol 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
• Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect.
In this leaflet:
1. What co-codamol is and what it is used for
2. Before you take co-codamol
3. How to take co-codamol
4. Possible side effects
5. How to store co-codamol
6. Further information
1. WHAT CO-CODAMOL IS AND WHAT IT IS USED FOR
The name of your medicine is Co-codamol 30mg/500mg Capsules (called co-codamol throughout this leaflet). Co-codamol contains two different medicines called codeine phosphate and paracetamol.
Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or in combination with other pain killers such as paracetamol. Co-codamol 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 CO-CODAMOL
Important things you should know about
co-codamol
• 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
Warnings and precautions
Do not take co-codamol 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 vision
• 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. Co-codamol 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
• You know that you metabolise, very rapidly, codeine into morphine
• You are breastfeeding or planning to breastfeed
Do not take co-codamol if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking co-codamol.
Take special care and check with your doctor before taking co-codamol 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 Anti-inflammatory 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 is 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 sick 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 co-codamol can affect the way some other medicines work. Also, some other medicines can affect the way co-codamol works.
While taking co-codamol 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 co-codamol.
Taking co-codamol with food and drink
You should not drink alcohol while you are taking these capsules. This is because taking co-codamol 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 co-codamol and speak to your doctor if:
• You are in the last three months of pregnancy
• In labour
• You are planning to breast-feed.
• Do not take codeine whilst you are breastfeeding. Codeine and morphine passes into breast milk.
Driving and using machines
Co-codamol can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive whilst 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 you doctor or pharmacist if you are not sure whether it is safe for you to drive whilst taking this medicine.
Important information about some of the ingredients of your co-codamol capsules Azorubine: This may cause allergic reactions.
Changing or stopping treatment
Chronic usage of co-codamol may lead to tolerance and dependence. If you have taken regular daily doses of co-codamol for a long time, do not increase the dose or suddenly stop treatment without discussing this with your doctor.
3. HOW TO TAKE CO-CODAMOL
Always take co-codamol 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 co-codamol 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
• Elderly people may be prescribed a lower dose
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
Co-codamol should not be given to children under 12 years of age due to the risk of severe breathing problems.
If you take more co-codamol 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 co-codamol
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, co-codamol 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 co-codamol
• 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 co-codamol and see a doctor or go to a hospital straight away if:
• You get 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 co-codamol
• 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
• 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 CO-CODAMOL
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.
6. FURTHER INFORMATION
What Co-codamol 30mg/500mg Capsules contain
• The active substances of Co-codamol 30mg/500mg 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 Co-codamol 30mg/500mg Capsules look like and contents of pack
Co-codamol 30/500 Capsules are grey and purple printed with the word ‘SOLPADOL’ in black ink.
They come in cartons of 100 capsules.
The Marketing Authorisation Holder is
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.
The Manufacturer is
FAMAR HEALTH CARE SERVICES MADRID, S.A.U., Avda. Leganes, 62, Alcorcon 28923 (Madrid)
Spain.
This leaflet was last updated in May 2015
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