Patient leaflet - CO-CODAMOL 15 MG / 500 MG TABLETS
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4. possible side effects
Like all medicines, Co-codamol 15mg/500mg Tablets can cause side effects, although not everybody gets them.
If you experience any of these symptoms, please tell your doctor or pharmacist immediately:
- Allergic reaction (skin rash, itching, swelling or shortness of breath)
- Serious skin reactions (very rare cases of serious skin reactions have been reported)
- Sudden pain in the upper part of your abdomen, if you have previously had your gall bladder removed
The following side effects have been reported:
- Dizziness or drowsiness
- Feeling sick or vomiting
Lying down may relieve these effects.
- Low blood cell counts (platelets and white blood cells) but these were not necessarily related to paracetamol
- Slow heart beat
- Constipation
- Stomach pains
- Bladder problems
- Light-headedness
- Narrowing of your pupils
- Confusion or changes in your mood
- Itchy skin
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: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store co-codamol 15mg/500mg tablets
Keep this medicine out of the sight and reach of children.
Do not use Co-codamol 15mg/500mg Tablets after the expiry date which is stated on the carton and blister foil. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. Do not use this medicine if you notice that the pack or any of the tablets are damaged.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information
What Co-codamol 15mg/500mg Tablets contain
The active substances are codeine phosphate hemihydrate and paracetamol. Each tablet contains 15mg of codeine phosphate hemihydrate and 500mg of paracetamol.
The other ingredients are pregelatinised starch, povidone (K-30), microcrystalline cellulose PH102, maize starch, crospovidone XL 10, colloidal anhydrous silica, magnesium stearate, purified water, polyvinyl alcohol part hydrolyzed, talc, titanium dioxide, lecithin (soya), xanthan gum.
What Co-codamol 15mg/500mg Tablets look like and contents of the pack
Co-codamol 15mg/500mg Tablets are white to off white oblong shaped, biconvex, film coated tablets with a break line on one side and plain on the other side.
Co-codamol 15mg/500mg Tablets are available in packs of 100 tablets.
Marketing Authorisation Holder
Key Pharmaceuticals Ltd.
Galen House, 83 High street,
Somersham, Cambridgeshire, PE28 3JB, UK
Manufacturer
Medreich PLC
Warwick House, Plane Tree Crescent,
Feltham, TW13 7HF, UK
This leaflet was last revised in September 2020.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Co-codamol 15mg/500mg Tablets
codeine phosphate hemihydrate and paracetamol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again
- If you have any further questions, ask your doctor, pharmacist or nurse
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4
What is in this leaflet
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1. What Co-codamol 15mg/500mg Tablets are and what they are used for
2. What you need to know before you take Co-codamol 15mg/500mg Tablets
3. How to take Co-codamol 15mg/500mg Tablets
4. Possible side effects
5. How to store Co-codamol 15mg/500mg Tablets
6. Contents of the pack and other information
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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.
Talk to your doctor, pharmacist before taking Co-codamol 15mg/500mg Tablets:
- If you are elderly and/or in poor health
- If you suffer from an enlarged prostate
- If you suffer from any bowel problems
- If you suffer from Addison’s disease
- If you suffer from any liver or kidney problems
If any of the above apply to you, it is important that you speak to your doctor or pharmacist before taking Co-codamol 15mg/500mg Tablets and they will decide what to do. It may still be safe for you to take Co-codamol 15mg/500mg Tablets.
- Do not take for longer than directed by your prescriber
- 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
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.
Other medicines and Co-codamol 15mg/500mg Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially important if you are taking:
- Medicines called Monoamine Oxidase inhibitors (MAOIs) used to treat depression, or have taken them the last two weeks (see section 2 “Do not take Co-codamol 15mg/500mg Tablets”). MAOIs are medicines such as moclobemide, phenelzine and tranylcypromine
- Medicines for depression, anxiety, other medicines known as tranquillisers, or hypnotics (medicines to help you sleep).
You may experience more drowsiness if you take these medicines with codeine
- Colestyramine (medicine for high cholesterol levels or diarrhoea). The absorption of paracetamol is reduced by this medicine
- Domperidone or metoclopramide (medicines to stop you feeling sick or vomiting). The speed of absorption of paracetamol may be increased by these medicines
- Anticoagulants, e.g. warfarin (medicine to prevent blood clots). There may be an increased risk of bleeding caused by prolonged regular use of paracetamol
- Medicines that you have bought yourself such as cough/cold remedies or other painkillers. Many of these will contain paracetamol and/or codeine and should not be taken while you are taking Co-codamol 15mg/500mg Tablets
Concomitant use of Co-codamol 15mg/500mg Tablets and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However if your doctor does prescribe Co-codamol 15mg/500mg Tablets together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.
Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
Co-codamol 15mg/500mg Tablets with food and alcohol
You should avoid alcohol when taking this product.
Food has no influence on Co-codamol 15mg/500mg Tablets.
Pregnancy and breast-feeding
Do not use this product or any other codeine-containing products if you are pregnant.
Do not take codeine while you are breast-feeding. Codeine and morphine pass into breast milk.
Driving and using machines
Co-codamol 15mg/500mg Tablets may make you feel drowsy. Do not drive or use machines until you know how they affect you.
This medicine 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:
3. how to take co-codamol 15mg/500mg tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose for adults and the elderly is two tablets taken every four hours. You should not take more than eight tablets in any 24-hour period.
Use in children and adolescents
The recommended dose for children aged 16 and over is two tablets taken every six hours. You should not take more than eight tablets in any 24-hour period.
The recommended dose for children aged 12 to 15 years is one tablet taken every six hours, up to a maximum of four tablets in any 24-hour period.
Doctors sometimes prescribe different doses to these. Read the pharmacist’s label, it will tell you exactly how many you should take.
This medicine should not be taken by children under 12 years of age, due to the risk of severe breathing problems.
This medicine should be taken orally (by mouth). The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
This medicine should only be taken when necessary. Do not take more than the stated dose and do not take for more than three days. If the pain does not improve after three days, talk to your doctor for advice.
If you take more Co-codamol 15mg/500mg Tablets than you should
It is always important to follow the dose recommended on the label. Talk to a doctor at once if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.
If you forget to take Co-codamol 15mg/500mg Tablets
If you forget to take a dose, it may be because your symptoms have been relieved and you may not need to take Co-codamol 15mg/500mg Tablets any more.
However, if you still suffer from pain take your dose as soon as you remember and then carry on as before. It is important that you do not take a double dose to make up for the forgotten dose.
If you stop taking Co-codamol 15mg/500mg Tablets
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
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