Co-Codamol 15mg/500mg Tablets
• slow heart beat
• constipation
• stomach pains
• sudden pain in the upper part of your abdomen, if you have previously had your gall bladder removed
• bladder problems
• light-headedness
• narrowing of your pupils
• confusion or changes in your mood 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 Yellow Card Scheme Website: 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 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 medicinal product does not require any special storage conditions.
Do not use Co-codamol 15mg/500mg Tablets if you notice that the pack or any of the tablets are damaged. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to 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, Polyvinyl Alcohol Part Hydrolyzed, Titanium dioxide, Talc, 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 break line on one side and plain on other side. Co-codamol 15mg/500mg Tablets are available in packs of 100 tablets.
PL 21880/0161
This leaflet was last revised in 04/2015
Marketing Authorisation Holder and Manufacturer
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK,
Email: info@medreich.co.uk
4 121XXXX
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 or pharmacist
• This medicine has been prescribed for you. 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
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
1. WHAT CO-CODAMOL 15MG/500MG TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Co-codamol 15/500mg Tablets. Co-codamol 15mg/500mg Tablets are one of a group of medicines called analgesics or painkillers. They are used to relieve moderate pain. Co-codamol 15mg/500mg Tablets contain codeine phosphate hemihydrate and paracetamol.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-CODAMOL 15MG/500MG TABLETS
Do not take Co-codamol 15mg/500mg Tablets if you
• are allergic to codeine phosphate hemihydrate, paracetamol or any of the other ingredients in Co-codamol 15mg/500mg Tablets (listed in section 6)
• are suffering from head injuries
• have been told by your doctor that you have a severe breathing difficulty called respiratory depression
• are taking, or have taken in the last two weeks, medicine to relieve depression (Monoamine Oxidase Inhibitors / MAOIs). Ask your doctor or pharmacist if you are not sure what types of medicine you are taking
• consume excessive amounts of alcohol on a regular basis
• are pregnant or breast-feeding
• are having (or have recently had) a severe but short-lasting asthma attack (acute asthma)
Talk to your doctor if any of the above apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Co-codamol 15mg/500mg Tablets if you
• are elderly and/or in poor health
• suffer from an enlarged prostate
• suffer from any bowel problems
• suffer from Addison’s disease
• 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 ®
COLOUR | Black
CUSTOMER: MEDREICH PLC, UK
ITEM CODE: 121XXXX-V1 (WOA)
Head -PDC
Prepared by: Date:
Head TT
Checked by: Date:
MED/COD/PIL/08
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Font Type & Size |
Times New Roman |
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Heading - 13 pts | |
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Body - 9 pts | |
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RA artwork code |
0161/O/PIL/001/INO |
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Version |
V-1 |
COMPONENT: Co-codamol Tablets - S/L - English - PIL
DIMENSION: 160 x 240 mm (open size)
COLOUR SCHEME: 2 - Red 032 C and Black
SPECIFICATION: Printed on 56 - 60 GSM maplitho paper.
Head - QC
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WIN\\192.168.1.33\pdc\Artworks\Medreich\UK Products\Co-Codamol\Tablets\Para + Codeine (500 + 15 mg)\PIL\Co-codamol Tablets SL English PIL.ai Internal Approval Issued on CD Issued on
15/20/23.05.14(RA)/03.09(MK)/
14(MA)/17.10(MA)/02.12.14(MA)/
16.04.15(MA)
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
Do NOT give this product to children under 12 years of age 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 for depression or anxiety or other medicines known as tranquillisers
• medicines to help you sleep
• colestyramine (medicine for high cholesterol levels or diarrhoea)
• domperidone or metoclopramide (medicines to stop you feeling sick or vomiting)
• anticoagulants, e.g. warfarin (medicine to prevent blood clots)
• 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
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 or breast-feeding, unless under the supervision of your doctor. Usually it is safe to take Co-codamol 15mg/500mg Tablets 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.
Driving and using machines
The 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 may be an offence to drive when taking this medicine
• However, you would not be committing an offence if: o The medicine has been taken to treat a medical
or dental problem
o You have taken it according to the information provided with the medicine o 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.
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.
Co-codamol 15mg/500mg Tablets should be taken orally (by mouth).
The dose for adults, the elderly and children aged 16 and over is two tablets taken every four hours. You should not take more than eight tablets in any 24-hour period. The dose for children aged 12 to 15 years is one tablet taken every four 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.
Use in children
This product should not be given to children under 12 years of age.
This medicine should only be taken when necessary. Do not take more than the stated dose and do not take every day for more than three days, unless told to do so by your doctor.
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
If you take more Co-codamol 15mg/500mg Tablets than you should
It is always important to follow the dose recommended on the label. If you take too many tablets, contact your nearest hospital casualty department or doctor immediately. Immediate medical advice should be sought in the event of an overdose.
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:
• dizziness or drowsiness
• feeling sick or vomiting
Lying down may relieve these effects.
• allergic reaction (skin rash, itching, swelling or shortness of breath)
If you experience any of these symptoms please tell your doctor or pharmacist immediately.
• low blood cell counts (platelets and white blood cells) but these were not necessarily related to paracetamol
This section is continued overleaf ^
© 121XXXX ®