Co-Codamol 8/500 Tablets
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PACKAGE LEAFLET - INFORMATION FOR THE USER
3. HOW TO TAKE CO-CODAMOL
CO-CODAMOL 8/500 TABLETS
Codeine Phosphate 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.
• Do not pass this medicine on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What co-codamol is and what it is used for 4. Possible side effects
2. What you need to know before you take co-codamol 5. How to store co-codamol
3. How to take co-codamol 6. Contents of the pack and other information.
1. WHAT CO-CODAMOL IS AND WHAT IT IS USED FOR
The name of your medicine is Co-codamol 8/500 Tablets (called co-codamol throughout this leaflet). Co-codamol contains two different medicines called codeine phosphate and paracetamol. It belongs to a group of medicines called analgesics (painkillers) and is used to treat headache including migraine, toothache, neuralgia, period pain, pain caused by rheumatism and arthritis and to relieve the symptoms of colds, flu and sore throats.
2. WHAT YOU NEED TO KNOW 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 tablets.
• Taking painkillers for headaches too often can make them worse.
Do not take co-codamol and tell your doctor if:
• You are allergic to the active substances or any of the other ingredients in your medicine (listed in Section 6)
Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs, arms, face, throat or tongue
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.
Children
Co-codamol must not be given to children under 12 years of age Warnings and precautions
Take special care and check with your doctor before taking co-codamol if:
• You have severe kidney or liver problems.
• You have a liver problem caused by alcohol
If you are not sure if the above applies to you, talk to your doctor or pharmacist before taking this medicine.
Other medicines and co-codamol
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.
Tell your doctor if you are taking any of the following medicines:
• Medicines used to thin the blood such as warfarin
• Metoclopramide or domperidone - used to stop you feeling sick (nausea) or being sick (vomiting)
• Colestyramine - for lowering blood cholesterol levels
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking co-codamol.
Pregnancy and breast-feeding
• If you are pregnant, think you may be pregnant or plan to get pregnant, talk to your doctor before taking these tablets.
• Usually it is safe to take co-codamol 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
Changing or stopping treatment
Taking co-codamol for a long time may lead to tolerance and dependence. Do not increase or suddenly stop treatment without discussing this with your doctor.
Always take co-codamol exactly as your doctor has told you. 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
• Swallow the tablets whole with a drink of water
• The usual dose of co-codamol is 2 tablets, taken together
• Wait at least 4 hours before taking another dose
• Do not take more than 8 tablets in any 24-hour period
Use in children: Co-codamol should not be given to children under 12 years of age.
If you take more co-codamol than you should:
• Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
• Remember to take any remaining tablets and the pack with you. This is so the doctor knows what you have taken.
If you forget to take co-codamol
If you forget to take a dose at the right time, take it as soon as you remember. However do not take a double dose to make up for a forgotten dose. Remember to leave at least 4 hours between doses.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine:
Stop taking co-codamol and sea a doctor or go to a hospital straight away if:
• 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
Talk to your doctor straight away if you notice any of the following serious side effects:
• 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
• Yellowing of your skin or eyes and your urine becomes darker in colour. This could be a liver problem, such as jaundice or hepatitis
• A severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body or you develop skin blisters. You may also feel generally unwell, have a fever, chills and aching muscles.
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).
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet.
5. HOWTO STORE CO-CODAMOL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the pack. The expiry date refers to the last day of that month.
Store your medicine in the original packaging in order to protect from moisture.
Do not store above 25°C. Do not throw away 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 8/500 Tablets contain
• The active substances are codeine phosphate and paracetamol. Each tablet contains 8mg of codeine phosphate and 500mg of paracetamol.
• The other ingredients are, maize starch, povidone, potassium sorbate, microcrystalline cellulose, stearic acid, magnesium stearate, talc, pregelatinised starch and purified water.
What Co-codamol 8/500 Tablets look like and contents of pack
• Flat, white tablets, marked with an S/4 on one side. They come in cartons of 50 and 100 tablets. Not all pack sizes may be marketed.
The Marketing Authorisation Holder and Manufacturer is
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.
This leaflet was updated in July 2012. "Zentiva" is a registered trademark © 2012 Zentiva
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Artwork Code No:-ZEN-0557312-9tt-UK-EX[524745] Version number:5 Edition No: 9 Product: CO-CODAMOL 8/500 TABLETS Market/Co untry: United Kingdom Artwork Type: Leafietffor 50's & 100's pack) Size(lxbxh/lxh)mm: 140mmx260mm |
Artwork Operator/Date: JOANITA/22.08.12 Folds: Prefolded to size 140 x 26 mm Machine: 1C 150 C Minimum Text Point: 8 PharmaCodeno: 5573 Colour: Blade | ||
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Final Artwork Approval (Indudes Text & Overall ) | |||
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Department |
Name |
Signature |
Date |
|
DRA- United Kingdom |
Allison Stacey | ||
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DRA- United Kingdom |
Janet Lewis | ||
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Packaging - Goa |
San tosh Desai | ||
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IQC-Coa |
P. Bulakh | ||
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QC-PMTD-Goa |
J.V.6okam | ||
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AVENTIS PHARMA-fiOA (QC |
-PMTD-Central Artwork Crea |
on Sevices-india-Contact Mr.J.V.Gokarn or MsJ.Desouza) | |
Plot L-121 Verna Industrial Estate, Verna,Goa^»03722 India Tel: 0091-832-2883228 Fax :0091-832-2783591) Details for internal reference :
Version 1,dated : 17.07.12 - Artwork prepared as per vista folder 92765B Version 2 dtd 21.07.12 - Corrections done.
Version 3 dtd 08.08.12 - Changes done as suggested.
Version 4 & 5 dtd 22.08.12 - Changes done as suggested.