Co-Codamol 30/500mg Effervescent Tablets
PATIENT INFORMATION LEAFLET CO-CODAMOL 30/500 mg EFFERVESCENT TABLETS
The name of this medicine is Co-codamol 30/500 mg Effervescent Tablets, which will be referred to as Co-codamol 30/500 throughout this leaflet.
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 your 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 Co-codamol 30/500 are and what they are used for
2. Before you take Co-codamol 30/500
3. How to take Co-codamol 30/500
4. Possible side effects
5. How to store Co-codamol 30/500
6. Further information
1. WHAT CO-CODAMOL 30/500 ARE AND WHAT THEY ARE USED FOR
The active ingredients in Co-codamol 30/500 are paracetamol and codeine phosphate hemihydrate.
Paracetamol and codeine belong to a group of medicines called analgesics (pain killers). Co-codamol 30/500 are used for the relief of severe pain.
2. BEFORE YOU TAKE CO-CODAMOL 30/500
Do not take Co-codamol 30/500 if you:
• are allergic (hypersensitive) to paracetamol, codeine or any of the other ingredients in the tablets (these are listed in Section 6, Further Information)
• are already taking other medicines containing paracetamol
• hav e a dependency to alcohol
• suffer from acute asthma
• hav e liver or kidney problems
• are on a low sodium diet
• hav e bowel or prostate problems
• are receiving monoamine oxidase inhibitor (MAOI) therapy. Co-codamol 30/500 should not be taken concurrently or within 14 days of MAOI's
Take special care with Co-codamol 30/500:
• Do not take for longer than directed by your doctor or pharmacist.
• Taking codeine regularly for a long period of time can lead to addiction, which might cause you to feel restless and irritable when you stop taking the tablets.
• Taking a painkiller for headaches too often or for too long can make them worse.
Taking other medicines
Do not take these tablets if you are already taking other medicines containing paracetamol.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, as they may decrease or increase the effect of Co-codamol 30/500:
• metoclopramide or domperidone (often taken for sickness or stomach problems)
• colestyramine (for high blood lipid levels)
• anticoagulants to reduce blood clotting (e.g. warfarin)
• MAOI's, and CNS depressants such as sleeping tablets, sedatives and some antihistamines
It may still be all right for you to take Co-codamol 30/500 and your doctor will be able to decide what is suitable for you.
Taking your medicine with food and drink
Co-codamol 30/500 should be dissolved in at least half a glass of water and can be taken with or without a meal.
Pregnancy and breast-feeding
Although there is no evidence that these tablets cause any ill effects during pregnancy, your doctor should advise you about taking them if you are pregnant. If you are breastfeeding, you may take these tablets but keep an eye on the baby for signs of drowsiness or poor feeding. If you notice this, stop taking the tablets and see your doctor.
Usually it is safe to take Co-codamol 30/500 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.
Ask your doctor or pharmacist for advice before taking any medicines.
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Driving and using machinery
These tablets may make you feel dizzy or drowsy. If this happens do not drive or operate machinery.
Important information about some of the ingredients of Co-codamol 30/500
Each of these tablets contains about 438 mg of sodium and may interfere if you are on a low sodium diet.
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This product also contains aspartame (a source of phenylalanine), which should not be given to anyone with phenylketonuria.
3. HOW TO TAKE CO-CODAMOL 30/500
Do not exceed the recommended doses. If painful symptoms are not relieved in a few days, consult your doctor.
Dosage
The usual doses for Co-codamol 30/500 are as follows:
Adults and children over 12 years:
1 or 2 tablets dissolved in water at 4 hourly intervals up to a maximum of 8 tablets in any 24 hour period. Do not continue to take these tablets for more than 3 days unless instructed by your doctor.
Not recommended for use in children under 12 years of age.
Method of Administration
For oral administration only. These tablets should be dissolved in at least half a glass of water before taking them. The solution should be drunk immediately after preparation. These tablets are meant to be dissolved first so don’t try to swallow them whole.
If you take more Co-codamol 30/500 than you should
If you have accidentally taken more than your prescribed dose, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you.
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. An overdose of paracetamol can cause serious liver damage, which may not show any signs for a day or two, by which time treatment may not be successful.
If you forget to take Co-codamol 30/500
If you forget to take one or more doses, take your next dose when you remember and then go on as prescribed. Do not take a double dose to make up for a forgotten dose.
If you have any further questions about this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Co-codamol 30/500 can cause side effects although not everybody gets them. If you get any of the following symptoms after taking these tablets, you should contact your doctor immediately:
• Any sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.
• An acute allergic reaction (anaphylaxis) or swelling of the skin.
The following effects have been reported:
• Skin rashes
• Cons tipation
• N ausea, vomiting
• L ight-headedness, dizziness,
• Confusion
• Dro wsiness
• Urinar y retention
• Rarely pancreatitis (inflammation of the pancreas which may cause severe abdominal pain that can spread through to your back)
There have been very rare reports of blood problems, so if you notice unusual bleeding or you bruise easily, tell your doctor as soon as possible.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CO-CODAMOL 30/500
Do not store your tablets above 25°C. Store in a dry place and protect from light.
Do not take this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Keep all medicines out of the reach and sight of children.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist howto dispose of medicines no longer required.
These measures will help to protect the environment.
6. FURTHER INFORMATION
What Co-codamol 30/500 mg Effervescent Tablets contain:
The active ingredients are paracetamol and codeine phosphate hemihydrate. Each tablet contains 500mg paracetamol and 30mg codeine phosphate hemihydrate.
The other ingredients are sodium hydrogen carbonate, citric acid anhydrous, sodium carbonate, povidone, simeticone, sodium saccharin, aspartame (E951) and polysorbate 80.
What Co-codamol 30/500 look like and the contents of the pack:
Co-codamol 30/500 mg Effervescent Tablets are white, circular, with a flat bevelled edge and plain on both sides.
Your medicine is available in blister packs of 30, 32, 56, 60, 84, 90 and 100 tablets (not all pack sizes may be marketed)
Marketing Authorisation Holder and Manufacturer:
The Product Licence holder responsible for the batch release is Neolab Ltd, 57 High Street, Odiham, Hants, RG29 1LF.
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neolab
This leaflet was last approved in Feb 2015.
NL/PB/CO/30500/1-L
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