CO-CODAMOL 15MG/500MG TABLETS

Active substance: PARACETAMOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Copaz® 15mg/500mg Tablets
Codeine Phosphate/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 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 symptoms are the same as yours. If any of the side effects
become serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
The product is known by the name above but will be referred to as Copaz Tablets throughout
the rest of this leaflet.
In this leaflet:
1. What Copaz Tablets are and what they are used for
2. Before you take Copaz Tablets
3. How to take Copaz Tablets
4. Possible side effects
5. How to store Copaz Tablets
6. Further information
1.WHAT COPAZ TABLETS ARE AND WHAT THEY ARE USED FOR
Copaz Tablets contain paracetamol and codeine. Paracetamol is an analgesic (relieves pain)
and an antipyretic (lowers raised temperatures). Codeine is a strong painkiller.
Copaz Tablets are used for the relief of moderate pain.
2. BEFORE YOU TAKE COPAZ TABLETS
Do not take with any other paracetamol-containing products. 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.
Do not take Copaz Tablets if:
• you know that you are allergic to paracetamol or codeine, or any of the other ingredients
(refer to section 6 below)
• you suffer from severe kidney or liver disease
• you suffer from asthma or any other breathing problems, for example chronic bronchitis
or emphysema
• you are taking monoamine oxidase inhibitors (MAOIs) or have been taking them within
the last two weeks. MAOIs such as phenelzine or isocarboxazid are medicines used to
treat depression
• you have just had a head injury or suffer from increased pressure on the brain
• you drink a lot of alcohol, or have done in the past
• you have recently had an operation to your gall bladder.
Copaz Tablets should not be given to children under 12 years of age.
Take special care and tell your doctor or pharmacist before taking Copaz Tablets if:
• you are elderly or weak
• you have any stomach pains or other sudden problems in your abdomen (belly)
• you have an underactive thyroid gland







you are prone to suffer from asthma
you have liver, kidney or thyroid problems, because the dose might need to be lower
you have problems with your adrenal glands (Addison’s disease – your doctor will advise
you)
you suffer from an enlarged prostate gland (if male) or narrowing of your urethra (tube
through which urine is passed)
you feel you have taken Copaz Tablets for a long time. You may develop a dependence
on Copaz Tablets which may be harmful.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. Some medicines interact
with each other and this can alter their effect. It is particularly important to tell your doctor or
pharmacist if you are taking the following medicines:
• MAOIs used to treat depression, taken within the last 14 days (refer to “do not take if” in
section 2 above)
• Sedatives and sleeping tablets, eg temazepam and diazepam
• Medicines for irregular heart beats (mexiletine, quinine or quinidine)
• Drugs used to dry fluids in the mouth and lungs known as anticholinergics
• Medicines to treat diarrhoea or sickness (metoclopramide, domperidone)
• Medicines used to treat problems of the stomach, gall bladder, heart burn or sickness,
(e.g. cimetidine, colestyramine)
• Other strong painkillers called opioids
• Medicines which prevent blood clotting (anticoagulants such as warfarin).
Copaz Tablets can interfere with some laboratory tests used for determining some diseases.
Copaz Tablets must not be taken with any other medicines containing paracetamol or
codeine. Some products which can be bought without a prescription may contain paracetamol
or codeine, so always check the labels for ingredients.
Taking Copaz Tablets with food and drink
Do not drink alcohol whilst taking Copaz Tablets. Swallow the tablets with a glass of water.
Do not bite or chew the tablets.
Pregnancy and breast-feeding
Copaz Tablets should not be used during pregnancy as they can affect the baby and can cause
breathing problems when the baby is born.
Usually it is safe to take Copaz 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. Ask your doctor or pharmacist before taking any
medicine.
Driving and using machines
Copaz Tablets may cause dizziness or drowsiness and you should not drive or operate
machinery if you are affected this way.
Codeine may disturb your vision.

3. HOW TO TAKE COPAZ TABLETS
Always take Copaz Tablets exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
The usual dosage is one or two tablets every four hours as needed. You should not take more
than 8 tablets in 24 hours. If you feel the effect of Copaz Tablets is too strong or too weak, or
your symptoms persist, speak to your doctor or pharmacist.
A lower dosage may be needed if you are elderly or have other medical problems.
Check with your doctor about this.
Copaz Tablets are not recommended for children under 12 years.
Do not take with any other paracetamol-containing products.
If you take more Copaz Tablets 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. Bring the remaining tablets and this
leaflet with you so that the medical staff know what you have taken.
If you forget to take Copaz Tablets
Do not take more than one dose at a time. If you forget to take a dose then take your next
dose at the usual time. Never take two doses at the same time.
If you stop taking Copaz Tablets
Copaz Tablets can become habit forming. This is called dependence, if you stop taking your
medicine suddenly it can cause symptoms such as sweating, fever, weakness and muscular
pains, restlessness and irritability. Your doctor will stop your tablets gradually to avoid you
having these withdrawal symptoms. If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Copaz Tablets can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are very rare.
Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or
itching (especially affecting your whole body) should be reported to a doctor immediately.
Other possible side effects are:
• feeling sick (nausea) and being sick (vomiting)
• light headedness, dizziness, sleepiness
• stomach pains, constipation.
Lying down may help these effects if they happen.
Other side effects include:
• a feeling of extra well being, or of disorientation
• small eye pupils, problems with vision, headaches
• slowing of the pulse
• difficulty in passing urine
• liver damage, especially in heavy drinkers
• changes in blood cells, such as low number of cells which fight infection and of cells
which are involved in blood clotting.
If any of the side effects become serious, or if you notice any side effect not listed in this
leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE COPAZ TABLETS




Keep this medicine out of the sight and reach of children.
Do not use Copaz Tablets after the expiry date which is stated on the carton. The expiry
date refers to the last day of that month.
• Keep this medicine in a dry place.
• Do not store above 25oC.
• Protect from light.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Copaz Tablets contain
The active substances are paracetamol, 500mg and codeine phosphate, 15mg.
The other ingredients are maize starch sifted, methylcellulose; talc; calcium stearate;
povidone; purified water; hypromellose; macrogol 3350.
What Copaz Tablets look like and contents of the pack
Copaz Tablets are white coated tablets available in aluminium blister packs or plastic
containers with child resistant lids of 28, 30, 56, 100 or 112 tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder and Manufacturer
Mercury Pharmaceuticals Ltd
No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK
Manufactured By
Bristol Laboratories Ltd., Laporte Way, Luton, Bedfordshire, LU4 8WL, UK
Haupt Pharma, Wolftratshausen GmbH,
Pfaffenriederstrasse 5, 82515, Wolfratshausen, Germany
This leaflet was last revised in March 2012.
Copaz is the registered trade mark of Mercury Pharma Group Limited.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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