ZAPAIN 30MG/500MG TABLETS

Active substance: PARACETAMOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

Zapain 30mg/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 Zapain Tablets throughout the rest of this leaflet.
In this leaflet:
1. What Zapain Tablets are and what they are used for
2. Before you take Zapain Tablets
3. How to take Zapain Tablets
4. Possible side effects
5. How to store Zapain Tablets
6. Further information
1.WHAT ZAPAIN TABLETS ARE AND WHAT THEY ARE USED FOR
Zapain Tablets contain paracetamol and codeine. Paracetamol is an analgesic (relieves pain) and an antipyretic (lowers raised temperatures).
Codeine is a strong painkiller.
Zapain Tablets are used for the relief of severe pain.
2. BEFORE YOU TAKE ZAPAIN 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 Zapain 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 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
• you have diarrhoea
• you are taking monoamine oxidase inhibitors (MAOIs) or have been taking them within the last two weeks. MAOIs such as phenelzine,
moclobemide or isocarboxazid are medicines used to treat depression.
Zapain Tablets should not be taken by children under 12 years of age.
Take special care and tell your doctor or pharmacist before taking Zapain 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 have liver, kidney problems, because the dose might need to be lower
• you have myasthenia gravis (muscle weakness, weakness of facial muscles including the eye muscles and difficulty in swallowing)
• you have a disease of the biliary tract
• you have problems with your adrenal glands (Addison’s disease)
• 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 Zapain Tablets for a long time. You may develop a dependence on Zapain 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
• Phenothiazines (medicines that calm your mood) or tricyclic antidepressants
• Antihypertensive drugs, diuretics (water pills)
• 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)
• Sodium oxybate used to treat sleepiness and sudden loss of muscle tone
• Other strong painkillers called opioids
• Medicines which prevent blood clotting (anticoagulants such as warfarin)
• Patients should not take any other paracetamol containing medicines whilst taking Zapain Tablets. Some products which can be bought without
a prescription may contain paracetamol or codeine, so always check the labels for ingredients.
Zapain Tablets can interfere with some laboratory tests used for determining some diseases.

Taking Zapain Tablets with food and drink
Do not drink alcohol whilst taking Zapain Tablets. Swallow the tablets with a glass of water. Do not bite or chew the tablets.
Pregnancy and breast-feeding
Zapain 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 Zapain 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
Zapain 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 ZAPAIN TABLETS
Always take Zapain Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Dose
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
Zapain 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.
Zapain Tablets are not recommended for children under 12 years.
Do not take with any other paracetamol-containing products.
If you take more Zapain 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 Zapain 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 Zapain Tablets
Zapain Tablets can become habit forming. This is called dependence, if you stop taking your medicine suddenly it can cause symptoms such as
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, Zapain 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 depression
• liver damage, especially in heavy drinkers
• restlessness or irritability
• hearing loss
• 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 ZAPAIN TABLETS
• Keep this medicine out of the sight and reach of children.
• Do not use Zapain 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 Zapain Tablets contain
• The active substances are paracetamol, 500mg and codeine phosphate, 30mg.
• The other ingredients are maize starch, methyl cellulose, talc, calcium stearate, povidone, purified water, hypromellose and macrogol 3350.
What Zapain Tablets look like and contents of the pack
Zapain Tablets are caplet shaped white tablets.
Zapain Tablets are available in aluminium blister packs or plastic containers with child resistant lids of 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
This leaflet was last revised in April 2012
10012/LF/2
Zapain is the registered trademark of Mercury Pharma Group Ltd.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Zapain® 30mg/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 Zapain Tablets
throughout the rest of this leaflet.
In this leaflet:
1.What Zapain Tablets are and what they are used for
2.Before you take Zapain Tablets
3.How to take Zapain Tablets
4.Possible side effects
5.How to store Zapain Tablets
6.Further information

1.WHAT ZAPAIN TABLETS ARE AND WHAT THEY ARE USED FOR
Zapain Tablets contain paracetamol and codeine. Paracetamol is an analgesic (relieves
pain) and an antipyretic (lowers raised temperatures). Codeine is a strong painkiller.
Zapain Tablets are used for the relief of severe pain.

2. BEFORE YOU TAKE ZAPAIN 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 Zapain 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 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
• you have diarrhoea
• you are taking monoamine oxidase inhibitors (MAOIs) or have been taking them
within the last two weeks. MAOIs such as phenelzine, moclobemide or
isocarboxazid are medicines used to treat depression.
Zapain Tablets should not be taken by children under 12 years of age.
Take special care and tell your doctor or pharmacist before taking Zapain 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 have liver, kidney problems, because the dose might need to be lower
• you have myasthenia gravis (muscle weakness, weakness of facial muscles
including the eye muscles and difficulty in swallowing)
• you have a disease of the biliary tract
• you have problems with your adrenal glands (Addison’s disease)
• 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 Zapain Tablets for a long time. You may develop a
dependence on Zapain 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
• Phenothiazines (medicines that calm your mood) or tricyclic antidepressants
• Antihypertensive drugs, diuretics (water pills)
• 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)
• Sodium oxybate used to treat sleepiness and sudden loss of muscle tone
• Other strong painkillers called opioids
• Medicines which prevent blood clotting (anticoagulants such as warfarin)
• Patients should not take any other paracetamol containing medicines whilst taking
Zapain Tablets. Some products which can be bought without a prescription may
contain paracetamol or codeine, so always check the labels for ingredients.
Zapain Tablets can interfere with some laboratory tests used for determining some diseases.
Taking Zapain Tablets with food and drink
Do not drink alcohol whilst taking Zapain Tablets. Swallow the tablets with a glass of
water. Do not bite or chew the tablets.
Pregnancy and breast-feeding
Zapain 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 Zapain 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
Zapain 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 ZAPAIN TABLETS
Always take Zapain Tablets exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
Dose
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 Zapain 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.
Zapain Tablets are not recommended for children under 12 years.
Do not take with any other paracetamol-containing products.
If you take more Zapain 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 Zapain 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 Zapain Tablets
Zapain Tablets can become habit forming. This is called dependence, if you stop
taking your medicine suddenly it can cause symptoms such as 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, Zapain 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 depression
• liver damage, especially in heavy drinkers
• restlessness or irritability
• hearing loss
• 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 ZAPAIN TABLETS
• Keep this medicine out of the sight and reach of children.
• Do not use Zapain 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 Zapain Tablets contain
• The active substances are paracetamol, 500mg and codeine phosphate, 30mg.
• The other ingredients are maize starch, methyl cellulose, talc, calcium stearate,
povidone, purified water, hypromellose and macrogol 3350.
What Zapain Tablets look like and contents of the pack
Zapain Tablets are caplet shaped white tablets.
Zapain Tablets are available in aluminium blister packs or plastic containers with child
resistant lids of 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:
Haupt Pharma, Wolftratshausen GmbH,
Pfaffenriederstrasse 5, 82515,
Wolfratshausen, Germany
This leaflet was last revised in April 2012
Zapain is the registered trademark of Mercury Pharma Group Ltd.
10012/LF/2

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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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