ZAPAIN 30MG/500MG TABLETS
Active substance(s): CODEINE PHOSPHATE
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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). This product contains codeine. Codeine belongs to a
group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or
in combination with other pain killers.
Zapain Tablets are used for the relief of severe pain. Zapain Tablets can be used in children over
12 years of age for the short-term relief of moderate pain that is not relieved by other painkillers
such as paracetamol or ibuprofen alone.
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. Do not use Zapain Tablets for pain relief in children and adolescents (0-18 years
of age) after removal of their tonsils or adenoids as Codeine in Zapain Tablets may cause
obstructive sleep apnoea syndrome (sleep disruption due to respiratory pauses). 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 know that you metabolise very rapidly codeine into morphine
• you are breast-feeding
• 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.
Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that
produces pain relief. Some people have a variation of this enzyme and this can affect people
in different ways. In some people, morphine is not produced or produced in very small
quantities, and it will not provide enough pain relief. Other people are more likely to get serious
side effects because a very high amount of morphine is produced. If you notice any of the
following side effects, you must stop taking this medicine and seek immediate medical advice:
slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick,
constipation, lack of appetite.
Warnings and precautions
Children and adolescents
Use in children and adolescents after surgery
Codeine should not be used for pain relief in children and adolescents after removal of their tonsils
or adenoids due to Obstructive Sleep Apnoea Syndrome (sleep disruption due to respiratory
pauses). They may be at increased risk of severe side effects in case of morphine toxicity.
Use in children with breathing problems:
Codeine is not recommended in children with breathing problems, since the symptoms of
morphine toxicity may be worse in these children.
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, e.g. 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. Do not take codeine while you are
breast-feeding. Codeine and morphine passes into breast milk.
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.
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 is an offence to drive if this medicine affects your ability to drive
• however, you would not be committing an offence if:
- the medicine has been prescribed to treat a medical or dental problem and
- you have taken it according to the instructions given by the prescriber or in the information
provided with the medicine and
- 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 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
Adults: The recommended dose is one or two tablets every four to six hours when needed, up
to a maximum of 8 tablets in any 24 hour period.
If you feel the effect of Zapain Tablets is too strong or too weak or your symptoms persist,
speak to your doctor or pharmacist. This medicine should not be taken for more than 3 days.
If the pain does not improve after 3 days, talk to your doctor for advice.
A lower dosage may be needed if you are elderly or have other medical problems.
Check with your doctor about this.
Do not take with any other paracetamol-containing products.
Use in children and adolescents
Children aged 16-18 years: The recommended dose is one to two tablets every 6 hours when
necessary up to a maximum of 8 tablets in 24 hours.
Children aged 12–15 years: The recommended dose is one tablet every 6 hours when
necessary up to a maximum of 4 tablets in 24 hours.
Zapain Tablets should not be used in children below the age of 12 years, due to the risk of
severe breathing problems.
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 knows 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.
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 the Yellow Card
Scheme at: 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 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 25˚C
• 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:
Mercury Pharmaceuticals Ltd.,
Capital House, 85 King William street, London EC4N 7BL, UK
Manufactured By:
Haupt Pharma, Wolftratshausen GmbH,
Pfaffenriederstrasse 5, 82515,
Wolfratshausen, Germany
This leaflet was revised in February 2018.
Zapain is the registered trademark of Mercury Pharma Group Ltd.
LF-104370-01
723481 GB6
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). This product contains codeine. Codeine belongs to a
group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or
in combination with other pain killers.
Zapain Tablets are used for the relief of severe pain. Zapain Tablets can be used in children over
12 years of age for the short-term relief of moderate pain that is not relieved by other painkillers
such as paracetamol or ibuprofen alone.
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. Do not use Zapain Tablets for pain relief in children and adolescents (0-18 years
of age) after removal of their tonsils or adenoids as Codeine in Zapain Tablets may cause
obstructive sleep apnoea syndrome (sleep disruption due to respiratory pauses). 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 know that you metabolise very rapidly codeine into morphine
• you are breast-feeding
• 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.
Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that
produces pain relief. Some people have a variation of this enzyme and this can affect people
in different ways. In some people, morphine is not produced or produced in very small
quantities, and it will not provide enough pain relief. Other people are more likely to get serious
side effects because a very high amount of morphine is produced. If you notice any of the
following side effects, you must stop taking this medicine and seek immediate medical advice:
slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick,
constipation, lack of appetite.
Warnings and precautions
Children and adolescents
Use in children and adolescents after surgery
Codeine should not be used for pain relief in children and adolescents after removal of their tonsils
or adenoids due to Obstructive Sleep Apnoea Syndrome (sleep disruption due to respiratory
pauses). They may be at increased risk of severe side effects in case of morphine toxicity.
Use in children with breathing problems:
Codeine is not recommended in children with breathing problems, since the symptoms of
morphine toxicity may be worse in these children.
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, e.g. 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. Do not take codeine while you are
breast-feeding. Codeine and morphine passes into breast milk.
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.
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 is an offence to drive if this medicine affects your ability to drive
• however, you would not be committing an offence if:
- the medicine has been prescribed to treat a medical or dental problem and
- you have taken it according to the instructions given by the prescriber or in the information
provided with the medicine and
- 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 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
Adults: The recommended dose is one or two tablets every four to six hours when needed, up
to a maximum of 8 tablets in any 24 hour period.
If you feel the effect of Zapain Tablets is too strong or too weak or your symptoms persist,
speak to your doctor or pharmacist. This medicine should not be taken for more than 3 days.
If the pain does not improve after 3 days, talk to your doctor for advice.
A lower dosage may be needed if you are elderly or have other medical problems.
Check with your doctor about this.
Do not take with any other paracetamol-containing products.
Use in children and adolescents
Children aged 16-18 years: The recommended dose is one to two tablets every 6 hours when
necessary up to a maximum of 8 tablets in 24 hours.
Children aged 12–15 years: The recommended dose is one tablet every 6 hours when
necessary up to a maximum of 4 tablets in 24 hours.
Zapain Tablets should not be used in children below the age of 12 years, due to the risk of
severe breathing problems.
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 knows 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.
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 the Yellow Card
Scheme at: 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 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 25˚C
• 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:
Mercury Pharmaceuticals Ltd.,
Capital House, 85 King William street, London EC4N 7BL, UK
Manufactured By:
Haupt Pharma, Wolftratshausen GmbH,
Pfaffenriederstrasse 5, 82515,
Wolfratshausen, Germany
This leaflet was revised in February 2018.
Zapain is the registered trademark of Mercury Pharma Group Ltd.
LF-104370-01
723481 GB6
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
