Skip to Content

UK Edition. Click here for US version.

ZAPAIN 30MG/500MG TABLETS

Active substance(s): CODEINE PHOSPHATE / CODEINE PHOSPHATE / CODEINE PHOSPHATE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Version No:
Product Name:

PACKAGE LEAFLET: INFORMATION FOR THE USER

Co-codamol 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.
In this leaflet:
1. What Co-codamol 30/500 Tablets are and what they are used for
2. Before you take Co-codamol 30/500 Tablets
3. How to take Co-codamol 30/500 Tablets
4. Possible side effects
5. How to store Co-codamol 30/500 Tablets
6. Further information

1. WHAT CO-CODAMOL 30/500 TABLETS ARE AND WHAT THEY ARE USED FOR
Co-codamol 30/500 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.
Co-codamol 30/500 Tablets are used for the relief of severe pain. Co-codamol 30/500 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.

100154/LF/027/07

Pack Size:
Component:
SKU:
Market:
Production Site:
Revision No.:
Revision Date:
Revised by:
CRF:

Co-codamol
30mg/500mg Tablets
100 Tablets
Leaflet
100154
UK
Bristol
2
01/03/2017
PAT
PR 8719

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

180 X 430 mm
N/A
N/A
N/A
N/A
Black

Non-Print Colours: Cutter
Tech App. Date:
Min. Font Size:

08/03/2017
8.5 pt

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, HPRA, etc ) and that Mercury Pharma have
license approval to distribute this component for
sale in the relevant market.

Accept Artwork / Reject Artwork
(Please strike off whichever NOT applicable)

2. BEFORE YOU TAKE CO-CODAMOL 30/500 TABLETS
Do not take with any other paracetamol-containing products. Do not take for longer than directed by your prescriber. Do not
use Co-codamol 30/500 Tablets for pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or
adenoids as Codeine in Co-codamol 30/500 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 Co-codamol 30/500 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.
Co-codamol 30/500 Tablets should not be taken by children under 12 years of age.
Take special care and tell your doctor or pharmacist before taking Co-codamol 30/500 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 Co-codamol 30/500 Tablets for a long time. You may develop a dependence on Co-codamol
30/500 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 Co-codamol 30/500 Tablets. Some
products which can be bought without a prescription may contain paracetamol or codeine, so always check the labels
for ingredients.
Co-codamol 30/500 Tablets can interfere with some laboratory tests used for determining some diseases.
Taking Co-codamol 30/500 Tablets with food and drink
Do not drink alcohol whilst taking Co-codamol 30/500 Tablets. Swallow the tablets with a glass of water. Do not bite or
chew the tablets.
Pregnancy and breast-feeding
Co-codamol 30/500 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.

Signature .......................................................................
Name .............................................................................
Date ...............................................................................

PAGE 1 OF 2

Version No:
Product Name:

Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
Co-codamol 30/500 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.

Pack Size:
Component:
SKU:
Market:
Production Site:
Revision No.:
Revision Date:
Revised by:
CRF:

Co-codamol
30mg/500mg Tablets
100 Tablets
Leaflet
100154
UK
Bristol
2
01/03/2017
PAT
PR 8719

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

180 X 430 mm
N/A
N/A
N/A
N/A
Black

Non-Print Colours: Cutter

3. HOW TO TAKE CO-CODAMOL 30/500 TABLETS
Always take Co-codamol 30/500 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 Co-codamol 30/500 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.
Co-codamol 30/500 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 Co-codamol 30/500 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 Co-codamol 30/500 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 Co-codamol 30/500 Tablets
Co-codamol 30/500 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, Co-codamol 30/500 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 CO-CODAMOL 30/500 TABLETS
• keep this medicine out of the sight and reach of children.
• do not use Co-codamol 30/500 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 Co-codamol 30/500 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 Co-codamol 30/500 Tablets look like and contents of the pack
Co-codamol 30/500 Tablets are caplet shaped white tablets.
Co-codamol 30/500 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,
Capital House, 85 King William Street,
London EC4N 7BL, UK
Manufactured By:
Bristol Laboratories Ltd.,
Laporte Way, Luton,
Bedfordshire, LU4 8WL, UK
This leaflet was revised in March 2017.

100154/LF/027/07

100154/LF/027/07

Tech App. Date:
Min. Font Size:

08/03/2017
8.5 pt

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, HPRA, etc ) and that Mercury Pharma have
license approval to distribute this component for
sale in the relevant market.

Accept Artwork / Reject Artwork
(Please strike off whichever NOT applicable)

Signature .......................................................................
Name .............................................................................
Date ...............................................................................

PAGE 2 OF 2

Expand Transcript

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.

Hide