Medication Guide App

CO-CODAMOL 30/500 TABLETS

Active substance: PARACETAMOL

View full screen / Print PDF » Download PDF ⇩

Transcript
Zentiva
LLET COCOD TABS 30 500 UT Z

Important side-effects you should know about co-codamol
• Taking a painkiller for headaches too often or for too long can make them worse.
• Taking codeine regularly for a long time can lead to addiction, which might cause you to
feel restless and irritable when you stop taking the tablets.
Stop taking co-codamol and see a doctor or go to a hospital straight away if:
• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty
in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle
rash (urticaria).
This may mean you are having an allergic reaction to co-codamol.
• You get serious skin reactions. Very rare cases have been reported.
Talk to your doctor straight away if you notice any of the following serious side effects:
• Severe stomach pain, which may reach through to your back. This could be a sign of
inflammation of the pancreas (pancreatitis). This is a very rare side effect.
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts
longer than a few days:
• Constipation
• Feeling sick (nausea), being sick (vomiting)
• Dizziness, light-headedness, drowsiness, confusion
• Difficulty in passing water
• Becoming dependent on codeine
• You get infections or bruise more easily than usual. This could be because of a blood
problem (such as agranulocytosis, neutropenia or thrombocytopenia)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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

LEAFLET
141
30305009
30305008

30305009

CO-CODAMOL 30/500 TABLETS
Codeine Phosphate and Paracetamol

60101300

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.





417613
19-MAR-14

Keep this leaflet. You may need to read it again
If you have any questions, ask your doctor or pharmacist
This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet.

8
KY
1 of 2
FRONT 5 BACK 1
210 X 140MM
RFL024

What is in this leaflet:
1. What co-codamol is and what it is used for
2. What you need to know before you take co-codamol
3. How to take co-codamol
4. Possible side effects
5. How to store co-codamol
6. Contents of the pack and other information

1. WHAT CO-CODAMOL IS AND WHAT IT IS USED FOR

N/A
N/A
N/A
Helvetica
Minimum Point Size of Text: 8pt

The name of your medicine is Co-codamol 30/500 Tablets (called co-codamol throughout
this leaflet). Co-codamol contains two different medicines called codeine phosphate and
paracetamol. 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 such as
paracetamol. Co-codamol is used to treat severe pain.

1

Black

Co-codamol 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.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the pack. The expiry date refers to
the last day of that month.
Store your medicine in the original packaging in order to protect from moisture.
Do not store above 25°C.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Co-codamol 30/500 Tablets contain
• The active substances are codeine phosphate and paracetamol. Each tablet contains
30mg of codeine phosphate and 500mg of paracetamol.
• The other ingredients are pregelatinised starch, maize starch, povidone, potassium
sorbate, microcrystalline cellulose, stearic acid, talc, magnesium stearate, and
croscarmellose sodium (type A).
What Co-codamol 30/500 Tablets look like and contents of pack
White capsule-shaped tablets, marked with the word SOLPADOL on one side.
They come in cartons of 100 tablets.
The Marketing Authorisation Holder is Zentiva, One Onslow Street, Guildford, Surrey,
GU1 4YS, UK
The Manufacturer is
Fawdon Manufacturing Centre, Edgefield Avenue, Fawdon, Newcastle upon Tyne, NE3 3TT, UK
This leaflet was last updated in February 2014
‘Zentiva’ is a registered trademark ©2014 Zentiva.
4

PACKAGE LEAFLET – INFORMATION FOR THE USER

30305009

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-CODAMOL
Important things you should know about co-codamol
• Do not take for longer than your doctor tells you to.
• 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.
Warnings and precautions
Do not take co-codamol and tell your doctor if:
• You are allergic to the active substances or any of the other ingredients in your medicine
(listed in Section 6).
Signs of an allergic reaction include a rash and breathing problems. There can also be
swelling of the legs, arms, face, throat or tongue.
• You have severe asthma attacks or severe breathing problems.
• You have recently had a head injury.
• You have been told by your doctor that you have increased pressure in your head. Signs
of this include: headaches, being sick (vomiting) and blurred vision.
• You have recently had an operation on your liver, gallbladder or bile duct.
• You are taking medicine to treat depression called MAOIs (monoamine oxidase
inhibitors) or have taken them in the last 2 weeks. MAOIs are medicines such as
moclobemide, phenelzine or tranylcypramine (see ‘Other medicines and co-codamol’).
• You are an alcoholic.
• The person going to take the tablets is under 12 years of age. Co-codamol must not be
given to children under 12 years of age.
1

FOR
ZENTIVA USE
ONLY
Zentiva Regulatory
Approved: Yes
No
Date:
Signature:

N/A

THESE
SIGNATURES
Zentiva - Head of Regulatory ARE
Approved: Yes
No
N/A
Date:FOR ZENTIVA
Signature:
HEAD OFFICE USE
Other - as required
Approved: Yes
No
ONLY
Date:
Signature:

30305009
60101300

07/04/2014 15:15 - VISTAlink folder 908671 - Page 1/3

Zentiva
LLET COCOD TABS 30 500 UT Z





You are under 18 years of age and have had your tonsils or adenoids removed due to
obstructive sleep apnoea syndrome
You know you metabolise very rapidly codeine into morphine
You are breastfeeding or planning to breastfeed

Do not take co-codamol if any of the above apply to you. If you are not sure, talk to your
doctor or pharmacist before taking co-codamol.
Take special care and check with your doctor before taking co-codamol if:
• You have severe kidney or liver problems.
• You have problems passing water or prostate problems.
• You have a bowel problem such as colitis or Crohn’s disease or a blockage of your bowel.
• You are elderly.
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.
Children and adolescents
Use in children and adolescents after surgery
Co-codamol should not be used for pain relief in children and adolescents after removal of
their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.
Use in children with breathing problems
Co-codamol is not recommended in children with breathing problems, since the symptoms of
morphine toxicity may be worse in these children.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before
taking this medicine.
Other medicines and co-codamol
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
This includes medicines obtained without a prescription, including herbal medicines. This is
because co-codamol can affect the way some other medicines work. Also, some other
medicines can affect the way co-codamol works.
While taking co-codamol you should not take any other medicines which contain
paracetamol
This includes some painkillers, cough and cold remedies. It also includes a wide range of
other medicines available from your doctor and more widely in shops.
Do not take this medicine, and tell your doctor, if you are taking:
• Medicines to treat depression called MAOIs (monoamine oxidase inhibitors) or have
taken them in the last 2 weeks. MAOIs are medicines such as moclobemide, phenelzine,
tranylcypramine
Tell your doctor if you are taking any of the following medicines:
• Medicines which make you drowsy or sleepy (CNS depressants)
• Medicines used to thin the blood such as warfarin
• Chloramphenicol - an antibiotic used for infections
• Metoclopramide or domperidone - used to stop you feeling sick (nausea) or being sick
(vomiting)
• Colestyramine - for lowering blood cholesterol levels
• The oral contraceptive pill
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before
taking co-codamol.
2

LEAFLET
141
30305009
30305008

Taking co-codamol with alcohol
You should not drink alcohol while you are taking these tablets. This is because taking
co-codamol can change the way alcohol affects you.
Pregnancy and breast-feeding
Talk to your doctor before taking these tablets if:
• You are pregnant, think you may be pregnant or plan to get pregnant
• You are planning to breastfeed
• Do not take co-codamol while you are breastfeeding. Codeine and morphine passes into
breast milk.

60101300
417613
19-MAR-14
8
KY
2 of 2

Driving and using machines
Co-codamol can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive whilst 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 you doctor or pharmacist if you are not sure whether it is safe for you to drive whilst
taking this medicine.
Changing or stopping treatment
Chronic usage of co-codamol may lead to tolerance and dependence. If you have taken
regular daily doses of co-codamol for a long time, do not increase the dose or suddenly stop
treatment without discussing this with your doctor.

N/A
210 X 140MM
RFL024
N/A
N/A
N/A
Helvetica
Minimum Point Size of Text: 8pt
1

3. HOW TO TAKE CO-CODAMOL
Always take co-codamol exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
• Do not take more than the recommended dose.
• Do not take for longer than your doctor tells you to.
Adults and children over 12
• Swallow the tablets whole with a drink of water.
• The usual dose of co-codamol is 2 tablets, taken together.
• Adults should wait at least 4 hours before taking another dose.
• Children aged 12 years and over should wait at least 6 hours before taking another dose
• Do not take more than 8 tablets in any 24-hour period.
• Elderly people may be prescribed a lower dose.
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.
Use in children
Co-codamol should not be given to children under 12 years of age due to the risk of severe
breathing problems.
If you take more co-codamol than you should
• Talk to a doctor at once if you take too much of this medicine even if you feel well. This is
because too much paracetamol can cause delayed, serious liver damage.
• Remember to take any remaining tablets and the pack with you. This is so the doctor
knows what you have taken.
If you forget to take co-codamol
If you forget to take a dose at the right time, take it as soon as you remember. However do not
take a double dose to make up for a forgotten dose. Remember to leave at least 4 hours
between doses.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine.
3

Black

FOR
ZENTIVA USE
ONLY
Zentiva Regulatory
Approved: Yes
No
Date:
Signature:

N/A

THESE
SIGNATURES
Zentiva - Head of Regulatory ARE
Approved: Yes
No
N/A
Date:FOR ZENTIVA
Signature:
HEAD OFFICE USE
Other - as required
Approved: Yes
No
ONLY
Date:
Signature:

30305009
60101300

07/04/2014 15:15 - VISTAlink folder 908671 - Page 2/3

11/07/2014 08:15 - VISTAlink folder 1085041 - Page 1/2

Expand view ⇕

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
(web5)