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CO-CODAMOL 15/500MG FILM-COATED TABLETS

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

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Package leaflet:
Information for the user

Co-codamol 15/500mg Film-coated Tablets
Codeine phosphate hemihydrate/paracetamol
Read all of this leaflet carefully before you start taking
this medicine because it contains important information
for you.
• Keep this leaflet. You may need to read it again.
• If you have further 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. See section 4.

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.

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

Use in children and adolescents after surgery

Children and adolescents

Co-codamol should not be taken by children under 12 years of
age.
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.

Use in children and adolescents with breathing
problems

Codeine is not recommended in children or adolescents with
breathing problems, since the symptoms of morphine toxicity
may be worse in these children.

Other medicines and Co-codamol

1 What Co-codamol is and what it is used for
The name of your medicine is Co-codamol.
Co-codamol contains two different analgesics (painkillers) called
paracetamol and codeine (as codeine phosphate hemihydrate).
Codeine belongs to a group of medicines called opioid
analgesics which act to relieve pain.
Co-codamol can be used in children over 12 years of age for the
short-term relief of moderate or severe pain that is not relieved
by other painkillers such as paracetamol or ibuprofen alone.

2 What you need to know before you take

Co-codamol

Do not take Co-codamol:

• if you are allergic to codeine, paracetamol or any of the other
ingredients of this 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
• if you are allergic to soya or peanut
• if you have severe asthma attacks or severe breathing
problems
• if you have recently had a head injury
• if you have severe liver problems
• if 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 eyesight
• if you have recently had an operation on your liver,
gallbladder or bile duct (biliary tract)
• if 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’)
• if you have acute alcoholism
• if you are a breastfeeding woman
• if you know that you metabolise codeine very rapidly into
morphine.
Do not take Co-codamol for longer than your doctor tells you to.
Do not use this product for pain relief in children and
adolescents (0-18 years of age) after removal of their tonsils or
adenoids due to obstructive sleep apnoea syndrome.

Warnings and precautions

Talk to your doctor or pharmacist before taking Co-codamol:
• if you have severe kidney problems
• if you have liver problems or are an alcoholic
• if you have problems passing water or prostate problems
• if you have an underactive thyroid gland
• if you have an addiction to opioids
• if you have problems with your adrenal glands
• if you have a bowel problem such as colitis or Crohn’s disease
or a blockage of your bowel
• if you are elderly
• if you have anaemia (a reduced number of red blood cells)
• If you are malnourished or dehydrated
• if the person going to take the tablets is under 18 years of age
and has breathing problems.

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
This is especially important in the case of:
• Medicines to treat depression.
• Medicines which make you drowsy or sleepy (CNS
depressants) such as sleeping pills, medicines to treat anxiety
or anaesthetics.
• Medicines used to thin the blood such as warfarin.
• Medicines for irregular heartbeats such as quinidine.
• Antibiotics used to treat infections (e.g. chloramphenicol,
rifampicin).
• Metoclopramide or domperidone - used to stop you feeling
sick (nausea) or being sick (vomiting).
• Cholestyramine - for lowering blood cholesterol levels.
• Probenecid – used to treat gout.
• The herbal remedy ‘St John Wort’.
• Cimetidine – used to treat heartburn and peptic ulcers.
• Other painkillers.
• Barbiturates (e.g. phenobarbital).
• Medicines to treat epilepsy (e.g. phenytoin, carbamazepine).
• The oral contraceptive pill.

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.
Co-codamol with food, drink and alcohol
You should not drink alcohol while you are taking these tablets.
This is because alcohol can increase the risk of serious side
effects.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Co-codamol should not be used during pregnancy unless
advised by your doctor. Regular use during pregnancy may
cause withdrawal symptoms in the newborn. If used, you should
use the lowest possible dose that reduces your pain and/or your
fever and use it for the shortest time possible.
Do not take Co-codamol while you are breastfeeding, since it
passes into breast milk.

Driving and using machines

You may feel dizzy or sleepy while taking Co-codamol. If this
happens, do not drive or use any tools or machines.

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.

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

Taking a painkiller for headaches too often or for too long can
make them worse.

Talk to your doctor or pharmacist if you are not sure whether it is
safe for you to drive while taking this medicine.

Never take more Co-codamol than recommended.Talk to a
doctor at once if you take too much of this medicine even if you
seem well. This is because too much paracetamol can cause
delayed, serious liver damage.
Continued top of next column

Continued over page

Paracetamol Codeine 500mg/15mg Tablets PIL - UK
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Co-codamol contains lecithin soya

Stop taking Co-codamol and see a doctor or go to a
hospital straight away if:

If you are allergic to peanut or soya, do not take this medicine.

• You have difficulty in breathing or you feel dizzy.
• 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.

3 How to take Co-codamol
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are
not sure.
• Do not take more than the recommended 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

Talk to your doctor straight away if you notice the
following serious side effect:

• 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.

Take this medicine by mouth.
Swallow the tablets whole with a drink of water. If necessary, the
tablets may be broken in half to make them easier to swallow.

Other side effects:

Adults

• The recommended dose of Co-codamol is 1 or 2 tablets.
• Wait at least 4 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.
• Patients with kidney problems may require longer intervals
between doses.

Common: may affect up to 1 in 10 people:
Drowsiness, headache, abnormal sweating, feeling sick (nausea),
being sick (vomiting), constipation, tiredness.

Children under 12 years

Rare: may affect up to 1 in 1,000 people:
You get infections or bruise more easily than usual. This could
be because of a blood problem (such as agranulocytosis,
neutropenia, pancytopaenia, anaemia or thrombocytopenia).
Difficulty sleeping, breathlessness, yellowing of the skin or white
of the eyes (symptoms of liver damage), skin rash.

Uncommon: may affect up to 1 in 100 people:
Dizziness, problems with vision, dryness of the mouth.

Co-codamol should not be given to children under 12 years of
age, due to the risk of severe breathing problems.

Children and adolescents 12 to 15 years

• The recommended dose of Co-codamol is 1 tablet.
• Wait at least 6 hours before taking another dose.
• Do not take more than 4 tablets in any 24-hour period.

Very Rare: may affect up to 1 in 10,000 people:
Kidney damage has been shown to occur very rarely in patients
receiving long term treatment with Co-codamol.

Adolescents aged 16 years and above and over 50kg
of body weight

Reporting of side effects

• The recommended dose of Co-codamol is 1 or 2 tablets.
• Wait at least 6 hours before taking another dose.
• Do not take more than 8 tablets in any 24-hour period.

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 Yellow card Scheme
Website: www.mhra.gov.uk/yellowcard

Instructions for use of child resistant blisters:

1. Do not try and push the tablet directly out of the pocket. The
tablet cannot be pushed out through the foil. Instead the foil
must be peeled back.
2. First, separate one blister cell from the rest of the strip at the
perforations

By reporting side effects you can help provide more information
on the safety of this medicine.

5 How to store Co-codamol
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated
on the carton or label after ‘EXP’. The expiry date refers to the last
day of that month.
This medicine does not require any special storage conditions.

3. Then carefully peel off the backing to open the pocket

Do not throw away any 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 contains

The active substances are codeine phosphate hemihydrate and
paracetamol. Each film-coated tablet contains 15mg of codeine
phosphate and 500mg of paracetamol.

4. You can then remove the tablet from the pocket

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, if it is almost time for your next dose, skip the missed
dose. Do not take a double dose to make up for a forgotten
dose. Remember to leave at least 4 hours between doses for
adults and 6 hours between doses for children and adolescents.

If you stop taking Co-codamol
Changing or stopping treatment

Long term usage of Co-codamol may lead to tolerance
and dependence. If you have taken regular daily doses of
Co-codamol for a long time, you may experience withdrawal
symptoms if you suddenly stop treatment. Contact your doctor
for advice on how to stop taking the tablets gradually to avoid
withdrawal symptoms.
If you have any further questions on the use of this medicine,
ask your doctor, pharmacist or nurse.

4 Possible side effects

The other ingredients are povidone (K29/32), magnesium
stearate, silica colloidal anhydrous, talc, sodium croscarmellose,
copovidone (25.2-30.8), cellulose microcrystalline,
hydroxypropylated starch (E1440), mannitol, lecithin soya
(E322), titanium dioxide (E171) and iron oxide yellow (E172).

What Co-codamol looks like and contents of pack
Co-codamol 15/500mg film-coated tablets are light yellow, oval,
8.5 x 17mm, biconvex tablets, marked ’5 15’ on one side with a
score line.
Pack Sizes: White PVC/Aluminium/PE/paper child resistant
blisters: 30 and 100 film-coated tablets.
The Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
This leaflet was last revised in November 2016

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

Important side effects you should know about

• 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 the tablets.

If you would like a
leaflet with larger text,
please contact
01271 385257.

Actavis, Barnstaple, EX32 8NS, UK
Continued top of next column

BBBA0267

Paracetamol Codeine 500mg/15mg Tablets PIL - UK
approved for print/date

Proof Round

1

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0267

Originator:
S.Anson
Origination Date: 21.11.16
Revision Date:
Revised By:

Technical
Approval

Date sent:
21.11.16
Date received: 22.11.16

Dimensions:
190 x 380
Min Body Text Size: 9pts
Supplier:
Actavis Bulgaria
Dupnitsa

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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.

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