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CODEINE/PARACETAMOL 60MG/1000MG FILM-COATED TABLETS

Active substance(s): CODEINE PHOSPHATE HEMIHYDRATE / PARACETAMOL

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Package leaflet: Information for the user
Codeine/Paracetamol 60mg/1000mg film-coated tablets
codeine phosphate and 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.

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

1.

What Codeine/Paracetamol is and what it is used for

The name of your medicine is Codeine/Paracetamol 60mg/1000mg film-coated tablets.
Codeine/Paracetamol 60mg/1000mg film-coated tablets contain 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.
Codeine/Paracetamol can be used in children over 16 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 Codeine/Paracetamol

Do not take Codeine/Paracetamol:
- 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 Codeine/Paracetamol’)
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 Codeine/Paracetamol 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 Codeine/Paracetamol:
if you have severe kidney problems
if you have liver problems
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
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
Taking a painkiller for headaches too often or for too long can make them worse
Never take more of Codeine/Paracetamol than recommended. A higher dose does not increase pain relief;
instead it can cause serious liver damage. The symptoms of liver damage occur first after a few days. It is
therefore very important that you contact your doctor as soon as possible if you have taken more
Codeine/Paracetamol than recommended in this leaflet.
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
Codeine/Paracetamol should not be taken by children under 16 years of age.
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.

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 Codeine/Paracetamol
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 Codeine/Paracetamol 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.
Codeine/Paracetamol 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.
Codeine/Paracetamol 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 Codeine/Paracetamol while you are breastfeeding, since it passes into breast milk.
Driving and using machines
You may feel dizzy or sleepy while taking Codeine/Paracetamol. If this happens, do not drive or use any
tools or machines.

Codeine/Paracetamol contains lecithin soya
If you are allergic to peanut or soya, do not take this medicine.
3.

How to take Codeine/Paracetamol

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
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.
Adults
The recommended dose of Codeine/Paracetamol is 1 tablet
Wait at least 4 hours before taking another dose
Do not take more than 4 tablets in any 24-hour period
Elderly people may be prescribed a lower dose
Patients with kidney problems may require longer intervals between doses
Adolescents over 50kg of body weight aged 16 years and above
The recommended dose of Codeine/Paracetamol is 1 tablet
Wait at least 6 hours before taking another dose
Do not take more than 4 tablets in any 24-hour period
Children under 16 years
Codeine/Paracetamol 60mg/1000mg should not be given to children under 16 years of age

For child resistant bottles only: Instructions for use of child resistant bottles:
Push down the lid and turn to open

If you take more Codeine/Paracetamol than you should
- Tell your doctor or go to your nearest hospital casualty department straight away - 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 Codeine/Paracetamol
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 adolescents over 16 years.
If you stop taking Codeine/Paracetamol
Changing or stopping treatment
Long term usage of Codeine/Paracetamol may lead to tolerance and dependence. If you have taken regular
daily doses of Codeine/Paracetamol 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

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
Stop taking Codeine/Paracetamol and see a doctor or go to a hospital straight away if:
- 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 Codeine/Paracetamol
- You get serious skin reactions. Very rare cases have been reported
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
Other side effects:
Common: may affect up to 1 in 10 people:
Drowsiness, headache, abnormal sweating, feeling sick (nausea), being sick (vomiting), constipation,
tiredness.

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

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 Codeine/Paracetamol
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
For tablet containers only: Shelf-life after first opening: 100 days.
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 Codeine/Paracetamol contains
The active substances are codeine phosphate hemihydrate and paracetamol. Each film-coated tablet
contains 60mg of codeine phosphate and 1000mg of paracetamol
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) and titanium dioxide (E171)
What Codeine/Paracetamol looks like and contents of pack
Codeine/Paracetamol 60mg/1000mg film-coated tablets are white, oval, 10.7 x 21.4mm, biconvex tablets,
marked ’10 6’ on one side with a scoreline and side scores.

Pack Sizes:
White PVC/Aluminium blisters: 8, 10, 16, 20, 24, 30, 40, 50 and 100 film-coated tablets
White plastic tablet containers: 50 and 100 film-coated tablets
Not all pack sizes may be marketed.
The Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court,
County Oak Way,
Crawley,
West Sussex.
RH11 7XA,
United Kingdom
Manufacturer:
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa 2600
Bulgaria
Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany
Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nürnberg
Germany
This leaflet was last revised in 04/2016.

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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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