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CO-CODAMOL 30/500MG TABLETS

Active substance(s): CODEINE PHOSPHATE / PARACETAMOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Co-codamol 30/500 mg Tablets

Codeine phosphate and 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 gets 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 is and what it is used for
2. Before you take Co-codamol
3. How to take Co-codamol
4. Possible side effects
5. How to store Co-codamol
6. Further information

1

Take special care with Co-codamol
Before taking this medicine, you need to know the
following:
• This product contains paracetamol.
• Do not take with any other paracetamol containing
products.
• If your symptoms last for more than 3 days talk to
your doctor.
• Do not take Co-codamol for longer than directed by
your doctor. Taking codeine regularly for a long time
can lead to addiction.
• Taking a painkiller for headaches for too long may
make them worse.

What Co-codamol is and what it is used
for

The name of your medicine is Co-codamol 30/500 mg
Tablets.

The active ingredients in Co-codamol are paracetamol
and codeine phosphate. 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.
Paracetamol is also an antipyretic which means that it
helps to reduce fever and lower your temperature.

Talk to your doctor or pharmacist before taking
Co-codamol if:
• You are pregnant or breast-feeding (see ʻPregnancy
and breast-feedingʼ below).
• You have asthma.
• You have serious problems with your liver or kidneys.
• You are elderly, as you may need a lower dose.
• You are being treated with depressants (medicines
used to treat anxiety).
• You have an enlarged prostate.
• You have an inflamed bowel or obstructive bowel
disorder.
• You have an under active thyroid.
• You have Addisonʼs disease.

Codeine can be used in children over 12 years of age
for the short-term relief of moderate to severe pain that
is not relieved by other painkillers such as paracetamol
or ibuprofen alone.

2

Before you take Co-codamol

Do not take Co-codamol:
• If you are allergic (hypersensitive) to paracetamol,
codeine or any of the other ingredients in Co-codamol
Tablets.
• If you drink excessive amounts of alcohol.
• If you have severe asthma, breathing problems or if
you are having an asthma attack.
• If you have recently had a head injury or have
increased pressure within your head (raised
intracranial pressure).
• If you have recently had surgery on your bile duct.
• If you are under 12 years of age.
• If you are taking a monoamine-oxidase inhibitor
(MAOI) or have taken a MAOI within the last 14 days.
These medicines are usually used to treat depression
and include tranylcypromine, phenelzine or
isocarboxazide
• 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
• If you know that you metabolise very rapidly codeine
into morphine
• If you are breastfeeding

Warnings and precautions
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.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines you have bought yourself without a
prescription.

If the answer to any of these questions is YES, tell your
doctor or pharmacist before taking Co-codamol tablets.

In particular you should tell your doctor if you are taking
any of the following:
• Barbiturates (to help you sleep or treat epilepsy).
• Anticonvulsants (to treat epilepsy).
• Antidepressants (tricyclics or MAOIs).
• Antipsychotics (to help mood disorders).
• Anxiolytics (to help with anxiety).
• Hypnotics (to help you sleep).
• Chloramphenicol (an antibiotic).
• Colestyramine (used to lower cholesterol).
• Cisapride, metoclopramide or domperidone (used to
help stop nausea and vomiting)

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.

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.

Continued on the next page >>

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Date prepared:
27/09/2013

Colours:
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Dimensions: 165 x 320 mm

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medicine and talk to your doctor immediately if you
notice any of the following symptoms:

• Anticoagulants (medicines used to thin the blood,
such as warfarin).
• Ciprofloxacin (an antibiotic).
• Cimetidine (for stomach ulcers).
• Ritonavir (used to treat HIV infection).

• You bruise more easily, have bleeding gums or bleed
for longer after cutting yourself or you feel tired or
look pale.
• You seem to be getting more infections than usual or
you develop ulcers in your mouth or throat.
• You have a severe abdominal pain (in the upper
middle or upper left part of the belly) usually
accompanied by sickness, diarrhoea or fever.
• You have an allergic reaction. The signs of an allergic
reaction may include: a rash, difficulty breathing or
swallowing, swelling of your lips, face, throat or
tongue.

Taking Co-codamol with food and drink
Do not drink alcohol while you are taking Co-codamol.
Alcohol may increase the sedative effects of
Co-codamol and make you very sleepy. It can also
increase the risk of some side effects.

Pregnancy and breast-feeding
Do not take codeine while you are breastfeeding.
Codeine and morphine passes into breast milk.
If you are pregnant or breast-feeding you should talk to
your doctor or pharmacist before taking any medicine.

Other more common side effects that some people
notice when taking Co-codamol are listed below:
• Constipation
• Nausea
• Drowsiness
• Confusion and
• Vomiting

Driving and using machines
Codeine may cause dizziness or drowsiness in some
people. Do not drive or use any tools or machines if you
are affected in this way and do not drink alcohol, as this
will make these effects worse. Other medicines may
also increase these effects.

3

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.

How to take Co-codamol

5

Always take Co-codamol tablets exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure. The usual dose is
described below.

Keep out of the reach and sight of children.

Do not use Co-codamol tablets after the expiry date
which is stated on the carton or blister.
The expiry date refers to the last day of that month.

These tablets are for oral administration. They should
be swallowed with a glass of water.

Dosage instructions
Children aged 12 years of above should take two tablets
every four hours, as needed. Do not take more than
eight tablets in 24 hours.
Elderly: Your doctor may have reduced the dose for you.
If this is the case follow your doctorʼs instructions.

Talk to your pharmacist before taking these tablets if
they are chipped or broken.

Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines that are no longer required. These
measures will help to protect the environment.

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

6

Do not take more tablets than your doctor has
prescribed for you.

Further information

What Co-codamol contains
The active ingredients in Co-codamol Tablets are
paracetamol, 500 mg and codeine phosphate, 30 mg.

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.

If you take more Co-codamol than you should
Always take the medicine as recommended by your
doctor. If you take too much medicine, tell your doctor
immediately or go to your local hospital emergency
department, even if you feel well. This is because there
is a delayed risk of serious liver damage.

The other ingredients are starch, sodium starch
glycollate, magnesium stearate, povidone (K-30),
colloidal silicon dioxide, talc, sodium lauryl sulphate,
glycerol and purified water.

What Co-codamol looks like and contents of the
pack
Co-codamol Tablets are white to off-white capsule
shaped tablets with a central break-line on one face.

If you forget to take Co-codamol
Take your usual dose as soon as you remember,
provided it is at least 4 hours since your last dose.
Never take a double dose to make up for a missed
dose.

They are available in packs of 60 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

If you stop taking Co-codamol
Do not stop taking these tablets immediately, it could
make you feel restless or irritable. Talk to your doctor
about reducing your dose gradually.

This leaflet was last revised in 09/2013.

If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4

How to store Co-codamol

Possible side effects

Like all medicines, Co-codamol can cause side effects,
although not everybody gets them. Tell your doctor if
you think your medicine is making you feel unwell.

It is very unlikely that you will experience the following
side effects. However, you should stop taking this

SZ00000LT000

Artwork Proof Box
Ref: N015 - in accordance woth codeine Art. 31 - PRAC rec.
Proof no.
008.0

Date prepared:
27/09/2013

Colours:
Black
Dimensions: 165 x 320 mm

Font size:
8pt
Fonts:
Helvetica

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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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