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Active substance: CODEINE PHOSPHATE

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Patient Information Leaflet

2. Before you take Tylex
Important information about Tylex:
• Do not take for longer than directed by your
• Taking codeine regularly for a long time can lead
to addiction, which might cause you to feel restless
and irritable when you stop the capsules
• Taking a painkiller for headaches too often or for
too long can make them worse.

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 further questions, please 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
• In this leaflet Tylex 30 mg / 500 mg Capsules, hard
will be called Tylex.
In this leaflet
1. What Tylex is for
2. Before you take Tylex
3. How to take Tylex
4. Possible side effects
5. How to store Tylex
6. Further information
1. What Tylex is for
Tylex can be used in adults and 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.
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.

Do not take Tylex if:
• For pain relief in children and adolescents
(0-18 years of age) after removal of their tonsils
or adenoids due to obstructive sleep apnoea
• You know that you metabolise very rapidly
codeine into morphine
• You are breastfeeding
• You are allergic to paracetamol or codeine
phosphate hemihydrate, or to any of the other
ingredients in Tylex (see section 6)
• You are taking other Paracetamol containing
• You are pregnant without first talking to your
• You are a child under 12 years old.
If any of the above applies to you talk to your
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.

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.
Check with your doctor before taking Tylex if:
• You have asthma (see end of section 2) or any
conditions that affect your breathing
• You have had a serious head injury or raised
pressure on the brain
• You have liver or kidney disease
• You have an underactive thyroid gland
• You suffer from urinary problems (e.g. difficulty in
passing water), including those associated with an
enlarged prostate gland
• You have a disease of the adrenal gland called
Addison’s disease
• You have decreased brain functioning
• You have inflammatory or obstructive bowel
• You have a condition called myasthenia gravis
which weakens the muscles
• You are elderly
• You feel weak
• You are debilitated.
If any of the above applies to you, talk to your
doctor before taking Tylex.
Taking other medicines
• Do not take Tylex with any other
paracetamol-containing products. Many
other medicines contain paracetamol,
including some you can buy without a
prescription (for example some cold and
“flu” remedies).
Tell your doctor if you are taking any of the
following medicines:
• Medicines to treat anxiety or depression
• Other painkillers

• Medicines to help you sleep
• Warfarin (a medicine used to thin the blood)
• Medicines used to treat stomach problems,
sickness or feeling sick
• Products used to treat diarrhoea (including
metaclopramide and domperidone)
• Cholestyramine (a medicine used to lower
cholesterol levels in the blood)
• Medicines to help relax muscles
• Any other medicine, including medicines obtained
without a prescription.
If any of the above applies to you, talk to your
doctor before taking Tylex.
Taking Tylex with food and drink
Do not drink alcohol whilst taking Tylex. If you
regularly drink large amounts of alcohol, you are at
risk of damaging your liver when taking paracetamol.
Pregnancy and breast-feeding
Do not take Tylex if you are pregnant or trying
to become pregnant without first talking to your
Do not take codeine while you are breastfeeding.
Codeine and morphine passes into breast milk.
Driving and using machines
Tylex may make you feel dizzy or tired. If this
happens to you, do not drive a vehicle, operate
machinery or carry out complex tasks.
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.

Warnings about the ingredients in Tylex
Tylex contains sodium metabisulfite and is
unsuitable for people who are sensitive to sulfite.

well, because there is a risk of delayed, serious liver

addiction. This might cause you to feel restless and
irritable when you stop taking Tylex.

People with asthma are more likely to be sensitive
to sulfite. Therefore, you should talk to your doctor
before taking Tylex if you are sensitive to sulfite or if
you suffer from asthma.

If you forget to take Tylex
It is important that you take Tylex at the right times.
If you forget to take a dose, take it as soon as you
remember, then carry on as before.
Do not take more than two capsules at once.

Taking Tylex for headaches too often or for too long
can make the headaches worse.

3. How to take Tylex
Always take Tylex exactly as your doctor has told

If you stop taking Tylex
You may feel irritable or restless when treatment
with Tylex is stopped.

Reporting of side effects
If you get any side effects, talk to your doctor or
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:
By reporting side effects you can help provide more
information on the safety of this medicine.

Your doctor will choose the dose that is right
for you.Your dose will be shown clearly on
the label that the pharmacist puts on your
medicine. If it does not, or you are not sure,
ask your doctor or pharmacist.
Children aged 12 years or above should take
Tylex capsules every 6 hours, as needed. Do
not take more than 8 capsules in 24 hours.
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.
Tylex should not be taken by children below
the age of 12 years, due to the risk of severe
breathing problems.
Adults and the elderly
• Swallow the Tylex capsule with water
• The label will tell you how many capsules to take
and how often
• The usual dose is one or two capsules every 4
• Do not take more than eight capsules in 24 hours
• If you are elderly you may need to take fewer
capsules. Please speak to your doctor about this.
If you feel the effect of this medicine is too strong
or too weak, talk to your doctor or pharmacist.
If you take more Tylex than you should
Do not take more Tylex than you should. If you
accidentally take too much, immediately go to
the nearest hospital casualty department or your
doctor.You should go to hospital, even if you feel

4. Possible side effects
Like all medicines, Tylex can cause side effects,
although not everybody gets them.
Seek immediate medical help if you have any
of the following symptoms:
• Feeling faint
• Swelling of the hands, feet, ankles, face, lips
or throat or blistering of the skin, mouth,
eyes and genitals
• Difficulty in breathing or wheezing,
shortness of breath.
Tell your doctor or pharmacist if you notice any of
the following side effects get serious or last longer
than a few days:
• Allergic reactions, including skin rash
• Feeling sick or being sick
• Light-headedness
• Dizziness
• Feeling sleepy
• Mood changes
• Constipation
• Severe stomach pains (pancreatitis)
• Stomach pains
• Itchy skin
• Deafness
• Problems with the blood (thrombocytopenia and
agranulocytosis). This is usually shown by tiredness,
weakness, or unexplained bruising or bleeding. This
side effect is very rare.
Taking codeine regularly for a long time can lead to

Taking a lot of Tylex for a long time can cause

5. How to store Tylex
Keep out of the sight and reach of children.
Do not use Tylex after the expiry date on the

What Tylex looks like
Tylex capsules are red and white with C30 printed
on them.
They come in bottles containing 24, 100, or 500
capsules. They also are supplied in blister strips
containing 7, 8, 14, 24, 28, 100, 300 or 600 capsules.
They are also supplied in plastic containers with 8,
16, 24, 32, 56, or 64 capsules. Not all pack sizes may
be marketed.
Marketing Authorisation Holder & Manufacturer
UCB Pharma Limited, 208 Bath Road, Slough,
Berkshire, SL1 3WE, UK.
This leaflet was last updated September 2015.

If this leaflet is difficult to read and you
would like it in a different format, please
contact UCB Pharma Limited, 208 Bath
Road, Slough, Berkshire, SL1 3WE, UK.

The expiry date refers to the last day of that month.
Store at or below 25°C. Keep container in the
outer carton.
Medicines should not be disposed of via wastewater
or household waste. Return all unused medicine to
your pharmacist.
6. Further Information
What Tylex contains
There are two active substances in Tylex: codeine
phosphate hemihydrate (30 mg) and paracetamol
(500 mg).
The other ingredients are; sodium metabisulfite
(E223), pregelatinised starch, calcium stearate,
docusate sodium with sodium benzoate (E211).
The capsule is made of gelatin, titanium dioxide
(E171), erythrosine (E127) and indigo carmine
(E132). The printing ink contains shellac, soya
lecithin, 2-ethoxyethanol, dimethylpolysiloxane
and iron oxide (E172).


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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.