TYLEX 30 MG/500 MG CAPSULES HARD

Active substance: PARACETAMOL

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1. What Tylex is for

Patient Information Leaflet

Tylex is a painkiller (analgesic) taken to relieve
severe pain.

Tylex

2. Before you take Tylex

®

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COUNTRY - PCC

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

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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.

FRONT

Codeine Phosphate Hemihydrate 30 mg
Paracetamol 500 mg

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, trying to
become pregnant or breast-feeding without first
talking to your doctor.
Usually it is safe to take Tylex while breast-feeding
as the levels of the active ingredients of this
medicine in breast milk are too low to cause your
baby any problems. However, some women who
are at increased risk of developing side effects at any
dose may have higher levels in their breast milk. If
any of the following side effects develop in you or
your baby, stop taking this medicine and seek
immediate medical advice; feeling sick, vomiting,
constipation, decreased or lack of appetite, feeling
tired or sleeping for longer than normal, and
shallow or slow breathing.
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.
Warnings about the ingredients in Tylex
Tylex contains sodium metabisulphite and is
unsuitable for people who are sensitive to sulphite.
People with asthma are more likely to be sensitive
to sulphite. Therefore, you should talk to your
doctor before taking Tylex if you are sensitive to
sulphite or if you suffer from asthma.

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30 mg / 500 mg
Capsules, hard

Important information about Tylex:
• Do not take for longer than directed by your
prescriber
• 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.
Do not take Tylex if:
• 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
medicines
• You are pregnant or breast-feeding without first
talking to your doctor
• You are a child under 12 years old.
If any of the above applies to you talk to your doctor.
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
disorders
• 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.

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3. How to take Tylex

4. Possible side effects

5. How to store Tylex

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BACK

What Tylex contains
There are two active substances in Tylex: codeine
phosphate hemihydrate (30 mg) and paracetamol
(500 mg).
The other ingredients are; sodium metabisulphite
(E223), pregelatinised starch, calcium stearate,
aerosol OT-B (dioctyl sodium sulfosuccinate and
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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6. Further Information

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.

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Keep out of the reach and sight of children.
Do not use Tylex after the expiry date on the
carton.
The expiry date refers to the last day of that month.
Store below 25°C. Store in the original packaging
and in a dry place to protect it from light and
moisture.
Medicines should not be disposed of via wastewater
or household waste. Return all unused medicine to
your pharmacist.

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 July 2011.

COUNTRY - PCC

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

Taking Tylex for headaches too often or for too
long can make the headaches worse.
Taking a lot of Tylex for a long time can cause
deafness.
If any of these side effects gets serious, or if you
notice any side effects not mentioned in this leaflet,
please tell your doctor or pharmacist.

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Always take Tylex exactly as your doctor has told you.
Important:
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.
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 hours
• 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.
Tylex is not suitable for children under 12 years old.
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
well, because there is a risk of delayed, serious liver
damage.
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
and do not take more than eight capsules in
each 24-hour period.

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

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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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