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TYLEX EFFERVESCENT

Active substance(s): CODEINE PHOSPHATE

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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 syndrome
• If you know that you metabolise very rapidly codeine into morphine
• If 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 medicines
• You are pregnant without first talking to your doctor
• You are a child under 12 years old

Patient Information Leaflet

If any of the above applies to you talk to your doctor.

tylex

®

30 mg / 500 mg

effervescent tablets
Codeine Phosphate Hemihydrate 30 mg
Paracetamol 500 mg

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 Effervescent Tablets 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.

2. Before you take Tylex
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 tablets
• Taking a painkiller for headaches too often or for too long can make
them worse

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 had a serious head injury or raised pressure on the brain
• You have any condition that affects your breathing
• You have liver or kidney disease
• You have an under-active 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 which weakens the muscles called myasthenia gravis
• You have been told to restrict your sodium intake
• You have a metabolic disorder called phenylketonuria, which requires
a diet low in an amino acid called phenylalanine
• 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 doctor. 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.
Warnings about the ingredients in Tylex
• Tylex contains 25 mg of aspartame per tablet. This may be harmful to
people with an inherited metabolic disease called phenylketonuria.
• Tylex contains 326.6 mg of sodium per tablet and may not be suitable for
people on a controlled sodium diet.
Tell your doctor or pharmacist before taking this medicine if either of the above
statements applies to you.

3. How to take Tylex
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.
Children aged 12 years or above should take Tylex tablets every 6
hours, as needed. Do not take more than 8 tablets 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.

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.

5. How to store Tylex
Keep out of the reach and sight of children.

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

Do not use Tylex after the expiry date on the carton. The expiry date refers to
the last day of that month.

Adults and the elderly
• Dissolve the tablet in one glass of water
• Drink the whole contents of the glass
• The label will tell you how many tablets to take and how often
• The usual dose is one or two tablets every 4 hours
• Do not take more than eight tablets in 24 hours
• If you are elderly you may need to take fewer tablets. Please speak to
your doctor about this.

Store below 25°C. Store in the original packaging and in a dry place to protect
it from light and moisture.

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 your tablets at the right times. If you forget to take
a dose, take it as soon as you remember, then carry on as before.

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: citric acid anhydrous (E330), sodium hydrogen
carbonate (E500), sodium carbonate anhydrous (E500), aspartame (E951),
macrogol 6000 and magnesium stearate (E572).
What Tylex looks like
Tylex effervescent tablets are round and white or off-white. They come in
packs of 1, 6, 8, 24, 30, 36, 42, 48, 90, 100 and 102 tablets. Not all pack sizes
may be marketed.

Do not take more than two tablets at once

Marketing Authorisation Holder & Manufacturer
UCB Pharma Ltd, 208 Bath Road, Berkshire, SL1 3WE, UK.

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

This leaflet was last updated November 2013

4. Possible side effects
Like all medicines, Tylex can cause side effects, although not everybody gets
them.

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

Country

Product

Component

UCB Tag No.

Version

Date

uk

tylex
effervescent

Leaflet

3,4,6,7

c

14-11-2013

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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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