TYLEX TABLETS

Active substance: PARACETAMOL

View full screen / Print PDF » Download PDF ⇩

Transcript
Package leaflet: Information for the patient
Tylex® 30 mg/500 mg Tablets
Codeine Phosphate Hemihydrate 30 mg, Paracetamol 500 mg
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 symptoms 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.
 In this leaflet Tylex Tablets will be called Tylex.
What is in this leaflet
1. What Tylex is and what it is used for
2. What you need to know before you take Tylex
3. How to take Tylex
4. Possible side effects
5. How to store Tylex
6. Contents of the pack and other information.
1. What Tylex is and what it is used 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 such as paracetamol..
2. What you need to know 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.
Do not take Tylex:

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 any of the
other ingredients of this medicine (listed in 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
If any of the above applies to you talk to your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tylex.
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 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.
Other medicines and Tylex

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.
Tylex with food, drink and alcohol
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, breast-feeding and fertility
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.
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.
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.
Adults and the elderly
 Swallow the Tylex tablet with water
 The label will tell you how many tablets to take and how often
 The usual dose is one or two tablets every 6 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.
Use in children and adolescents
Children aged 12 years or above should take Tylex tablets every 6 hours, as needed.
Do not take more than eight tablets in 24 hours. Tylex should not be taken by children
below the age of 12 years, due to the risk of severe breathing problems.
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 tablets at once.
If you stop taking Tylex
You may feel irritable or restless when treatment with Tylex is stopped.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.
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 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.
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
(see details below). By reporting side effects you can help provide more information
on the safety of this medicine.
UK
The Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie
5. How to store Tylex
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated 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.
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 this pack and other information
What Tylex contains
There are two active substances in Tylex: codeine phosphate hemihydrate (30 mg)
and paracetamol (500 mg).
The other ingredients are; powdered cellulose, sodium starch glycolate, maize starch,
pregelatinized starch, magnesium stearate, colloidal silica anhydrous, carnauba wax,
purified water and Opadry 11 white film coating (contains lactose, hydroxyproply
methylcellulose, titanium dioxide, polyethylene glycol).
The printing ink contains: Shellac, ethylalcohol, isopropyl alcohol, n-butyl alcohol,
propylene glycol, ammonium hydroxide, conchineal (EEC No. 120).
What Tylex looks like and contents of the pack
Tylex tablets are white, film-coated, capsule-shaped tablets with “TYLEX” printed on
both sides.
They come in bottles containing 8, 24, 32, 40, 48, 56, 64, 100, or 500 tablets. Not all
pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
UCB Pharma Ltd, 208 Bath Rd, Slough, Berkshire, SL1 3WE, UK.
This leaflet was last revised in June 2014.
If this leaflet is difficult to read and you would like it in a different format, please
contact UCB Pharma Ltd, 208 Bath Rd, Slough, Berkshire, SL1 3WE, UK.

Expand view ⇕

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.

Hide
(web1)