TYLEX 30 MG/500 MG CAPSULES HARD

Active substance: CODEINE PHOSPHATE

View full screen / Print PDF » Download PDF ⇩

Transcript
295 mm
190 mm

12 mm

2 mm

2 mm

Patient Information Leaflet

Tylex

®

30 mg / 500 mg
Capsules, hard

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.

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.

2 mm
160 mm
190 mm

12 mm

2 mm

COUNTRY - PCC

1. What Tylex is for

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.

148 mm

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

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

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.

10 mm

10 mm

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.

2. Before you take Tylex

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.

FRONT

Codeine Phosphate Hemihydrate 30 mg
Paracetamol 500 mg

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.

Text area
124 x 275 mm

S_I_2554-1.pdf - Page 1 of 3 - June 14, 2010 - 08:29:50

160 mm

295 mm
190 mm

12 mm

2 mm

2 mm

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.
3. How to take Tylex

2 mm
160 mm
190 mm

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 November 2013.

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.

12 mm

2 mm

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).

BACK

5. How to store Tylex
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.

6. Further Information

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.

148 mm

4. Possible side effects














10 mm

10 mm

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

Text area
124 x 275 mm

S_I_2554-1.pdf - Page 2 of 3 - June 14, 2010 - 08:29:50

160 mm

Country

Product

Component

UCB Tag No.

Version

Date

uk

tylex capsules

Leaflet

33

d

14.11.13

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
(web2)