Tylex 30mg/500mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Codeine phosphate; Paracetamol

Available from:

UCB Pharma Ltd

ATC code:

N02AJ06

INN (International Name):

Codeine phosphate; Paracetamol

Dosage:

30mg ; 500mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070100; GTIN: 5015366000323 5015366000330 5015366000347

Patient Information leaflet

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.
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 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
• 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
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 tha

Summary of Product characteristics

OBJECT 1
TYLEX CAPSULES
Summary of Product Characteristics Updated 17-Feb-2016 | UCB Pharma
Limited
1. Name of the medicinal product
Tylex 30 mg / 500 mg capsules, hard or Medocodene 30 mg /500 mg
capsules, hard.
2. Qualitative and quantitative composition
Each capsule contains 500 mg of paracetamol and 30 mg of codeine
phosphate hemihydrate.
Excipients: Sodium metabisulfite (E223) 0.36 mg/capsule.
For the full list of excipients see section 6.1.
3. Pharmaceutical form
Capsules, hard.
Hard gelatin capsules with white body and red cap, both with 'C30'
printed in black.
4. Clinical particulars
4.1 Therapeutic indications
Tylex Capsules is indicated in patients older than 12 years of age for
the treatment of acute moderate pain
which is not considered to be relieved by other analgesics such as
paracetamol or ibuprofen (alone).
4.2 Posology and method of administration
Codeine should be used at the lowest effective dose for the shortest
period of time.
The duration of treatment should be limited to 3 days and if no
effective pain relief is achieved the
patients/carers should be advised to seek the views of a physician.
ADULTS
Tylex capsules are given orally. The usual dose is one or two capsules
up to 4 times a day at intervals not
less than 6 hours. Maximum daily dose should not exceed 240 mg of
codeine phosphate (i.e., not more
than eight capsules per 24 hours should be taken)
ELDERLY
A reduced dose may be required.
PAEDIATRIC POPULATION
Children aged 12 years to 18 years
The recommended codeine dose for children 12 years and older should be
30 to 60 mg every 6 hours
when necessary up to a maximum dose of 240 mg daily. The dose is based
on the body weight (0.5-
1mg/kg).
Children aged less than 12 years
Codeine should not be used in children below the age of 12 years
because of the risk of opioid toxicity
due to the variable and unpredictable metabolism of codeine to
morphine (see sections 4.3 and 4.4).
Dosage should be adjusted according to the severity of the pain and
the response of the patient. However,
it shoul