Tylex 30 mg / 500 mg Hard Capsules
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
31-08-2022
Summary of Product characteristics
(SPC)
31-08-2022
Active ingredient:
Codeine phosphate hemihydrate; Paracetamol
Available from:
UCB (Pharma) Ireland Limited
ATC code:
N02AJ; N02AJ06
INN (International Name):
Codeine phosphate hemihydrate; Paracetamol
Dosage:
30/500 milligram(s)
Pharmaceutical form:
Capsule, hard
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Opioids in combination with non-opioid analgesics; codeine and paracetamol
Authorization status:
Marketed
Authorization date:
1997-02-21
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
TYLEX® 30 MG / 500 MG HARD CAPSULES
CODEINE PHOSPHATE HEMIHYDRATE,
PARACETAMOL
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 any 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 signs of illness 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.
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 contains two different medicines called paracetamol and codeine
phosphate hemihydrate. 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. Paracetamol is an
analgesic which acts to relieve pain and
fever.
Tylex is used in adults and adolescents from 12 to 18 years of age for
the short-term relief of moderate
pain that is not relieved by other painkillers such as paracetamol or
ibuprofen alone.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TYLEX
DO NOT TAKE TYLEX:
•
if you are allergic to paracetamol or codeine phosphate hemihydrate,
or any of the other ingredients
of this medicine (listed in section 6).
•
if you are a child under 12 years old.
•
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 have severe asthma attacks or severe breathing problems.
•
if you are an alcoholic.
•
if you have r
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Summary of Product characteristics
Health Products Regulatory Authority
29 August 2022
CRN00D4DM
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tylex 30 mg / 500 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg of codeine phosphate hemihydrate and 500
mg of paracetamol.
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 capsule with white opaque body and red cap, both with
“C30” printed in black.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tylex Capsules is indicated for use 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
POSOLOGY
_Adults_:
The usual dose is one or two capsules up to 4 times a day at intervals
of not less than 6 hours. Maximum daily dose should not
exceed 240 mg of codeine phosphate hemihydrate (i.e. not more than
eight capsules per 24 hours should be taken).
_Duration of treatment:_
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.
Dosage should be adjusted according to the severity of the pain and
the response of the patient. However, it should be kept in
mind that tolerance to codeine can develop with continued use and that
the incidence of untoward effects is dose related.
Doses of codeine higher than 60 mg fail to give commensurate relief of
pain but merely prolong analgesia and are associated
with an appreciably increased incidence of undesirable side effects.
_Elderly:_
As for adults, however a reduced dose may be required. See warnings.
_Paediatric population_:
_Children aged less than 12 years:_
Codeine should not be used in children below the age of 12
yearsbecau
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