ZYDOL SR 50mg prolonged-release tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
08-01-2024
Summary of Product characteristics
(SPC)
19-02-2022
Active ingredient:
Tramadol hydrochloride
Available from:
Grunenthal Pharma Ltd
ATC code:
N02AX; N02AX02
INN (International Name):
Tramadol hydrochloride
Dosage:
50 milligram(s)
Pharmaceutical form:
Prolonged-release tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Other opioids; tramadol
Authorization status:
Marketed
Authorization date:
2007-07-27
Patient Information leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYDOL SR 50 MG, PROLONGED-RELEASE TABLETS
Tramadol hydrochloride
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 ZYDOL SR is and what it is used for
2.
What you need to know before you take ZYDOL SR
3.
How to take ZYDOL SR
4.
Possible side effects
5.
How to store ZYDOL SR
6.
Contents of the pack and other information
1. WHAT ZYDOL SR IS AND WHAT IT IS USED FOR
Tramadol - the active substance in ZYDOL SR - is a painkiller
belonging to the class of opioids that
acts on the central nervous system. It relieves pain by acting on
specific nerve cells of the spinal cord
and brain.
ZYDOL SR is used for the treatment of moderate to severe pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYDOL SR
DO NOT TAKE ZYDOL SR
-
if you are allergic to tramadol or any of the other ingredients of
this medicine (listed in section
6);
-
in acute poisoning with alcohol, sleeping pills, pain relievers or
other psychotropic medicines
(medicines that affect mood and emotions);
-
if you are also taking MAO inhibitors (certain medicines used for
treatment of depression) or
have taken them in the last 14 days before treatment with ZYDOL SR
(see "Other medicines
and ZYDOL SR");
-
if you are an epileptic and your fits are not adequately controlled by
treatment;
-
as a substitute in drug withdrawal.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking ZYDOL SR
-
if you think that you are addicted to other pain relievers (opioids);
-
if you suffer from consciousness disorders (if y
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
18 February 2022
CRN00CJN6
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ZYDOL SR 50mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: tramadol hydrochloride
Each prolonged-release tablet contains 50 mg tramadol hydrochloride.
Excipient with known effect: Each prolonged-release tablet contains
2.5 mg lactose monohydrate (see section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
Pale yellow coloured, round, biconvex, film-coated tablets, marked
with the manufacturer's logo on one side and T0 on the
other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of moderate to severe pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be adjusted to the intensity of the pain and the
sensitivity of the individual patient. The lowest effective dose
for analgesia should generally be selected. Daily doses of 400 mg
tramadol hydrochloride should not be exceeded, except in
special clinical circumstances.
Unless otherwise prescribed, ZYDOL SR should be administered as
follows:
_Adults and adolescents above the age of 12 years_
The usual initial dose is 50-100 mg tramadol hydrochloride twice
daily, morning and evening. If pain relief is insufficient, the
dose may be titrated upwards to 150 mg or 200 mg tramadol
hydrochloride twice daily (see section 5.1).
ZYDOL SR should under no circumstances be administered for longer than
absolutely necessary. If long-term pain treatment
with ZYDOL SR is necessary in view of the nature and severity of the
illness, then careful and regular monitoring should be
carried out (if necessary with breaks in treatment) to establish
whether and to what extent further treatment is necessary.
_Paediatric population:_
ZYDOL SR is not suitable for children below the age of 12 years.
_Elderly patients_
A dose adjustment is not usually necessary in patients up to 75 years
without clinically manifest hepatic or
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