ZYDOL SR 50 Milligram Tablet Prolonged Release
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
12-03-2016
Summary of Product characteristics
(SPC)
21-10-2016
Active ingredient:
TRAMADOL HYDROCHLORIDE
Available from:
Grünenthal Ltd
ATC code:
N02AX02
INN (International Name):
TRAMADOL HYDROCHLORIDE
Dosage:
50 Milligram
Pharmaceutical form:
Tablet Prolonged Release
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Other opioids
Authorization status:
Authorised
Authorization date:
2007-07-27
Patient Information leaflet
m1-3-1-leaflet-1189-1-9-sr50mg-tablets-v8-clean.doc
Date: July 2015
Details: Type IAin
– change to HPRA to IMB
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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.
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 an
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Summary of Product characteristics
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 c
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