ZYDOL SR 200 Milligram Tablet Prolonged Release
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
07-11-2015
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:
200 Milligram
Pharmaceutical form:
Tablet Prolonged Release
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Other opioids
Authorization status:
Authorised
Authorization date:
2004-12-22
Patient Information leaflet
ie-spc-sr-100mg-clean
Date: Jul 2015
Details: Type IAin – change to HPRA from IMB
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PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYDOL SR 100 MG, 150 MG, AND 200 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 symptoms 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 (section 4)
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 IS AND WHAT IT IS USED FOR
The full name of your medicine is ‘ZYDOL SR 100 mg, 150
mg or 200mg prolonged-
release tablets’. It is referred to as ‘ZYDOL SR’
in the rest of this leaflet.
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,
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ZYDOL SR 200 mg prolonged-release tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 200 mg tramadol hydrochloride.
Excipient: 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 tablets
Slightly brownish orange coloured, round biconvex film-coated tablets marked with manufacturer’s logo on one side
and T3 on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of moderate to severe pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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. The total 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).
Children
ZYDOL SR is not suitable for children below the age of 12 years.
Older patients
A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal
insufficiency. In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary, the dosage
interval is to be extended according to the patient’s requirements.
Renal insufficiency/dialysis and hepatic impairment
In patients with renal and/or
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