Zydol 50 mg Capsules
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
07-10-2014
Summary of Product characteristics
(SPC)
07-10-2014
Active ingredient:
Tramadol hydrochloride
Available from:
Imbat Limited
ATC code:
N02AX; N02AX02
INN (International Name):
Tramadol hydrochloride
Dosage:
50 milligram(s)
Pharmaceutical form:
Capsule, hard
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Other opioids; tramadol
Authorization status:
Authorised
Authorization date:
2007-07-27
Patient Information leaflet
Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYDOL
® 50MG CAPSULES
(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 (section 4).
IN THIS LEAFLET:
1.
What Zydol is and what it is used for
2.
What you need to know before you take Zydol
3.
How to take Zydol
4.
Possible side effects
5.
How to store Zydol
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 50mg Capsules’. It is
referred to as ‘Zydol’ in the rest of this leaflet.
Tramadol - the active substance in Zydol - 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 is used for the treatment of moderate to severe pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ZYDOL
DO NOT TAKE ZYDOL
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 (see “Other medicines
and Zydol”)
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
if you think that you are addict
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zydol 50 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50mg tramadol hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
_Product imported from the United Kingdom:_
Yellow/yellow shiny hard gelatine capsules.
4 CLINICAL PARTICULARS
As per PA1189/001/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1189/001/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Capsules contents:_
Microcrystalline cellulose
Sodium starch glycolate
Magnesium stearate
Colloidal anhydrous silica
_Capsule shell:_
Gelatine
Sodium Laurilsulfate
Yellow iron oxide (E172)
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C
Store in the original container.
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6.5 NATURE AND CONTENTS OF CONTAINER
PVC/foil blister strips in a cardboard carton. Pack size 100 capsules.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL
Read the complete document
