ZYDOL 100 mg / 2 ml Solution for Injection
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
07-12-2018
Summary of Product characteristics
(SPC)
05-03-2020
Active ingredient:
Tramadol hydrochloride
Available from:
Grunenthal Pharma Ltd
ATC code:
N02AX; N02AX02
INN (International Name):
Tramadol hydrochloride
Dosage:
100mg/2ml milligram(s)/millilitre
Pharmaceutical form:
Solution for injection
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Other opioids; tramadol
Authorization status:
Not marketed
Authorization date:
1993-04-16
Patient Information leaflet
m1-3-1-leaflet-1189-1-4-v11-tracked (00000002)
Details: Type IAin – updates following PSUSA
Mar 2018
Page 1
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYDOL 100 MG / 2 ML SOLUTION FOR INJECTION
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 receive ZYDOL
3.
How to use 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 100 mg / 2 ml solution for
injection’. 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 RECEIVE 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 substit
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
04 March 2020
CRN009DR0
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ZYDOL 100 mg / 2 ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ZYDOL 100 mg / 2 ml Solution for injection ampoule contains 100
mg tramadol hydrochloride in 2 ml solution, i.e. 50 mg
tramadol hydrochloride per ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear colourless, aqueous solution.
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 dose of
400 mg tramadol hydrochloride should not be exceeded,
except in special clinical circumstances.
Unless otherwise prescribed, ZYDOL should be administered as follows:
Adults and adolescents above the age of 12 years
The usual dosage is 50 or 100 mg 4-6 hourly (see section 5.1).
Intravenous injections must be given slowly over 2-3 minutes.
For post-operative pain, administer an initial bolus of 100 mg. During
the 60 minutes following the initial bolus, further doses
of 50mg may be given every 10-20 minutes, up to a total dose of 250mg
including the initial bolus. Subsequent doses should
be 50mg-100mg 4-6 hourly up to a total daily dose of 400mg.
Children above the age of 1 year
The recommended single dose of tramadol hydrochloride is 1 mg/kg to 2
mg/kg body weight. The total daily dose of 8 mg
tramadol hydrochloride per kg body weight or 400 mg tramadol
hydrochloride, whichever is lower, should not be exceeded
per day. On account of their high dosage strengths, capsules,
prolonged release tablets and dispersible tablets are not
intended for children below the age of 12 years.
Older patients
A dose adjustment is not usually necessary in patients up to 75 years
without clinicall
Read the complete document
