ZYDOL 50 mg Hard Capsules
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
19-02-2022
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:
Capsule, hard
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Other opioids; tramadol
Authorization status:
Marketed
Authorization date:
1993-04-16
Patient Information leaflet
Date: January 2022
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYDOL 50 MG HARD 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 Capsules is and what it is used for
2.
What you need to know before you take ZYDOL Capsules
3.
How to take ZYDOL Capsules
4.
Possible side effects
5.
How to store ZYDOL Capsules
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 50 mg Hard 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
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 50 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, hard contains 50 mg tramadol hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Yellow/yellow, shiny oblong, hard gelatin capsules.
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
400mg active substance should not be exceeded, except in
special clinical circumstances.
Unless otherwise prescribed, ZYDOL should be administered as follows:
Adults and adolescents aged of 12years and over
ACUTE PAIN: An initial dose of 100 mg is usually necessary. This can
be followed by doses of 50 or 100mg at 4-6 hourly intervals,
and duration of treatment should be matched to clinical need (see
section 5.1).
PAIN ASSOCIATED WITH CHRONIC CONDITIONS: An initial dose of 50 mg is
advised and then titration according to pain severity.
The need for continued treatment should be assessed at regular
intervals as withdrawal symptoms and dependence have been
reported (see section 4.4)
Children
ZYDOL capsules are 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.
Patients with renal insufficiency/dialysis and hepatic insufficiency
In patients with renal and/or hepatic insufficiency the elimination of
tramadol is delayed. In these patients prolongation of the
dosage intervals should be
Read the complete document
