Tradol SR 200 mg Prolonged release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tramadol hydrochloride

Available from:

Rowex Ltd

ATC code:

N02AX; N02AX02

INN (International Name):

Tramadol hydrochloride

Dosage:

200 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other opioids; tramadol

Authorization status:

Marketed

Authorization date:

2005-09-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Tradol SR 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 signs of illness are the same as yours.

If you get any of the side effects, talk to your doctor or pharmacist.
This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Tradol SR is and what it is used for
2. What you need to know before you take Tradol SR
3. How to take Tradol SR
4. Possible side effects
5. How to store Tradol SR
6. Contents of the pack and other information.
1 WHAT TRADOL SR IS AND WHAT IT IS USED FOR
Tramadol, the active substance in Tradol SR, is a painkiller
(analgesic) of the opioid
group. Its pain alleviating effect is due to its influence on specific
nerve cells in the
spinal cord and in the brain.
Tradol SR is used in the treatment of moderate to severe pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRADOL SR
DO NOT TAKE TRADOL SR

if you are allergic to tramadol or any of the other ingredients of
this medicine
(listed in section 6)

if you have acute intoxication with alcohol, sleeping agents,
painkillers, opioids or
other psychotropic agents (medicines which influence mood, emotional
status and
disposition)

if you are taking or have taken in the last two weeks, certain
medicines called
‘monoamine oxidase inhibitors’ or MAOIs (used to treat
depression). The
combination could result in a serious, potentially life-threatening
interaction (see
“Other medicines and Tradol SR”).

if you have epilepsy that is not controlled with your current medicine

as a drug substitute for the treatment of drug addiction.
WARNINGS AND PRECAUTIONS
Talk to your doc

Summary of Product characteristics

Health Products Regulatory Authority
27 October 2021
CRN00CJGZ
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tradol SR 200 mg Prolonged release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Prolonged release tablet contains 200 mg of tramadol
hydrochloride.
Excipients with known effect: Each tablet contains 118.0mg of lactose
(as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release tablet.
Flat, round, bi-layer tablets. Initial layer white, slow release layer
green with one-sided identification mark
TR
/
200R.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of moderate to severe pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of Administration: Oral
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
400mg tramadol hydrochloride should not be exceeded,
except in special clinical circumstances.
Unless otherwise prescribed. Tradol 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
dosage may be titrated upwards to 150 mg or 200 mg tramadol
hydrochloride twice daily.
Paediatric Population
Tradol SR is not suitable for children below the age of 12 years.
Elderly 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 impairment
In patients with renal and/or hepatic insufficiency the elimination of
tramadol is delayed. In these patients prolongation of the
dosage intervals should be carefully conside