By-Madol SR 150 mg prolonged-release capsules, hard

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Tramadol hydrochloride

זמין מ:

Ethypharm

קוד ATC:

N02AX; N02AX02

INN (שם בינלאומי):

Tramadol hydrochloride

כמות:

150 milligram(s)

טופס פרצבטיות:

Prolonged-release capsule, hard

סוג מרשם:

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

איזור תרפויטי:

Other opioids; tramadol

מצב אישור:

Not marketed

תאריך אישור:

2006-10-27

עלון מידע

P_REF – P_REVISION (P_APPLICATION_DATE)
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PACKAGE LEAFLET: INFORMATION FOR THE USER
BY-MADOL SR 150 MG PROLONGED-RELEASE CAPSULES, HARD
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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What By-Madol SR is and what it is used for
2.
What you need to know before you take By-Madol SR
3.
How to take By-Madol SR
4.
Possible side effects
5.
How to store By-Madol SR
6.
Contents of the pack and other information
1.
WHAT BY-MADOL SR IS AND WHAT IT IS USED FOR
Tramadol hydrochloride – the active substance of By-Madol SR
–belongs to a group of medicines
known as opioid analgesics or painkillers. Its pain-relieving action
is due to its effect on specific nerve
cells in the spinal cord and brain.
By-Madol SR is used in the treatment of moderate to severe pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BY-MADOL SR
DO NOT TAKE BY-MADOL SR:
•
if you are allergic to tramadol or any of the other ingredients of
this medicine (listed in sec-
tion 6).
•
if you are intoxicated with alcohol or with sedative drugs include
sleeping pills, other pain-
killers or psychotropic medicines (medicines that affect mood and
emotions)
•
if you are taking, or have taken in the last two weeks, certain
medicines called “monoamine oxi-
dase inhibitors” or MAOIs (used to treat depression). The
combination could result in a serious,
potentially life threatening interaction (see “Other medicines and
By-Madol SR”)
•
if you have epilepsy that is not controlled with your current

מאפייני מוצר

Health Products Regulatory Authority
10 November 2023
CRN00DQ7K
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
By-Madol SR 150 mg prolonged-release capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 prolonged-release capsule contains 150 mg of tramadol hydrochloride
equivalent to 131.73 mg tramadol.
Excipients with known effects:
16.05mg Sucrose/prolonged-release capsule
10.9 ng benzoic acid/prolonged-release capsule
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard
Capsules with opaque yellow cap and body, containing white spherical
microgranules
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For moderate to severe pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
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.
Adults and adolescents aged 12 years and over:
150 mg tramadol hydrochloride twice daily (corresponding to 300 mg of
tramadol hydrochloride/day), morning and evening
administration recommended.
The smallest effective analgesic dose should always be used. Daily
doses of 400 mg of active substance must not be exceeded,
unless exceptional medical reasons require so. A minimum interval of 8
hours must be respected between administrations.
_Paediatric population_
By-Madol SR is not suitable for use in children below 25 kg body
weight which in general does not allow for individualized
dosage in children below 12 years of age. Consequently, a more
suitable form of administration should be used.
_Geriatric 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