Maxitram SR 150mg capsules

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Tramadol hydrochloride

Disponible depuis:

Chiesi Ltd

Code ATC:

N02AX02

DCI (Dénomination commune internationale):

Tramadol hydrochloride

Dosage:

150mg

forme pharmaceutique:

Modified-release capsule

Mode d'administration:

Oral

classe:

Schedule 3 (CD No Register Exempt Safe Custody)

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 04070200; GTIN: 5028613002469

Notice patient

TRAMADOL HCL 50MG, 100MG, 150MG, 200MG PROLONGED-RELEASE CAPSULES,
HARD
1.3.1 – PRODUCT INFORMATION
EDITION 07/2019
1/8
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
MAXITRAM SR 50 MG, 100 MG, 150 MG AND 200 MG
PROLONGED-RELEASE CAPSULE, 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 MAXITRAM SR is and what it is used for
2.
What you need to know before you take MAXITRAM SR
3.
How to take MAXITRAM SR
4.
Possible side effects
5.
How to store MAXITRAM SR
6.
Contents of the pack and other information
1.
WHAT MAXITRAM SR IS AND WHAT IT IS USED FOR
Tramadol hydrochloride – the active substance of MAXITRAM 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.
MAXITRAM SR is used in the treatment of moderate to severe pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAXITRAM SR
DO NOT TAKE MAXITRAM SR:
•
if you are allergic to tramadol or any of the other ingredients of
this medicine (listed in
section
6).
•
if you are intoxicated with alcohol or with sedative drugs including
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
oxidase inhibitors” or MAOIs (used to treat depression). The
combination could result in a
serious, potentially life threatening intera

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
MAXITRAM SR 150mg prolonged-release capsule, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MAXITRAM SR 150 mg prolonged-release capsule, hard: 1
prolonged-release
capsule contains 150mg of tramadol hydrochloride equivalent to
131.73mg
tramadol.
Excipients with known effects:
0.011mg Methyl parahydroxybenzoate/prolonged-release capsule
0.0034mg Propyl parahydroxybenzoate/prolonged-release capsule
16.05mg Sucrose/prolonged-release capsule
For the full list of excipients, see section
3
PHARMACEUTICAL FORM
Prolonged-release capsule, hard
MAXITRAM
SR
150mg
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
MAXITRAM 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 requi