MST CONTINUS suspension 60 mg

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Morphine

Beszerezhető a:

Mundipharma Pharmaceuticals Limited

ATC-kód:

N02AA; N02AA01

INN (nemzetközi neve):

Morphine

Adagolás:

60 milligram(s)

Gyógyszerészeti forma:

Prolonged-release granules for oral suspension

Recept típusa:

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

Terápiás terület:

Natural opium alkaloids; morphine

Engedélyezési státusz:

Marketed

Engedély dátuma:

1996-11-18

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
_MST_
_®_
_ CONTINUS_
_®_ SUSPENSION 20 MG, 30 MG AND 60 MG
Morphine sulfate
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. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What _MST CONTINUS _suspension is and what it is used for
2.
What you need to know before you take _MST CONTINUS _suspension
3.
How to take _MST CONTINUS _suspension
4.
Possible side effects
5.
How to store _MST CONTINUS _suspension
6.
Contents of the pack and other information
1.
WHAT _MST CONTINUS _SUSPENSION IS AND WHAT IT IS USED FOR
This suspension has been prescribed for you by your doctor to relieve
severe pain over a period of 12 hours. It
contains the active ingredient morphine which belongs to a group of
medicines called strong analgesics or
‘painkillers’.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE _MST CONTINUS_ SUSPENSION
DO NOT TAKE _MST CONTINUS _SUSPENSION IF:

you are allergic (hypersensitive) to morphine or any of the other
ingredients of the suspension (listed
in section 6);

you have breathing problems, such as obstructive airways disease or
respiratory depression. Your
doctor will have told you if you have these conditions. Symptoms may
include breathlessness,
coughing or breathing more slowly or weakly than expected;

you have a head injury that causes a severe headache or makes you feel
sick. This is because the
suspensions may make these symptoms worse or hide the extent of the
head injury;

you have a condition where the small bowel (part of your gut) does not
work properly (paralytic
ile

Termékjellemzők

Health Products Regulatory Authority
24 April 2019
CRN008PF0
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MST CONTINUS suspension 60 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains Morphine equivalent to Morphine Sulfate 60 mg.
Excipients with known effect:
Ponceau 4R (E124)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release granules for oral suspension
Pink granules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prolongedrelief of severe and intractable pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
A patient presenting with severe pain, uncontrolled by weaker opioids
(e.g. dihydrocodeine) should normally be started on 30
mg 12 hourly. Patients previously on normal release oral morphine
should be given the same total daily dose as MST
CONTINUS suspension but in divided doses at 12-hourly intervals.
Increasing severity of pain will require an increased dosage of the
suspension. Higher doses should be made, where possible
in 30-50% increments as required. The correct dosage for any
individual patient is that which is sufficient to control pain with
no, or tolerable, side effects for a full 12 hours. It is recommended
that the 200-mg strength is reserved for patients who have
already been titrated to a stable analgesic dose using lower strengths
of morphine or other opioid preparations.
Patients receiving MST CONTINUS suspension in place of parenteral
morphine should be given a sufficiently increased dosage
to compensate for any reduction in analgesic effects associated with
oral administration. Usually such increased requirement is
of the order of 100%. In such patients, individual dose adjustments
are required.
Paediatric Population:
The use of MST CONTINUS suspension in children has not been
extensively evaluated. For children with severe cancer pain, a
starting dose in the range of 0.2 to 0.8 mg morphine per kg bodyweight
12 hourly is recommended. Doses should then be
titrated as for adults