MST Continus 100mg Prolonged-release tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Morphine sulfate

Disponible depuis:

Mundipharma Pharmaceuticals Limited

Code ATC:

N02AA; N02AA01

DCI (Dénomination commune internationale):

Morphine sulfate

Dosage:

100 milligram(s)

forme pharmaceutique:

Prolonged-release tablet

Type d'ordonnance:

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

Domaine thérapeutique:

Natural opium alkaloids; morphine

Statut de autorisation:

Marketed

Date de l'autorisation:

1983-11-29

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
_MST_
_®_
_ CONTINUS_
_®_ 5 MG, 10 MG, 15 MG, 30 MG, 60 MG AND 100 MG PROLONGED-RELEASE TABLETS
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 _
tablets are and what they are used for
2.
What you need to know before you take
_MST CONTINUS _
tablets
3.
How to take
_MST CONTINUS _
tablets
4.
Possible side effects
5.
How to store
_MST CONTINUS _
tablets
6.
Contents of the pack and other information
1.
WHAT _MST CONTINUS _TABLETS ARE AND WHAT THEY ARE USED FOR
These tablets have been prescribed for you by your doctor to relieve
severe pain over a period of 12 hours. They
contain the active ingredient morphine which belongs to a group of
medicines called strong analgesics or
‘painkillers’.
_MST CONTINUS_
TABLETS ARE DESIGNED TO WORK PROPERLY OVER 12 HOURS WHEN SWALLOWED
WHOLE. IF A TABLET IS
BROKEN, CRUSHED, DISSOLVED OR CHEWED, THE ENTIRE 12 HOUR DOSE MAY BE
ABSORBED RAPIDLY INTO YOUR BODY.
THIS CAN BE DANGEROUS, CAUSING SERIOUS PROBLEMS SUCH AS AN OVERDOSE,
WHICH MAY BE FATAL.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE _MST CONTINUS_ TABLETS
DO NOT TAKE _MST CONTINUS _TABLETS IF:
•
you are allergic (hypersensitive) to morphine or any of the other
ingredients of
_ MST CONTINUS_
tablets
(listed in section 6);
•
you have breathing problems, such as obstructive airways disease,
respiratory depression or severe
asthma. Your doctor will have told you if you have these conditions.
Symptoms may include
breathlessnes

Résumé des caractéristiques du produit

Health Products Regulatory Authority
13 March 2023
CRN00DFF9
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
MST Continus 100mg Prolonged release tablets
1 NAME OF THE MEDICINAL PRODUCT
MST Continus 100mg Prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains morphine equivalent to morphine sulfate 100 mg.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated prolonged-release tablet
Grey tablets marked with the Napp logo on one side and 100mg on the
other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prolonged relief of severe and intractable pain and in the
short term control of post-operative 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 tablets but in divided doses at 12-hourly intervals.
Increasing severity of pain will require an increased dosage of the
tablets. 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 tablets 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
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