MST Continus 60 mg Prolonged-release tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Morphine sulfate

Commercializzato da:

Mundipharma Pharmaceuticals Limited

Codice ATC:

N02AA; N02AA01

INN (Nome Internazionale):

Morphine sulfate

Dosaggio:

60 milligram(s)

Forma farmaceutica:

Prolonged-release tablet

Tipo di ricetta:

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

Area terapeutica:

Natural opium alkaloids; morphine

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

1983-11-29

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
_ADIZEM_
_®_
_-XL _120 MG, 180 MG, 240 MG AND 300 MG PROLONGED-RELEASE_ _CAPSULES
Diltiazem 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. This includes
any possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What
_ADIZEM-XL _
capsules are and what they are used for
2.
What you need to know before you take
_ADIZEM-XL_
capsules
3.
How to take
_ADIZEM-XL_
capsules
4.
Possible side effects
5.
How to store
_ADIZEM-XL _
capsules
6.
Contents of the pack and other information
1.
WHAT _ADIZEM-XL_ CAPSULES ARE AND WHAT THEY ARE USED FOR
These capsules have been prescribed for you to treat angina (chest
pain caused by a reduction of oxygen to
the heart muscle) or high blood pressure (hypertension). They contain
the active ingredient diltiazem.
Diltiazem belongs to a group of medicines called calcium antagonists.
Calcium antagonists help more blood
to reach the heart and reduce blood pressure. The other ingredients of
_ADIZEM-XL _
capsules are listed in
section 6 of this leaflet.
_ADIZEM-XL _CAPSULES ARE DESIGNED TO WORK PROPERLY OVER 24 HOURS. IF
THE CAPSULES ARE CRUSHED OR
CHEWED, THE ENTIRE 24 HOUR DOSE MAY BE ABSORBED RAPIDLY INTO YOUR
BODY. THIS CAN BE DANGEROUS,
CAUSING SERIOUS PROBLEMS SUCH AS AN OVERDOSE.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE_ ADIZEM-XL _CAPSULES
DO NOT TAKE _ADIZEM-XL _CAPSULES_ _IF YOU:
•
are allergic (hypersensitive) to diltiazem or any of the other
ingredients of the capsules (see section 6
‘Further Information’);
•
have a very slow (less than 40 beats per minutes) or irregular hear

Scheda tecnica

Health Products Regulatory Authority
13 March 2023
CRN00DFF9
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MST Continus 60 mg Prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains morphine equivalent to morphine sulfate 60 mg.
Excipients with known effect:
Lactose anhydrous 40 mg
Sunset Yellow (E110)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated, prolonged-release tablet
Orange tablets marked with the Napp logo on one side and 60mg 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
re