Sevredol 50 mg Film-Coated Tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Morphine sulfate

Disponibil de la:

Mundipharma Pharmaceuticals Limited

Codul ATC:

N02AA; N02AA01

INN (nume internaţional):

Morphine sulfate

Dozare:

50 milligram(s)

Forma farmaceutică:

Film-coated tablet

Tip de prescriptie medicala:

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

Zonă Terapeutică:

Natural opium alkaloids; morphine

Statutul autorizaţiei:

Marketed

Data de autorizare:

1996-06-10

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
_SEVREDOL_
_®_ 10 MG, 20 MG AND 50 MG FILM-COATED 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, 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
_SEVREDOL _
tablets are and what they are used for
2.
What you need to know before you take
_SEVREDOL _
tablets
3.
How to take
_SEVREDOL _
tablets
4.
Possible side effects
5.
How to store
_SEVREDOL _
tablets
6.
Contents of the pack and other information
1.
WHAT _SEVREDOL _TABLETS ARE AND WHAT THEY ARE USED FOR
These tablets have been prescribed for you by your doctor to relieve
severe pain. They contain 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 _SEVREDOL_ TABLETS
DO NOT TAKE _SEVREDOL _TABLETS IF:
•
you are allergic (hypersensitive) to morphine or any of the other
ingredients of the tablets (see section
6 ‘Further Information’);
•
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
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
tablets 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
ileus), your stomach empti

Caracteristicilor produsului

Health Products Regulatory Authority
13 March 2023
CRN00DFF9
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sevredol 50 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg Morphine Sulfate.
Also contains 167.5 mg lactose.
For a full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pale green, film coated, biconvex, capsule-shaped tablet, marked with
a scoreline with ” IR” to the left and “50” to the right with
a plain reverse side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of severe pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children over 12 years.
The dosage of_ SEVREDOL_ tablets is dependent on the severity of pain
and the patient's previous history of analgesic
requirements. One tablet to be taken every four hours or as directed
by a physician. Increasing severity of pain or tolerance to
morphine will require increased dosage of _SEVREDOL_ tablets using 10
mg, 20 mg or 50 mg alone or in combination to achieve
the desired relief.
Patients receiving _SEVREDOL_ 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.
Elderly
A reduction in adult dosage may be advisable.
Paediatric population
_SEVREDOL_ tablets 50 mg are not recommended in children.
Route of administration
Oral.
Discontinuation of therapy
An abstinence syndrome may be precipitated if opioid administration is
suddenly discontinued. Therefore, the dose should be
gradually reduced prior to discontinuation.
4.3 CONTRAINDICATIONS
Morphine products are contraindicated in patients with:
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13 March 2023
CRN00DFF9
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