m-Eslon SR

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Morphine sulfate pentahydrate 200mg;  

Available from:

Multichem NZ Limited

INN (International Name):

Morphine sulfate pentahydrate 200 mg

Dosage:

200 mg

Pharmaceutical form:

Modified release capsule

Composition:

Active: Morphine sulfate pentahydrate 200mg   Excipient: Dibutyl sebacate Ethylcellulose Gelatin Macrogol 4000 Purified talc Sugar spheres

Units in package:

Blister pack, Al/PVC, 10 capsules

Class:

Class B1 Controlled Drug

Prescription type:

Class B1 Controlled Drug

Manufactured by:

Siegfried Ltd

Therapeutic indications:

For the prolonged relief of chronic, moderate to severe pain in adults. Use in Non-Malignant Pain: The use of m-Eslon SR tablets for the treatment of pain which is not due to malignancy should be restricted to situations where: o All other conservative methods of analgesia have been tried and have failed; o The pain is having a significant impact on the patient's quality of life; o There is no psychological contraindication, drug seeking behaviour or history of drug misuse.

Product summary:

Package - Contents - Shelf Life: Blister pack, Al/PVC - 10 capsules - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2001-03-13

Summary of Product characteristics

NEW ZEALAND DATA SHEET
M-ESLON
Page 1 of 17
1. PRODUCT NAME
m-Eslon SR, morphine sulphate, modified release capsule, 10 mg, 30 mg,
60 mg, 100 mg and
200 mg.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
m-Eslon SR 10 mg: each capsule contains microgranules providing 10 mg
of morphine sulphate.
m-Eslon SR 30 mg: each capsule contains microgranules providing 30 mg
of morphine sulphate.
m-Eslon SR 60 mg: each capsule contains microgranules providing 60 mg
of morphine sulphate.
m-Eslon SR 100 mg: each capsule contains microgranules providing 100
mg of morphine
sulphate.
m-Eslon SR 200 mg: each capsule contains microgranules providing 200
mg of morphine
sulphate.
For the full list of excipients see 6.1.
3. PHARMACEUTICAL FORM
Modified release capsules filled with off-white spherical
microgranules.
m-Eslon SR 10 mg: size 4 capsules with natural transparent body and
yellow cap, printed 10
mg in black ink.
m-Eslon SR 30 mg: size 4 capsules with natural transparent body and
pink cap, printed 30 mg
in black ink.
m-Eslon SR 60 mg: size 3 capsules with natural transparent body and
orange cap, printed 60
mg in black ink.
m-Eslon SR 100 mg: size 2 capsules with natural transparent body and
white cap, printed 100
mg in black ink.
m-Eslon SR 200 mg: size 0 capsules with natural transparent body and
cap, printed 200 mg in
black ink.
4. CLINICAL PARTICULARS
4.1
Therapeutic indications
For the prolonged relief of chronic, moderate to severe pain in
adults.
Use in Non-Malignant Pain
The use of m-Eslon SR for the treatment of pain which is not due to
malignancy should be
restricted to situations where:
-
All other conservative methods of analgesia have been tried and have
failed;
NEW ZEALAND DATA SHEET
M-ESLON
Page 2 of 17
-
The pain is having a significant impact on the patient’s quality o
f life;
-
There is no psychological contraindication, drug seeking behaviour or
history of drug
misuse.
4.2
Dose and method of administration
Administration and dosing of morphine should be individualised bearing
in mind the properties
of the drug