Sevredol

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Morphine sulfate pentahydrate 20mg

Available from:

Mundipharma New Zealand Ltd

INN (International Name):

Morphine sulfate pentahydrate 20 mg

Dosage:

20 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Morphine sulfate pentahydrate 20mg Excipient: Hypromellose Lactose Macrogol 400 Magnesium stearate Opaspray pink M-1-5503 Povidone Pregelatinised maize starch Purified talc Purified water

Units in package:

Blister pack, 10, 10 tablets

Class:

Class B1 Controlled Drug

Prescription type:

Class B1 Controlled Drug

Manufactured by:

Macfarlan Smith Ltd

Therapeutic indications:

SEVREDOL tablets are indicated for the relief of both acute and chronic severe pain in adults and children aged three years and above.

Product summary:

Package - Contents - Shelf Life: Blister pack, 10 - 10 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, 10 - 10 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1993-06-15

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Sevredol tablets
Mar 2024
Page 1 of 17
SEVREDOL® TABLETS
Morphine sulphate
1 PRODUCT NAME
SEVREDOL
®
10 mg and 20 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains morphine sulphate 10 mg or 20 mg
Excipient with known affect: Lactose, anhydrous
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
SEVREDOL tablets are capsule shaped, biconvex, scored, film-coated
tablets approximately 12 mm in
length with the strength on one side and "IR" on the other side of the
score line. The colours of the
tablets are as follows: 10 mg blue and 20 mg pink.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SEVREDOL tablets are indicated for the relief of both acute and
chronic severe pain in adults and
children aged three years and above.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
ADULTS AND CHILDREN OVER 12 YEARS:
SEVREDOL tablets should be given every four hours. The dosage is
dependent upon the nature and
severity of the pain, the patient's condition and their previous
history of analgesic therapy. The correct
dosage per individual patient is that which controls the pain and is
well tolerated. A patient initially
presenting with severe and intractable pain will normally be started
on SEVREDOL 10 mg every 4
hours. This dose should be increased every 4 hours until the desired
relief is achieved.
SWITCHING FROM SEVREDOL TO LONG-ACTING MORPHINE:
Add the amount of morphine needed to achieve pain relief over a
24-hour period. Divide this total in
half, rounding up to nearest tablet strength and administer the long
acting morphine preparation as
a twice daily dose. The first dose of the long acting morphine
preparation should be given as a
replacement of the last dose of SEVREDOL tablets. Any recurrence of
pain will require an increase in
the dose but not the frequency of the long acting morphine
preparation. Breakthrough pain should
be treated with immediate-release morphine, such as SEVREDOL tablets,
as rescue dose and not
with long-acting formulations.
There is no