Zomorph 10mg modified-release capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Morphine sulfate

Available from:

Ethypharm UK Ltd

ATC code:

N02AA01

INN (International Name):

Morphine sulfate

Dosage:

10mg

Pharmaceutical form:

Modified-release capsule

Administration route:

Oral

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5027229000104

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOMORPH CAPSULES
(morphine sulfate, 10mg, 30mg, 60mg, 100mg, 200mg)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
–
Please 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. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
–
If you suffer from any side effects that get serious, or if you notice
any side effects not
listed in this leaflet, please tell your doctor.
IN THIS LEAFLET:
1.
What Zomorph capsules are and what they are used for
2.
Before you take Zomorph capsules
3.
How to take Zomorph capsules
4.
Possible side effects
5.
How to store Zomorph capsules
6.
Further information
1.
WHAT ZOMORPH CAPSULES ARE AND WHAT THEY ARE USED FOR
Zomorph capsules belong to a group of medicines called opioid
analgesics. They contain the
active ingredient morphine sulfate in a special slow-release form
which gives relief from
severe pain, particularly pain associated with cancer.
2.
BEFORE YOU TAKE ZOMORPH CAPSULES
DO NOT TAKE ZOMORPH CAPSULES IF:

you have an allergy (hypersensitivity) to morphine sulfate or any of
the other
ingredients in the product _(see Section 6 and end of Section 2)_

you have breathing difficulties

you have unexplained abdominal pains

you have liver problems

you have raised intracranial pressure (severe headache), for example
from a head injury

you have convulsions (fits)

you have recently consumed a large amount of alcohol, or have been
intoxicated

paralytic ileus (bowel obstruction)

you have ever taken monoamine oxidase inhibitors (MAOIs) for
depression, or have
done so in the last 14 days

the patient is a child.
TAKE SPECIAL CARE WITH ZOMORPH CAPSULES
The dose should be reduced or stopped if you:

are elderly

are in a state of shock

have liver or kidney problems

have an underactive thyroid or adrenal gland

have a

Summary of Product characteristics

OBJECT 1
ZOMORPH CAPSULES
Summary of Product Characteristics Updated 14-Oct-2016 | Ethypharm UK
Ltd
1. Name of the medicinal product
ZOMORPH capsules 10mg, 30mg, 60mg, 100mg, 200mg
2. Qualitative and quantitative composition
• Morphine sulphate BP 10mg
• Morphine sulphate BP 30mg
• Morphine sulphate BP 60mg
• Morphine sulphate BP 100mg
• Morphine sulphate BP 200mg
3. Pharmaceutical form
Sustained-release capsules.
4. Clinical particulars
4.1 Therapeutic indications
Severe chronic pain and/or pain resistant to other analgesics, in
particular pain associated with cancer.
4.2 Posology and method of administration
Route of administration : orally.
As directed by a medical practitioner.
Recommended dosage
Adults: Recommended dosage is one capsule twice daily, at 12-hourly
intervals.
Elderly: As with all narcotics, a reduction in dosage may be advisable
in the elderly, as appropriate.
Children: Not recommended.
The capsules should not be chewed and should normally be swallowed
whole.
The dosage varies according to the severity of pain and the previous
analgesic treatments received by the
patient.
If the pain persists, or if the patient develops tolerance to
morphine, the dosage may be increased by
prescribing the 10mg, 30mg, 60mg, 100mg and 200mg capsules in various
combinations or alone to
obtain the desired relief.
Patients previously treated with immediate-release oral morphine
should receive the same daily dose of
sustained-release capsules, but in two divided doses at 12-hourly
intervals.
Patients previously treated with parenteral morphine should be given a
sufficiently increased dosage to
compensate for any reduction of the analgesic effect associated with
oral administration. The dosage
should be adjusted to meet the individual requirements of each
patient.
For patients who cannot swallow the capsules, their contents can be
administered directly in semi-solid
food (puree, jam, yoghurt) or via gastric or gastrostomy tubes of a
diameter of more than 16 F.G. with an
open distal end or lateral pores. It i