Arrow - Morphine LA

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Morphine sulfate pentahydrate 60mg

Disponible desde:

Teva Pharma (New Zealand) Limited

Designación común internacional (DCI):

Morphine sulfate pentahydrate 60 mg

Dosis:

60 mg

formulario farmacéutico:

Modified release tablet

Composición:

Active: Morphine sulfate pentahydrate 60mg Excipient: Hyetellose Hypromellose Lactose monohydrate Magnesium stearate Opadry orange OY-3533 Povidone Purified talc

Unidades en paquete:

Blister pack, 10 tablets

clase:

Class B1 Controlled Drug

tipo de receta:

Class B1 Controlled Drug

Fabricado por:

Macfarlan Smith Ltd

indicaciones terapéuticas:

ARROW-MORPHINE LA tablets are indicated for the prolonged relief of opioid responsive severe and intractable pain in adults. Use in Non-Malignant Pain: The use of ARROW-MORPHINE LA tablets 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; · The pain is having a significant impact on the patient's quality of life; · There is no psychological contraindication, drug seeking behaviour or history of drug abuse.

Resumen del producto:

Package - Contents - Shelf Life: Blister pack, - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, - 20 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, - 1000 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, Polypropylene with LDPE lid - 10 tablets - 36 months from date of manufacture stored at or below 25°C

Fecha de autorización:

1993-02-16

Información para el usuario

CONSUMER MEDICINE INFORMATION
ARROW – MORPHINE LA
MORPHINE SULPHATE 10 MG, 30 MG, 60 MG AND 100 MG LONG ACTING TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ARROW – MORPHINE LA
tablets.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor weighed the risks
of you taking ARROW –
MORPHINE LA tablets against the benefits this medicine is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT ARROW – MORPHINE LA IS USED FOR
Morphine is a pain reliever that belongs to a group of medicines
called opioid analgesics. It
acts mainly on the central nervous system and on smooth muscle.
The special tablet core is designed to prolong the release of the
active over time (L.A. stands
for “long acting”).
ARROW – MORPHINE LA is used for prolonged relief of opioid
responsive severe pain.
Your doctor, however, may have prescribed ARROW – MORPHINE LA
tablets for another
purpose. Ask your doctor if you have any questions why ARROW –
MORPHINE LA tablets
have been prescribed for you.
This medicine is a controlled drug (Class B1) and can only be obtained
on prescription from
your doctor.
BEFORE YOU TAKE ARROW – MORPHINE LA
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ARROW – MORPHINE LA IF YOU HAVE HAD AN ALLERGIC REACTION
TO:
•
morphine sulphate
•
other opioids
•
any ingredients listed at the end of this leaflet
Symptoms of an allergic reaction include:
•
shortness of breath, wheezing or difficulty breathing
•
swelling of the face, lips, tongue or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE ARROW – MORPHINE LA IF YOU ARE PREGNANT OR
BREASTFEEDING.
DO NOT GIVE ARROW – MORPHINE LA TABLETS TO CHILDREN.
DO NOT TAKE ARROW – MORPHINE LA IF YOU HAVE THE FOLLOWING MEDICAL
CONDITIONS:
•
Breathing problem

Ficha técnica

Version 3.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Arrow – Morphine LA, 10 mg, 30 mg, 60 mg and 100 mg long acting
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each controlled release tablet contains 10 mg, 30 mg, 60 mg or 100 mg
of morphine sulphate.
Excipient with known effect:
lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Each 10 mg controlled release tablet is a smooth biconvex buff
coloured film coated round tablet
embossed with 10 on one side and contains 10 mg Morphine Sulphate
Ph.Eur.
Each 30 mg controlled release tablet is a smooth biconvex violet
coloured film coated round tablet
embossed with 30 on one side and contains 30 mg Morphine Sulphate
Ph.Eur.
Each 60 mg controlled release tablet is a smooth biconvex orange
coloured film coated round tablet
embossed with 60 on one side and contains 60 mg Morphine Sulphate
Ph.Eur.
Each 100 mg controlled release tablet is a smooth biconvex grey
coloured film coated round tablet
embossed with 100 on one side and contains 100 mg Morphine Sulphate
Ph.Eur.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Arrow – Morphine LA tablets are indicated for the prolonged relief
of opioid responsive severe and
intractable pain in adults.
USE IN NON-MALIGNANT PAIN
The use of Arrow – Morphine LA tablets 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;
•
The pain is having a significant impact on the patient’s quality of
life;
•
There is no psychological contraindication, drug seeking behaviour or
history of drug misuse
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
_Adults _
The dosage is dependent upon the severity of the pain and the patients
previous history of analgesic
requirements. The tablets should normally be administered twice daily
at 12 hourly intervals. One or
two 10 mg tablets twice daily is the recommended starting dosage for a
patient presenting with severe
pain. With