Morphine Sulfate 10mg/5ml Oral Solution

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Morphine sulphate

Commercializzato da:

Wockhardt UK Limited

Codice ATC:

N02AA; N02AA01

INN (Nome Internazionale):

Morphine sulphate

Dosaggio:

10 mg/5ml

Forma farmaceutica:

Oral solution

Via di somministrazione:

oral administration

Confezione:

100ml, 250ml and 500ml

Tipo di ricetta:

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

Gruppo terapeutico:

Opioid analgesic

Area terapeutica:

Natural opium alkaloids; morphine

Indicazioni terapeutiche:

For the relief of severe pain

Stato dell'autorizzazione:

Not marketed

Data dell'autorizzazione:

2015-10-30

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
MORPHINE SULFATE 10MG/5ML ORAL SOLUTION
Morphine Sulfate
(Referred to as Morphine Sulfate Oral Solution in the remainder of the
leaflet)
Read all of this leaflet carefully before you start taking this
medicine.
•
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 any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
WHAT IS IN THIS LEAFLET:
1. What Morphine Sulfate Oral Solution is and what it is used for
2. What you need to know before you take Morphine Sulfate Oral
Solution
3. How to take Morphine Sulfate Oral Solution
4. Possible side effects
5. How to store Morphine Sulfate Oral Solution
6. Contents of the pack and other information
1. WHAT MORPHINE SULFATE ORAL SOLUTION IS AND WHAT IT IS USED FOR
The name of your medicine is Morphine Sulfate 10mg/5ml Oral Solution
(called
Morphine Sulfate Oral Solution in this leaflet).

It contains a medicine called morphine sulfate. This belongs to a
group of
medicines called ‘opioid analgesics’

It is used to relieve severe pain
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MORPHINE SULFATE ORAL
SOLUTION
DO NOT TAKE MORPHINE SULFATE ORAL SOLUTION:

If you are allergic (hypersensitive) to morphine sulfate or any of the
other
ingredients of this medicine (listed in Section 6)

If you have problems with your lungs or breathing such as
‘hypoventilation’ or
‘Chronic Obstructive Pulmonary Disorder’ (COPD)

If you are having an asthma attack

If you have sudden or recent liver problems

If you have recently had a head injury

If you have something called ‘phaeochromocytoma’. This is a rare
tumour which
is not malignant

If you have fits (convulsions) or increased pressure inside your skull

If the pe

Scheda tecnica

Health Products Regulatory Authority
12 June 2020
CRN009N9Y
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Morphine Sulfate 10mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml dose contains 10mg of Morphine Sulfate.
Excipient(s) with known effect:
Methyl parahydroxybenzoate (E218) – 9.00mg/5ml
Propyl parahydroxybenzoate (E216) – 1.00mg/5ml
Sucrose – 1500.00mg/5ml
Glucose, liquid – 500.00mg/5ml
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution.
A clear colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of severe pain in adults, adolescents (aged 13-18
years) and children (ages 1-12 years).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: Usual dose 10-20 mg (5 - 10ml) every 4 hours.
Maximum daily dose: 120 mg per day
_Paediatric population:_
Children 13-18 years:
Recommended dose 5-20 mg (2.5 – 10 ml) every 4 hours
Maximum daily dose: 120 mg per day
Children 6-12 years:
Recommended dose 5-10 mg (2.5 – 5 ml) every 4 hours
Maximum daily dose: 60 mg per day
Children 1-5 years:
Recommended dose 5 mg (2.5 ml) every 4 hours
Maximum daily dose: 30 mg per day
Children under 1 year:
Not recommended
Dosage can be increased under medical supervision according to the
severity of the pain and the patient's previous history of
analgesic requirements.
_Special populations:_
Reduction in dosage may be appropriate in the elderly and in patients
with chronic hepatic disease (for acute hepatic disease
see section 4.3), renal impairment, severe hypothyroidism,
adrenocortical insufficiency, prostatic hypertrophy, shock or where
sedation is undesirable.
_ _
Method of Administration
For oral use.
_ _
When patients are transferred from other morphine preparations oral
preparations dosage titration may be appropriate.
Health Products Regulatory Authority
12 June 2020
CRN009N9Y
Page 2 of 9
Morphine Sulfate is readily absorbed from the gastro-intestinal tract
following oral admini