Oramorph Oral Solution 10 mg/5 ml

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Morphine sulfate

Pieejams no:

Boehringer Ingelheim International GmbH

ATĶ kods:

N02AA; N02AA01

SNN (starptautisko nepatentēto nosaukumu):

Morphine sulfate

Deva:

10 mg/5ml

Zāļu forma:

Oral solution

Ārstniecības joma:

Natural opium alkaloids; morphine

Autorizācija statuss:

Marketed

Autorizācija datums:

1990-07-16

Lietošanas instrukcija

THIS MEDICINE CONTAINS MORPHINE SULFATE WHICH IS AN OPIOID, WHICH
CAN CAUSE ADDICTION. YOU CAN GET WITHDRAWAL SYMPTOMS IF YOU STOP
TAKING IT SUDDENLY.
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 troublesome or serious, or if you
notice
any side effects not listed in this leaflet, please tell your doctor
or
pharmacist.
IN THIS LEAFLET:
1. What ORAMORPH Oral Solution is and what it is used for
2. Before you take ORAMORPH Oral Solution
3. How to take ORAMORPH Oral Solution
4. Possible side effects
5. How to store ORAMORPH Oral Solution
6. Further information
1. WHAT ORAMORPH ORAL SOLUTION IS AND WHAT IT IS USED FOR
The name of your medicine is ORAMORPH Oral Solution 10 mg/5 ml
(called ORAMORPH in this leaflet).
• This medicine has been prescribed for you for relief of severe
pain
• It contains a medicine called morphine sulfate, which belongs to
a class of medicines called opioids, which are ‘pain relievers’
• This medicine has been prescribed to you and should not be given
to anyone else
• Opioids can cause addiction and you may get withdrawal symptoms
if you stop taking it suddenly. Your prescriber should have explained
how long you will be taking it for and when it is appropriate to stop,
how to do this safely
2. BEFORE YOU TAKE ORAMORPH ORAL SOLUTION
DO NOT TAKE ORAMORPH IF:
• You are allergic (hypersensitive) to morphine sulfate or any of
the
other ingredients of ORAMORPH (listed in Section 6 below)
• You have problems with your lungs or breathing such as
‘hypoventilation’ or ‘Chronic Obstructive Pulmonary Disease’
(COPD)
• You are having an asthma attack
• You have sudden or recent liver problems
• You have recently had a head injury
• You have something

Produkta apraksts

Health Products Regulatory Authority
28 September 2020
CRN009Y85
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oramorph Oral Solution 10 mg/5 ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Morphine Sulfate 10 mg per 5 ml.
Excipient(s) with known effect: Each 5 ml also contains 1500 mg
Sucrose, 500 mg corn syrup (contains glucose), 0.525 ml
Ethanol (96%), 9 mg Methyl parahydroxybenzoate (E218) and 1 mg Propyl
parahydroxybenzoate (E216).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution
A clear, colourless oral solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of severe pain in adults, adolescents (aged 13-18
years) and children (aged 1‑12 years).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults: _Recommended dose 10-20 mg (5-10 ml) 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_:
Reductions 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.
Discontinuation of therapy
Prior to starting treatment with opioids, a discussion should be held
with patients to put in place
a strategy for ending treatment with Oramorph in order to minimise the
risk of addiction and
drug withdrawal syndrome (see section 4.4).
Health Products Regulatory Authority
28 September 2020
CR