Oramorph solution oral

País: Armênia

Língua: inglês

Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes ativos:

morphine (morphine sulfate)

Disponível em:

L.Molteni & C. Dei F.lli Alitti Societa di Esercizio S.p.A

Código ATC:

N02AA01

DCI (Denominação Comum Internacional):

morphine (morphine sulfate)

Dosagem:

20mg/ml

Forma farmacêutica:

solution oral

Unidades em pacote:

20ml glass vial with dropper

Tipo de prescrição:

Prescription

Status de autorização:

Registered

Data de autorização:

2017-08-08

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ORAMORPH
® 20 MG/ML ORAL SOLUTION
Morphine sulfate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse
have told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Oramorph is and what it is used for
2.
What you need to know before you take Oramorph
3.
How to take Oramorph
4.
Possible side effects
5.
How to store Oramorph
6.
Contents of the pack and other information
1.
WHAT ORAMORPH IS AND WHAT IT IS USED FOR
The full name of your medicine is Oramorph 20 mg/ml oral solution. In
this leaflet the shorter
name Oramorph is used. Oramorph contains the active substance morphine
(as sulfate). It belongs
to a group of medicines called “opioid analgesics”.
It is used to relieve severe chronic pain and/or pain resistant to
other pain killers, in particular
cancer pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ORAMORPH
DO NOT TAKE ORAMORPH IF:

You are allergic to morphine sulfate or any of the other ingredients
of this medicine (listed in
section 6);

You have abdominal diseases (all the forms of acute abdomen) or loss
of intestinal movements
(paralytic ileus);

The patient is a child aged less than 1 year;

You have problems with your breathing (respiratory depression,
respiratory insufficiency);

You have liver disease (severe hepatocellular insufficiency);

You are having an asthma attack;

You have heart failure caused by long term chronic lung disease (heart
failure secondary to
chronic lung disease);

You have recently suffered any head injury;

You suffer from headache: this could be a signal of increased pressure
in

Características técnicas

1
SUMMARY OF THE PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Oramorph 20 mg/ml oral solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each one ml of oral solution contains: morphine sulfate 20 mg
(4-8-16 drops or 0.25-0.5-1.0 ml of oral solution contain 5-10-20 mg
of morphine sulfate,
respectively).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral solution
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Severe chronic pain and/or pain resistant to other pain killers, in
particular cancer pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults: _
The starting dose is 10-20 mg morphine sulfate (corresponding to 8-16
drops of oral solution) every
4 hours.
_Children:_
_Children between 6 and 12 years: _
The maximum dose is 5-10 mg morphine sulfate
(corresponding to 4-8 drops of oral solution) every 4 hours.
_Children between 1 and 5 years: _
The maximum dose is 5 mg morphine sulfate (corresponding
2
to 4 drops of oral solution) every 4 hours.
Use in children under 1 year of age is not recommended.
The dose can be increased under medical advice according to severity
of pain and previous
treatments with analgesics.
Reduction of the dose is advisable in elderly and debilitated
patients.
Duration of the treatment is necessarily variable depending on
severity of pain and on type of
pathology.
_ _
When patients shift from a different morphine-containing product to
Oramorph, adjustment of the
dosage is advisable.
Orally administered morphine sulfate is rapidly absorbed by the
gastrointestinal tract, however,
when Oramorph is used as a substitute for morphine injection, it is
usually necessary to increase the
dosage of 50% to 100% to achieve the same analgesic effect.
DISCONTINUATION OF THERAPY
An abstinence syndrome may be precipitated if opioid administration is
suddenly discontinued.
Therefore the dose should be gradually reduced prior to
discontinuation.
4.3 CONTRAINDICATIONS
-
Hypersensitivity to the active substance or any of the excipients.
Hypersensitivity to morphine