ORAMORPH SYRUP 2MG/ML [SIN16036P]

Product Info

ORAMORPH SYRUP 2MG/ML

[SIN16036P]

4.1 Therapeutic indications
Oramorph is indicated for the symptomatic relief of severe chronic pain.

4.2 Posology and method of administration
Posology
The Oramorph dose is adjusted depending on the severity of pain and with regards to the individual sensitivity of the patient.
Under medical control the dose can be increased depending on the severity of pain and depending on the use of analgesics so far.
For oral use.
The solution should be administered with some liquid (water or juice).
The recommended dose depends on the individual pain condition and is for
Adults: initial dose usually 10–30 mg morphine sulfate pentahydrate (corresponding to 5–15 ml Oramorph 2 mg/ml - syrup) every 4–6 hours.
Immediately prior to administration the prescribed Oramorph dose is measured with the aid of the provided measuring pipette of 5 ml, graduated with marks on every 0.25 ml.

Elderly patients:
In elderly patients or in patients that should not experience sedation the dosage should be reduced.
Older patients (usually 75 years and older) and patients with poor overall physical condition may be sensitive to morphine. Therefore, the adjustment of dose has to be done more carefully and / or the dosage intervals have to be extended. As appropriate, lower dosage strengths have to be given instead.

Patients with impaired liver and/or kidney function:
In patients with liver and/or kidney dysfunction and if a delayed gastrointestinal passage is suspected Oramorph should be dosed especially carefully.

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 to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Diarrhoea caused by poisoning.

• Acute respiratory insufficiency or respiratory depression, obstructive airways disease.

• Concurrent administration with monoamine oxidase (MAO) inhibitors or within 2 weeks of Discontinuation of treatment with MAO (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The risk-benefit of morphine use should be evaluated when the following medical problems are present:

• Acute abdomen.

• Asthma attacks and acute and severe bronchial obstruction.

• Cardiac arrhythmias.

• History of convulsions (see Sect. 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Acute alcohol intoxication.

• Agitation in patients secondary to use of alcohol or hypnotics, emotional instability, suicidal ideation.

• Head injury and conditions with increased intracranial pressure.

• Acute liver disorders (hepatitis, hepatic porphyria).

• Paralytic ileus.

• Coma.

• Patients with phaeochromocytoma. Morphine and some other opioids can induce the release of endogenous histamine and thereby stimulate catecholamine release.

• Pregnancy and lactation (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).