OMNOPON Solution for injection Ref.[51213] Active ingredients: Codeine Morphine Papaverine

Exceeding the prescribed dose, together with prolonged and continuous use of OMNOPON 20 FRESENIUS, may lead to dependency and addiction.

OMNOPON 20 FRESENIUS is an addictive medicine with an addiction liability equal to morphine. OMNOPON 20 FRESENIUS should be given with caution or in reduced doses to old or debilitated patients and to patients with hypothyroidism, hyperthyroidism, adrenocortical insufficiency, impaired kidney or liver function, prostatic hyperplasia, hypotension, shock, inflammatory or obstructive bowel disorders, myasthenia gravis, depressed respiratory reserve or supraventricular tachycardia.

Caution is advised in the presence of cardiac conduction disorders or unstable cardiovascular disease.

Administration during labour may cause respiratory depression in the newborn infant. Administration to the mother during Caesarean section should only be performed after clamping of the umbilical cord.

Great care is required when OMNOPON 20 FRESENIUS is administered to infants, especially neonates, as they may be more sensitive to respiratory depression.

Risk from concomitant use of sedative medicines such as benzodiazepines or related medicines

Concomitant use of OMNOPON 20 FRESENIUS and sedative medicines such as benzodiazepines or related medicines may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe OMNOPON 20 FRESENIUS concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible. The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).

Ethyl alcohol content

OMNOPON 20 FRESENIUS contains 50,88 mg ethyl alcohol per dosage unit.

OMNOPON 20 FRESENIUS must not be administered within two weeks of administration of monoamine oxidase inhibitors (see section 4.3).

The concomitant use of opioids as in OMNOPON 20 FRESENIUS with sedative medicines such as benzodiazepines or related medicines increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dose and duration of concomitant use should be limited (see section 4.4).

The depressant effects are enhanced by CNS depressants such as alcohol, anaesthetics, hypnotics and sedatives, tricyclic antidepressants and phenothiazines.

Cyclizine may counteract the haemodynamic benefits of OMNOPON 20 FRESENIUS.

OMNOPON 20 FRESENIUS may enhance the sedative and hypotensive effects of antipsychotics.

The sedative effects of anxiolytics may be enhanced by the simultaneous use of OMNOPON 20 FRESENIUS.

The gastrointestinal effects of OMNOPON 20 FRESENIUS may delay the absorption of other compounds or may be counteractive as with metoclopramide.

OMNOPON 20 FRESENIUS should not be used as premedication when ciprofloxacin is used for surgical prophylaxis as serum levels of ciprofloxacin are reduced and adequate cover may not be obtained during surgery.

OMNOPON 20 FRESENIUS crosses the placenta and is also excreted in breast milk. This should be borne in mind when considering its use in patients during pregnancy or breastfeeding (see section 4.4).

OMNOPON 20 FRESENIUS may cause drowsiness.

OMNOPON 20 FRESENIUS may modify patients' reactions (driving ability, behaviour in traffic, etc.) to a varying extent depending on the dosage administered and individual susceptibility. Patients should be warned not to drive a vehicle and use machinery until any effects have worn off.

In normal doses the most common side effects are nausea, anorexia, constipation, confusion, sweating and occasionally vomiting.

Adverse reactions are listed below as MedDRA preferred term by system organ class and frequency. Frequencies are defined as: very common (>1/10), common (≥1/100 and <1/10), uncommon (≥1/1 000 and <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000), frequency not known (cannot be estimated from the available data).

The following side effects may occur (some of these effects occur more commonly in ambulant patients than in those at rest in bed):

Immune system disorders

Rare: Anaphylactic reactions.

Common: Dose-related histamine-releasing effect which may be responsible in part for reactions such as urticaria, pruritis, hypotension and flushing.

Psychiatric disorders

Very common: Hallucinations, dysphoria, tolerance*.

Common: Mood changes.

Frequency not known: Dependence*.

^* Tolerance and dependence may occur with repeated administration.

Nervous system disorders

Very common: Drowsiness.

Common: Dry mouth, headache, vertigo, raised intracranial pressure, convulsions (especially in infants and children), hypothermia.

Frequency not known: Dizziness, restlessness.

Eye disorders

Common: Miosis.

Cardiac disorders

Common: Bradycardia, tachycardia.

Frequency not known: Palpitations.

Vascular disorders

Common: Facial flushes, orthostatic hypotension, hypotension (following larger doses).

Respiratory, thoracic and mediastinal disorders

Very common: Respiratory depression (following larger doses), with circulatory failure and deepening coma. Death may occur from respiratory failure.

Hepato-biliary disorders

Frequency not known: Jaundice, eosinophilia and signs of altered liver function may occur.

Musculoskeletal and connective tissue disorders

Frequency not known: Muscle rigidity has been reported following high doses.

Renal and urinary disorders

Frequency not known: Micturition may be difficult and there may be ureteric or biliary spasm; an antidiuretic effect is also possible.

Reproductive system and breast disorders

Common: Decreased libido or potency.

General disorders and administration site conditions

Common: Contact dermatitis has been reported and pain and irritation may occur on injection.

Post-marketing data

Rare: Increased risk of abdominal pain, including pancreatitis has been reported.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of OMNOPON 20 FRESENIUS is important. It allows continued monitoring of the benefit/risk balance of OMNOPON 20 FRESENIUS. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.

Health care providers are asked to report any suspected adverse drug reactions to the Holder of the Certificate of Registration at the following email address: safety.fksa@fresenius-kabi.com and to the relevant medicine’s regulatory authority in the country where the product is marketed.

In the absence of compatibility studies, OMNOPON 20 FRESENIUS should not be mixed with other medicines.