Omnopon Solution

OMNOPON 20 FRESENIUS contains 3 opioid types of medicines namely morphine, papaverine and codeine. Morphine and codeine are two powerful medicines with pain relieving properties. Papaverine is a smooth muscle relaxant.

OMNOPON 20 FRESENIUS is used:

• For the relief of severe or very severe pain, before and just after an operation.
• To treat coughing or wheezing that occurs with heart failure (when your heart muscle doesn’t pump blood as well as it should).
• To treat pulmonary oedema (a condition caused by excess fluid in the lungs, making it difficult to breathe).
• To treat coronary occlusion (a condition where there is a partial or complete obstruction of blood flow in a coronary artery).
• To treat pulmonary embolism (a blood clot that occurs in the lung).

OMNOPON 20 FRESENIUS should not be given to you if you:

• Are hypersensitive (allergic) to morphine, papaverine, codeine or any of the other ingredients of OMNOPON 20 FRESENIUS (listed in section 6 of this leaflet).
• Are suffering from breathing difficulties such as asthma or if you are having an asthma attack.
• Are in a coma.
• Suffer from alcoholism.
• Suffer from fits or seizures.
• Have suffered a head injury or are experiencing severe and undiagnosed headaches.
• Have stomach pains.
• Suffer from heart failure (when your heart muscle doesn’t pump blood as well as it should) that resulted from lung disease.
• Suffer from a tumour of the adrenal gland (phaeochromocytoma).
• Suffer from obstruction of the intestine due to paralysis of the intestinal muscles (paralytic ileus).
• Are currently taking medicines known as monoamine oxidase inhibitors (see section “Other medicines and OMNOPON 20 FRESENIUS”).
• Suffer from atrioventricular block (a condition where the electrical signal that controls the heartbeat is partially or completely blocked).

Warnings and precautions:

Talk to your doctor before receiving OMNOPON 20 FRESENIUS if you:

• Suffer from opioid addiction.
• Suffer from thyroid problems.
• Suffer from problems with your adrenal glands.
• Have liver or kidney problems.
• Are a male patient having problems with your prostate.
• Suffer from low blood pressure.
• Are in shock (with symptoms such as sweating, a fast pulse and cold, clammy skin).
• Suffer from bowel problems.
• Suffer from myasthenia gravis (a disease that leads to muscle weakness and rapid fatigue of muscles under voluntary control).
• Have an unusually fast heartbeat.
• Suffer from any heart disorders.
• Are in labour.

Take special care with OMNOPON 20 FRESENIUS if you:

• Are elderly or very ill.
• Experience any shortness of breath.

Do not share any medicines prescribed for you with any other person. You will not be expected to give yourself OMNOPON 20 FRESENIUS. It will be given to you by a doctor or a person who is qualified to do so.

OMNOPON 20 FRESENIUS will be given to you as an injection into a vein (intravenously), under the skin (subcutaneously) or into a muscle (intramuscularly). Your doctor will tell you how long your treatment with OMNOPON 20 FRESENIUS will last. If you have the impression that the effect of OMNOPON 20 FRESENIUS is too strong or too weak, tell your doctor or pharmacist.

If you receive more OMNOPON 20 FRESENIUS than you should:

Since a health care provider will administer OMNOPON 20 FRESENIUS he/she will control the dosage. However, in the event of overdosage, your doctor will manage the overdose.

If a dose of OMNOPON 20 FRESENIUS is missed:

Since a health care provider will administer OMNOPON 20 FRESENIUS, it is unlikely that the dose will be missed.

OMNOPON 20 FRESENIUS can have side effects. Not all side effects reported for OMNOPON 20 FRESENIUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using OMNOPON 20 FRESENIUS, please consult your doctor, pharmacist or other health care provider for advice.

If any of the following happens, stop receiving OMNOPON 20 FRESENIUS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to OMNOPON 20 FRESENIUS. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Tolerance or dependence to OMNOPON 20 FRESENIUS (see section “Warnings and precautions”).
• Mood changes, confusion, hallucinations (seeing or hearing things that are not real).
• Seizures (fits).
• Faster or slower heartbeat than usual.
• Slowed breathing or difficulty breathing.
• Yellowing of skin or whites of the eyes (jaundice).
• Difficulty passing urine.
• Hypothermia (a dangerous drop in body temperature, with symptoms such as shivering, drowsiness and feeling weak).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Nausea, vomiting, loss of appetite.
• Dry mouth, headache, drowsiness.
• A feeling of spinning (vertigo).
• Pinpoint pupils.
• Facial flushing.
• Feeling faint on standing up from a seated position.
• Low blood pressure.
• Reduced sex drive.
• Skin itching or rash, pain or irritation at the injection site.

Less frequent side effects:

• Abdominal pain, including inflamed and irritated pancreas.

Frequency not known:

• Dizziness, restlessness.
• Muscle tension, stiffness or muscle pain.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. Patients are asked to report any suspected adverse drug reactions to the Holder of the Certificate of Registration at the following email address: [email protected] and to the relevant medicine’s regulatory authority in the country where the product is marketed.

• Protect form light and store at or below 25 °C.
• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
• Do not use after the expiry date printed on the carton.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).