Morphine Sulphate 10 mg/1 ml Solution

Morphine Sulphate Fresenius contains the active ingredient morphine sulphate. Morphine Sulphate Fresenius is used for the relief of severe and persistent pain where non-narcotic pain relief medication is ineffective.

Morphine Sulphate Fresenius should not be administered to you:

• if you are hypersensitive (allergic) to morphine sulphate or any of the other ingredients of Morphine Sulphate Fresenius (see section 6 for other ingredients)
• if you are taking medicines used to treat depression known as monoamine oxidase inhibitors (MAOIs) (e.g. phenelzine, tranylcypromine, moclobemide or selegiline) or have taken them in the last 10 days
• if you have difficulty in breathing, shortness of breath, suffer from chronic asthma, chronic lung disease and any obstructive airway disease
• if you have excessive bronchial secretion
• if you are an alcoholic
• if you have convulsive disorders (fits and seizures)
• if you have head injuries or increased pressure in the head
• if you suffer from heart problems
• if you have severe stomach cramps caused by a condition known as biliary colic
• if you are at risk of having a blocked intestine (paralytic ileus)
• if you are suffering from a tumour of the adrenal gland known as a phaeochromocytoma
• if you suffer from severe diarrhoea
• if you are pregnant or breastfeeding.

Warnings and precautions

Special care should be taken with Morphine Sulphate Fresenius. Tell your doctor if you have any of the following medical conditions:

• Hypothyroidism – underactive thyroid gland.
• Adrenocortical insufficiency – undersupply of corticosteroid hormones by the body.
• Impaired kidney or liver function.
• Enlarged prostate.
• Convulsions (fits and seizures).
• Shock (the symptoms of which include sweating, a fast pulse and cold, clammy skin).
• Inflammatory or obstructive bowel disorders.
• Myasthenia gravis – weakness of selected muscles.
• Lung and/or breathing disorders.
• Hypotension – low blood pressure (the symptoms of which include dizziness or light-headedness).
• Biliary tract disease.
• If you are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
• Loss of libido, impotence, cessation of menstruation. This may be because of decreased sex hormone production.
• Abstinence symptoms or dependence. The most common abstinence symptoms are mentioned in section 3. If this occurs, your doctor may change the type of medicine or the interval between doses.

You will not be expected to give yourself Morphine Sulphate Fresenius. It will be given to you by a person who is qualified to do so. Your doctor will decide what the dose is and for how long you will receive Morphine Sulphate Fresenius. This will vary from patient to patient. It will depend on the reason for receiving Morphine Sulphate Fresenius and other factors, such as your physical condition, weight, age as well as other medications that you are taking at the time or after.

For most conditions, Morphine Sulphate Fresenius is usually given as a continuous intravenous infusion or in divided doses throughout the day. However, in certain cases a single dose is required for the control of pain. Morphine Sulphate Fresenius injection is administered either:

• directly into the muscle (intramuscular), beneath the skin (subcutaneous) or into sheath/membrane surrounding the spinal cord (intrathecal)
• as a slow injection directly into the vein (intravenous) or
• as a slow intravenous infusion directly into the vein on a continuous basis.

If you receive more Morphine Sulphate Fresenius than you should Since a healthcare provider will administer Morphine Sulphate Fresenius, he/she will control the dosage. However, in the event of an overdosage, your doctor will manage the overdosage. In the unlikely event of an overdose, you may experience any of the following symptoms:

• Cold, clammy skin.
• Confusion.
• Convulsions.
• Dizziness.
• Drowsiness.
• Low blood pressure.
• Nervousness or restless.
• Constriction of the pupils.
• Slow heartbeat.
• Slow or troubled breathing.

Missed Morphine Sulphate Fresenius doses Since a healthcare provider will administer Morphine Sulphate Fresenius, it is unlikely that the dose will be missed.

Morphine Sulphate Fresenius can have side effects. Not all side effects reported for Morphine Sulphate Fresenius are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving Morphine Sulphate Fresenius, please consult your doctor, pharmacist or other healthcare provider for advice.

If any of the following happens, stop receiving Morphine Sulphate Fresenius and tell your doctor immediately:

• Swelling of the hands, feet, ankles, face, lips and 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 Morphine Sulphate Fresenius. You may need urgent medical attention or hospitalisation.

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

• Changes in heart rate and/or an awareness of your heart beating.
• Collapsed lung, wheezing, difficulty in speaking.
• Slow or troubled breathing.
• Convulsions (fits or seizures).
• Withdrawal symptoms or dependence (symptoms may include body aches, shaking, flu-like symptoms, large pupils, an intense feeling of unsatisfaction, anxiety and irritability).
• Severe skin reaction with blistering, widespread scaly skin, pus-filled spots together with fever. This could be a condition called Acute Generalized Exanthematous Pustulosis (AGEP).

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

Tell your doctor if you notice anything of the following:

Frequent side effects:

• A feeling of light-headedness (which would be due to lowering of blood pressure) especially when standing,
• Increased sweating,
• Warm sensation of the face,
• Drowsiness,
• Nausea (feeling sick), vomiting (being sick), constipation,
• Unusual tiredness or weakness.

Less frequent side effects:

• Loss of appetite,
• False sense of well-being (unpleasant or uncomfortable mood),
• A feeling of restless,
• Decreased in sexual drive, inability to get an erection,
• Sleeplessness,
• Confusion,
• Hallucinations (seeing, feeling or hearing things that are not there),
• Headache,
• Dry mouth,
• Stomach cramps or pain,
• A condition when the bowel does not work properly (paralytic ileus),
• Inflammation of the colon,
• Feeling faint when getting up from a seated position,
• Biliary spasm (spasms in the lower stomach area),
• Rash
• Muscle rigidity (muscle stiffness),
• Trembling or uncontrolled muscle movements,
• Difficulty in urinating,
• Pain and irritation at the site of injection.
• Abdominal pain, including inflamed and irritated pancreas.

Side effects with frequency unknown

• Nightmares or unusual dreams,
• Convulsions
• Blurred vision,
• Dependence,
• Mood changes,
• Sensation of whirling and loss of balance (vertigo),
• Increased sensitivity to pain,
• Feeling of extreme happiness,
• The pupil of your eye becomes smaller,
• Ringing or buzzing in the ears (tinnitus),
• Changes in body temperature from feeling cold to sweating,
• Sleep apnoea (breathing pauses during sleep),
• Symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system, e.g. severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever.

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

Store all medicines out of reach of children. Morphine Sulphate Fresenius will be stored in the pharmacy or in the hospital wards. The injection is protected from light and kept in a cool dry place at or below 25 °C.