Morphine 10 mg/15 mg Injection

MORPHINE UNIMED contains the active ingredient morphine sulphate. MORPHINE UNIMED belongs to a group of medicines called opioid analgesics. It works by blocking the pain signals from reaching your brain.

MORPHINE UNIMED is used for the treatment of: Relief of serve and persistent pain associated with cancer, heart attacks and after surgery.

MORPHINE UNIMED should not be administered to you if you are or have:

• if you are hypersensitive (allergic) to Morphine sulphate or any of the other ingredients of MORPHINE UNIMED (listed in section 6).
• if you are currently 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 14 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 suffer from severe diarrhoea

Warnings and precautions

Special care should be taken with MORPHINE UNIMED Tell your doctor if you have any of the following medical conditions:

• If you suffer from an opioid addiction;
• If you suffer from hypothyroidism (under active thyroid gland);
• If you suffer from adrenocortical insufficiency (a lack of hormones produced by the adrenal gland);
• If you have problems with your kidneys or liver;
• if you are a male and suffer from problems with your prostate;
• if you have epilepsy (a condition causing seizures);
• if you suffer from shock (the symptoms of which include sweating, a fast pulse and cold, clammy skin);
• if you suffer from problems with your bowel;
• if you have weak muscular movement and rapid fatigue of muscles under voluntary control (myasthenia gravis);
• if you have lung and/or breathing disorders;
• 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 hypotension-low blood pressure (the symptoms of which include dizziness or light-headedness);
• if you suffer from problems with your gallbladder
• If you are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
• if you have a history of mental health disorders (difficulty in thinking, understanding and judging clearly which causes loss of touch with reality), if you have depression, anxiety and suffer from alcohol or drug abuse.

Taking opioids or receiving opioids (as contained in MORPHINE UNIMED) over a long period of time:

• Produces tolerance (where you develop a requirement for increased doses of MORPHINE UNIMED to achieve the same pain-relieving effects.
• Produces dependence, such that when people stop taking/receiving opioids, they have physical and psychological symptoms of withdrawal (such as muscle cramping, diarrhoea, and anxiety).
• Maybe associated with decreased sex hormone levels and increased prolactin. Symptoms may include loss of libido, erectile dysfunction in men and cessation of menstruation in females.

Opioid addiction can cause life-threatening health problems, including the risk of overdose. Speak to your doctor if you experience any of these effects or if you are concerned.

Your doctor will decide what the dose is and for how long you will receive MORPHINE UNIMED. This will vary from patient to patient. It will depend on the reason for receiving MORPHINE UNIMED 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 UNIMED 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 UNIMED injection is administered either:

• directly into the muscle (intramuscular) or beneath the skin (subcutaneous)
• as a slow injection directly into the vein (intravenous)
• as a slow intravenous infusion directly into the vein as a continuous basis.

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

• Cold, clammy skin.
• Confusion.
• Convulsions.
• Dizziness.
• Drowsiness.
• Low blood pressure.

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

MORPHINE UNIMED can have side effects. Not all side effects reported for MORPHINE UNIMED are included in this leaflet. Should your general health worsen while receiving MORPHINE UNIMED please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking MORPHINE UNIMED 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 UNIMED. 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).

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.
• Difficulty in emptying bladder (urinary retention),
• Inability to get an erection,

Less frequent side effects:

• Loss of appetite,
• False sense of well-being (unpleasant or uncomfortable mood),
• A general feeling of discomfort or illness,
• Nervousness or restlessness,
• 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),
• Depression,
• Decreased in sexual drive,
• Mood swings,
• Headache,
• Unusual excitement or restlessness, especially in children,
• Feeling of spinning or moving (vertigo),
• Contraction of the pupil of the eye and rapid, repetitive, uncontrolled movements of the eyes,
• 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, (orthostatic hypotension),
• Low blood pressure,
• Increase in liver enzymes,
• Difficulty or painful urination, frequent urge to urinate,
• Biliary spasm (spasms in the lower stomach area),
• Rash

Side effects with frequency unknown

• Nightmares or unusual dreams,
• Convulsions,
• Blurred vision or double vision,
• Rapid heartbeats,
• Increased blood pressure,
• 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.
• Liver damage
• Breakdown of muscles (Rhabdomyolysis),
• Renal failure

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

• Store at or below 25 °C.
• Protect from light.
• Keep out of the reach of children
• Store in the original package.
• Do not use after the expiry date stated on the pack.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).