Oramorph Oral 20 MG Drops

ORAMORPH ® ORAL DROPS 20MG/ML is a strong-acting painkiller from the group of opiates. It is used for the relief of severe pain in adults.

Do not take ORAMORPH ® ORAL DROPS 20MG/ML :

• if you are hypersensitive (allergic) to morphine sulphate or any of the other ingredients of ORAMORPH ® ORAL DROPS 20MG/ML (listed in section 6).
• if you have an existing bowel obstruction (ileus).
• if you have unclear acute painful abdominal symptoms (acute abdomen).
• if you have a head injury or any another medical condition that’s causing a growing pressure inside your skull with a decrease in the level of consciousness, unless you are being ventilated.
• if you struggle to breathe or your airways are compromised.
• if you are pregnant or breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking ORAMORPH ® ORAL DROPS 20MG/ML. Special care should be taken with ORAMORPH ® ORAL DROPS 20MG/ML :

• if there is dependence on opioids
• if there is loss of consciousness
• if you have disease states in which a disturbance of the respiratory center and respiratory function is present
• if you have altered heart (cor pulmonale) due to chronic congestion of the pulmonary circulation
• if you there is increased intracranial pressure
• if you have low blood pressure associated with low circulating blood volume (hypotension with hypovolaemia)
• if you have enlarged prostate gland (prostatic hypertrophy) with residual urine (risk of bladder rupture (tear of the bladder) due to urinary retention)
• if you have a urinary tract constrictions or colic biliary diseases
• if you have obstructive (associated with stenosis) and inflammatory bowel disease
• if you have an adrenal gland tumour (phaeochromocytoma)
• if you have inflammation of the pancreas (pancreatitis)
• if you have an underactive thyroid (hypothyroidism)
• if you have epileptic seizures or increased sensitivity to convulsions.

Do not share medicines prescribed for you with any other person. Always take ORAMORPH ® ORAL DROPS 20MG/ML exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The dose of ORAMORPH ® ORAL DROPS 20MG/ML must be adapted to the severity of the pain and your individual sensitivity. Unless otherwise prescribed, the usual range of single and daily doses for adults is according to the following table on the basis of a single dose of 0,2 to 0,3 mg morphine sulphate/kg of body weight:

The doses can be repeated after 4 to 6 hours. The maximum daily dose should not exceed 4 - 6 times the single doses. If higher daily doses are required, appropriate dosage can be obtained using the other alternative strengths or in combination with ORAMORPH ® ORAL DROPS 20MG/ML.

Hepatic or renal dysfunction: In patients with hepatic or renal impairment and suspected delayed gastrointestinal passage, ORAMORPH ® ORAL DROPS 20MG/ML is to be dosed very carefully.

Elderly: Patients in advanced age (usually 75 years of age) and patients with poor body general conditions may be more sensitive to morphine. Therefore, make sure that the dose adjustment is conservative and/or to select longer dosing intervals. If necessary, switch to lower dosage strengths.

Special instructions for dose adjustment: For readjustment of the dosage, possibly use forms with a lower content of active substance, also in addition to an existing therapy with prolonged-release tablets.

ORAMORPH ® ORAL DROPS 20MG/ML can have side effects. Not all side effects reported for ORAMORPH ® ORAL DROPS 20MG/ML are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ORAMORPH ® ORAL DROPS 20MG/ML, please consult your health care provider for advice.

If any of the following happens, stop taking / using ORAMORPH ® ORAL DROPS 20MG/ML and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Serious allergic reaction which causes difficulty in breathing and dizziness. These are all very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Headache
• Dizziness
• Mood changes
• Changes in awareness
• Sleep disturbances
• Disturbance in thinking and feeling (e.g. thought disorders, cognitive problems or hallucinations, confusion)
• Nausea
• Dry mouth
• Constipation
• Vomiting (especially at the beginning of treatment)
• Loss of appetite
• Taste disturbances
• Problems in emptying the bladder
• Sweating
• Hives
• Itching

Less frequent side effects:

• Drop in blood pressure and / or shortness of breath (anaphylactic reactions)
• Shaking (tremor)
• Involuntary muscle twitching
• Epileptic seizures
• Particularly at high doses, Increased sensitivity to pain that does not respond to further increase in the dose of morphine
• Dependence
• Decrease in libido or erectile dysfunction
• Blurred vision
• Double vision
• Nystagmus
• Pupillary constriction
• High level of pancreatic enzymes (seen on blood test)
• Inflammation of the pancreas
• Intestinal obstruction
• Severe abdominal pain
• Biliary colic
• High level of liver enzymes (seen on blood test)
• Renal colic
• Muscle cramps
• Muscle rigidity
• Convulsions of the muscles of the airways (bronchospasm)
• Shortness of breath (dyspnea)

Store all medicines out of reach of children. Store at or below 25 °C. Store in the original package / container. Keep the bottle in the carton to protect from light.

After opening the bottle, ORAMORPH ® ORAL DROPS 20MG/ML shelf-life is of 90 days. Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry date refers to the last day of the month. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).