Oramorph: detailed information

Patient Information Leaflet

ORAMORPH 10 mg/5 ml oral solution, 30 mg/5 ml oral solution, 100 mg/5 ml oral solution

Morphine sulfate
Please read all of this leaflet carefully before you start taking this medicine as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Oramorph is and what it is used for
What you need to know before taking Oramorph
How to take Oramorph
Possible side effects
How to store Oramorph
Contents of the pack and other information

1. What Oramorph is and what it is used for

Oramorph contains the active substance sodium morphine sulfate, which belongs to a group of medicines called opioid analgesics.
This medicine is indicated for the treatment of severe chronic pain, particularly pain caused by cancer, when other pain-relieving medicines are not effective.

2. What you should know before using Oramorph

Do not take Oramorph if:

you are allergic to morphine sulfate, to similar substances, or to any of the other ingredients of this medicine (listed in section 6);
you suffer from abdominal problems (all forms of acute abdomen) or intestinal problems (paralytic ileus);
the person taking this medicine is a child under 6 years of age;
you have severe breathing problems (respiratory depression, respiratory failure);
you have severe liver problems (severe hepatocellular insufficiency);
you suffer from asthma attacks;
you have heart problems caused by chronic lung diseases (cardiac failure secondary to chronic lung disease);
you have recently suffered head injuries (cranial trauma);
you suffer from severe headaches: this may be a sign of increased pressure inside the skull (intracranial hypertension);
you have recently undergone surgery on the biliary tract;
you suffer from uncontrolled seizures or epilepsy;
you have consumed large amounts of alcohol or are experiencing alcohol withdrawal (acute alcoholism, delirium tremens);
you are taking other medicines that act on the central nervous system, such as hypnotics, sedatives, tranquillizers (see section “Other medicines and Oramorph”);
you are taking the following medicines (see section “Other medicines and Oramorph”):
monoamine oxidase inhibitors (MAOIs), including furazolidone, used to treat depression. In this case, at least 2–3 weeks must have passed since stopping treatment with the antidepressant before starting Oramorph;
naltrexone, used in the treatment of morphine dependence;
you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Oramorph.
Take this medicine with caution and inform your doctor if:

you suffer from brain function disorders due to brain diseases (organic-cerebral conditions);
you suffer from lung problems (respiratory insufficiency, chronic lung diseases, bronchial hypersecretion);
you suffer from breathing disorders (reduced ventilatory reserve) due to spinal problems (kyphoscoliosis) or obesity;
you suffer from renal colic or biliary colic;
you are a man and suffer from prostate problems (prostatic hypertrophy);
you have thyroid problems (myxedema, hyperthyroidism);
you have inflammation or other liver diseases (acute hepatitis, acute hepatopathies);
you suffer from chronic kidney (chronic renal conditions) or chronic liver (chronic hepatic conditions) problems;
you suffer from adrenal gland problems (adrenocortical insufficiency);
you have a serious circulatory problem (shock);
you have very low blood pressure (severe hypotensive states);
you suffer from intestinal disorders (slowed gastrointestinal transit and inflammatory or obstructive intestinal conditions);
you have used opioid substances for a long time and at high doses (opioid dependence);
you suffer from heart problems (cardiovascular conditions, cardiac arrhythmias);
you have recently undergone surgery on the urinary tract (urinary ducts);
you are over 65 years old;
you are debilitated.

Contact your doctor, pharmacist, or nurse if you notice any of the following symptoms while taking Oramorph:

increased sensitivity to pain despite increasing doses (hyperalgesia). Your doctor will decide whether a dose adjustment or a change in strong analgesic ("painkiller") is needed (see section 2);
weakness, fatigue, loss of appetite, nausea, vomiting, or low blood pressure. These may be symptoms of insufficient cortisol production by the adrenal glands, and you may need hormonal supplementation;
loss of libido, impotence, cessation of menstruation. These may be due to decreased production of sex hormones;
if you have previously been dependent on drugs or alcohol, also inform your doctor if you feel you are becoming dependent on Oramorph while using it. You may find yourself thinking frequently about when you can take the next dose, even if it is not needed for pain relief;
symptoms of withdrawal or dependence. The most common withdrawal symptoms are listed in section 3. If this occurs, your doctor may change the type of medicine or the dosing intervals.

Please note that morphine, due to its effects on pain, pupils, and level of consciousness, may mask certain symptoms and make clinical assessment difficult, potentially interfering with the diagnosis of acute abdominal conditions by the physician.
The use of Oramorph, especially if prolonged, may lead to the development of tolerance and dependence. Your body may become accustomed to this medicine (tolerance), making the dose less effective, thus requiring higher doses or more frequent administration.
Dependence can be both physical and psychological and develops with repeated administration of the medicine. It is characterized by an overwhelming need to continue taking the drug or a similar substance.
Furthermore, do not stop treatment abruptly, as this may trigger withdrawal symptoms (see also section 3 “If you stop taking Oramorph”).
Therefore, take Oramorph only for the treatment of pain that cannot be managed with less potent painkillers, and always under strict medical supervision.
Effects on anti-doping tests
For individuals engaged in sports, the use of Oramorph without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children
This medicine is contraindicated in children under 6 years of age (see section “Do not take Oramorph”).
Other medicines and Oramorph
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines, as Oramorph may affect how some medicines work or other medicines may affect how Oramorph works.
Do not take Oramorph together with:

medicines called MAOIs (monoamine oxidase inhibitors), used to treat depression. In this case, you may take Oramorph only 2 or 3 weeks after stopping treatment with antidepressants (see section “Do not take Oramorph”);
naltrexone, used in the treatment of morphine dependence (see section “Do not take Oramorph”);
alcohol or medicines containing alcohol, as this increases the sedative effect of morphine, alters the state of wakefulness, and makes driving dangerous.

Inform your doctor or pharmacist before taking Oramorph if you are taking any of the following medicines, as dose adjustments may be necessary:

rifampicin, used to treat infections such as tuberculosis, as it reduces the effectiveness of morphine;
cimetidine, used to treat stomach problems, and other medicines that increase morphine levels in the blood (cytochrome P system inhibitors);
medicines that thin the blood (oral anticoagulants, such as dicoumarol), as morphine may enhance their effects on blood coagulation;
medicines used to treat blood clots (e.g., clopidogrel, prasugrel, ticagrelor), as their effect may be delayed or reduced when taken with morphine;
medicines that promote urine elimination (diuretics), as their diuretic action may be reduced.

Exercise particular caution when using Oramorph and inform your doctor if you are taking:

medicines used to relieve pain (alfentanil, codeine, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, oxycodone, pethidine, phenoperidine, remifentanil, sufentanil, tramadol) or to suppress cough (dextromethorphan, noscapine, pholcodine, codeine, ethylmorphine), belonging to the opioid analgesic group;
medicines used to treat seizures or induce anesthesia (barbiturates);
medicines used to treat muscle stiffness (muscle relaxants) and allergies (sedating H1 antihistamines);
medicines to promote sleep or calmness, such as benzodiazepines and other anxiolytics, hypnotics, sedative antidepressants, neuroleptics. Concomitant use of Oramorph and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available. However, if your doctor prescribes Oramorph together with sedative medicines, the dose and duration of concomitant treatment must be limited by the doctor. Inform your doctor about all sedative medicines you are taking and follow the dosage recommendations carefully. It may be helpful to inform friends or family members about the signs and symptoms listed above. Contact your doctor if you experience such symptoms. Oramorph with food, drinks, and alcohol Do not drink alcoholic beverages while taking this medicine. Alcohol may increase the undesirable effects of Oramorph.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Oramorph, like other similar medicines (narcotic analgesics), is generally contraindicated during pregnancy, as it may cause breathing problems (respiratory depression) or withdrawal symptoms in the newborn if you have used this medicine continuously.
If Oramorph is used for a prolonged period during pregnancy, there is a risk that the newborn may experience symptoms of substance withdrawal requiring medical treatment.
Since morphine passes into breast milk, do not take Oramorph during breastfeeding or avoid breastfeeding while taking Oramorph.
Driving and using machines
Avoid driving vehicles or operating machinery during treatment with Oramorph, especially if you consume alcohol, medicines containing alcohol, or medicines that depress brain function (sedatives) (see sections “Other medicines and Oramorph” and “Oramorph with alcohol”).

3. How to take Oramorph

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
This medicine is an oral solution to be taken by mouth (oral route).

Dosage
Your dose will be determined by your doctor according to the severity of your condition and your response to treatment. Always take the dose prescribed by your doctor.
The recommended initial dose for adults is 10–20 mg (one or two single-dose containers of 10 mg).
Your doctor may decide to increase the dose depending on the intensity of pain and whether other pain-relieving medicines (analgesics), including morphine injections, have previously been used, using the single-dose container of 30 mg/5 ml or the single-dose container of 100 mg/5 ml.
The duration of treatment depends on the intensity of pain (pain symptoms) and the type of illness.

Use in children
Do not use this medicine in children under 6 years of age.

Children aged between 6 and 12 years: the maximum recommended dose is 5–10 mg (half or one single-dose container of 10 mg) every 4 hours.

Use in elderly and debilitated patients
If you are over 65 years of age or are debilitated, your doctor may decide to reduce your dose.

How to take it
Detach one container from the strip and open it by twisting the top forcefully.
The solution may be diluted in water or other non-alcoholic beverages immediately before use.

If you take more Oramorph than you should
If you have taken more Oramorph than you should, speak to a doctor or go to hospital immediately. Take the medicine package with you.
In case of accidental ingestion/overdose of Oramorph, the following symptoms may occur:

Constriction of the pupil (miosis);
Breathing problems (respiratory depression);
Low blood pressure (hypotension);
Circulatory and heart function disorders (circulatory failure);
Deep unconsciousness (profound coma).

People who have taken an overdose may develop aspiration pneumonia due to inhalation of vomit or foreign bodies, with symptoms including shortness of breath, cough, and fever. Overdose may also cause breathing difficulties leading to unconsciousness or even death.

If you forget to take Oramorph
If you forget a dose, skip the missed dose and take the next one at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Oramorph
Do not stop treatment with Oramorph without first discussing it with your doctor, as this may lead to undesirable effects (see section Warnings and precautions). If you intend to stop treatment with Oramorph, ask your doctor how to gradually reduce the dose to avoid withdrawal symptoms.
Abruptly stopping treatment may cause a "withdrawal syndrome" with symptoms such as:

Yawning;
Dilated pupils;
Tearing, runny nose, sneezing;
Goosebumps;
Muscle tremor;
Headache;
Weakness;
Sweating;
Intense feelings of dissatisfaction, anxiety, irritability, sleep disturbances or inability to sleep (insomnia);
Restlessness, agitation;
Decreased appetite (anorexia);
Flu-like symptoms;
Stomach pain, nausea, vomiting, weight loss, diarrhoea, fluid loss (dehydration);
Bone pain, abdominal and muscular cramps;
Increased heart rate (tachycardia);
Increased breathing rate (tachypnea);
Increased blood pressure (hypertension);
Increased body temperature, blood vessel disorders (vasomotor disturbances).

These symptoms appear within a few hours of stopping treatment, peak in intensity within 36–72 hours, and then gradually subside. If left untreated, symptoms usually disappear within 5–14 days.
Therefore, do not stop treatment with Oramorph without first consulting your doctor.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects at the beginning of treatment, usually transient, are:

drowsiness,
confusion,
nausea and vomiting. Constipation is a frequent side effect that does not diminish with ongoing treatment. All these side effects are predictable and require appropriate management. If treatment is suddenly discontinued, a withdrawal syndrome may occur (see sections “Warnings and precautions” and “How to take Oramorph”).

Important side effects or symptoms to monitor and what to do if affected:

severe allergic reaction causing difficulty in breathing or dizziness;
serious breathing problems (respiratory depression), breathing failure (respiratory arrest), collapse.

Oramorph, even at therapeutic doses, causes respiratory depression and may lead to serious consequences in patients with pre-existing bronchopulmonary diseases.
If you experience any of these important side effects, seek immediate medical advice.
The following are side effects associated with Oramorph. There are insufficient data available to determine the frequency of the individual effects listed.

reduced heart rate (bradycardia), sudden feeling of weakness (pre-syncope), temporary loss of consciousness (syncope), reduced blood circulation (circulatory depression) and low blood pressure (hypotension), which is more severe in case of reduced blood volume (hypovolemia);
pupil constriction (miosis), visual disturbances;
headache, dizziness, increased pressure in the brain (intracranial pressure), which may worsen symptoms of pre-existing brain disorders;
increased sensitivity to pain;
sweating;
excitation, insomnia, irritability, agitation, excessive happiness (euphoria) and excessive low mood (dysphoria), sedation;
weakness (asthenia);
involuntary muscle contractions (myoclonus), especially in elderly patients or those with severe kidney problems (renal failure), in case of overdose or if the dose has been increased too rapidly;
nausea, vomiting, constipation;
dry mouth;
reduced urine production (oliguria) and difficulty urinating (urinary retention), more severe in presence of pre-existing urinary tract disorders (urethroprostatic stenotic pathology);
flushing of the face, neck and upper chest, itching, hives and other skin rashes;
sweating;
alteration in the production of certain hormones (increase in vasopressin, reduction in adrenocorticotropic hormone, thyroid-stimulating hormone, 17-hydroxy and 17-ketocorticosteroids);
biliary cramps that may cause pain in the upper abdomen or back (biliary spasm), with temporary increase in blood levels of certain enzymes (amylase and lipase);
depression of mood, nightmares, hallucinations, mental clouding (mental obtundation) and states of indifference, especially if elderly;
symptoms of withdrawal or dependence (for symptoms, see section 3: “If you stop taking Oramorph”).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following address:
https://www.aifa.gov.it/content/segnalazioni-reazioni- avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oramorph

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.".
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Oramorph contains
The active substance is morphine sulfate.
Each single-dose container of Oramorph 10 mg/5 ml contains 10 mg of morphine sulfate.
Each single-dose container of Oramorph 30 mg/5 ml contains 30 mg of morphine sulfate.
Each single-dose container of Oramorph 100 mg/5 ml contains 100 mg of morphine sulfate.

Other ingredients: disodium edetate, citric acid, purified water.

Description of the appearance of Oramorph and contents of the package
Oramorph 10 mg/5 ml oral solution. One pack contains 20 single-dose containers of 5 ml.
Oramorph 30 mg/5 ml oral solution. One pack contains 20 single-dose containers of 5 ml.
Oramorph 100 mg/5 ml oral solution. One pack contains 20 single-dose containers of 5 ml.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. – Strada Statale 67 Fraz. Granatieri –
Scandicci (FI) – Italy

Manufacturer
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A.
Strada Statale 67 Fraz. Granatieri
Scandicci (FI)

Patient Information Leaflet

ORAMORPH 2 mg/ml oral solution

Morphine sulfate
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Oramorph is and what it is used for
What you need to know before taking Oramorph
How to take Oramorph
Possible side effects
How to store Oramorph
Contents of the pack and other information

1. What Oramorph is and what it is used for

Oramorph contains the active substance sodium sulfate morphine, which belongs to a group of medicines called opioid analgesics.
This medicine is indicated for the treatment of severe chronic pain, particularly pain caused by cancer, when other pain-relieving medicines are not effective.

2. What you need to know before taking Oramorph

Do not take Oramorph if:

you are allergic to morphine sulfate, substances similar to it, or any of the other ingredients of this medicine (listed in section 6);
you suffer from abdominal problems (all forms of acute abdomen) or intestinal problems (paralytic ileus);
the person taking this medicine is a child under 1 year of age;
you have severe breathing problems (respiratory depression, respiratory failure);
you have severe liver problems (severe hepatocellular insufficiency);
you suffer from asthma attacks;
you have heart problems caused by chronic lung diseases (cardiac failure secondary to chronic lung disease);
you have recently suffered head injuries (cranial trauma);
you suffer from severe headaches: this may be a sign of high pressure inside the skull (intracranial hypertension);
you have recently undergone biliary tract surgery;
you suffer from uncontrolled seizures or epilepsy;
you have consumed large amounts of alcohol or are experiencing alcohol withdrawal (acute alcoholism, delirium tremens);
you are taking other medicines that act on the nervous system, such as hypnotics, sedatives, tranquilizers (see section “Other medicines and Oramorph”);
you are currently taking the following medicines (see section “Other medicines and Oramorph”):
monoamine oxidase inhibitors (MAOIs), including furazolidone, used to treat depression. In this case, at least 2–3 weeks must have passed since stopping treatment with the antidepressant before starting Oramorph;
naltrexone, used in the treatment of morphine dependence;
you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Oramorph.

Take this medicine with caution and inform your doctor if:

you suffer from brain function disorders due to brain diseases (organic cerebral conditions);
you suffer from lung problems (respiratory failure, chronic pulmonary diseases, bronchial hypersecretion);
you suffer from breathing disorders (reduced ventilatory reserve) due to spinal problems (kyphoscoliosis) or obesity;
you suffer from renal or biliary colic;
you are a man suffering from prostate problems (prostatic hypertrophy);
you have thyroid problems (myxedema, hyperthyroidism);
you have inflammation or other liver diseases (acute hepatitis, acute hepatopathies);
you suffer from chronic kidney (chronic renal conditions) or chronic liver (chronic hepatic conditions) problems;
you suffer from adrenal gland problems (adrenocortical insufficiency);
you have a serious circulatory problem (shock);
you have very low blood pressure (severe hypotensive states);
you suffer from intestinal disorders (slowed gastrointestinal transit and inflammatory or obstructive intestinal conditions);
you have used opioid substances for a long time and at high doses (opioid dependence);
you suffer from heart problems (cardiovascular conditions, cardiac arrhythmias);
you have recently undergone urinary tract surgery (urinary ducts);
you are over 65 years old;
you are debilitated.

Contact your doctor, pharmacist, or nurse if you notice any of the following symptoms while taking Oramorph:

increased sensitivity to pain, despite increasing doses (hyperalgesia). Your doctor will decide whether a dose adjustment or a change in strong analgesic ("painkiller") is needed (see section 2);
weakness, fatigue, loss of appetite, nausea, vomiting, or low blood pressure. These may be symptoms of insufficient cortisol production by the adrenal glands, and hormone supplementation may be required;
loss of libido, impotence, cessation of menstruation. This may be due to decreased production of sex hormones;
if you have previously been dependent on drugs or alcohol, also inform your doctor if you feel you are becoming dependent on Oramorph while using it. You may find yourself thinking frequently about when you can take the next dose, even if you do not need it for pain;
symptoms of withdrawal or dependence. The most common withdrawal symptoms are listed in section 3. If this occurs, your doctor may change the type of medicine or the dosing intervals.

Effects on anti-doping tests
For individuals engaged in sports, using Oramorph without therapeutic need constitutes doping and may result in a positive anti-doping test.

Children
This medicine is contraindicated in children under 1 year of age (see section “Do not take Oramorph”).

Other medicines and Oramorph
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines, including over-the-counter medicines, as Oramorph may affect how certain medicines work or other medicines may affect how Oramorph works.

Do not take Oramorph together with:

medicines called MAOIs (monoamine oxidase inhibitors), used to treat depression. In this case, you may take Oramorph only 2 or 3 weeks after stopping treatment with antidepressants (see section “Do not take Oramorph”);
naltrexone, used in the treatment of morphine dependence (see section “Do not take Oramorph”);
alcohol or medicines containing alcohol, as this increases the sedative effect of morphine, alters the state of wakefulness, and makes driving dangerous.

Inform your doctor before taking Oramorph if you are taking any of the following medicines, as dose adjustments may be necessary:

rifampicin, used to treat infections such as tuberculosis, as it reduces the effectiveness of morphine;
cimetidine, used to treat stomach problems, and other medicines that increase morphine levels in the blood (cytochrome-P450 system inhibitors);
medicines that thin the blood (oral anticoagulants, such as dicoumarol), as morphine may enhance their effects on coagulation;
medicines used to treat blood clots (e.g., clopidogrel, prasugrel, ticagrelor), as their effect may be delayed and reduced when taken with morphine;
medicines that promote urine elimination (diuretics), as their diuretic effect may be reduced.

Pay special attention when using Oramorph and inform your doctor if you are taking:

medicines used to relieve pain (alfentanil, codeine, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, oxycodone, pethidine, phenoperidine, remifentanil, sufentanil, tramadol) or to treat cough (dextromethorphan, noscapine, pholcodine, codeine, ethylmorphine), belonging to the opioid analgesic group;
medicines used to treat seizures and induce anesthesia (barbiturates);
medicines used to relieve muscle stiffness (muscle relaxants) and for allergies (sedating H1 antihistamines);
medicines to promote sleep or calmness, such as benzodiazepines and other anxiolytics, hypnotics, sedative antidepressants, neuroleptics.

Concomitant use of Oramorph and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Oramorph together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all sedative medicines you are taking and carefully follow the dosing recommendations provided by your doctor. It may be helpful to inform friends or family members about the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.

Oramorph with food, drinks, and alcohol
Do not drink alcoholic beverages while taking this medicine. Alcohol may increase the undesirable effects of Oramorph.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Oramorph, like other similar medicines (narcotic analgesics), is generally contraindicated during pregnancy, as it may cause breathing problems (respiratory depression) or withdrawal symptoms in the newborn if you have used this medicine continuously.
If Oramorph is used for a long time during pregnancy, there is a risk that the newborn may experience withdrawal symptoms requiring medical treatment.
Since morphine passes into breast milk, do not take Oramorph during breastfeeding or avoid breastfeeding while being treated with Oramorph.
The medicine contains alcohol (see section “Oramorph 2 mg/ml syrup contains sucrose, glucose, parahydroxybenzoates, and ethanol”).

Driving and using machines
Avoid driving vehicles or operating machinery while being treated with Oramorph, especially if you consume alcohol, medicines containing alcohol, or medicines that depress brain function (sedatives) (see sections “Other medicines and Oramorph” and “Oramorph with alcohol”).

Oramorph 2 mg/ml syrup contains sucrose, glucose, parahydroxybenzoates, and ethanol
Sucrose and glucose are two sugars. If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this medicine.
It may be harmful to teeth.
Parahydroxybenzoates may cause allergic reactions (including delayed reactions).
This medicine contains 80 mg of alcohol (ethanol) per milliliter, equivalent to 8%. The alcohol content in a 5 ml dose of this medicine is equivalent to 10 ml of beer or 4 ml of wine.
The amount of alcohol in this medicine does not appear to have an effect in adults and adolescents, and its effects in children are not evident. Some effects may occur in very young children, for example, drowsiness.
The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.
If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine.
If you are alcohol-dependent, talk to your doctor before taking this medicine.

3. How to take Oramorph

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
This medicine is an oral solution to be taken by mouth.
Dosage
Your dose will be determined by the doctor according to the severity of your condition and your
response to treatment. Always take the dose prescribed by your doctor.
Your doctor may decide to increase the dose depending on the intensity of your pain and whether
other pain-relieving medicines (analgesics), including morphine injections, have been used previously.
The recommended initial dose for adults is 10–20 mg (5–10 ml) every 4 hours.
The duration of treatment depends on the intensity of the pain (pain symptoms) and the type of
disease.
Use in children
Do not use this medicine in children under 1 year of age.

Children aged 1 to 5 years: the maximum recommended dose is 5 mg (2.5 ml) every 4 hours.
Children aged 6 to 12 years: the maximum recommended dose is 5–10 mg (2.5–5 ml) every 4 hours.

Use in elderly and debilitated patients
If you are over 65 years of age or are debilitated, your doctor may decide to reduce your dose.
If you take more Oramorph than you should
If you have taken more Oramorph than prescribed, contact a doctor immediately or go to hospital.
Take the medicine package with you.
In case of accidental ingestion/overdose of Oramorph, the following symptoms may occur:

constricted pupils (miosis);
breathing problems (respiratory depression);
low blood pressure (hypotension);
circulatory and heart function disorders (circulatory failure);
deep unconsciousness (deep coma).

People who have taken an overdose may develop aspiration pneumonia due to inhalation of vomit or foreign bodies, with symptoms such as shortness of breath, cough, and fever.
People who have taken an overdose may also experience breathing difficulties leading to unconsciousness or even death.
If you forget to take Oramorph
If you forget a dose, skip the missed dose and take the next one as scheduled. Do not take a double dose to make up for a forgotten dose.
If you stop taking Oramorph
Do not stop treatment with Oramorph without first discussing it with your doctor, as this may cause unwanted effects (see section Warnings and precautions). If you wish to discontinue treatment with Oramorph, ask your doctor how to gradually reduce the dose to avoid withdrawal symptoms.
Abruptly stopping treatment may lead to a “withdrawal syndrome” with symptoms such as:

yawning;
dilated pupils;
tearing, runny nose, sneezing;
goosebumps;
muscle tremors;
headache;
weakness;
sweating;
intense feelings of dissatisfaction, anxiety, irritability, sleep disturbances or inability to sleep (insomnia);
restlessness, agitation;
loss of appetite (anorexia);
flu-like symptoms;
stomach pain, nausea, vomiting, weight loss, diarrhoea, fluid loss (dehydration);
bone pain, abdominal and muscular cramps;
increased heart rate (tachycardia);
increased breathing rate (tachypnea);
high blood pressure (hypertension);
increased body temperature, blood vessel disturbances (vasomotor disturbances).

These symptoms appear within a few hours after stopping treatment, peak in intensity within 36–72 hours, and then gradually subside. If untreated, symptoms usually disappear within 5–14 days.
Therefore, do not stop treatment with Oramorph without first consulting your doctor.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects at the beginning of treatment, which are usually transient, are:

drowsiness,
confusion,
nausea and vomiting. Constipation is a frequent side effect that does not diminish as treatment continues. All these side effects are predictable and require appropriate management. If treatment is suddenly stopped, withdrawal syndrome may occur (see sections “Warnings and precautions” and “How to take Oramorph”).

Important side effects or symptoms to monitor and what to do if affected:

severe allergic reaction causing breathing difficulties or dizziness;
serious breathing problems (respiratory depression), respiratory arrest, collapse. Oramorph causes respiratory depression even at therapeutic doses and may lead to serious consequences in patients with pre-existing bronchopulmonary diseases.

If you experience any of these important side effects, seek immediate medical advice.
The following are side effects associated with Oramorph. There are insufficient data available to determine the frequency of the individual side effects listed.

reduced heart rate (bradycardia), sudden feeling of weakness (presyncope), temporary loss of consciousness (syncope), reduced blood circulation (circulatory depression), and low blood pressure (hypotension), which is more severe in case of reduced blood volume (hypovolemia);
narrowing of the pupil (miosis), visual disturbances;
headache (cephalalgia), dizziness, increased pressure in the brain (intracranial pressure), which may worsen symptoms of pre-existing brain disorders;
increased sensitivity to pain;
sweating;
excitement, insomnia, irritability, agitation, excessive happiness (euphoria), and excessive depression of mood (dysphoria), sedation;
weakness (asthenia);
involuntary muscle contractions (myoclonus), especially in elderly patients or those with severe kidney problems (renal insufficiency), in case of overdose or if the dose has been increased too rapidly;
nausea, vomiting, constipation;
dry mouth;
reduced urine production (oliguria) and difficulty urinating (urinary retention), which is more severe in the presence of pre-existing urinary tract disorders (urethroprostatic stenotic pathology);
flushing of the face, neck, and upper chest, itching, urticaria, and other skin rashes;
sweating;
alteration in the production of certain hormones (increase in vasopressin, decrease in adrenocorticotropic hormone, thyroid-stimulating hormone, 17-hydroxy and 17-ketocorticosteroids);
biliary cramps which may cause pain in the upper abdomen or back (biliary spasm), with a temporary increase in blood levels of certain enzymes (amylase and lipase);
depression of mood, nightmares, hallucinations, mental clouding (mental obtundation), and apathetic states, especially if elderly;
symptoms of withdrawal or dependence (for symptoms, see section 3: “If you stop taking Oramorph”).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni- avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oramorph

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
Do not store above 25°C.
Store in the original packaging to protect the medicine from light.
After first opening the bottle, the product should be used within 3 months. Remember to record the date of first opening on the packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Oramorph contains

The active substance is morphine sulfate. Each ml of syrup contains 2 mg of morphine sulfate.
The other components are: sucrose, glucose syrup, methylparaben, propylparaben, ethyl alcohol, purified water.

Description of the appearance of Oramorph and package contents
100 ml bottle with child-resistant closure and adapter for pipette, supplied with a separate dosing pipette.
250 ml and 500 ml bottles supplied with a dosing cup.
Marketing Authorization Holder
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. – Strada Statale 67 Fraz. Granatieri –
Scandicci (FI) – Italy
Manufacturer
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A.
Strada Statale 67 Fraz. Granatieri
50018 Scandicci (FI)
Patient Information Leaflet

ORAMORPH 20 mg/ml oral solution

Morphine sulfate
Please read this leaflet carefully before using this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Oramorph is and what it is used for
What you need to know before taking Oramorph
How to take Oramorph
Possible side effects
How to store Oramorph
Contents of the pack and other information

1. What Oramorph is and what it is used for

Oramorph contains the active substance sodium morphine sulfate, which belongs to a group of medicines called opioid analgesics.
This medicine is indicated for the treatment of severe chronic pain, particularly for pain caused by cancer, when other pain-relieving medicines are not effective.

2. What you need to know before using Oramorph

Do not take Oramorph if:

you are allergic to morphine sulfate, to similar substances, or to any of the other ingredients of this medicine (listed in section 6);
you suffer from abdominal problems (all forms of acute abdomen) or intestinal problems (paralytic ileus);
the person taking this medicine is a child under 1 year of age;
you have severe breathing problems (respiratory depression, respiratory failure);
you have severe liver problems (severe hepatocellular insufficiency);
you suffer from asthma attacks;
you have heart problems caused by chronic lung diseases (heart failure secondary to chronic lung disease);
you have recently had head injuries (cranial trauma);
you suffer from severe headaches: this may be a sign of increased pressure inside the skull (intracranial hypertension);
you have recently undergone surgery on the biliary tract;
you suffer from uncontrolled seizures or epilepsy;
you have consumed large amounts of alcohol or are experiencing alcohol withdrawal (acute alcoholism, delirium tremens);
you are taking other medicines that act on the central nervous system, such as hypnotics, sedatives, tranquillisers (see section “Other medicines and Oramorph”);
you are currently taking any of the following medicines (see section “Other medicines and Oramorph”):
monoamine oxidase inhibitors (MAOIs), including furazolidone, used to treat depression. In this case, at least 2–3 weeks must have passed since stopping treatment with the antidepressant before starting Oramorph;
naltrexone, used in the treatment of morphine dependence;
you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions

Talk to your doctor or pharmacist before taking Oramorph.
Take this medicine with caution and inform your doctor if:

you suffer from brain function disorders due to brain diseases (organic cerebral conditions);
you suffer from lung problems (respiratory failure, chronic pulmonary diseases, bronchial hypersecretion);
you suffer from breathing disorders (reduced ventilatory reserve) due to spinal problems (kyphoscoliosis) or obesity;
you suffer from renal colic or biliary colic;
you are a man and suffer from prostate problems (prostatic hypertrophy);
you have thyroid problems (myxedema, hyperthyroidism);
you have inflammation or other liver diseases (acute hepatitis, acute hepatopathies);
you suffer from chronic kidney (chronic renal conditions) or chronic liver (chronic hepatic conditions) problems;
you suffer from adrenal gland disorders (adrenocortical insufficiency);
you have a severe circulatory problem (shock);
you have very low blood pressure (severe hypotensive states);
you suffer from intestinal disorders (slowed gastrointestinal transit and inflammatory or obstructive intestinal conditions);
you have been taking opioid substances for a long time and at high doses (opioid dependence);
you suffer from heart problems (cardiovascular conditions, cardiac arrhythmias);
you have recently undergone surgery on the urinary tract (urinary ducts);
you are over 65 years old;
you are debilitated.

Talk to your doctor, pharmacist, or nurse if you notice any of the following symptoms while taking Oramorph:

increased sensitivity to pain, despite taking increasing doses (hyperalgesia). Your doctor will decide whether a dose adjustment or a change in the strong analgesic (“painkiller”) is needed (see section 2);
weakness, fatigue, loss of appetite, nausea, vomiting, or low blood pressure. These may be symptoms indicating that your adrenal glands are producing insufficient cortisol, and you may need to take hormonal supplements;
loss of libido, impotence, cessation of menstruation. These may be due to decreased production of sex hormones;
if you have previously been dependent on drugs or alcohol, also inform your doctor if you feel you are becoming dependent on Oramorph while using it. You may start thinking frequently about when you can take the next dose, even if you do not need it for pain relief;
symptoms of withdrawal or dependence. The most common withdrawal symptoms are listed in section 3. If this occurs, your doctor may change the type of medicine or the dosing intervals. Please note that morphine, due to its effects on pain, pupils, and level of consciousness, may mask certain symptoms and make clinical assessment difficult, and may interfere with the diagnosis of any acute abdominal conditions.

The use of Oramorph, especially if prolonged, may lead to the development of tolerance and dependence.
Your body may become accustomed to this medicine (tolerance), making the dose taken less effective, and therefore you may require higher doses administered at more frequent intervals.
Dependence may be both physical and psychological and is a condition that develops with repeated administration of the medicine. It is characterised by an overwhelming need to continue taking the drug or another substance with similar properties.
Furthermore, you must not stop treatment abruptly, as this may cause withdrawal symptoms (see also section 3 “If you stop taking Oramorph”).
Therefore, take Oramorph only for the treatment of pain that cannot be managed with less potent pain-relieving medicines, and always under strict medical supervision.

Effects on anti-doping tests
For individuals engaged in sports, the use of Oramorph without therapeutic need constitutes doping and may result in a positive anti-doping test.

Children
This medicine is contraindicated in children under 1 year of age (see section “Do not take Oramorph”).

Other medicines and Oramorph
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those purchased without a prescription, because Oramorph may affect how some medicines work or because other medicines may affect how Oramorph works.
Do not take Oramorph together with:

medicines called MAOIs (monoamine oxidase inhibitors), used to treat depression. In this case, you may take Oramorph only after 2 or 3 weeks have passed since stopping treatment with antidepressants (see section “Do not take Oramorph”);
naltrexone, used in the treatment of morphine dependence (see section “Do not take Oramorph”);
alcohol or medicines containing alcohol, as this increases the sedative effect of morphine, alters the state of alertness, and makes driving dangerous.

Inform your doctor before taking Oramorph if you are taking any of the following medicines, as dose adjustments may be necessary:

rifampicin, used to treat infections such as tuberculosis, as it reduces the effectiveness of morphine;
cimetidine, used to treat stomach problems, and other medicines that increase morphine levels in the blood (cytochrome P450 system inhibitors);
medicines that thin the blood (oral anticoagulants, such as dicoumarol), as morphine may enhance their effects on blood coagulation;
medicines used to treat blood clots (e.g., clopidogrel, prasugrel, ticagrelor), as their effect may be delayed and reduced when taken in combination with morphine;
medicines that promote urine elimination (diuretics), as their diuretic effect may be reduced.

Pay special attention when using Oramorph and inform your doctor if you are taking:

medicines used to relieve pain (alfentanil, codeine, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, oxycodone, pethidine, phenoperidine, remifentanil, sufentanil, tramadol) or to treat cough (dextromethorphan, noscapine, pholcodine, codeine, ethylmorphine), belonging to the opioid analgesic group;
medicines used to treat seizures and to induce anaesthesia (barbiturates);
medicines used to treat muscle stiffness (muscle relaxants) and allergies (sedating H1 antihistamines);
medicines to promote sleep or to calm anxiety, such as benzodiazepines and other anxiolytics, hypnotics, sedative antidepressants, neuroleptics. The concomitant use of Oramorph and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available. However, if your doctor prescribes Oramorph together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor. Inform your doctor about all sedative medicines you are taking and follow carefully the dosage recommendations provided. It may be helpful to inform friends or family members about the above-mentioned signs and symptoms. Contact your doctor if you experience such symptoms.

Oramorph with food, drinks, and alcohol
Do not drink alcoholic beverages while taking this medicine. Alcohol may increase the undesirable effects of Oramorph.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Oramorph, like other similar medicines (narcotic analgesics), is generally contraindicated during pregnancy, as it may cause breathing problems (respiratory depression) or withdrawal symptoms in the newborn if you have used this medicine continuously.
If Oramorph is used for a prolonged period during pregnancy, there is a risk that the newborn may experience withdrawal symptoms (substance withdrawal) that require medical treatment.
Since morphine passes into breast milk, do not take Oramorph while breastfeeding or avoid breastfeeding during treatment with Oramorph.
Oramorph contains sodium benzoate, which may increase jaundice in newborns (see section “Oramorph contains sodium benzoate”).

Driving and using machines
Avoid driving vehicles or operating machinery during treatment with Oramorph, especially if you consume alcohol, medicines containing alcohol, or medicines that depress brain function (sedatives) (see sections “Other medicines and Oramorph” and “Oramorph with alcohol”).

Oramorph 20 mg/ml contains benzoate and sodium.
This medicine contains 0.5 mg of sodium benzoate per 8-drop dose, equivalent to 1 mg per 1 ml.
Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age (see section “Pregnancy and breastfeeding”).
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take Oramorph

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
This medicine is an oral solution to be taken by mouth (orally).
Dosage
Your dose will be determined by your doctor according to the severity of your condition and your response to treatment. Always take the dose prescribed by your doctor.
Your doctor may decide to increase the dose depending on the intensity of pain and on whether other pain-relieving medicines (analgesics), including morphine injections, have been used previously.
The recommended initial dose for adults is 10–20 mg, corresponding to 0.5–1 ml or 8–16 drops of solution every 4 hours.
The duration of treatment depends on the intensity of pain (pain symptoms) and the type of illness.
Use in children
Do not use this medicine in children under 1 year of age.

Children aged 1 to 5 years: the recommended maximum dose is 5 mg, corresponding to 0.25 ml or 4 drops of solution every 4 hours.
Children aged 6 to 12 years: the recommended maximum dose is 5–10 mg, corresponding to 0.25–0.5 ml or 4–8 drops every 4 hours.

Use in elderly and debilitated patients
If you are over 65 years of age or are debilitated, your doctor may decide to reduce your dose.
If you take more Oramorph than you should
If you have taken more Oramorph than prescribed, contact a doctor immediately or go to the nearest hospital. Take the medicine package with you.
In case of accidental ingestion/overdose of Oramorph, the following symptoms may occur:

constricted pupils (miosis);
breathing problems (respiratory depression);
low blood pressure (hypotension);
circulatory and heart function disorders (circulatory failure);
deep unconsciousness (profound coma). Individuals who have taken an overdose may develop aspiration pneumonia due to vomiting or foreign body inhalation, with symptoms such as shortness of breath, cough, and fever. Overdose may also cause breathing difficulties leading to unconsciousness or even death.

If you forget to take Oramorph
If you forget a dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.
If you stop taking Oramorph
Do not stop treatment with Oramorph without first discussing it with your doctor. This is because withdrawal effects may occur (see section Warnings and precautions). If you wish to discontinue treatment with Oramorph, ask your doctor how to gradually reduce the dose to avoid withdrawal symptoms.
Abruptly stopping treatment may lead to a "withdrawal syndrome" with symptoms such as:

yawning;
dilated pupils;
tearing, runny nose, sneezing;
goosebumps;
muscle tremors;
headache;
weakness;
sweating;
intense feelings of dissatisfaction, anxiety, irritability, sleep disturbances or inability to sleep (insomnia);
restlessness, agitation;
decreased appetite (anorexia);
flu-like symptoms;
stomach pain, nausea, vomiting, weight loss, diarrhea, fluid loss (dehydration);
bone pain, abdominal and muscular cramps;
increased heart rate (tachycardia);
increased breathing rate (tachypnea);
high blood pressure (hypertension);
increased body temperature, blood vessel disorders (vasomotor disturbances).

These symptoms appear within a few hours after stopping treatment, peak in intensity within 36–72 hours, and then gradually subside. If left untreated, symptoms usually resolve within 5–14 days.
Therefore, do not stop treatment with Oramorph without first consulting your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The most common side effects at the beginning of treatment, usually transient, are:

drowsiness,
confusion,
nausea and vomiting. Constipation is a frequent side effect that does not diminish as treatment continues. All of these side effects are predictable and require appropriate management. If treatment is suddenly discontinued, a withdrawal syndrome may occur (see sections “Warnings and precautions” and “How to take Oramorph”).

Important side effects or symptoms to monitor and what to do if affected:

severe allergic reaction causing breathing difficulties or dizziness;
serious breathing problems (respiratory depression), breathing blockage (respiratory arrest), collapse. Oramorph, even at therapeutic doses, causes respiratory depression and may lead to serious consequences in patients with pre-existing bronchopulmonary diseases. If you experience these important side effects, seek immediate medical advice.

Listed below are the side effects of Oramorph. There are insufficient data available to establish the frequency of the individual effects listed.

reduced heart rate (bradycardia), sudden feeling of weakness (pre-syncope), temporary loss of consciousness (syncope), reduced blood circulation (circulatory depression), and low blood pressure (hypotension), which is more severe in case of reduced blood volume (hypovolemia);
pupil constriction (miosis), visual disturbances;
headache (cephalalgia), dizziness, increased pressure in the brain (intracranial pressure), which may worsen symptoms of pre-existing brain diseases;
increased sensitivity to pain;
sweating;
excitement, insomnia, irritability, agitation, excessive happiness (euphoria), and excessive low mood (dysphoria), sedation;
weakness (asthenia);
involuntary muscle contractions (myoclonus), especially in elderly patients or those suffering from severe kidney problems (renal insufficiency), in case of overdose or if the dose has been increased too rapidly;
nausea, vomiting, constipation;
dry mouth;
reduced urine production (oliguria) and difficulty urinating (urinary retention), more severe in the presence of pre-existing urinary tract problems (urethroprostatic stenotic pathology);
redness of the face, neck, and upper chest, itching, urticaria and other skin rashes;
sweating;
alteration in the production of certain hormones (increased vasopressin, reduced adrenocorticotropic hormone, reduced thyroid-stimulating hormone, reduced 17-hydroxy and 17-ketocorticosteroids);
biliary colic which may cause pain in the upper abdomen or back (spasms of the biliary tract), with a temporary increase in blood levels of certain enzymes (amylase and lipase);
low mood (depression), nightmares, hallucinations, mental clouding (mental obtundation), and states of indifference, especially if elderly;
withdrawal or dependence symptoms (for symptoms, see section 3: “If you stop taking Oramorph”).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni- avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oramorph

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”.
Do not store above 25°C.
Store in the original packaging to protect the medicine from light.
After first opening of the bottle, the product should be used within 3 months. Remember to record the date of first opening on the container.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Oramorph contains

The active substance is morphine sulfate. Each ml of oral solution contains 20 mg of morphine sulfate.
The other components are: disodium edetate, sodium benzoate, citric acid, purified water.

Description of the appearance of Oramorph and contents of the pack
Oramorph 20 mg/ml is an oral solution, available in the following pack sizes:
20 ml bottle with integrated dropper
100 ml bottle with dosing pipette
30 ml and 120 ml bottles with graduated dropper
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. – Strada Statale 67 Fraz. Granatieri –
Scandicci (FI) – Italy

Manufacturer
20 ml bottle with integrated dropper:
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67 Fraz. Granatieri, 50018
Scandicci (FI)
Italy

30 ml bottle with graduated dropper, 100 ml bottle with separate dosing pipette, and 120 ml bottle with graduated dropper:
Istituto de Angeli srl, Località Prulli, 50066 Reggello (FI)
Italy