Oramorph

Leaflet accompanying the packaging: patient information

Oramorph, 20 mg/ml, oral drops, solution

Morphine sulfate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What Oramorph is and what it is used for
• 2. Important information before taking Oramorph
• 3. How to take Oramorph
• 4. Possible side effects
• 5. How to store Oramorph
• 6. Contents of the packaging and other information

1. What Oramorph is and what it is used for

The name of the medicine is Oramorph, 20 mg/ml, oral drops, solution. In this leaflet, the shorter name Oramorph is used. Oramorph contains morphine (in the form of sulfate) as the active substance. It belongs to a group of medicines called "opioids". Oramorph is used for severe pain or pain that cannot be controlled by other medicines (especially cancer pain), in adults, adolescents, and children (over 1 year of age).

2. Important information before taking Oramorph

When not to take Oramorph

• if the patient is allergic to morphine sulfate or any of the other ingredients of this medicine (listed in section 6)
• if the patient has consumed a large amount of alcohol ("alcohol intoxication")
• if the patient is highly agitated due to alcohol consumption or taking sedative medicines ("hypnotics")
• in case of suspected intestinal obstruction
• in case of acute abdominal syndrome
• in case of acute liver disease
• in case of head injury or increased intracranial pressure
• in case of asthma or sudden and severe breathing problems
• in case of severe breathing difficulties ("respiratory depression")
• if the patient is taking MAO inhibitors (used to treat depression) or has taken them within the last 2 weeks
• in case of pregnancy or breastfeeding.

Do not take Oramorph if any of the above statements apply to the patient. In case of doubts, before starting Oramorph, consult a doctor or pharmacist.

Warnings and precautions

Before starting Oramorph, discuss with a doctor or pharmacist if the patient:

• has breathing problems caused by obstruction or diseases that affect their breathing (such as scoliosis, emphysema, or severe obesity)
• has heart and breathing problems (pulmonary heart disease)
• has increased intracranial pressure
• has low blood pressure in combination with low blood volume
• is not fully conscious
• has had surgery within the last 24 hours
• is to undergo surgery within 24 hours to relieve pain ("chordotomy")
• has chronic kidney or liver problems, pancreatitis, hypothyroidism, adrenal problems, or tumors called "pheochromocytoma" (chromaffin tumor)
• has prostate enlargement with urine retention in the bladder
• has inflammatory bowel disease or bowel problems that cause obstruction
• has bile duct or urinary tract obstruction
• has colic caused by gallstones or kidney stones
• has had bile duct surgery
• has problems with stomach emptying
• has epilepsy or has seizures (fits)
• takes medicines similar to morphine (such as buprenorphine, nalbuphine, pentazocine) or medicines that counteract the effects of morphine (such as naloxone).

If any of the above recommendations apply to the patient (or the patient is unsure), before taking Oramorph, consult a doctor or pharmacist. If any of the following symptoms occur while taking Oramorph, consult a doctor or pharmacist:

• Increased sensitivity to pain despite taking increasing doses (hyperalgesia). The doctor will decide whether a dose change or a change in strong pain medication ("pain medication") is needed (see section 3).
• Weakness, fatigue, loss of appetite, nausea, vomiting, or low blood pressure. This may indicate that the adrenal glands are not producing enough cortisol and hormone supplementation may be necessary.
• Loss of libido, impotence, cessation of menstruation. This may be due to decreased production of sex hormones.
• If the patient is or has been addicted to drugs or alcohol. The patient should also tell their doctor if they feel they are becoming addicted to Oramorph while taking it. If so, the patient may often think about when they can take the next dose, even if they don't need it to relieve pain.
• In connection with Oramorph treatment, acute generalized exanthematous pustulosis (AGEP) has been reported. Symptoms usually occur within the first 10 days of treatment. Tell your doctor if you have ever had a severe skin rash or skin peeling after taking Oramorph or other opioids, or if you have had blisters and (or) ulcers in the mouth. Stop taking Oramorph and seek medical attention immediately if you notice any of the following symptoms: blisters, widespread skin peeling, or pustular eruptions with fever.
• Respiratory disorders associated with sleep. Oramorph may cause sleep-related respiratory disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). These symptoms may include moments of breath-holding during sleep, waking up at night due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If the patient or another person notices these symptoms, they should consult a doctor. The doctor may consider reducing the dose of Oramorph.
• Tell your doctor if the patient experiences severe abdominal pain that may radiate to the back, nausea, vomiting, or fever, as these may be symptoms related to pancreatitis and bile duct disease.
• Withdrawal symptoms or addiction. The most common withdrawal symptoms are listed in section 3. If they occur, the doctor may change the type of medicine or the time between doses.
• 3. If they occur, the doctor may change the type of medicine or the time between doses.

Operations, tests, and controls

• Patients taking Oramorph are more likely to have intestinal or respiratory problems after surgery. Therefore, doctors will exercise special caution before and after the procedure.
• The pain-relieving effect of morphine may mask serious post-operative complications, such as intestinal perforation.
• If the patient has adrenal problems, doctors will perform control tests in case steroid medication needs to be administered.

Tolerance, addiction, and compulsive use

This medicine contains morphine, which is an opioid medicine. If the patient takes Oramorph for a long time, their body may get used to it (this is called "tolerance"). This will mean that the medicine becomes less effective.

• It is less likely to happen if the amount taken is just enough to relieve the pain. To reduce this risk, Oramorph should always be taken exactly as the doctor has told the patient.
• The dose should be taken as recommended by the doctor every day at the right time.

Repeated use of opioids can lead to reduced effectiveness of the medicine (the patient gets used to it, which is known as tolerance to the medicine). Repeated use of Oramorph can also lead to addiction, abuse, and compulsive use, which can result in life-threatening overdose. The risk of these adverse reactions may increase with increasing dose and duration of use. Addiction or compulsive use can cause the patient to feel a loss of control over how much medicine to take or how often to take it. The risk of addiction or compulsive use varies from person to person. The risk of addiction to Oramorph or its compulsive use may be higher if:

• the patient or any of their relatives have ever abused or been addicted to alcohol, prescription drugs, or illicit drugs ("addiction");
• the patient smokes;
• the patient has ever had mood disorders (depression, anxiety disorders, or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If any of the following symptoms occur while taking Oramorph, it may indicate addiction or compulsive use:

• the patient needs to take the medicine for a longer period than prescribed by the doctor;
• the patient needs to take a higher dose than recommended;
• the patient uses the medicine for reasons other than those for which the doctor prescribed it, such as "to calm down" or "to be able to sleep";
• the patient has repeatedly tried to stop or control the use of the medicine but has failed;
• after stopping the medicine, the patient feels unwell and feels better when they take it again ("withdrawal effect").

If any of these symptoms are noticed, the patient should discuss the best treatment strategy with their doctor, including when it is appropriate to stop the treatment and how to do it safely (see section 3 "Stopping Oramorph").

Children and adolescents

Due to its concentration, Oramorph is not suitable for children who have not reached the age of 1.

Oramorph and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take, including those obtained without a prescription and herbal medicines. The patient should not take this medicine and should inform their doctor or pharmacist if they are taking or using any of the following medicines:

• MAO inhibitors (used to treat depression), even if taken within the last 2 weeks
• medicines similar to morphine (such as buprenorphine, nalbuphine, pentazocine) or medicines that counteract the effects of morphine (such as naloxone). The patient should not take Oramorph if any of the above statements apply. In case of doubts, before starting Oramorph, consult a doctor or pharmacist. The patient should also inform their doctor or pharmacist if they are taking or using any of the following medicines:
• medicines that help with sleep or sedation - such as sedatives, anesthetics, and sleep medicines
• sedative medicines, such as benzodiazepines or related medicines. Concurrent use with Oramorph increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, which can be life-threatening. For this reason, concurrent use of these medicines may only be considered if other treatment options are not possible. However, if the doctor prescribes Oramorph with other sedative medicines, their dose and duration of concurrent treatment should be limited by the doctor. The patient should inform their doctor about all sedative medicines they are taking and follow the doctor's instructions for dosing. It may be helpful to inform friends or relatives to be aware of the above symptoms. The patient should consult a doctor if these symptoms occur.
• medicines for mental health problems, such as depression (called "tricyclic antidepressants") or schizophrenia (called "phenothiazines"), such as clomipramine and amitriptyline.
• These medicines can enhance the "depressing" effect of Oramorph, especially on breathing. Alcohol also has this effect.
• other medicines for mental health problems.
• These medicines can increase side effects, such as constipation, dry mouth, and urinary problems (so-called "anticholinergic" side effects).
• medicines called "antihistamines"
• medicines that prevent vomiting (antiemetics)
• medicines used to treat Parkinson's disease
• cimetidine - used to treat stomach ulcers and other stomach problems
• muscle relaxants used during surgical procedures
• medicines used to treat high blood pressure
• rifampicin - an antibiotic used to treat, for example, tuberculosis
• some medicines used to treat blood clots (e.g., clopidogrel, prasugrel, ticagrelor) may have delayed and reduced effect when taken with morphine
• gabapentin or pregabalin used to treat epilepsy and pain caused by nervous system disorders (neuropathic pain).

If any of the above recommendations apply to the patient, before taking Oramorph, consult a doctor or pharmacist.

Oramorph with alcohol

Do not drink alcohol while taking Oramorph.

Pregnancy, breastfeeding, and fertility

• Do not take Oramorph if the patient is pregnant or thinks they may be pregnant or is planning to have a baby. It may affect the baby. If Oramorph is used for a long time during pregnancy, there is a risk that the newborn will have withdrawal symptoms (abstinence), which should be treated by a doctor.
• Do not breastfeed while taking Oramorph, as small amounts may pass into breast milk.
• Do not plan a pregnancy while taking this medicine. The patient and their partner should use effective contraception while taking this medicine. If the patient becomes pregnant while taking this medicine, they should contact their doctor immediately.

Driving and using machines

• Do not drive vehicles, ride a bike, or operate any tools or machines while taking this medicine. While taking this medicine, the patient may feel drowsy and be less alert - even at normal doses.
• This effect is more pronounced at the start of treatment or after a dose increase. The effect is also more pronounced if the patient drinks alcohol or takes other medicines that can cause drowsiness. The time after which it is safe to resume driving or operating machines is highly individual and must be determined by a doctor.

Oramorph contains sodium benzoate.This medicine contains 1 mg of sodium benzoate per ml (16 drops).

Sodium

This medicine contains less than 1 mmol of sodium per ml (16 drops), which means the medicine is considered "sodium-free".

3. How to take Oramorph

This medicine should always be taken exactly as the doctor has told the patient. In case of doubts, consult a doctor or pharmacist. Before starting and regularly during treatment, the doctor will discuss with the patient what to expect from Oramorph, when and for how long to take it, when to consult a doctor, and when to stop taking the medicine (see also "Stopping Oramorph" in this section).

Dosage

The doctor will determine the dose based on the intensity of the pain, the patient's age, the use of other medicines, and liver function. The doctor may increase the dose based on:

• the intensity of the pain
• previous use of painkillers.

In case of smaller doses, Oramorph is available in the form of a 2 mg/ml oral solution.

What dose to take

Oral administration. The solution should be taken with a certain amount of liquid (water or juice). This medicine can be taken with or without food. The patient should strictly follow the time intervals of 4 or 4 to 6 hours. The effect of this medicine lasts for about 4 hours.

How to measure the dose

• To open the bottle, press and turn the cap at the same time.
• To measure the dose, count the drops from the 20 ml bottle (1 drop = 1.25 mg of morphine sulfate): 4 drops = 5 mg of morphine 8 drops = 10 mg of morphine 16 drops = 20 mg of morphine 24 drops = 30 mg of morphine
• After pouring the medicine, close the bottle tightly with the cap. Oramorph is not suitable for long-term use.

Elderly patients (over 75 years)

Elderly patients (75 years and older) and patients in poor general health may be more sensitive to morphine. Therefore, a lower dose may be given.

Patients with liver, kidney, or heart problems

The doctor will exercise special caution when determining the dose for patients with liver, kidney, or heart problems. The doctor will also do so in the case of patients with prolonged passage of food through the stomach and intestines.

Taking a higher dose of Oramorph than recommended

In case of taking a higher dose of Oramorph than recommended, consult a doctor or go to the nearest hospital immediately. In such a situation, the following symptoms may occur:

• breathing difficulties, which can lead to loss of consciousness, and even death
• very small pupils (pupil constriction)
• low blood pressure
• drowsiness - from mild fatigue to severe drowsiness
• cold and clammy skin.

In people who have taken a higher dose than recommended, pneumonia caused by inhaling vomit or foreign bodies may occur; symptoms include shortness of breath, cough, and fever. The effect on the patient depends on the amount of morphine taken. Information for the doctor: see the section Information intended for healthcare professionals only.

Missing a dose of Oramorph

This medicine should always be taken exactly as the doctor has told the patient. If the patient forgets to take a dose, they should consult a doctor. Do not take a double dose to make up for a missed dose.

Stopping Oramorph

Do not stop taking Oramorph without talking to a doctor. If the patient wants to stop taking Oramorph, they should ask their doctor how to gradually reduce the dose to avoid withdrawal symptoms. Withdrawal symptoms may include body aches, tremors, diarrhea, abdominal pain, nausea, flu-like symptoms, rapid heartbeat, and dilated pupils. Psychological symptoms include intense dissatisfaction, anxiety, and irritability. If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Oramorph can cause side effects, although not everybody gets them. Important side effects or symptoms to look out for and what to do if they occur:

• Severe allergic reaction, which causes breathing difficulties or dizziness.
• Severe skin reaction with blisters, widespread skin peeling, and pustular eruptions with fever. This may be a condition called acute generalized exanthematous pustulosis (AGEP). If these severe side effects occur, consult a doctor immediately. If the patient notices any of the following side effects, they should tell their doctor or pharmacist: Very common:occur in more than 1 in 10 patients
• mood changes, mainly euphoria, but depression may also occur. Common:occur in 1 in 10 patients
• dizziness or headache
• changes in well-being (mainly drowsiness, but sometimes also increased activity or agitation)
• insomnia
• disorders of thinking and perception (feeling anxious, hallucinations, confusion)
• pupil constriction
• nausea or vomiting (more common at the start of treatment)
• constipation
• loss of appetite, abdominal pain, or taste disorders
• excessive sweating
• allergic reactions, such as hives and itching. Uncommon:occur in 1 in 100 patients
• breathing difficulties, bronchospasm (bronchial constriction)
• flushing of the face
• disorientation, agitation, dizziness, drowsiness, or increased drowsiness, or mood changes
• abnormal heartbeat (palpitations)
• dry mouth
• colic or biliary colic
• urinary retention (inability to empty the bladder), passing less urine than usual, spasms of the urethra. Rare:occur in 1 in 1,000 patients
• severe allergic reactions (anaphylactic and anaphylactoid reactions), asthma attacks in sensitive patients
• chills or low body temperature
• increased intracranial pressure
• blurred vision, double vision, and abnormal eye movements
• low blood pressure, slow or fast heartbeat, general muscle weakness, which can lead to fainting and heart failure
• increased levels of pancreatic enzymes (shown in blood tests) or symptoms related to pancreatitis and bile duct disease, such as severe abdominal pain that may radiate to the back, nausea, vomiting, or fever. Very rare:occur in less than 1 in 10,000 patients
• sudden shortness of breath
• Schwartz-Bartter syndrome (SIADH) with low sodium levels in the blood
• tremors, involuntary muscle twitching, seizures
• morphine addiction
• low sex drive or impotence
• intestinal obstruction, abdominal pain
• increased liver enzyme levels (shown in blood tests)
• other skin reactions, such as rash and skin swelling (reversible upon discontinuation of the medicine). Morphine releases histamine and consequently can cause hives, other skin reactions, and itching
• muscle cramps, muscle stiffness. Frequency not known:frequency cannot be estimated from the available data
• sleep apnea (moments of breath-holding during sleep)
• increased sensitivity to pain
• withdrawal symptoms (symptoms - see section 3: Stopping Oramorph).

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309. Website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be gathered on the safety of the medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Oramorph

The bottle should be stored in an outer carton to protect it from light. Do not store above 25°C. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and bottle after "EXP". The expiry date refers to the last day of the month stated. The shelf life after opening the bottle of Oramorph: 3 months. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Oramorph contains

• The active substance of Oramorph is morphine sulfate. 1 ml of the aqueous solution contains 20 mg of morphine sulfate.
• The other ingredients are sodium edetate, sodium benzoate (E 211), citric acid (to adjust pH), and purified water.

What Oramorph looks like and contents of the pack

Oramorph is a nearly colorless aqueous solution for oral use, which is available in a 20 ml bottle with a dropper.

Marketing authorization holder and manufacturer

• L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67, Tosco Romagnola, 50018 Scandicci (FI), Italy

This medicinal product is authorized in the Member States of the EEA under the following names:

Austria: Oramorph, 20 mg/ml Croatia: Oramorph, 20 mg/ml Czech Republic: Morfin sulfát Ardez, 20 mg/ml Slovenia: Oramorph, 20 mg/ml, peroral drops, solution

Date of last revision of the leaflet: 12/2023

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Information intended for healthcare professionals only:

Overdose

Symptoms:
Symptoms of morphine overdose and poisoning are: respiratory depression, aspiration pneumonia, miosis (pinpoint pupils), and hypotension. In the case of significant hypoxia, the pupils are dilated, there is respiratory arrest (respiratory rate 2-4 per minute), the patient becomes cyanotic. In more severe cases, there may be circulatory failure and deep coma. Initially, blood pressure remains normal, but it drops significantly as the poisoning progresses. Tachycardia, bradycardia, and rhabdomyolysis may occur. Body temperature drops. Skeletal muscles relax, and generalized seizures may occur, especially in children. Respiratory failure or complications such as pulmonary edema may lead to death.
Treatment of overdose:
First and foremost, it is recommended to clear the airways and maintain their patency, as well as provide assisted or controlled ventilation. In the case of significant overdose, it is recommended to administer 0.4-0.8 mg of naloxone intravenously. If necessary, administration can be repeated at 2-3 minute intervals or replaced with an infusion of 2 mg in 500 ml of saline or 5% dextrose solution (0.004 mg/ml). The infusion rate depends on the previously administered doses and should be adjusted according to the patient's response. Since the effect of naloxone wears off after a relatively short time (2-3 hours), the patient should be closely monitored until spontaneous breathing returns. A single dose of naloxone in children is 0.01 mg per kg of body weight. Naloxone should not be administered if morphine overdose does not cause clinically significant respiratory or circulatory depression. Naloxone must be administered with extreme caution to individuals with known or suspected physical dependence on morphine. In such cases, sudden or complete antagonism of opioid effects may cause acute withdrawal syndrome. Further supportive measures (oxygen administration, vasoconstrictor agents, intravenous volume supplementation) depend on the patient's condition. Gastric lavage should be performed within the first 2 hours of morphine ingestion and only in patients who respond to treatment.