MORPHINE HYDROCHLORIDE MONICO

Package leaflet: Information for the user

monico morphine hydrochloride

10 mg/1 ml Injection solution
20 mg/1 ml Injection solution
50 mg/5 ml Injection solution
100 mg/5 ml Injection solution
100 mg/10 ml Injection solution
200 mg/10 ml Injection solution
morphine hydrochloride
generic medicine
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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What monico morphine hydrochloride is and what it is used for
2. What you need to know before using monico morphine hydrochloride
3. How to use monico morphine hydrochloride
4. Possible side effects
5. How to store monico morphine hydrochloride
6. Contents of the pack and other information

1. What is morfina cloridrato monico and what is it used for

Morfina cloridrato monico contains the active substance morphine hydrochloride, belonging to a group of medicines called opioid analgesics (opioid painkillers), which act on the nervous system to reduce pain.
This medicine is indicated for the treatment of moderate to severe pain:

• when other pain-relieving treatments have not been effective;
• due to tumours (neoplasms);
• due to heart problems (myocardial infarction);
• following surgical procedures;
• due to lung problems (acute pulmonary edema).

Morphine is also indicated to induce anaesthesia during childbirth (epidural analgesia in labour) and in surgical procedures (general and loco-regional anaesthesia).

2. What you should know before using morphine hydrochloride monico

Tolerance, dependence
This medicine contains morphine, an opioid medicine. Repeated use of opioids may make the medicine less effective (you become accustomed to it, a phenomenon known as tolerance). Repeated use of morphine hydrochloride monico may also lead to dependence and abuse, which can result in a potentially fatal overdose. The risk of these adverse effects may increase with higher doses and prolonged duration of use.
Dependence may make you feel as though you no longer have control over the amount of medicine you need or how often you must take it.
The risk of developing dependence varies from person to person. You may have a higher risk of becoming dependent on morphine hydrochloride monico if:

• you or a family member has previously suffered from abuse or dependence on alcohol, prescription medicines, or illegal substances ("addiction");
• you are a smoker;
• you have previously had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

The appearance of any of the following signs during treatment with morphine hydrochloride monico may indicate dependence:

• you feel the need to take the medicine for longer than prescribed by your doctor;
• you need to take a higher dose than recommended;
• you use the medicine for reasons other than those prescribed, for example, "to stay calm" or "to help sleep";
• you have repeatedly tried to stop or control the use of this medicine without success;
• when you stop treatment with the medicine you feel unwell, and you feel better when you resume taking it ("withdrawal effects").

If you notice any of these signs, consult your doctor to discuss the best therapeutic approach for you, including when it may be appropriate to discontinue treatment and how to do so safely (see section 3 "If you stop treatment with morphine hydrochloride monico").

Do not use morphine hydrochloride monico

• if you are allergic to morphine hydrochloride, to other medicines similar to morphine hydrochloride monico, or to any of the other ingredients of this medicine (listed in section 6); if you are allergic, you may experience facial flushing, itching, breathing difficulties due to bronchial constriction (bronchospasm), or more severe allergic reactions (anaphylactic reactions);
• if you suffer from stomach or intestinal problems (acute abdomen, paralytic ileus);
• if you suffer from breathing difficulties (respiratory depression);
• if you suffer from severe liver problems (severe hepatocellular insufficiency);
• if you suffer from heart problems associated with other respiratory disorders (secondary heart failure and chronic lung diseases);
• if you have suffered head trauma (trauma) or have increased pressure in the head (intracranial hypertension);
• if you have undergone surgery on the liver or bile ducts (biliary tract);
• during a respiratory crisis (asthma due to bronchitis);
• if you suffer from seizures;
• if you suffer from uncontrolled epilepsy;
• if you suffer from alcohol dependence (acute alcoholism, delirium tremens);
• if you suffer from central nervous system depression, particularly due to other medicines (hypnotics, sedatives, tranquillisers);
• if you are being treated with medicines for depression (monoamine oxidase inhibitors), furazolidone, or if you have discontinued treatment with these medicines less than 2–3 weeks ago;
• if you are being treated with naltrexone, used to treat dependence on morphine and other opium derivatives;
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Contact your doctor, pharmacist, or nurse if you notice any of the following symptoms during treatment with morphine hydrochloride monico:

• 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 indicate 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 reduced 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 morphine hydrochloride monico 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;
• symptoms of withdrawal or dependence; the most common withdrawal symptoms are described in section 3; if this occurs, your doctor may change the type of medicine or the dosing schedule.

Exercise particular caution with morphine hydrochloride monico:
Acute generalized exanthematous pustulosis (AGEP) has been reported in association with treatment with morphine hydrochloride monico. Symptoms usually appear within the first 10 days of treatment. Inform your doctor if you have previously developed severe skin rashes or skin peeling, or skin rash with blisters and/or mouth ulcers after taking morphine hydrochloride monico or other opioids. Discontinue use of morphine hydrochloride monico and contact your doctor immediately if you observe any of the following symptoms: skin rash with blisters, widespread scaly skin, or pus-filled spots together with fever.

Sleep-related breathing disorders
Morphine hydrochloride monico may cause sleep-related breathing disorders, such as sleep apnea (breathing pauses during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include breathing pauses during sleep, nighttime awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting, or fever, as these could be symptoms associated with inflammation of the pancreas (pancreatitis) or bile ducts.

Use this medicine with caution if:

• you are elderly, very elderly, or debilitated; in such cases, a dose reduction may be necessary;
• you suffer from heart problems due to lung diseases;
• you suffer from brain disorders (organic brain conditions);
• you have breathing problems (respiratory insufficiency and chronic lung diseases, particularly if accompanied by increased bronchial secretions, airway obstruction, and reduced ventilatory reserve, as in kyphoscoliosis and obesity);
• you suffer from kidney or gallbladder problems (renal and biliary colic);
• you have prostate problems (prostatic hypertrophy);
• you have altered levels of thyroid hormones (myxedema, hypothyroidism);
• you suffer from liver problems (hepatitis and acute hepatopathies);
• your liver or kidneys are not functioning properly;
• you suffer from hormonal problems (adrenocortical insufficiency);
• you have severe low blood pressure (severe hypotensive states) and loss of consciousness (shock);
• you suffer from digestive problems (slowed or blocked gastrointestinal motility, intestinal disorders due to inflammation or obstruction);
• you suffer from muscle disorders (myasthenia gravis);
• you suffer from heart rhythm and circulation problems (cardiovascular disorders, cardiac arrhythmias) or problems with heart valves (aortic valve dysfunction) and heart circulation (coronary disorders).

Morphine, due to its analgesic effect, its action on consciousness, pupil size, and respiration, may mask certain symptoms and make their evaluation by the doctor difficult.
Administration of morphine, especially if prolonged, may lead to the development of tolerance (progressive need for higher doses to achieve the same effect) and dependence. Therefore, morphine should only be used under medical supervision and in cases where other painkillers have not been effective.

• Tolerance to morphine manifests as a reduction in the effectiveness and duration of the analgesic effect. If you develop dependence on this medicine, your dose may be increased. The increase in dose does not pose risks to respiration (respiratory depression). Tolerance to this medicine resolves within a few days after discontinuation of treatment.

• Dependence on morphine occurs simultaneously with tolerance, especially close to the time of stopping morphine administration. Dependence is characterized by a series of symptoms (collectively known as "withdrawal syndrome") such as widespread pain sensation, diarrhea, increased blood pressure (hypertension), and feeling cold, which appear within a few hours after the last dose. Withdrawal symptoms peak within 36–72 hours and then gradually subside. The most frequent symptoms in the first 24 hours are restlessness, yawning, pupil dilation (mydriasis), tearing, runny nose (rhinorrhea), increased sweating, and goosebumps (piloerection).
  After 24 hours, involuntary muscle contractions (fasciculations and muscle spasms), abdominal and leg pain, back pain (lumbago), headache (cephalalgia), sneezing, weakness, anxiety, irritability, sleep disturbances or insomnia, agitation, loss of appetite (anorexia), nausea, vomiting, diarrhea, fluid loss (dehydration), weight loss, increased heart rate (tachycardia), increased respiratory rate (tachypnea), increased blood pressure (hypertension), increased body temperature (fever), and vascular (vasomotor) disturbances may occur.
  If left untreated, these symptoms may resolve within 5–14 days.
  Dependence and tolerance develop slowly if morphine is administered clinically to prevent pain rather than on an as-needed basis. Morphine hydrochloride monico will be administered in a clinical or hospital setting by specialized personnel, so the development of high-grade dependence and tolerance is rare.
  However, it is essential that you remain under close medical supervision during treatment with this medicine.
  Discontinuation of treatment must be gradual and always occur under strict medical observation. In cases of high-grade tolerance, specialist intervention may be required. Morphine should not be used in painful conditions that respond to less potent analgesics, in order to eliminate even the slightest risk of developing dependence (see section “If you stop treatment with morphine hydrochloride monico”).
  For athletes: using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
  Children
  Morphine should be administered to children only when strictly necessary, especially in newborns.
  Other medicines and morphine hydrochloride monico
  Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
  Combining morphine hydrochloride monico with antidepressants (tricyclic antidepressants) and medicines acting on inflammation (aspirin, non-steroidal anti-inflammatory drugs) is effective in enhancing analgesic effects, allowing for a reduction in the dose of morphine.
  If you have pain (with a neurological component), combining morphine hydrochloride monico with medicines for epilepsy treatment (carbamazepine, anticonvulsants) may increase the analgesic and sedative effects.
  If you have pain due to brain nerve inflammation (neuralgias), thalamic lesions (thalamic syndrome), or spinal cord injuries, morphine hydrochloride monico may not be effective. In such cases, other medicines (anticonvulsants, antidepressants, and long-acting phenothiazines) may be required.
  Do not use morphine hydrochloride monico if you are being treated with:

• medicines for depression (monoamine oxidase inhibitors) and furazolidone, because combining these medicines may cause low blood pressure (hypotension) and breathing difficulties (respiratory depression, see section “Warnings and precautions”);

• naltrexone and similar medicines used to treat morphine dependence (see section “Warnings and precautions”), because they may mask the analgesic effect of morphine;

• other medicines containing alcohol and alcoholic beverages (see section “Morphine hydrochloride monico with alcohol”), because they increase the sedative effect of morphine, alter wakefulness, and make driving dangerous (see section “Driving and use of machines”).

Use morphine hydrochloride monico with caution if you are being treated with:

• rifampicin, a medicine used to treat bacterial infections; concurrent use may reduce the effect of morphine; during and after rifampicin therapy, your doctor will monitor you to determine whether a dose adjustment of morphine is needed;
• certain medicines used to treat blood clots (e.g., clopidogrel, prasugrel, ticagrelor), which may have delayed and reduced effects when taken with morphine;
• cimetidine and other cytochrome P450 inhibitors; combining morphine with cimetidine may cause confusion and breathing problems if you are undergoing mechanical blood filtration (hemodialysis); these medicines increase the effect and duration of morphine;
• barbiturates, used to treat seizures and to induce anesthesia;
• other pain medicines (morphine agonist analgesics, such as alfentanil, codeine, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, oxycodone, pethidine, phenoperidine, remifentanil, sufentanil, tramadol);
• medicines used to treat cough (morphine antitussives, such as codeine, and morphine-like agents, such as dextromethorphan);
• other sedative medicines (neuroleptics), used to treat depression (antidepressants), muscle stiffness (muscle relaxants), allergies (antihistamines), or to induce anesthesia (anesthetics), because they may increase morphine’s effects on respiration and on your ability to drive or operate machinery (see section “Driving and use of machines”);
• medicines used to prevent blood clot formation (oral anticoagulants, including dicoumarol); morphine may enhance the effects of these medicines;
• medicines used to increase fluid elimination (diuretics); morphine may reduce the effect of these medicines and cause urine retention (urinary retention), especially if you have prostate problems (early prostatism).

Many medicines may interact with morphine hydrochloride injectable preparation, potentially causing significant changes in their effects. These include:

• gabapentin or pregabalin, used to treat epilepsy and nerve-related pain (neuropathic pain).

The use of morphine hydrochloride monico together with sedative medicines (such as benzodiazepines or related drugs) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, the combined use of morphine hydrochloride monico with these medicines should only be considered when no alternative treatments are available. However, if your doctor prescribes morphine hydrochloride monico together with sedative medicines, the dose and duration of concomitant treatment should be minimized.
Inform your doctor about all sedative medicines you are taking and follow the recommended doses carefully. It may be helpful to inform family members and friends to watch for the signs and symptoms described above. Contact your doctor if you experience any of the symptoms listed.

Morphine hydrochloride monico with alcohol
Consumption of alcoholic beverages and medicines containing alcohol is not recommended during treatment with morphine hydrochloride monico, as alcohol may increase sedative effects and breathing disturbances.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Do not use morphine hydrochloride monico during pregnancy unless absolutely necessary, such as in cases of severe pain.
Prolonged use of this medicine, as well as other similar medicines (narcotic analgesics), may cause breathing problems (respiratory depression) in the newborn or symptoms of dependence (withdrawal symptoms).
If morphine hydrochloride monico is used for a long time during pregnancy, there is a risk that the newborn may experience withdrawal symptoms from substance abuse, which require medical treatment.
Administration should be avoided in premature deliveries or during the second stage of labour (when the cervix reaches 4–5 cm).

Breastfeeding
Morphine passes into breast milk. Your doctor will assess whether breastfeeding or treatment should be discontinued.

Driving and use of machines
This medicine may cause effects that significantly impair your ability to drive or operate machinery. Avoid driving and operating machinery during treatment with this medicine.
These effects may be greater if you take this medicine together with alcohol or other sedative medicines (see sections “Morphine hydrochloride monico with alcohol” and “Other medicines and morphine hydrochloride monico”).

3. How to use morphine hydrochloride monico

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your
doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what you can expect
from using morphine hydrochloride monico, when and for how long it is necessary to use it, when to contact your doctor, and when treatment should be stopped (see also "If you stop treatment with morphine hydrochloride
monico" in this section).
This medicine will be administered to you by a doctor or nurse, under the skin (subcutaneous route), into a muscle
(intramuscular route), into a vein (intravenous route), or into the epidural space.
The contents of the vial may be diluted in physiological saline (sodium chloride 0.9%) or another solvent (5% glucose).
Your doctor will adjust the dose according to your age and general health condition.

Use in adults
Treatment of acute pain:

• subcutaneous or intramuscular administration: the recommended dose is 10 mg, repeated if necessary every 4 hours;
• direct intravenous administration: the recommended dose is between 2 mg and 10 mg per 70 kilograms of body weight, administered over 4–5 minutes.

Post-surgical pain treatment:

• epidural administration: the recommended dose is between 2 mg and 5 mg; this dose provides pain relief for 24 hours; if necessary, your doctor may decide to increase the dose by 1–2 mg at regular intervals to assess effectiveness; do not exceed 10 mg within 24 hours;
• continuous intravenous infusion: the recommended initial dose is 2–4 mg over 24 hours. Your doctor may decide to increase the dose by 1–2 mg if necessary.

Treatment of pain associated with lung problems (acute pulmonary edema)
The recommended dose is between 5 mg and 10 mg, administered by slow intravenous injection (2 mg per minute).

Treatment of pain associated with cardiac arrest (myocardial infarction)
The recommended dose is 10 mg, followed by another 10 mg if necessary, administered slowly by direct intravenous injection (2 mg per minute).

Use in newborns

• slow intravenous administration (bolus): the recommended dose is between 40 and 100 micrograms per kilogram of body weight, administered over at least 5–10 minutes, every 4–6 hours;
• intravenous infusion:
  • in premature infants: the recommended initial dose is between 25 and 50 micrograms per kilogram of body weight, followed by a maintenance dose of 5 micrograms per kilogram of body weight per hour;
  • in full-term infants: the recommended initial dose is between 50 and 100 micrograms per kilogram of body weight, followed by 10–20 micrograms per kilogram of body weight per hour.

Use in children up to 12 years of age
In children under 12 years of age, this medicine should be used only when strictly necessary:

• intravenous administration (bolus): the recommended dose is between 100 and 200 micrograms per kilogram of body weight, up to 6 times daily;
• infusion: should only be performed after an initial dose (bolus administration); the recommended dose is between 10 and 30 micrograms per kilogram of body weight per hour.

Use in adolescents aged 12 to 18 years:

• intravenous administration (bolus): the recommended dose is between 2.5 mg and 10 mg, up to 6 times daily;
• infusion: should only be performed after an initial dose (bolus administration); the recommended dose is between 10 and 30 micrograms per kilogram of body weight per hour.

Use in elderly and debilitated patients
Your doctor will decide whether to reduce the dose based on your health condition (see section "Warnings and
precautions").

Use in patients with kidney or liver problems
If you have liver or kidney problems (hepatic and/or renal insufficiency), your doctor will reduce the dose. In severe cases, the dose may be halved.

If you use more morphine hydrochloride monico than you should
This medicine will be administered by a doctor or nurse, so overdose is unlikely. However, if you think you have been given too much of this medicine, contact your doctor immediately or go to the nearest hospital.
Symptoms of morphine overdose may include:

• breathing problems (respiratory depression, respiratory arrest), collapse, coma, or death;
• circulatory problems;
• altered level of consciousness;
• pupil constriction (miosis);
• lowered body temperature (hypothermia);
• muscle flaccidity, breakdown of muscle cells (rhabdomyolysis), potentially leading to impaired kidney function (renal failure);
• aspiration pneumonia due to vomiting or foreign bodies, with symptoms such as dyspnea, cough, and fever.

In severe cases, inadequate blood circulation (circulatory failure), coma, collapse, and death may occur. During coma, relaxation of organs (sphincter relaxation) and increased pupil diameter (mydriasis) may occur.
In milder cases, symptoms may include:

• nausea, vomiting;
• tremors;
• behavioral changes (dysphoria);
• decreased body temperature (hypotheria);
• decreased blood pressure (hypotension).

If you have taken/ingested an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to use morphine hydrochloride monico
This medicine will be administered by a doctor or nurse, so it is unlikely that a dose will be missed. However, do not use a double dose to make up for a missed dose.

If you stop treatment with morphine hydrochloride monico
Do not stop treatment with this medicine abruptly; consult your doctor before stopping treatment.
If you wish to discontinue treatment with morphine hydrochloride monico, ask your doctor how to gradually reduce the dosage to avoid withdrawal symptoms. Withdrawal symptoms may include muscle aches, tremors, diarrhea, stomach pain, nausea, flu-like symptoms, rapid heartbeat, and dilated pupils. Psychological symptoms may include intense feelings of dissatisfaction, anxiety, and irritability.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using monohydrate hydrochloride morphine and contact your doctor immediately if you notice a severe skin reaction with blisters, widespread scaly skin, pus-filled spots together with fever. This could be a condition called acute generalized exanthematous pustulosis (AGEP).

The following side effects may occur:
Not known (frequency cannot be estimated from the available data):

• severe allergic reaction causing breathing difficulties or dizziness;
• changes in hormone levels (decrease in CRF (corticotropin-releasing factor), ACTH (adrenocorticotropic hormone), LH (luteinizing hormone), FSH (follicle-stimulating hormone), androgens, estrogens, increase in prolactin, ADH (antidiuretic hormone));
• excitement, irritability, agitation, changes in behaviour (euphoria, dysphoria);
• sleep loss (insomnia);
• sedation;
• reduced mood tone;
• feeling of weakness (asthenia);
• confusion (mental obtundation), states of indifference;
• headache (cephalalgia);
• dizziness;
• sweating;
• dry mouth;
• increased internal pressure in the head, which may worsen pre-existing brain disorders;
• vision problems, constriction of the pupils (miosis);
• sensation of dizziness due to decreased blood pressure when standing up (orthostatic hypotension);
• temporary loss of consciousness (syncope);
• breathing problems (respiratory depression, respiratory arrest), even severe if you suffer from bronchial or lung disorders (atelectasis);
• circulatory depression;
• collapse;
• nausea, vomiting;
• digestive blockage (closure of the sphincter of Oddi and increased biliary pressure which may cause nausea and colicky pain);
• decreased gastric and intestinal secretions, increased tone of intestinal smooth muscle, and slowed peristaltic wave leading to constipation (spastic-type constipation);
• redness of the face, neck and chest, sweating, itching, skin irritation (urticaria and other skin changes);
• withdrawal syndrome or dependence (see section “Warnings and precautions”);
• reduced urine output (hormonal oliguria), as morphine prolongs bladder emptying times, although rapid tolerance to this effect develops;
• increased sensitivity to pain;
• sleep apnoea (breathing pauses during sleep);
• symptoms associated with inflammation of the pancreas (pancreatitis) and biliary tract, for example severe pain in the upper abdomen possibly radiating to the back, nausea, vomiting or fever.

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 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 morphine hydrochloride monico

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.”. The expiry date refers to the last day of that month.
Store the ampoules in their original packaging to protect the medicine from heat and light.
Caution: do not use solutions if they appear discoloured. The ampoules are for single use only; discard any unused solution.
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 morfina cloridrato monico contains
Morfina cloridrato monico 10 mg/1 ml Solution for injection

• The active substance is morphine hydrochloride trihydrate. Each vial contains 10 mg of morphine hydrochloride trihydrate.
• The other component is water for injections.

Morfina cloridrato monico 20 mg/1 ml Solution for injection

• The active substance is morphine hydrochloride trihydrate. Each vial contains 20 mg of morphine hydrochloride trihydrate.
• The other component is water for injections.

Morfina cloridrato monico 50 mg/5 ml Solution for injection

• The active substance is morphine hydrochloride trihydrate. Each vial contains 50 mg of morphine hydrochloride trihydrate.
• The other component is water for injections.

Morfina cloridrato monico 100 mg/5 ml Solution for injection
Morfina cloridrato monico 100 mg/10 ml Solution for injection

• The active substance is morphine hydrochloride trihydrate. Each vial contains 100 mg of morphine hydrochloride trihydrate.
• The other component is water for injections.

Morfina cloridrato monico 200 mg/10 ml Solution for injection

• The active substance is morphine hydrochloride trihydrate. Each vial contains 200 mg of morphine hydrochloride trihydrate.
• The other component is water for injections.

Description of the appearance of morfina cloridrato monico and package contents
morfina cloridrato monico 10 mg/1 ml Solution for injection: carton containing 1 or 5 glass vials of 10 mg/1 ml.
morfina cloridrato monico 20 mg/1 ml Solution for injection: carton containing 1 or 5 glass vials of 20 mg/1 ml.
morfina cloridrato monico 50 mg/5 ml Solution for injection: carton containing 5 glass vials of 50 mg/5 ml.
morfina cloridrato monico 100 mg/5 ml Solution for injection: carton containing 5 glass vials of 100 mg/5 ml.
MORFINA CLORIDRATO MONICO 100 mg/10 ml Solution for injection: carton containing 5 glass vials of 100 mg/10 ml.
MORFINA CLORIDRATO MONICO 200 mg/10 ml Solution for injection: carton containing 5 glass vials of 200 mg/10 ml.

Marketing Authorization Holder and Manufacturer
Monico spa
Via Ponte di Pietra 7, 30173 Venezia Mestre – Italy

The following information is intended exclusively for physicians or healthcare professionals.
Morphine hydrochloride must not be mixed with other medicinal products.
Morphine salts are incompatible with aminophylline, sodium salts of barbiturates and phenytoin, sodium aciclovir, furosemide, sodium heparin, pethidine, chlorpheniramine, promethazine and edisylates.
Physical-chemical incompatibility (precipitate formation) has been demonstrated between solutions of morphine sulfate and 5-fluorouracil.