Morphine hydrochloride Molteni

Package leaflet: Information for the user

Morphine Hydrochloride Molteni 10 mg/ml injection solution, 20 mg/ml injection solution

Equivalent medicine
Please read all of this leaflet carefully before you start using 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.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• 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:

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

1. What Morfina Cloridrato Molteni is and what it is used for

Morfina Cloridrato Molteni contains the active substance morphine hydrochloride, which belongs to a group of medicines called opioid analgesics, acting 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, particularly in cases of pain due to:
• tumours (neoplasia);
• heart problems (myocardial infarction);
• following surgical procedures;
• severe lung problems (acute pulmonary oedema);
• inducing anaesthesia:
• during childbirth (epidural labour analgesia);
• during surgical procedures (general and loco-regional anaesthesia).

2. What you should know before using Morphine Hydrochloride Molteni

Do not use Morphine Hydrochloride Molteni if:

• you are allergic to morphine hydrochloride, to other medicines of the same class as Morphine Hydrochloride Molteni, 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 narrowing (bronchospasm), or more severe allergic reactions (anaphylactic reactions);
• you suffer from stomach or intestinal problems (acute abdomen, paralytic ileus);
• you suffer from breathing difficulties (respiratory depression);
• you have severe liver problems (severe hepatocellular insufficiency);
• you have heart problems associated with other respiratory disorders (heart failure secondary to chronic lung disease);
• you have sustained head trauma or have increased pressure in the head (trauma, intracranial hypertension);
• you have undergone surgery on the liver or biliary tract (bile ducts);
• during a respiratory crisis (asthma due to bronchitis);
• you suffer from seizures;
• you have uncontrolled epilepsy;
• you have consumed large amounts of alcohol or are experiencing alcohol withdrawal (acute alcoholism, delirium tremens);
• you are taking other medicines acting on the central nervous system, such as hypnotics, sedatives, or tranquilizers (see section “Other medicines and Morphine Hydrochloride Molteni”);
• you are being treated with medicines for depression (monoamine oxidase inhibitors, furazolidone), or if you have stopped treatment with these medicines less than 2–3 weeks ago (see section “Other medicines and Morphine Hydrochloride Molteni”);
• you are being treated with naltrexone, used to treat dependence on morphine and other opioids;
• you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Morphine Hydrochloride Molteni.
Use this medicine with caution and inform your doctor if:

• you are elderly, very elderly, or debilitated; in these cases, a dose reduction may be necessary;
• you suffer from heart disorders due to lung diseases;
• you have brain disorders (organic cerebral 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 have kidney or gallbladder problems (renal and biliary colic);
• you have prostate problems (prostatic hypertrophy);
• you have thyroid problems (myxedema, hypothyroidism);
• you suffer from liver problems (hepatitis and acute hepatopathies);
• your liver or kidneys are not functioning properly;
• you suffer from hormonal disorders (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 tract, intestinal disorders due to inflammation or obstruction);
• you suffer from muscle disorders (severe myasthenia gravis);
• you suffer from heart rhythm and circulatory disorders (cardiovascular conditions, cardiac arrhythmias), or have heart valve problems (aortic valve dysfunction) or heart circulation problems (coronary disorders).

Contact your doctor, pharmacist, or nurse if you notice any of the following symptoms
during use of Morphine Hydrochloride Molteni:

• increased sensitivity to pain despite increasing doses (hyperalgesia). Your doctor will decide whether a dose adjustment or a change in analgesic 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 hormone supplementation may be required;
• 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, inform your doctor if you feel you are becoming dependent on Morphine Hydrochloride Molteni 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 adjust dosing intervals.

Morphine, due to its pain-relieving (analgesic) effect, its action on consciousness, pupil size, and respiration, may mask certain symptoms and make them difficult for the doctor to assess.
Administration of morphine, especially if prolonged, may lead to the development of tolerance and
dependence. Therefore, morphine should only be used under medical supervision and when other pain-relieving medicines have not been effective.

• Tolerance to morphine manifests as reduced effectiveness and shorter duration of analgesic action. If you develop tolerance to this medicine, your dose will be increased. Dose increases do not pose risks for respiration (respiratory depression). Tolerance to this medicine resolves within a few days after discontinuation.
• Dependence on morphine develops concurrently with tolerance and is characterized by the need to continue using the medicine. In such cases, abrupt discontinuation of the drug may lead to a series of symptoms collectively known as withdrawal syndrome: widespread pain sensation, diarrhea, increased blood pressure (hypertension), chills, restlessness, yawning, pupil dilation (mydriasis), tearing, runny nose (rhinorrhea), increased sweating and goosebumps (piloerection), involuntary muscle contractions (fasciculations and muscle spasms), abdominal and leg pain, back pain (lumbago), headache (cephalgia), sneezing, weakness, anxiety, irritability, sleep disturbances or insomnia, agitation, loss of appetite (anorexia), nausea, vomiting, fluid loss (dehydration), weight loss, increased heart rate (tachycardia), increased breathing rate (tachypnea), elevated body temperature (fever), and blood vessel (vasomotor) disturbances. Withdrawal symptoms peak within 36–72 hours and then gradually subside over 5–14 days.

Dependence and tolerance develop very slowly if morphine is used correctly under strict medical supervision.
Discontinuation of treatment must be gradual and always occur under close medical supervision (see section “If you stop treatment with Morphine Hydrochloride Molteni”).
For athletes: using the drug without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children
Morphine should be administered to children only in specific cases and when strictly necessary, especially in newborns.
Other medicines and Morphine Hydrochloride Molteni
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Combining Morphine Hydrochloride Molteni with certain antidepressants (tricyclic antidepressants) and medicines acting on inflammation (aspirin, non-steroidal anti-inflammatory drugs) may enhance the analgesic effects of morphine and allow for a reduced dose.
If you have pain with a neurological component, combining Morphine Hydrochloride Molteni with medicines used to treat epilepsy (anticonvulsants such as carbamazepine) may increase the analgesic and sedative effects.
If you have pain due to nerve inflammation (pure neuralgias), brain lesions (thalamic syndrome), or spinal cord injuries, Morphine Hydrochloride Molteni may not be effective. In such cases, other medicines (anticonvulsants, antidepressants, and long-acting phenothiazines) may be required.
Do not use Morphine Hydrochloride Molteni if you are taking:

• 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, a medicine used to treat alcohol or opioid dependence, because it may block the analgesic effect of morphine;
• medicines containing alcohol, because alcohol increases the sedative effect of morphine (see sections “Morphine Hydrochloride Molteni and alcohol” and “Driving and use of machinery”). Use Morphine Hydrochloride Molteni with caution if you are taking:
• rifampicin, a medicine used to treat infections (e.g., tuberculosis). Concurrent use may reduce the effect of morphine. During and after treatment with rifampicin, your doctor will monitor you to determine whether morphine dose adjustment is needed;
• cimetidine, a medicine used to treat ulcers, and other medicines that increase morphine levels in the blood (cytochrome P system inhibitors);
• barbiturates, medicines used to treat seizures and induce anesthesia;
• concomitant use of Morphine Hydrochloride Molteni 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 Morphine Hydrochloride Molteni 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 the dosage recommendations carefully. It may be helpful to inform friends or family to watch for the symptoms listed above. Contact your doctor if you experience such symptoms.
• other pain medicines such as alfentanil, codeine, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, oxycodone, pethidine, phenoperidine, remifentanil, sufentanil, tramadol;
• medicines used to treat cough such as codeine and dextromethorphan;
• other medicines causing sedation, for example medicines used to calm (neuroleptics), treat depression (antidepressants), relieve muscle stiffness (muscle relaxants), treat allergies (antihistamines), or induce anesthesia (anesthetics), as they may enhance morphine's effects;
• medicines that prevent blood clotting (oral anticoagulants), such as dicoumarol. Morphine may potentiate the effects of these medicines;
• medicines used to treat blood clots (e.g., clopidogrel, prasugrel, ticagrelor), because their effect may be delayed and reduced when taken with morphine;
• medicines that promote urine elimination (diuretics). Morphine may reduce the effect of these medicines and cause urine retention (urinary retention), especially if you have prostate problems (early prostatism).

Morphine Hydrochloride Molteni and alcohol
Consumption of alcoholic beverages or medicines containing alcohol is not recommended during treatment with Morphine Hydrochloride Molteni, as alcohol may increase sedative effects and respiratory disturbances.
Pregnancy, breastfeeding, and fertility
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 Molteni during pregnancy, except in cases of absolute necessity, such as severe pain.

This medicine, like other similar medicines (narcotic analgesics), may cause breathing problems or withdrawal symptoms. This medicine may cause breathing problems or withdrawal symptoms in the newborn.
If Morphine Hydrochloride Molteni is used for a prolonged period during pregnancy, there is a risk that the newborn may show symptoms of substance withdrawal requiring medical treatment.
Administration should be avoided during premature labor or during the second stage of labor (when the cervix reaches 4–5 cm).

• Breastfeeding Morphine passes into breast milk. Your doctor will assess whether to discontinue breastfeeding or morphine treatment.

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

3. How to use Morphine Hydrochloride Molteni

This medicine is administered by injectable route 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).
The doctor will adjust the dose according to your age and your general health condition.

Use in adults

Treatment of acute pain:

• Subcutaneous or intramuscular injection: the dose is 10 mg, repeated if necessary every 4 hours.
• Intravenous injection: the initial dose ranges between 2 mg and 10 mg per 70 kg of body weight, administered over 4-5 minutes.

Post-surgical pain treatment:

• Epidural injection: the recommended dose ranges between 2 mg and 5 mg. This dose provides pain relief for 24 hours. If necessary, the doctor may decide to increase the dose by 1-2 mg at regular intervals. Do not exceed 10 mg within 24 hours.
• Continuous infusion injection: the recommended initial dose is 2-4 mg in 24 hours. The doctor may decide to increase the dose by 1-2 mg if necessary.

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

Treatment of pain associated with cardiac activity blockage (myocardial infarction)
The recommended dose is 10 mg, followed by another 10 mg if needed, administered by slow intravenous injection (2 mg per minute).

Use in newborns

• Slow intravenous injection: the recommended dose ranges between 40 and 100 micrograms per kg of body weight, administered over at least 5-10 minutes, every 4-6 hours.
• Infusion injection:
  • In premature infants: the initial dose ranges between 25 and 50 micrograms per kg of body weight, followed by a second administration of 5 micrograms per kg of body weight per hour;
  • In full-term infants: the initial dose ranges between 50 and 100 micrograms per kg of body weight, followed by 10-20 micrograms per kg of body weight per hour.

Use in children up to 12 years of age
In children under 12 years of age, use this medicine only in specific and truly necessary cases:

• Intravenous injection: the dose ranges between 100 and 200 micrograms per kg of body weight, up to 6 times daily;
• Infusion injection: to be performed only after an initial intravenous dose has been administered. The dose ranges between 10 and 30 micrograms per kg of body weight per hour.

Use in adolescents aged 12 to 18 years:

• Intravenous injection: the recommended dose ranges between 2.5 mg and 10 mg, up to 6 times daily;
• Infusion injection: to be performed only after an initial intravenous dose has been administered. The dose ranges between 10 and 30 micrograms per kg of body weight per hour.

Use in elderly and debilitated patients
The 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 suffer from liver or kidney problems (hepatic and/or renal insufficiency), the doctor will reduce the dose. In severe cases, the dose may be halved.

If you use more Morphine Hydrochloride Molteni than you should
If you think you have used an excessive amount of this medicine, inform your doctor immediately or go to the nearest hospital.
Symptoms of morphine overdose include:

• nausea, vomiting;
• tremors;
• behavioral changes (dysphoria);
• breathing difficulties;
• decreased blood pressure (hypotension) and circulatory problems;
• altered state of consciousness up to respiratory arrest, collapse, and coma;
• pupil constriction (miosis);
• lowered body temperature (hypothermia);
• muscle flaccidity. In severe cases, inadequate blood circulation (circulatory failure) and coma may occur, potentially leading to death. Individuals who have taken an excessive dose may develop aspiration pneumonia due to inhalation of vomit or foreign bodies, whose symptoms may include dyspnea, cough, and fever. Such individuals may also experience respiratory difficulties leading to unconsciousness or even death.

If you forget to use Morphine Hydrochloride Molteni
If you have missed a dose, continue treatment as prescribed by your doctor. Under no circumstances should you use a double dose to make up for the missed dose.

If you stop using Morphine Hydrochloride Molteni
Do not stop treatment without first discussing it with your doctor. If you intend to discontinue treatment with Morphine Hydrochloride Molteni, ask your doctor how to gradually reduce the dosage to avoid withdrawal symptoms. Withdrawal symptoms may include muscle pain, tremors, diarrhea, stomach pain, nausea, flu-like symptoms, rapid heartbeat, and dilated pupils. Psychological symptoms include intense feelings of dissatisfaction, anxiety, and irritability.

If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:

• severe allergic reaction causing breathing difficulties or dizziness;
• changes in hormone levels (decrease in CRF, ACTH, LH, FSH, androgens, estrogens; increase in prolactin, ADH);
• excitement, irritability, agitation, behavioural changes (euphoria, dysphoria);
• sleep disturbance (insomnia);
• sedation;
• reduced mood tone;
• feeling of weakness (asthenia);
• confusion (mental obtundation), states of indifference;
• headache;
• increased sensitivity to pain;
• sweating;
• dizziness;
• increased intracranial pressure, which may worsen pre-existing brain disorders;
• vision problems, pupil constriction (miosis);
• sensation of dizziness due to drop in blood pressure when standing up (orthostatic hypotension);
• sudden loss of consciousness (syncope);
• breathing problems (respiratory depression), even severe if you suffer from bronchial or lung disorders (atelectasis);
• respiratory arrest;
• circulatory depression;
• collapse;
• nausea, vomiting;
• dry mouth;
• digestive problems;
• constipation;
• biliary colic;
• flushing of the face, neck and chest, sweating, itching, skin irritation (urticaria and other skin reactions);
• withdrawal syndrome or dependence (for symptoms, see section 3: If you stop treatment with Morfina Cloridrato Molteni);
• urinary retention.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
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 Morfina Cloridrato Molteni

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.”. The expiry date refers to the last day of that month.
The solution should be colourless or pale yellow, without residues. Do not use this medicine if you notice that the solution has turned a deeper yellow, has a different colour, or has a residue at the bottom.
Store the vials in their original packaging to protect the medicine from light.
The vials 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 Molteni contains
Morfina Cloridrato Molteni 10 mg/ml injectable solution

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

Morfina Cloridrato Molteni 20 mg/ml injectable solution

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

Description of the appearance of Morfina Cloridrato Molteni and contents of the pack
Morfina Cloridrato Molteni 10 mg/ml injectable solution, 1 ml vial, packs of 1 vial or 5 vials.
Morfina Cloridrato Molteni 20 mg/ml injectable solution, 1 ml vial, packs of 1 vial or 5 vials.
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 (Florence)

The following information is intended exclusively for physicians and 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 acyclovir, furosemide, sodium heparin, pethidine, chlorpheniramine, promethazine, and edisylates.
Physical-chemical incompatibility (precipitate formation) has been demonstrated between morphine sulfate solutions and 5-fluorouracil.

Package leaflet: information for the user

Morphine Hydrochloride Molteni 50 mg/5ml injectable solution, 100 mg/5ml injectable solution, 100 mg/10 ml injectable solution, 200 mg/10 ml injectable solution

Equivalent medicinal product
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.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Morfina Cloridrato Molteni is and what it is used for

Morfina Cloridrato Molteni contains the active substance morphine hydrochloride, which belongs to a group of medicines called opioid analgesics that 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, particularly in cases of pain due to:
• tumours (neoplasms);
• heart problems (myocardial infarction);
• following surgical procedures;
• severe lung problems (acute pulmonary edema);
• inducing anaesthesia:
• during childbirth (epidural analgesia in labour);
• during surgical procedures (general and loco-regional anaesthesia).

2. What you must know before using Morfina Cloridrato Molteni

Do not use Morfina Cloridrato Molteni if:

• you are allergic to morphine hydrochloride, to other medicines of the same class as Morfina Cloridrato Molteni, 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 narrowing (bronchospasm), or more severe allergic reactions (anaphylactic reactions);
• you suffer from stomach or intestinal problems (acute abdomen, paralytic ileus);
• you suffer from breathing difficulties (respiratory depression);
• you suffer from severe liver problems (severe hepatocellular insufficiency);
• you suffer from heart problems associated with other respiratory disorders (heart failure secondary to chronic lung disease);
• you have suffered head trauma or have increased pressure inside the head (trauma, intracranial hypertension);
• you have undergone surgery on the liver or biliary tract (bile ducts);
• during a respiratory crisis (asthma due to bronchitis);
• you suffer from seizures;
• you suffer from uncontrolled 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, or tranquilizers (see section “Other medicines and Morfina Cloridrato Molteni”);
• you are being treated with medicines for depression (monoamine oxidase inhibitors, furazolidone), or if you have stopped treatment with these medicines less than 2–3 weeks ago (see section “Other medicines and Morfina Cloridrato Molteni”);
• you are being treated with naltrexone, used to treat morphine and other opioid dependence;
• you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Morfina Cloridrato Molteni.
Use this medicine with caution and inform your doctor if:

• you are elderly, very old, 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 cerebral 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 thyroid problems (myxedema, hypothyroidism);
• you suffer from liver problems (hepatitis and acute hepatopathies);
• your liver or kidneys are not functioning properly;
• you suffer from hormonal disorders (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 function, intestinal disorders due to inflammation or obstruction);
• you suffer from muscle disorders (severe myasthenia gravis);
• you suffer from disturbances in heart rhythm and circulation (cardiovascular disorders, cardiac arrhythmias), or suffer from heart valve problems (aortic valve dysfunction) and heart circulation problems (coronary disorders).

Talk to your doctor, pharmacist, or nurse if you notice any of the following symptoms
during use of Morfina Cloridrato Molteni:

• increased sensitivity to pain, despite taking increasing doses (hyperalgesia). Your doctor will decide whether a dose adjustment or a change in analgesic is needed (see section 2);
• weakness, fatigue, loss of appetite, nausea, vomiting, or low blood pressure. This may indicate insufficient cortisol production by the adrenal glands, and you may need hormonal supplementation;
• loss of libido, impotence, cessation of menstruation. This may be due to reduced production of sex hormones;
• if you have previously been dependent on drugs or alcohol, inform your doctor if you feel you are becoming dependent on Morfina Cloridrato Molteni 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 schedule. Morphine, due to its analgesic effect, its action on consciousness, pupil size, and respiration, may mask certain symptoms and make them difficult for the doctor to evaluate.

Administration of morphine, especially if prolonged, may lead to the development of tolerance and
dependence. Therefore, morphine may only be used under medical supervision and in cases where other
analgesic medicines have not been effective.

• Tolerance to morphine manifests as a reduction in the effectiveness and duration of the analgesic effect. If you develop tolerance to this medicine, your dose will be increased. Dose escalation does not pose risks for respiration (respiratory depression). Tolerance to this medicine resolves within a few days after discontinuation of treatment.
• Dependence on morphine develops concurrently with tolerance and is characterized by the need to continue using the medicine. In this case, abrupt discontinuation of the drug may lead to a series of symptoms collectively known as withdrawal syndrome: generalized pain, diarrhea, increased blood pressure (hypertension), chills, restlessness, yawning, pupil dilation (mydriasis), tearing, runny nose (rhinorrhea), increased sweating and goosebumps (piloerection), involuntary muscle contractions (fasciculations and muscle spasms), abdominal and leg pain, back pain (lumbago), headache (cephalalgia), sneezing, weakness, anxiety, irritability, sleep disturbances or loss (insomnia), agitation, loss of appetite (anorexia), nausea, vomiting, fluid loss (dehydration), weight loss, increased heart rate (tachycardia), increased respiratory rate (tachypnea), elevated body temperature (fever), and vascular disturbances (vasomotor symptoms). Withdrawal symptoms peak within 36–72 hours and then gradually subside over 5–14 days.

Dependence and tolerance develop very slowly if morphine is used correctly under strict medical supervision.
Discontinuation of treatment must be gradual and always occur under close medical supervision (see section “If you stop using Morfina Cloridrato Molteni”).
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children
Morphine should be administered to children only in special cases and when strictly necessary, especially in newborns.
Other medicines and Morfina Cloridrato Molteni
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other
medicine, including those without a prescription.
Combining Morfina Cloridrato Molteni with certain antidepressants (tricyclic antidepressants) and with
medicines acting on inflammation (aspirin, non-steroidal anti-inflammatory drugs) may enhance
morphine’s analgesic effects and allow for dose reduction.
If you have pain with a neurological component, combining Morfina Cloridrato Molteni with
medicines used to treat epilepsy (anticonvulsants such as carbamazepine) may increase
analgesic and sedative effects.
If you have pain due to nerve inflammation (pure neuralgias), brain lesions (thalamic syndrome), or spinal cord injuries, Morfina Cloridrato Molteni may not be effective. In
such cases, other medicines may be required (anticonvulsants, antidepressants, and long-acting phenothiazines).
Do not use Morfina Cloridrato Molteni if you are taking:

• 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, a medicine used to treat alcohol or opioid dependence, because it may block morphine’s analgesic effect;
• medicines containing alcohol, because alcohol increases morphine’s sedative effect (see sections “Morfina Cloridrato Molteni and alcohol” and “Driving and use of machinery”).

Use Morfina Cloridrato Molteni with caution if you are taking:

• rifampicin, a medicine used to treat infections (e.g., tuberculosis). Concurrent use may reduce morphine’s effect. During and after rifampicin therapy, your doctor will monitor you and adjust the morphine dose if necessary;
• cimetidine, a medicine used to treat ulcers, and other medicines that increase morphine blood levels (cytochrome P450 system inhibitors);
• barbiturates, medicines used to treat seizures and induce anesthesia;
• concomitant use of Morfina Cloridrato Molteni 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 Morfina Cloridrato Molteni 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 the doctor’s dosage recommendations carefully. It may be helpful to inform friends or family members to watch for the symptoms listed above. Contact your doctor if you experience such symptoms.
• other pain medicines, such as alfentanil, codeine, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, oxycodone, pethidine, phenoperidine, remifentanil, sufentanil, tramadol;
• medicines used to treat cough, such as codeine and dextromethorphan;
• other medicines that cause sedation, for example, medicines used to calm (neuroleptics), treat depression (antidepressants), treat muscle stiffness (muscle relaxants), treat allergies (antihistamines), or induce anesthesia (anesthetics), as they may enhance morphine’s effects;
• medicines that prevent blood clotting (oral anticoagulants), such as dicoumarol. Morphine may potentiate the effects of these medicines;
• medicines used to treat blood clots (e.g., clopidogrel, prasugrel, ticagrelor), because their effect may be delayed and reduced when taken with morphine;
• medicines that promote urine elimination (diuretics). Morphine may reduce the effect of these medicines and cause urinary retention, especially if you have prostate problems (early prostatism).

Morfina Cloridrato Molteni and alcohol
Consumption of alcoholic beverages or medicines containing alcohol is not recommended during treatment with
Morfina Cloridrato Molteni, as alcohol may enhance sedative effects and respiratory disturbances.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

• Pregnancy

Do not use Morfina Cloridrato Molteni during pregnancy, except in cases of absolute necessity, such as severe pain.
This medicine, like other similar medicines (narcotic analgesics), may cause breathing problems or withdrawal symptoms. This medicine may cause breathing problems or withdrawal symptoms in the newborn.
If Morfina Cloridrato Molteni is used for a prolonged period during pregnancy, there is a risk that the newborn may experience withdrawal symptoms (substance dependence) requiring medical treatment.
Administration should be avoided during premature labor or during the second stage of labor (when the cervix is dilated to 4–5 cm).

• Breastfeeding
  Morphine passes into breast milk. Your doctor will assess whether it is necessary to discontinue breastfeeding or morphine treatment.

Driving and use of machinery
Avoid driving vehicles and operating machinery during treatment with Morfina Cloridrato Molteni.
This medicine may cause effects that significantly impair your ability to drive or operate machinery. These effects may be greater if you take this medicine together with alcohol or other medicines (see sections “Morfina Cloridrato Molteni and alcohol” and “Morfina Cloridrato Molteni and other medicines”).

3. How to use Morphine Hydrochloride Molteni

This medicinal product is administered by injectable route 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 solution (sodium chloride 0.9%) or in another solvent (5% glucose).
The doctor will adjust the dose according to your age and your general health condition.

Use in adults
Treatment of acute pain:

• Subcutaneous or intramuscular injection: the dose is 10 mg, repeated if necessary every 4 hours.
• Intravenous injection: the initial dose ranges between 2 mg and 10 mg per 70 kg of body weight, administered over 4–5 minutes.

Post-surgical pain treatment:

• Epidural injection: the recommended dose ranges between 2 mg and 5 mg. This dose provides pain relief for 24 hours. If necessary, the doctor may decide to increase the dose by 1–2 mg at regular intervals. Do not exceed 10 mg within 24 hours.
• Continuous infusion injection: the recommended initial dose is 2–4 mg in 24 hours. The doctor may decide to increase the dose by 1–2 mg if necessary.

Treatment of severe lung problems (acute pulmonary edema)
The recommended dose ranges between 5 mg and 10 mg, administered by slow intravenous injection (2 mg per minute).
Treatment of pain associated with cardiac activity blockage (myocardial infarction)
The recommended dose is 10 mg, followed by another 10 mg if necessary, administered by slow intravenous injection (2 mg per minute).

Use in neonates

• Slow intravenous injection: the recommended dose ranges between 40 and 100 micrograms per kg of body weight, administered over at least 5–10 minutes, every 4–6 hours.
• Infusion injection:
• In premature infants: the initial dose ranges between 25 and 50 micrograms per kg of body weight, followed by a continuous infusion of 5 micrograms per kg of body weight per hour;
• In full-term infants: the initial dose ranges between 50 and 100 micrograms per kg of body weight, followed by 10–20 micrograms per kg of body weight per hour.

Use in children up to 12 years of age
In children under 12 years of age, use this medicine only in special cases and when strictly necessary:

• Intravenous injection: the dose ranges between 100 and 200 micrograms per kg of body weight, up to 6 times daily;
• Infusion injection: must be performed only after an initial intravenous dose has been administered. The dose ranges between 10 and 30 micrograms per kg of body weight per hour.

Use in adolescents aged 12 to 18 years:

• Intravenous injection: the recommended dose ranges between 2.5 mg and 10 mg, up to 6 times daily;
• Infusion injection: must be performed only after an initial intravenous dose has been administered. The dose ranges between 10 and 30 micrograms per kg of body weight per hour.

Use in elderly and debilitated patients
The 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 suffer from liver or kidney problems (hepatic and/or renal insufficiency), the doctor will reduce the dose. In severe cases, the dose may be halved.

If you use more Morphine Hydrochloride Molteni than you should
If you think you have used an excessive amount of this medicine, inform your doctor immediately or go to the nearest hospital.
Symptoms of morphine overdose include:

• nausea, vomiting;
• tremors;
• behavioral changes (dysphoria);
• breathing difficulties;
• low blood pressure (hypotension) and circulatory problems;
• altered level of consciousness up to respiratory arrest, collapse, and coma;
• pupil constriction (miosis);
• decreased body temperature (hypothermia); muscle flaccidity.
• In severe cases, inadequate blood circulation (circulatory failure) and coma may occur, which can lead to death. Individuals who have taken an excessive dose may develop aspiration pneumonia due to vomiting or foreign body inhalation, with symptoms possibly including dyspnea, cough, and fever. Individuals who have taken an excessive dose may also experience respiratory difficulties leading to unconsciousness or even death.

If you forget to use Morphine Hydrochloride Molteni
If you have missed a dose, continue treatment as prescribed by your doctor. Under no circumstances should you take a double dose to make up for the missed dose.
If you stop using Morphine Hydrochloride Molteni
Do not stop treatment without first discussing it with your doctor. If you intend to discontinue treatment with Morphine Hydrochloride Molteni, ask your doctor how to gradually reduce the dosage to avoid withdrawal symptoms. Withdrawal symptoms may include muscle pain, tremors, diarrhea, stomach pain, nausea, flu-like symptoms, rapid heartbeat, and dilated pupils. Psychological symptoms include intense feelings of dissatisfaction, anxiety, and irritability.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions may occur:

• severe allergic reaction causing difficulty in breathing or dizziness;
• changes in hormone levels (decrease in CRF, ACTH, LH, FSH, androgens, estrogens; increase in prolactin, ADH);
• excitation, irritability, agitation, behavioural changes (euphoria, dysphoria);
• sleep disturbance (insomnia);
• sedation;
• reduced mood tone;
• feeling of weakness (asthenia);
• confusion (mental obtundation), states of indifference;
• headache (cephalalgia);
• increased sensitivity to pain;
• sweating;
• dizziness;
• increased intracranial pressure, which may worsen pre-existing brain disorders;
• visual disturbances, pupil constriction (miosis);
• sensation of dizziness due to drop in blood pressure upon standing (orthostatic hypotension);
• sudden loss of consciousness (syncope);
• breathing problems (respiratory depression), even severe if you suffer from bronchial or lung disorders (atelectasis);
• respiratory arrest;
• circulatory depression;
• collapse;
• nausea, vomiting;
• dry mouth;
• digestive disturbances;
• constipation;
• biliary colic;
• flushing of the face, neck and chest, sweating, itching, skin irritation (urticaria and other skin reactions);
• withdrawal syndrome or dependence (for symptoms, see section 3: If you stop treatment with Morfina Cloridrato Molteni);
• urinary retention.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor, pharmacist or nurse.
You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Morfina Cloridrato Molteni

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.". The expiry date refers to the last day of that month.
The solution should be colourless or pale yellow, without residues. Do not use this medicine if you notice that the solution has turned a deeper yellow, has a different colour, or has a residue at the bottom.
Store the vials in their original packaging to protect the medicine from light.
The vials 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Morfina Cloridrato Molteni contains
Morfina Cloridrato Molteni 50 mg/5 ml injectable solution

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

Morfina Cloridrato Molteni 100 mg/5 ml injectable solution

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

Morfina Cloridrato Molteni 100 mg/10 ml injectable solution

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

Morfina Cloridrato Molteni 200 mg/10 ml injectable solution

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

Description of the appearance of Morfina Cloridrato Molteni and package contents
Morfina Cloridrato Molteni 50 mg/5 ml injectable solution, 5 ml vial, packs of 1 or 5 vials.
Morfina Cloridrato Molteni 100 mg/5 ml injectable solution, 5 ml vial, packs of 1 or 5 vials.
Morfina Cloridrato Molteni 100 mg/10 ml injectable solution, 10 ml vial, packs of 1 or 5 vials.
Morfina Cloridrato Molteni 200 mg/10 ml injectable solution, 10 ml vial, packs of 1 or 5 vials.
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 (Florence)

The following information is intended for healthcare professionals only.

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 edetates.
Physical-chemical incompatibility (precipitate formation) has been demonstrated between morphine sulfate solutions and
5-fluorouracil.