МОРФИНА 10 мг/мл Инъекционный раствор

Содержание инструкции

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

morfina cloridrato monico

10 mg/1 ml Injectable solution
20 mg/1 ml Injectable solution
50 mg/5 ml Injectable solution
100 mg/5 ml Injectable solution
100 mg/10 ml Injectable solution
200 mg/10 ml Injectable solution

morfina cloridrato

equivalent medicine

Read this leaflet carefully before taking this medicineas 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is morphine hydrochloride monico and what is it used for

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

• when other treatments with painkillers have not been effective;
• due to tumors (neoplasms);
• due to heart problems (myocardial infarction);
• after surgical procedures;
• due to lung problems (acute pulmonary edema).

Morphine is also indicated to induce anesthesia in childbirth (labor analgesia-epidural) and in surgical
procedures (general and loco-regional anesthetic).

2. What you need to know before using morphine hydrochloride monic

Tolerance, dependence
This medicine contains morphine, an opioid medicine. Repeated use of opioids can make the medicine
less effective (you get used to it, a phenomenon known as tolerance). Repeated use of morphine hydrochloride monic
can also lead to dependence and abuse, which can cause an overdose that could be fatal. The risk of
these undesirable effects may increase with a higher dose and prolonged use.
Dependence can make you feel like you no longer have control over the amount of medicine you need or the
frequency with which you have to use it.
The risk of developing dependence varies from person to person. You may be at greater risk of becoming
dependent on morphine hydrochloride monic if:

• you or a family member has suffered in the past from abuse or dependence on alcohol, prescription drugs or illegal substances (“dependence”);
• you are a smoker;
• you have had problems with your mood in the past (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 the use of morphine hydrochloride monic may be an indication of dependence:
• you need to take the medicine for a longer period than indicated by the 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 promote 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 when you resume using it you feel better (“withdrawal symptoms”). If you notice any of these signs, consult your doctor to discuss the best therapeutic path for you, including cases where it is appropriate to stop treatment and how to stop it safely (see paragraph 3 If you stop treatment with morphine hydrochloride monic).

Do not use morphine hydrochloride monic

• if you are allergic to morphine hydrochloride, to other similar medicines, belonging to the same class of morphine hydrochloride monic or to any of the other components of this medicine (listed in paragraph 6); if you are allergic you may experience redness of the face, itching, difficulty breathing due to narrowing of the bronchi (bronchospasm) or more serious allergic reactions (anaphylactic reactions);
• if you suffer from problems with your stomach or intestines (acute abdomen, paralytic ileus);
• if you suffer from difficulty breathing (respiratory depression);
• if you suffer from severe liver problems (severe hepatocellular insufficiency);
• if you suffer from heart problems associated with other respiratory disorders (cardiac decompensation secondary to and chronic lung disease);
• if you have suffered head trauma (trauma) or have increased pressure in your head (increased intracranial pressure);
• if you have undergone surgery on the liver or gallbladder (bile ducts);
• during a breathing 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 states of depression of the central nervous system, in particular due to other medicines (hypnotics, sedatives, tranquilizers);
• if you are being treated with medicines to treat depression (monoamine oxidase inhibitors), furazolidone or if you have stopped treatment with these medicines less than 2-3 weeks ago;
• if you are being treated with naltrexone, to treat dependence on morphine and other opium derivatives;
• if you are pregnant and during breastfeeding (see the paragraph “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor, pharmacist or nurse if you notice the appearance of any of the following symptoms during
the use of morphine hydrochloride monic:

• increased sensitivity to pain despite taking increasing doses (hyperalgesia); the doctor will decide whether a change in dose or a change in the strong painkiller (“analgesic”) is necessary (see paragraph 2);
• weakness, fatigue, loss of appetite, nausea, vomiting or low blood pressure; this may indicate a symptom that the adrenal glands are producing insufficient amounts of cortisol hormone and you may need to take a hormone supplement;
• loss of libido, impotence, cessation of menstruation; this may be due to a decrease in the production of sex hormones;
• if you have been dependent on drugs or alcohol in the past; also let them know if you feel like you are becoming dependent on morphine hydrochloride monic while you are using it; you may have started to think a lot about when you can take the next dose, even if you don't need it for pain;
• withdrawal or dependence symptoms; the most common withdrawal symptoms are mentioned in paragraph 3; if this occurs, the doctor may change the type of medicine or the timing between doses.

Take particular care with morphine hydrochloride monic:
Acute generalized exanthematous pustulosis (AGEP) has been reported in association with treatment with morphine
hydrochloride monic. Symptoms usually appear within the first 10 days of treatment. Tell your doctor if you have
previously developed severe skin rashes or scaling of the skin, rash with blisters and/or mouth ulcers
after taking morphine hydrochloride monic or other opioids. Stop using morphine hydrochloride monic
and consult your doctor immediately if you notice any of the following symptoms: rash with blisters,
widespread scaly skin or pus-filled spots together with fever.
Sleep-related breathing disorders
Morphine hydrochloride monic can cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing
during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include
pauses in breathing during sleep, awakenings at night due to shortness of breath, difficulty staying asleep, or
excessive daytime sleepiness. If you or another person observes these symptoms, consult your doctor. The
doctor may consider reducing the dose.
Consult your doctor if you experience severe upper abdominal pain with possible radiation to the
back, nausea, vomiting or fever, as these may be symptoms associated with inflammation of the pancreas
(pancreatitis) and bile ducts.
Use this medicine with caution if:

• you are an elderly, very elderly person or if you are debilitated; in these cases it may be necessary to reduce the dose;
• you suffer from heart problems due to lung disease;
• you suffer from brain disorders (organic-cerebral conditions);
• you have breathing problems (respiratory failure and chronic lung diseases, especially if accompanied by increased bronchial secretion, airway closure and reduced ventilatory reserve, such as in the case of kyphoscoliosis and obesity);
• you suffer from kidney and gallbladder problems (renal and biliary colic);
• you have prostate problems (prostatic hypertrophy);
• you have an alteration in the levels of thyroid hormones (myxedema, hypothyroidism);
• you suffer from liver problems (hepatitis and acute liver diseases);
• your liver or kidneys are functioning less than adequately;
• you suffer from hormonal problems (adrenocortical insufficiency);
• you have a severe drop in blood pressure (severe hypotensive states) and loss of consciousness (shock);
• you suffer from digestive problems (slowing or blockage of the gastrointestinal tract, intestinal disorders due to inflammation or obstruction);
• you suffer from muscle problems (myasthenia gravis);
• you suffer from alterations in the rhythm and function of the heart and circulation (cardiovascular conditions, cardiac arrhythmias) or suffer from problems with the heart valves (aortic valve dysfunction) and circulation of the heart (coronary disorders).

Morphine, due to its analgesic (pain-relieving) effect, its action on consciousness, pupil diameter and breathing, can mask some symptoms and make it difficult to assess them by the doctor.
The administration of morphine, especially if prolonged, can cause the appearance of tolerance (progressive need
for higher doses to obtain the same effect) and dependence. Therefore, morphine can only be used under
medical supervision and in cases where other pain relievers have not been effective.

• Tolerance to morphine occurs with a reduction in the effectiveness and duration of the analgesic effect. If you should develop dependence on this medicine, your dose will be increased. Increasing the dose does not entail risks for breathing (respiratory depression). Tolerance to this medicine ends after a few days of stopping treatment.
• Dependence on morphine occurs simultaneously with tolerance, especially near the interruption of morphine administration. Dependence is characterized by a series of symptoms (which together constitute the “withdrawal syndrome”) such as: widespread pain, diarrhea, increased blood pressure (hypertension), feeling cold, which appear within a few hours of taking the last dose. Withdrawal symptoms reach their peak intensity within 36-72 hours for

then gradually regress. The most frequent symptoms in the first 24 hours are restlessness, yawning, dilation
of the pupils (mydriasis), tearing, runny nose (rhinorrhea), increased sweating and goosebumps
(horripilation).
After 24 hours, involuntary muscle contractions (fasciculations and muscle spasms) may appear,
pain in the abdomen and legs, back pain (lumbago), headache (cephalalgia), sneezing, weakness, anxiety,
irritability, alterations or loss of sleep (insomnia), agitation, loss of appetite (anorexia), nausea,
vomiting, diarrhea, loss of fluids (dehydration), weight loss, increased heart rate (tachycardia), increased breathing rate (tachypnea), increased blood pressure
(hypertension), increased body temperature (fever) and disorders of the blood vessels (vasomotor).
If left untreated, these symptoms can disappear in 5-14 days.
Dependence and tolerance develop slowly if morphine is administered in a clinical setting to prevent pain and not on demand. Morphine hydrochloride monic will be administered to you in the clinic or in
hospital by specialized personnel, so it is rare to develop dependence and tolerance of such a high degree.
However, it is necessary that during treatment with this medicine you are kept under strict medical control.
Discontinuation of treatment must be gradual and must always occur under strict medical supervision. If
cases of high-grade tolerance should occur, the intervention of specialists is necessary. The
morphine should not be used in those painful states that respond to pain relievers less potent than morphine,
this in order to eliminate even the minimum risk of developing dependence (see the paragraph “If you stop the
treatment with morphine hydrochloride monic”).

For those who play sports:the use of the drug without therapeutic necessity constitutes doping and may in any case determine
positive results in anti-doping tests.

Children
Morphine should only be administered to children in cases of real need, especially in newborns.

Other medicines and morphine hydrochloride monico
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
The association of morphine hydrochloride monico with antidepressants (tricyclic antidepressants) and medicines that act
on inflammation (aspirin, non-steroidal anti-inflammatory drugs) is effective in increasing the analgesic effects,
allowing a decrease in the dose of morphine.
If you experience pain (with a neurological component), the association of morphine hydrochloride monico with medicines for the
treatment of epilepsy (carbamazepine, anticonvulsants) may increase the analgesic and sedative effect.
If you experience pain due to inflammation of the brain nerves (neuralgia), lesions of the thalamus (thalamic syndrome)
or spinal cord lesions, morphine hydrochloride monico may not be effective. In these cases, it may be necessary
to use other medicines (anticonvulsants, antidepressants and long-acting phenothiazines).
Do not use morphine hydrochloride monico if you are being treated with:

• medicines for the treatment of depression (monoamine oxidase inhibitors) and furazolidone because the association of these medicines can cause a decrease in blood pressure (hypotension) and difficulty breathing (respiratory depression, see the section “Warnings and precautions”);
• naltrexone and similar medicines used to treat morphine dependence (see the section “Warnings and precautions”) because it may mask the analgesic effect of morphine;
• other medicines containing alcohol and alcoholic beverages (see the section “morphine hydrochloride monico with alcohol”), because they increase the sedative effect of morphine altering the state of wakefulness and making driving dangerous (see the section “Driving and operating machinery”).

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

• rifampicin, a medicine used to treat infections caused by bacteria; concomitant use may cause a decrease in the effect of morphine; during and at the end of rifampicin therapy, your doctor will perform checks to establish a dose adjustment of morphine, if necessary;
• certain drugs used to treat blood clots (e.g. clopidogrel, prasugrel, ticagrelor) may have a delayed and reduced effect if taken in combination with morphine
• cimetidine and other drugs that are cytochrome P450 inhibitors; the association of morphine and cimetidine can cause confusion and breathing problems if you are undergoing mechanical blood filtration (hemodialysis); these medicines cause an increase in the effect and duration;
• barbiturates, used to treat seizures and to induce anesthesia;
• other medicines for pain (morphine agonist analgesics, such as alfentanil, codeine, dextromoramide, destropropoxyphene, dihydrocodeine, fentanyl, oxycodone, pethidine, phenoperidine, remifentanil, sulfentanil, tramadol);
• medicines used to treat cough (morphine antitussives, such as codeine and morphine-like, such as dextromethorphan);
• other sedative medicines (neuroleptics), used to treat depression (antidepressants), for the treatment of muscle stiffness (muscle relaxants), for allergies (antihistamines), to induce anesthesia (anesthetics), because they can increase the effects of morphine on breathing and on the ability to drive vehicles and use machinery (see the section “Driving and operating machinery”);
• medicines used to prevent blood clot formation (oral anticoagulants, including dicoumarol); morphine may potentiate the effects of these medicines;
• medicines used to increase the elimination of fluids (diuretics); morphine may decrease the effect of these medicines and cause urinary retention, especially if you suffer from prostate problems (early prostatism).

Many drugs can interact with morphine hydrochloride injectable preparation, with a possible significant alteration
of their effects. These drugs include:

• gabapentin or pregabalin for the treatment of epilepsy and pain due to nerve problems (neuropathic pain)
• .

The use of morphine hydrochloride monico together with sedative medicines (such as benzodiazepines or related drugs) increases
the risk of drowsiness, difficulty breathing (respiratory depression), coma and could be life-threatening.
For this reason, the use of morphine hydrochloride monico together with these medicines should be considered only
when alternative treatments are not available. However, if your doctor prescribes morphine hydrochloride monico
together with sedative medicines, the dose and duration of concomitant treatment should be reduced by the doctor.
Tell your doctor about all the sedative medicines you are taking and carefully follow the doses recommended by your doctor.
It may be helpful to tell relatives and friends to pay attention to the appearance of the signs and symptoms described
above. Contact your doctor if you experience any of the described symptoms.

Morphine hydrochloride monico with alcohol
The consumption of beverages and medicines containing alcohol is not recommended if you are being treated with morphine
hydrochloride monico because alcohol can increase the sedative effects and breathing problems.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy or if you are breastfeeding with breast milk, ask
your doctor or pharmacist for advice before using this medicine.

Pregnancy
Do not use morphine hydrochloride monico during pregnancy unless absolutely necessary, such as the presence of
severe pain.
Prolonged use of this medicine, as well as other similar medicines (narcotic analgesics), can
cause breathing problems (respiratory depression) in the newborn or withdrawal symptoms (withdrawal crises).
If morphine hydrochloride monico is used for a long time during pregnancy, there is a risk that the newborn will present
substance withdrawal symptoms (withdrawal) that must be treated by a doctor.
Administration should be avoided in premature deliveries or during the second stage of labor (when the cervix
reaches 4-5 cm).

Breastfeeding
Morphine passes into breast milk. Your doctor will assess the need to discontinue breastfeeding or treatment.

Driving and operating machinery
This medicine can cause effects that significantly alter your ability to drive vehicles and use
machinery. Avoid driving vehicles and using machinery during treatment with this medicine.
These effects may be greater if you take this medicine in combination with alcohol or other sedative medicines (see the sections “morphine hydrochloride monico with alcohol” and “Other medicines and morphine hydrochloride monico”).

3. How to use morphine hydrochloride monico

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what you can expect from the use of morphine hydrochloride monico, when and for how long it is necessary to use it, when to contact your doctor and when it is necessary to stop treatment (see also If you stop taking morphine hydrochloride monico, in this paragraph).
This medicine will be administered to you by a doctor or a nurse, under the skin (subcutaneously), into a muscle (intramuscularly), into a vein (intravenously) or into the epidural space.
It is possible to dilute the contents of the vial in physiological solution (sodium chloride 0.9%) or in another solvent (glucose 5%).
The doctor will adjust the dose taking into account your age and your state of health.

Use in adults
Treatment of acute pain:

• administration under the skin or into a muscle: the recommended dose is 10 mg to be repeated, if necessary, every 4 hours;
• direct administration into a vein: the recommended dose is between 2 mg and 10 mg per 70 kilograms of body weight, administered in 4-5 minutes.

Treatment of pain after surgery:

• epidural administration: the recommended dose is between 2 and 5 mg; this dose provides pain relief for 24 hours; if necessary, the doctor will decide to increase the dose by 1-2 mg, at regular intervals, to assess that it is effective; do not exceed the dose of 10 mg in 24 hours;
• administration for continuous infusion into a vein: the recommended initial dose is 2-4 mg in 24 hours. The doctor will 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, for slow and direct injection into a vein (2 mg per minute).

Treatment of pain associated with heart activity blockage (myocardial infarction)
The recommended dose is 10 mg followed by another 10 mg if necessary, for slow direct administration into a vein (2 mg per minute).

Use in newborns

• slow administration into a vein (bolus): the recommended dose is between 40 and 100 micrograms per kilogram of body weight in at least 5-10 minutes, every 4-6 hours;
• administration for infusion into a vein:
• in premature babies: the recommended initial dose is between 25 and 50 micrograms per kilogram of body weight; this dose should be followed by a second administration (loading dose) of 5 micrograms per kilogram of body weight per hour;
• in full-term babies: 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
In children under 12 years of age, the use of this medicine should only occur in cases of real necessity:

• administration into a vein (bolus): the recommended dose is between 100 and 200 micrograms per kilogram of body weight, up to 6 times a day;
• administration for infusion: to be carried out only after administering an initial dose (bolus administration); the recommended dose is between 10-30 micrograms per kilogram of body weight per hour.

Use in adolescents from 12 to 18 years:

• administration into a vein (bolus): the recommended dose is between 2.5 and 10 mg up to 6 times a day;
• administration for infusion: to be carried out only after administering an initial dose (bolus administration); the recommended dose is between 10 and 30 micrograms per kilogram of body weight per hour.

Use in the elderly and debilitated patients
The doctor will decide whether to reduce the dose, based on your state of health (see the paragraph “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 the most severe cases, the dose may be halved.

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

• breathing problems (respiratory depression, respiratory arrest), collapse, coma or death;
• problems with blood circulation;
• alteration of the state of consciousness;
• constriction of the pupil (miosis);
• lowering of body temperature (hypothermia);
• flaccidity of the muscles, breakdown of muscle cells (rhabdomyolysis), up to alteration of kidney activity (renal failure);
• pneumonia due to inhalation of vomit or foreign bodies, whose symptoms may include shortness of breath, cough and fever.

In severe cases, insufficient blood circulation (circulatory failure), coma, collapse and death can develop. During coma, relaxation of the organs (relaxation of the sphincters), increase in the diameter of the pupils (mydriasis) can occur.
In less severe cases, the symptoms may be:

• nausea, vomiting;
• tremors;
• behavioral changes (dysphoria);
• decrease in body temperature (hypothermia);
• decrease in blood pressure (hypotension).

In case of ingestion/taking an excessive dose of this medicine, immediately warn your doctor or go to the nearest hospital.

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

If you stop taking morphine hydrochloride monico
Do not suddenly stop treatment with this medicine; consult your doctor before stopping treatment.
If you intend to stop treatment with morphine hydrochloride monico, ask your doctor how to gradually reduce the dosage in order 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 an intense feeling of dissatisfaction, anxiety and irritability.
If you have any doubts 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 morfina cloridrato monico and contact your doctor immediately if you experience 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 based on available data):

• severe allergic reaction causing difficulty breathing 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, altered behavior (euphoria, dysphoria);
• sleep loss (insomnia);
• sedation;
• reduced mood;
• feeling of weakness (asthenia);
• confusion (mental dullness), states of indifference;
• headache;
• dizziness;
• sweating
• dry mouth;
• increased pressure inside the head which may worsen pre-existing brain disorders;
• vision problems, narrowing of the pupils (miosis);
• feeling of dizziness, due to a decrease in blood pressure, when getting up (orthostatic hypotension);
• temporary loss of consciousness (syncope);
• breathing problems (depression, respiratory arrest), which may be severe if you have problems with your bronchi or lungs (atelectasis);
• circulatory depression;
• collapse;
• nausea, vomiting;
• blockage of digestion (closure of the sphincter of Oddi and increased pressure in the bile ducts which can cause nausea and biliary colic pains);
• decreased secretions of the stomach and intestines, increased tone of the intestinal smooth muscles and slowing of the peristaltic wave which leads to constipation (spastic 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”);
• decreased urine output (hormonal oliguria), as morphine prolongs bladder emptying time but rapid tolerance develops to this effect;
• increased sensitivity to pain;
• sleep apnea (pauses in breathing during sleep);
• symptoms associated with inflammation of the pancreas (pancreatitis) and bile ducts, such as severe pain in the upper abdomen with possible radiation to the back, nausea, vomiting or fever.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through 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 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 “Scad.”. The expiry date
refers to the last day of that month.
Store the vials in the original packaging to protect the medicine from heat and light.
Caution: do not use the solutions if they appear coloured. The vials are for single use, discard any solution that you do not
use.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What contains morfina cloridrato monico
morfina cloridrato monico 10 mg/1 ml Injectable solution

• The active ingredient 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 Injectable solution

• The active ingredient 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 Injectable solution

• The active ingredient 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 Injectable solution
morfina cloridrato monico 100 mg/10 ml Injectable solution

• The active ingredient 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 Injectable solution

• The active ingredient 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 contents of the pack
morfina cloridrato monico 10 mg/1 ml Injectable solution: pack containing 1 or 5 glass vials of 10 mg/1 ml.
morfina cloridrato monico 20 mg/1 ml Injectable solution: pack containing 1 or 5 glass vials of 20 mg/1 ml.
morfina cloridrato monico 50 mg/5 ml Injectable solution: pack containing 5 glass vials of 50 mg/5 ml.
morfina cloridrato monico 100 mg/5 ml Injectable solution: pack containing 5 glass vials of 100 mg/5 ml.
MORFINA CLORIDRATO MONICO 100 mg/10 ml Injectable solution: pack containing 5 glass vials of 100
mg/10 ml.
MORFINA CLORIDRATO MONICO 200 mg/10 ml Injectable solution: pack containing 5 glass vials of 200
mg/10 ml.

Marketing authorisation holder and manufacturer
Monico spa
Via Ponte di Pietra 7, 30173 Venezia Mestre – Italy

The following information is intended exclusively for doctors or healthcare professionals.
Morphine hydrochloride should not be mixed with other medicines.
Morphine salts are incompatible with aminophylline, sodium barbiturates and phenytoin, acyclovir sodium, furosemide,
sodium heparin, pethidine, chlorpheniramine, promethazine and edisilates.
Physical-chemical incompatibility (formation of precipitates) between solutions of morphine sulfate and 5-
fluorouracil has been demonstrated.