Package Insert: Information for the User

Morphine B. Braun 10 mg/ml Injectable Solution

morphine, hydrochloride

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Morfina B. Braun belongs to the group of opioid analgesics. It is indicated in the following cases:

- Intense pain treatment.

- Immediate postoperative pain.

- Malignant chronic pain.

- Pain caused by myocardial infarction.

- When there is difficulty breathing (dyspnea) associated with left ventricular insufficiency and pulmonary edema.

- Anxiety due to surgical procedures.

No use Morfina B. Braun

- If you have had any allergic reaction to morphine hydrochloride or any other opioid analgesic.

- If you have any of the following diseases:

- respiratory diseases (respiratory depression or severe obstructive respiratory disease),

- coagulation disorders or infection at the injection site (for epidural and intrathecal administration routes).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Morfina B. Braun.

If you have any of the following diseases, your doctor will perform a special clinical check:

- increased intracranial pressure,

- brain injury,

- chronic asthma,

- low blood pressure (hypotension),

- hypothyroidism (deficient thyroid secretion),

- rapid heart rate (supraventricular tachycardia),

- benign prostatic hypertrophy or urethral stricture (urethral stenosis),

- biliary tract dysfunction,

- intestinal disorders such as severe inflammatory bowel disease,

- history of drug dependence.

Consult your doctor, pharmacist, or nurse if you experience any of the following symptoms while using this medication:

- Increased sensitivity to pain despite taking increasingly larger doses (hyperalgesia). Your doctor will decide if you need a dose adjustment or switch to a potent analgesic (see section 2).

- Weakness, fatigue, decreased appetite, nausea, vomiting, or low blood pressure. This could indicate that the adrenal glands produce insufficient amounts of cortisol hormone, and you may need to take hormone supplements.

- Loss of libido, impotence, cessation of menstruation. This could be due to reduced production of sex hormones.

- If you have a history of alcoholism or drug addiction. Also inform your doctor if you think you are starting to depend on Morfina B. Braun while using it. You may have started thinking too much about when you can take the next dose, even though you don't need it for pain.

- Symptoms of withdrawal or dependence.The most common symptoms of withdrawal are described in section 3. If they appear, your doctor may change the medication or modify the dosing interval.

- If you experience severe upper abdominal pain that may radiate to the back, nausea, vomiting, or fever, as it could be symptoms associated with pancreatitis and biliary tract inflammation.

Your doctor will take special precautions when administering it to very young patients, elderly patients, severely debilitated patients, or patients with renal or hepatic insufficiency, as they may be more sensitive to the effects of morphine.

Special caution with morphine:

Generalized acute pustular exanthema (PEGA) associated with morphine treatment has been reported. Symptoms usually occur within the first 10 days of treatment. Inform your doctor if you have ever suffered from severe skin rash or skin peeling, blisters, and/or mouth sores after taking morphine or other opioids. Stop using this medication and seek medical attention immediately if you notice any of the following symptoms: blisters, widespread skin peeling, or pus-filled points (pustules) accompanied by fever.

Sleep-related respiratory disorders:

This medication may cause sleep-related respiratory disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakening due to dyspnea, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Tolerance, dependence, and addiction

This medication contains morphine, an opioid. Repeated use of opioids may lead to reduced medication effectiveness (tolerance). Repeated use of this medication may also cause dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and longer use.

Dependence or addiction may cause a sense of lack of control over the amount of medication to be used or the frequency of use.

The risk of dependence or addiction varies from person to person. You may have a higher risk of dependence or addiction to morphine if:

• You or any family member has abused or had dependence on prescription medications or illegal drugs ("addiction").
• You smoke.
• You have ever had mood problems (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental health conditions.

If you notice any of the following symptoms while taking morphine, it could be a sign of dependence or addiction:

• You need to take the medication for a longer period than recommended by your doctor.
• You need to take a higher dose than recommended.
• You are using the medication for reasons other than those prescribed, such as "to stay calm" or "to help you sleep".
• You have made repeated and unsuccessful attempts to stop using the medication or control its use.
• You feel unwell when you stop using the medication, and you feel better once you take it again ("withdrawal symptoms").

If you notice any of these symptoms, consult your doctor to determine the best course of treatment for you, including when it is appropriate to discontinue the medication and how to do it safely (see section 3 "If you interrupt treatment with Morfina B. Braun").

Abrupt interruption of treatment, if you have physical dependence on morphine, may precipitate withdrawal syndrome.

Symptoms of withdrawal may also occur after administration of an opioid antagonist (naloxone or naltrexone) or an agonist/antagonist (pentazocine).

This medication should only be used by experienced doctors, and the necessary equipment for artificial respiration should be available at all times, as well as an opioid antagonist.

Your doctor will take into account:

- When using the intravenous route, that you remain lying down to reduce adverse effects.

- When using the epidural and intrathecal routes, use an appropriately sized needle and correct placement of the needle and catheter in the epidural space.

Your doctor will inject slowly in the lumbar region, performing an aspiration to reduce the risk of accidental intravascular administration.

Use in athletes

This medication contains a component that may result in a positive analytical result for doping control.

Other medications and Morfina B. Braun

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

The administration of morphine with the following medications may require adjusting the dose of one or both medications.

It is essential to inform your doctor if you use any of the following medications:

- antidiarrheals,

- blood pressure-lowering medications (anti-hypertensives),

- antimuscarinics (as they may increase the risk of severe constipation),

- monoamine oxidase inhibitors (MAOIs),

- naltrexone,

- rifampicin, for example, to treat tuberculosis,

- gabapentin and pregabalin for the treatment of epilepsy and pain caused by nerve problems (neuropathic pain),

- The concomitant use of morphine and sedatives such as benzodiazepines or other related medications increases the risk of somnolence, respiratory depression, coma, and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes morphine with sedatives, you should limit the dose and duration of concomitant treatment. Inform your doctor of all sedatives you are taking and follow your doctor's recommendations strictly about the dose. It may be helpful to inform friends or family members to recognize the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms,

- Some medications used in the treatment of blood clots (e.g., clopidogrel, prasugrel, ticagrelor) may have a delayed and reduced effect when taken with morphine.

There is another group of medications that may increase the effects of morphine. In this case, your doctor will adjust the dose of both medications:

- medications that cause central nervous system depression, as they may potentiate respiratory depression and hypotension,

- neuromuscular blockers, as they may prolong the effects of respiratory difficulty,

- opioid agonist analgesics, as they may cause additive effects in respiratory depression and hypotension,

- pentazocine, nalbuphine, and butorphanol.

In the case of patients receiving treatment with medications such as buprenorphine and naloxone, the effects of morphine may be reduced.

Consult your doctor or pharmacist if you are unsure.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Your doctor will evaluate the risk-benefit ratio, as morphine crosses the placenta. Regular use during pregnancy may cause physical dependence in the fetus, leading to withdrawal symptoms in the newborn, such as convulsions, irritability, excessive crying, tremors, hyperactive reflexes, fever, vomiting, diarrhea, sneezing, and yawning, which should be treated by a doctor.

Morphine is excreted in breast milk. Although no problems have been described in humans, the possible effects on the infant are unknown, and your doctor will evaluate whether to discontinue or continue breastfeeding.

Driving and operating machinery

Do not drive or operate tools or machines, as this medication may cause somnolence.

Morfina B. Braun contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per ampoule; it is essentially "sodium-free".

This medication will be administered by healthcare personnelonly by intravenous, intramuscular, subcutaneous, epidural, and intrathecal routes

Your doctor will determine the most suitable dose for you.

Dosing varies according to the administration route, pain intensity, and other medications administered concurrently.

Before starting treatment and periodically during treatment, your doctor will explain what you can expect from the use of Hydrochloride of Morphine Trihydrate, when and how long you need to take it, when to contact your doctor, and when to discontinue it (see also the section "If you interrupt treatment with Morfina B. Braun").

As a general rule, in adults, the usual doses are as follows:

-Subcutaneous or intramuscular:

5-20 mg /4 hours; 10 mg initial dose.

Pain relief during childbirth: 10 mg.

-Intravenous:

2.5 - 15 mg diluted in 4-5 ml of sterile water for injection or with 0.9% sodium chloride solution and administer slowly intravenously over 4-5 minutes.

- Patients with acute myocardial infarction:

2 - 15 mg of hydrochloride of morphine trihydrate may be administered in increasing doses (1 - 3 mg) every 5 minutes.

- Continuous intravenous infusion:

. Initial dose: 0.8-10 mg/h, increasing subsequently based on patient response

. Maintenance dose: 0.8-80 mg/h, although higher doses (150 mg/h) may sometimes be necessary. Very high doses (275-440 mg/h) may be required for several hours or days to provide relief in cases of intense pain.

-Epidural (lumbar region):

5 mg. If necessary, administer additional doses of 1 or 2 mg after 1 hour, not exceeding a total dose of 10 mg in 24 hours.

-Intrathecal (lumbar region):

0.2 - 1 mg / 24 hours.

The administration of hydrochloride of morphine trihydrate via epidural or intrathecal routes during childbirth may cause adverse effects in the neonate, especially if premature. Intrathecal administration of up to 1 mg of hydrochloride of morphine trihydrate has little effect on the first stage of labor, but may prolong the second stage.

Older adults and debilitated patients may require lower doses.

Use in children and adolescents:

In children, the usual doses are as follows:

-Subcutaneous or intramuscular:

0.1 - 0.2 mg/kg/4 hours as needed, not exceeding 15 mg in 24 hours.

-Intravenous:

0.05 - 0.1 mg/kg administered slowly, not exceeding 15 mg in 24 hours.

- In children with intense chronic pain:

. Continuous intravenous infusion:

0.04- 0.07 mg/kg/h

. Maintenance dose: 0.025-1.79 mg/kg/h.

- For postoperative analgesia, maintenance doses of 0.01-0.04 mg/kg/h by continuous intravenous infusion are required.

In neonates, drug elimination is slower, and they are more susceptible to central nervous system effects; it is recommended not to exceed a dose of 0.015 - 0.02 mg/kg/h by continuous intravenous infusion.

This medication should not be used via epidural or intrathecal routes in children.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

If you use more Morfina B. Braun than you should

Overdose is characterized by respiratory depression with bradypnea (slow breathing) accompanied or not by central nervous system depression.People who have taken an overdose may also experience difficulty breathing that may lead to loss of consciousness or even death.

People who have taken an overdose may suffer from aspiration pneumonia; symptoms may include shortness of breath, cough, and fever.

The recommended treatment for overdose is:

- Maintain a respiratory tract and ensure adequate respiration with oxygen, if necessary by assisted respiration.

- Administer naloxone (0.4 to 2 mg) in a single dose, preferably intravenously. Naloxone injection may be repeated at intervals of 2 to 3 minutes.

- Administer intravenous fluids and/or vasopressors.

- Continue patient monitoring.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service phone: 91.562 04 20, indicating the medication and the amount used. Bring this leaflet with you.

If you interrupt treatment with Morfina B. Braun

Do not stop treatment with morphine unless your doctor approves. If you want to stop treatment with this medication, ask your doctor how to gradually reduce the dose to avoid withdrawal symptoms. Withdrawal symptoms may include generalized pain, tremors, diarrhea, stomach pain, nausea, flu-like symptoms, palpitations, and dilated pupils. Psychological symptoms include a deep sense of dissatisfaction, anxiety, and irritability.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop using this medicine and seek medical attention immediately if you observe any of the following symptoms:

. Severe allergic reaction that causes difficulty breathing or dizziness.

. Severe skin reaction with blisters, generalized skin peeling, pus-filled spots (pustules) along with fever. It could be a disease called generalized acute pustular psoriasis (GAPP).

Other possible side effects:

- Very common (>1/10):

.Gastrointestinal disorders:: nausea, vomiting, constipation.

.Nervous system disorders:somnolence, disorientation, sweating, euphoria, and in prolonged treatments, tolerance.

- Less common (>1/1000, <1

.Nervous system disorders:: headache, agitation, tremor, convulsions, anxiety, depression, muscle rigidity, hallucinations, difficulty sleeping.

.Gastrointestinal disorders:: dry mouth, laryngeal spasm, diarrhea, abdominal cramps, taste alterations.

.Cardiac disorders:: cardiac arrest, tachycardia, and bradycardia, hypertension, hypotension, intracranial hypertension, collapse.

.Respiratory disorders:: respiratory depression, difficulty breathing (apnea).

.Renal and urinary disorders:; reduced libido, impotence.

.Eye disorders:: blurred vision, nystagmus, diplopia, miosis.

.Skin disorders:: edema, pruritus, urticaria, rashes, contact dermatitis, pain at the injection site.

- Very rare (<1

- Unknown frequency (cannot be estimated from available data):

. Increased sensitivity to pain.

. Abstinence or dependence symptoms (see section 3: If you stop treatment with Morfina B. Braun).

. Sleep apnea (pauses in breathing during sleep).

. Symptoms associated with pancreatitis and biliary tract inflammation, such as severe upper abdominal pain that may radiate to the back, nausea, vomiting, or fever.

The epidural or intrathecal administration does not eliminate the risk of severe side effects. Respiratory depression can occur shortly after administration due to direct venous redistribution to the respiratory centers of the central nervous system.

Additionally, delayed respiratory depression may occur up to 24 hours after administration, possibly as a result of rostral extension. After epidural or intrathecal administration of morphine, urinary retention often occurs, especially in men, which may persist for 10 to 20 hours after injection, requiring catheterization.

Additionally, generalized pruritus often occurs, depending on the dose.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine

Conservebelow 25°C and in the original packaging.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date indicated on the packaging after CAD.The expiration date is the last day of the month indicated..

The contents of the ampoules must be used immediately after opening. Once the packaging is opened, discard the unused portion of the solution.

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications that you no longer need at the SIGRE collection point at the pharmacy.In case of doubt,ask your pharmacist how to dispose of the containers and medications that you no longer need.This will help protect the environment.

Composition of Morfina B. Braun

The active principle is hydrochloride of morphine (as trihydrate). Each ampoule contains 10 mg of hydrochloridetrihydrateof morphine (equivalent to 7.6 mg of morphine base).

The other components (excipients) are sodium chloride and water for injection preparations.

Appearance of Morfina B. Braun and content of the container

Transparent injectable solution that is presented in amber glass ampoules of 1 ml capacity.

Containers containing 1 and 10 ampoules.

Marketing Authorization Holder:

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191 Rubí (Barcelona),

Spain.

Responsible for manufacturing:

B. Braun Medical, S.A.

Ronda de los Olivares, Parcela 11,

Polígono Industrial Los Olivares,

23009,Jaén (Jaén),

Spain,

Last review date of this leaflet:October 2024.

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices. http//www.aemps.gob.es/

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This information is intended solely for doctors or healthcare professionals:

This medicine is incompatible with bases, bromides, iodides, potassium permanganate, and tartaric acid. It is also incompatible with iron, lead, magnesium, silver, copper, and zinc salts.

Handle in the usual aseptic conditions for the use of injectable solutions.

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