Package Insert: Information for the User

Morphine B. Braun 20 mg/ml Injectable Solution in Vial

morphine, hydrochloride

Read this entire 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.

1. What is Morphine B. Braun and how is it used

2. What you need to know before starting to use Morphine B. Braun

3. How to use Morphine B. Braun

4. Possible adverse effects

5. Storage of Morphine B. Braun

6. Contents of the package and additional information

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

- For the treatment of intense pain.

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

No use Morfina B. Braun

- If you are allergic to morphine hydrochloride or any of the other components of this medication (listed in section 6).

- If you have respiratory diseases (depression or severe obstructive respiratory disease).

- If you have acute bronchial asthma.

- If you have been treated with antidepressant medications known as monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing treatment.

- If you have acute and/or severe liver disease.

- If you have a head injury; increased intracranial pressure.

- If you are in a coma.

- If you have renal and biliary tract spasms.

- If you have acute alcoholism.

- If you have a risk of paralytic ileus (reduced intestinal motility).

- If you have ulcerative colitis (inflammatory disease of the colon and rectum that causes diarrhea with or without blood and abdominal pain).

- If you are in shock (a condition in which the body is not receiving sufficient blood flow and is characterized by low blood pressure, anxiety, confusion, pale skin, dizziness, sweating, chest pain, and sometimes loss of consciousness).

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

Warnings and Precautions

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

- If you have a prostate adenoma or urethral stricture.

- If you have a malfunctioning gallbladder.

- If you have severe inflammatory intestinal disease.

- If you have hypothyroidism (produces insufficient thyroid hormones).

- Elevated intracranial pressure (if you have severe headache or dizziness) or brain injury.

- If your kidneys do not function properly.

- If your liver does not function properly.

- If you have obstructive respiratory diseases or chronic asthma.

- If you have heart and circulation diseases, hypotension, and tachycardia.

- In patients undergoing treatment with central nervous system depressants (CNS).

Consult your doctor or pharmacist or nurse if you experience any of the following symptoms:

- 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 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.Common withdrawal symptoms are described in section 3. If they appear, your doctor may change medication or modify the interval between doses.

- 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 weakened patients, or those with renal or hepatic insufficiency, as they may be more sensitive to the effects of morphine.

Special caution is recommended with morphine:

Generalized acute pustular exanthema (GPE) 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 a 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) along with 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 can lead to reduced medication effectiveness (tolerance). Repeated use of this medication can also cause dependence, abuse, and addiction, which may 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 you should use or the frequency with which you should use it.

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 had any mental health 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 your 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 discontinuation 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).

Use in athletes

This medication contains morphine, which may give a positive result in doping control tests.

Other medications and Morfina B. Braun

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

There are a series of medications with which morphine is not recommended to be used, unless it is strictly necessary:

- Anti-diarrheal medications (medications for the treatment of diarrhea).

- Anti-hypertensive medications (medications to reduce blood pressure).

- Antimuscarinic medications (as they may increase the risk of severe constipation).

- Monoamine oxidase inhibitors (MAOIs) (medications for the treatment of depression) or within two weeks of discontinuing use.

- Naltrexone, (used to help people who suffer from addiction to narcotics or alcohol to stop using these substances).

- 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, only consider concomitant use when other treatment options are not possible. However, if your doctor prescribes morphine along with sedatives, you should limit the dose and duration of concomitant treatment. Inform your doctor of all sedatives you are taking and strictly follow your doctor's recommendations regarding the dose. It may be helpful to inform friends or family members to recognize the signs and symptoms indicated above. Contact your doctor if you have 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 produce central nervous system depression.

- Neuromuscular blockers (medications used to produce muscle relaxation before surgical procedures).

- Analgesics (pain medications) with a similar effect to opioids.

- Opioids (such as pentazocine, nalbuphine, and butorphanol).

There is a group of medications that reduce the effect of morphine, including:

• Buprenorphine.
• Naloxone.

Use of Morfina B. Braun with food, drinks, and alcohol

The concomitant administration of this medication with alcohol produces mutual potentiation of toxicity, with increased central depression.

Pregnancy and lactation and fertility

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

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, hyperreflexia, fever, increased respiratory rate, hiccups, and diarrhea), which should be treated by a doctor.

The use of this medication is only accepted in the absence of safer alternatives.

Morphine is excreted in breast milk. Although no problems have been described in humans, the possible effects on the infant are unknown, so your doctor should evaluate the benefit-risk balance.

Driving and operating machinery

Ask your doctor if you can drive or operate machinery during treatment with this medication. It is essential to observe how this medication affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be especially careful at the start of treatment, after increasing the dose, after changing the formulation, and/or when taking it concomitantly with other medications.

Morfina B. Braun contains sodium

This medication contains 70.8 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 3.54% of the recommended daily maximum sodium intake for an adult.

This medication will be administered only by healthcare personnel.

The dose and duration of treatment will be individualized by your doctor based on the potency and duration of the medication used, the intensity of the pain, other medications administered simultaneously, and the patient's response.

The injection can be administered in a vein (intravenous injection), in a muscle (intramuscular injection) or under the skin (subcutaneous injection). It can be administered intermittently (for example, every 4 hours) or continuously (for example, through slow infusion).

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 often you need to take it, when to contact your doctor and when to interrupt it (see also the section "If you interrupt treatment with Morfina B. Braun").

Use in children and adolescents

This medication should not be used epidurally and intrathecally in children.

If you use moreMorfina B. Braunthan you should

In case of overdose or accidental ingestion, consult your doctor or the Toxicological Information Service immediately. Phone (91) 562 04 20 indicating the medication and the amount used.

An overdose is characterized by respiratory depression with bradypnea (decreased respiratory frequency), accompanied or not by central nervous system depression. People who have taken an overdose may also experience difficulty breathing that can cause loss of consciousness or even death.

People who have taken an overdose may suffer from pneumonia due to inhalation of vomit or foreign particles; symptoms may include shortness of breath, cough, and fever.

If you forgot to use Morfina B. Braun

Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with Morfina B. Braun

Do not stop treatment with morphine unless your doctor approves it. 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 may cause side effects, although not everyone will experience them.

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

• Severe allergic reaction that causes difficulty breathing or dizziness.
• Severe skin reaction with blisters, widespread skin peeling, pus-filled spots (pustules) along with fever. It could be a condition called generalized acute pustular psoriasis (GAPP).

Other possible side effects:

Very common (may affect more than 1 in 10 patients)

• Nausea.
• Vomiting.
• Constipation.
• Difficulty swallowing.

Common (may affect up to 1 in 10 patients)

• Diarrhea.
• Abdominal cramps.
• Drowsiness.
• Disorientation.
• Sweating.
• Euphoria (extreme feeling of happiness).

With prolonged treatment

• Tolerance.
• Dry mouth.
• Alterations in taste.
• Increased or decreased heart rate.
• Heart arrest.
• High blood pressure.
• Low blood pressure.
• Increased intracranial pressure.
• Collapse.
• Laryngeal spasm.
• Respiratory depression.
• Urinary retention.
• Reduced libido (reduced sexual desire).
• Impotence.
• Blurred vision.
• Rapid, involuntary eye movement (nystagmus).
• Diplopia (double vision).
• Miosis (excessive pupil constriction).
• Edema (fluid retention).
• Itching.
• Urticaria.
• Skin eruptions.
• Contact dermatitis.
• Pain at the injection site.

Rare (may affect up to 1 in 100 people)

• Headache.
• Restlessness.
• Tremor.
• Convulsions.
• Mood alteration (anxiety, depression).
• Muscle rigidity.
• Alucinations.
• Difficulty sleeping.
• Anaphylactic reaction after intravenous injection.

Frequency not known (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 for symptoms).
• Sleep apnea (pauses in breathing during sleep).
• Symptoms associated with pancreatitis and biliary system inflammation, for example, severe upper abdominal pain that may radiate to the back, nausea, vomiting, or fever.

This medicine may cause physical dependence when used for a long period. If you stop treatment with morphine suddenly, it may trigger an abstinence syndrome characterized by the following symptoms: restlessness, anxiety, palpitations, tremors, or sweating.

Reporting of side effects

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

Keep out of sight and reach of children.

This medication does not require any special temperature for conservation. Store in the original packaging to protect it from light.

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

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

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

Morphine B. Braun Composition

The active principle is hydrochloride of morphine (as trihydrate). Each vial contains 400 mg of hydrochloride trihydrate of morphine (equivalent to 304 mg of morphine base).

The other components per vial are sodium chloride and water for injectable preparations.

Appearance of Morphine B. Braun and packaging contents

Transparent injectable solution that is presented in topaz glass vials of 20 ml capacity.

Packaging of 1 vial.

Marketing Authorization Holder:

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191Rubí (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 must be administered by healthcare personnel and only by subcutaneous, intramuscular, intravenous, intrathecal, and epidural routes.

Hydrochloride of morphine trihydrate may be administered intermittently (e.g. every 4 hours) or continuously (e.g. by slow infusion).

At all times, the necessary equipment for artificial respiration as well as an opioid antagonist medication must be available.

Instructions for the correct use of Morphine B. Braun

• The patient must remain lying down when administered intravenously to reduce adverse effects.
• For epidural or intrathecal administration, it is preferable to inject in the lumbar region. Before epidural administration, the correct placement of the needle or catheter in the epidural space must be checked. An aspiration may be performed to check the presence of cerebrospinal fluid or blood, indicating subdural or intravascular placement, respectively.

This medicine is incompatible with alkalis, bromides, iodides, potassium permanganate, tannic acid, and vegetable astringents, with iron, lead, magnesium, silver, copper, and zinc salts.

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