Morphine B. Braun 20 mg/ml solution for injection in vial

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Morfina B. Braun 20 mg/ml injection solution in vial

morphine, hydrochloride

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Morfina B. Braun is and what it is used for
2. What you need to know before using Morfina B. Braun
3. How to use Morfina B. Braun
4. Possible adverse effects
5. How to store Morfina B. Braun
6. Contents of the pack and other information

1. What Morfina B. Braun is and what it is used for

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

• For the treatment of severe pain.
• When dyspnea (difficulty breathing) associated with left ventricular failure and pulmonary edema is present.

2. What you need to know before using Morfina B. Braun

Do not use Morfina B. Braun

• If you are allergic to morphine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• If you have respiratory diseases (respiratory depression or severe obstructive respiratory disease).
• If you have acute bronchial asthma.
• If you have been treated with antidepressant medicines known as monoamine oxidase inhibitors (MAOIs), or within 14 days after stopping such 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 spasms of the renal or biliary tract.
• If you have acute alcoholism.
• If you are at risk of paralytic ileus (reduced intestinal motility).
• If you have ulcerative colitis (an inflammatory disease of the colon and rectum causing diarrhea with or without blood and abdominal pain).
• If you are in shock (a condition in which the body is not receiving adequate blood flow, characterized by low blood pressure, anxiety, confusion, pale skin, dizziness, sweating, chest pain, and sometimes loss of consciousness).
• Blood coagulation disorders or infection at the injection site (for epidural and intrathecal administration routes).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Morfina B. Braun.

• If you have prostate adenoma or urethral stenosis (narrowing).
• If you have gallbladder dysfunction.
• If you have severe inflammatory bowel disease.
• If you have hypothyroidism (insufficient production of thyroid hormones).
• Increased intracranial pressure (if you have severe headache or dizziness) or brain injury.
• If your kidneys are not functioning properly.
• If your liver is not functioning properly.
• If you have obstructive respiratory diseases or chronic asthma.
• If you have heart or circulatory diseases, hypotension, or tachycardia.
• In patients receiving treatment with drugs that depress the central nervous system (CNS).

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

• Increased sensitivity to pain despite taking higher doses (hyperalgesia). Your doctor will decide whether you need a dose adjustment or a switch to a stronger analgesic (see section 2).
• Weakness, fatigue, loss of appetite, nausea, vomiting, or low blood pressure. These may indicate that your adrenal glands are producing insufficient cortisol, and you may need hormonal supplementation.
• Loss of libido, impotence, or cessation of menstruation. These may 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 becoming dependent on Morfina B. Braun while using it. You may find yourself thinking excessively about when you can take the next dose, even if you do not need it for pain.
• Symptoms of withdrawal or dependence. The most common withdrawal symptoms are described in section 3. If these occur, your doctor may change your medication or adjust the dosing interval.
• If you experience severe upper abdominal pain radiating to the back, nausea, vomiting, or fever, as these may be symptoms associated with inflammation of the pancreas (pancreatitis) or biliary tract.

Your doctor will exercise particular caution when administering this medicine to very young patients, elderly patients, severely debilitated patients, or those with renal or hepatic impairment, who may be more sensitive to the effects of morphine.

Special caution with morphine is recommended:

Acute generalized exanthematous pustulosis (AGEP) has been reported in association with morphine treatment. Symptoms usually occur within the first 10 days of treatment. Inform your doctor if you have ever had a severe skin rash, skin peeling, blisters, and/or mouth sores after taking morphine or other opioids. Discontinue this medicine and seek immediate medical attention if you notice any of the following symptoms: blisters, widespread skin peeling, or pus-filled spots (pustules), along with fever.

Sleep-related breathing disorders:

This medicine may cause sleep-related breathing disorders such as sleep apnea (breathing pauses during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, waking up at night due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Tolerance, dependence, and addiction

This medicine contains morphine, which is an opioid. Repeated use of opioids may lead to reduced effectiveness of the medicine (becoming accustomed to it, known as tolerance). Repeated use of this medicine may also lead to dependence, abuse, and addiction, which could potentially result in fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.

Dependence or addiction may cause a feeling of lack of control over the amount of medicine you need to take or how often you need to take 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 been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You smoke.
• You have ever had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

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

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

Abrupt discontinuation of treatment, if you are physically dependent on morphine, may precipitate a withdrawal syndrome.

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

Use in athletes

This medicine contains morphine, which may result in a positive doping test.

Other medicines and Morfina B. Braun

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

There are several medicines with which the use of morphine is not recommended unless strictly necessary:

• Antidiarrheals (medicines for treating diarrhea).
• Antihypertensives (medicines to lower blood pressure).
• Antimuscarinics (as they may increase the risk of severe constipation).
• Monoamine oxidase inhibitors (MAOIs) (medicines for treating depression), or within two weeks after stopping such treatment.
• Naltrexone (used to help people dependent on narcotics or alcohol to stop using them).
• Rifampicin, for example, for treating tuberculosis.
• Gabapentin and pregabalin for treating epilepsy and nerve-related pain (neuropathic pain).
• Concomitant use of morphine and sedatives such as benzodiazepines or other related medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes morphine together with sedative medicines, the dose and duration of concomitant treatment should be limited. Inform your doctor of all sedative medicines you are taking and strictly follow your doctor's dosage recommendations. It may be helpful to inform friends or family members so they can recognize the symptoms mentioned above. Contact your doctor if you experience these symptoms.
• Some medicines used to treat blood clots (e.g., clopidogrel, prasugrel, ticagrelor) may have delayed and reduced effects when taken with morphine.

There is another group of medicines that may increase the effects of morphine. In such cases, your doctor will adjust the dose of both medicines:

• Medicines that cause central nervous system depression.
• Neuromuscular blockers (medicines used to induce muscle relaxation during surgical procedures).
• Analgesics (pain medicines) with opioid-like effects.
• Opioids (such as pentazocine, nalbuphine, and butorphanol).

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

• Buprenorphine.
• Naloxone.

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

Concomitant administration of this medicine with alcohol results in mutual potentiation of toxicity, increasing central nervous system depression.

Pregnancy and breastfeeding 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 medicine.

Morphine crosses the placenta. Regular use during pregnancy may cause physical dependence in the fetus, leading to withdrawal symptoms in the newborn (such as seizures, irritability, excessive crying, tremors, hyperactive reflexes, fever, increased respiratory rate, hyperreflexia, vomiting, increased stool frequency and diarrhea, sneezing, and yawning), which require medical treatment.

The use of this medicine is only acceptable when no safer alternatives are available.

Morphine is excreted in breast milk. Although no problems have been reported in humans, the possible effects on the infant are unknown; therefore, your doctor must assess the benefit-risk balance.

Driving and use of machines

Ask your doctor whether you can drive or operate machinery during treatment with this medicine. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taking this medicine together with other medicines.

Morfina B. Braun contains sodium

This medicine contains 70.8 mg of sodium (a main component of table/cooking salt) per vial. This corresponds to 3.54% of the maximum daily sodium intake recommended for an adult.

3. How to use Morfina B. Braun

This medicine will only be administered by healthcare professionals.

The dose and duration of treatment will be individually determined by your doctor, depending on the strength and duration of action of the opioid used, the intensity of pain, other medications being administered simultaneously, and the patient's response.

The injection may be given into a vein (intravenous injection), into a muscle (intramuscular injection), or under the skin (subcutaneous injection). It can be administered intermittently (e.g., every 4 hours) or continuously (e.g., by slow infusion).

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

Use in children and adolescents

This medicine must not be used by epidural or intrathecal routes in children.

If you use more Morfina B. Braun than you should

In case of overdose or accidental ingestion, contact your doctor or the Toxicology Information Service immediately. Telephone (91) 562 04 20, indicating the medicine and amount taken.

Overdose is characterized by respiratory depression with bradypnea (reduced respiratory rate), with or without depression of the central nervous system. Individuals who have taken an overdose may also experience difficulty breathing leading to loss of consciousness or even death.

Individuals who have taken an overdose may develop aspiration pneumonia from vomit or foreign particles; symptoms may include shortness of breath, cough, and fever.

If you forget to use Morfina B. Braun

Do not use a double dose to make up for a missed dose.

If you stop treatment with Morfina B. Braun

Do not stop treatment with morphine unless approved by your doctor. If you wish to discontinue treatment with this medicine, ask your doctor how to gradually reduce the dose to avoid withdrawal symptoms. Withdrawal symptoms may include generalized aches, tremors, diarrhoea, stomach pain, nausea, flu-like symptoms, palpitations, and pupil dilation. Psychological symptoms may include a profound feeling of dissatisfaction, anxiety, and irritability.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

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

• Severe allergic reaction causing difficulty breathing or dizziness.
• Severe skin reaction with blistering, widespread peeling of the skin, pustules (pus-filled spots) together with fever. This could be a condition called acute generalized exanthematous pustulosis (AGEP).

Other possible adverse effects:

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

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

Common (may affect up to 1 in 10 people)

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

With prolonged treatment

• Tolerance.
• Dry mouth.
• Taste disturbances.
• Increased or decreased heart rate.
• Cardiac arrest.
• High blood pressure.
• Low blood pressure.
• Increased intracranial pressure.
• Collapse.
• Laryngeal spasm.
• Respiratory depression.
• Urinary retention.
• Reduced libido (decreased sexual desire).
• Impotence.
• Blurred vision.
• Rapid, involuntary eye movements (nystagmus).
• Diplopia (double vision).
• Miosis (excessive pupil constriction).
• Oedema (fluid retention).
• Itching.
• Urticaria.
• Skin rashes.
• Contact dermatitis.
• Pain at injection site.

Uncommon (may affect up to 1 in 100 people)

• Headache.
• Agitation.
• Tremor.
• Seizures.
• Mood disturbances (anxiety, depression).
• Muscle rigidity.
• Hallucinations.
• Difficulty sleeping.
• Anaphylactic reaction after intravenous injection.

Frequency not known (cannot be estimated from available data):

• Increased sensitivity to pain.
• Symptoms of withdrawal or dependence (for a list of symptoms, see section 3: If you stop taking Morphine B. Braun).
• Sleep apnoea (breathing pauses during sleep).
• Symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary system, 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 of time. If morphine treatment is stopped abruptly, a withdrawal syndrome may be triggered, characterised by the following symptoms: restlessness, anxiety, palpitations, tremors or sweating.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of Human Medicines at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Morphine B. Braun

Keep out of sight and reach of children.

This medicine does not require any special storage temperature. Store in the original packaging to protect from light.

The contents of the ampoules must be used immediately after opening. After opening the container, discard any unused portion of the solution.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Morfina B. Braun

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

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

Appearance of Morfina B. Braun and contents of the pack

Clear injectable solution presented in 20 ml amber glass vials.

Pack sizes: 1 vial.

Marketing Authorization Holder:

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191 Rubí (Barcelona),

Spain.

Manufacturer:

• Braun Medical, S.A.

Ronda de los Olivares, Parcela 11,

Polígono Industrial Los Olivares,

23009 Jaén (Jaén),

Spain.

Date of the most recent review of this summary: October 2024.

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products: http://www.aemps.gob.es/

This information is intended exclusively for healthcare professionals:

This medicine must be administered by healthcare personnel and only via subcutaneous, intramuscular, intravenous, intrathecal, or epidural routes.

Trihydrated morphine hydrochloride may be administered intermittently (e.g., every 4 hours) or continuously (e.g., by slow infusion).

Apparatus for artificial respiration and an opioid antagonist must always be readily available.

Instructions for the correct use of Morfina B. Braun

• The patient should remain lying down during intravenous administration to reduce adverse effects.
• For epidural or intrathecal administration, lumbar region injection is preferred. Prior to epidural administration, correct placement of the needle or catheter in the epidural space must be confirmed. Aspiration may be performed to check for cerebrospinal fluid or blood, which would indicate subdural or intravascular placement, respectively.

This medicinal product is incompatible with alkalis, bromides, iodides, potassium permanganate, tannic acid, and vegetable astringents, as well as salts of iron, lead, magnesium, silver, copper, and zinc.

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