Morphine Serra 20 mg/ml solution for injection

Patient Information Leaflet

Introduction

Patient Information Leaflet

Morphine SERRA 20 mg/ml injectable solution

Morphine hydrochloride (trihydrate)

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are adverse effects not listed in this leaflet.

Package leaflet contents:

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

1. What Morfina Serra is and what it is used for

Morphine is an opioid analgesic that acts directly on the pain center. In humans, its action results in analgesia and often narcosis.

This medicine is indicated for:

• Treatment of severe pain
• Treatment of pain associated with myocardial infarction
• Treatment of insomnia caused by severe pain

2. What you need to know before using Morfina Serra

Do not use Morfina Serra

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• in patients in shock.
• in patients with states of anoxia (near-total lack of oxygen in a tissue), especially in the presence of cyanosis (bluish discoloration of the skin).
• in patients with excessive bronchial secretions or bronchial asthma.
• in patients with respiratory depression or severe obstructive respiratory disease.
• in patients treated with monoamine oxidase inhibitors (medications used to treat depression) or within 10 days after stopping such treatment.
• in case of infection at the injection site, and in patients with severe coagulation disorders, epidural or intrathecal administration is contraindicated.

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 Morfina Serra may also cause dependence, abuse, and addiction, which could potentially lead to a 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 Morfina Serra if:

• You or any member of your family 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 Morfina Serra, 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, for example, "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 taking the medicine, and feel better once you resume taking it ("withdrawal effects").

If you experience any of these symptoms, consult your doctor to determine the best course of treatment for you, including when it is appropriate to stop the medicine and how to do so safely (see section 3 "If you stop treatment with Morfina Serra").

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Morfina Serra:

• 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 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).

Consult your doctor or pharmacist if you experience any of the following symptoms while using Morfina Serra:

• Increased sensitivity to pain despite taking increasingly higher doses (hyperalgesia). Your doctor will decide whether you need a dose adjustment or a switch to another potent analgesic (see section 2).
• Weakness, fatigue, decreased appetite, nausea, vomiting, or low blood pressure. This could indicate that your adrenal glands are producing insufficient cortisol hormone, and you may need to take hormonal supplements.
• Loss of libido, impotence, cessation of menstruation. This 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 beginning to become dependent on Morfina Serra while using it. You may have started thinking excessively about when you can take the next dose, even when not needed for pain.
• Symptoms of withdrawal or dependence. The most common withdrawal symptoms are described in section 3. If they occur, your doctor may change your medicine or modify the dosing interval.

Repeated administration of Morfina Serra leads to tolerance, characterized by the need to progressively increase the dose, along with psychological and physical dependence. Cross-tolerance and cross-dependence exist among opioids acting on the same pain receptors. Dependence usually occurs after 1–2 weeks of therapeutic dosing, although some dependence may appear within 2–3 days.

Abrupt discontinuation of treatment in patients with physical dependence may precipitate a withdrawal syndrome. Withdrawal symptoms may also occur after administration of a medication with opioid-opposing effects (naloxone or naltrexone) or a medication with similar/opposing effects (pentazocine) in patients dependent on opioids. Physiological dependence may develop, evident by the withdrawal syndrome that occurs if treatment is abruptly discontinued. Without treatment, most of these symptoms resolve within 5 to 14 days, although a secondary withdrawal syndrome with irritability, insomnia, and muscle aches may persist for several months.

Use in elderly patients: Special caution is required in elderly patients due to their heightened sensitivity. Elderly individuals are more susceptible to the effects of morphine.

In alcoholic patients or those with a history of drug dependence: Special caution is required due to the patient's predisposition to drug addiction.

It should be administered with caution in very young patients, as they may be more sensitive to the effects of morphine.

Special caution is advised with Morfina Serra:

Acute generalized exanthematous pustulosis (AGEP) has been reported in association with Morfina Serra treatment. Symptoms typically occur within the first 10 days of treatment. Inform your doctor if you have ever experienced a severe skin rash, skin peeling, blisters, and/or mouth sores after taking Morfina Serra or other opioids. Stop using Morfina Serra 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

Morfina Serra may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels during sleep). 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.

Contact your doctor if you experience severe upper abdominal pain that may radiate to the back, nausea, vomiting, or fever, as these could be symptoms associated with inflammation of the pancreas (pancreatitis) or bile ducts.

Use in athletes

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

Morfina Serra may alter the results of the following laboratory tests:

• Blood: increased (biological) levels of creatine kinase and prolactin.
• Decreased (biological) levels of testosterone.

Use of Morfina Serra with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines, including those obtained without a prescription, homeopathic remedies, herbal medicines, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one or more medicines.

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

• Some medicines for the treatment of diarrhea may increase severe constipation and CNS depression.
• Medicines for high blood pressure and other medicines causing hypotension.
• Medicines that, when administered with Morfina Serra, may increase the risk of severe constipation.
• Monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression).
• Naltrexone (used to help people addicted to narcotics or alcohol to stop using these substances).

A large number of drugs may interact with morphine hydrochloride injection, significantly altering its effects. These include:

• Gabapentin or pregabalin, used to treat epilepsy and nerve-related pain (neuropathic pain).

Some medicines, when taken at the same time as Morfina Serra, may affect morphine's mechanism of action, increasing its effects:

• Medicines that cause CNS depression.
• Neuromuscular blockers (medicines used to induce muscle relaxation during surgical procedures).
• Analgesics with opioid-like effects (concomitant administration may cause additive effects on CNS depression).
• Opioids (such as: pentazocine, nalbuphine, butorphanol).

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

• Buprenorphine (a medicine used to treat opioid dependence).
• Naloxone (a medicine used to treat respiratory depression).

This is especially important if you are taking any of the following medicines or medicines for:

• Rifampicin, for example, to treat tuberculosis.
• Some medicines used to treat blood clots (e.g., clopidogrel, prasugrel, ticagrelor) may have delayed and reduced effects when taken with morphine.
• Cimetidine may increase the effect of morphine.

The concomitant use of Morfina Serra and sedatives such as benzodiazepines or other related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes Morfina Serra together with sedative medicines, the dose and duration of concomitant treatment should be limited. Inform your doctor about 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.

Use of Morphine Hydrochloride with food, drinks, and alcohol

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

Pregnancy, lactation and fertility

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

This drug crosses the placenta. Regular use during pregnancy may cause physical dependence in the fetus, leading to withdrawal symptoms in the newborn. The use of this medicine is only acceptable when safer alternatives are unavailable.

Morphine passes into breast milk.

Although problems have not been reported in humans, the potential adverse effects on the breastfed infant are unknown; therefore, your doctor must assess the benefit-risk balance.

If Morphine Serra is used for prolonged periods during pregnancy, there is a risk that the newborn may experience withdrawal symptoms, which must be treated by a physician.

Driving and use of machines

Ask your doctor whether you can drive or operate machinery while being treated with Morphine Serra. 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 other medicines concomitantly.

Morphine Serra contains sodium chloride

This medicine contains less than 23 mg (1 mmol) of sodium per ampoule and is therefore considered essentially "sodium-free".

3. How to use Morfina Serra

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse. Your doctor will determine the duration of your treatment with Morfina Serra. Do not stop treatment prematurely, as the expected therapeutic effect may not be achieved.

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

If you feel that the effect of Morfina Serra is too strong or too weak, inform your doctor or pharmacist.

Subcutaneous or intramuscular route:

• Adults: pain: 5.9 – 23.4 mg of morphine hydrochloride trihydrate every 4 hours.

Intravenous route:

• Adults: pain associated with myocardial infarction: 2.3 – 17.6 mg of morphine hydrochloride trihydrate, with incremental doses (1.2 – 3.5 mg of morphine hydrochloride trihydrate) administered every 5 minutes as needed. For continuous intravenous administration (by continuous infusion), the recommended initial rate in adults is 0.9 – 11.7 mg/h of morphine hydrochloride trihydrate, subsequently adjusted according to response, up to a maximum of 93.6 mg/h of morphine hydrochloride trihydrate. In cases of particularly severe pain, intravenous infusion rates of up to 514.8 mg of morphine hydrochloride trihydrate/h have been used.

Epidural route:

• Adults: 5.9 mg of morphine hydrochloride trihydrate. If necessary, additional doses of 1.2 or 2.3 mg of morphine hydrochloride trihydrate may be administered after one hour, without exceeding a total dose of 11.7 mg of morphine hydrochloride trihydrate/24 hours.

Intrathecal route:

• Adults: 0.23 – 1.2 mg of morphine hydrochloride trihydrate/24 h.

Elderly and debilitated patients may require lower doses than those indicated for adults.

In renal or hepatic impairment, the dose should be adjusted according to the degree of renal or hepatic functional impairment.

• Dosages and dosing intervals should be individualized based on the severity of pain, the patient's condition, other concomitantly administered medications, and the patient's response.
• With repeated administration, tolerance may develop.

If you use more Morfina Serra than you should

If you have used more Morfina Serra than recommended, contact your doctor or pharmacist immediately or call the toxicology information service at: 91 562 04 20, indicating the medication and the amount used. It is advisable to bring the medication's packaging and leaflet to the healthcare professional.

Accidental overdose intoxication manifests as: respiratory depression with bradypnea (decreased respiratory rate), with or without central nervous system depression.

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

Individuals who have taken an overdose may also experience difficulty breathing leading to loss of consciousness or even death.

The recommended treatment for overdose consists of:

• Maintaining a patent airway and instituting controlled or assisted ventilation.
• Administering naloxone (0.4 to 2 mg) as a single dose, preferably intravenously. The naloxone injection may be repeated at intervals of two to three minutes. Since the duration of action of naloxone is considerably shorter than that of epidural or intrathecal morphine, repeated administration of the drug may be necessary. It should be borne in mind that naloxone may also inhibit the analgesic effects of morphine and may precipitate withdrawal symptoms in patients with physical dependence.
• Administering intravenous fluids and/or vasopressors (drugs used when a patient's blood pressure drops too low), using other supportive measures as needed.
• Continuing patient monitoring.

If you forget to use Morfina Serra

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

If you stop using Morfina Serra

Do not stop treatment with Morfina Serra unless approved by your doctor. If you wish to discontinue treatment with Morfina Serra, consult your doctor on 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 pupillary dilation. Psychological symptoms include a profound feeling of dissatisfaction, anxiety, and irritability.

Abrupt discontinuation of treatment in patients with physical dependence may precipitate a withdrawal syndrome characterized by the following symptoms, varying in intensity among individuals: yawning, lacrimation, rhinorrhea (nasal discharge), sweating, mydriasis (pupillary dilation), tremor, gooseflesh, anorexia (loss of appetite), restlessness, vomiting, fever, hyperpnea (increased depth and rate of breathing), hypertension, and diarrhea.

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

4. Possible adverse effects

Like all medicines, Morfina Serra can cause adverse effects, although not everyone will experience them.

The adverse effects of morphine are generally frequent and moderately significant. In most cases, the adverse effects are pharmacological extensions and primarily affect the central nervous system and the digestive and respiratory systems.

Important adverse reactions or symptoms to be aware of and what to do if they occur:

Severe allergic reaction causing difficulty breathing or dizziness.

If you experience these serious adverse effects, consult a doctor immediately.

The most characteristic adverse reactions are:

• Very common (may affect more than 1 in 10 people): nausea, vomiting, difficulty swallowing, constipation.

• Common (may affect up to 1 in 10 people): diarrhea, abdominal cramps, drowsiness, disorientation, sweating, euphoria; with prolonged treatment: tolerance, dry mouth, taste disturbances, increased or decreased heart rate, cardiac arrest, high blood pressure, low blood pressure, increased intracranial pressure, laryngeal spasm, collapse, respiratory depression, apnea (episodes of breathing cessation during sleep), urinary retention, reduced libido (decreased sexual desire), impotence, blurred vision, jerky eye movements, diplopia (double vision), miosis (excessive pupil constriction), edema, itching, urticaria, skin rashes, contact dermatitis, pain at the injection site.

• Uncommon (may affect up to 1 in 100 people): headache, agitation, tremor, convulsions, mood disturbances (anxiety, depression), muscle stiffness, hallucinations, insomnia, generalized allergic reaction after intravenous injection.

• Frequency unknown: increased sensitivity to pain, withdrawal or dependence symptoms (for symptoms, see section 3: If you stop treatment with Morfina Serra), sleep apnea (breathing pauses during sleep), symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system, for example, severe upper abdominal pain that may radiate to the back, nausea, vomiting, or fever.

Stop using Morfina Serra and seek immediate medical attention if you notice any of the following symptoms:

Severe skin reaction with blisters, widespread skin peeling, pustules (pus-filled spots) along with fever. This could be a condition called acute generalized exanthematous pustulosis (AGEP).

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Morfina Serra

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

Do not store above 25°C.

This medicine contains no preservatives; therefore, any opened ampoules not used immediately should be discarded.

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 drains or household waste. Unused medicines and their containers should be taken to a SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Morphine Serra

• The active substance is morphine hydrochloride (as trihydrate). Each ampoule contains 23.4 mg of morphine hydrochloride trihydrate, equivalent to 20 mg of morphine hydrochloride (equivalent to 17.8 mg of morphine base).
• The other components (excipients) are: sodium chloride, hydrochloric acid (for pH adjustment), and water for injections.

Appearance of the product and contents of the pack

Morphine Serra is presented as a clear, sterile, transparent injectable solution, free from precipitates.

The packs contain 1 ampoule of 1 ml of solution.

Marketing Authorization Holder and Manufacturer

Laboratorios SERRA PAMIES S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Spain

The most recent revision of this leaflet was in February 2026

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Rapid intravenous injection of opioid analgesics may cause anaphylactoid reactions; therefore, it should only be administered by physicians experienced in this route of administration, and equipment for artificial ventilation and opioid antagonist drugs must be readily available.

When this medicine is administered by epidural or intrathecal route, patients must be adequately monitored for at least 24 hours, as respiratory depression may occur.

When morphine is administered parenterally, the patient should be lying down and remain recumbent to minimize adverse reactions such as hypotension, dizziness, confusion, nausea, and vomiting.

For epidural or intrathecal administration, lumbar injection is preferred due to the increased risk of respiratory depression when administered in the thoracic region.

If morphine is administered by epidural or intrathecal route during childbirth, it may readily pass into the fetal circulation, potentially causing respiratory depression in the neonate, especially if premature.

Prior to epidural administration, correct placement of the needle or catheter in the epidural space must be verified. Aspiration may be performed to check for the presence of cerebrospinal fluid or blood, which would indicate subdural or intravascular placement, respectively.

In patients with shock, impaired perfusion may prevent complete absorption following intramuscular or subcutaneous administration. Repeated administration may lead to overdose due to unexpectedly high absorption when circulation is restored.

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