Morphine Serra 10 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MORPHINE SERRA 10 mg/ml injection solution

Morphine hydrochloride (trihydrate)

Read the entire 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 must not give it to other people, even if they have the same symptoms as you, because it could 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.

Leaflet contents:

1. What Morphine Serra is and what it is used for.
2. What you need to know before using Morphine Serra
3. How to use Morphine Serra
4. Possible adverse effects
5. How to store Morphine 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 in 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 (medicines used to treat depression) or during the 10 days following discontinuation of 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 lead to dependence, abuse, and addiction, which could result in potentially 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 frequently 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 using the medicine, and you feel better once you resume taking it ("withdrawal effects").

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 medicine and how to do so safely (see section 3 "If you interrupt 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 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, decreased appetite, nausea, vomiting, or low blood pressure. This could indicate insufficient cortisol production by the adrenal glands, and you may need hormonal supplements.
• Loss of libido, impotence, or 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 depend on Morfina Serra while using it. You may have started 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 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 occur among opioids acting on the same pain receptors. Dependence usually develops 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 drug with an opposite effect to opioids (naloxone or naltrexone) or a drug with similar/opposite effect (pentazocine) in patients dependent on opioids. Physiological dependence may occur, evident by the withdrawal syndrome that arises 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 increased 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.

Special caution should be exercised 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 usually 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. Discontinue use of 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 respiratory disorders

Morfina Serra may cause sleep-related respiratory disorders, such as sleep apnea (breathing pauses during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, nighttime awakening 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 finding in doping control tests.

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

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

Use of Morfina Serra with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including over-the-counter medicines, homeopathic remedies, herbal medicines, and other health-related products, as it may be necessary to discontinue treatment or adjust the dose of one or more of them.

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

• Some medicines for treating diarrhea may increase severe constipation and CNS depression.
• Medicines for treating high blood pressure and other medicines that cause hypotension.
• Medicines that, when used with Morfina Serra, may increase the risk of severe constipation.
• Monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression).
• Naltrexone (used to help people dependent on 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 simultaneously with Morfina Serra, may affect the mechanism of action of morphine, increasing its effects:

• Medicines that cause CNS depression.
• Neuromuscular blockers (medicines used to induce muscle relaxation during surgical procedures).
• Analgesics with effects similar to opioids (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, for treating 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.
• Concomitant use of Morfina Serra and sedatives such as benzodiazepines or other related medicines increases the risk of drowsiness, difficulty breathing (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 recommendations regarding dosage. It may be helpful to inform friends or family members so they can recognize the signs and 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, with increased central depression.

Pregnancy, 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.

This drug crosses the placenta. Regular use during pregnancy may cause physical dependence in the fetus, leading to withdrawal symptoms in the newborn. Use of this medicine is only acceptable if no safer alternatives are available.

Morphine passes into breast milk.

Although no problems have been reported in humans, possible adverse effects on the infant are unknown; therefore, your doctor must evaluate the benefit-risk balance.

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

Driving and use of machines

Ask your doctor whether you can drive or operate machinery during treatment with Morfina 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 used concomitantly with other medicines.

Morfina 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 provided 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 it (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 if needed. For continuous intravenous administration (via continuous infusion), the recommended initial rate in adults is 0.9–11.7 mg/h of morphine hydrochloride trihydrate, adjusted subsequently based on response, up to a maximum of 93.6 mg/h of morphine hydrochloride trihydrate. In cases of particularly severe pain, intravenous infusion rates 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 recommended for adults.

In renal or hepatic insufficiency, 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, concomitant 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 you should, contact your doctor or pharmacist immediately or call the toxicology information service at: 91 562 04 20, indicating the medication and amount used. It is recommended to bring the medication packaging and leaflet to the healthcare professional.

Accidental overdose intoxication manifests as: respiratory depression with bradypnea (reduced respiratory rate), accompanied or not by central nervous system depression.

Individuals who have taken an overdose may develop aspiration pneumonia from vomiting 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 initiating controlled or assisted ventilation.
• Administering naloxone (0.4 to 2 mg) as a single dose, preferably intravenously. Naloxone injections 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 forgotten doses.

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 for each individual: yawning, lacrimation, rhinorrhea (nasal discharge), sweating, mydriasis (pupil 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 experiences them.

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

Important adverse reactions or symptoms to watch for and actions to take 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): diarrhoea, abdominal cramps, somnolence, 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, apnoea (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), oedema, itching, urticaria, skin rashes, contact dermatitis, pain at the injection site.

• Uncommon (may affect up to 1 in 100 people): headache, agitation, tremor, seizures, mood disturbances (anxiety, depression), muscle rigidity, 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 taking Morfina Serra), sleep apnoea (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, pus-filled spots (pustules) together 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 must 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 or household waste. Unused medicines and their containers should be handed over to the SIGRE point at your pharmacy. If you are unsure, please consult your pharmacist on how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Morfina Serra

• The active substance is morphine hydrochloride (as trihydrate). Each ampoule contains 11.7 mg of morphine hydrochloride trihydrate, equivalent to 10 mg of morphine hydrochloride (equivalent to 8.9 mg of morphine base).
• The other components (excipients) are: sodium chloride, hydrochloric acid (for pH adjustment), and water for injections.

Appearance of the medicinal product and contents of the pack

Morfina Serra is presented as a clear, sterile, particle-free, transparent injectable solution.

Packaging contains either 1 ampoule or 10 ampoules 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 medicinal product 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, administration should only be performed by physicians experienced in this route of administration, and equipment for artificial ventilation and opioid antagonist medications must be readily available.

When this medicinal product is administered epidurally or intrathecally, patients must be adequately monitored for at least 24 hours, as respiratory depression may occur.

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

For epidural or intrathecal administration, lumbar injection is preferred due to the increased risk of respiratory depression associated with thoracic administration.

If morphine is administered epidurally or intrathecally during childbirth, it may readily enter the fetal circulation and cause respiratory depression in the neonate, particularly if the neonate is 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 recovers.

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