Morphine kalceks

Package leaflet: Information for the user

Morphine Kalceks, 10 mg/ml, solution for injection
Morphini hydrochloridum trihydricum
Read the entire leaflet carefully before using the medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Morphine Kalceks is and what it is used for
2. Important information before using Morphine Kalceks
3. How to use Morphine Kalceks
4. Possible side effects
5. How to store Morphine Kalceks
6. Contents of the pack and other information

1. What Morphine Kalceks is and what it is used for

Morphine Kalceks contains morphine as the active substance and belongs to a group of medicines called natural opioid alkaloids. This medicine is used to relieve severe pain when other painkillers do not provide adequate relief.

2. Important information before using Morphine Kalceks

When not to use Morphine Kalceks:

• if the patient is allergic to morphine hydrochloride trihydrate or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a large amount of mucus in the respiratory tract;
• if the patient has breathing disorders;
• in acute liver disease;
• in cases of anxiety states in patients abusing alcohol or sleeping medications.

Warnings and precautions
There is a risk of developing dependence on Morphine Kalceks.
Before starting treatment with Morphine Kalceks, consult a doctor, pharmacist, or nurse if the patient:

• has dependence on other painkillers (opioids);
• is undergoing peritoneal dialysis;
• has been diagnosed with asthma;
• has respiratory spasms;
• has head injuries;
• has low blood pressure accompanied by reduced circulating blood volume;
• has thyroid dysfunction;
• has impaired liver or kidney function;
• has inflammatory bowel diseases;
• has pancreatitis;
• has biliary or urinary tract spasms;
• has enlarged prostate gland;
• has muscle weakness known as myasthenia gravis;
• is currently being treated with MAO inhibitors (medications used to treat depression).

If any of the following symptoms occur during treatment with Morphine Kalceks, consult a doctor, pharmacist, or nurse:

• Increased sensitivity to pain despite increasing the dose of the medicine (hyperalgesia). The doctor will decide whether a dosage adjustment or use of a stronger painkiller is necessary (see section 2).
• Weakness, fatigue, loss of appetite, nausea, vomiting, or low blood pressure. These may be symptoms of insufficient cortisol production by the adrenal glands, and hormone supplementation may be required.
• Loss of libido, impotence, or amenorrhea. This may result from reduced secretion of sex hormones.
• If the patient has previously been addicted to drugs or alcohol. You should also inform the doctor if the patient notices developing dependence on Morphine Kalceks during treatment. For example, when the patient frequently thinks about taking another dose, even if it is not needed to relieve pain.
• Symptoms of withdrawal or dependence. The most common withdrawal symptoms are listed in section 3. In such cases, the doctor may change the medication or adjust the interval between doses.

Tolerance, dependence, and compulsive use
This medicine contains morphine, which is an opioid. Repeated use of opioids may lead to reduced effectiveness of the medicine (the patient becomes accustomed to it, known as drug tolerance). Repeated use of Morphine Kalceks may also lead to dependence, abuse, and compulsive use, which may result in life-threatening overdose. The risk of these adverse effects may increase with higher doses and prolonged treatment duration.
Dependence or compulsive use may cause the patient to lose control over how much medicine to take or how often to take it.
The risk of dependence or compulsive use varies between individuals. The risk of becoming dependent on Morphine Kalceks or compulsively using it may be higher if:

• the patient or any of their relatives have ever abused or been dependent on alcohol, prescription drugs, or narcotics ("addiction");
• the patient smokes cigarettes;
• the patient has ever had mood disorders (depression, anxiety disorders, or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If any of the following symptoms occur during treatment with Morphine Kalceks, this may indicate dependence or compulsive use:

• the patient needs to take this medicine for longer than prescribed by the doctor;
• the patient needs to take a higher dose than prescribed;
• the patient uses this medicine for reasons other than those for which the doctor prescribed it, e.g., "to calm down" or "to be able to sleep";
• the patient has made several unsuccessful attempts to stop or control the use of this medicine;
• after stopping the medicine, the patient feels unwell and experiences improved well-being when taking the medicine again ("withdrawal effect").

If any of these symptoms are observed, discuss with the doctor the best treatment strategy for the patient, including when it is appropriate to discontinue treatment and how to safely stop it (see section 3: Discontinuation of Morphine Kalceks treatment).
Lower doses of Morphine Kalceks are recommended for elderly patients.
This medicine should not be used to relieve pain of unknown origin or pain associated with mental disorders.
Acute generalized exanthematous pustulosis (AGEP) has been reported during treatment with Morphine Kalceks. Symptoms usually appear within the first 10 days of treatment. Inform the doctor if the patient has ever experienced severe skin rash, skin peeling, blisters, and/or oral mucosal ulcers after taking Morphine Kalceks or other opioids. Morphine Kalceks should be discontinued immediately and medical help sought without delay if the patient notices any of the following symptoms: appearance of blisters, extensive skin peeling, or pustular rash accompanied by fever.
This medicine should not be used as monotherapy during an attack of biliary or renal colic, as it may increase spasm intensity. In such cases, Morphine Kalceks should be used in combination with spasmolytic (muscle-relaxing) drugs.
Consult a doctor if the patient experiences severe upper abdominal pain radiating to the back, nausea, vomiting, or fever, as these may be symptoms related to pancreatitis or biliary tract disease.
The effect of this medicine may be enhanced in patients who have had encephalitis.
Sleep-related breathing disorders: Morphine Kalceks may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include episodes of stopped breathing during sleep, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. Inform the doctor if the patient or someone else observes these symptoms. The doctor may consider reducing the dose.

Morphine Kalceks and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
This is particularly important when using the following medicines:

• Rifampicin, used to treat, for example, tuberculosis
• Some medicines used to treat blood clots (e.g. clopidogrel, prasugrel, ticagrelor) may have delayed and reduced effects when taken together with morphine
• Concurrent use of Morphine Kalceks and sedatives, e.g. benzodiazepines or related drugs, increases the risk of drowsiness, breathing difficulties (respiratory depression), or coma, which may be life-threatening. Therefore, combination therapy should only be considered when no other treatment options are available. If Morphine Kalceks is used together with sedatives, the doctor should limit the dose and duration of concurrent use. The patient should inform the doctor about all sedative medicines being taken and strictly follow the prescribed dosage. It may be helpful to inform the patient's friends or relatives about the possibility of the above-mentioned symptoms. If the described symptoms occur, consult a doctor.

The effectiveness of treatment may be affected by concomitant use of Morphine Kalceks with certain other medicines.
Combinations to be avoided when using Morphine Kalceks:

• sedatives and hypnotics containing barbiturates (methohexital, pentothal, phenobarbital);
• medicines used to treat depression or Parkinson's disease (MAO inhibitors) (moclobemide, selegiline).

The above-mentioned medicines, when used in combination with Morphine Kalceks, may impair respiratory function.
Medicines that may require dose adjustment:

• medicines used to treat epilepsy and pain caused by nervous system disorders (neuropathic pain) (gabapentin, pregabalin);
• medicines used to treat depression (clomipramine, amitriptyline, nortriptyline);
• some other pain relievers (buprenorphine, nalbuphine, pentazocine).

Other medicines that may affect the action of Morphine Kalceks or medicines whose action may be
affected by Morphine Kalceks:

• antispasmodic medicines (baclofen);
• sedatives containing benzodiazepines (nitrazepam, flunitrazepam, tirazepam, midazolam);
• sedatives reducing itching (hydroxyzine);
• central nervous system stimulants (methylphenidate);
• medicines used to treat hemorrhages within the meninges (nimodipine);
• medicines used against HIV virus (ritonavir).

Morphine Kalceks and alcohol
Avoid combining with alcohol, as it may lead to worsening of respiratory function.

Pregnancy, breastfeeding, and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Fertility
In animal studies, this medicine showed a negative effect on fertility. This medicine may cause harm to the developing fetus. Therefore, women and men of reproductive age should use appropriate contraceptive methods. Discuss this with the doctor.
Pregnancy
If Morphine Kalceks has been used during pregnancy for a prolonged period, there is a risk of neonatal withdrawal syndrome, which should be treated by a doctor. Administration of morphine during childbirth may cause respiratory dysfunction in the newborn.
Breastfeeding
Morphine passes into breast milk. Therefore, Morphine Kalceks should not be used during breastfeeding.

Driving and operating machinery
Patients should not drive vehicles or operate machinery while taking Morphine Kalceks. This medicine may affect the patient's reaction ability.

Morphine Kalceks contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per ml of solution, meaning the medicine is considered "sodium-free".

3. How to use Morphine Kalceks

This medicine should always be used exactly as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
Before starting treatment and regularly during therapy, the doctor will discuss with the patient what
to expect from using Morphine Kalceks, when and for how long the medicine should be taken, when
to contact the doctor, and when to stop using the medicine (see also "Stopping Morphine Kalceks"
in this section).
The dose is individually determined by the doctor and depends on age, body weight, severity of
pain, previously used pain-relieving medicines, and prior history of pain.
Elderly patients
A lower dose is recommended.
Hepatic or renal impairment
A lower dose is recommended.
Dose reduction is recommended in patients with bronchial asthma, upper airway obstruction,
head injury, peritoneal dialysis, hypotension associated with hypovolemia, hypothyroidism,
intestinal inflammation, pancreatitis, or biliary or ureteric colic.
This medicine may be administered intravenously, intramuscularly, or subcutaneously.
Taking more Morphine Kalceks than recommended
If an excessive dose of Morphine Kalceks is taken or if the medicine is accidentally ingested by a
child, contact a doctor immediately. Symptoms of overdose include pinpoint pupils, low blood
pressure, breathing difficulties that may lead to loss of consciousness and even death. Individuals
who have taken an excessive dose may develop pneumonia due to aspiration of vomit or foreign
material; symptoms may include shortness of breath, cough, and fever.
In severe cases, circulatory disturbances and coma may occur.
If you miss a dose of Morphine Kalceks
Do not take a double dose to make up for a missed dose.
Stopping Morphine Kalceks
If the patient suddenly stops taking Morphine Kalceks or switches to certain other strong pain
medicines, withdrawal symptoms may occur.
Do not stop taking Morphine Kalceks unless otherwise instructed by the doctor. To discontinue
Morphine Kalceks, consult the doctor, who will decide how to gradually reduce the dose to avoid
withdrawal symptoms. Withdrawal symptoms may include body aches, tremors, diarrhea, stomach
pain, nausea, flu-like symptoms, rapid heartbeat, and dilated pupils. Psychological symptoms may
include intense feelings of dissatisfaction, anxiety, and irritability.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist,
or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Respiratory depression is a serious, uncommon adverse reaction associated with the use of morphine, which may occur in up to 1 in 100 people. If a patient experiences breathing difficulties, medical advice must be sought immediately to initiate treatment for respiratory dysfunction.

Seek immediate medical attention if any of the following occur:

• Severe allergic reactions causing difficulty breathing or dizziness.
• Severe skin reaction with blistering, widespread peeling of the skin, pustular rash accompanied by fever. This may be a condition called acute generalized exanthematous pustulosis (AGEP).

Common (may occur in up to 1 in 10 patients): drowsiness, dizziness, pinpoint pupils, nausea, vomiting, constipation, difficulty in urination, increased secretion of antidiuretic hormone (ADH).
Uncommon (may occur in up to 1 in 100 patients): depressed mood, confusion, bronchospasm, spasm of urinary and biliary tracts, itching, sensation of emptiness in the head.
Rare (may occur in up to 1 in 1,000 patients): palpitations, rapid heartbeat (tachycardia), fainting, dizziness upon standing quickly, high blood pressure, low blood pressure, swelling of feet and legs.
Not known (frequency cannot be estimated from available data): euphoria, drowsiness, memory and concentration disturbances, muscle spasms, sleep apnoea (episodes of breathing cessation during sleep), dry mouth, symptoms related to pancreatitis and biliary tract inflammation (e.g. severe upper abdominal pain radiating to the back, nausea, vomiting or fever), urticaria, involuntary muscle jerks (myoclonus), increased sensitivity to pain, sweating, withdrawal symptoms or dependence (for information on symptoms, see section 3: Discontinuation of Morphine Kalceks treatment).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Morphine Kalceks

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Exp.
The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Morphine Kalceks contains

• The active substance is morphine hydrochloride trihydrate. Morphine Kalceks contains 10 mg/ml of morphine hydrochloride trihydrate, corresponding to 7.6 mg/ml of morphine.
• The other ingredients are: sodium chloride, concentrated hydrochloric acid, water for injections.

What Morphine Kalceks looks like and contents of the pack
1 ml of a clear, colourless or slightly yellow solution for injection in colourless glass ampoules (Type I).
Pack size: 10 ampoules
Marketing Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E
Riga, LV-1057
Latvia
This medicinal product is authorised in the European Economic Area countries under the following names:
Sweden: Morfin Kalceks, 10 mg/ml, injektionsvätska, lösning
Netherlands: Morfine Kalceks 10 mg/ml, oplossing voor injectie
Poland: Morphine Kalceks
Czech Republic: Morphine Kalceks
Hungary: Morphine Kalceks 10 mg/ml oldatos injekció
Portugal: Morfina Kalceks
Slovakia: Morphine Kalceks
Spain: Morfina Kalceks 10 mg/ml solución inyectable EFG