Morphine Kalceks

Package Leaflet: Information for the User

Morphine Kalceks, 10 mg/ml, Solution for Injection

Morphine Hydrochloride Trihydrate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

Morphine Kalceks contains the active substance morphine and belongs to a group of medicines called natural opioid analgesics. This medicine is used to relieve severe pain, when other painkillers have not been effective.

2. Important information before using Morphine Kalceks

When not to use Morphine Kalceks:

• if you are allergic to morphine hydrochloride trihydrate or any of the other ingredients of this medicine (listed in section 6);
• if you have a large amount of mucus in the airways;
• if you have breathing difficulties;
• in case of acute liver disease;
• in case of anxiety disorders in patients who abuse alcohol or sedatives.

Warnings and precautions

There is a risk of dependence on Morphine Kalceks. Before starting treatment with Morphine Kalceks, discuss this with your doctor, pharmacist, or nurse if you:

• are dependent on other painkillers (opioids);
• are undergoing peritoneal dialysis;
• have asthma;
• have respiratory spasms;
• have head injuries;
• have low blood pressure with decreased circulating blood volume;
• have thyroid function disorders;
• have liver or kidney function disorders;
• have inflammatory bowel disease;
• have pancreatitis;
• have spasms of the bile or urinary tract;
• have an enlarged prostate;
• have muscle weakness called myasthenia;
• are taking MAOI inhibitors (medicines used to treat depression).

If you experience any of the following symptoms while taking Morphine Kalceks, consult your doctor, pharmacist, or nurse:

• Increased sensitivity to pain, despite increased doses of the medicine (hyperalgesia). Your doctor will decide whether a change in dosage or the 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 adrenal insufficiency and hormone supplements may be necessary.
• Loss of sexual desire, impotence, amenorrhea. This may be due to decreased sex hormone secretion.
• If you have a history of drug or alcohol dependence. You should also tell your doctor if you notice that you are becoming dependent on Morphine Kalceks while taking it. For example, when you start thinking about taking the next dose frequently, even if you don't need it to relieve pain.
• Withdrawal symptoms or dependence. The most common withdrawal symptoms are listed in section 3. In this case, your doctor may change the medicine or the time between doses.

Tolerance, dependence, and addictive use This medicine contains morphine, which is an opioid. Repeated use of opioids can lead to decreased effectiveness of the medicine (the patient gets used to it, which is known as tolerance). Repeated use of Morphine Kalceks can also lead to dependence, abuse, and addictive use, which can result in life-threatening overdose. The risk of these side effects may increase with increasing dose and duration of use. Dependence or addictive use can cause the patient to feel a loss of control over how much medicine to take or how often to take it. The risk of dependence on Morphine Kalceks or its addictive use varies from person to person. The risk of dependence on Morphine Kalceks or its addictive use may be higher if:

• you or a family member have ever abused or been dependent on alcohol, prescription drugs, or illicit drugs ("dependence");
• you smoke;
• you have ever had mood disorders (depression, anxiety disorders, or personality disorders) or have been treated by a psychiatrist for other mental illnesses.

If you experience any of the following symptoms while taking Morphine Kalceks, it may indicate dependence or addictive use:

• you need to take the medicine for a longer period than prescribed by your doctor;
• you need to take a higher dose than prescribed;
• you use the medicine for reasons other than those for which your doctor prescribed it, for example, "to calm down" or "to fall asleep";
• you have made repeated unsuccessful attempts to stop or control the use of the medicine;
• after stopping the medicine, you feel unwell, and your condition improves when you take the medicine again ("withdrawal effect").

If you notice any of these symptoms, discuss the best treatment strategy with your doctor, including when it is appropriate to stop treatment and how to do it safely (see section 3: Stopping Morphine Kalceks). Elderly patients should use smaller doses of Morphine Kalceks. This medicine should not be used to relieve pain of unknown origin or pain associated with mental disorders. Morphine Kalceks has been associated with the development of acute generalized exanthematous pustulosis (AGEP). Symptoms usually occur within the first 10 days of treatment. You should tell your doctor if you have ever had a severe skin rash or skin peeling after taking Morphine Kalceks or other opioids, or if you have had blisters or ulcers in the mouth. You should stop taking Morphine Kalceks and consult your doctor immediately if you notice any of the following symptoms: blisters, widespread skin peeling, or pus-filled spots with fever. This medicine should not be used as monotherapy during an attack of biliary or renal colic, as it may increase the force of contraction. In such cases, Morphine Kalceks should be used in combination with spasmolytic agents. You should consult your doctor if you experience severe abdominal pain that radiates to the back, nausea, vomiting, or fever, as these may be symptoms related to pancreatitis and bile duct disorders. The effect of this medicine may be enhanced in patients who have had brain inflammation. Respiratory depression associated with sleep: Morphine Kalceks may cause respiratory depression associated with sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). These symptoms may include moments of stopped breathing during sleep, waking up at night due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. You should consult your doctor if you or someone else notices these symptoms. Your doctor may consider reducing the dose of the medicine.

Morphine Kalceks and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. This is especially important for the following medicines:

• Rifampicin, used to treat tuberculosis
• Certain medicines used to treat blood clots (e.g., clopidogrel, prasugrel, ticagrelor) may have delayed and reduced effect when taken with morphine
• Concomitant use of Morphine Kalceks and sedatives, such as benzodiazepines or derivatives, increases the risk of drowsiness, breathing difficulties (respiratory depression), or coma and can be life-threatening. Therefore, combination therapy should only be considered when other treatment options are not available. If Morphine Kalceks is used with sedatives, the doctor should limit the dose and duration of concomitant use. The patient should tell the doctor about all sedatives being taken and strictly follow the prescribed dose. It may be helpful to inform friends or family members of the patient about the possibility of these symptoms. If these symptoms occur, consult a doctor.

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

• Sedatives and sleeping pills containing barbiturates (methohexital, pentothal, phenobarbital);
• Medicines used to treat depression or Parkinson's disease (MAO inhibitors) (moclobemide, selegiline).

These medicines used in combination with Morphine Kalceks may weaken 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);
• Certain other painkillers (buprenorphine, nalbuphine, pentazocine).

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

• Muscle relaxants (baclofen);
• Sedatives containing benzodiazepines (nitrazepam, flunitrazepam, triazolam, midazolam);
• Sedatives that reduce itching (hydroxyzine);
• Stimulants of the central nervous system (methylphenidate);
• Medicines used to treat bleeding in the brain (nimodipine);
• Medicines used to treat HIV (ritonavir).

Morphine Kalceks and alcohol

Alcohol should be avoided, as it may worsen respiratory function.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine. FertilityIn animal studies, this medicine has shown a negative effect on fertility. This medicine may cause harm to the developing fetus. Therefore, women and men of childbearing age should use appropriate contraceptive methods. Discuss this with your doctor. PregnancyIf Morphine Kalceks has been used during pregnancy for a long time, there is a risk of withdrawal symptoms in the newborn (abstinence syndrome), which should be treated by a doctor. The use of morphine during childbirth may cause respiratory depression in the newborn. BreastfeedingMorphine passes into breast milk. Therefore, Morphine Kalceks should not be used during breastfeeding.

Driving and using machines

Do not drive or operate machinery while taking Morphine Kalceks, as this medicine may affect your reaction ability.

Morphine Kalceks contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per ml of solution, which means it is essentially "sodium-free".

3. How to use Morphine Kalceks

This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Before and regularly during treatment, your doctor will discuss with you what to expect when using Morphine Kalceks, when and for how long to take it, when to consult a doctor, and when to stop the medicine (see also "Stopping Morphine Kalceks" in this section). The dose is individually determined by your doctor. It depends on age, body weight, pain intensity, previously used painkillers, and previous pain. Elderly patientsIt is recommended to use smaller doses of the medicine. Impaired liver and kidney functionIt is recommended to use smaller doses of the medicine. It is recommended to reduce the dose of the medicine in patients with asthma, obstruction of the upper airways, head injuries, peritoneal dialysis, hypotension associated with hypovolemia, hypothyroidism, liver or kidney function disorders, inflammatory bowel disease, pancreatitis, spasms of the bile or urinary tract. The medicine can be administered intravenously, intramuscularly, or subcutaneously.

Using a higher dose of Morphine Kalceks than recommended

In case of overdose or accidental ingestion of the medicine by a child, consult a doctor. Symptoms of overdose include: pinpoint pupils, low blood pressure, breathing difficulties, which can lead to loss of consciousness and even death. People who have taken an overdose may develop pneumonia from aspiration of vomit or foreign bodies; symptoms may include shortness of breath, cough, and fever. In severe cases, circulatory disorders and coma may occur.

Missing a dose of Morphine Kalceks

Do not take a double dose to make up for a forgotten dose.

Stopping Morphine Kalceks

If you suddenly stop using Morphine Kalceks or use other strong painkillers, you may experience withdrawal symptoms. Do not stop using Morphine Kalceks unless your doctor tells you to. To stop using Morphine Kalceks, consult your doctor, who will decide how to gradually reduce the dose to avoid withdrawal symptoms. Withdrawal symptoms may include body aches, seizures, diarrhea, stomach pain, nausea, flu-like symptoms, rapid heartbeat, and dilated pupils. Psychological symptoms include intense dissatisfaction, anxiety, and irritability. If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Morphine Kalceks can cause side effects, although not everybody gets them. Respiratory depression is a serious, not very common side effect associated with morphine use, which may occur in up to 1 in 100 people. If you have breathing difficulties, consult your doctor immediately to receive treatment for respiratory depression. You should immediatelyconsult your doctor if you experience:

• severe allergic reactions causing breathing difficulties or dizziness.
• severe skin reactions with blisters, widespread skin peeling, or pus-filled spots with fever. This may be a condition called acute generalized exanthematous pustulosis (AGEP).

Common (may affect up to 1 in 10 people):drowsiness, dizziness, constricted pupils, nausea, vomiting, constipation, difficulty urinating, increased secretion of antidiuretic hormone (ADH). Uncommon (may affect up to 1 in 100 people):low mood, confusion, bronchospasm, spasms of the urinary and bile ducts, itching, feeling of emptiness in the head. Rare (may affect up to 1 in 1,000 people):rapid heartbeat, palpitations, fainting, dizziness when standing up quickly, high blood pressure, low blood pressure, swelling of the feet and ankles. Not known (frequency cannot be estimated from the available data):euphoria (feeling of happiness), drowsiness, memory and concentration disorders, convulsions, sleep apnea (moments of stopped breathing during sleep), dry mouth, symptoms related to pancreatitis and bile duct disorders (e.g., severe abdominal pain radiating to the back, nausea, vomiting, or fever), hives, involuntary muscle contractions (myoclonus), increased sensitivity to pain, sweating, withdrawal symptoms or dependence (information on symptoms - see section 3: Stopping Morphine Kalceks).

Reporting side effects

If you experience any side effects, including any not listed in the package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Morphine Kalceks

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

6. Contents of the pack and other information

What Morphine Kalceks contains

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

What Morphine Kalceks looks like and contents of the pack

1 ml of clear, colorless or yellowish solution for injection in colorless glass ampoules (type I). Pack size: 10 ampoules

Marketing authorization holder and manufacturer

AS KALCEKS Krustpils iela 71E, Riga, LV-1057, Latvia

This medicine is authorized in the Member States of the European Economic Area 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

Date of last revision of the package leaflet: 11/2024