10 mg / ml solution for injection
morphine hydrochloride
What Morphine Kalceks is and what it is used for
Morphine Kalceks contains the active substance morphine and is part of a group of medicines called natural opium alkaloids. This medicine is used to relieve severe pain when other painkillers do not have sufficient effect.
Morphine contained in Morphine Kalceks may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Morphine Kalceks
Do not use Morphine Kalceks
- if you are allergic to morphine hydrochloride or any of the other ingredients of this medicine. (listed in section 6).
- in conditions with a lot of mucus in the airways
- in case of impaired respiratory function
- in acute liver disease
- in case of anxiety in patients who are under the influence of alcohol or sleeping pills
Warnings and cautions
There is a risk of habit formation with Morphine Kalceks.
Talk to your doctor, pharmacist, or nurse before using Morphine Kalceks if you:
- is addicted to other painkillers ( opioids )
- get peritoneal dialysis
- have asthma
- have cramps in the airways
- has head injury
- have low blood pressure with decreased blood volume
- has impaired thyroid function
- have impaired liver or kidney function
- have inflammatory bowel disease
- have inflammation of the pancreas
- have cramps in the bile ducts or ureters
- has enlarged prostate
- has myasthenia gravis (a disease with muscle weakness)
- have concomitant treatment with MAO inhibitors (antidepressants)
Talk to your doctor, pharmacist, or nurse if you experience any of the following symptoms while using Morphine Kalceks:
- increased pain sensitivity even though you are taking increasing doses (hyperalgesia). Your doctor will decide if you need to change the dose or switch to another strong analgesic (painkiller), (see section 2)
- weakness, fatigue, loss of appetite, nausea, vomiting or low blood pressure . This can be a symptom that the adrenal glands are producing too little of the hormone et cortisol , and you may therefore need to take hormone supplements
- loss of libido , impotence , missed periods. This may be due to decreased production of sex hormones
- if you have once been addicted to drugs or alcohol. Also tell us if you feel you are becoming addicted to Morphine Kalceks while using it. You may have started thinking a lot about when you can take the next dose , even if you do not need it for the pain
- withdrawal symptoms or addiction. The most common withdrawal symptoms are mentioned in section 3. If this happens, your doctor may change the type of medicine or the times between doses .
In the treatment of elderly patients, a lower dose of Morphine Kalceks is recommended.
This medicine should not be used to treat the pain of unknown origin or for pain associated with mental illness.
This medicine should not be given alone during gallstone or kidney stone attacks as it may increase seizures. In such cases, Morphine Kalceks should be given in combination with antispasmodics ( antispasmodics ).
The effect of this drug may be exacerbated after encephalitis.
Other medicines and Morphine Kalceks
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is especially important if you are taking:
- rifampicin to e.g. treat tuberculosis
- Concomitant use of Morphine Kalceks and sedatives such as benzodiazepines or related drugs increases the risk of drowsiness, difficulty breathing ( respiratory depression ) and coma , and may be life-threatening. Concomitant use should therefore only be considered when other treatment options are lacking. However, if your doctor prescribes Morphine Kalceks together with sedative medicines, your doctor should limit the dose and the duration of concomitant treatment. Tell your doctor about all sedativesmedicines you are taking, and carefully follow your doctor’s dose recommendation. It may be helpful to ask friends or relatives to be aware of the signs and symptoms mentioned above. Contact a doctor when you experience such symptoms.
The effect of the treatment can be affected if Morphine Kalceks is taken at the same time as certain other medicines.
Combinations to avoid with Morphine Kalceks:
- sedatives and sleeping pills containing barbiturates (methohexital, pentotal, phenobarbital)
- antidepressants or Parkinson’s syndrome (MAO inhibitors) (moclobemide, selegiline )
These medicines, in combination with Morphine Kalceks, may impair respiratory function.
Drugs that may require dose adjustment:
- antiepileptic drugs ( gabapentin )
- antidepressants (clomipramine, amitriptyline, nortriptyline)
- some other painkillers (buprenorphine, nalbufine, pentazocine)
Other drugs that can affect or be affected by Morphine Kalceks:
- anticonvulsant drug (baclofen)
- sedatives containing benzodiazepines (nitrazepam, flunitrazepam , triazolam, midazolam)
- sedative drugs that reduce itching ( hydroxizine )
- central stimulant drug (methylphenidate)
- medicines for bleeding in the meninges (nimodipine)
- anti- HIV drugs (ritonavir)
Mofin Kalceks with alcohol
Combination with alcohol should be avoided as respiratory function may be impaired.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Fertility
In animal studies, this drug has shown side effects on animal fertility and it can cause harm to the growing fetus. Therefore, fertile women and men should use effective contraception. Discuss this with your doctor.
Pregnancy
With long-term use of Morphine Kalceks during pregnancy, there is a risk that the newborn baby will develop symptoms of drug withdrawal ( abstinence ) which must be treated by a doctor. The use of morphine during childbirth may cause the newborn to have impaired respiratory function.
Breast-feeding
Morphine passes into breast milk. Morphine Kalceks should therefore not be used during breastfeeding.
Driving and using machines
You must not drive or use machines when you receive Morphine Kalceks. This medicine may affect your ability to react.
How to use Morphine Kalceks
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is individual and determined by a doctor. It depends on your age, weight, the severity of the pain, and previous medication and pain.
Older
You will receive a lower dose.
Hepatic or renal impairment
You will receive a lower dose.
The dose may need to be reduced for patients with bronchial asthma, upper respiratory tract obstruction, head injuries, peritoneal dialysis, low blood pressure with reduced blood volume, decreased thyroid function, inflammatory bowel disease, inflammation of the pancreas, urinary tract spasms.
It can be given intravenously, intramuscularly, or subcutaneously.
If you use more Morphine Kalceks than you should
Symptoms of overdose include pin-sized pupils, low blood pressure, difficulty breathing leading to unconsciousness or even death. People who have taken an overdose can get pneumonia by pulling down vomit or foreign matter in the lungs, with symptoms such as shortness of breath, cough, and fever. Circulatory disorders and coma can occur in severe cases.
If you forget to use Morphine Kalceks
Do not take a double dose to make up for a forgotten dose.
If you stop using Morphine Kalceks
Withdrawal symptoms may occur if you suddenly stop taking Morphine Kalceks or if you use certain other strong painkillers.
Do not stop taking Morphine Kalceks unless you have agreed to do so with your doctor. If you want to stop taking Morphine Kalceks, ask your doctor how to lower your dose slowly to avoid withdrawal symptoms. Withdrawal symptoms can include body aches, tremors, diarrhea, abdominal pain, nausea, flu-like symptoms, palpitations, and enlarged pupils. Psychological symptoms include an intense feeling of dissatisfaction, anxiety/worry, and irritability.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Impaired respiratory function is a serious, less common side effect of morphine that may affect up to 1 in 100 people. If you have difficulty breathing, contact your doctor immediately for treatment of your impaired respiratory function.
If you have a severe allergic reaction that makes it difficult to breathe or dizzy, contact your doctor immediately.
Common (may affect up to 1 in 10 people): Drowsiness, dizziness, pupil reduction, nausea, vomiting, constipation, difficulty urinating, increased ADH release ( a hormone ).
Uncommon (may affect up to 1 in 100 people): Depression, confusion, respiratory cramps, urinary tract or bile duct cramps, itching, dizziness.
Rare (may affect up to 1 in 1,000 people): Palpitations, tachycardia, fainting, dizziness when getting up quickly, high blood pressure, low blood pressure, swelling of the feet and legs.
Has been reported (occurs in an unknown number of users): Euphoria (feeling of happiness), sleep, memory and concentration disorders, convulsions, dry mouth, hives, involuntary muscle twitching (myoclonus), increased pain sensitivity, sweating, withdrawal symptoms, or addiction (see the section, for symptoms 3: if you stop taking Morphine Kalceks).
How to store Morphine Kalceks
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Store in the original package. Sensitive to light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
– The active substance is morphine hydrochloride.
Morphine Kalceks contains 10 mg/ml morphine hydrochloride equivalent to 7.6 mg/ml morphine.
The other ingredients are hydrochloric acid ( pH adjustment), water for injections.
What the medicine looks like and contents of the pack
1 ml 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 53, Riga, LV-1057, Latvia
This medicinal product is authorized under the European Economic Area under the names:
| Sweden: | Morphine Kalceks, 10 mg/ml, solution for injection |
| Netherlands: | Morphine Kalceks 10 mg/ml solution for injection |
| Poland: | Morphine Kalceks |
| Czech Republic: | Morphine Kalceks |
| Portugal: | Morphine Kalceks |
| Slovakia: | Morphine Kalceks |
| Spain: | Morphine Kalceks 10 mg/ml injectable solution |
| Czech Republic: | Morphine Kalceks |
| Portugal: | Morphine Kalceks |
| Slovakia: | Morphine Kalceks |
| Spain: | Morphine Kalceks 10 mg/ml injectable solution EFG |