10 mg / ml, solution for injection
morphine hydrochloride
What Morphine Abcur is and what it is used for
Morphine Abcur is a drug used to relieve severe pain, and it is part of a group of drugs called natural opium alkaloids.
Morphine hydrochloride contained in Morphine Abcur may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Morphine Abcur
Do not use Morphine Abcur
- 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 Abdur
Talk to your doctor, pharmacist, or nurse before using Morphine Abdur
- if you are addicted to other painkillers ( opioids )
- in asthma
- in case of spasm of the respiratory tract
- in case of head injury
- at low blood pressure with decreased blood volume
- in case of impaired thyroid function
- in case of impaired liver or kidney function
- in inflammatory stomach disease
- in inflammation of the pancreas
- in case of spasm of the bile ducts or ureters
- in enlarged prostate
- in myasthenia gravis (a disease with muscle weakness)
- 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 Abcur 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 Abcur is recommended.
This medicine should not be used for the treatment of pain of unknown origin or pain associated with mental illness.
This medicine should not be used alone in gallstone or kidney stone attacks as it may increase seizures. In these cases, Morphine Abcur should be used together with antispasmodics ( antispasmodics ).
The effects of this drug may be exacerbated after encephalitis.
Other medicines and Morphine Abcur
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of the treatment can be affected if Morphine Abcur is taken at the same time as certain other medicines.
Morphine Abcur may impair respiratory function during concomitant treatment with:
- sedatives and hypnotics (methohexital, pentotal, fenemal, meprobamate)
- antidepressants (MAO inhibitors) (moclobemide, selegiline )
The effect of Morphine Abcur is enhanced by:
- sedatives and hypnotics (methohexital, pentotal, phenobarbital)
- antidepressants (clomipramine, amitriptyline, nortriptyline)
- MAO inhibitors (moclobemide, selegiline )
The effect of Morphine Abcur is reduced during concomitant treatment with certain other painkillers (buprenorphine, nalbuphine, pentazocine).
During concomitant treatment with rifampicin (to treat tuberculosis, for example ), one dose of Morphine Abcur may need to be increased.
Some medicines used to prevent blood clots (eg clopidogrel, prasugrel, ticagrelor) may have a delayed or reduced effect when taken with morphine.
During concomitant treatment with gabapentin (to treat epilepsy, for example ), one dose of Morphine Abcur or gabapentin may need to be reduced.
Concomitant use of Morphine Abcur and sedatives such as benzodiazepines or related agents 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 Abcur together with sedative drugs, your doctor should limit the dose and duration of concomitant treatment. Tell your doctor about all the sedative medicines 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.
Morphine Abcur with food, drink and 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.
In animal studies, this medicine has shown negative effects on the fertility of animals and can cause birth defects. Fertile women and men should therefore use effective contraception. Discuss this with your doctor.
If Morphine Abcur is used for a long time 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.
Morphine passes into breast milk. Morphine Abcur should therefore not be used during breastfeeding.
Driving and using machines
During treatment with Morphine Abcur, the reactivity may be reduced. This should be taken into account when sharper attention is required, for example when driving a car and operating machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Morphine Abcur
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.
Adults:
The usual dose is 1-1.5 ml of solution for injection given subcutaneously or intramuscularly 1-3 times daily. In urgent cases, morphine can be given slowly intravenously.
Older:
A lower dose is recommended for elderly patients.
Use in patients with liver or kidney problems:
A lower dose is recommended for patients with liver or kidney problems.
If you use more Morphine Abcur than you should
People who have taken an overdose can get pin-sized pupils, low blood pressure, and in severe cases circulatory disorders and can get pneumonia from pulling down vomiting or foreign matter in the lungs, with symptoms such as shortness of breath, cough, and fever.
People who have taken an overdose may also have difficulty breathing which leads to unconsciousness, coma, or even death.
If you forget to use Morphine Abcur
Do not take a double dose to make up for a forgotten dose.
If you stop using Morphine Abcur
Do not stop taking Morphine Abcur unless you have agreed to do so with your doctor. If you want to stop taking Morphine Abcur, 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 or pharmacist
or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Morphine Abcur and contact a doctor immediately or see the nearest emergency department if you experience the following symptoms:
- breathing difficulties. This may be a sign of respiratory depression (impaired respiratory function) (less common side effect ).
- severe allergic reaction that makes it difficult to breathe or dizzy.
Contact a doctor immediately if you experience any of the following:
- Chronic or recurrent abdominal pain, sometimes with nausea, vomiting, bloating and constipation (these may be signs of a condition called opioid-induced bowel problems). The frequency of this side effect is unknown (affects an unknown number of users).
Other side effects that may occur:
Common (may affect up to 1 in 10 people):
- drowsiness
- pupil reduction
- nausea
- vomiting
- constipation
- problems urinating
- increased ADH – release (a hormone that causes the body to accumulate water and dilute the blood, reduces the amount of sodium )
- respiratory cramps
Uncommon (may affect up to 1 in 100 people):
- Depression
- spasm of the ureters or bile ducts
- itching
- dizziness
- fainting sensation
Rare (may affect up to 1 in 1,000 people):
- dizziness as one quickly gets up
Has been reported (occurs in an unknown number of users):
- concern
- dry mouth
- seizures (cramps)
- itchy rash ( hives )
- increased sensitivity of the skin
- increased sensitivity to pain
- stinging or numb feeling in the skin ( paresthesia )
- excessive sweating
- withdrawal symptoms or addiction (for symptoms, see section 3: If you stop taking Morphine Abcur).
- palpitations, slow heartbeats, fast heartbeats
How to store Morphine Abcur
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 ampoule one in the outer carton. 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.
- The other ingredients are hydrochloric acid , water for injections.
What the medicine looks like and contents of the pack
Morphine Abcur, a solution for injection ( injection ), is a clear solution.
1 ml in brown glass ampoules in packs of 5 or 10 ampoules.
5 ml in brown glass ampoules in packs of 10 ampoules .
Marketing Authorisation Holder
Abcur AB
Box 1452
251 14 Helsingborg
Manufacturer
L Molteni & Dei F.LLI Alitti Societa di Esercizio SpA
Strada Statale 67
Fraz Granatieri
50018 Scandicci F irenze
Italy