1 mg / ml, 10 mg / ml and 20 mg / ml solution for
infusion
morphine hydrochloride trihydrate
What Sendolor is and what it is used for
Sendolor contains the active substance morphine. Morphine belongs to a group of drugs called strong analgesics or “painkillers”. Sendolor is used to treat severe acute pain, cancer pain, and breakthrough pain in cancer.
Morphine contained in Sendolor may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
What you need to know before using Sendolor
Do not use Sendolor
– If you are allergic to morphine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
– If you have large amounts of mucus in your airways
– If you have acute liver disease
– If you have impaired breathing (shortness of breath)
– If you feel upset/worried when you are under the influence of alcohol or drugs for sleep problems
Warnings and cautions
This drug carries a risk of addiction and often addiction. Tolerance may develop (a higher dose is needed to get the same pain relief).
Talk to your doctor, pharmacist, or nurse before using Sendolor if you have:
– asthma
– cyanosis (bluish discoloration of the skin)
– head injuries
– low blood pressure with reduced blood volume
– underactive thyroid gland
– impaired liver function
– impaired kidney function
– inflammatory intestinal disease and disorders of the normal function of the gastrointestinal tract
– pancreatitis
– biliary spasm
– urinary tract spasm
– seizures (abnormal, involuntary contractions of muscles)
– withdrawal symptoms
Talk to your doctor, pharmacist, or nurse if you experience any of the following symptoms while using Sendolor:
– Increased sensitivity to pain 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 may 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 that you are becoming addicted to Sendolor 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.
Children and young people
All children, especially newborns, are at risk of having respiratory problems with this medicine. The doctor gives morphine with special caution to children under one year of age.
Other medicines and Sendolor
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
- Concomitant use of Sendolor and sedatives such as benzodiazepines or related agents increase the risk of drowsiness, low blood pressure, 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 Sendolor
with sedatives, 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.
- Rifampicin ( antibiotics ) can make morphine disappear faster from the body.
- Some medicines used to prevent blood clots (eg clopidogrel, prasugrel, ticagrelor) may have a delayed or reduced effect when taken with morphine.
- Cimetidine increases the analgesic effect of morphine without major effects on respiratory capacity.
- Nimodipine, a calcium channel blocker, enhances the analgesic effect in cancer patients who need regular morphine dose increases to control the pain.
- MAO inhibitors (used to treat depression) may increase the effects of morphine on respiration and blood pressure (shortness of breath and low blood pressure ).
- Serotonin poisoning (a neurotransmitter) cannot be ruled out in combination with morphine and MAO inhibitors (used to treat depression).
- Combined treatment with morphine stimulants/inhibitors (buprenorphine, nalbuphine, pentazocine (analgesic opioids )) reduces the analgesic effect of morphine and thus increases the risk of withdrawal symptoms.
Sendolor with food, drink, and alcohol
Sendolor may cause impaired breathability, which may be exacerbated in combination with alcohol. Avoid alcohol (even small amounts) during treatment with this medicine.
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. With long-term use of Sendolor during pregnancy, there is a risk that the newborn baby will develop symptoms of drug withdrawal ( abstinence ) which must be treated by a doctor.
Morphine can harm the fetus and has adverse effects on fertility. Therefore, fertile men and women should use effective contraception.
Morphine is excreted in breast milk. Sendolor should not be used during breastfeeding.
Driving and using machines
Morphine affects the ability to drive and use machines. This should be considered when sharper attention is required, e.g. while driving.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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. Therefore, read all the information in this leaflet for
guidance. If you are not sure, talk to your doctor or pharmacist.
Sendolor contains sodium
Sendolor 1 mg / ml, solution for infusion contains 354.5 mg sodium (the main ingredient in table salt / table salt) per 100 ml. This corresponds to 17.7% of the highest recommended daily intake of sodium for adults.
Sendolor 10 mg / ml, solution for infusion contains 295.4 mg sodium (the main ingredient in table salt / table salt) per 100 ml. This corresponds to 14.8% of the highest recommended daily intake of sodium for adults.
Sendolor 20 mg / ml, solution for infusion contains 236.3 mg sodium (the main ingredient in table salt / table salt) per 100 ml. This corresponds to 11.8% of the highest recommended daily intake of sodium for adults.
How to use Sendolor
Use for children and adolescents
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dosage one is individual and determined by your doctor. It depends on your age, weight, the severity of the pain, and previous medications and pains. If you are elderly or have impaired liver or kidney function, your doctor may prescribe a lower dose.
If you use more Sendolor than you should
Symptoms of overdose include very small pupils, impaired breathing, and low blood pressure. Circulatory disorders and coma can occur in severe cases. 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. People who have taken an overdose may also have difficulty breathing that
leads to unconsciousness or even death.
If you have ingested too much medicine or if e.g. a child inhaled the medicine accidentally contact a doctor, or hospital for risk assessment and advice
If you forget to use Sendolor
Do not take a double dose to make up for a forgotten dose.
If you stop using Sendolor
Do not stop treatment with Sendolor unless you have agreed to do so with your doctor. If you want to stop treatment with Sendolor, ask your doctor how to lower the 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.
The most serious side effects of this medicine are: accumulation of fluid in the tissues and airways of the lungs leading to impaired breathing (pulmonary edema ), skin rash ( urticaria ), both less common, severe allergic reaction ( anaphylactic reaction ), non-allergic hypersensitivity reaction ( anaphylactic reaction) ), both with unknown frequency. Contact a doctor immediately if you experience any of these side effects.
Very common (may affect more than 1 user in 10):
- drowsiness.
Common (may affect up to 1 in 10 people):
- confusion
- difficulty sleeping
- dizziness
- headache
- somnolence
- sedation
- contracted pupil is
- anorexia
- dry mouth
- vomiting
- constipation
- nausea
- contact eczema
- sweating
- inability to empty the bladder
Uncommon (may affect up to 1 in 100 people):
- allergic reaction
- concern
- euphoria _
- hallucinations
- mood swings
- dysphoria (dissatisfaction)
- cramps
- condition with increased muscle tension
- abnormal heartbeat
- redness of the face
- breathing difficulties
- itching
- pain and irritation at the site of administration
Rare (may affect up to 1 in 1,000 people):
- orthostatic hypertension (high blood pressure when standing)
No known frequency (cannot be calculated from the available data):
- drug addiction
- increased pain sensitivity
- slow heart rate
- fast heartbeat
- elevated liver enzymes
- decreased sexual drive
- decreased ability to get and maintain an erection
- Withdrawal symptoms or addiction (for symptoms, see section 3: If you stop taking Sendolor).
- drug tolerance
- muscle stiffness
How to store Sendolor
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 label and carton after EXP.
The expiration date is the last day of the specified month. Use immediately after opening the outer bag.
Store the bag in the outer bag. 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 packaging and other information
Content declaration
The active substance is morphine hydrochloride. The other ingredients are sodium chloride, hydrochloric acid, and water for injections.
What the medicine looks like and the contents of the pack
The solution for infusion is transparent and (almost) colorless.
Sendolor 1 mg / ml solution contains 10 ml (100 mg) in an uncoloured bag.
Sendolor 10 mg / ml solution contains 100 ml (1000 mg) in an uncoloured bag
Sendolor 20 mg / ml solution contains 100 ml (2000 mg) in an uncoloured bag.
The bags are packed in outer bags. Between the bag and the outer bag is a small oxygen-absorbing bag.
An outer carton contains 1, 5, or 10 outer bags.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Eurocept International BV
Trapani 5
1244 RL Ankeveen
Netherlands
Information provided by:
Frostpharma AB
Berga Backe 2
182 53 Danderyd