1 mg \/ ml, 10 mg \/ ml and 20 mg \/ ml solution for <\/p>\n\n\n\n
infusion Sendolor contains the active substance morphine.\u00a0Morphine belongs to a group of drugs called strong\u00a0analgesics\u00a0or “painkillers”.\u00a0Sendolor is used to treat severe\u00a0acute\u00a0pain, cancer pain, and breakthrough pain in cancer.<\/p>\n\n\n\n – If you are allergic to morphine hydrochloride or any of the other ingredients of this medicine (listed in section 6) This drug carries a risk of addiction and often addiction.\u00a0Tolerance may develop (a higher\u00a0dose\u00a0is needed to get the same pain relief). All children, especially newborns, are at risk of having respiratory problems with this medicine.\u00a0The doctor gives morphine with special caution to children under one year of age.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n Sendolor may cause impaired breathability, which may be exacerbated in combination with alcohol. Avoid alcohol (even small amounts) during treatment with this medicine.<\/a><\/p>\n\n\n\n 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.\u00a0With long-term use of Sendolor during pregnancy, there is a risk that the newborn baby will develop symptoms of drug withdrawal (\u00a0abstinence\u00a0) which must be treated by a doctor.<\/p>\n\n\n\n Morphine can harm the fetus and has adverse effects on\u00a0fertility.\u00a0Therefore, fertile men and women should use effective contraception.<\/p>\n\n\n\n Morphine affects the ability to drive and use machines.\u00a0This should be considered when sharper attention is required, e.g.\u00a0while driving. 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.<\/p>\n\n\n\n Always use this medicine exactly as your doctor or pharmacist has told you.\u00a0Ask your doctor or pharmacist if you are unsure. Symptoms of overdose include very small\u00a0pupils, impaired breathing, and low\u00a0blood pressure.\u00a0Circulatory disorders and\u00a0coma\u00a0can occur in severe cases.\u00a0People who have taken an overdose can get\u00a0pneumonia\u00a0by pulling down vomit or foreign matter in the lungs, with symptoms such as shortness of breath, cough, and fever.\u00a0People who have taken an overdose may also have difficulty breathing that Do not take a double\u00a0dose\u00a0to make up for a forgotten\u00a0dose.<\/p>\n\n\n\n Do not stop treatment with Sendolor unless you have agreed to do so with your doctor.\u00a0If you want to stop treatment with Sendolor, ask your doctor how to lower the\u00a0dose\u00a0slowly to avoid withdrawal symptoms.\u00a0Withdrawal symptoms can include body aches, tremors, diarrhea, abdominal pain, nausea,\u00a0flu-like symptoms, palpitations, and enlarged\u00a0pupils.\u00a0Psychological symptoms include an intense feeling of dissatisfaction, anxiety\/worry, and irritability.\u00a0If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Very common (may affect more than 1 user in 10):<\/em><\/p>\n\n\n\n Common (may affect up to 1 in 10 people):<\/em><\/p>\n\n\n\n Uncommon (may affect up to 1 in 100 people):<\/em><\/p>\n\n\n\n Rare (may affect up to 1 in 1,000 people):<\/em><\/p>\n\n\n\n No known frequency (cannot be calculated from the available data):<\/em><\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the label and carton after EXP.<\/p>\n\n\n\n The expiration date is the last day of the specified month. Use immediately after opening the outer bag.<\/p>\n\n\n\n Store the bag in the outer bag. Sensitive to light.<\/p>\n\n\n\n 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.<\/a><\/p>\n\n\n\n The active substance is morphine hydrochloride.\u00a0The other ingredients are sodium chloride,\u00a0hydrochloric acid, and water for injections.<\/p>\n\n\n\n The solution for infusion is transparent and (almost) colorless.<\/p>\n\n\n\n Sendolor 1 mg \/ ml solution contains 10 ml (100 mg) in an uncoloured bag.<\/p>\n\n\n\n Sendolor 10 mg \/ ml solution contains 100 ml (1000 mg) in an uncoloured bag<\/p>\n\n\n\n Sendolor 20 mg \/ ml solution contains 100 ml (2000 mg) in an uncoloured bag.<\/p>\n\n\n\n The bags are packed in outer bags. Between the bag and the outer bag is a small oxygen-absorbing bag.<\/p>\n\n\n\n An outer carton contains 1, 5, or 10 outer bags.<\/p>\n\n\n\n
morphine hydrochloride trihydrate<\/a><\/p>\n\n\n\nWhat Sendolor is and what it is used for<\/h2>\n\n\n\n
Morphine contained in Sendolor may also be approved for the treatment of other conditions not mentioned in this leaflet.\u00a0Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
<\/p>\n\n\n\nWhat you need to know before using Sendolor<\/h2>\n\n\n\n
Do not use Sendolor<\/h2>\n\n\n\n
– If you have large amounts of mucus in your airways
– If you have\u00a0acute\u00a0liver 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<\/p>\n\n\n\nWarnings and cautions<\/h2>\n\n\n\n
Talk to your doctor, pharmacist, or nurse before using Sendolor if you have:
–\u00a0asthma
– cyanosis (bluish discoloration of the skin)
– head injuries
– low\u00a0blood pressure\u00a0with reduced blood volume
– underactive\u00a0thyroid gland
– impaired liver function
– impaired kidney function
–\u00a0inflammatory 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<\/p>\n\n\n\n
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\u00a0doses\u00a0(hyperalgesia).\u00a0Your doctor will decide if you need to change the\u00a0dose\u00a0or switch to another strong\u00a0analgesic\u00a0(painkiller), (see section 2).
Weakness, fatigue, loss of appetite, nausea, vomiting, or low\u00a0blood pressure.\u00a0This may be a symptom that the adrenal glands are producing too little of the\u00a0hormone\u00a0et\u00a0cortisol, and you may therefore need to take hormone supplements.
– Loss of\u00a0libido, impotence, missed periods.\u00a0This may be due to decreased production of sex hormones.
– If you have once been addicted to drugs or alcohol.\u00a0Also, tell us if you feel that you are becoming addicted to Sendolor while using it.\u00a0You may have started thinking a lot about when you can take the next\u00a0dose, even if you do not need it for the pain.
Withdrawal symptoms or addiction.\u00a0The most common withdrawal symptoms are mentioned in section 3. If this happens, your doctor may change the type of medicine or the times between\u00a0doses.<\/p>\n\n\n\nChildren and young people<\/h2>\n\n\n\n
Other medicines and Sendolor<\/h2>\n\n\n\n
with\u00a0sedatives, your doctor should limit the\u00a0dose\u00a0and duration of concomitant treatment.\u00a0Tell your doctor about all\u00a0the sedative medicines you are taking, and carefully follow your doctor’s dose recommendation.\u00a0It may be helpful to ask friends or relatives to be aware of the signs and symptoms mentioned above.\u00a0Contact a doctor when you experience such symptoms.<\/li><\/ul>\n\n\n\nSendolor with food, drink, and alcohol<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Morphine is excreted in breast milk.\u00a0Sendolor should not be used during breastfeeding.<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0Descriptions of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Therefore, read all the information in this leaflet for
guidance.\u00a0If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\nSendolor contains sodium<\/h2>\n\n\n\n
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.<\/p>\n\n\n\n
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.<\/a><\/p>\n\n\n\nHow to use Sendolor<\/h2>\n\n\n\n
Use for children and adolescents<\/h2>\n\n\n\n
Dosage\u00a0one is individual and determined by your doctor.\u00a0It depends on your age, weight, the severity of the pain, and previous medications and pains.\u00a0If you are elderly or have impaired liver or kidney function, your doctor may prescribe a lower\u00a0dose.<\/p>\n\n\n\nIf you use more Sendolor than you should <\/h2>\n\n\n\n
leads to unconsciousness or even death.
If you have ingested too much medicine or if e.g.\u00a0a child inhaled the medicine accidentally contact a doctor, or hospital for risk assessment and advice<\/p>\n\n\n\nIf you forget to use Sendolor<\/h2>\n\n\n\n
If you stop using Sendolor<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
The most serious\u00a0side effects\u00a0of this medicine are: accumulation of fluid in the\u00a0tissues\u00a0and airways of the lungs leading to impaired breathing (pulmonary\u00a0edema\u00a0), skin rash (\u00a0urticaria\u00a0), both less common, severe\u00a0allergic reaction\u00a0(\u00a0anaphylactic reaction\u00a0), non-allergic\u00a0hypersensitivity\u00a0reaction ( anaphylactic reaction)\u00a0), both with unknown frequency.\u00a0Contact a doctor immediately if you experience any of these\u00a0side effects.<\/p>\n\n\n\nHow to store Sendolor<\/h2>\n\n\n\n
Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n