1 mg / ml solution for injection
morphine hydrochloride trihydrate
What Morphine Unimedic is and what it is used for
Morphine Unimedic contains the active ingredient morphine hydrochloride which has a strong analgesic effect.
Morphine Unimedic is used for severe pain such as pain in cancer and as pain relief after surgery or injuries in external violence.
Morphine hydrochloride trihydrate contained in Morphine Unimedic 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 Unimedic
Do not use Morphine Unimedic
You should not be given Morphine Unimedic:
- if you are allergic to morphine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- in conditions with large amounts of mucus in the respiratory tract
- in conditions with impaired breathability
- in acute liver disease
- in cases of anxiety (upset) in patients under the influence of alcohol or sleeping pills
Warnings and cautions
There is a risk of addiction when using Morphine Unimedic. When treatment is no longer necessary, the dose may need to be gradually reduced to avoid side effects.
Talk to your doctor, pharmacist, or nurse before receiving Morphine Unimedic if you have:
- an addiction to painkillers ( opioids )
- asthma
- head injury
- low blood pressure with decreased blood volume
- impaired thyroid function
- impaired liver or kidney function
- inflammatory bowel disease
- inflammation of the pancreas
- bile duct or urinary tract spasms
In the treatment of the elderly, a lower dose of Morphine Unimedic is recommended due to an increased risk of impaired respiratory capacity.
As constipation is a common side effect, you may need to use laxatives while taking Morphine Unimedic.
Children and young people
All children, especially newborns, are at risk of developing respiratory problems with this medicine. The doctor gives morphine with special care to children under one year of age.
Other medicines and Morphine Unimedic
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is especially true:
- sedatives and sleeping pills ( barbiturates such as methohexital, pentotal, phenobarbital, meprobamate)
- drugs for the treatment of depression (clomipramine, amitriptyline, nortriptyline and monoxidase inhibitors, ie MAO inhibitors such as moclobemide)
- drugs for the treatment of Parkinson’s disease ( selegiline )
- some other painkillers (buprenorphine, nalbufine, pentazocine, diclofenac )
- drugs for the treatment of tuberculosis (rifampicin)
- medicines to treat epilepsy (gabapentin)
Morphine Unimedic with alcohol
Morphine Unimedic may cause impaired breathability with concomitant use of even small amounts of alcohol. Concomitant use of Morphine Unimedic and alcohol should therefore be avoided.
Pregnancy and breastfeeding
Men or women of childbearing potential should not receive Morphine Unimedic unless contraceptives are used.
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Morphine Unimedic should not be given during pregnancy unless the doctor decides that the benefit to the mother outweighs the risk to the baby. If Morphine Unimedic is used for a long period during pregnancy, the newborn baby may show symptoms of abstinence. The use of morphine during childbirth can cause breathing problems for the newborn. It can also affect the length of labor.
Breast-feeding
Morphine is excreted in breast milk. Morphine Unimedic should not be used during breastfeeding.
Driving and using machines
The effects and possible side effects of Morphine Unimedic greatly affect the ability to drive and use machines. Ask your doctor when it is safe to drive and use 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 Unimedic
This medicine will be given by healthcare professionals with relevant training and experience. Your doctor will decide which dose is right for you.
If you take more Morphine Unimedic then you should
Morphine Unimedic will be given to you under the supervision of a healthcare professional. If you are concerned that you have received more of this medicine than you should, contact your doctor or nurse. Symptoms of overdose include: very small pupils, decreased breathing, low blood pressure. Circulatory disorders and coma can occur in severe cases.
If you have any further questions, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (affects up to 1 in 10 people):
- drowsiness
- small pupils are
- nausea, vomiting, constipation
- problem with urination
- increased release of ADH (a hormone )
- itching
Uncommon (affects up to 1 in 100 people):
- lowered mood
- impaired respiration, spasm in the airways
- spasm in the urinary tract and bile ducts
- dizziness
Rare (affects up to 1 in 1,000 people):
- feeling faint when standing up quickly
- fast, strong or irregular heartbeat
- fast heartbeat
- high or low blood pressure
- swollen feet and legs
- fainting
No known frequency (can not be calculated from the available data):
- feeling of elation
- problems with sleep, memory and concentration
- cramps
- dry mouth
- hives
- muscle contractions
- experience or see things that are not real, confusion
How to store Morphine Unimedic
Do not use immediately after opening.
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.
Any unused product or waste material should be disposed of by local requirements.
Contents of the pack and other information
Content declaration
Content declaration
- The active substance is morphine hydrochloride trihydrate.
1 ml solution for injection contains 1 mg of morphine hydrochloride trihydrate equivalent to 0.76 mg of morphine.
10 ml solution for injection contains 10 mg of morphine hydrochloride trihydrate equivalent to 7.6 mg of morphine. - The other ingredients are sodium chloride and water.
What the medicine looks like and contents of the pack
10 ml clear solution in clear glass ampoules in packs of 10 ampoules.
Marketing Authorization Holder and Manufacturer
Manufacturer
Unimedic AB
Storjordenvägen 2
864 31 Matfors, Sweden