10 mg / ml solution for injection
morphine hydrochloride
What Morphine Meda is and what it is used for
Morphine Meda contains morphine hydrochloride which has a strong analgesic effect.
Morphine Meda is used for severe pain, such as pain in cancer.
Morphine contained in Morphine Meda 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 any further questions, and always follow their instructions.
What you need to know before using Morphine Meda
Do not use Morphine Meda
- if you have a lot of mucus in the airways, impaired breathing, acute liver disease, in anxiety due to alcohol and sleeping pills.
- if you are allergic to morphine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
However, never stop taking this medicine without consulting your doctor.
Warnings and cautions
Talk to your doctor or pharmacist if you experience any of the following symptoms while using Morphine Meda:
- 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 loweredproduction 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 Meda while you are taking 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 insection 3. If this happens, your doctor may change the type of medicine or the times between doses .
Tell your doctor if you have asthma, airway obstruction, any head injuries, peritoneal dialysis, low blood pressure due to decreased blood volume, decreased thyroid function, decreased liver or kidney function, inflammation of the pancreas ( pancreatitis ), inflammatory bowel disease, inflammatory bowel disease bile duct or urethral seizures as Morphine Meda should be used with caution in these conditions.
Always consult your doctor before changing the medication.
Other medicines and Morphine Meda
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of Morphine Meda and certain medicines increase the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and may be life-threatening. Examples of these drugs are:
- other strong painkillers (opioids)
- sedatives, hypnotics, antiepileptic drugs (eg benzodiazepines , certain antihistamines and barbiturates )
- anesthetics for anesthesia before e.g. an operation
- certain medicines for mental illness (phenothiazines)
- muscle relaxants
Due to this, concomitant use of Morphine Meda and the above medicines should only be considered by your doctor when other treatment options are not possible. If your doctor prescribes Morphine Meda at the same time as any of the above medicines, your dose and duration of treatment should be limited by your doctor. Tell your doctor if you are taking any of the above medicines and carefully follow your doctor’s dose recommendations. It may be helpful to inform friends or relatives about being aware of the signs and symptoms listed above. Contact your doctor if you experience any of these symptoms.
The effect of the treatment can also be affected if Morphine Meda is taken with certain other medicines:
- anticonvulsants (baclofen),
- certain antidepressants (clomipramine, nortriptyline, amitriptyline and so-called MAO inhibitors ),
- drugs used to treat ADHD (methylphenidate),
- certain antibiotics used against tuberculosis (rifampicin),
- certain medicines given after bleeding into the meninges (nimodipine),
- anti- HIV drugs (ritonavir),
- antiepileptic drugs ( gabapentin ),
- some medicines used to prevent blood clots (eg clopidogrel, prasugrel, tikagrelor) may have a delayed and reduced effect when taken with morphine
- drugs used for pain or opioid dependence (buprenorphine).
Morphine Meda and alcohol
Alcohol should not be used during treatment with Morphine Meda, as the combination may cause impaired breathing.
Pregnancy and breastfeeding
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.
There is a risk that the fetus is affected. Therefore, always consult a doctor before using Morphine Meda during pregnancy.
With long-term use of Morphine Meda 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 passes into breast milk. Morphine should therefore not be used during breastfeeding. Always consult your doctor before using Morphine Meda while breastfeeding.
Driving and using machines
During treatment with Morphine Meda, the ability to react may be reduced. This should be taken into account when sharper attention is required, e.g. when driving and operating machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. 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.
This medicine contains sodium and sodium metabisulfite
Morphine Meda 10 mg/ml, solution for injection in 1 ml glass ampoule contains less than 1 mmol (23 mg) sodium, ie is essential ‘sodium-free’.
Morphine Meda 10 mg/ml, solution for injection in a 10 ml glass ampoule contains 32 mg of sodium corresponding to 1.6% of the WHO’s highest recommended daily intake (2 grams of sodium for adults).
Sodium metabisulfite can in rare cases cause severe hypersensitivity reactions and convulsions in the trachea.
How to use Morphine Meda
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor who adjusts it individually for you.
If you take more Morphine Meda than you should
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 which leads to unconsciousness or even death.
If you stop using Morphine Meda
Do not stop taking Morphine Meda unless you have agreed to do so with your doctor. If you want to stop taking Morphine Meda, 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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important signs or symptoms to be observant of and what to do if you are affected:
• Severe allergic reaction that makes it difficult to breathe or dizzy.
If you get these important side effects, talk to your doctor immediately.
Common (affects more than 1 user in 100): Constipation, drowsiness, nausea, vomiting, urinary incontinence, difficulty in urinating, pupil reduction. Increased ADH release. _
Uncommon (affects less than 1 user in 100): Bile and urinary tract cramps, dizziness, mood swings, bronchoconstriction, itching, shortness of breath, dizziness, confusion.
Rare (affects less than 1 user in 1,000): Dizziness when getting up quickly, palpitations, fast pulse, high or low blood pressure, fluid accumulation peripherally, for example in the legs, fainting.
Has been reported (occurs in an unknown number of users): Elevation, sleep, memory and concentration disorders, seizures, dry mouth, hives, muscle twitching. Hallucinations, states of confusion. Increased sensitivity to pain, sweating, withdrawal symptoms, or addiction (for symptoms, see section 3: If you stop taking Morphine Meda).
How to store Morphine Meda
Store in the original package. Sensitive to light.
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. The expiration date is the last day of the specified month.
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. 1 ml solution for injection
- 10 mg / ml corresponding to morphine 7.6 mg / ml.
- The other ingredients are: sodium chloride 7.5 mg / ml, sodium metabisulfite 1 mg / ml, disodium edetate 0.1 mg / ml, Hydrochloric acid to pH 3.0-3.5, water for injections (to 1 ml).
What the medicine looks like and contents of the pack
Clear colorless liquid. The solution has a pH of about 3.
Glass ampoules are 10 x 1 ml and 10 x 10 ml.
Marketing Authorisation Holder
Meda AB
Box 906
170 09 Solna