10 + 0.4 mg / ml solution for injection
morphine hydrochloride + hyoscin hydrobromide
What Morphine-Scopolamine Meda is and what it is used for
Morphine-scopolamine Meda contains morphine hydrochloride which has a strong analgesic effect and hyoscine hydrobromide which has an inhibitory and sedative effect.
Morphine-scopolamine Meda is used for pain relief before surgery.
Morphine contained in Morphine-scopolamine Meda may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 you use Morphine-scopolamine Meda
Do not use Morphine-scopolamine Meda
- if you have a lot of mucus in the airways, impaired breathing, acute liver disease, in case of anxiety, under the influence of alcohol and sleeping pills or in case of hypersensitivity to morphine or any of the excipients.
- if you are allergic to morphine hydrochloride, hyoscin hydrobromide or any of the other ingredients of Morphine-scopolamine Meda (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 taking Morphine-scopolamine Meda:
– Increased pain sensitivity even though you are taking increasing doses (hyperalgesia). The doctor is coming
to decide if you need to change the dose or switch to another strong analgesic
(analgesics), (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 lowered
production of sex hormones.
– If you have once been addicted to drugs or alcohol. Also, tell me if you feel
that you are becoming addicted to Morphine-scopolamine Meda while you are 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.
Your doctor should be informed if you have asthma, airway obstruction, any head injury, peritoneal dialysis, low blood pressure due to decreased blood volume, decreased thyroid function, decreased liver or kidney function, inflammation of the pancreas ( pancreatitis ), inflammatory gastritis, inflammatory bowel disease problems with bile ducts or ureters because Morphine-scopolamine Meda should be used with caution in these conditions.
Always consult your doctor before changing the medication.
Other medicines and Morphine-scopolamine Meda
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of Morphine-scopolamine 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 and antiepileptic drugs (eg benzodiazepines , certain antihistamines and barbiturates ),
- anesthetics for anesthesia before e.g. an operation
- certain medicines for mental illness (phentiazines),
- muscle relaxants.
Due to this, concomitant use of Morphine-scopolamine Meda and the above medicines should only be considered by your doctor when other treatment options are not possible. If your doctor prescribes Morphine-scopolamine Meda at the same time as any of the above medicines, dose one and the 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-scopolamine 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 TBC (rifampicin),
- certain medicines given after bleeding into the meninges (nimodipine),
- anti- HIV drugs (ritonavir),
- antiepileptic drugs ( gabapentin ),
- certain 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).
The treating physician, therefore, needs to know all the concomitant medication.
Morphine-scopolamine Meda and alcohol
Alcohol should not be used in connection with the treatment of Morphine-scopolamine Meda, as the combination may cause impaired respiratory capacity.
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-scopolamine Meda during pregnancy.
With long-term use of Morphine-scopolamine Meda during pregnancy, there is a risk that the newborn may 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 a doctor before using Morphine-scopolamine Meda while breastfeeding.
Driving and using machines
During treatment with Morphine-scopolamine 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.
Morphine-scopolamine Meda contains sodium metabisulfite
Patients who are hypersensitive to sodium metabisulfite should avoid this product as sodium metabisulfite may in rare cases cause severe hypersensitivity reactions and bronchospasm.
Morphine-scopolamine Meda contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per ampoule, ie essentially ‘sodium-free’.
How to use Morphine-scopolamine 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 Scopolamine 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-scopolamine Meda
Do not stop treatment with Morphine-scopolamine Meda unless you have agreed to do so with your doctor. If you want to stop taking Morphine-scopolamine 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, Morphine-scopolamine Meda 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, urinary incontinence, difficulty in urinating, pupil reduction. Increased ADH release. _ Increased heart rate. Hypotension. Dry mouth.
Uncommon (affects less than 1 user in 100): Bile and urinary tract cramps, dizziness, mood swings, bronchoconstriction, itching, shortness of breath, dizziness, confusion. Nausea, vomiting.
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 unknown numbers of users): Elevation, sleep, memory and concentration disorders, seizures, dry mouth, hives, muscle twitching. Hallucinations, delirium. Increased sensitivity to pain, sweating, withdrawal symptoms, or addiction (for symptoms, see section 3: If you stop taking Morphine-scopolamine Meda).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Morphine-scopolamine Meda
Store in the original package. Sensitive to light.
Keep out of sight and reach of children.
Used before 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
1 milliliter of solution for injection contains:
Active substance: Morphine hydrochloride 10 mg / ml + Hyoscin hydrobromide 0.4 mg / ml
Other ingredients: Sodium chloride 7.5 mg / ml, sodium metabisulfite (E223) 1 mg / ml, disodium edetate 0.1 mg / ml, hydrochloric acid to pH about 3.0, sodium hydroxide, water for injections (to 1 ml).
What the medicine looks like and contents of the pack
Clear colorless to the pale yellow-brown solution. The solution has a pH of about 3.
Glass ampoule is 10 x 1 ml.
Marketing Authorisation Holder
Meda AB
Box 906
170 09 Solna