Lioresal 50 micrograms / ml, solution for injection / infusion; Lioresal 0.5 mg / ml, solution for injection or infusion; Lioresal 2 mg / ml solution for injection or infusion
baklofen
What Lioresal is and what it is used for
Lioresal belongs to a group of medicines called muscle relaxants. Lioresal is given as an injection into the spinal canal directly into the spinal fluid ( intrathecal injection ) and reduces severe muscle cramps (spasticity).
Lioresal is used to treat severe, prolonged muscle spasm (spasticity) that occurs in various diseases, for example:
- brain or spinal cord injuries or diseases
- multiple sclerosis , which is a progressive (progressive) nerve disease of the brain and spinal cord with physical and mental symptoms.
- tetanus
Lioresal is used for adults and children aged 4 years and up. It is used when other medicines are taken orally (by mouth), including medicines containing baclofen, have failed or caused unacceptable side effects.
The baclofen contained in Lioresal may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Lioresal
Do not use Lioresal
- If you are allergic to baclofen or any of the other ingredients of this medicine (listed in section 6).
- Via a route of administration other than the spinal canal.
Warnings and cautions
Contact your doctor immediately if you notice that your pump or catheter is not working properly and you get signs of withdrawal symptoms, as this can be life-threatening (see section 3 “If treatment with Lioresal interrupted”).
Talk to your doctor, pharmacist, or nurse before using Lioresal:
- If you have an infection .
- If you have had a head injury. In patients with spasticity due to head injury, intrathecal treatment ( injection into the spinal canal) should not be initiated with Lioresal until the symptoms of spasticity are stable and can be safely assessed.
- If you have a mental illness (eg schizophrenia).
- If you have Parkinson’s disease .
- If you have epilepsy .
- If you have heart or breathing problems. Monitoring of cardiovascular and respiratory functions is necessary during the initial test phase, especially if you have heart or respiratory problems.
- If you have insufficient blood circulation in the brain ( cerebrovascular insufficiency ).
- If you have impaired kidney function.
- If you have / have had autonomic dysreflexia: a reaction to overstimulation in the nervous system that quickly leads to severely elevated blood pressure , anxiety, sweating, goosebumps, pulsating headaches and unusually low / high heart rate.
- If you have impaired circulation of fluid in the brain and spinal cord.
- If you have acute or chronic conditions of confusion.
- If you have a crooked back (scoliosis).
Some people treated with baclofen have had thoughts of harming themselves or committing suicide or have attempted suicide. Most of these people also had depression, had used too much alcohol, or were prone to thoughts of committing suicide. If you ever have thoughts of injuring yourself or committing suicide, talk to your doctor or a hospital immediately. Also, ask a family member or close friend to tell you if they are worried about any changes in your behavior and ask them to read this leaflet.
Contact your doctor immediately if you think that Lioresal does not work as well as usual. It is important to check that there are no problems with the infusion pump.
Lioresal treatment must not be stopped abruptly due to the risk of discontinuation of effects. Make sure you do not forget to visit the hospital to replenish the infusion pump reservoir (see section 3 “If treatment with Lioresal is interrupted”).
Children and young people
Lioresal is not recommended for children under 4 years of age. Children must have a sufficiently large body to accommodate the implanted infusion pump. There are limited clinical data in children under 4 years of age.
Older
Elderly patients (over 65 years of age) may be more susceptible to side effects. Elderly patients should therefore be closely monitored for the occurrence of side effects.
Other medicines and Lioresal
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you are taking any of the following medicines as they may or may not be affected by Lioresal:
- Levodopa , carbidopa: medicines to treat Parkinson’s disease .
- Strong painkillers, e.g. morphine.
- Drugs that have a dampening effect on the central nervous system ( CNS- dampening drugs), e.g. sleep-inducing drugs.
- Drugs to treat high blood pressure .
Concomitant use of anesthetics may increase the risk of heart failure and seizures.
Lioresal with alcohol
Do not drink alcohol during treatment with Lioresal as baclofen may enhance the alcohol-suppressing effect on the central nervous system.
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.
Pregnancy
There is limited experience with the use of baclofen when injecting it into the spinal canal during pregnancy. If you are pregnant, do not use Lioresal unless your doctor considers it necessary and if the expected benefit to the mother outweighs the potential risk to the baby.
Breast-feeding
Lioresal passes into breast milk, but the risk of affecting the baby is considered unlikely at normal doses. Talk to your doctor before using Lioresal while breastfeeding.
Driving and using machines
During treatment with Lioresal, the ability to drive or use machines may be impaired.
Some people may feel drowsy, have dizziness, eye problems (double vision), difficulty controlling movement or have hallucinations when treated with Lioresal. If this applies to you, do not drive or do anything that requires increased attention until these effects have disappeared. Before driving or using machines, consult your doctor.
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.
Lioresal contains sodium
One ampoule of 1 ml and one ampoule of 5 ml of Lioresal solution for injection / infusion contains less than 1 mmol sodium (23 mg), ie essentially ‘sodium-free’.
One ampoule of 20 ml Lioresal solution for injection/infusion contains 70.9 mg sodium (the main ingredient in table salt/table salt) per ampoule. This corresponds to 3.5% of the maximum recommended daily intake of sodium for adults.
This should be considered by patients on a low-salt diet.
How to take Lioresal
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Lioresal should only be given by a specially trained doctor.
The recommended dose is:
Dose one varies depending on the condition of each person and depends on how you respond to the medicine. Your doctor will determine your dose after testing how you respond to this medicine.
First, your doctor will give you a single dose of Lioresal to see if the medicine is right for you. If your symptoms improve, a special pump that provides Lioresal will be continuously inserted (implanted), usually into the abdominal wall. Your doctor will give you all the information you need to use the infusion pump and dosing information. Make sure you understand everything.
You start with a low dose that is gradually increased over a few days with the doctor’s supervision until you get the dose that suits you.
You will be closely monitored, concerning, among other things, heart and lung function, in an environment with complete equipment and by trained personnel in connection with the start of drug treatment and during the period the correct dose is determined immediately after implantation of the infusion pump and dose changes. You will be assessed regularly for the dose you need, for any side effects or signs of infection. The function of the administration system (pump and associated equipment) will also be checked.
You must visit the doctor to refill the infusion pump so that the medicine in the pump does not run out, otherwise, the cramps may return as you will not receive a sufficiently high dose of Lioresal. You may also experience side effects and symptoms that could potentially occur with sudden discontinuation of treatment (see “If treatment with Lioresal is discontinued” later in this section).
If your muscle elasticity does not improve or if you start having cramps again, either gradually or suddenly, contact your doctor immediately.
Use for children and adolescents
Lioresal is not recommended for children under 4 years of age (see section 2).
If treatment with Lioresal is stopped
It is very important that you, and those who care for you, can recognize the signs of withdrawal of Lioresal.
These symptoms can occur as a result of the pump not working properly due to problems with the battery, catheter, or alarm. Symptoms usually appear within a few hours to up to a couple of days after stopping treatment with Lioresal.
Signs and symptoms of withdrawal are:
- Increased muscle cramps, too high muscle tension ( muscle tone ).
- Difficulty with muscle movements, muscle stiffness.
- Increased heart rate or heart rate .
- Itching , tingling, burning or numbness ( paresthesia ) in the hands or feet.
- Palpitation. Anxiety.
- High cup temperature.
- Low blood pressure .
- Changed mental state e.g. agitation, confusion, hallucinations, abnormal thoughts and deviant behavior, seizures.
- Persistent painful erection in the penis (priapism).
- Infection (blood poisoning).
If you notice any of the above signs, contact a doctor immediately. These signs can be followed by symptoms and side effects that can be life-threatening if you do not receive treatment immediately.
Method of administration
Lioresal should only be given in the spinal canal ( intrathecal use).
Usage time
Determined by the doctor.
During long-term treatment, some patients find that Lioresal becomes less effective. Your doctor may recommend temporary treatment interruptions to counteract this.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You are more likely to get side effects if the starting dose is too high or if the dose is increased too fast.
Some side effects may be or may be serious. Contact a doctor immediately or see the nearest emergency department if you experience any of the following:
Uncommon (may affect up to 1 in 100 people):
- Suicidal thoughts and suicide attempts.
Rare (may affect up to 1 in 1,000 people):
- Life-threatening withdrawal symptoms due to sudden discontinuation of medication due to the infusion system not working properly. For a description of the signs of withdrawal symptoms, see section 3 “If treatment with Lioresal is interrupted”.
Other side effects that may occur:
Very common (may affect more than 1 user in 10):
- Drowsiness, drowsiness.
- Reduced muscle tension.
Common (may affect up to 1 in 10 people):
- Anxiety, restlessness, depression.
- Epileptic seizures.
- Confusion.
- Fatigue, dizziness, headache.
- Ant crawls.
- Speech disorders.
- Drowsiness.
- Difficulty sleeping.
- Problems with vision with blurred vision or double vision.
- Slow heartbeat.
- Respiratory problems (impaired respiratory function, shortness of breath), pneumonia ( pneumonia ).
- Hives , itching .
- Nausea, vomiting, constipation, diarrhea.
- Dry mouth , decreased appetite, increased salivation.
- Tissue swelling of the face, hands or feet.
- Low blood pressure .
- Urinary incontinence (urine leakage), difficulty urinating.
- Sexual disorder.
- Feeling weak.
- Pain, fever, chills.
- Increased muscle tension, muscle weakness.
Uncommon (may affect up to 1 in 100 people):
- Dehydration.
- Feeling of excitement ( euphoria ), persecution mania ( paranoia ), hallucinations.
- Difficulty coordinating muscle movements ( ataxia ).
- Impaired memory.
- Involuntary, jerky movements of the eyes ( nystagmus ).
- High blood pressure .
- Blood clot formation in a vein ( venous thrombosis ).
- Redness or pale skin.
- Heavy sweating.
- Intestinal obstruction, difficulty swallowing, lack of taste,
- Hair loss.
- Feeling unusually cold.
Has been reported (occurs in an unknown number of users)
- Depression.
- Slow breathing.
- Increased curvature of the spine laterally (scoliosis).
- Difficulty getting or maintaining an erection ( erectile dysfunction ).
Some side effects may be due to the infusion pump, e.g. infection of the infusion system pocket in the abdominal wall, inflammation at the tip of the catheter, overdose due to improper use of the pump.
For a description of signs of overdose, see section 3 “If you are given too much Lioresal”.
Technical malfunction of the infusion system resulting in overdose or overdose has been reported.
How to store Lioresal
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the carton and ampoule. The expiration date is the last day of the specified month.
Because the drug is restricted to hospital use, the hospital discards drugs that are no longer used.
Contents of the pack and other information
Content declaration
- The active substance is baclofen
- The other ingredients are sodium chloride and water for injections
What the medicine looks like and contents of the pack
Appearance
Colorless glass ampoules .
Pack sizes
Lioresal 50 micrograms/ml is supplied in cartons containing 5 glass ampoules of 1 ml each.
Lioresal 0.5 mg/ml is supplied in cartons containing 1 20 ml glass ampoule.
Lioresal 2 mg/ml is supplied in a carton containing 1 5 ml glass ampoule.
Marketing Authorization Holder and Manufacturer
Novartis Sverige AB, Box 1218, 164 28 Kista