Lioresal 10 mg
Lioresal 10 mg
30 tabletsActive ingredient: baclofen
1. What is Lioresal and what it is used?
Baclofen is a drug from the group of muscle relaxants. It is used to treat muscle spasticity in diseases of the central nervous system (CNS).Lioresal is used to reduce and alleviate an increased muscle tone (spasticity), which occurs in various diseases such as cerebral palsy, multiple sclerosis, cerebrovascular accidents, spinal cord diseases and other disorders of the central nervous system.
2. What should you consider before taking Lioresal?
Lioresal should not be used,• if you are allergic to baclofen, wheat starch or any of the excipients listed in section 6 of this medicine.
• if you are suffering from epilepsy and other convulsive disorders.
• if you suffer from inadequate kidney function in the final stage (ESRD).
Lioresal 25 is not suitable for the treatment of increased muscle tone (spasticity) in diseases of the rheumatic type, parkinsonism or because of (peripheral) injuries.
Take special care when taking Lioresal is required if you have any of the following diseases:
• renal impairment
• severe hepatic impairment
• disturbances of breathing
• disorders of urination
• gastrointestinal ulcers
• acute or chronic confusional states
• severe mental disorders
• disorders of cerebral blood flow (cerebrovascular disorders)
• bulbar-paralytic symptoms (z. B. slowed, slurred, nasal speech, swallowing, chewing, possibly respiratory disorders, laryngeal paralysis)
• syringomyelia (certain disease of the spinal cord with flaccid paralysis in the shoulder area and pronounced shrinkage [atrophy] of the affected muscles)
• acute intoxication, such. As with alcohol or sleeping pills
At the beginning of therapy frequent checks are necessary to detect possible side effects such as muscle weakness and general u. U. abrupt loss of tone (falling!), Tiredness or confusion quickly and be able to make a dose adjustment.
If you suffer from liver dysfunction, or diabetes (diabetes mellitus), your laboratory values should be checked periodically to ensure that your basic disease does not deteriorate.
If your kidney function has come to a virtual standstill (end-stage), the doctor will give you 25 only Lioresal if the benefit outweighs the risk (see section 3. "How to take Lioresal?").
Particular caution is required if Lioresal is combined with drugs or medical devices which significantly affect kidney function. Renal function should be closely monitored and the daily dose of Lioresal be adjusted accordingly in order to avoid poisoning with baclofen.
Besides the interruption of treatment can be used in patients with baclofen intoxication as an alternative treatment unscheduled hemodialysis. Haemodialysis effectively removes baclofen from the body, alleviates clinical symptoms of overdose and shortens the recovery time.
Children and adolescents
Lioresal is not suitable for children weighing less than 33 kg.Elderly
The experience with Lioresal shows that it can often lead to side effects in this patient group. Therefore, elderly patients should be carefully monitored for the occurrence of side effects.Taking Lioresal with other medicines
Tell your doctor or pharmacist if you are taking other medicines / apply, have recently taken / used or intend to take / apply other medicines.Concomitant use of other muscle relaxants or drugs that have a dampening effect on the functions of the central nervous system (psychotropic, soporific, sedative antidepressants, lithium, substances with morphine-like drugs), there may be mutual reinforcement effect. In particular, the simultaneous consumption of alcohol should be avoided, because the interactions are unpredictable with alcohol.
Concomitant administration of Lioresal and antihypertensive drugs (antihypertensives) can lead to increased blood pressure. In these cases, therefore, a particularly careful blood pressure control is required.
Treatment with baclofen possibly resulting in some cases to an increase in certain liver tests (SGOT, SGPT). This must be considered in a review of laboratory results into account.
Pharmaceuticals or medical devices that significantly impact renal function, excretion of baclofen can decrease the extent that can be expected toxic effects (see section "Take special care when taking ...").
Taking Lioresal with food and beverages
While taking Lioresal you should avoid alcohol, as it can lead to undesirable gain or an unpredictable change in the effect of the drug.
pregnancy and breast feeding period
There are no adequate data from the use of Baclofen in pregnant women. Lioresal should not be used during pregnancy and lactation, unless clearly necessary. If you need to take Lioresal during pregnancy, your baby may have cramps after taking (seizures).Ask. Before taking / using any medicine your doctor or pharmacist for advice
Driving and using machines
During treatment with Lioresal your ability to participate actively drive or operate machinery due to the possible occurrence of dizziness, sedation, drowsiness and blurred vision may be substantially impaired. Please note particularly that the simultaneous use of alcohol, that effect exacerbated. At the beginning of treatment to drive vehicles, operate machinery, or other dangerous activities should be made dependent on the decision of the treating physician, with your responses and the respective dosage should be considered. If you are employed in dangerous jobs, you should receive specific instructions from the doctor.Important information about some of the ingredients of Lioresal
Lioresal tablets contain wheat starch. Wheat starch may contain small amounts of gluten, but also for patients suffering from celiac disease, are considered acceptable.Other Safety Precautions
If surgery (including dental) is planned or emergency treatment is necessary, you should tell your doctor that you are taking Lioresal.3. How to take Lioresal?
Take this medicine exactly as your doctor has told a. Ask yourself if you are not sure with your doctor or pharmacist.The therapy should always be started gradually at a low dose to keep side effects to a minimum. The lowest optimal effective dose is recommended. The optimal dose for maintaining the effect is to be determined individually in each case. Unless otherwise prescribed by the doctor, the usual dose is:
adult
For the initiation of treatment low dosed dosage forms to 5 mg or 10 mg baclofen available. (Please note the leaflet!)
Following treatment initiation, the optimal daily dose is usually 1-3 tablets Lioresal (dose range 10-30 mg Baclofen per day), which are distributed on 2-4 individual doses.
The maximum daily dose is 3 tablets Lioresal 25 (corresponding to 75 mg Baclofen per day); only in rare cases - usually under stationary conditions - daily doses of 3½ to 4½ tablets Lioresal 25 (dose range 90-120 mg Baclofen per day) are required.
Elderly patients and patients with increased muscle tension cerebral origin
Elderly and debilitated patients suffering from organic brain diseases, cardiovascular diseases, from insufficient respiratory function (respiratory failure) or hepatic and renal function, and in patients with increased muscle tension cerebral origin, the dose should be increased particularly slow. Your doctor will monitor you adequately for any adverse effects.
Patients with renal impairment
If your kidney function is limited, your doctor will reduce the dose possibly. In very severe renal impairment since doses of 5 mg daily baclofen signs of overdose may occur.
If your kidney function has come to a virtual standstill (end-stage), the doctor will give you 25 only Lioresal if the benefit outweighs the risk. It must be close monitoring to a prompt diagnosis of early signs and / or symptoms of intoxication (eg. Drowsiness, lethargy) to make.
Children and adolescents (0 to <18 years)
For the treatment of younger children and for initiating the treatment of older children lower metered dosage forms to 5 mg or 10 mg baclofen available. (Please note the leaflet!)
The treatment of children is adjusted according to body weight. They usually start with a very low dose (corresponding to about 0.3 mg per kg per day), divided into 2-4 single doses (preferably over 4 doses). Then the dosage is carefully increased gradually until it meets the requirements of each child. The dosage can thus be from 0.75 to 2 mg / kg body weight. The total daily dose must for children under 8 years do not exceed the maximum of 40 mg / day. For children older than 8 years, the maximum daily dose is 60 mg / day. Lioresal 25 is not suitable for children weighing less than 33 kg. During lactation, the dose should be kept as low as possible.
type of application
To improve the gastrointestinal tolerability should the tablets preferably with meals take (with liquid) or with milk.
The tablets may be divided into equal halves.
Take the tablets every day at the same time a. It will also help you to remember when to take the tablets.
Duration of treatment
Treatment with baclofen is a long-term treatment usually. About the time decided by the treating physician.
If (more than 2-3 months) treatment on medical advice is to be terminated back after prolonged use, Lioresal is 25 discontinued gradually by your doctor within about 3 weeks.
If serious adverse reactions occur, please inform your doctor immediately! Do not listen to, Lioresal 25 taking without talking to your doctor. Please speak with your doctor or pharmacist if you have the impression that the effect of Lioresal 25 is too strong or too weak.
If you have a larger amount of Lioresal taken 25 than you should
If you have more tablets taken Lioresal 25 as prescribed, notify a doctor immediately. This will possibly bring about an intensive monitoring and initiate treatment.
At too high a dosage following signs occurrence can:
• Nausea and vomiting
• excessive salivation (drooling)
• difficulty breathing
• diarrhea
• reduced consciousness and unconsciousness (coma)
• hallucinations and confusion
• sleepiness
• physical restlessness
• Seizures
• changes in the EEG (burst suppression pattern and triphasic waves)
• relaxation of muscles (hypotonia)
• hypotension or increase
• slowed, accelerated or irregular pulse
• abnormal decreased body temperature.
Because baclofen is primarily excreted via the kidneys, enough liquid should be supplied. In patients with renal failure, in severe cases of poisoning, hemodialysis (also unscheduled) may be useful.
If you forget to take Lioresal 25
Do not take a double dose if you have forgotten dose, but continue to take as provided continued.
If you stop taking Lioresal 25
Talk definitely with your doctor before you arbitrarily interrupt treatment with Lioresal 25 or prematurely! You could otherwise endanger the success of treatment or may cause withdrawal reactions (see sections "method of administration" and "What side effects are possible?").
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects are possible?
Like all medicines, this medicine can cause side effects, although not everybody gets them.The frequency of possible side effects listed below are defined as:
Very common: More than 1 in 10 people
Common: affects 1 to 10 of 100
Uncommon: affects 1 to 10 of 1000
Rare: 1 to 10 users in 10,000
Very rare: less than 1 in 10,000
Not known: frequency can not be estimated from the available data
The incidence of adverse events is dose-dependent.
Especially at the beginning of treatment, at too rapid dose escalation, or at high doses, can often nausea, drowsiness and sedation, and often fatigue, vomiting and dizziness occur with sufficient muscle-relaxing (myotonolytischer) effect. It may be an undesirable weakening of the remaining arbitrary power. These side effects are usually temporary and can be attenuated or eliminated by reducing the dosage. They are rarely so severe that discontinuation of therapy is required.
Frequently observed side effects are dry mouth, low blood pressure, the heart (palpitation), decreasing cardiac output, shaking (tremor), movement disorders (ataxia), nystagmus (nystagmus), abnormal focus of the eye (accommodation disorder), vision problems, headache, dizziness, muscle weakness, muscle pain , nausea, retching, vomiting, diarrhea, constipation, gastrointestinal disorders, urinary symptoms (frequent urination, enuresis, dysuria), impaired respiratory function (respiratory depression), rash (rash) or hives, increased perspiration (hyperhidrosis) and depression, elevated mood (euphoria), hallucinations, insomnia, nightmares and confusion especially in the elderly.
Rarely difficulty speaking, dysgeusia, abdominal pain, subjective discomfort (paresthesia), agitation (agitation), urinary retention, erectile dysfunction or hepatic dysfunction may occur.
Very rare hypersensitivity reactions and decreased body temperature (hypothermia).
In very rare cases, a specific brain disease (acute encephalopathy) was observed with EEG changes, disorientation, tremors, physical excitability and muscle twitching after baclofen treatment. After discontinuation of baclofen these symptoms disappeared.
In one case, were involuntary movement disorders in the facial area, such. As smacking, chewing movements and blinking, observed, which disappeared after discontinuation of baclofen.
In one case, certain liver enzymes (SGOT, SGPT) reported increased values were dose-dependent and after discontinuation return to normal. In addition, (frequency unknown) (see "Taking Lioresal 25 other medicines" under) was increased blood sugar levels observed.
If you have epilepsy, it may be that easier or more seizures occur to you.
Some patients experienced a paradoxical response to muscle spasms.
Wheat starch may cause hypersensitivity reactions.
Abrupt discontinuation of baclofen
After several months, high-dose baclofen treatment may after abrupt discontinuation of treatment or abrupt dose reduction to impaired concentration, delirium, confusion, visual and auditory hallucinations, physical restlessness (agitation) to psychotic, manic or paranoid disorders, the occurrence of local or generalized seizures up to status epilepticus to dyskinesia, tachycardia, hyperthermia and - come to a temporary reinforcement of spasticity - as rebound phenomenon.
After the abrupt cessation of intrathecal formulation of Lioresal a clinical picture described that resembled an autonomous dysreflexia, malignant hyperthermia, neuroleptic malignant syndrome, or other conditions that are associated with a state of increased metabolism or an extended breakdown of muscle tissue.
Except in the case of serious side effects occur should only be tapered off deposed within around 3 weeks baclofen after prolonged use (more than 2-3 months).
If you notice any side effects, contact your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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