Buy Lioresal Malaysia

Package insert: Information for the patient

Lioresal 10 mg tablets Lioresal 25 mg baclofen tablets

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

- Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.
• This medicine has only been prescribed for you. Do not pass it on to others, even if the symptoms of the disease are the same as yours, as this can be dangerous.
• If you experience side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See paragraph 4.

Contents of this brochure:

1. What Lioresal is and what it is used for
2. What you need to know before you take Lioresal
3. How to take Lioresal
4. possible side effects
5. How to store Lioresal
6. Contents of the pack and other information

1. What Lioresal is and what it is used for

   Lioresal contains the active ingredient baclofen, which belongs to a class of medicines known as "central muscle relaxants". Baclofen relaxes the muscles.

   Adults

   Lioresal is indicated for the treatment of manifestations characterized by increased muscle tone and contraction (spastic hypertension):

   • in multiple sclerosis
   • for diseases of the spinal cord infectious, degenerative, traumatic, tumor-related origin, unknown for example:
     • spastic paralysis of the spine
     • Amyotrophic Lateral Sclerosis
     • Syringomyelia
     • transverse myelitis
     • Paraplegia or traumatic paraparesis
     • Marrow compression conditions
   • following brain damage, especially in:
     • pediatric disease (childhood encephalopathy)
     • Brain blood vessel disease (brain vasculopathy)
     • Brain disease due to cancer or degeneration.

       Children and adolescents (0 to 18 years)

       Lioresal is indicated for the treatment of symptoms of increased muscle tone and muscle contraction (spastic hypertension):

   • following brain damage, especially in:
     • Stroke or transient ischemic attack
     • Brain disease due to cancer or degeneration
   • for diseases of the spinal cord infectious, degenerative, traumatic, tumor-related origin, unknown for example:
     • multiple sclerosis
     • spastic paralysis of the spine
     • Amyotrophic Lateral Sclerosis
     • Syringomyelia
     • transverse myelitis
     • Paraplegia or traumatic paraparesis
     • Marrow compression conditions.

2. What you need to know before you take Lioresal Do not use Lioresal

   • if you / your child are allergic to baclofen or any of the other ingredients

     Medicine (listed in section 6).

     Warnings and precautions

     Talk to your doctor or pharmacist before taking Lioresal.

     Tell your doctor who is paying special attention to the prescription of Lioresal and who keeps you / your child under close supervision if

   • Have mood disorders (e.g. psychosis, schizophrenia, depressive disorders or

     manic)

   • suffers from confusing conditions
   • Have Parkinson's
   • Have epilepsy
   • have or have had a stomach or a first intestinal ulcer (gastric ulcer)
   • have blood vessel disorders in the brain
   • Breathing problems
   • Have liver problems
   • Have kidney problems
   • Urination problems due to an increase in muscle tone that controls urine output (hypertension of the bladder sphincter)
   • You are pregnant: Your baby may have it immediately after delivery

     Seizures and other symptoms associated with sudden withdrawal of treatment (see "If you / your child stop taking Lioresal").

     If you do some laboratory tests to assess liver function (aspartate aminotransferase and alkaline phosphatase) or blood sugar levels while you are being treated with Lioresal, be aware that these values may change. Your doctor will have you or your child examined regularly, especially if you have liver problems or diabetes.

     children

     Clinical data on the use of Lioresal in children under one year of age are limited, so the doctor will carefully consider the use of this medicine in these patients.

     Other drugs and Lioresal

     Tell your doctor or pharmacist if you are using, have recently used, or could use other medicines.

   • Parkinson's medicines (e.g. levodopa, carbidopa)
   • Medicines that cause a decrease in the activity of the central nervous system, for example:
     • other medicines to relax your muscles, e.g. B. tizanidine
     • synthetic opioids
   • morphine
   • Medicines for depression of the tricyclic class
   • Lithium (medicine for mood disorders)
   • Antihypertensives (medicines for high blood pressure)
   • Medicines that affect kidney function.

     The doctor will keep you / your child under strict control and check whether the dose of Lioresal or any other medicine should be changed.

     Lioresal with alcohol

     The use of Lioresal with alcohol can increase the calming effects and the risk of breathing difficulties.

     Pregnancy, lactation and fertility

     If you are pregnant, breast-feeding, planning to become pregnant, or plan to breast-feed, ask your doctor or pharmacist for advice before taking this medicine.

     pregnancy

     There are no adequate studies in pregnant women. Baclofen crosses the placenta. Therefore, if you are pregnant, the medicine is only prescribed in emergencies and under the direct supervision of your doctor.

     If you need to take Lioresal during pregnancy, your baby may experience seizures and other symptoms if treatment is stopped immediately after childbirth (see "If you / your child stop taking Lioresal" and "Warnings and precautions" ).

     lactation

     Baclofen is excreted in breast milk in small amounts, so no undesirable effects are expected for the baby.

     fertility

     There is no data on the activity of baclofen on human fertility, nor is there any data that supports certain recommendations for women of childbearing age.

     Drive and use machines

     Lioresal can cause dizziness, sedation, sleepiness, and vision problems. Therefore, patients who have experienced these symptoms should not drive vehicles (including bicycles) or operate machinery.

     Lioresal contains wheat starch

     This medicine contains wheat starch. This medicine can be given to people with celiac disease. People with a wheat allergy (other than celiac disease) should not take this medicine.

3. How to take Lioresal

   Always use this medicine exactly as your doctor has told you. If you have any doubts

   Your doctor will first prescribe the lowest possible dose of Lioresal to treat your condition, which may then gradually increase.

   If no therapeutic benefit is discernible 6-8 weeks after the maximum dose has been reached, your doctor will decide whether Lioresal therapy should be continued or discontinued.

   Lioresal tablets should be taken with some liquid during meals.

   Use in adults

   The daily dose should preferably be divided into three administrations.

   Remember that the doctor:

   • You start treatment with the starting dose of 5 mg taken three times a day
   • The daily dose of 15 mg, divided into 3 administrations, increases every 3 days and until the effective dose is reached.

     The optimal dose is generally between 30 and 80 mg per day, up to 100 - 120 mg in

     Hospital patients carefully monitored.

     If you are a patient who is particularly sensitive to medicines, your doctor may prescribe a lower initial daily dose (5 or 10 mg) and gradually reach the optimal dose.

     Use in children and adolescents (0 to 18 years)

     The maximum total daily dose in children under 8 years is 40 mg per day and in children over 8 years 60 mg per day.

     Do not use Lioresal tablets in children weighing less than 33 kg. Note that the doctor:

   • treatment begins with a very low dose (approx. 0.3 mg / kg body weight per

     Day) divided into 2-4 cans (preferably in 4 cans)

   • carefully increase the dose approximately every 1 week until the effective dose is reached.

     The usual daily dose for maintenance therapy is between 0.75 and 2 mg / kg

     Body weight.

     Use in patients with kidney problems

     If you / your child have kidney problems, the doctor will prescribe a lower dose of Lioresal. If you / your child is on chronic hemodialysis, your doctor will work out the optimal dose, usually around 5 mg a day.

     If you / your child have an incurable form of kidney failure, your doctor will prescribe Lioresal only when there is a real need and monitor you / your child closely to detect signs and symptoms of toxicity early (e.g. sleepiness, lethargy).

     Use in patients with liver problems

     Your doctor will take special care when prescribing Lioresal.

     Use in elderly patients (age ≥ 65 years)

     Your doctor will pay special attention to the prescription of Lioresal and keep it under control to determine any side effects.

     Use in patients with spastic conditions due to brain damage

     Your doctor will pay special attention to the prescription of Lioresal and keep you / your child under it

     If you take more Lioresal than you should

     If you accidentally take an overdose of Lioresal, tell your doctor immediately or go to the nearest hospital.

     If you take more Lioresal than you should, you can experience:

     • drowsiness
     • decreased state of consciousness
     • Reduction in breathability
     • coma
     • confusion
     • Hallucinations
     • excitement
     • cramps
     • Electroencephalogram (EEG) abnormalities
     • Visual disturbances
     • general reduction in muscle tone
     • short and sudden contractions of one or more muscles (myoclonus)
     • Decrease or absence of reflexes
     • Expansion of the veins and arteries in the limbs
     • Increase or decrease pressure
     • Slow down or speed up heartbeat
     • Changes in the rhythm of the heart
     • Decrease in body temperature
     • Nausea, vomiting, diarrhea
     • increased saliva secretion
     • Increased blood levels of some liver enzymes.

       Taking substances or medicines that affect the central nervous system (e.g. alcohol, diazepam, tricyclic antidepressants) at the same time may worsen the syndrome associated with taking an excessive dose of Lioresal.

       If you / your child forget to take Lioresal

       Do not use a double dose to make up for a forgotten dose.

       If you / your child stop taking Lioresal

       You / your child should not stop taking Lioresal abruptly unless you have experienced serious side effects or swallowed an overdose of Lioresal. Lioresal treatment must always be stopped gradually, with the dose gradually reduced over a period of 1-2 weeks.

       If you stop taking Lioresal abruptly, you may experience anxiety, confusion, delirium, hallucinations, psychotic, manic or paranoid disorders, convulsions, involuntary movements of the tongue, mouth, trunk and extremities, an acceleration of the heartbeat and an increased body temperature and a temporary worsening of spasticity known as the "rebound phenomenon".

       If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

   Side effects mainly occur at the beginning of therapy (e.g. sedation, sleepiness), if the dose is increased too quickly, if high doses are used or if the patient is older.

   However, these effects are often temporary and can be eliminated or reduced by reducing the dose. They have rarely been so serious that treatment has to be stopped.

   The side effects may be more serious in patients with a history of psychiatric illness or in brain blood vessel disorders (e.g. stroke), and in elderly patients.

   Epilepsy patients are more likely to get seizures. Some patients showed increased muscle spasticity in response to treatment.

   Many of the reported side effects are related to the underlying disease to be treated.

   Very common side effects (may affect more than 1 in 10 people)

   • drowsiness
   • Sedative
   • nausea

     Common side effects (may affect up to 1 in 10 people)

   • Reduction in breathability
   • fatigue
   • confusing state
   • dizziness
   • a headache
   • insomnia
   • euphoria
   • depression
   • Muscle weakness
   • Loss of coordination (ataxia)
   • tremor
   • Hallucinations
   • nightmares
   • Muscle pain (myalgia)
   • Nystagmus (undulatory and involuntary rhythmic vibrations of the eyes)
   • dry mouth
   • Visual disturbances
   • Decrease in blood volume
   • low blood pressure
   • Gastrointestinal diseases
   • Choking, vomiting
   • constipation
   • diarrhea
   • excessive sweating
   • Rash
   • frequent release of small amounts of urine (pollakiuria)
   • involuntary and complete loss of urine (bedwetting)
   • Difficulty urinating (dysuria)
   • Speech disorders in which words are pronounced slowly and incorrectly (dysarthria)
   • Change in taste (dysgeusia)
   • pain in the stomach
   • impaired liver function
   • Urine retention
   • Erectile dysfunction

     Very rare side effects (may affect up to 1 in 10,000 people)

   • Decrease in body temperature

     Unknown side effects (frequency cannot be estimated from the available data)

   • slow heartbeat
   • Hives
   • Withdrawal syndrome due to discontinuation of treatment
   • increased blood sugar level
   • Difficulty breathing during sleep (sleep apnea syndrome)

     Reporting of side effects

     If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

     By reporting side effects you can provide more information on the safety of this medicine.

5. How to store Lioresal

   Protect the medicine from moisture and heat.

   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. / Expires". The expiry date refers to the last day of this month.

   Do not throw medication into wastewater or household waste. Ask your pharmacist how you can get rid of medicines you no longer use. This helps protect the environment.

6. Contents of the pack and other information What Lioresal contains

   Lioresal 10 mg tablets

   • The active substance is baclofen. Each tablet contains 10 mg baclofen.
   • The other ingredients are wheat starch, magnesium stearate, povidone, microcrystalline cellulose and colloidal anhydrous silica.

     Lioresal 25 mg tablets

     • The other ingredients are wheat starch, magnesium stearate, povidone, microcrystalline cellulose and colloidal anhydrous silica.

Description of the appearance of Lioresal and contents of the pack Each pack of Lioresal 10 mg tablets contains 50 tablets. Each pack of Lioresal 25 mg tablets contains 50 tablets.