Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BACLOFEN
Prestige Pharma Sdn Bhd
BACLOFEN
100Tablet Tablets; 200Tablet Tablets; 500Tablet Tablets; 50Tablet Tablets
Sriprasit Pharma Co. Ltd.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ LIOBAC TABLET Baclofen (10 mg) 1 WHAT IS IN THE LEAFLET 1. What LIOBAC is used for 2. How LIOBAC works 3. Before you use LIOBAC 4. How to use LIOBAC 5. While you are using it 6. Side effects 7. Storage and Disposal of LIOBAC 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT LIOBAC IS USED FOR LIOBAC is used to reduce excess tension in your muscles which causes spasms. It reduces spasms and the pain that happen in various illnesses such as multiple sclerosis and diseases or injuries of the spinal cord. It helps to make you more mobile and better able to manage your daily activities. HOW LIOBAC WORKS LIOBAC contains the active ingredient Baclofen. It belongs to a group of medicines called muscle relaxants. It works by restoring the normal balance and reducing muscle hyperactivity. In this way, it allows for more normal muscle movements. BEFORE YOU USE LIOBAC - _When you must not use it_ Do not take this medicine if: • You are hypersensitive to the active ingredient or any ingredients in the formulation or any other similar medicines. • You have peptic ulcer disease. _If you are not sure whether you should start _ _taking this medicine, consult your doctor. _ - _Before you start to use it _ Tell your doctor if you have allergies to any other medicines, food, preservatives or dyes. Tell your doctor if you have or have had any medical conditions, especially: • any psychiatric problems • epilepsy and muscle spasticity • peptic ulcers • abnormal increase in muscle tone (sphincter hypertonia) • liver problems • diabetes If you are pregnant, intend to become pregnant or nursing, consult your doctor before using this medicine. - _Taking other medicines _ Please tell your doctor or pharmacist if you are taking any other medicines, including medicines obtained without a prescription, herbal medicines or natural products. Some medicines may be affected by LIOBAC, or may affect how well it works. You may need to tak Прочитайте повний документ
CONTENT Each plain tablet contains Baclofen 10 mg. PRODUCT DESCRIPTION White round tablet embossed with “SPS”, “L05” and a breakline on one side and plain on the other. PROPERTIES _PHARMACODYNAMICS _ Baclofen, an analogue of gamma-aminobutyric acid (GABA), is a centrally acting skeletal muscle relaxant. It inhibits monosynaptic and polysynaptic transmission at the spinal cord level by stimulating the GABA β receptors, resulting in inhibition of the release of the excitatory amino acids glutamate and aspartate. Baclofen may act at supraspinal sites producing CNS depression but has no effect on neuromuscular impulse transmission. Baclofen also exerts an antinociceptive effect but the clinical significance of this is unknown. _PHARMACOKINETICS _ _Absorption: _ Baclofen is rapidly and completely absorbed from the gastrointestinal tract following an oral dose. The peak plasma concentration occurs in 0.5 to 3 hours following ingestion, but the rate and extent of absorption vary between patients, and vary inversely with the dose._ _ _Distribution: _ The distribution volume of baclofen is 0.7 L/kg and approximately 30% of baclofen is bound to plasma protein. In cerebrospinal fluid, the active substance concentrations are approximately 8.5 times lower than in the plasma._ _ _Metabolism: _About 15% is metabolized in the liver to the pharmacologically inactive, β-(p-chlorophenyl)-4-hydroxybutyric acid._ _ _Elimination: _The plasma elimination half-life of baclofen is about 3 – 4 hours. About 75% of the dose is excreted via the kidney within 72 hours, mainly as unchanged drug. The remainder of the dose, including 5% in the form of metabolites, is excreted in faeces._ _ INDICATION LIOBAC is indicated for the alleviation of spasticity of the skeletal muscles in multiple sclerosis and other spastic conditions occurring from spinal cord diseases of infectious, degenerative, traumatic, neoplastic or unknown origin (e.g. spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, trauma Прочитайте повний документ