País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Baclofen 10mg
Noumed Pharmaceuticals Limited
10 mg
Tablet
Active: Baclofen 10mg Excipient: Colloidal silicon dioxide Magnesium stearate Maize starch Microcrystalline cellulose Povidone
Prescription
" Spasticity of the skeletal muscles in multiple sclerosis. " Spastic conditions occurring in spinal-cord diseases of infectious, degenerative, traumatic, neoplastic, or unknown origin: e.g. spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, traumatic paraplegia or paraparesis, and compression of the spinal cord; muscle spasm of cerebral origin, especially where due to infantile cerebral palsy, as well as following cerebrovascular accidents or in the presence of neoplastic or degenerative brain disease.
Package - Contents - Shelf Life: Blister pack, PVC/Al in outer carton - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture
2021-01-29
New Zealand Consumer Medicine Information 1 BACLOFEN (NOUMED) _BACLOFEN PH.EUR. _ 10 mg uncoated tablets WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Baclofen (Noumed). This leaflet answers some common questions about Baclofen (Noumed). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Baclofen (Noumed) against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT BACLOFEN (NOUMED) IS USED FOR Baclofen (Noumed) is used to reduce excess tension in your muscles which causes spasms. These spasms happen in various illnesses such as multiple sclerosis and diseases or injuries of the spinal cord. Because this medicine reduces spasms and the pain that goes with them, it helps to make you more mobile. This can help you to manage your daily activities more easily. Baclofen (Noumed) contains the active ingredient baclofen. It belongs to a group of medicines called muscle relaxants. It works by reducing the excessive stiffness and/or spasms in your muscles. Your doctor may have prescribed Baclofen (Noumed) for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY BACLOFEN (NOUMED) HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. New Zealand Consumer Medicine Information 2 BEFORE YOU USE BACLOFEN (NOUMED) _ _ _WHEN YOU MUST NOT USE IT _ DO NOT USE BACLOFEN (NOUMED) IF YOU HAVE AN ALLERGY TO: • any medicine containing baclofen • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue, or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE BACLOFEN (NOU Llegiu el document complet
NEW ZEALAND DATA SHEET Page 1 of 14 1 PRODUCT NAME Baclofen (Noumed) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg Baclofen For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet, uncoated. Presentation Baclofen (Noumed) are white coloured, round shaped, flat tablets, debossed with ‘B’ and ‘10’ separated by break line on one side and plain on the other side. The tablets can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Spasticity of the skeletal muscles in multiple sclerosis. Spastic conditions occurring in spinal- cord diseases of infectious, degenerative, traumatic, neoplastic, or unknown origin: e.g. spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, traumatic paraplegia or paraparesis, and compression of the spinal cord; muscle spasm of cerebral origin, especially where due to infantile cerebral palsy, as well as following cerebrovascular accidents or in the presence of neoplastic or degenerative brain disease. 4.2 Dose and method of administration Treatment Treatment should always be initiated with small, gradually increasing doses of Baclofen (Noumed). The optimum daily dosage should be individually adapted to the patient’s requirements in such a way that clonus, flexor and extensor spasms, and spasticity are reduced, but that adverse effects are as far as possible avoided. In order to prevent excessive weakness and falling, Baclofen (Noumed) should be used with caution when spasticity is needed to sustain upright posture and balance in locomotion or whenever spasticity is used to maintain function. It may be important to maintain some degree of muscle tone and allow occasional spasms to help support circulatory function. NEW ZEALAND DATA SHEET Page 2 of 14 Baclofen (Noumed) should be taken during meals with a little liquid. The daily dosage should be given in divided doses, preferably 3 in adults and 4 in children. Dose Adults Treatment should as a rule be started with a dosage Llegiu el document complet