País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
baclofen, Quantity: 10 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet, uncoated
Excipient Ingredients: microcrystalline cellulose; maize starch; povidone; colloidal anhydrous silica; magnesium stearate
Oral
100 tablets
(S4) Prescription Only Medicine
Suppression of voluntary muscle spasm in: multiple sclerosis; spinal lesions of traumatic, infectious, degenerative, neoplastic and unknown origin, causing skeletal hypertonus, spastic and dyssynergic bladder dysfunction. Not recommended in Parkinson's disease or spasticity arising from strokes, cerebral palsy or rheumatoid disorders.
Visual Identification: Off-white, round, flat bevelled edged tablets, debossed with BL score line 10 on one side and plain on other.; Container Type: Bottle; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2003-01-09
STELAX- Consumer Medicine Information Page 1 of 5 STELAX baclofen CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about STELAX. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking STELAX against the benefits they expect it will have for you. TALK TO YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE. Keep this leaflet with your medicine. You may need to read it again. WHAT STELAX IS USED FOR STELAX is used to treat muscle spasms that occur in various illnesses such as multiple sclerosis and diseases and injuries of the spinal cord. STELAX belongs to a group of medicines called muscle relaxants. These medicines reduce excess tension in your muscles that cause spasms and pain. Reducing these spasms may help to increase your mobility and make everyday activities easier to manage. Your doctor may have prescribed this medicine for another reason. Ask your doctor if you have any questions about why it has been prescribed for you. It is available only with a doctor's prescription. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE STELAX IF YOU ARE ALLERGIC TO MEDICINES CONTAINING BACLOFEN OR 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 IT IF THE EXPIRY DATE (EXP.) PRINTED ON THE PACK HAS PASSED. DO NOT TAKE IT IF THE PACKAGING SHOWS SIGNS OF TAMPERING OR THE TABLETS DO NOT LOOK QUITE RIGHT. _BEFORE YOU START TO TAKE IT _ TELL YOUR DOCTOR IF YOU ARE PREGNANT OR INTEND TO BECOME PREGNANT OR YOU ARE BREASTFEEDING. There is very little information on the use of this medicine in pregnancy or while breast- feeding. Your doctor can discuss with you th Leia o documento completo
1 AUSTRALIAN PRODUCT INFORMATION – STELAX (BACLOFEN) TABLETS 1 NAME OF THE MEDICINE Baclofen. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Stelax tablets come in two strengths and contain either 10 mg or 25 mg of baclofen. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM STELAX 10, Round, off-white tablet, marked BL 10 on one side and plain on the other; STELAX 25, Round, off-white tablet, marked BL 25 on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Suppression of voluntary muscle spasm in: • Multiple sclerosis • Spinal lesions of traumatic, infectious, degenerative, neoplastic and unknown origin, causing: o Skeletal hypertonus o Spastic and dyssynergic bladder dysfunction Not recommended in Parkinson's disease or spasticity arising from strokes, cerebral palsy or rheumatoid disorders. 4.2 D OSE AND METHOD OF ADMINISTRATION Treatment with baclofen should always be started in hospital, using small doses which are then gradually increased stepwise. The lowest dose compatible with an optimal response is recommended. The optimum daily dosage should be individually adapted to each patient's requirements so that clonus, flexor and extensor spasms, and spasticity are reduced, at the same time retaining enough muscle tone to permit active movements and avoiding adverse effects as far as possible. 2 In order to prevent excessive weakness and falling, baclofen 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. Abrupt discontinuation of treatment should be avoided (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). In adults baclofen should be given in at least three divided doses daily. DOSAGE REGIMEN As a rule, treatment should be started with a dose of 5 mg three times daily, subsequently in Leia o documento completo