देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
baclofen, Quantity: 10 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet
Excipient Ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; maize starch
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 and spastic and dyssynergic bladder dysfunction.
Visual Identification: white, oval shaped, flat-faced, bevel-edged tablets scored and engraved "APO B10" on one side, plain on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2001-03-01
APO-BACLOFEN TABLETS _Contains the active ingredient baclofen_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Baclofen Tablets. It contains the active ingredient baclofen. It is used to treat: • multiple sclerosis • spinal cord damage resulting from disease or physical injury Baclofen belongs to a group of medicines called muscle relaxants. It is used to reduce excess tension in your muscles which causes spasms. Because this medicine reduces spasms and the pain that goes with them, it helps to make you more mobile. This helps you to manage your daily activities more easily. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. There is no evidence that this medicine is addictive. This medicine is available only with a doctor's prescription. _USE IN CHILDREN_ Baclofen should be used with extreme caution in children under 16 years of age as only limited information is available. Baclofen should not be used in children who weigh less than 33 kg. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • baclofen • any of the ingredients listed at the end of this leaflet Symptoms of an allergic reaction may include: • cough, shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue, throat or other parts of the body पूरा दस्तावेज़ पढ़ें
1 AUSTRALIAN PRODUCT INFORMATION APO-BACLOFEN (BACLOFEN) TABLETS 1 NAME OF THE MEDICINE Baclofen 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg or 25 mg of baclofen. EXCIPIENTS WITH KNOWN EFFECT Lactose monohydrate For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM APO-BACLOFEN 10 MG TABLETS White, oval, flat-faced, bevel-edged tablets, scored and engraved “APO B10” on one side. APO-BACLOFEN 25 MG TABLETS White, round, flat-faced, bevel-edged tablets, scored on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Suppression of voluntary muscle spasm in: ▪ Multiple sclerosis; ▪ Spinal lesions of traumatic, infectious, degenerative, neoplastic and unknown origin, causing skeletal hypertonus and spastic and dyssynergic bladder dysfunction. Baclofen is not recommended in Parkinson's disease or spasticity arising from strokes, cerebral palsy or rheumatoid disorders. 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Baclofen 10 mg and 25 mg tablets are intended for oral administration. DOSAGE 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, while at the same time retaining enough muscle tone to permit active movements, and avoiding adverse effects as far as possible. 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. 2 Abrupt discontinuation of treatment should be avoided (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Baclofen should be taken during पूरा दस्तावेज़ पढ़ें