Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
baclofen, Quantity: 10 mg
Novartis Pharmaceuticals Australia Pty Ltd
Tablet, uncoated
Excipient Ingredients: povidone; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; wheat starch
Oral
100
Medicine Registered
(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: white scored tablet marked KJ, CG on reverse; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1991-08-02
LIORESAL ® TABLETS L i o r e s a l ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING LIORESAL? Lioresal contains the active ingredient baclofen. Lioresal belongs to a group of medicines called muscle relaxants. Lioresal is used to reduce the stiffness or spasms in your muscles to help make you more mobile and able to manage your daily activities. For more information, see Section 1. Why am I using Lioresal? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE LIORESAL? Do not use if you have ever had an allergic reaction to Lioresal or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Lioresal? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Lioresal and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE LIORESAL? • Your doctor will tell you exactly how many tablets of Lioresal to take. • Do not exceed the recommended dose prescribed by your doctor. • Treatment is usually started in hospital with small doses of Lioresal. The dose is then gradually increased to an amount that works best for you More instructions can be found in Section 4. How do I use Lioresal? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING LIORESAL? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Lioresal. • Keep all doctor's appointments, so that your progress can be checked. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly, unless your doctor tells you to DRIVING OR USING MACHINES • Be careful before you drive or use any machines or tools until you know how Lioresal affects you Прочетете целия документ
1 AUSTRALIAN PRODUCT INFORMATION – LIORESAL (BACLOFEN) TABLETS 1 NAME OF THE MEDICINE The active ingredient of Lioresal is a gamma-aminobutyric acid derivative, baclofen, or - (Aminomethyl)-p-chlorohydrocinnamic acid, a racaemic mixture of the R(-) and S(+) isomers. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Baclofen is a white or almost white, odourless or practically odourless, crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Lioresal tablets contain 10 mg or 25 mg baclofen. The tablets also contain the following excipients: colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, povidone, wheat starch. Excipient with known effect: wheat starch. Wheat starch may contain gluten, but only in trace amounts. 3 PHARMACEUTICAL FORM Tablets containing baclofen 10mg: white, round, flat with bevelled edges; marked with KJ and score, CG on reverse. Bottles of 100. Tablets containing baclofen 25mg: white, round, flat with bevelled edges; marked with UR and score, CG on reverse. Bottles of 100 and blister packs of 50 and 100. 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: - skeletal hypertonus - 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 Lioresal should always be started in hospital, using small doses which are then gradually increased in a stepwise manner. The lowest dose compatible with an optimal response is recommended. The optimum daily dosage should be individualised 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 weak Прочетете целия документ