Pays: Israël
Langue: anglais
Source: Ministry of Health
BACLOFEN
NOVARTIS ISRAEL LTD
M03BX01
TABLETS
BACLOFEN 10 MG
PER OS
Required
NOVARTIS FARMA S.P.A., ITALY
BACLOFEN
BACLOFEN
Muscle spasticity of various origins.
2020-11-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 THE MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY LIORESAL ® 10 MG TABLETS LIORESAL ® 25 MG TABLETS COMPOSITION: Each tablet contains: Each tablet contains: baclofen 10 mg baclofen 25 mg Inactive ingredients and allergens: see section 2 "Important information about some of this medicine's ingredients" and section 6 “Further information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Lioresal is intended for muscle spasms caused by different factors. THERAPEUTIC GROUP: Antispastic with spinal site attack. Lioresal is used to reduce and relieve excessive muscle stiffness and/or spasms due to various diseases and conditions. Muscle relaxation by Lioresal improves the ability to move and makes it easier to perform daily activities. If you have questions about how Lioresal works or why this medicine has been prescribed for you, refer to the doctor. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (allergic) to baclofen or to any of the other ingredients of the medicine, see section 6. • You have or have ever had a stomach ulcer. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH LIORESAL, TELL THE DOCTOR IF: • You had a stroke. • You have epilepsy. • You have any mental illness. • You are being treated for high blood pressure. • You have Parkinson’s disease. • You suffer from liver, kidney or lung disease. • You have diabetes. • You have difficulties in urinating. • You are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”). • You have an intolerance to wheat s Lire le document complet
LIO API JAN22 V1 Page 1 of 10 1. NAME OF THE MEDICINAL PRODUCT Lioresal ® Tablets 10mg Lioresal ® Tablets 25mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient is: Baclofen = (β-(Aminomethyl)-p-chlorohydrocinnamic acid a racemic mixture of the R,(-) and S, (+) isomers). One tablet contains 10mg baclofen One tablet contains 25mg baclofen Excipient(s) with known effect: Wheat starch (containing gluten) For excipients see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lioresal is indicated for muscle spasticity of various origins. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE Treatment should always be initiated with small, gradually increasing doses of Lioresal. The lowest dose compatible with an optimal response is recommended. The optimum daily dosage should be individualized in such a way that clonus, flexor and extensor spasms and spasticity are reduced, but adverse effects are avoided as far as possible. In order to prevent excessive weakness and falling, Lioresal 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. If no benefit is apparent within 6 to 8 weeks of achieving the maximum dosage, a decision should be taken whether to continue with Lioresal. Discontinuation of the treatment should always be gradual by successively reducing the dosage over a period of approximately 1 to 2 weeks, except in overdose-related emergencies, or where serious adverse effects have occurred (see Section 4.4). ADULTS: Treatment should be started with a dosage of 15 mg daily, preferably in 2 to 4 divided doses. Dose should be titrated upwards cautiously, by 15 mg/day increments at 3-day intervals until the requisite daily dosage has been attained. In certain patients reacting LIO API JAN22 V1 Page 2 of 10 sens Lire le document complet