Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
URSODEOXYCHOLIC ACID
RAFA LABORATORIES LTD
A05AA02
FILM COATED TABLETS
URSODEOXYCHOLIC ACID 500 MG
PER OS
Required
DR. FALK PHARMA, GERMANY
URSODEOXYCHOLIC ACID
URSODEOXYCHOLIC ACID
For the symptomatic treatment of primary biliary cirrhosis (PBC), in patients without decompensated hepatic cirrhosis.
2018-08-31
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is sold with a doctor's prescription only URSOFALK ® 500 FILM-COATED TABLETS ACTIVE INGREDIENT: Each tablet of URSOFALK 500 contains: Ursodeoxycholic acid 500 mg. For a list of inactive ingredients, please see section 6. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, please refer to your doctor or pharmacist. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? This medicine is intended for the symptomatic treatment of primary biliary cirrhosis, in patients without decompensated liver cirrhosis. THERAPEUTIC GROUP: Bile acids. _ _ 2. BEFORE YOU TAKE THE MEDICINE DO NOT USE THE MEDICINE IF: Do not use if you are sensitive (allergic) to the active ingredient (bile acids) or to any of the other ingredients this medicine contains (for a list of inactive ingredients, please see section 6). Do not use if you suffer from acute inflammation of the gall bladder and/or biliary tract. Do not use if you suffer from an obstruction of the biliary tract. Do not use if you suffer from biliary colic (may be manifested by frequent pain/cramps in the upper abdomen). Do not use if you suffer from calcified gallstones. Do not use if your gall bladder does not contract properly. SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE This medicine should be used under medical supervision (see also 'Tests and follow up' in section 3). If you have suffered in the past from any of the conditions mentioned in the section 'Do not use the medicine if'- inform your doctor. If you suffer from diarrhea during the treatment, inform your doctor immediately, as your doctor may decide to reduce the dosage of the medicine or to stop its use. In rar Perskaitykite visą dokumentą
1 Ursofalk 500mg -DL-Feb 2016-02 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT URSOFALK 500MG FILM-COATED TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg of ursodeoxycholic acid as the active substance. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Appearance: white, oval, biconvex film-coated tablets with a break line on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic treatment of primary biliary cirrhosis (PBC), in patients without decompensated hepatic cirrhosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION There are no age restrictions on the use of Ursofalk 500mg tablets. For patients weighing less than 47 kg or patients who are unable to swallow Ursofalk 500mg tablets, Ursofalk 250 mg capsules are available. For the symptomatic treatment of primary biliary cirrhosis (PBC) The daily dose depends on body weight and ranges from 1½ to 3½ tablets (14 2 mg of ursodeoxycholic acid per kg of body weight). For the first 3 months of treatment, Ursofalk 500mg tablets should be taken divided over the day. When the liver function parameters improve, the daily dose may be taken once daily in the evening. Body weight (kg) Ursofalk 500mg tablets FIRST 3 MONTHS SUBSEQUENTLY morning midday evening evening (1 x daily) 47 – 62 ½ ½ ½ 1½ 63 – 78 ½ ½ 1 2 79 – 93 ½ 1 1 2½ 94 – 109 1 1 1 3 2 Over 110 1 1 1½ 3½ The tablets should be swallowed with some liquid. They must be taken regularly. The use of Ursofalk 500mg tablets in primary biliary cirrhosis may be continued indefinitely. In patients with primary biliary cirrhosis, in rare cases the clinical symptoms may worsen at the beginning of treatment, e.g. the itching may increase. In this event, therapy should first be continued with half an Ursofalk 500mg tablet or one Ursofalk 250mg capsule daily, and the dose then gradually increased (weekly increase of the daily dose by half a tablet or one Ursofalk 250 mg capsule) until th Perskaitykite visą dokumentą