Properties
What is it?
SUROL 500 mg film-coated tablets are taken orally. • Active substance: Each tablet contains 500 mg of ursodeoxycholic acid as the active substance. • Excipient(s): microcrystalline cellulose, polyvinylpyrrolidone, pregelatinized corn starch, colloidal anhydrous silica, sodium stearyl fumarate, hydroxypropyl methylcellulose, polyethylene glycol, titanium dioxide. Read this leaflet carefully before you start taking this medicine, as it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you, do not pass it on to others. • When visiting a doctor or hospital, tell your doctor that you are taking this medicine. • Follow the instructions exactly. Do not take higher or lower doses than prescribed. Package leaflet: 1. Description and use of SUROL 2. What you need to consider before using SUROL 3. How to use SUROL 4. Possible side effects 5. Storage of SUROL 1. Description and use of SUROL Ursodeoxycholic acid, the active substance of SUROL®, is a naturally occurring bile acid found in small amounts in human bile. SUROL is used to dissolve cholesterol gallstones less than 15 mm in diameter in the gallbladder, which are not visible on X-ray, in patients with preserved gallbladder function, and for the treatment of reflux gastritis (inflammation of the esophagus caused by bile acid reflux), as well as for the symptomatic treatment of primary biliary cirrhosis (PBC; liver cirrhosis caused by inflammation of the bile ducts) in the absence of decompensated liver cirrhosis (serious liver disease where the existing liver tissue cannot compensate for the impaired liver function). 2. What you need to consider before using SUROL® Do not use SUROL: • if you are hypersensitive to ursodeoxycholic acid or any of the other ingredients of SUROL®. • if you have signs of inflammation of the bile ducts or biliary tract. • if you have an obstruction of the biliary tract (obstruction of the bile ducts or bile duct). Do not take the tablets if you think any of the above conditions apply to you. Consult your doctor for advice. Take special care with SUROL: • if your gallbladder is not visible on X-ray, • if you have calcified gallstones, • if you have impaired gallbladder motility, • if you frequently experience biliary colic (spasmodic pain in the upper abdomen). Additional information: SUROL® is used under medical supervision. In the first three months of treatment, liver function tests should be performed at 4-week intervals, then every 3 months. SUROL® is not suitable for patients weighing less than 47 kg. If any of these warnings applied to you at any point in your life, consult your doctor. Use of SUROL with food and drink: No interactions between SUROL and food or drink are known. Pregnancy: Consult your doctor or pharmacist before taking this medicine. There is insufficient data on the use of the drug in women during the first trimester of pregnancy. Do not take ursodeoxycholic acid during pregnancy unless your doctor decides it is necessary. If you become pregnant during treatment, contact your doctor or pharmacist immediately. Breastfeeding: Consult your doctor or pharmacist before taking this medicine. Ursodeoxycholic acid is not used during breastfeeding as it is not known whether it is excreted in breast milk. If SUROL treatment is necessary, breastfeeding should be discontinued. Effects on ability to drive and use machines: No side effects of SUROL on the ability to drive and use machines have been reported. Use with other medicines: Combined use with certain medicines may lead to different effects. The effect of the following medicines may be reduced when taking SUROL: • Cholestyramine and colestipol (lipid-lowering agents) or antacids containing aluminum hydroxide and/or smectite (aluminum oxide) (medicines that bind stomach acid). If you need to take one of these medicines, take it at least 2 hours before or 2 hours after taking SUROL®. • Ciprofloxacin and dapsone (antibiotics), nitrendipine (for high blood pressure) and other medicines metabolized in the same way. If your doctor considers it necessary, they should adjust the dosage of these medicines. The effect of the following medicines is reduced when taking SUROL: • Cyclosporine (a medicine that suppresses the immune system). If you are being treated with cyclosporine, your doctor should check the cyclosporine levels in your blood and, if necessary, adjust the cyclosporine dose. If you are taking or have recently taken any medicine, including medicines obtained without a prescription, tell your doctor or pharmacist. 3. How to use SUROL Correct use and dosage/frequency of administration: Always use SUROL® exactly as your doctor has told you. If you are unsure about how to use the medicine, ask your doctor. Adults: Dissolving cholesterol gallstones: Dosage: 2 capsules for patients weighing up to 60 kg, equivalent to a dose of 10 mg per kg of body weight per day. 3 capsules for 61-80 kg 4 capsules for 81-100 kg 5 capsules for over 100 kg The tablets should be swallowed whole with a small amount of liquid before bedtime. The tablets should be taken regularly. Duration of SUROL treatment for dissolving cholesterol gallstones: Treatment usually requires a course of 6-24 months. If no reduction in stone size is observed after a 12-month course of treatment, treatment should be discontinued. Your doctor should check the results of the treatment every 6 months. At each control, the calcification of the stones should be checked and compared with previous results. Treatment should be discontinued if calcification is present. Treatment of reflux gastritis: Take one capsule before chewing with a small amount of liquid, every night before bedtime. Duration of treatment: The recommended duration of treatment is 10-14 days. The doctor will decide on the duration of treatment based on the patient's clinical picture. Symptomatic treatment of primary biliary cirrhosis (liver cirrhosis caused by inflammation of the bile ducts): For the first three months of treatment, SUROL® capsules are taken in divided doses throughout the day. After improvement of liver function, the total daily dose is taken once a day in the evening. Weight (kg) (VA) Daily dose (mg/kg body weight) Tablets First 3 months Morning Afternoon Evening Evening 1x1 per day 47-62 12-16 1 1 1 3 63-78 13-16 1 1 2 4 79-93 13-16 1 2 2 5 94-109 14-16 2 2 2 6 >110 2 2 3 7 Not recommended for individuals weighing less than 47 kg. The tablets should be swallowed whole with a small amount of liquid. It is important to take the medicine regularly. Duration of treatment for primary biliary cirrhosis: The duration of SUROL® use in the treatment of primary biliary cirrhosis is not limited. In the treatment of primary biliary cirrhosis, symptoms of the disease (such as itching) may occasionally worsen at the beginning of treatment. This is rarely observed. If this occurs, SUROL treatment will continue with low daily doses, and the daily doses will be increased until the recommended doses indicated in the table are reached. Method of administration: Taken orally. Different age groups: Use in children: There is no age restriction for the use of SUROL. The use of SUROL depends on the patient's body weight and condition. Use in elderly patients: There is no age restriction for the use of SUROL. The use of SUROL® depends on the patient's body weight and condition. Special groups; Liver failure: See recommendations for dosage in the symptomatic treatment of primary biliary cirrhosis (liver cirrhosis caused by inflammation of the bile ducts) in the section ~Correct use and dosage/frequency of administration~. Kidney failure: No special administration method is required. If you think that the effect of SUROL is too strong or too weak, consult your doctor or pharmacist. If you take more SUROL than you should: If you take more SUROL tablets than you should, consult your doctor or pharmacist. Overdose may cause diarrhea. If diarrhea persists, inform your doctor, as a dose reduction may be necessary. If diarrhea worsens, ensure you drink enough fluids to restore water-electrolyte balance. If you forget to take SUROL: Do not take a double dose to make up for a missed dose. Continue treatment with the usual dose. Possible effects of stopping SUROL® treatment: Contact your doctor if you stop SUROL treatment or plan to stop it earlier. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Gastrointestinal side effects: Frequent (more than 1 in 100 people and less than 1 in 10 people): Softening of the stool and diarrhea have been observed during treatment with ursodeoxycholic acid in clinical studies. Very rare (less than 1 in 10,000 people): Severe pain in the upper right abdomen developed during treatment of primary biliary cirrhosis. Hepatobiliary disorders: Very rare (less than 1 in 10,000 people): Calcification of gallstones may occur during treatment with ursodeoxycholic acid. Decompensation of liver cirrhosis was observed during the initial stage of treatment of primary biliary cirrhosis, which partially subsides after discontinuation of treatment. Hypersensitivity reactions: Very rarely (less than 1 in 10,000 people): Hives (hay fever) may develop. Tell your doctor or pharmacist if you experience any side effects not listed in this leaflet. 5. Storage of SUROL® Store SUROL out of reach of children, in its original packaging. Store at room temperature not exceeding 25°C. Use before the expiry date. Do not use SUROL after the expiry date indicated on the packaging. Dispensing category: Pharmaceutical product group III, available without prescription. Marketing authorization holder: Helba İlaç İç ve Dış Sanayi Ticaret Anonim Şirketi Cemlik Mahallesi Pamuk Sk. A Blok, No:12-16/17 Ümraniye-İstanbul/ Turkey Tel: +90 216 365 41 47 Fax: +90 216 365 41 48 E-mail: helba@helba.com.tr Manufacturer: MERKEZ LABORATORY PHARMACEUTICAL AND TRADE Co. Tashdelen, Şirri Çelik Bulvarı, Ayça Sokak No:6 Çekmeköy – Istanbul/ Turkey Tel.: +90 216 4844166 Fax: +90 216 4844191 E-mail: mtm@merkezlab.com