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Go to top of the page PACKAGE LEAFLET: INFORMATION FOR THE USER Protium® 40 mg gastro-resistant tablets Pantoprazole Read all of this leaflet carefully before you start taking this medicine. - 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. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: What Protium is and what it is used for Before you take Protium How to take Protium Possible side effects How to store Protium Further information Go to top of the page WHAT PROTIUM IS AND WHAT IT IS USED FOR Protium is a selective “proton pump inhibitor”, a medicine which reduces the amount of acid produced in your stomach. It is used for treating acid-related diseases of the stomach and intestine. Protium is used for treating: Adults and adolescents 12 years of age and above: - Reflux oesophagitis. An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid. Adults: - An infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (Eradication therapy). The aim is to get rid of the bacteria and so reduce the likelihood of these ulcers returning. - Stomach and duodenal ulcers. - Zollinger-Ellison-Syndrome and other conditions producing too much acid in the stomach. Go to top of the page BEFORE YOU TAKE PROTIUM Do not take Protium - If you are allergic (hypersensitive) to pantoprazole or to any of the other ingredients of Protium (see section 6). - If you are allergic to medicines containing other proton pump inhibitors. Take special care with Protium - If you have severe liver problems. Please tell your doctor if you ever had problems with your liver in the past. He will check your liver enzymes more frequently, especially when you are taking Protium as a long-term treatment. In the case of a rise of liver enzymes the treatment should be stopped. - If you have reduced body stores or risk factors for reduced vitamin B12 and receive long-term treatment with pantoprazole. As with all acid reducing agents, pantoprazole may lead to a reduced absorption of vitamin - If you are taking a medicine containing atazanavir (for the treatment of HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice. Tell your doctor immediately if you notice any of the following symptoms: - an unintentional loss of weight - repeated vomiting - difficulty in swallowing - vomiting blood - you look pale and feel weak (anaemia) - you notice blood in your stools - severe and/or persistent diarrhoea, as Protium has been associated with a small increase in infectious diarrhoea. Your doctor may decide that you need some tests to rule out malignant disease because pantoprazole also alleviates the symptoms of cancer and could cause delay in diagnosing it. If your symptoms continue in spite of your treatment, further investigations will be considered. If you take Protium on a long-term basis (longer than 1 year) your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor. Taking other medicines Protium may influence the effectiveness of other medicines, so tell your doctor if you are taking - Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because Protium may stop these and other medicines from working properly. - Warfarin and phenprocoumon, which affect the thickening, or thinning of the blood. You may need further checks. - Atazanavir (used to treat HIV-infection). Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding There are no adequate data from the use of pantoprazole in pregnant women. Excretion into human milk has been reported. If you are pregnant, or think you may be pregnant, or if you are breast-feeding, you should use this medicine only if your doctor considers the benefit for you greater than the potential risk for your unborn child or baby. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines If you experience side effects like dizziness or disturbed vision, you should not drive or operate machines. Go to top of the page HOW TO TAKE PROTIUM Always take Protium exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. When and how should you take Protium? Take the tablets 1 hour before a meal without chewing or breaking them and swallow them whole with some water. Unless told otherwise by your doctor, the usual dose is: Adults and adolescents 12 years of age and above: To treat reflux oesophagitis The usual dose is one tablet a day. Your doctor may tell you to increase to 2 tablets daily. The treatment period for reflux oesophagitis is usually between 4 and 8 weeks. Your doctor will tell you how long to take your medicine. Adults: For the treatment of an infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (Eradication therapy). One tablet, two times a day plus two antibiotic tablets of either amoxicillin, clarithromycin and metronidazole (or tinidazole), each to be taken two times a day with your pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before your evening meal. Follow your doctor’s instructions and make sure you read the package leaflets for these antibiotics. The usual treatment period is one to two weeks. For the treatment of stomach and duodenal ulcers. The usual dose is one tablet a day. After consultation with your doctor, the dose may be doubled. Your doctor will tell you how long to take your medicine. The treatment period for stomach ulcers is usually between 4 and 8 weeks. The treatment period for duodenal ulcers is usually between 2 and 4 weeks. For the long-term treatment of Zollinger-Ellison-Syndrome and of other conditions in which too much stomach acid is produced. The recommended starting dose is usually two tablets a day. Take the two tablets 1 hour before a meal. Your doctor may later adjust the dose, depending on the amount of stomach acid you produce. If prescribed more than two tablets a day, the tablets should be taken twice daily. If your doctor prescribes a daily dose of more than four tablets a day, you will be told exactly when to stop taking the medicine. Special patient groups: - If you have kidney problems, moderate or severe liver problems, you should not take Protium for eradication of Helicobacter pylori. - If you suffer from severe liver problems, you should not take more than one tablet 20 mg pantoprazole a day (for this purpose tablets containing 20 mg pantoprazole are available). - Children below 12 years. These tablets are not recommended for use in children below 12 years. If you take more Protium than you should Consult your doctor or pharmacist. There are no known symptoms of overdose. If you forget to take Protium Do not take a double dose to make up for the forgotten dose. Take your next, normal dose at the usual time. If you stop taking Protium Do not stop taking these tablets without first talking to your doctor or pharmacist. If you have any further questions about the use of this product, ask your doctor or pharmacist. Go to top of the page POSSIBLE SIDE EFFECTS Like all medicines, Protium can cause side effects, although not everybody gets them. The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data) If you get any of the following side effects, stop taking these tablets and tell your doctor immediately, or contact the casualty department at your nearest hospital: Serious allergic reactions (frequency rare): swelling of the tongue and/or throat, difficulty in swallowing, hives (nettle rash), difficulties in breathing, allergic facial swelling (Quincke’s oedema / angioedema), severe dizziness with very fast heartbeat and heavy sweating. Serious skin conditions (frequency not known): blistering of the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson-Syndrome, Lyell-Syndrome, Erythema multiforme), and sensitivity to light. Other serious conditions (frequency not known): yellowing of the skin or whites of the eyes (severe damage to liver cells, jaundice) or fever, rash, and enlarged kidneys sometimes with painful urination, and lower back pain (serious inflammation of the kidneys). Other side effects are: Uncommon (affects 1 to 10 users in 1,000) headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; itching; feeling weak, exhausted or generally unwell; sleep disorders. Taking a proton pump inhibitor like pantoprazole, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis). Rare (affects 1 to 10 users in 10,000) distortion or complete lack of the sense of taste; disturbances in vision such as blurred vision; hives; pain in the joints; muscle pains; weight changes; raised body temperature; high fever; swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in males. Very Rare (affects less than 1 user in 10,000) disorientation. Not known (frequency cannot be estimated from the available data) Hallucination, confusion (especially in patients with a history of these symptoms); decreased sodium level in blood. If you are on Protium for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium. Side effects identified through blood tests: Uncommon (affects 1 to 10 users in 1,000) an increase in liver enzymes. Rare (affects 1 to 10 users in 10,000) an increase in bilirubin; increased fat levels in blood; sharp drop in circulating granular white blood cells, associated with high fever. Very Rare (affects less than 1 user in 10,000) a reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal; a reduction in the number of white blood cells, which may lead to more frequent infections; coexisting abnormal reduction in the number of red and white blood cells, as well as platelets. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Go to top of the page HOW TO STORE PROTIUM Keep out of the reach and sight of children. Do not use Protium after the expiry date, which is stated on the carton and the container after EXP. The expiry date refers to the last day of that month. For HDPE bottles: Do not use tablets beyond 120 days after first opening of the bottle. This medicine does not require any special storage conditions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Go to top of the page FURTHER INFORMATION What Protium contains - The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate). - The other ingredients are: Core: sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate. Coating: hypromellose, povidone K25, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer (1:1), polysorbate 80, sodium laurilsulfate, triethyl citrate. Printing ink: shellac, red, black and yellow iron oxide (E172) and ammonia solution, concentrated. What Protium looks like and contents of the pack Yellow, oval, biconvex gastro-resistant tablet imprinted with “P 40” on one side. Packs: bottles (high density polyethylene container with low density polyethylene screw cap closure) and blister (ALU/ALU blister) without cardboard reinforcement or with cardboard reinforcement (blister wallet). Protium is available in the following pack sizes: tablets. Hospital packs with 50, 90, 100, 140, 140 (10x14), 150 (10x15), 700 (5x140) gastro-resistant tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Takeda GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Germany Manufacturer Takeda GmbH Production Site Oranienburg Lehnitzstraße 70-98 D-16515 Oranienburg Germany Marketing Company Takeda Products Ireland Ltd. Unit 2051 Castle Drive Citywest Business Campus Dublin 24 Ireland This medicine is authorised in the Member States of the EEA under the following names: Name of Member State Name of the medicine Austria Pantoloc 40 mg-Filmtabletten, Zurcal 40 mg-Filmtabletten Belgium Pantozol, Zurcale Bulgaria Controloc Cyprus Controloc Czech Republic Controloc 40 mg Denmark Pantoloc Estonia Controloc 40 mg Finland Somac 40 mg France Eupantol 40 mg, Inipomp 40 mg, Germany Pantozol 40 mg, Pantoprazol NYC 40 mg, Rifun 40 mg, Zurcal S 40 mg Greece Controloc, Zurcazol Hungary Controloc 40 mg Ireland Protium Italy Pantorc, Pantopan, Pantecta, Peptazol Latvia Controloc 40 mg Lithuania Controloc 40 mg Luxembourg Pantozol-40, Panto-Byk-40 Netherlands Pantozol, Pantoprazol Nycomed 40 mg Norway Somac Poland Controloc 40 Portugal Pantoc 40 mg, Zurcal 40 mg, Apton 40 mg, Pantoprazole ALTANA 40 mg Romania Controloc 40 mg Slovakia Controloc 40 mg Slovenia Controloc 40 mg Spain Pantecta 40 mg comprimidos gastrorresistentes, Anagastra 40 mg comprimidos gastrorresistentes, Ulcotenal 40 mg comprimidos gastrorresistentes Sweden Pantoloc This leaflet was last approved in 02/2013 Detailed information on this medicinal product is available on the website of the Heads of Medicines Agencies (HMA) http://www.hma.eu IRL F.1/0213/6xxxxxx
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Controloc (pantoprazolum) želučanootporne tablete- upute U uputi ćete pronaći sljedeće informacije: - Što je Controloc i za što se koristi - Prije primjene Controloca - Kako uzimati Controloc - Moguće nuspojave - Kako čuvati Controloc - Dodatne informacije Cijena Controloc pakiranja 14*20mg tableta je 48.50 kuna. Što je Controloc i za što se koristi Controloc je selektivni ”inhibitor protonske pumpe”, lijek koji smanjuje količinu kiseline koju luči Vaš želudac. Koristi se za liječenje bolesti želuca i crijeva uzrokovanih kiselinom. Controloc se koristi za: Kod odraslih i djece starije od 12 godina: - liječenje refluksnog ezofagitisa (upale jednjaka, odnosno cijevi koja povezuje grlo i želudac, izazvane podizanjem kiseline iz želuca u jednjak) Kod odraslih: - liječenje infekcije bakterijom Helicobacter pylori kod bolesnika sa želučanim ili duodenalnim ulkusima, u kombinaciji s dva antibiotika (trojna terapija). Cilj liječenja je riješiti se bakterije i smanjiti vjerojatnost ponovne pojave ulkusa - liječenje ulkusa želuca i dvanaesnika - liječenje Zollinger-Ellisonovog sindroma i drugih stanja pri kojima se u želucu luči previše kiseline Prije primjene Controloca Ne uzimajte Controloc: - ako ste preosjetljivi (alergični) na pantoprazol, sojino ulje ili bilo koji od pomoćnih sastojaka lijeka (vidjeti poglavlje 6.). - ako ste alergični na druge lijekove iz skupine inhibitora protonske pumpe Budite oprezni s Controlocom: - ako imate ozbiljne teškoće s jetrom. Recite liječniku ukoliko ste ikad patili od jetrenih tegoba. U tom ćete slučaju češće provjeravati jetrene enzime, pogotovo ako je terapija Controlocom dugotrajna. U slučaju porasta jetrenih enzima liječenje treba prekinuti. - ako ste na dugotrajnoj terapiji Controlocom, a imate smanjene zalihe vitamina B12 ili čimbenike rizika za smanjenje količine vitamina B12. Pantoprazol, kao i drugi blokatori lučenja želučane kiseline, može smanjiti apsorpciju vitamina B12 - ako istovremeno uzimate lijek koji sadrži atazanavir (za liječenje HIV infekcija). Upitajte liječnika za savjet. Odmah se javite liječniku ukoliko primijetite neke od navedenih simptoma: - nenamjerni gubitak težine - učestalo povraćanje - teškoće s gutanjem - povraćanje krvi - blijedi ste i osjećate slabost (anemija) - krv u stolici - težak i/ili učestao proljev, jer je Controloc povezan s blagim porastom učestalosti infektivnih proljeva. Liječnik će Vas možda uputiti na dodatne pretrage da bi se isključila maligna bolest, jer pantoprazol može ublažiti simptome karcinoma i odgoditi njegovo otkrivanje. Ukoliko se simptomi nastave unatoč terapiji, možda će biti potrebne daljnje pretrage. Kod dugotrajnog liječenja, naročito ako traje dulje od godine dana, liječnik će Vas vjerojatno redovito kontrolirati. Ako primijetite nove ili neuobičajene simptome, spomenite ih liječniku. Uzimanje drugih lijekova: Controloc može promijeniti djelovanje drugih lijekova, stoga obavijestite liječnika ukoliko uzimate: - lijekove koji sadrže ketokonazol, itrakonazol i posakonazol (koriste se za liječenje gljivičnih infekcija) ili erlotinib (koristi se za liječenje nekih oblika raka); jer Controloc može spriječiti djelovanje tih i drugih lijekova - varfarin ili fenprokumon, koji djeluju na zgrušavanje krvi, odnosno razrjeđuju je. Možda ćete trebati dodatne pretrage - atazanavir (koristi se za liječenje HIV infekcija) Molimo recite liječniku ili ljekarniku ukoliko uzimate ili ste nedavno uzimali druge lijekove, uključujući i one koji se izdaju bez recepta. Trudnoća i dojenje: Nema dovoljno podataka o upotrebi pantoprazola u trudnoći. Dokazano je izlučivanje u majčino mlijeko. Ako ste trudni, mislite da ste trudni ili dojite, ovaj lijek uzimajte samo ako liječnik procjeni da je korist za Vas veća od potencijalnog rizika za plod/dijete. Prije uzimanja bilo kakvih lijekova upitajte liječnika ili ljekarnika. Upravljanje vozilima i rad na strojevima: Ukoliko primijete nuspojave poput vrtoglavice ili poremećaja vida, ne upravljajte vozilima i ne radite na strojevima. Važne informacije o nekim sastojcima Controloca Controloc sadrži sojino ulje. Ne uzimajte ovaj lijek ukoliko ste alergični na soju ili kikiriki. Kako uzimati Controloc Controloc uvijek koristite prema uputi liječnika. Ako niste sigurni kako, potražite savjet liječnika ili ljekarnika. Kako i kada uzimati Controloc? Tablete uzimajte jedan sat prije obroka. Progutajte ih cijele, bez žvakanja ili drobljenja, s malo tekućine. Ukoliko liječnik nije drugačije odredio, uobičajene doze su: Odrasli i djeca iznad 12 godina starosti: Liječenje refluksnog ezofagitisa: Uobičajena doza je jedna tableta dnevno. Liječnik može povećati dozu na 2 tablete dnevno. Za liječenje refluksnog ezofagitisa obično je potrebna terapija u trajanju od 4 do 8 tjedna. Liječnik će odrediti koliko dugo ćete uzimati lijek. Odrasli: Liječenje infekcije bakterijom Helicobacter pylori kod bolesnika sa želučanim i duodenalnim ulkusima, u kombinaciji s dva antibiotika (trojna terapija): uzima se jedna tableta dva puta na dan zajedno s dvije tablete antibiotika koji sadrže amoksicilin, klaritromicin ili metronidazol (ili tinidazol). Antibiotik uzimate dva puta na dan s tabletom pantoprazola. Prva tableta pantoprazola se uzima jedan sat prije doručka, a druga jedan sat prije večernjeg obroka. Slijedite upute liječnika i pročitajte Upute o lijeku za antibiotike koje uzimate. Uobičajene su sljedeće kombinacije koje se uzimaju dva puta na dan: - Controloc 40 mg + 500 mg klaritromicina + 1000 mg amoksicilina - Controloc 40 mg + 250-500 mg klaritromicina + 400-500 mg metronidazola (ili 500 mg tinidazola) - Controloc 40 mg + 400-500 mg metronidazola (ili 500 mg tinidazola) + 1000 mg amoksicilina Uobičajeno trajanje terapije je jedan do dva tjedna. Liječenje ulkusa želuca i dvanaesnika Uobičajena doza je jedna tableta na dan. Liječnik može preporučiti i veću dozu, a odredit će i trajanje terapije. Uobičajeno trajanje liječenja za ulkus želuca je 4 do 8 tjedana, a za ulkus dvanaesnika 2 do 4 tjedna. Ovaj članak ima više stranica: