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Go to top of the page Package leaflet: Information for the patient SOMAC Control 20 mg gastro-resistant tablets Pantoprazole Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects , talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks. - You should not take SOMAC Control tablets for more than 4 weeks without consulting a doctor. What is in this leaflet What SOMAC Control is and what it is used for What you need to know before you take SOMAC Control How to take SOMAC Control Possible side effects How to store SOMAC Control Contents of the pack and other information Go to top of the page What SOMAC Control is and what it is used for SOMAC Control contains the active substance pantoprazole, which blocks the ‘pump’ that produces stomach acid. Hence it reduces the amount of acid in your stomach. SOMAC Control is used for the short-term treatment of reflux symptoms (for example heartburn, acid regurgitation) in adults. Reflux is the backflow of acid from the stomach into the gullet (“foodpipe”), which may become inflamed and painful. This may cause you symptoms such as a painful burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation). You may experience relief from your acid reflux and heartburn symptoms after just one day of treatment with SOMAC Control, but this medicine is not meant to bring immediate relief. It may be necessary to take the tablets for 2-3 consecutive days to relieve the symptoms. You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks. Go to top of the page What you need to know before you take SOMAC Control Do not take SOMAC Control: - if you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6 ) - if you are taking a medicine containing atazanavir (for the treatment of HIV-infection) . See ‘Other medicines and SOMAC Control’. Warnings and precautions Talk to your doctor before taking SOMAC Control - if you have been treated for heartburn or indigestion continuously for 4 or more weeks - if you are over 55 years old and taking non-prescription indigestion treatment on a daily basis - if you are over 55 years old with any new or recently changed reflux symptoms - if you have previously had a gastric ulcer or stomach surgery - if you have liver problems or jaundice (yellowing of skin or eyes) - if you regularly see your doctor for serious complaints or conditions - if you are due to have an endoscopy or a breath test called a C-urea test. Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease: - an unintentional loss of weight (not related to a diet or an exercise programme) - vomiting, particularly if repeated - vomiting blood; this may appear as dark coffee grounds in your vomit - you notice blood in your stools; which may be black or tarry in appearance - difficulty in swallowing or pain when swallowing - you look pale and feel weak (anaemia) - chest pain - stomach pain - severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea. Your doctor may decide that you need some tests. If you are due to have a blood test, tell your doctor that you are taking this medicine. You may experience relief from your acid reflux and heartburn symptoms after just one day of treatment with SOMAC Control, but this medicine is not meant to bring immediate relief. You should not take it as a preventive measure. If you have been suffering from repetitive heartburn or indigestion symptoms for some time, remember to see your doctor regularly. Children and adolescents SOMAC Control should not be used by children and adolescents under 18 years of age due to a lack of safety information in this younger age group. Other medicines and SOMAC Control Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. SOMAC Control may stop certain other medicines from working properly. Especially medicines containing one of the following active substances: - atazanavir (used to treat HIV-infection). You must not use SOMAC Control if you are taking atazanavir. See ‘Do not take SOMAC Control’. - ketoconazole (used for fungal infections). - warfarin and phenprocoumon (used to thin blood and prevent clots). You may need further blood tests. - methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate your doctor may temporarily stop your SOMAC Control treatment because pantoprazole can increase levels of methotrexate in the blood. Do not take SOMAC Control with other medicines which limit the amount of acid produced in your stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an H2 antagonist (e.g. ranitidine, famotidine). However, you may take SOMAC Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed. Pregnancy and, breast-feeding You should not take this medicine if you are pregnant or while-breastfeeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines If you experience side effects like dizziness or disturbed vision, you should not drive or use machines. Go to top of the page How to take SOMAC Control Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one tablet a day. Do not exceed this recommended dose of 20 mg pantoprazole daily. You should take this medicine for at least 2-3 consecutive days. Stop taking SOMAC Control when you are completely symptom-free. You may experience relief from your acid reflux and heartburn symptoms after just one day of treatment with SOMAC Control, but this medicine is not meant to bring immediate relief. If you have no symptom-relief after taking this medicine for 2 weeks continuously, consult your doctor. Do not take SOMAC Control tablets for more than 4 weeks without consulting your doctor. Take the tablet before a meal, at the same time every day. You should swallow the tablet whole with some water. Do not chew or break the tablet. If you take more SOMAC Control than you should Tell your doctor or pharmacist if you have taken more than the recommended dose. If possible take your medicine and this leaflet with you. If you forget to take SOMAC Control Do not take a double dose to make up for the forgotten dose. Take your next, normal dose, the next day, at your usual time. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Go to top of the page Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor immediately or contact the casualty department at your nearest hospital, if you get any of the following serious side effects. Stop taking this medicine straight away, but take this leaflet and/or the tablets with you. - Serious allergic reactions (rare: may affect up to 1 in 1,000 people): Hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock and angioedema. Typical symptoms are: swelling of the face, lips, mouth, tongue and/or throat, which may cause difficulty in swallowing or breathing, hives (nettle rash), severe dizziness with very fast heartbeat and heavy sweating. - Serious skin reactions (frequency not known: frequency cannot be estimated from the available data): rash with swelling, blistering or peeling of the skin, losing skin and bleeding around eyes, nose, mouth or genitals and rapid deterioration of your general health, or rash when exposed to the sun. - Other serious reactions (frequency not known): yellowing of the skin and eyes (due to severe liver damage), or kidney problems such as painful urination and lower back pain with fever. Other side effects include: - Uncommon side effects (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; bellyache and discomfort; skin rash or hives; itching; feeling weak, exhausted or generally unwell; sleep disorders; increase in liver enzymes in a blood test. - Rare side effects: distortion or complete lack of the sense of taste; disturbances in vision such as blurred vision; pain in the joints; muscle pains; weight changes; raised body temperature; swelling of the extremities; depression; increased bilirubin and fat levels in blood (seen in blood tests), breast enlargement in males; high fever and a sharp drop in circulating granular white blood cells (seen in blood tests). - Very rare side effects (may affect up to 1 in 10,000 people): disorientation; reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal; 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 (seen in blood tests). - Frequency not known: hallucination, confusion (especially in patients with a history of these symptoms); decreased level of sodium in blood; decreased level of magnesium in blood. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Website: www.hpra.ie E-mail: medsafety@hpra.ie By reporting side effects you can help provide more information on the safety of this medicine. Go to top of the page How to store SOMAC Control Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date, which is stated on the carton and the blister after ‘EXP’. The expiry date refers to the last day of that month. Store in the original package in order to protect from moisture. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. Go to top of the page Contents of the pack and other information What SOMAC Control contains - The active substance is pantoprazole. Each tablet contains 20 mg pantoprazole (as sodium sesquihydrate). - The other ingredients are: - Core: sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate. - Coating: hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer, sodium lauril sulfate, polysorbate 80, triethyl citrate. - Printing ink: shellac, red, black and yellow iron oxide (E172) and ammonia solution, concentrated. What SOMAC Control looks like and contents of the pack The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with “P20” on one side. SOMAC Control is available in Alu/Alu blisters with or without cardboard reinforcement. Packs containing 7 or 14 gastro-resistant tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Takeda GmbH Byk-Gulden-Straße 2 78467 Konstanz Germany Manufacturer Takeda GmbH Production site Oranienburg Lehnitzstraße 70-98 16515 Oranienburg Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Ireland Takeda Products Ireland Limited This leaflet was last revised in 02/2015. Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/. The following recommendations for lifestyle and dietary changes may also help to relieve heartburn or acid related symptoms. - Avoid large meals - Eat slowly - Stop smoking - Reduce alcohol and caffeine consumption - Reduce weight (if overweight) - Avoid tight-fitting clothing or belts - Avoid eating less than three hours before bedtime - Elevate bedhead (if you suffer from nocturnal symptoms) - Reduce intake of food that can cause heartburn. These might include: Chocolate, peppermint, spearmint, fatty and fried food, acidic food, spicy food, citrus fruits and fruit juices, tomatoes.
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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: