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1 mg and 2 mg tablets Prucalopride succinate Consumer Medicine Information What is in this leaflet This leaflet answers some common questions about RESOTRANS. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking RESOTRANS against the benefits this medicine is expected to have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet while being treated. You may need to read it again. What RESOTRANS is used for RESOTRANS tablets are used for the treatment of long-standing constipation in adults in whom conventional medicines used to treat constipation (laxatives) fail to provide adequate relief. RESOTRANS is not used to treat constipation due to other medical conditions including disorders which involve the over-production or under-production of hormones from the endocrine gland, disorders that involve an alteration in normal metabolism, disorders of the nervous system and constipation due to use of medicines including opioid medicines such as codeine, oxycodone and morphine. RESOTRANS contains the active ingredient prucalopride succinate. It acts on the muscle wall of the gut, helping to restore the normal functioning of the bowel. Your doctor may have prescribed this medicine for another reason. Ask your doctor if you have any questions about why it has been prescribed for you. There is no evidence that this medicine is addictive. This medicine is available only with a doctor's prescription. Before you take RESOTRANS When you must not take it Do not take RESOTRANS if you have an allergy to: prucalopride, the active ingredient in the medicine any of the ingredients listed at the end of this leaflet. RESOTRANS contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Symptoms of an allergic reaction may include rash, itching or hives on the skin, shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body. Do not take RESOTRANS if: you are on kidney dialysis (a procedure used to remove waste products from the blood of a person with kidney failure) if you suffer from perforation or obstruction of the gut wall, or severe inflammation of the intestines if you had recent bowel surgery. If you are not sure whether you should take this medicine, talk to your doctor. Before you start to take RESOTRANS: Tell your doctor if you have or have had any medical conditions, especially the following: severe kidney disease severe liver disease any other serious medical problem such as lung or heart disease, neurological or psychiatric disorders or other endocrine disorders, cancer or AIDS for which you are currently under supervision by your doctor You must tell your doctor if you: are pregnant or planning to become pregnant. It is recommended not to take RESOTRANS if you are pregnant or if you intend to become pregnant, unless your doctor advises you to do so. are breastfeeding or wish to breastfeed. When breast-feeding, prucalopride can pass into breast milk, and although there is no evidence that this is harmful, it is better not to use this medicine while breastfeeding unless your doctor advises you to do so. If you have not told your doctor about any of the above, tell them before you start taking RESOTRANS. Do not take this medicine if the packaging is torn or shows signs of tampering. Do not take this medicine beyond the expiry date (month and year) printed on the pack. The medicine must not be given to children or adolescents (under 18 years of age). Taking other medicines: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines that you can buy without a prescription from a pharmacy, supermarket or health food shop. In particular, tell your doctor if you are taking the following medicines: ketoconazole (an antifungal agent) erythromycin, an antibiotic used to treat infections medicines known to cause irregular heart beat or other heart problems atropine-like substances These medicines may be affected by RESOTRANS or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines. You doctor or pharmacist will have more information on medicines to be careful with or avoid while taking this medicine. RESOTRANS does not interact with the following medicines: warfarin, digoxin, paroxetine and oral contraceptives. How to take RESOTRANS Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet. How much to take The usual dose for most patients is one 2 mg tablet once a day. If you are older than 65 years, the starting dose is one 1 mg tablet once a day, which your doctor may increase to 2 mg once a day if needed. Your doctor may also recommend a lower dose of one 1 mg tablet daily if you have severe kidney or liver disease. How to take it This medicine can be taken with or without food and drinks, at any time of the day. When to take it This medicine should be taken once a day. You must take this medicine every day for as long as your doctor prescribes it. Your doctor may want to reassess your condition and the benefit of continued treatment after the first 4 weeks and thereafter at regular intervals. If you forget to take it If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking it as you would normally. Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect. If you have trouble remembering to take your medicine, ask your pharmacist for some hints. If you stop taking it If you stop taking RESOTRANS, your constipation symptoms may come back again. If you have taken too much (overdose) Immediately telephone your doctor or the Poisons Information Centre for advice or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much RESOTRANS. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Poisons Information Centre telephone numbers: Australia: 13 11 26 New Zealand: 0800 POISON or 0800 764 766. Keep these telephone numbers handy. It is important to keep to the dose as prescribed by your doctor. If you have taken more RESOTRANS than you should, it is possible that you will get diarrhoea, headache and/or nausea. In case of diarrhoea, make sure that you drink enough water. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. While you are taking RESOTRANS If you experience severe diarrhoea after taking RESOTRANS, certain medicines such as the oral contraceptive pill may not work properly and the use of an extra method of contraception is recommended. Things you must do Always follow your doctor's instructions carefully Tell your doctor immediately if you become pregnant while you are taking this medicine Tell your doctor or pharmacist that you are taking this medicine if you are about to be started on any new medicines. Things you must not do Do not give your medicine to anyone else, even if they have the same condition as you. Do not use this medicine to treat any other complaints unless your doctor tells you to. Do not stop taking your medicine or lower the dose without checking with your doctor. Things to be careful of Be careful driving or operating machinery until you know how RESOTRANS affects you. RESOTRANS has been associated with dizziness and fatigue particularly during the first day of treatment which may have an effect on driving and using machines. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous. Side Effects All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some side effects. Do not be alarmed by this list of possible side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have. Tell your doctor if you experience any of the following and they worry you: headache nausea weakness dizziness fatigue abnormal bowel sounds flatulence general feeling of discomfort or uneasiness (malaise) Tell your doctor as soon as possible if you have any of the following as you may need medical attention: anorexia fever diarrhoea vomiting disturbed digestion (dyspepsia) increase in frequency of passing urine (pollakiuria) abdominal pain Tell your doctor immediately if you notice any of the following: tremors pounding heart rectal bleeding. Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects. After using RESOTRANS Storage Keep your tablets in their blister pack until it is time to take them. If you take the tablet out of the blister pack, they may not keep well. Keep RESOTRANS in a cool dry place where the temperature stays below 30°C. Do not store this medicine or any other medicines in a bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines. Keep this medicine where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines. Disposal If your doctor tells you to stop taking RESOTRANS or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over. Product Description What it looks like RESOTRANS 1 mg tablets are white to off-white, round, biconvex tablets marked PRU 1 on one side. RESOTRANS 2 mg tablets are pink, round, biconvex shaped tablets marked PRU 2 on one side. Ingredients The active ingredient in RESOTRANS tablets is prucalopride succinate. The 1 mg tablet contains 1 mg of prucalopride and the 2 mg tablet contains 2 mg of prucalopride in pack sizes of 7 and 28 enteric coated tablets. The other ingredients in the 1 mg tablet are lactose, cellulose - microcrystalline, magnesium stearate, silica - colloidal anhydrous, hypromellose, titanium dioxide, macrogol 3000 and glycerol triacetate. The other ingredients in the 2 mg tablet are lactose , cellulose - microcrystalline, magnesium stearate, silica - colloidal anhydrous, hypromellose, titanium dioxide, macrogol 3000, glycerol triacetate, iron oxide red, iron oxide yellow and indigo carmine CI73015. Sponsor JANSSEN-CILAG Pty Ltd 1-5 Khartoum Rd Macquarie Park NSW 2113 Australia This leaflet was prepared in January 2015. TGA registration number: 1mg tablet - AUST R 176747 2mg tablet - AUST R 176746 RESOTRANS ® is a registered trademark of Ortho-McNeil-Janssen Pharmaceuticals, Inc. for prucalopride oral tablets.
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DETRALEX® (diosminum, hesperidinum)- uputa o lijeku Što je Detralex® ? Jedna filmom obložena tableta sadrži 500 mg pročišćene mikronizirane smjese flavonoida koja se sastoji od 450 mg diosmina (90%) i 50 mg flavonoida izraženih kao hesperidin (10%). Ostali sastojci su: natrijev škroboglikolat, vrste A, celuloza mikrokristalična, želatina, magnezijev stearat, talk, glicerol, hipromeloza, makrogol 6000, natrijev laurilsulfat, željezov oksid žuti (E172), željezov oksid crveni (E172), titanov dioksid (E171) Cijena Detralex pakiranja s 30 tableta je 116.24 kuna. PAKIRANJE Detralex®: 30 tableta u kutiji. FARMAKOTERAPIJSKA SKUPINA Detralex® tablete pripadaju skupini lijekova koji se zovu vazoprotektivi, pripravci koji stabiliziraju kapilare, bioflavonoidi. NAČIN I MJESTO IZDAVANJA Detralex® se izdaje na recept, u ljekarni. TERAPIJSKE INDIKACIJE Detralex® tablete koriste se za liječenje simptoma kronične venske insuficijencije i simptome akutnog hemoroidalnog sindroma. KONTRAINDIKACIJE Kada se Detralex® ne smije uzimati? Nemojte uzimati Detralex® tablete ukoliko ste preosjetljivi na bilo koji sastojak ovog lijeka. Budete li imali pitanja, obratite se svome liječniku ili ljekarniku. MJERE OPREZA/ POSEBNA UPOZORENJA Na što trebate paziti uzimajući Detralex®? Trudnoća i dojenje: Sigurnost uzimanja Detralexa tijekom trudnoće i dojenja još nije istražena, zbog toga se u tom razdoblju ne preporuča. Ako ste trudni ili dojite, opće je pravilo da se prije uzimanja bilo kojeg lijeka najprije posavjetujete s liječnikom. Kod akutnog hemoroidalnog sindroma Detralex ne može nadomjestiti specifično liječenje drugih analnih smetnji. Liječenje treba biti kratkotrajno. Ako simptomi brzo ne nestanu, valja učiniti proktološku pretragu i ponovno odrediti liječenje. Kod kroničnih smetnji u venskoj cirkulaciji liječenje je najuspješnije u kombinaciji s pravilno uravnoteženim načinom života: - bolesnici se ne smiju zadrživati na suncu, stajati dulje vremena i trebaju smanjiti prekomjernu tjelesnu težinu. - pješačenje i kod nekih bolesnika nošenje specijalnih čarapa poboljšava cirkulaciju. Utjecaj na sposobnost upravljanja vozilima i strojevima: Utjecaj Detralex filmom obloženih tableta na upravljanje motornim vozilima i strojevima nije dokazano INTERAKCIJE Može li se Detralex®uzimati istodobno s drugim lijekovima? Slučajevi interakcija Detralexa s drugim lijekovima nisu zabilježena. Svog liječnika ili ljekarnika obavijestite i ako uzimate ili ste donedavno uzimali bilo koji drugi lijek, pa i onaj koji ste nabavili bez recepta. DOZIRANJE I NAČIN PRIMJENE Kako trebate uzimati Detralex®? Strogo se pridržavajte liječnikovih uputa. Ne mijenjajte dozu i nemojte prekidati uzimanje lijeka, a da se prethodno niste posavjetovali sa svojim liječnikom. Kronična venska insuficijencija: Bolesnici uzimaju jednu tabletu dva puta na dan. Liječenje valja produljiti nekoliko mjeseci ili čak godina. Akutni hemoroidalni sindrom: Prva četiri dana bolesnici uzimaju dvije tablete tri puta na dan, a sljedeća tri dana dvije tablete dva puta na dan. Način primjene Na usta. Progutajte tabletu s čašom vode. Trajanje liječenja Liječnik će Vas obavijestiti o trajanju liječenja. Ne prekidajte uzimanje lijeka, a da se prethodno niste posavjetovali sa svojim liječnikom. PREDOZIRANJE Što je potrebno učiniti, ako ste uzeli previše tableta Detralex®-a? Ako ste uzeli veću dozu nego što ste trebali, odmah se posavjetujte sa svojim liječnikom ili ljekarnikom. Slučajevi predoziranja Detralexom još nisu zabilježeni. NUSPOJAVE Koje neželjene učinke može uzrokovati Detralex®? Kao i ostali lijekovi, i Detralex® može izazvati nuspojave. Česte nuspojave (javljaju se 1 do 10 slučajeva na 100 bolesnika): mučnina, povraćanje, proljev, bol u trbuhu. Rijetke nuspojave (javljaju se 1 do 10 slučajeva na 10000 bolesnika): glavobolja, malaksalost, vrtoglavica, osip, svrbež, urtikarija. O svakoj nuspojavi obavijestite svog liječnika ili ljekarnika. ROK VALJANOSTI Označen je na pakiranju. Lijek se ne smije rabiti nakon isteka roka valjanosti. NAČIN ČUVANJA LIJEKA Čuvati u originalnoj ambalaži pri temperaturi do 30° C. Čuvati izvan dohvata i pogleda djece. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Servier Pharma d.o.o., Budmanijeva 1, 10000 Zagreb IME I ADRESA PROIZVOĐAČA Les Laboratoires Servier Industrie 905 route de Saran, 45520 Gidy, Francuska Napomena: Ovo nisu službene upute. Za službene upute obratite se ljekarniku ili proizvođaču. Pilex protiv hemoroida Brzo ublažava hemoroide. od 369 kn Epiderm biljni balzam Djelotvorno ublažava kožne probleme.