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Go to top of the page PACKAGE LEAFLET: INFORMATION FOR THE USER Xefo Rapid 8 mg film-coated tablets Lornoxicam 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 Xefo Rapid is and what it is used for Before you take Xefo Rapid How to take Xefo Rapid Possible side effects How to store Xefo Rapid Further information Go to top of the page WHAT XEFO RAPID IS AND WHAT IT IS USED FOR Xefo Rapid is a non-steroidal anti-inflammatory drug and antirheumatic drug (NSAID) of the oxicam class. It is intended for short term treatment of acute mild to moderate pain. Go to top of the page BEFORE YOU TAKE XEFO RAPID Do not take Xefo Rapid - if you are allergic (hypersensitive) to lornoxicam or any of the other ingredients of Xefo Rapid 8 mg film-coated tablets; - if you are taking other NSAIDs such as acetylsalicylic acid (for instance, aspirin); ibuprofen and COX-2 inhibitors; - if you are hypersensitive to other NSAIDs including acetylsalicylic acid (for instance, aspirin); - if you suffer from thrombocytopenia (low blood platelet count which increases risk of bleeding or bruising); - if you suffer from severe heart failure; - if you suffer from gastrointestinal bleeding, rupture and bleeding of a blood vessel in the brain, or other bleeding disorders; - if you have a history of gastrointestinal bleeding or perforation, related to previous therapy with NSAIDs; - if you suffer from an active peptic ulcer or have a history of recurrent peptic ulcer; - if you suffer from severe liver impairment; - if you suffer from severe kidney impairment; - if you are in the last three months of your pregnancy. Take special care with Xefo Rapid - if you have impaired kidney function; - if you have a history of high blood pressure and⁄or heart failure; - if you suffer from ulcerative colitis or Crohn’s disease; - if you have a history of bleeding tendency; - if you have a history of asthma; - if you suffer from SLE (lupus erythematosus, a rare immunological disease). Your doctor may have to monitor you by laboratory tests on a frequent basis if - you suffer from blood coagulation disorder, - you suffer from impaired liver function, - you are elderly, - or you will be treated with Xefo Rapid for more than 3 months. You should inform your doctor if you are going to be treated with heparin or tacrolimus, while taking at the same time Xefo Rapid. If you experience any unusual abdominal symptoms such as abdominal bleeding, skin reactions such as skin rash, damage to the internal lining of the nostrils, mouth, eyelids, ears, genitals or anus, or other signs of hypersensitivity, you should stop taking Xefo Rapid and contact your doctor immediately. Medicines such as Xefo Rapid may be associated with a small increase of the risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or the duration of treatment. You should discuss your treatment with your doctor or pharmacist if - you have heart problems, - you had previously a stroke, - or you think that you might be at risk of developing these conditions (for example, if you have high blood pressure, diabetes or high cholesterol, or you are a smoker). Avoid using Xefo Rapid during varicella (chickenpox) infections. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Do not take Xefo Rapid if you are taking other NSAIDs such as acetylsalicylic acid (for instance, aspirin), ibuprofen and COX-2 inhibitors. Ask your doctor or pharmacist if you are uncertain. Xefo Rapid may interfere with other medicines. Be particularly careful if you are taking any of the following: - Cimetidine - used in the treatment of heartburn and peptic ulcers; - Anticoagulants, such as heparin or phenprocoumon - used to prevent the formation of blood clots; - Corticosteroids; - Methotrexate - used in treatment of cancer and immunological diseases; - Lithium; - Immunosuppresive agents, such as ciclosporine or tacrolimus; - Heart medicines, such as digoxin, ACE-inhibitors, beta-adrenergic blockers; - Diuretics; - Quinolone antibiotics; - Anti-platelet agents - medicines used to prevent heart attacks and strokes; - SSRI (Selective Serotonin Reuptake Inhibitors) – used in the treatment of depression; - Sulphonylureas, for instance glibenclamide - used in the management of diabetes; - Inducers and inhibitors of CYP2C9-isoenzymes (such as the antibiotic rifampicin or the antifungal medicine fluconazole), as they might have an effect on the way in which your body breaks down Xefo Rapid; - Angiotensin II receptor blocker - used to treat high blood pressure, kidney damage due to diabetes and congestive heart failure; - Pemetrexed - used to treat some forms of lung cancer. Taking Xefo Rapid with food and drink Xefo Rapid film-coated tablets are intended for oral use. Take this medicine before meals with a sufficient amount of liquid. Taking this medicine with food is not recommended because this may reduce its effectiveness. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Fertility Using Xefo Rapid may impair fertility and is not recommended for women attempting to become pregnant. Women who have difficulties becoming pregnant, or who are undergoing investigation of infertility, should consult with a doctor and consider stopping treatment with Xefo Rapid. Pregnancy During the first 6 months of pregnancy treatment with Xefo Rapid is not recommended, unless explicitly advised by your doctor. You must not take Xefo Rapid during the last three months of your pregnancy. Breastfeeding If you are breastfeeding treatment with Xefo Rapid is not recommended, unless explicitly advised by your doctor. Driving and using machines Xefo Rapid has negligible or no influence on the ability to drive or use machinery. Go to top of the page HOW TO TAKE XEFO RAPID Always take Xefo Rapid exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose for adults is 8-16 mg divided in doses of 8 mg: 8 mg taken twice a day or 16 mg taken once a day. On the first day you take Xefo Rapid the dose can be 16 mg followed by 8 mg 12 hours later. After the first day do not take more than 16 mg a day. Xefo Rapid tablets must be swallowed with sufficient amounts of liquid. Do not take Xefo Rapid with a meal, as food can reduce the effectiveness of Xefo Rapid. Xefo Rapid is not recommended for children and adolescents below 18 years old, due to lack of data. If you take more Xefo Rapid than you should Please contact your doctor or the pharmacist if you have taken more Xefo Rapid than prescribed. In case of an overdose, you may expect the following symptoms: nausea, vomiting, symptoms associated with central nervous system (such as dizziness or disturbances in vision). If you forget to take Xefo Rapid Do not take a double dose to make up for a forgotten tablet. If you have any further questions on the use of this product, ask your doctor or pharmacist. Go to top of the page POSSIBLE SIDE EFFECTS Like all medicines, Xefo Rapid can cause side effects, although not everybody gets them. Medicines such as Xefo Rapid may be associated with a small increase in the risk of heart attack or stroke. If you experience any unusual abdominal symptoms such as abdominal bleeding, skin reactions such as skin rash, damage to the internal lining of the nostrils, mouth, eyelids, ears, genitals or anus, or other signs of hypersensitivity, you should stop taking Xefo and contact your doctor immediately. If you get any of the following side effects, stop taking this medicine and tell your doctor immediately, or contact the emergency department at your nearest hospital: - shortness of breath, chest pains, or ankle swelling appear or get worse; - severe or continuous stomach pain or your stools become black; - yellowing of the skin and eyes (jaundice) – these are signs of liver problems; - an allergic reaction - which can include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue, or throat which may cause difficulty in breathing; - fever, blistering eruption or inflammation especially on hands and feet or in the mouth area (Stevens-Johnson syndrome); - exceptionally, serious infections of the skin in case of varicella (chickenpox). Undesirable effects associated with using Xefo Rapid are given below. Common side effects (affect 1 to 10 users in 100) - mild and passing headache and dizziness, - nausea, abdominal pain, upset stomach, diarrhoea and vomiting. Uncommon side effects (affect 1 to 10 users in 1,000) - weight loss (anorexia), inability to sleep, depression; - eye discharges (conjunctivitis); - feeling dizzy, ringing in the ears (tinnitus); - cardiac failure, irregular heartbeat, rapid heart rate, feeling blushed; - constipation, excessive wind (flatulence), belching, dry mouth, gastritis, peptic ulcer, upper abdominal pain, duodenal ulcer, mouth ulcers; - increase in liver function tests (as seen from blood tests) and feeling unwell (malaise); - rash, itching, increased sweating, redness of the skin (erythema), angiooedema (rapid swelling of the deeper layers of skin, usually of the face), hives (urticaria), oedema, stuffy nose as a result of an allergy (rhinitis); - hair loss; - arthralgia (pain in the joints). Rare side effects (affects 1 to 10 users in 10,000) - sore throat; - anaemia, reduction in the blood cell count (thrombocytopenia and leukopenia), weakness; - hypersensitivity, anaphylactoid reaction and anaphylaxis (organism reaction characterized usually by face swelling, flushing, difficulties breathing and lightheadedness); - confusion, nervousness, agitation, feeling sleepy (somnolence), paraesthesia (tingling sensations), abnormal sense of taste, tremor, migraine, visual disturbances; - elevated blood pressure, hot flush; - bleeding, haematoma (bruising), prolonged bleeding time; - difficulty in breathing (dyspnoea), cough, bronchospasm; - perforated ulcer, vomiting of blood, gastrointestinal bleeding, black tarry stools; - inflammation in the mouth, oesophagitis (inflammation of the gullet), gastro-oesophageal reflux, difficulty in swallowing, aphthous stomatitis (ulcers), inflammation of the tongue, - abnormal liver function; - skin problems, such as eczema, rash; - bone pain, muscle cramp, muscle pain; - urinary problems, such as the need to wake up and urinate during the night (nocturnia) or an increase in the levels of urea and creatinine in the blood. Very rare side effects (affect less than 1 user in 10,000) - liver damage, hepatitis (inflammation of the liver), jaundice, cholestasis (interrupted flow of bile from the liver); - bruising, oedema, severe skin disorder (Stevens-Johnson syndrome, Toxic epidermal necrolysis); - aseptic meningitis; - NSAID class effects: neutropenia, agranulocytosis, aplastic anaemia, hemolytic anaemia, kidney toxicity. 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 XEFO RAPID Keep out of the reach and sight of children. Do not store above 30°C. Do not use Xefo after the expiry date which is stated on the carton or on the bottle after EXP. The expiry date refers to the last day of that month. 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 Xefo Rapid contains - The active substance is lornoxicam - One film-coated tablet contains 8 mg lornoxicam - The other ingredients are: Cellulose, microcrystalline, Sodium hydrogen carbonate, Calcium hydrogen phosphate, anhydrous, Low substituted hydroxypropylcellulose, Hydroxypropylcellulose, Calcium stearate (in the core); Titanium dioxide (E171), Talc, Propylene glycol, Hypromellose (in the film); What Xefo Rapid looks like and contents of the pack Xefo Rapid 8 mg film-coated tablet is a white to yellowish round biconvex film-coated tablet. Xefo Rapid is distributed in pack sizes of 6, 10, 20, 30, 50, 100 and 250 film-coated tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Takeda UK Limited Building 3 Glory Park Glory Park Avenue Wooburn Green BUCKS HP10 0DF UK Manufacturer Takeda GmbH Plant Oranienburg Lehnizstrassee 70-98 DE-16515 Oranienburg Germany This medicinal product is authorised in the Member States of the EEA under the following names: Austria Xefo Rapid 8 mg - Filmtabletten Belgium Xefo Acute 8mg filmomhulde tabletten Bulgaria Kceфo Paпид Czech Republic Xefo Rapid 8 mg Denmark Xefo Rapid Estonia Xefo Rapid France Xefoacu Greece Xefo Rapid Hungary Xefo Rapid 8 mg filmtabletta Ireland Xefo Rapid Italia XEFO RAPID Lithuania Xefo Rapid 8 mg pėvele dengtos tabletės Latvia Xefo Rapid 8 mg apvalkotā tablete Luxembourg Xefo Acute 8 mg comprimés enrobés Poland Xefo Rapid Portugal Acabel Rapid Romania Xefo Rapid 8 mg The Netherlands Xefo Rapid Slovakia Xefo Rapid filmom obalené tablety 8 mg Slovenia Xefo Rapid 8 mg filmsko obložene tablete Spain Acabel Rapid 8 mg c omprimidos recubiertos con película Sweden Xefo Akut United Kingdom Xefo Rapid 8 mg tablets This leaflet was last approved in 09/2014.
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LEVITRA tablete – upute o korištenju Ova uputa sadrži sljedeća poglavlja: - Što je Levitra za što se koristi - Prije nego počnete uzimati Levitru - Kako uzimati Levitru - Moguće nuspojave - Kako čuvati Levitru - Dodatne informacije ŠTO JE LEVITRA I ZA ŠTO SE KORISTI Levitra pripada grupi lijekova koji se koriste u liječenju tegoba u postizanju i održavanju erekcije (erektilna disfunkcija). Erekcijske tegobe Najmanje jedan od deset muškaraca povremeno ima tegobe pri postizanju ili održavanju erekcije. Uzroci mogu biti fizički ili psihički, odnosno, za što postoji najveća vjerojatnost, kombinacija i jednih i drugih. Štogod bio uzrok, učinak je isti: promjene na glatkim mišićima i krvnim žilama čine da u penisu nema dovoljno krvi da se ukruti i održi krutim. Kako djeluje LEVITRA? Levitra djeluje samo ako ste seksualno stimulirani. Smanjuje aktivnost prirodnih kemijskih spojeva u vašem tijelu koji otklanjanju erekciju.LEVITRA omogućuje da erekcija traje dovoljno dugo da možete uspješno okončati spolni odnos. PRIJE NEGO POČNETE UZIMATI LEVITRU Nemojte uzimati LEVITRU: - ako ste alergični (preosjetljivi) na vardenafil ili bilo koji drugi sastojak LEVITRE (vidi pomoćne tvari u poglavlju 6. Dodatne informacije). U znake alergijske reakcije spadaju osip, svrbež, otok lica usana i kratkoća daha. - uzimate li nitrate, primjerice glicerol trinitrat za anginu pektoris, ili spojeve koji oslobađaju dušikov oksid, primjerice amil nitrit; uzimanje ovih lijekova istodobno s LEVITROM može ozbiljno utjecati na vaš krvni tlak. - uzimate li lijekove za HIV ritonavir ili indinavir - ako ste stariji od 75 godina i uzimate antimikotike ketokonazol ili itrakonazol - imate li ozbiljnih problema sa srcem ili jetrom - ako ste na dijalizi bubrega - ako ste nedavno pretrpjeli moždani udar ili srčani infarkt - imate li ili ste imali niski krvni tlak - postoji 11 u vašoj obiteljskoj anamnezi podatak da je netko bolovao od degenerativnih bolesti očiju (kakva je retinitis pigmentosa) - ako ste ikad imali gubitak vida zbog oštećenja optičkog živca uzrokovanog nedovoljnom opskrbom krvlju koji se naziva nearterijska anteriorna ishemička optička neuropatija (NAION) Budite posebno oprezni s Levitrom - imate li srčanih tegoba; za vas spolni odnosi mogu biti rizični - bolujete li od srčane aritmije (nepravilan rad srca) ili bilo koje prirođene srčane bolesti koja utječe na vaš elektrokardiogram - imate li tjelesnu manu koja utječe na oblik penisa: prirođenu angulaciju (iskrivljenost uda) ili Peyronijevu bolest ili kavernoznufibrozu - imate li bolest koja može izazvati dugotrajnu erekciju (prijapizam) (npr. bolest srpastih stanica, multipli mijelom i leukemiju) - imate li čir na želucu (koji se još naziva i gastrični ili peptički ulkus) - imate li poremećaj zgrušavanja krvi (npr. hemofiliju) - uzimate li bilo koji drugi lijek za liječenje erekcijskih tegoba - ako se kod vas javi iznenadno smanjenje iii gubitak vida prestanite uzimati Levitru i odmah posjetite svog liječnika. LEVITRA je namijenjena muškarcima starijima od 18 godina. Lijek nije namijenjen za primjenu kod žena, djece ili muškaraca mladih od 18 godina. Uzimanje drugih lijekova s Levitrom Obavijestite svog liječnika ili ljekarnika o svim lijekovima koje uzimate ili ste ih nedavno- uzimali, pa i o onima koje ste nabavili bez recepta (npr. o biljnim i vitaminskim pripravcima). Istodobna primjena LEVITRE i većine drugih lijekova obično prolazi bez problema. No, neki lijekovi ipak mogu izazvati probleme, a posebice ovi: - nitrati, lijekovi za anginu pektoris ili spojevi koji oslobađaju dušikov oksid, primjerice amil nitrit. Istodobno uzimanje LEVITRE i ovih lijekova može ozbiljno utjecati na vaš krvni tlak. Nemojte uzeti LEVITRU, već se obratite svom liječniku. - antiaritmici, npr. kinidin, prokainamid, amiodaron ili sotalol - lijekovi za HIV ritonavir ili indinavir - antimikotici ketokonazol ili itrakonazol - makrolidni antibiotik eritromicin ili klaritromicin, - alfa-blokatori— vrsta lijekova koja se koristi za liječenje visokog krvnoga tlaka i benigne hiperplazije prostate. Ukoliko ste nedavno uzimali bilo koji od navedenih lijekova, molimo da o tome obavijestite svog liječnika iii ljekarnika. Uzimanje hrane i pića s LEVITROM - LEVITRU možete uzimati s hranom ili bez nje — no bolje ne nakon teškog ili punomasnog obroka, jer to može odgoditi učinak lijeka. - kad uzimate LEVITRU, ne pijte sok od grejpfruta. On može utjecati na uobičajenu učinkovitost lijeka. - alkoholno piće može pogoršati erekcijske tegobe. Upravljanje vozilima i strojevima U nekih ljudi LEVITRA može izazvati omaglicu ili smetnje vida. Imate li nakon uzimanja LEVITRE omaglicu ili smetnje vida, nemojte voziti, niti rukovati bilo kakvim alatima ili strojevima. KAKO UZIMATI LEVITRU LEVITRU uvijek uzimajte onako kako vas je uputio liječnik, a niste li u nešto sigurni, posavjetujte se s liječnikom ili ljekarnikom. Uobičajena doza je 10 mg. Tabletu LEVITRE uzmite približno 25 do 60 minuta prije spolnog odnosa. Ako ste spolno uzbuđeni, u razdoblju od 25 minuta pa do četiri do pet sati nakon uzimanja tablete, erekciju možete postići u bilo kojem trenutku. - tabletu popijte s čašom vode. - LEVITRU možete uzeti istodobno s hranom ili bez nje — no bolje ne nakon teškog ili punomasnog obroka. LEVITRU ne uzimajte više od jedanput na dan. Obavijestite svog liječnika ako mislite đa vam je LEVITRA prejaka ili preslaba. Orgona vam mogu preporučiti drugačiju dozu lijeka, ovisno o tome kako na vas djeluje. Ako uzmete više LEVITRE nego što ste trebali U muškaraca koji su uzeli veću dozu LEVITRE može se razviti veći broj nuspojava ili se mogu javiti jaki bolovi u križima. Uzmete li veću dozu LEVITRE nego što ste smjeli, obavijestite svog liječnika. U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom LEVITRE obratite se svom liječniku ili ljekarniku. MOGUĆE NUSPOJAVE Kao i svi lijekovi i LEVITRA može izazvati nuspojave. Većina tih učinaka blaga je ili umjerena. Učestalost nuspojava je opisana u sljedećim kategorijama: Vrlo česte nuspojave (Mogu se javiti u 1 (li više osoba od njih 10) - glavobolja - crvenilo u licu Česte nuspojave (Mogu se razviti u između I od 10 i 1 od 100 osoba) - probavne smetnje - mučnina - omaglica - začepljen nos ili iscjedak iz nosa Manje česte nuspojave (Mogu se pojaviti kod manje od 1 od 100 osoba) - osjetljivost kože na sunčevo svjetlo - visok ili nizak krvni tlak - bolovi u leđima ili mišićima - poremećaj vida - crveno oko ili suzne oči - osip - pospanost - utjecaj na nalaze krvnih pretraga kojima se provjerava jetrena funkcija - povišenje razine mišićnog enzima (kreatin -fosfokinaze) u krvi - nedostatak zraka - ubrzano ili snažno kucanje srca - krvarenje iz nosa - otok lica Rijetke nuspojave (Mogu se pojaviti u 1 do I 0 na 10000 osoba) - nesvjestica - ukočenost mišića - povišeni očni tlak (glaukom) - produžene ili bolne erekcije - alergijska reakcija - učinci na srce (kao angina pektoris) - anksioznost - otok grla - privremeni gubitak pamćenja (poput tranzitorne opće amnezije) - konvulzije Postoje izvješća o djelomičnom, iznenadnom, privremenom ili trajnom smanjenju ili gubitku vida na jednom ili na oba oka. Iznenadno smanjenje ili gubitak sluha su bili prijavljeni. Ako primijetite bilo koju nuspojavu potrebno je obavijestiti liječnika ili ljekarnika. KAKO ČUVATI LEVITRU LEVITRU morate čuvati izvan dohvata i pogleda djece. Lijek ne smijete upotrijebiti nakon isteka roka valjanosti, navedenog na pakovanju. Lijekovi se ne smiju izlijevati u kanalizaciju niti odlagati u kućni otpad. Posavjetujte se sa svojim ljekarnikom o tome kako zbrinuti lijekove koje više ne trebate. Ove mjere će pomoći očuvanju okoliša. DODATNE INFORMACIJE Što LEVITRA sadrži Djelatna tvar: vardenafIl Jedna tableta sadrži 5, 10 ili 20 mg vardenafila u obliku vardenafilklorid trihidrata. Pomoćne tvari: krospovidon, magnezijev stearat, celuloza, mikrokristalična, silicijev dioksid, koloidni, bezvodni, hipromeloza, makrogol 400, titanijev dioksid (E 171), željezov oksid, žuti (E 172), željezov oksid, crveni (E 172). Pakiranje Levitre 10 i 20 mg: Filmom obložene tablete LEVITRA od 20 mg narančaste su boje, na jednoj strani označene BAYER-ovim križićem, a na drugoj oznakom jakosti (10 ili 20). Količina: 2 ili 4 fIlmom obložene tablete u blisteru, u kutiji. Ime i adresa proizvođača: Bayer Schering Pharma AG, D-51368 Leverkusen, Njemačka Način i mjesto izdavanja: na recept, u ljekarni. Napomena: Ovo su neslužbene i skraćene upute. Za službene upute obratite se ljekarniku ili proizvođaču.