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WHAT APROVEL IS AND WHAT IT IS USED FOR Aprovel belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Aprovel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Aprovel slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. Aprovel is used in adult patients - to treat high blood pressure (essential hypertension) - to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function. WHAT YOU NEED TO KNOW BEFORE YOU TAKE APROVEL Do not take Aprovel - if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6) - if you are more than 3 months pregnant. (It is also better to avoid Aprovel in early pregnancy – see pregnancy section) if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren Warnings and precautions Talk to your doctor before taking Aprovel and if any of the following apply to you: - if you get excessive vomiting or diarrhoea - if you suffer from kidney problems - if you suffer from heart problems - if you receive Aprovel for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function - if you are going to have an operation (surgery) or be given anaesthetics - if you are taking any of the following medicines used to treat high blood pressure - an ACE inhibitor (for example enalapril, lisinopril, ramipiril), in particular if you have diabetes-related kidney problems. - aliskiren Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also information under the heading “Do not take Aprovel”. You must tell your doctor if you think you are (or might become) pregnant. Aprovel is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section). Children and adolescents This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established. Other medicines and Aprovel Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may need to change your dose and/or to take other precautions: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Aprovel” and “Warnings and precautions”). You may need to have blood checks if you take: - potassium supplements - salt substitutes containing potassium - potassium-sparing medicines (such as certain diuretics) - medicines containing lithium If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced. Aprovel with food and drink Aprovel can be taken with or without food. Pregnancy and breast-feeding Pregnancy You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Aprovel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Aprovel. Aprovel is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy. Breast-feeding Tell your doctor if you are breast-feeding or about to start breast-feeding. Aprovel is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely. Driving and using machines No studies on the effects on the ability to drive and use machines have been performed. Aprovel is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines. Aprovel contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine. HOW TO TAKE APROVEL Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Method of administration Aprovel is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Aprovel with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Aprovel until your doctor tells you otherwise. Patients with high blood pressure The usual dose is 150 mg once a day. The dose may later be increased to 300 mg once daily depending on blood pressure response. Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease. The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years. The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment. Use in children and adolescents Aprovel should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately. If you take more Aprovel than you should: If you accidentally take too many tablets, contact your doctor immediately. If you forget to take Aprovel: If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention. As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Aprovel and contact your doctor immediately. The frequency of the side effects listed below is defined using the following convention: Very common: may affect more than 1 in 10 people Common: may affect up to 1 in 10 people Uncommon: may affect up to 1 in 100 people Side effects reported in clinical studies for patients treated with Aprovel were: - Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium. - Common (may affect up to 1 10 people): dizziness, feeling sick/ vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported. - Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain. Some undesirable effects have been reported since marketing of Aprovel. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis). Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet United Kingdom You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard Ireland 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. HOW TO STORE APROVEL 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 on the blister after EXP. The expiry date refers to the last day of that month. Do not store above 30°C. 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. CONTENTS OF THE PACK AND OTHER INFORMATION What Aprovel contains - The active substance is irbesartan. Each tablet of Aprovel 300 mg contains 300 mg irbesartan. - The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax. What Aprovel looks like and contents of the pack Aprovel 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side. Aprovel 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets. Unidose blister packs of 56 x 1 film-coated tablet for delivery in hospitals are also available. Not all pack sizes may be marketed. Marketing Authorisation Holder: Sanofi Clir SNC 54, rue La Boétie France Manufacturer: CHINOIN PRIVATE CO. LTD. Lévai u.5. 2112 Veresegyház Hungary Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/ For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
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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.