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Patient Leaflet Updated 24-Aug-2017 | Eli Lilly and Company Limited Cialis 5mg film-coated tablets Package leaflet: Information for the user CIALIS 5 mg film-coated tablets Tadalafil Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. What is in this leaflet: What CIALIS is and what it is used for What you need to know before you take CIALIS How to take CIALIS Possible side effects 5 How to store CIALIS Contents of the pack and other information What CIALIS is and what it is used for CIALIS contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. CIALIS 5 mg is used to treat adult men with: What you need to know before you take CIALIS Do not take CIALIS if you: Warnings and precautions Talk to your doctor before taking CIALIS. Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem you should tell your doctor. Since benign prostatic hyperplasia and prostate cancer may have the same symptoms, your doctor will check you for prostate cancer before starting treatment with CIALIS for benign prostatic hyperplasia. CIALIS does not treat prostate cancer. Before taking the tablets, tell your doctor if you have: It is not known if CIALIS is effective in patients who have had: If you experience sudden decrease or loss of vision, stop taking CIALIS and contact your doctor immediately. Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking CIALIS and contact your doctor immediately. CIALIS is not intended for use by women. Children and adolescents CIALIS is not intended for use by children and adolescents under the age of 18. Other medicines and CIALIS Tell your doctor if you are taking, have recently taken or might take any other medicines Do not take CIALIS if you are already taking nitrates. Some medicines may be affected by CIALIS or they may affect how well CIALIS will work. Tell your doctor or pharmacist if you are already taking: CIALIS with drink and alcohol Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well CIALIS will work and should be taken with caution. Talk to your doctor for further information. Fertility When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility. Driving and using machines Some men taking CIALIS in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines. CIALIS contains lactose: If you have an intolerance to some sugars, contact your doctor before taking this medicine. How to take CIALIS Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. CIALIS tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food. Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take CIALIS, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may increase the risk of dizziness when standing up. For the treatment of erectile dysfunction The recommended dose is one 5 mg tablet taken once a day at approximately the same time of the day. Your doctor may adjust the dose to 2.5 mg based on your response to CIALIS. This will be given as a 2.5mg tablet. Do not take CIALIS more than once a day. When taken once a day CIALIS allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day. Once a day dosing of CIALIS may be useful to men who anticipate having sexual activity two or more times per week. It is important to note that CIALIS does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction. Drinking alcohol may affect your ability to get an erection. For the treatment benign prostatic hyperplasia The dose is one 5 mg tablet taken once a day at approximately the same time of the day. If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once a day. Do not take CIALIS more than once a day. If you take more CIALIS than you should Contact your doctor. You may experience side effects described in section 4. If you forget to take CIALIS Take your dose as soon as you remember but do not take a double dose to make up for a forgotten tablet. You should not take CIALIS more than once a day. 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. These effects are normally mild to moderate in nature. If you experience any of the following side effects stop using the medicine and seek medical help immediately: Other side effects have been reported: Common (seen in 1 to 10 in every 100 patients) Uncommon (seen in 1 to 10 in every 1,000 patients) Rare (seen in 1 to 10 in every 10,000 patients) Heart attack and stroke have also been reported rarely in men taking CIALIS. Most of these men had known heart problems before taking this medicine. Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported. Some additional rare side effects have been reported in men taking CIALIS that were not seen in clinical trials. These include: The side effect dizziness has been reported more frequently in men over 75 years of age taking CIALIS. Diarrhoea has been reported more frequently in men over 65 years of age taking CIALIS. 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. You can also report side effects directly via the national reporting system United Kingdom: or Ireland: Malta: By reporting side effects you can help provide more information on the safety of this medicine. How to store CIALIS 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 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 store above 25°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 CIALIS contains What CIALIS looks like and contents of the pack CIALIS 5 mg is a light yellow film-coated tablet in the shape of an almond and has "C 5" marked on one side. CIALIS 5 mg is available in blister packs containing 14, 28 or 84 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Manufacturer: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. This leaflet was last revised in February 2017. Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL http://www.lilly.co.uk
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Allegra tablete (120mg) – Uputa o lijeku - Budite prvi i komentirajte! - 4 min čitanja Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne podatke. - Uvijek uzmite ovaj lijek točno onako kako je propisano u ovoj uputi ili kako su Vam rekli Vaš liječnik ili ljekarnik. - Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati. - Ako imate dodatnih pitanja, obratite se svom ljekarniku. - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio 4. - Obavezno se obratite liječniku ako se ne osjećate bolje ili ako se osjećate lošije nakon 5 dana. Dostupan je i lijek s istom djelatnom tvari u pakiranju od 30 tableta koji je namijenjen za liječenje simptoma alergije samo prema preporuci liječnika. Važno je da liječnik utvrdi točnu dijagnozu i potrebu za dugotrajnim liječenjem antihistaminikom. Ovo je potrebno da bi se izbjegle situacije u kojima se antialergijski lijekovi uzimaju za liječenje simptoma za koje je pogrešno razmotreno da su uzrokovani alergijom. Što se nalazi u ovoj uputi: - Što je Allegra i za što se koristi - Što morate znati prije nego počnete uzimati Allegru - Kako uzimati Allegru - Moguće nuspojave - Kako čuvati Allegru - Sadržaj pakiranja i druge informacije 1.Što je Allegra i za što se koristi Allegra sadrži feksofenadinklorid, koji je antihistaminik. Allegra 120 mg tablete mogu uzimati odrasli i adolescenti od 12 godina nadalje za ublažavanje simptoma povezanih s peludnom groznicom (sezonski alergijski rinitis) kao što su kihanje, osjećaj svrbeža u nosu, curenje iz nosa ili začepljen nos, osjećaj svrbeža očiju, crvenilo i suzenje očiju. Što morate znati prije nego počnete uzimati Allegru Nemojte uzimati Allegru ako ste alergični na feksofenadin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Allegru - ako imate problema s jetrom ili bubrezima - ako imate ili ste ikada imali srčanu bolest, s obzirom da ovaj lijek može uzrokovati ubrzane ili nepravilne srčane otkucaje - ako ste starije dobi. Ako se bilo što od ovdje navedenog odnosi na Vas ili ako niste sigurni, prije uzimanja Allegre obratite se svome liječniku ili ljekarniku. Drugi lijekovi i Allegra Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove. Lijekovi koji se uzimaju za liječenje loše probave, a sadrže aluminij i magnezij, mogu utjecati na djelovanje Allegre, smanjujući količinu apsorbiranog lijeka. Preporučuje se napraviti razmak od oko 2 sata između uzimanja Allegre i sredstva protiv loše probave. Trudnoća i dojenje Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.Ne uzimajte Allegru ako ste trudni, osim ako nije neophodno. Allegra se ne preporučuje tijekom dojenja. Upravljanje vozilima i strojevima Nije vjerojatno da Allegra utječe na sposobnost vožnje ili upravljanja strojevima. Međutim, prije nego vozite ili upravljate strojevima morate biti sigurni da Vam lijek ne uzrokuje pospanost ili omaglicu. Kako uzimati Allegru Uvijek uzmite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako su Vam rekli Vaš liječnik ili ljekarnik. Provjerite sa svojim liječnikom ili ljekarnikom, ako niste sigurni. Odrasli i djeca od 12 godina nadalje: - Preporučena doza je jedna tableta (120 mg) dnevno. - Uzmite tabletu prije obroka, s vodom. - Ako se simptomi ne ublaže unutar 5 dana od početka uzimanja lijeka, kontaktirajte liječnika. Ako uzmete više Allegre nego što ste trebali Ako uzmete previše tableta, odmah obavijestite svojeg liječnika ili najbližu službu hitne pomoći. Simptomi predoziranja u odraslih su omaglica, omamljenost, umor i suha usta. Ako ste zaboravili uzeti Allegru Nemojte uzeti dvostruku dozu da biste nadoknadili tabletu zaboravljenu tabletu. Uzmite sljedeću dozu u uobičajeno vrijeme. U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili ljekarniku. Moguće nuspojave Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga. Prestanite uzimati Allegru i odmah se obratite liječniku , ako iskusite nuspojave kao što su oticanje lica, usana, jezika ili grla i probleme s disanjem, jer to mogu biti znakovi ozbiljne alergijske reakcije. Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba): - glavobolja - omamljenost - mučnina - omaglica Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba): - umor - pospanost Ostale nuspojave čija je učestalost nepoznata (ne može se procijeniti iz dostupnih podataka): - problemi sa spavanjem (nesanica) - poremećaji spavanja - loši snovi - nervoza - brzi ili nepravilni srčani otkucaji - proljev - osip i svrbež - koprivnjača - ozbiljne alergijske reakcije koje mogu uzrokovati oticanje lica, usana, jezika ili grla, crvenilo praćeno osjećajem vrućine, stezanje u prsima i problemi s disanjem. Prijavljivanje nuspojava Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. Ovo uključuje i svaku mogu ću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava na: Agencija za lijekove i medicinske proizvode , Odsjek za farmakovigilanciju Roberta Frangeša Mihanovića 9 10 000 Zagreb Republika Hrvatska Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka. Kako čuvati Allegru Ovaj lijek čuvajte izvan dohvata i pogleda djece. Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza „Rok valjanosti“. Rok valjanosti odnosi se na zadnji dan navedenog mjeseca. Lijek ne zahtijeva nikakve posebne uvjete čuvanja. Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad. Pitajte svog ljekarnika kako baciti lijekove koje više ne koristite. Ove će mjere pomoći u očuvanju okoliša. Sadržaj pakiranja i druge informacije Što Allegra sadrži Djelatna tvar je feksofenadinklorid. Jedna tableta sadrži 120 mg feksofenadinklorida. Pomoćne tvari su: - Jezgra tablete: mikrokristalična celuloza, prethodno geliran kukuruzni škrob, umrežena karmelozanatrij, magnezijev stearat. - Film ovojnica: hipromeloza, povidon, titanijev dioksid (E171), bezvodni koloidni silicijev dioksid, makrogol 400, željezov oksid (E172). Kako Allegra 120 mg izgleda i sadržaj pakiranja Allegra 120 mg filmom obložene tablete su boje breskve, oblika kapsule s oznakama „012“ na jednoj strani i slovom „e“ na drugoj strani. Pakiranje sadrži 10 tableta u blisteru. Napomene: Nositelj odobrenja za stavljanje lijeka u promet sanofi-aventis Croatia d.o.o. Heinzelova 70 Zagreb Proizvođač Sanofi-Synthelabo Ltd Edgefield Avenue, Fawdon Newcastle upon Tyne, Tyne and Wear, NE3 3TT, Velika Britanija Sanofi Winthrop Industrie 30-36, avenue Gustave Eiffel, 37100 Tours Francuska Sanofi Winthrop Industrie 56, route de Choisy-au-Bac, 60205 Compiègne Francuska Način i mjesto izdavanja lijeka Izdaje se bez recepta, u ljekarni i specijaliziranim prodavaonicama za promet na malo lijekovima.