http___www.krenizdravo.net_korisno_upute_allegra-tablete-120mg-uputa-o-lijeku_1.xml
1.1 2.1 3.1 3.2 4.1 5.1 5.2 5.3 6.1 6.2 6.3 7.1 8.1 9.1 10.1 11.1 12.1 13.1 13.2 13.3 13.4 14.1 15.1 16.1 17.1 17.2 18.1 19.1 19.2 20.1 21.1 22.1 23.1 24.1 24.2 25.1 26.1 26.2 27.1 28.1 29.1 30.1 31.1 32.1 33.1 34.1 35.1 36.1 37.1 38.1 38.2 39.1 40.1 40.2 41.1 42.1 43.1 44.1 45.1 46.1 47.1 48.1 48.2 49.1 49.2 49.3 50.1 51.1 52.1 52.2 53.1 54.1 54.2 55.1 56.1 56.2 57.1 58.1 59.1 60.1 61.1 62.1 63.1 64.1 65.1 66.1 67.1 68.1 69.1 70.1 71.1 72.1 72.2 72.3 72.4 73.1 74.1 75.1 75.2 76.1 76.2 77.1 77.2 77.3 78.1 78.2 79.1 79.2 80.1 80.2 81.1 81.2 82.1 82.2 83.1 84.1 85.1 86.1 87.1 88.1 89.1 90.1 91.1
Lacidipine 2 mg, 4 mg, 6 mg Film-Coated Tablets Lacidipine - 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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. What Lacidipine is and what it is used for What you need to know before you take Lacidipine How to take Lacidipine Possible side effects How to store Lacidipine Contents of the pack and other information Lacidipine tablets contain a medicine called lacidipine. This belongs to a group of medicines called ‘calcium channel blockers’. Lacidipine helps to relax your blood vessels so that they get wider. This helps the blood to flow more easily and lowers the blood pressure. Lacidipine tablets taken regularly as prescribed by your doctor will help to lower your blood pressure (to treat hypertension). - if you are pregnant, likely to get pregnant or are breast-feeding - if you are allergic to lacidipine, other calcium channel blocker medicines or any of the other ingredients of this medicine (listed in section 6) - if you have the heart problem ‘aortic stenosis’. This is a narrowing of a valve in your heart, which restricts blood flow - if you have had a heart attack within the last month. Do not take Lacidipine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking the medicine. You should stop taking Lacidipine if you get chest pain (angina) or a fast, weak pulse, rapid shallow breathing, low blood pressure, cold clammy skin, blue lips or feel dizzy, faint, weak or sick. Talk to your doctor or pharmacist before taking Lacidipine: - if you have an uneven heart beat or any other heart problems - if you have or have ever had any liver problems. If you are having any blood tests, tell the person giving the test that you are taking this medicine. This is because Lacidipine can affect results relating to your liver. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Lacidipine can affect the way some other medicines work. Also some other medicines can affect the way Lacidipine works. In particular, tell your doctor or pharmacist if you are taking any of the following medicines: - medicines for high blood pressure - medicines to control your heart beat (called ‘anti-arrhythmics’) - medicines for depression called ‘tricyclic antidepressants’ - sleeping tablets or sedatives - antibiotics - antihistamines - used for hayfever and other allergies - cimetidine - used for stomach problems - tetracosactide and corticosteroids. Do not take this medicine with grapefruit juice. Do not take Lacidipine if you are pregnant, likely to get pregnant or are breast-feeding. You may feel dizzy while taking Lacidipine. If this happens, do not drive or use any tools or machines. If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine. Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. It is important to take the right number of tablets at the right time of day. - The usual starting dose is 2 mg every morning. - After 3-4 weeks this may be increased to 4 mg every morning. - If necessary, the dose may be increased again to 6 mg every morning which is the maximum daily dose. - Swallow the tablets whole with a drink of water. - Do not take with grapefruit juice. The 4 mg tablet can be divided into equal doses. If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you, even if there are no tablets left. If you forget a dose in the morning, take it as soon as you remember it on the same day. However, if you remember the next day, take your normal dose on that morning. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of the medicine, ask your doctor or pharmacist. Like all medicines, this medicine can cause side effects, although not everybody gets them. - angina, this is a type of chest pain. This is uncommon in people taking Lacidipine and is more likely to occur when you start taking this medicine - allergic reactions, the signs may include: rapid swelling of the face, mouth and throat which may cause difficulty breathing. The side effects described below have been experienced by people taking Lacidipine. They are listed as either common, uncommon, rare or very rare. Common (may affect up to 1 in 10 people) - dizziness, headache, fast or uneven heart beat (also called palpitations), flushing, swelling particularly of the ankles. These side effects usually go away as treatment continues - fast heart beat - upset stomach, feeling sick (nausea) - rash, redness of the skin, itching - an increase in the amount of water (urine) that you pass - feeling weak - changes in results of blood tests relating to your liver Uncommon (may affect up to 1 in 100 people) - chest pain (angina) including chest pain that is getting worse - low blood pressure for example feeling faint, fainting - swelling of the gums Rare (may affect up to 1 in 1,000 people) - rapid swelling of the face, mouth and throat which may cause difficulty breathing - nettle rash (urticaria) - muscle cramps Very rare (may affect up to 1 in 10,000 people) 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 Yellow Card Scheme, website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. Keep this medicine out of the sight and reach of children. This medicine does not need any special temperature storage conditions. The tablets should be kept in the original container to protect them from light. Do not remove any tablets from the foil until you are ready to take them. Do not use this medicine after the expiry date which is stated on the carton and the blister pack after EXP. The expiry date refers to the last day of that month. 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. The active substance is lacidipine. Each tablet contains 2 mg, 4 mg or 6 mg. The other ingredients are lactose monohydrate, povidone, crospovidone and magnesium stearate. The film coating contains hypromellose, titanium dioxide and macrogol 400. The 2 mg tablets are film-coated, round and white in colour. They have the logo on one side and the code ‘225’ on the other. The 4 mg tablets are film-coated, oval and white in colour. They have the logo on one side and the codes ‘2’ and ‘24’ separated by a break line on the other. The 6 mg tablets are film-coated, oval and white in colour. They have the logo on one side and the code ‘226’ on the other. Lacidipine tablets are available in blister packs of 28 tablets. Not all pack sizes may be marketed. Dr. Reddy’s Laboratories (UK) Ltd. 6 Riverview Road Beverley East Yorkshire HU17 0LD United Kingdom This leaflet was last revised in 02/2019
1.1 2.1 3.1 4.1 5.1 6.1 6.2 7.1 8.1 8.2 8.3 9.1 10.1 11.1 12.1 13.1 14.1 15.1 16.1 17.1 18.1 19.1 20.1 21.1 22.1 23.1 24.1 25.1 26.1 27.1 28.1 29.1 30.1 31.1 32.1 33.1 34.1 35.1 36.1 37.1 38.1 39.1 40.1 40.2 41.1 42.1 42.2 43.1 44.1 45.1 46.1 47.1 48.1 48.2 49.1 50.1 51.1 52.1 53.1 54.1 55.1 56.1 57.1 58.1 59.1 60.1 61.1 62.1 63.1 64.1 65.1 66.1 67.1 68.1 69.1 70.1 71.1 72.1 73.1 74.1 75.1 75.2 76.1 77.1 78.1 79.1 80.1 81.1 82.1 83.1 83.2 84.1 85.1 85.2 85.3 86.1 87.1 88.1 88.2 89.1 90.1 91.1 92.1 93.1 94.1 95.1 96.1 97.1 98.1 99.1 100.1 101.1 102.1 103.1 104.1 105.1 106.1 107.1 108.1 109.1
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.