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Bricanyl® Tablets 5 mg terbutaline sulfate - 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 Bricanyl Tablets are and what they are used for What you need to know before you take Bricanyl Tablets How to take Bricanyl Tablets Possible side effects How to store Bricanyl Tablets Contents of the pack and other information Bricanyl Tablets contain a medicine called terbutaline sulfate. This belongs to a group of medicines called beta-agonists. These work by relaxing certain muscles. For example, they open up the airways in the lungs. - Bricanyl Tablets are used for the regular treatment of breathing disorders such as asthma. They help to relieve tightening of the chest and difficulty breathing (bronchospasm). Bricanyl should not be used alone for the regular treatment of asthma or other breathing conditions. If you are using Bricanyl every day then your doctor should have also prescribed you another type of medication such as an “inhaled corticosteroid”, which helps reduce the swelling and inflammation in your lungs. - If you are allergic to terbutaline sulfate or any of the other ingredients of this medicine (listed in Section 6). Talk to your doctor or pharmacist before taking Bricanyl Tablets if: - You are pregnant and you have had problems with your pregnancy. - You are diabetic. If so, you may need some additional blood sugar tests when you start taking Bricanyl Tablets. - You have a history of heart disease, irregular heart rhythm or angina. - You have an overactive thyroid gland. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Bricanyl Tablets. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. Bricanyl Tablets can affect the way that some medicines work and some medicines can have an effect on Bricanyl Tablets. In particular, tell your doctor or pharmacist if you are taking any of the following medicines: - Steroid medicines (such as prednisolone). - Xanthine medicines (such as theophylline or aminophylline). - Beta-blocker medicines (such as atenolol or propranolol), including eye drops (such as timolol). - Water tablets, also known as diuretics (such as frusemide). If you are to undergo surgery with general anaesthetics it is important that you inform your doctor about all medicine you use, including Bricanyl to protect you from adverse effects (e.g. irregular heart beat). If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Bricanyl should be used with caution at the end of pregnancy since it relaxes the womb. Bricanyl Tablets are not likely to affect you being able to drive or use machines. Bricanyl Tablets contain lactose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The instructions on the label should remind you of what the doctor said. Adults and young people over 16 years - The recommended starting dose is half a tablet three times in 24 hours. This dose is usually taken for the first 1 to 2 weeks. - Your doctor may increase the dose to one tablet three times a day. Use in Children (7 to 15 years) - The recommended starting dose is half a tablet twice a day. - The doctor may increase the dose to half a tablet three times a day. - Your breathing is getting worse. - You often wake up at night with asthma. - You start getting chest tightness. - You are not getting relief from your current dose. These signs could mean your asthma is not being controlled and you may need different or additional treatment straight away. If you have accidentally taken too much of this medicine, contact your doctor or pharmacist for advice. If you forget to have a dose, have it as soon as you remember. However, if it is almost time for the next dose, wait until then and take the next dose as normal. Do not take a double dose to make up for a forgotten dose. Do not stop taking your medicine without first discussing it with your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Like all medicines, this medicine can cause side effects, although not everybody gets them. - Allergic reactions. The signs may include a swollen face, skin rash, breathing problems, low blood pressure (feeling faint) and collapse. It is not known exactly how often this happens. If this happens to you, stop taking Bricanyl Tablets and see a doctor straight away. - Sudden wheezing soon after taking Bricanyl Tablets. It is not known exactly how often this happens. If this happens to you, stop taking Bricanyl Tablets and see a doctor straight away. Very common (may affect more than 1 in 10 people) - Trembling or shaking. - Headache. Common (may affect up to 1 in 10 people) - Fast heart beats. - Pounding heart beats (palpitations). - Cramp or feeling tense. - Low levels of potassium in your blood which may cause muscle weakness, thirst, or ‘pins and needles’. Not known (frequency cannot be estimated from the available data) - Unusual or irregular heart beats. - Chest pain (due to heart problems such as angina). Tell your doctor if you develop this symptom whilst receiving treatment with Bricanyl Tablets, but do not stop using this medicine unless told to. - Feeling sick (nausea). - Mouth and throat irritation. - Changes in sleeping patterns and changes in behaviour, such as feeling agitated, restless or “hyperactive”. Do not be concerned by this list of side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 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 report side effects directly via the Yellow Card Scheme at: 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. - Do not take this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month - 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. The active substance is terbutaline sulfate. Each Bricanyl Tablet contains 5 mg of terbutaline sulfate. The other ingredients are lactose monohydrate (see section 2 “Bricanyl Tablets contain Lactose”), maize starch, povidone, microcrystalline cellulose and magnesium stearate. Bricanyl Tablets are off-white. They have ‘A/BT’ and a score on one side and the symbol ‘5’ on the other side. Bricanyl Tablets are available in glass bottles or securitainers of 100 and 500 tablets. Not all pack sizes may be marketed. The Marketing Authorisation for Bricanyl Tablets is held by AstraZeneca UK Ltd 600 Capability Green Luton LU1 3LU UK Bricanyl Tablets are manufactured by AstraZeneca AB SE-151 85 Södertälje Sweden To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: Please be ready to give the following information: Product name Bricanyl Tablets Reference number 17901/0116 This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in September 2020. Bricanyl is a trademark of the AstraZeneca group of companies. © AstraZeneca 2020
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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.