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Sycrest 5mg and 10mg Sublingual Tablets Last Updated on eMC 06-Jan-2015 View changes | Lundbeck Limited Contact details Having problems opening this PDF? Download Acrobat Reader The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged. Please click on the link to the left to view the PIL in PDF format. Text only version for the visually impaired Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link to the left. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. Sycrest 5mg and 10mg Sublingual Tablets Package leaflet: Information for the patient Sycrest® 5 mg sublingual tablets Sycrest® 10 mg sublingual tablets asenapine Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet What Sycrest is and what it is used for What you need to know before you take Sycrest How to take Sycrest Possible side effects How to store Sycrest Contents of the pack and other information What Sycrest is and what it is used for Sycrest contains the active substance asenapine. This medicine belongs to a group of medicines called antipsychotics. Sycrest is used to treat moderate to severe manic episodes associated with bipolar I disorder in adults. Antipsychotic medicines affect the chemicals that allow communication between nerve cells (neurotransmitters). Illnesses that affect the brain, such as bipolar I disorder, may be due to certain chemicals in the brain, such as dopamine and serotonin, being out of balance and these imbalances may cause some of the symptoms you may be experiencing. Exactly how this medicine works is unknown, however, it is believed to adjust the balance of these chemicals. Manic episodes associated with bipolar I disorder is a condition with symptoms such as feeling “high”, having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. What you need to know before you take Sycrest Do not take Sycrest If you are allergic to asenapine or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Sycrest. Sycrest has not been studied in elderly patients with dementia. However, elderly patients with dementia, who are treated with other similar types of medicine, may have an increased risk of stroke or death. Sycrest is not approved for the treatment of elderly patients with dementia and is not recommended for use in this particular group of patients. Sycrest may cause low blood pressure. In the early stages of treatment, some people may faint, especially when getting up from a lying or sitting position. This will usually pass on its own but if it does not, tell your doctor. Your dose may need to be adjusted. Sycrest may cause weight gain. Tell your doctor immediately if you experience - involuntary rhythmic movements of the tongue, mouth and face. Withdrawal of Sycrest may be needed. - fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome”). Immediate medical treatment may be needed. Check with your doctor or pharmacist before taking Sycrest: - if you have ever been diagnosed with a condition whose symptoms include high body temperature and muscle stiffness (also known as neuroleptic malignant syndrome). - if you have ever experienced abnormal movements of the tongue or face (tardive dyskinesia). You should be aware that both of these conditions may be caused by this type of medicine. - if you have a heart disease or a treatment for heart disease that makes you prone to low blood pressure - if you are diabetic or prone to diabetes - you have Parkinson’s disease or dementia - if you have epilepsy (seizures) - if you experience any difficulty in swallowing (dysphagia) - if you have severe liver problems. If you do, you should not take Sycrest - if you have difficulty controlling core body temperature - if you have thoughts of suicide Be sure to tell your doctor if you meet any of these conditions as he/she may want to adjust your dose or monitor you for a while. Also contact your doctor immediately if any of these conditions develops or worsens while using Sycrest. Children and adolescents Use of Sycrest below the age of 18 years is not recommended due to insufficient information on whether it is safe and effective in this age group. Other medicines and Sycrest Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines may reduce the effect of Sycrest. If you are taking other medicines, Sycrest should be taken last. You should tell your doctor if you are taking antidepressant medicines (specifically fluvoxamine, paroxetine or fluoxetine), as it may be necessary to change your Sycrest or antidepressant medicine dose. You should tell your doctor if you are taking medicines for Parkinson’s disease (such as levodopa), as this medicine may make them less effective. Since Sycrest works primarily in the brain, interference from other medicines (or alcohol) that work in the brain could occur due to an additive effect on brain function. Since Sycrest can lower blood pressure, care should be taken when Sycrest is taken with other medicines that lower blood pressure. Sycrest with food, drink and alcohol Do not eat or drink for 10 minutes after taking this medicine. You should avoid drinking alcohol when taking this medicine. Pregnancy and breast-feeding 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. Do not take Sycrest while you are pregnant, unless your doctor tells you so. If you are taking this medicine and you become pregnant or you plan to get pregnant, ask your doctor as soon as possible whether you may continue taking Sycrest. Do not breast-feed when taking Sycrest. The following symptoms may occur in newborn babies, of mothers that have used Sycrest in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor. Driving and using machines Sycrest may affect your concentration or alertness. Make sure these abilities are not affected before you drive or operate machinery. How to take Sycrest Always take this medicine exactly as your doctor or pharmacist has told you. Sycrest is not advised if you are unable to take the tablet as described below. Check with your doctor or pharmacist if you are not sure. If you are unable to take this medicine as is described below, the treatment may not be effective for you. The recommended dose is a tablet of 5 mg or 10 mg two times a day. One dose should be taken in the morning and one dose should be taken in the evening. Instructions for use - Do not remove a tablet from the blister until ready to take it. - Use dry hands when touching the tablet. - Do not push the tablet through the blister. Do not cut or tear the blister. - Peel back the coloured tab (Figure 1). - Gently remove the tablet (Figure 2). Do not crush the tablet. - To ensure optimal absorption, place the tablet under the tongue and wait until it dissolves completely (Figure 3). The tablet will dissolve in saliva within seconds. - Do not swallow or chew on the tablet. - Do not eat or drink for 10 minutes after taking the tablet. If you take more Sycrest than you should If you take too much Sycrest, contact a doctor straight away. Take the medicine pack with you. In case of overdose you may feel sleepy or tired, or have abnormal body movements, problems with standing and walking, feel dizzy due to low blood pressure and feel agitated and confused. If you forget to take Sycrest Do not take a double dose to make up for a forgotten dose. If you miss one dose, take your next dose as usual. If you miss two or more doses, contact your doctor or pharmacist. If you stop taking Sycrest If you stop taking Sycrest, you will lose the effects of this medicine. You should not stop taking this medicine, unless your doctor tells you as your symptoms may return. 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 patients have experienced the following side effects while taking this medicine: Very common side effects (may affect more than 1 in 10 people) - anxiety - sleepiness Common side effects (may affect up to 1 in 10 people) - weight gain - increased appetite - slow or sustained muscle contractions - restlessness - involuntary muscle contractions - slow movements, tremor - sedation - dizziness - change in taste - numb feeling of the tongue or in the mouth - muscle tightness - fatigue - increase in the level of liver proteins Uncommon side effects (may affect up to 1 in 100 people) - high blood sugar - fainting episode - convulsion - abnormal muscle movements: a collection of symptoms known as extrapyramidal symptoms (EPS) which may include one or more of the following: abnormal movements of muscles, tongue, or jaw, slow or sustained muscle contractions, muscle spasms, tremor (shaking), abnormal movements of the eyes, involuntary muscle contractions, slow movements, or restlessness - speech problems - abnormal slow or fast heartbeat - middle heart block - abnormal electrocardiogram (prolongation of the QT interval) - low blood pressure upon standing - low blood pressure - tingling of the tongue or in the mouth - swollen or painful tongue - difficulty in swallowing - sexual dysfunction - lack of regular menstrual periods Rare side effects (may affect up to 1 in 1,000 people) - changes in the levels of white blood cells - neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever, and severe muscle stiffness) - difficulties in focusing with the eyes - blood clots in blood vessels to the lungs causing chest pain and difficulty in breathing - muscle disease presenting as unexplained aches and pains - male breast enlargement - leakage of milk or fluid from the breast Side effects with unknown frequency (cannot be estimated from the available data) - allergic reactions (these usually involve a combination of effects such as difficulty in breathing or swallowing, swollen face, lips, tongue or throat, skin rash, itching and increased heart rate. Seek medical attention immediately if you experience these symptoms). - ulcers, soreness, redness, swelling, and blisters within the mouth - unpleasant sensations in the legs (also called restless legs syndrome) - nausea - increased saliva (drooling) 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard Ireland: Earlsfort Terrace IRL - Dublin 2 Malta: How to store Sycrest 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 blister and on the carton. The expiry date refers to the last day of that month. Store this medicine in the original package in order to protect from light and moisture. This medicinal product does not require any special temperature storage conditions. 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 Sycrest contains - The active substance is asenapine. Each Sycrest tablet contains either 5 mg or 10 mg of the active substance. The exact amount is shown on your Sycrest tablet pack. - The other ingredients are gelatin and mannitol (E421). What Sycrest looks like and contents of the pack The 5 mg sublingual tablets are round white to off-white tablets marked with “5” on one side. The 10 mg sublingual tablets are round white to off-white tablets marked with “10” on one side. The sublingual tablets are provided in peelable blisters containing 10 tablets each. Packs may contain 20, 60 or 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Kloosterstraat 6 NL-5349 AB Oss The Netherlands Manufacturer Organon (Ireland) Ltd. Drynam Road Swords Co. Dublin Ireland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Lundbeck House Caldecotte Lake Business Park Caldecotte Milton Keynes MK7 8LG UK This leaflet was last revised in November 2014. Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
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Zalasta tablete (5/10mg) – Uputa o lijeku Proizvođač: Jadran Galenski laboratorij Samo na recept? DA Primjena: antipsihotik Skoči na: » opis » primjena » doziranje » mjere opreza » napomene Opis Što sadržava Zalasta Svaka tableta sadržava 5 mg odnosno 10 mg olanzapina. Pomoćne tvari: - laktoza monohidrat, celuloza, preželatinirani škrob, kukuruzni škrob, silicijev-dioksid koloidni (bezvodni), magnezij-stearat. Pakiranje Kutija sa 28 tableta (4 OPA/Al/PVC blistera s po 7 tableta) Način i mjesto izdavanja Izdaje se na liječnički recept , samo u ljekarnama. Rok valjanosti Otisnut je na pakiranju. Lijek se ne smije upotrebljavati nakon isteka roka valjanosti. Način čuvanja Čuvati na temperaturi do 25º, izvan dohvata djeci. Primjena Što je Zalasta Zalasta spada u skupinu antipsihotika. Zašto se Zalasta koristi Zalasta je namjenjena za liječenje duševnih smetnji, za koje je karakteristično da čujete, vidite ili osjećate stvari, kojih u stvarnosti nema, da pogrešno razmišljate, da ste neobično sumnjičavi i da se povlačite u sebe. Kod tih duševnih smetnji možete biti bezvoljni (depresivni), osjećati strah ili napetost. Zalasta je namjenjena i liječenju srednje teške do teške manične epizode te prevenciji ponovne pojave epizoda bipolarnog afektivnog poremećaja u bolesnika koji su dobro reagirali na početno liječenje. Doziranje Kako uzimati Zalastu Točno se pridržavajte liječnikovih uputa. Doze ne smijete mijenjati niti prekidati liječenje bez prethodnoga savjetovanja s liječnikom. Vaš će vam liječnik reći koliko tableta na dan morate uzeti i koliko ih dugo trebate uzimati. Lijek uzimajte jednom dnevno, prema uputama liječnika. Preporučuje se da uzimate lijek svaki dan u približno isto vrijeme. Nije važno da li lijek uzimate s hranom ili bez nje. Tablete progutajte cijele, s malo vode. Odrasli Preporučena je početna doza olanzapina u liječenju shizofrenije 10 mg na dan. Preporučena je početna doza olanzapina kao osnovnog liječenja (monoterapije) manične epizode 15 mg jednom na dan ili 10 mg olanzapina na dan ako se koristi u kombinaciji s drugim lijekovima. Preporučena je početna doza kod prevencije ponovne pojave epizode bipolarnog afektivnog poremećaja 10 mg na dan. U bolesnika koji su dobro regairali na početno liječenje olanzapinom, liječenje treba nastaviti istom dozom. U slučaju pojave nove manične, depresivne ili miješane epizode treba nastaviti s primjenom olanzapine (uz eventualnu prilagodbu doze) te ovisno o kliničkoj slici, dodatno liječiti prateće simptome poremećaja raspoloženja. Tijekom liječenja shizofrenije i manične epizode te prevencije ponovne pojave epizode bipolarnog afektivnog poremećaja dnevna se doza može postupno prilagođavati, ovisno o individualnom kliničkom statusu, u rasponu od 5 do 20 mg na dan. Povećanje doze iznad uobičajene početne dnevne doze od 10 mg preporučuje se samo nakon odgovarajuće kliničke procjene i to u intervalima koji ne bi smjeli biti manji od 24 sata. Djeca i adolescenti Učinkovitost i sigurnost primjene olanzapina u djece i adolescenata do 18 godina nije utvrđena. Stariji bolesnici Preporučuje se u bolesnika starijih od 65 godina, kod kojih opće kliničko stanje zahtijeva prilagođavanje doze započeti liječenje nižom dozom lijeka (5 mg na dan). Bolesnici s poremećenom funkcijom jetre ili bubrega Preporučuje se započeti liječenje nižom dozom lijeka (5 mg na dan) te se, po potrebi, doza oprezno povećava. Usporena razgradnja lijeka Poznato je da osobe ženskog spola i starije osobe, odnosno nepušači usporeno razgrađuju lijek u tijelu, zbog čega se povećava mogućnost nakupljanja lijeka i njegovog štetnog djelovanja. U prisustvu više čimbenika koji mogu utjecati na usporenu razgradnju lijeka, opravdano je započeti liječenje nižom dozom lijeka (5 mg na dan) te se, po potrebi, doza oprezno povećava. Ne prekidajte uzimanje lijeka samo zato što se osjećate bolje. Jako je važno da uzimate Zalastu toliko dugo koliko vam je liječnik propisao. Ako ste uzeli više Zalaste nego što ste trebali Ukoliko ste uzeli veću dozu lijeka nego što biste smjeli, odmah se posavjetujte s liječnikom ili ljekarnikom. Ako ste uzeli više tableta nego što je propisano, odmah se javite vašem liječniku ili najbližoj bolnici. Ako propustite uzeti Zalastu Ne uzimajte dvostruku dozu ukoliko ste zaboravili uzeti prijašnju dozu. Ako ste zaboravili uzeti lijek, samo nastavite uzimati lijek prema uobičajenom rasporedu. Mjere opreza Upozorite liječnika imate li kakvu kroničnu bolest, metabolički poremećaj, ako ste preosjetljivi ili uzimate kakve druge lijekove. Lijekovi ove vrste mogu uzrokovati neobične pokrete, prije svega lica i jezika. Ukoliko se to pojavi za vrijeme primjene Zalaste, obavijestite svog liječnika. Vrlo rijetko ova vrsta lijekova uzrokuje povišenu temperaturu, brže disanje, znojenje, krutost mišića, pospanost. U takvim slučajevima prestanite uzimati Zalastu i odmah se javite liječniku. Primjena Zalaste u starijih bolesnika s demencijom se ne preporučuje radi mogućih ozbiljnih nuspojava. Ako patite od demencije, treba obavijestiti liječnika ako ste imali moždani udar ili »mali« moždani udar. Prije početka primjene Zalaste kažite svom liječniku ako imate bolest jetre ili bubrega, srčanu bolest, Parkinsonovu bolest, epilepsiju, tegobe s prostatom, ako imate zapletaj crijeva, bolesti krvi ili šećernu bolest. Iako nije utvrđena uzročna povezanost između pojave venske trombembolije i liječenja olanzapinom, preporučuje se u bolesnika sa shizofrenijom utvrditi prisutnost faktora rizika za nastanak trombembolije i poduzeti sve preventivne mjere. Ako ste stariji od 65 godina preporučuje se da liječnik kontrolira vaš krvni tlak. Tko ne bi trebao koristiti Zalastu Zalastu ne smijete uzimati ako ste preosjetljivi na olanzapin ili druge sastojke lijeka i ako imate glaukom uskog kuta. Trudnoća i dojenje Posavjetujte se s liječnikom ili ljekarnikom prije nego uzmete bilo koji lijek! Odmah obavijestite svoga liječnika ako ste trudni ili sumnjate na trudnoću. Ne smijete uzimati Zalastu za vrijeme trudnoće osim u slučaju kada ste se o tome posavjetovali s liječnikom. Ne uzimajte lijek za vrijeme dojenja. Utjecaj na sposobnost upravljanja vozilima i strojevima Zalasta može uzrokovati pospanost i tako utjecati na vaše psiho-fizičke sposobnosti. Ako se osjećate pospano, ne smijete upravljati motornim vozilima ili strojevima i morate o tome obavijestiti liječnika Nuspojave Kao svi lijekovi i Zalasta može imati nuspojave. Za vrijeme liječenja Zalastom mogu se pojaviti sljedeće nuspojave: - pospanost - povećanje tjelesne težine - vrtoglavica - porast apetita - zadržavanje vode u organizmu - povećana potreba za kretanjem - zatvor - suha usta - nemir - neobični pokreti - drhtanje ruku - krutost mišića - poteškoće pri govoru - promjena u koncentraciji nekih krvnih stanica i masnoća u krvotoku. Neki bolesnici mogu na početku primjene lijeka osjećati vrtoglavicu ili nesvjesticu, posebno kod ustajanja iz ležećeg ili sjedećeg položaja. U kliničkim ispitivanjima starijih bolesnika s demencijom, liječenje olanzapinom povezano je s povećanom učestalosti smrti i cerebrovaskularnih nuspojava u usporedbi s placebom. Vrlo česte nuspojave povezane s primjenom olanzapina u ovoj dobnoj skupini bile su abnormalan hod i padovi. Primjena Zalaste može pogoršati simptome Parkinsonove bolesti. Rijetko može Zalasta uzrokovati osip, ubrzani srčani ritam i reakciju preosjetljivosti na sunce. Vrlo rijetko uzrokuje bolest jetre, vensku trombemboliju, produljenu i/ili bolnu erekciju i tegobe pri mokrenju. Neki bolesnici imali su visoki šećer u krvi ili pogoršanje šećerne bolesti s ketoacidozom (ketoni u krvi i urinu) ili komom, koji su se javili vrlo rijetko. Vrlo rijetko su kod naglog prekida liječenjem olanzapinom opisani akutni simptomi kao što su: - znojenje - nesanica - tresavica - osjećaj tjeskobe - opća slabost s nagonom za povraćanje i povraćanje Liječnik će vam u tom slučaju predložiti postupno smanjenje doze prije prekida liječenja. Za vrijeme dugotrajne primjene ove vrste lijeka kod nekih je bolesnica došlo do istjecanja mlijeka iz prsiju, a također je došlo do neredovite ili izostanka menstruacije. Vrlo rijetko se mogu dojenčad, čije majke su uzimale olanzapin u zadnjem tromjesečju trudnoće tresti ili biti pospana. Rijetko se javljuju epileptički napadi. U većini slučajeva to se dogodilo u bolesnika koji su imali epileptičke napade u povijesti bolesti. Opazite li bilo koju nuspojavu, pa ako i nije spomenuta u ovoj uputi, obavijestite svoga liječnika ili ljekarnika. Koji lijekovi mogu dovesti do interakcija sa Zalastom Obavijestite svoga liječnika ili ljekarnika uzimate li ili ste prije kratkoga vremena uzimali bilo koji drugi lijek, pa i onda ako ste ga dobili bez recepta. Obavijestite svoga liječnika ako uzimate lijekove za liječenje Parkinsonove bolesti. Možete se osjećati pospano ako uzimate Zalastu u kombinaciji s antidepresivima ili s lijekovima koje koristite kada osjećate tjeskobu i strah odnosno lijekovima koji vam pomažu da lakše zaspete. Posebno je važno da obavijestite svoga liječnika ako uzimate fluvoksamin (antidepresiv), ketokonazol (antimikotik) ili ciprofloksacin (antibiotik), jer ti lijekovi mogu povećati koncentraciju olanzapina u krvi. Olanzapin nije pokazao interakcije pri istodobnoj primjeni s litijem ili biperidenom. Obavijestite svoga liječnika ako uzimate valproat (lijek koji se koristi u liječenju epilepsije). Istovremeno sa Zalastom možete koristiti samo lijekove koje vam je odobrio vaš liječnik. Uzimanje Zalaste zajedno s hranom i pićem Hrana ne utječe na prijelaz olanzapina iz probavnih organa u krvotok (apsorpcija). Potreban je oprez kod istovremene primjene Zalaste i alkohola jer može uzrokovati pospanost. Napomene Proizvođač “JADRAN”- Galenski laboratorij d.d., Pulac bb, Rijeka, Hrvatska u suradnji s KRKA d.d., Novo mesto, Slovenija Nositelj odobrenja za stavljanje lijeka u promet “JADRAN”-Galenski laboratorij d.d., Pulac bb, Rijeka, Hrvatska Amantilla Relax Značajno ublažava stres i tjeskobu. Tensilen Prirodno rješenje za stres, umor i iscrpljenost.