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Last Updated on eMC 17-Dec-2013 View changes | Orion Pharma (UK) 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. Package leaflet: information for the user Stalevo 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone 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 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. What is in this leaflet: What Stalevo is and what it is used for What you need to know before you take Stalevo How to take Stalevo Possible side effects 5 How to store Stalevo Contents of the pack and other information What Stalevo is and what it is used for Stalevo contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet. Stalevo is used for the treatment of Parkinson’s disease. Parkinson’s disease is caused by low levels of a substance called dopamine in the brain. Levodopa increases the amount of dopamine and hence reduces the symptoms of Parkinson’s disease. Carbidopa and entacapone improve the antiparkinson effects of levodopa. What you need to know before you take Stalevo Do not take Stalevo if you - are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this medicine (listed in section 6) - have narrow-angle glaucoma (an eye disorder) - have a tumour of the adrenal gland - are taking certain medicines for treating depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO-inhibitors) - have ever had neuroleptic malignant syndrome (NMS – this is a rare reaction to medicines used to treat severe mental disorders) - have ever had non-traumatic rhabdomyolysis (a rare muscle disorder) - have a severe liver disease. Warnings and precautions Talk to your doctor or pharmacist before taking Stalevo if you have or have ever had: - a heart attack or any other diseases of the heart including cardiac arrythmias, or of the blood vessels - asthma or any other disease of the lungs - a liver problem, because your dose may need to be adjusted - kidney or hormone-related diseases - stomach ulcers or convulsions - if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation of the colon - any form of severe mental disorder like psychosis - chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in your eyes may need to be monitored. Consult your doctor if you are currently taking: - antipsychotics (medicines used to treat psychosis) - a medicine which may cause low blood pressure when rising from a chair or bed. You should be aware that Stalevo may make these reactions worse. Consult your doctor if during the treatment with Stalevo you: - notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in your blood pressure. If any of this happens, contact your doctor immediately - feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour - find yourself suddenly falling asleep, or if you feel very drowsy. If this happens, you should not drive or use any tools or machines (see also section 'Driving and using machines') - notice that uncontrolled movements begin or get worse after you started to take Stalevo. If this happens, your doctor may need to change the dose of your antiparkinson medicine - experience diarrhoea: monitoring of your weight is recommended in order to avoid potentially excessive weight loss - experience progressive anorexia, asthenia (weakness, exhaustion) and weight decrease within a relatively short period of time. If this happens, a general medical evaluation including liver function should be considered - feel the need to stop using Stalevo, see section 'If you stop taking Stalevo'. Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These behaviours are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or a preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to review your treatments. Your doctor may take some regular laboratory tests during a long term treatment with Stalevo. If you must undergo surgery, please tell your doctor that you are using Stalevo. Stalevo is not recommended to be used for treatment of extrapyramidal symptoms (e.g. involuntary movements, shaking, muscle rigidity and muscle contractions) caused by other medicines. Children and adolescents Experience with Stalevo in patients under 18 years is limited. Therefore, the use of Stalevo in children is not recommended. Other medicines and Stalevo Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Do not take Stalevo if you are taking certain medicines for treating depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors). Stalevo may increase the effects and side effects of certain medicines. These include: - medicines used to treat depression such as moclobemide, amitryptiline, desipramine, maprotiline, venlafaxine and paroxetine - rimiterole and isoprenaline, used to treat respiratory diseases - adrenaline, used for severe allergic reactions - noradrenaline, dopamine and dobutamine, used to treat heart diseases and low blood pressure - alpha-methyldopa, used to treat high blood pressure - apomorphine, which is used to treat Parkinson’s disease. The effects of Stalevo may be weakened by certain medicines. These include: - dopamine antagonists used to treat mental disorders, nausea and vomiting - phenytoin, used to prevent convulsions - papaverine used to relax the muscles. Stalevo may make it harder for you to digest iron. Therefore, do not take Stalevo and iron supplements at the same time. After taking one of them, wait at least 2 to 3 hours before taking the other. Stalevo with food and drink Stalevo may be taken with or without food. For some patients, Stalevo may not be well absorbed if it is taken with, or shortly after eating protein-rich food (such as meats, fish, dairy products, seeds and nuts). Consult your doctor if you think this applies to you. Pregnancy, breast-feeding and fertility 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. You should not breast-feed during treatment with Stalevo. Driving and using machines Stalevo may lower your blood pressure, which may make you feel light-headed or dizzy. Therefore, be particularly careful when you drive or when you use any tools or machines. If you feel very drowsy, or if you sometimes find yourself suddenly falling asleep, wait until you feel fully awake again before driving or doing anything else that requires you to be alert. Otherwise, you may put yourself and others at risk of serious injury or death. Stalevo contains sucrose Stalevo contains sucrose (1.9 mg/tablet). If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product. How to take Stalevo Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. For adults and elderly: - Your doctor will tell you exactly how many tablets of Stalevo to take each day. - The tablets are not intended to be split or broken into smaller pieces. - You should take only one tablet each time. - Depending on how you respond to treatment, your doctor may suggest a higher or lower dose. - If you are taking Stalevo 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg or 150 mg/37.5 mg/200 mg tablets, do not take more than 10 tablets each day. Talk to your doctor or pharmacist if you think the effect of Stalevo is too strong or too weak, or if you experience possible side effects If you take more Stalevo than you should If you have accidentally taken more Stalevo tablets than you should, talk to your doctor or pharmacist immediately. In case of an overdose you may feel confused or agitated, your heart rate may be slower or faster than normal or the color of your skin, tongue, eyes or urine may change. If you forget to take Stalevo Do not take a double dose to make up for a forgotten tablet. If it is more than 1 hour until your next dose: Take one tablet as soon as you remember, and the next tablet at the normal time. If it is less than 1 hour until your next dose: Take a tablet as soon as you remember, wait 1 hour, then take another tablet. After that carry on as normal. Always leave at least an hour between Stalevo tablets, to avoid possible side effects. If you stop taking Stalevo Do not stop taking Stalevo unless your doctor tells you to. In such a case your doctor may need to adjust your other antiparkinson medicines, especially levodopa, to give sufficient control of your symptoms. If you suddenly stop taking of Stalevo and other antiparkinsonian medicines it may result in unwanted side effects. 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. Many of the side effects can be relieved by adjusting the dose. If you during the treatment with Stalevo experience the following symptoms, contact your doctor immediately: - Your muscles get very rigid or jerk violently, you get tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in your blood pressure. These can be symptoms of neuroleptic malignant syndrome (NMS, a rare severe reaction to medicines used to treat disorders of the central nervous system) or rhabdomyolysis (a rare severe muscle disorder). - Allergic reaction, the signs may include hives (nettle rash), itching, rash, swelling of your face, lips, tongue or throat. This may cause difficulties in breathing or swallowing. Very common (may affect more than 1 in 10 people) - uncontrolled movements (dyskinesias) - feeling sick (nausea) - harmless reddish-brown discoloration of urine - muscle pain - diarrhoea Common (may affect up to 1 in 10 people) - light-headedness or fainting due to low blood pressure, high blood pressure - worsening of Parkinsons`s symptoms, dizziness, drowsiness - vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation - inability to sleep, hallucinations, confusion abnormal dreams (including nightmares), tiredness - mental changes – including problems with memory, anxiety and depression (possibly with thoughts of suicide) - heart or artery disease events (e.g. chest pain), irregular heart rate or rhythm - more frequent falling - shortness of breath - increased sweating, rashes - muscle cramps, swelling of legs - blurred vision - anaemia - decreased appetite, decreased weight - headache, joint pain - urinary tract infection Uncommon (may affect up to 1 in 100 people) - heart attack - bleeding in the gut - changes in the blood cell count which may result in bleeding, abnormal liver function tests - convulsions - feeling agitated - psychotic symptoms - colitis (inflammation of the colon) - discolourations other than urine (e.g. skin, nail, hair, sweat) - swallowing difficulties - inability to urinate The following side effects have also been reported: - hepatitis (inflammation of the liver) - itching You may experience the following side effects: - Inability to resist the impulse to perform an action that could be harmful, which may include: - strong impulse to gamble excessively despite serious or personal family consequences - altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive - uncontrollable excessive shopping or spending - binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger). Tell your doctor if you experience any of these behaviors; they will discuss ways of managing or reducing the symptoms. If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. How to store Stalevo 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 bottle and the carton after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help to protect the environment. Contents of the pack and other information What Stalevo contains - The active substances of Stalevo are levodopa, carbidopa and entacapone. - Each Stalevo 150 mg/37.5 mg/200 mg tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone. - The other ingredients in the tablet core are croscarmellose sodium, magnesium stearate, maize starch, mannitol (E421) and povidone (E1201). - The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium stearate, polysorbate 80, red iron oxide (E172), sucrose, titanium dioxide (E171), and yellow iron oxide (E172). What Stalevo looks like and contents of the pack Stalevo 150 mg/37.5 mg/200 mg: brownish or greyish red, elongated-ellipse shaped, unscored film-coated tablets marked with ‘LCE 150’ on one side. Stalevo comes in six different pack sizes (10, 30, 100, 130, 175 or 250 tablets). Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Orionintie 1 FI-02200 Espoo Finland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. This leaflet was last revised in. August 2013 Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
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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. Afrička šljiva Za normalnu funkciju prostate i urinarnog trakta. Epimen za potenciju Za čvrstu i dugotrajnu erekciju.