http___lysobact.ba_bs_uputstva-za-pacijente_lysobact-p-spray__1.xml
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In this manual : WHAT IS FLECTORTISSUGELEP 1%, medicated plaster and WHEN IS IT USED? WHAT YOU SHOULD KNOW BEFORE USING FLECTORTISSUGELEP 1%, medicated plaster HOW DO I USE FLECTORTISSUGELEP 1% medicated plaster? WHAT ARE THE POSSIBLE SIDE EFFECTS? HOW TO USE FLECTORTISSUGELEP 1%, medicated plaster? ADDITIONAL INFORMATION WHAT IS FLECTORTISSUGELEP 1%, medicated plaster and WHEN IS IT USED? Pharmacotherapeutic class This medicine is a non-steroidal anti-inflammatory drug (NSAID). This medicine is indicated in adults (over 15 years of age) for the symptomatic treatment of pain of tendino-ligamentary origin, and post-traumatic pain: sprains and contusions. This medicine is indicated in adults for the treatment of painful flare-ups of osteoarthritis of the knee, after an initial medical opinion. WHAT YOU SHOULD KNOW BEFORE USING FLECTORTISSUGELEP 1%, medicated plaster List of information needed before taking the medicine Not applicable. Never use FLECTORTISSUGELEP 1%, medicated plaster - if you are allergic to Diclofenac, aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the other components of this product (see What does FLECTORTISSUGELEP 1% medicated plaster contain?). - If you have broken skin, regardless of the type of injury: oozing lesions, eczema, infected lesions, burns or wounds. - In case of an evolving digestive ulcer. - From the 6th month of pregnancy In case of doubt, it is essential to ask your doctor or pharmacist for advice. Precautions for use; special warnings Be careful with FLECTORTISSUGELEP 1%, medicated plaster This medicine is for adults only (over 15 years of age). Do not apply to mucous membranes or the eyes. Do not use under occlusive bandages. If a rash appears after application, treatment must be stopped immediately. In order to avoid any risk of skin reaction during exposure to solar radiation (photosensitisation), it is preferable to avoid any direct exposure to the sun or in a UV cabin during the treatment. Never apply more than the recommended dose (see Dosage). Respect the frequency and duration of treatment indicated in this leaflet or recommended by your doctor. To be used with caution under medical supervision: - in case of heart, kidney or liver disease, - in case of a history of ulcer or digestive bleeding and, - in cases of inflammatory bowel disease. - in subjects with a history of asthma, allergic disease or allergy to aspirin or other NSAIDs, administration of this drug may result in respiratory discomfort or an asthma attack. By extrapolation with other routes of administration. Interactions with other drugs Taking or using other medications Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Interactions with food and drink Not applicable. Interactions with herbal products or alternative therapies Not applicable. Use during pregnancy and lactation Pregnancy and breastfeeding Pregnancy During the first and second trimesters of pregnancy, this medicine should only be used on the advice of your doctor and taken for short periods. Prolonged use of this medicine is strongly discouraged. From the beginning of the 6th month of pregnancy, you should NOT take this medicine under any circumstances, as its effects on your child may have serious consequences, particularly in terms of cardio-pulmonary and renal health, even with a single dose. If you have taken this medicine when you are more than five months pregnant, talk to your obstetrician-gynecologist so that appropriate monitoring can be offered to you. Ask your doctor or pharmacist for advice before taking any medicine. Breastfeeding There are no experimental data on the excretion of Diclofenac epolamine into human or animal milk, therefore, the use of FLECTORTISSUGELEP should be avoided when breast-feeding. Ask your doctor or pharmacist for advice before taking any medication. Not applicable. Effects on ability to drive and use machines Driving and using machines Although the occurrence of such effects is very unlikely when using skin preparations such as FLECTORTISSUGELEP, patients who have previously experienced dizziness or other central nervous system disorders while taking NSAIDs should not drive or operate machinery. List of excipients with a known effect List of excipients with a notable effect:propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216). HOW TO USE FLECTORTISSUGELEP 1% medicated plaster Instructions for proper use Not applicable. Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment Always follow the dosage instructions given by your doctor. In case of uncertainty, consult your doctor or pharmacist. Dosage FLECTORTISSUGELEP is used topically at the following dosage: - Treatment of painful flare-ups of osteoarthritis of the knee: 7 days, to be continued, if necessary, but not exceeding a maximum of 14 days of treatment. - Treatment of pain of tendino-ligamentary origin: 7 days. If pain persists after 7 days, consult your doctor, who will decide whether to continue the treatment. - Treatment of sprains and bruises: 3 days, up to 7 days maximum if necessary. If there is no improvement after 3 days of treatment, consult your doctor. If there is no improvement during the recommended treatment period, a doctor should be consulted. Method of administration Cut the envelope containing FLECTORTISSUGELEP (box of 2, 5, 10 or 14 medicated plasters) where indicated. Remove one FLECTORTISSUGELEP and carefully close the envelope with the slide. Remove the clear plastic sheet that protects the adhesive surface of FLECTORTISSUGELEP. Apply the adhesive surface of FLECTORTISSUGELEP to the joint or painful area. FLECTORTISSUGELEP can be held in place by an elastic net, if the area to be treated requires it. In all cases, follow the recommendations of your doctor or pharmacist. Symptoms and instructions in case of overdose If you have used more FLECTORTISSUGELEP 1%, medicated plaster than you should have You should tell your doctor or pharmacist. Instructions in case of missed doses If you forget to use FLECTORTISSUGELEP 1% medicated plaster Do not take a double dose to make up for the dose you forgot to take. Risk of withdrawal syndrome Not applicable. WHAT ARE THE POSSIBLE SIDE EFFECTS? Description of side effects Like all medicines, FLECTORTISSUGELEP 1%, medicated plaster is likely to have side effects, although not everyone is susceptible. If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist. - Skin reactions are sometimes reported: itching, redness of the skin, rash, eczema, skin inflammation. - Allergic reactions or skin reactions after exposure to the sun and UV light have been observed in exceptional cases. In all such cases, treatment should be stopped immediately and your doctor notified. - Other general effects of non-steroidal anti-inflammatory drugs may also occur, depending on the condition of the treated area and the duration of treatment. In these cases, you should inform your doctor. HOW TO STORE FLECTORTISSUGELEP 1%, medicated plaster Keep out of the reach and sight of children. Do not use FLECTORTISSUGELEP 1% medicated plaster after the expiry date stated on the box. The expiry date refers to the last day of the month. Store at a temperature not exceeding +25°C. After first opening the sealed envelope: Store for a maximum of 3 months. Do not dispose of the medicine in the sewage system or in the household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment. If necessary, warnings about visible signs of deterioration Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment. ADDITIONAL INFORMATION Full list of active ingredients and excipients What does FLECTORTISSUGELEP 1% medicated plaster contain? The active substance is: As diclofenac epolamine For a medicated plaster of 10 cm x 14 cm. The other components are: Carrier: Polyester non-woven backing. Adhesive layer (active gel): Gelatin, povidone K90, liquid sorbitol (non-crystallizable), heavy kaolin, titanium dioxide (E 171), propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), disodium edetate (E 385), tartaric acid, aluminium aminoacetate, sodium carmellose, sodium polyacrylate, 1,3-butylene glycol, polysorbate 80, perfume DALIN PH (propylene glycol, benzyl salicylate, phenyl ethyl alcohol, alpha amylcinnamic aldehyde, hydroxycitronellal, phenyl ethyl acetate, cinnamyl acetate, benzyl acetate, terpineol, cinnamic alcohol, cyclamenaldehyde), purified water. Pharmaceutical form and content What is FLECTORTISSUGEP 1%, MEDICINAL SPRAY and what does it contain? This medicine is in the form of a medicated plaster. The plasters are packaged in a sealed envelope containing 2 or 5 plasters. Not all presentations may be marketed. Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different Holder Laboratoires GENEVRIER SA 280, rue de Goa Les Trois Moulins - Parc de Sophia Antipolis 06600 Antibes Operator LABORATOIRES GENEVRIER S.A. 280 RUE DE GOA LES TROIS MOULINS PARC DE SOPHIA ANTIPOLIS 06600 ANTIBES Manufacturer LABORATOIRES GENEVRIER S.A. 280 RUE DE GOA LES TROIS MOULINS PARC DE SOPHIA ANTIPOLIS 06600 ANTIBES Names of the medicinal product in the Member States of the European Economic Area Not applicable. Date of approval of the package leaflet The last date on which this package insert was approved was {date}. MA under exceptional circumstances Not applicable. Detailed information on this medicinal product is available on the website of Afssaps (France). Information for healthcare professionals only Not applicable. HEALTH EDUCATION ADVICE If you have just suffered a trauma or contusion, or if you have osteoarthritis of the knee, you can use FLECTORTISSUGELEP to relieve your pain, but: If you have a sprained ankle - if you absolutely cannot stand on your leg to take 4 steps, - or if a haematoma (bruise) appears within 24 to 48 hours or if there is a deformation or a very important oedema (swelling), you must consult your doctor who alone will judge the necessity of an X-ray and an orthopaedic treatment. In case of tendino-ligamentary pain if the pain is such that you cannot use the upper or lower limb that is causing you pain, you must consult your doctor without delay. In case of knee osteoarthritis, your doctor has made the diagnosis your doctor has diagnosed your knee osteoarthritis and has prescribed a treatment with FLECTORTISSUGELEP which should allow your pain to diminish or even disappear completely within 15 days. If a new attack of pain occurs, you will recognize your mechanical pain when going up and down stairs or when walking, especially on uneven ground. You can use FLECTORTISSUGELEP under these conditions. If the pain is different: predominantly nocturnal or accompanied by redness, rash, severe swelling, fever, malaise or diffuse pain, you should consult your doctor immediately. In all cases if there is a complete functional impotence, you must consult your doctor without delay.
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UPUTSTVO ZA PACIJENTA LYSOBACT P SPRAY® sa aromom banane sprej za usnu sluznicu, otopina lizozim/piridoksin Prije upotrebe pažljivo pročitajte ovo uputstvo! Ovaj lijek možete kupiti bez ljekarskog recepta. Potrebno je da se pridržavate ovog uputstva kako bi primjenom lijeka dobili najbolje rezultate. Uputstvo sačuvajte. Možda ćete željeti ponovo da ga pročitate. Ako imate dodatnih pitanja obratite se ljekaru ili farmaceutu. U ovom uputstvu možete pročitati: - Šta je lijek LYSOBACT P SPRAY® i za šta se primjenjuje - Prije nego počnete primjenjivati lijek LYSOBACT P SPRAY® - Kako primjenjivati lijek LYSOBACT P SPRAY® - Moguća neželjena djelovanja - Kako čuvati lijek LYSOBACT P SPRAY® - Dodatne informacije Ova stranica je također dostupna na: Engleski Lijek LYSOBACT P SPRAY® sadrži dvije aktivne supstance, lizozim hidroklorid i piridoksin hidroklorid. Pripada grupi lijekova koji djeluju na respiratorni sistem – lokalni antiseptik. Lijek se primjenjuje za liječenje blage grlobolje koja nije praćena povišenom tjelesnom temperaturom, afti i ranica u ustima u odraslih i djece starije od 2 godine. Lijek LYSOBACT P SPRAY® ne smijete primjenjivati: - Ako ste Vi ili Vaše dijete preosjetljivi na lizozim hidroklorid ili piridoksin hidroklorid ili na bilo koje druge sastojke lijeka (navedene u dijelu 6. Dodatne informacije) - Ako ste Vi ili Vaše dijete preosjetljivi na jaja (jer je lizozim izdvojen iz bjelanceta kokošijeg jajeta) - Ako je Vaše dijete mlađe od 2 godine Ako se bilo šta od navedenog odnosi na Vas razgovarajte sa Vašim ljekarom ili farmaceutom prije primjene ovog lijeka. Budite oprezni s lijekom LYSOBACT P SPRAY® Primjenom velikih doza piridoksina (vitamina B6) tokom dužeg vremenskog perioda (više mjeseci, ili čak godina) mogu se javiti trnci, poremećaj ravnoteže, drhtanje ruku i stopala, te otežana koordinacija pokreta, koji se obično povlače nakon prestanka primjene lijeka. Ovaj lijek ne smijete primjenjivati duže od 5 dana, s obzirom da bi lijek mogao dovesti do poremećaja ravnoteže normalne mikroflore usne šupljine sa rizikom širenja bakterijske ili gljivične infekcije. Bol u grlu U slučaju pojave drugih simptoma (povišena temperatura, gnojni ispljuvak, otežano gutanje), pogoršanja ovih simptoma ili ukoliko ne dođe do poboljšanja u roku od 5 dana, posavjetujte se sa Vašim ljekarom. Afte, ranice u ustima U slučaju da se lezije prošire, njihovo trajanje produži ili u slučaju nastanka povišene temperature, odmah se posavjetujte sa Vašim ljekarom. Primjena drugih lijekova s lijekom LYSOBACT P SPRAY® Imajte u vidu da se ove informacije mogu odnositi i na lijekove koje više ne primjenjujete, kao i na lijekove koje planirate da primjenjujete u budućnosti. Obavijestite svog ljekara ako primjenjujete, ili ste nedavno primjenjivali neki drugi lijek, uključujući i lijek koji se nabavlja bez ljekarskog recepta. Ne primjenjujte nekoliko antiseptika istovremeno. Ovaj lijek sadrži lizozim hidroklorid i piridoksin hidroklorid. Postoje i drugi lijekovi sličnog sadržaja. Ne primjenjujte ih istovremeno sa lijekom LYSOBACT P SPRAY® da ne bi prekoračili maksimalne preporučene doze lijeka (vidjeti doziranje i način primjene). Primjena hrane i pića s lijekom LYSOBACT P SPRAY® Primjena hrane i pića ne bi trebala uticati na efikasnost lijeka LYSOBACT P SPRAY®. Trudnoća i dojenje Prije nego što počnete da primjenjujete neki lijek, posavjetujte se sa svojim ljekarom ili farmaceutom. Trudnoća Kao mjera opreza, ne preporučuje se primjena ovog lijeka tokom trudnoće. Dojenje S obzirom da nema dovoljno podataka o izlučivanju lizozima u majčino mlijeko, te na veliki udio piridoksina, lijek treba izbjegavati za vrijeme dojenja. Upravljanje vozilima i mašinama LYSOBACT P SPRAY® ne utiče na sposobnost upravljanja vozilima i/ili rukovanja mašinama. Ostala upozorenja LYSOBACT P SPRAY® sadrži sorbitol nekristalizirajući (E 420). Ako Vam je ljekar rekao da imate bolest tzv. nepodnošenja nekih šećera, prije nego počnete primjenjivati ovaj lijek posavjetujte se sa svojim ljekarom. Može imati blago laksativno djelovanje. LYSOBACT P SPRAY® sadrži metilparahidroksibenzoat (E 218) i propilparahidroksibenzoat (E 216) koji mogu uzrokovati alergijske reakcije (moguće i reakcije odgođene preosjetljivosti). LYSOBACT P SPRAY® sadrži propilenglikol. Može uzrokovati alkoholu slične simptome. Lijek primijenite prema priloženom uputstvu. Ako mislite da je djelovanje lijeka prejako ili preslabo, posavjetujte se sa ljekarom ili farmaceutom. Način primjene - Preporučuje se primjena lijeka samo za jednog pacijenta. - Prije prve primjene, potrebno je skinuti zaštitnu kapicu sa pumpice za raspršivanje. - Nakon toga, aplikator za sprej raspršivač laganim pritiskom postavite na pumpicu za raspršivanje. - Aplikator je bočno pomičan i osigurava pravilnu aplikaciju spreja u usnu šupljinu. - Aplikator trebate okrenuti prema gore, pod pravim uglom u odnosu na bočicu. - Prije prve aplikacije spreja, pumpicu za raspršivanje trebate prvo pritisnuti nekoliko puta, dok se ne postigne ujednačeno raspršivanje. - Usta trebate potpuno otvoriti, usmjeriti aplikator prema oboljelom mjestu i pritisnuti pumpicu za raspršivanje onoliko puta koliko je naznačeno u doziranju lijeka. - Za vrijeme raspršivanja trebate zadržati dah. - Nakon primjene lijeka, aplikator trebate okrenuti prema dolje, pri čemu se raspršivanje blokira. Doziranje Ovaj lijek je namijenjen odraslim i djeci starijoj od 2 godine. Pri jednom pritisku pumpice za raspršivanje oslobađa se 0,20 ml otopine koja sadrži 4 mg lizozima i 2 mg piridoksina. Za pojedinačnu dozu, potrebno je pet puta pritisnuti pumpicu za raspršivanje. Odrasli i djeca starija od 6 godina: pet puta pritisnuti pumpicu za raspršivanje, 6-8 puta na dan. Djeca u dobi 2-6 godina: pet puta pritisnuti pumpicu za raspršivanje, 3 puta na dan. Djeca mlađa od 2 godine: LYSOBACT P SPRAY® se ne preporučuje djeci mlađoj od 2 godine. Između svake primjene mora postojati razmak od najmanje 1 sata. Liječenje traje 5 dana. Ako ne dođe do poboljšanja stanja nakon 5 dana liječenja, posavjetujte se sa Vašim ljekarom. Ako primijenite više lijeka LYSOBACT P SPRAY® nego što ste trebali Ako ste primijenili veću količinu lijeka od propisane, odmah se obratite svom ljekaru ili farmaceutu! Ako Vi ili Vaše dijete primijenite više lijeka LYSOBACT P SPRAY® nego što ste trebali ili slučajno progutate nešto tečnosti direktno iz bočice, odmah se javite Vašem ljekaru. Ponesite sa sobom pakovanje lijeka, da biste mogli pokazati koji lijek ste progutali. Primjenom velikih doza lijeka tokom dužeg vremenskog perioda (više mjeseci, ili čak godina) moguća je pojava periferne neuropatije (trnci, drhtanje ruku i stopala, mišićna slabost) koja se obično povlači nakon prestanka primjene lijeka. Ako ste zaboravili primijeniti lijek LYSOBACT P SPRAY® Ako ste zaboravili primijeniti lijek, ne primjenjujte dvostruku količinu lijeka naknadno, već nastavite primjenu lijeka prema uobičajenom rasporedu. Ako zaboravite primijeniti LYSOBACT P SPRAY®, učinite to čim se sjetite. Nakon toga, nastavite s primjenom lijeka prema uobičajenom rasporedu i na preporučeni način. Ako prestanete primjenjivati lijek LYSOBACT P SPRAY® Ukoliko naglo prestanete primjenjivati ovaj lijek, ne očekuju se nikakvi štetni uticaji na Vaš organizam. U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom lijeka LYSOBACT P SPRAY® obratite se svom ljekaru ili farmaceutu. Kao i svi drugi lijekovi tako i lijek LYSOBACT P SPRAY® može izazvati neželjena djelovanja, mada se ona ne moraju ispoljiti kod svih. Može doći do pojave alergijskih reakcija kao što su: - Kožni osip, jak svrbež na koži, osjetljivost kože na sunčevo svjetlo (fotosenzitivnost). - Teška alergijska reakcija (anafilaktički šok), iznenadno oticanje lica i vrata (Kvinkeov edem). Prijavljivanje sumnje na neželjena djelovanja lijeka U slučaju bilo kakvih neželjenih reakcija nakon primjene lijeka potrebno je obavijestiti Vašeg ljekara ili farmaceuta. Ovo podrazumijeva sve moguće neželjene reakcije koje nisu navedene u ovom uputstvu o lijeku, kao i one koje jesu. Lijek LYSOBACT P SPRAY® morate čuvati izvan dohvata i pogleda djece. Čuvati na temperaturi do 25 °C. Ne zamrzavati. Rok trajanja: 24 mjeseca. Lijek LYSOBACT P SPRAY® se ne smije koristiti poslije isteka roka upotrebe navedenog na pakovanju. Šta lijek LYSOBACT P SPRAY® sadrži 1 ml lijeka LYSOBACT P SPRAY® sadrži lizozim hidroklorida 20,00 mg (što odgovara 800 000 FIP jedinica) i piridoksin hidroklorida 10 mg. Pri jednom pritisku pumpice za raspršivanje oslobađa se 0,20 ml otopine koja sadrži 4 mg lizozima i 2 mg piridoksina. Lijek LYSOBACT P SPRAY® sadrži sljedeće pomoćne supstance: cetilpiridin klorid, sorbitol nekristalizirajući (E 420), propilenglikol, metilparahidroksibenzoat (E 218), propilparahidroksibenzoat (E 216), aromu banane, saharin natrij, natrij hidroksid, prečišćenu vodu. Kako lijek LYSOBACT P SPRAY® izgleda i sadržaj pakovanja Lijek LYSOBACT P SPRAY® je bistra, bezbojna do svijetložuta otopina. Sadržaj pakovanja: smeđa staklena bočica 30 ml ili bijela PE bočica 30 ml sa pumpicom za raspršivanje sa zaštitnom kapicom i aplikatorom za sprej raspršivač. Pumpica oslobađa 0,20 ml po pritisku. Ime i adresa nositelja dozvole za stavljanje gotovog lijeka u promet Bosnalijek d.d., Sarajevo, Jukićeva 53, Bosna i Hercegovina Ime i adresa proizvođača lijeka Bosnalijek d.d., Sarajevo, Jukićeva 53, Bosna i Hercegovina Režim izdavanja lijeka Lijek se izdaje bez ljekarskog recepta. Datum i broj dozvole za stavljanje lijek u promet LYSOBACT P SPRAY® sa aromom banane, 30 ml, (20 mg/ml + 10 mg/ml), sprej za usnu sluznicu, otopina (staklena bočica): 04-07.3-1-4553/17 od 02.03.2018. LYSOBACT P SPRAY® sa aromom banane, 30 ml, (20 mg/ml + 10 mg/ml), sprej za usnu sluznicu, otopina (polietilenska bočica): 04-07.3-1-4596/17 od 02.03.2018.