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In this manual : WHAT IS MAGNEVIE B6 100 mg/10 mg, film-coated tablet AND WHAT IS IT USED FOR? WHAT YOU SHOULD KNOW BEFORE TAKING MAGNEVIE B6 100 mg/10 mg film-coated tablet HOW TO TAKE MAGNEVIE B6 100 mg/10 mg, film-coated tablet? WHAT ARE THE POSSIBLE SIDE EFFECTS? HOW TO CONSERVE MAGNEVIE B6 100 mg/10 mg, film-coated tablet? ADDITIONAL INFORMATION WHAT IS MAGNEVIE B6 100 mg/10 mg, film-coated tablet AND WHAT IS IT USED FOR? Pharmacotherapeutic class MINERAL SUPPLEMENT. This medicine contains magnesium. The combination of a number of the following symptoms may indicate a magnesium deficiency: - nervousness, irritability, mild anxiety, transient fatigue, minor sleep disturbances, - manifestations of anxiety, such as digestive spasms or palpitations (healthy heart), - muscle cramps, tingling. The intake of magnesium can improve these symptoms. If there is no improvement in these symptoms after one month of treatment, it is not worth continuing. WHAT YOU SHOULD KNOW BEFORE TAKING MAGNEVIE B6 100 mg/10 mg, film-coated tablet List of information needed before taking this medicine If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine. Never take MAGNEVIE B6 100 mg/10 mg, film-coated tablet in the following cases: - Known allergy to one of the constituents of this medicine (see composition), - severe renal insufficiency (failure of kidney functions). IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE. Precautions for use; special warnings Take care with MAGNEVIE B6 100 mg/10 mg, film-coated tablet: Special warnings This medicine should not be used in patients with galactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption syndrome (rare hereditary diseases). High doses of pyridoxine (or vitamin B6) over a long period of time (months or years) may cause tingling and disturbance of balance, tremors of the hands and feet, and difficulties in the coordination of movements. These effects are usually reversible when treatment is stopped. Precautions for use The dosage is not suitable for children under 12 years. In case of moderate renal insufficiency, precautions should be taken to avoid the risk of increased magnesium in the blood. IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE. Interactions with other medicines Taking or using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including phosphate or calcium salts, even if they are 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 The use of this medicine may be considered during pregnancy if necessary, regardless of the term. If you discover that you are pregnant during treatment, consult your doctor as only he/she can judge the need to continue the treatment. Breastfeeding It is recommended that the dose of 20 mg/day of vitamin B6 not be exceeded in women who are breastfeeding. Ask your doctor or pharmacist for advice before taking any medication. Not applicable. Effects on ability to drive and use machines Not applicable. List of excipients with a known effect List of excipients with a notable effect: lactose. HOW TO TAKE MAGNEVIE B6 100 mg/10 mg, film-coated tablet Instructions for proper use Not applicable. Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment This medicine is intended for adults and children aged 12 to 15 years. Dosage In adults: 3 to 4 tablets per day divided into 2 or 3 intakes during meals. For children aged 12 to 15 years: 2 to 4 tablets per day, divided into 2 or 3 doses with meals. If you feel that the effect of MAGNEVIE B6 100 mg/10 mg, film-coated tablet is too strong or too weak, consult your doctor or pharmacist. How to take it Take by mouth. The tablets should be swallowed as they are with a glass of water. Frequency of administration The daily dose should preferably be divided into several doses before or during a meal. Duration of treatment If the symptoms do not improve after one month of treatment, there is no need to continue the treatment. Symptoms and instructions in case of overdose If you have taken more MAGNEVIE B6 100 mg/10 mg film-coated tablets than you should have: Oral magnesium overdose does not usually lead to toxic reactions in cases of normal kidney function. Magnesium intoxication may, however, develop in cases of renal failure. Instructions in case of missed dose(s) If you forget to take MAGNEVIE B6 100 mg/10 mg, film-coated tablet: do not take a double dose to make up for the one you have forgotten to take. Risk of withdrawal syndrome Not applicable. WHAT ARE THE POSSIBLE SIDE EFFECTS? Description of side effects Like all medicines, MAGNEVIE B6 100 mg/10 mg, film-coated tablet is likely to have undesirable effects, although not everyone is subject to them: - diarrhea, - abdominal pain, - skin reactions, - allergic reactions. If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist. HOW TO STORE MAGNEVIE B6 100 mg/10 mg, film-coated tablet Keep out of the reach and sight of children. Do not use MAGNEVIE B6 100 mg/10 mg, film-coated tablet after the expiry date stated on the box. The expiry date refers to the last day of the month. No special storage precautions. If necessary, warnings against certain 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 MAGNEVIE B6 100 mg/10 mg, film-coated tablet contain? The active ingredients are: As anhydrous magnesium citrate For one film-coated tablet. The other components are: Core: anhydrous lactose, macrogol 6000, magnesium stearate. Film coating: hypromellose, macrogol 6000, titanium dioxide (E171), talc. Pharmaceutical form and content What is MAGNEVIE B6 100 mg/10 mg, film-coated tablet and what does it contain? This medicine is presented as film-coated tablets. Boxes of 30, 60, 90 or 120. All presentations may not be marketed. Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different Holder SANOFI-AVENTIS FRANCE 1-13, BOULEVARD ROMAIN ROLLAND Operator SANOFI-AVENTIS FRANCE 9, BOULEVARD ROMAIN ROLLAND Manufacturer SANOFI WINTHROP INDUSTRIE 1, RUE DE LA VIERGE AMBARES ET LAGRAVE 33565 CARBON BLANC CEDEX or SANOFI WINTHROP INDUSTRIE 56 ROUTE DE CHOISY AU BAC 60205 COMPIEGNE 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 reserved for health professionals Not applicable. HEALTH EDUCATION ADVICE Health education advice recommended in the case of a combination of symptoms that may suggest a magnesium deficiency: - a balanced diet, rich in green vegetables, meat, cocoa, milk, pulses, - moderate consumption of alcohol, coffee or tea, stop smoking, limit exposure to stress, - regular physical activity, - sufficient sleep, respecting the daily rhythm. Warning signs that require medical attention: Do not attempt to take care of yourself if: - your symptoms are accompanied by other general signs (loss of appetite, weight loss, fever), - your symptoms persist beyond one month, or if they get worse, - your symptoms are accompanied by other disturbances such as: profound sadness, felt as moral pain, loss of pleasure or interest in any activity. These signs may be symptoms of a more serious disease, a medical opinion is necessary.
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UPUTSTVO ZA PACIJENTA LYSOBACT® 20 mg/10 mg, komprimovane lozenge lizozim/piridoksin Pažljivo pročitajte ovo uputstvo jer ono sadrži informacije koje su važne za Vas! 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: Ova stranica je također dostupna na: Albanski Makedonski Srpski Ukrajinski Engleski Hrvatski Lijek LYSOBACT sadrži dvije aktivne supstance koje se zovu lizozim klorid i piridoksin klorid. 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 6 godina. Lijek LYSOBACT ne smijete primjenjivati: - Ako je Vaše dijete mlađe od 6 godina. - Ako ste preosjetljivi na lizozim klorid ili piridoksin klorid ili na bilo koje druge sastojke lijeka (navedene u dijelu 6. Dodatne informacije). - Ako ste preosjetljivi na jaja (jer je lizozim izdvojen iz bjelanceta kokošijeg jajeta). Budite oprezni s lijekom LYSOBACT 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 ako se lezije prošire, njihovo trajanje produži ili u slučaju nastanka povišene temperature, odmah se posavjetujte sa Vašim ljekarom. Primjena drugih lijekova s lijekom LYSOBACT 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 klorid i piridoksin klorid. Postoje i drugi lijekovi sličnog sadržaja. Ne primjenjujte ih istovremeno sa lijekom LYSOBACT da ne bi prekoračili maksimalne preporučene doze lijeka (vidjeti doziranje i način primjene). Primjena hrane i pića s lijekom LYSOBACT Primjena hrane i pića ne bi trebala uticati na efikasnost lijeka LYSOBACT. Trudnoća i dojenje Prije nego što počnete da primjenjujete neki lijek, posavjetujte se sa svojim ljekarom ili farmaceutom. Trudnoća Kao mjera opreza, preporučuje se da se ovaj lijek ne primjenjuje 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 ne utiče na sposobnost upravljanja vozilima i/ili rukovanja mašinama. Ostala upozorenja Lijek LYSOBACT sadrži laktozu. U slučaju netolerancije na neki od šećera, obratite se Vašem ljekaru prije primjene ovog lijeka. Lijek primijenite prema priloženom uputstvu. Ako mislite da je djelovanje lijeka prejako ili preslabo, posavjetujte se sa ljekarom ili farmaceutom. Doziranje: Ovaj lijek je namijenjen odraslima i djeci starijoj od 6 godina. Uobičajena doza je 6 do 8 komprimovanih lozengi tokom dana. Način primjene: Lijek se primjenjuje oralno (na usta). Komprimovane lozenge treba ostaviti da se polako istope ispod jezika. Učestalost primjene Između svakog uzimanja mora postojati razmak od najmanje 1 sata. Trajanje liječenja Liječenje traje 5 dana. Ako ne dođe do poboljšanja stanja nakon 5 dana liječenja, posavjetujte se sa Vašim ljekarom. Ako primijenite više lijeka LYSOBACT nego što ste trebali Ako ste primijenili veću količinu lijeka od propisane, odmah se obratite svom ljekaru ili farmaceutu! 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. U slučaju predoziranja odmah se javite svome ljekaru, kako bi Vam mogao pružiti pomoć. Ako ste zaboravili primijeniti lijek LYSOBACT Ako ste zaboravili primijeniti lijek, ne primjenjujte dvostruku količinu lijeka naknadno, već nastavite primjenu lijeka prema uobičajenom rasporedu. Ako zaboravite primijeniti LYSOBACT, učinite to čim se sjetite. Nakon toga, nastavite s primjenom lijeka LYSOBACT prema uobičajenom rasporedu i na preporučeni način. Ako prestanete primjenjivati lijek LYSOBACT Ovaj lijek primjenjujte onoliko dugo koliko Vam je propisao ljekar. Nagli prekid primjene ovog lijeka ne bi trebao štetno uticati na Vaš organizam. Kao i svi drugi lijekovi tako i lijek LYSOBACT 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 morate čuvati izvan dohvata i pogleda djece. Čuvati na temperaturi do 30 °C. Rok trajanja: 5 godina. Lijek LYSOBACT se ne smije upotrijebiti nakon isteka roka upotrebe navedenog na pakovanju Šta lijek LYSOBACT sadrži Jedna LYSOBACT komprimovana lozenga sadrži: lizozim klorida 20 mg i piridoksin klorida (vitamin B6) 10 mg. LYSOBACT komprimovane lozenge sadrže sljedeće pomoćne supstance: laktozu, tragakant, saharin natrij, magnezij stearat, vanilin. Kako lijek LYSOBACT izgleda i sadržaj pakovanja LYSOBACT komprimovane lozenge su bijele do gotovo bijele boje, glatkih neoštećenih bridova, okruglog oblika sa utisnutom diobenom crtom sa jedne strane, a ravne glatke površine sa druge strane, prečnika 8 mm. LYSOBACT komprimovane lozenge su pakovane u kutije sa sadržajem 10 komprimovanih lozengi (1 blister sa po 10 komprimovanih lozengi) i kutije koje sadrže 30 komprimovanih lozengi (3 blistera sa po 10 komprimovanih lozengi). Proizvođač Bosnalijek d.d., Jukićeva 53, Sarajevo, Bosna i Hercegovina Proizvođač gotovog lijeka Bosnalijek d.d., Jukićeva 53, Sarajevo, Bosna i Hercegovina Nosilac dozvole za stavljanje lijeka u promet Bosnalijek d.d., Jukićeva 53, Sarajevo, Bosna i Hercegovina Režim izdavanja lijeka Lijek se izdaje bez ljekarskog recepta. Broj i datum rješenja o dozvoli za stavljanje gotovog lijeka u promet Lysobact 10 komprimovanih lozengi: 04-07.3-2-3046/17 od 20.07.2017. Lysobact 30 komprimovanih lozengi: 04-07.3-2-3062/17 od 20.07.2017.