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Contents
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8. The leaflet format was set by the Ministry of Health and its content has been reviewed and approved by it BYETTA BYETTA 5 Hg 10 pg Solution for injection Solution for injection Presented in a prefilled pen Presented in a prefilled pen containing 1 2 ml containing 2 4 ml The pen delivers a fixed dose The pen delivers a fixed dose of 5 microgram of 10 microgram Each prefilled pen contains 60 doses of Byetta for subcutaneous injection twice daily for 30 days of use Composition Each ml contains Exenatide 0 25 mg Inactive ingredients Metacresol mannitol glacial acetic acid sodium acetate trihydrate water for injections Therapeutic group Peptide with incretin like action Therapeutic activity Byetta is used to improve control of your blood glucose blood sugar level in patients with type 2 diabetes Byetta is given in addition to oral medications for the treatment of diabetes Diabetes occurs when the body does not produce a sufficient amount of insulin for control of blood glucose level or when the body is unable to use the insulin properly Byetta enhances the secretion of insulin when blood glucose levels are high When should the preparation not be used Do not use this medicine if you are pregnant or breastfeeding Do not use this medicine if you are sensitive to any of its ingredients Do not take this medicine without consulting a doctor before starting treatment If you are suffering from sev
9. A NNAYVI AYTA 7ND T AY 07U AT VION NIN NPT y 201127111971013 7W 1103 WwW 7Y MI ROMA 7IDN 0N ODN AOT NW WE ANN Ny U7 II IN 072 2192 lt 3 ITD NON 1 0191 qwinnl IN 03 AND 031 2373713 7111771 7Y TWAT D 7I7JW 011120 VT 27271 1771 ITD NON 1 191 7ID ON 79N NIND AIT pnw NIVEN NAPY D N Y7 OAT A 1179112 VW qnwarna VPW 7N DX IX AT 7V2 IN N7W 17 NIYIN D W IN Aw N17 792 TA KONA DY YY NN7 77y N 779N 1 1272 NON NININ 97 PV DY7NINN AINA 7Y WAY7 X D0 1NX7 DI 30 77W07 OIA ONY 27D 5 7U 1315 DY 779 PT 719077 7 Dra D DYD 47 10 7U jN7 171717 N 790M0 RONDA 11271217 DNNN3 IDOI OW 18 7 27 NONNA 271211121 21712 WUID UN NIVY DINO 790NN NON Y VAIW 1 53 DAN DIN IT NONNI 0121107 W IATa ANAN NINA NX O I IT NIN 7Y 2717 W ANZA DT IT NON 71017 NNIW ON TN 3 NID nw 710 7 PN DIN DIW 70 A T NI N7 A TI7Y A NX 37 DWN NAY ANI IN 257192 MN NIYO N70 ON DAWDD IN NIIN INO Nin NI7 N37 21137 7I7Y NONY 77W AN py PT NID 7 TY NDI7 N97 YW 211277721917 7W WIN W DIN D OND N7713 NPN NON NTN TANI 71720 MTM OYA WIN W7 NIOWON NINA 79 NND NI YI IN JOAN WV UTN7 273 NW NN AWA AON 71717 w wal 371AN NAN 397 NITIN 60 77003 NINU DT 722 OIA D DYD NON 7771117 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS PREPARATIONS 1986 The dispensing of this medicine requires a doctor s prescription Read this package insert carefully in its entirety before using this medicine
10. I7Y PAID ANY OT NDIN AIO NID nny 121 NITY A 711121012 1111122 117192 2 Nan7 77U yawaA NwWINN NX 5322117 ANNA NX 7171977 WY NONY UID UN 77U31 7 NININ 11703 1157 X9N7 7D 7Y Y TIN7 77y PNW 27917117 IN MWD 1127 N W 23 QN ON DNNN NENONN J 2 NAN NIIT7 7 7y NINN 25913112 7O ANY AT MAA DX IX NOON 279111 N 701 QN DX 1237 TNID3 1111191317 2 111213112 2121317 NI7 Y IN IN 611120 YNN7 12 79132 7 Mian 711127712 nionn niyoin 1 777W OF DIN N 7Y ANNNA Y DUN PR FVD DA NNI 7710 NINI D nion nnA 111212 7 7017 NII IN I TN7NY ODI3D IPX 7ID3 N DY 1271 13 win w AON PT NANI 111917711 11390 7Y VWN N7I7YI 721711 NANNA NX NONN AON qWaw NNN NN 77 NYY 237 XON DY YVON AD 11117 VAY 52172 NAWN UR non WT N 70N MOND NANT 197 NYU 1111197 111177 YNN Nj7 OI 3 O1N 7 MON NNT MDNDO AIRW ANNR IN FON DY 710 7 Y7DID IN DY 71017 ww 71 DYNN NAXwWY DYA NYA7N NIONN iad AX 70 9 NX yawn Y 1117123 71 MOND NNN NNN Nivw 4 IN 1197 NYU 111197 710 7 w NIVOIN D RUZ MIYDIN Y DIN7 NI7I7Y N3 WID UN DTI NNN 7U PNN 1717197 90102 JOA AND NDwNA NINA PN IN AVION NIN INDO WX AND ANN DVN 77U NYOMN WN AT JANDA ATO AWTIN AN NYT NMAYY ATN TNA OTN 1117211030 NIIN ANN7 Wy DT WN NOTIN 779 MTN AX ANIA aN WA AID ANAND 7 NTNI D NION NN NI3 NDN NII7 NIYOIN DN UNZIOZIO AON AONN DY Wn MNN NON UNINN7 ATTY MAAD IN 71373 MININ AWTIN NNN UN AND 71727 617121 271121772191 7W 0 jpn 7ID ON JOIN 7Y NOMA yYINT W AT M
11. PA8795000IL1 1986 I nwnn PTPN D N7IN NIIN 97 2325 17Y NOI OWA N3 N IT NON NDINNA WNNWN OWA IDID TY 17 NN PY 7 IT 7Y WINI 7733 DIN NINN Mwy yY 12773 NT 7Y OND NON NON 2770 10 27770 5 17 1117 NDN 17 1117 NDAN N7N ATTN OY WAIN NIN NaN Oy 0 7N 2 4 TONN 7 1 2 TONN 7W nylay 232 Mnwn vyn 7U nylay nan Mnwn vyn A 7 10 a n 5 W 30 7 DI NNIY NN 27 717117 NON NID 60 VON NWM AVN OY 7D WINY 2230 Exenatide 0 25 mg 722 YN D DPY 2772 0 Metacresol mannitol glacial acetic acid sodium acetate trihydrate water for injections OZR NWT NI7 YD W TODD 272019733 7 TINI NIT yO NN AON 2 2102 117210 17112 OTA AIDA NID 7Y NO 7UN WD W7 NWI NONI M102 719 07 NON PT N 70N 93100 Ni9nn7 4012 DT VIDA NID 7Y N1173 DWY 7101 ODN AN WN AAN WAND 11177119 0 DTN 7IDYNN NX 7 37 712 VX QAN WAND IN AMA DT DION NIN AWARD PAN wWN9N7 59127 NYON NON 1wWoNnr 01010007 P N NN APYN IN INA WA UND NNN WANWYN 7N ANNA 13 330 TAN NIWAN 77 NYIT DN WONw7 PN NINN 197 NOI YVIPN7 7aN NONNA WNNwW 7 N OT7N TA N 7OIWN IN NON 111172 11711212 11 7210 317 ON DYN NWN NWI NINN IN AAA 71111 71311112 MIAN AVIAN 11 7210 QN ON IN DITAN 7ANO 7 TNO Nina NID MMN DANN A777 711 7711 117320 ON A7A7N 7117712 1117117 IDON NX 771171117 D 7I7Y I7X DANY 17170 2774 DE Dra Nn 7Y ANNNA yown YR DAAD 7W X7 01337 7I7Y 1371119710 21072 NON DY TM IT 7911112 win wn AAI NMA Any 7y NINA O97 7
12. TD 25027 DY NON 3N OY NX IN OYA D NO DNN ND 7T 1127 12 OY7 MANA NwNNwA AA ONDN NX NUN X N0ND7 VIX NOD PADON 7227207 Y O7 NIN TD NDN DY NININA N77 NONNA 7ID ON NX 7109117 PX QNIN 222 71910 7N ON OA In 7y1n yN 1710111 IN I D T7 7W OT awin7 YIND 1120 21 7122 71207 W NINN NNN 72I IT 71 ma DNNN N 77 J73 NIYO DX IN AN 11112 N70 ON NNN yN 92 YI Qe NOMNN NTR 1 N3NI D 7IN N 3 7W I D WNT TD A7INA AN7NNA 7I5 07 NAWI IT ANNN NDID NWN NNIIN N77 ANN 21127 N JNN IN PHY 5721377 11 291311 VINN 7N 7 TN7 NT7I7Y NIN NANN 1 1300 NNNN N 701 WNW DYD 723 AMA MINA 771137 W Fwina Nionn 710 7 PN 7 D M qN DNX 09 70 MIONN UNI WID UND OF 30 TY NONIAN OYA 21211007 NN NOMN 1 MANN DX D2 NONVAN OY NX 5971 DI 30 7 2 C 8 C aw MINDI NPN NONIN OY NX 0117 w AN NOA 1197 25 C 7 NNNN ONN7 U win wa n7 nn ay NOY VWOINA WONWN7 IND 17 7X MANN ONNAWD OVN NX ONN7 J N D W7 N1 1373 N7321 591 7117 1171003 11191311 D 7DINN NIONNN ATANA N1N 157 DA NX 77 790W N73 YYII N7 77y 790 7U 1770 722 MWN 7U MN YANN 7 DNNN ATN ANINA NNW NIONN ONN7 pN 136873144711 00 136883144611 00 nd5nnn DIWN 0 N71 Dna ANAND 7 7 MN 46120 2160 T N VA NIU 7 7 7N DIWN 7Y3 BYET H 03 985
13. ch of children and or infants to avoid poisoning If you have taken an overdose or if a child has accidentally swallowed the medicine proceed immediately to a hospital emergency room and bring the package of the medicine with you Do not induce vomiting unless explicitly instructed to do so by a doctor This medicine has been prescribed for the treatment of your ailment in another patient it may cause harm Do not give this medicine to your relatives neighbors or acquaintances Do not take medicines in the dark Check the label and the dose each time you take your medicine Wear glasses if you need them Storage Starting from the day you first use the pen it can be used for up to 30 days After 30 days discard the Byetta pen even if there is solution left in the pen Before opening store refrigerated at 2 C 8 C Once in use store below 25 C Protect from light Do not use this preparation if it has been frozen Do not store the pen with the needle attached Even if kept in their original container and stored as recommended medicines may be kept for a limited period only Please note the expiry date of the medicine In case of doubt consult your dispensing pharmacist Do not store different medications in the same package License number 13688314461 1 00 13687314471 1 00 Manufacturer Lilly Pharma Giessen Germany License holder Eli Lilly Israel Ltd RO Box 2160 Herzliya 46120
14. ere kidney disease or are on dialysis If you are suffering from a severe problem with your stomach emptying or from a severe gastrointestinal disease If you suffered from pancreatitis gallstones very high triglyceride levels or from alcoholism these conditions may raise the risk of getting pancreatitis How will this medicine affect your daily life Use of this medicine concomitantly with a sulfonylurea type medicine can cause hypoglycemia low blood glucose levels Hypoglycemia may impair alertness and therefore caution should be exercised when driving a car operating dangerous machinery and in any other activity which requires alertness Using Byetta may reduce your appetite increase your feeling of satiation and reduce your weight Warnings If you are sensitive to any type of food or medicine inform your doctor before commencing treatment with this medicine Drug interactions If you are taking another drug concomitantly or if you have just finished treatment with another medicine inform the attending doctor in order to prevent hazards or lack of efficacy arising from drug interactions This is especially important for medicines belonging to the following groups Sulfonylurea see also sections How will this medicine affect your daily life and Side effects that require special attention Warfarin or coumarol derivatives Use of this medicine concurrently with insulin has not been scientifically establis
15. hed Byetta slows stomach emptying and can affect the absorption of oral medications whose passage through the stomach should be rapid Consult your doctor about the time at which your orally administered medicines should be taken For example antibiotics should be taken at least one hour before injecting Byetta Medicines that are supposed to be taken with food should be taken with a snack or a meal at a time when Byetta is not administered Medicines with a coating that prevents their breakdown in the stomach such as proton pump inhibitors should be taken at least one hour before or four hours after injecting Byetta Side effects In addition to the desired effect of the medicine adverse reactions may occur during the course of treatment such as diarrhea nausea vomiting headache dizziness gastrointestinal disturbance or discomfort abdominal pain redness at the injection site feeling jittery excessive sweating weakness decreased appetite weight loss Nausea is the most common side effect but it usually disappears within a short time following the period of adaptation to the medicine Side effects that require special attention Hypoglycemia may occur when Byetta is given with a sulfonylurea medicine The signs of hypoglycemia can include headache drowsiness weakness dizziness confusion irritability hunger rapid pulse sweating and nervousness In such a case the doctor should be consulted regarding the manner of trea
16. re An overdose of Byetta can cause nausea vomiting dizziness or signs of hypoglycemia Refer to the doctor immediately Directions for use The Byetta package does not include needles See the detailed Pen User Manual included in the package Inject Byetta under the skin Subcutaneous injection only in the area of the thigh the abdomen or the arm Inject Byetta twice daily at anytime within 60 minutes before your morning and evening meals or before two other main meals of the day approximately 6 hours or more apart Do not inject Byetta after a meal Byetta does not affect the rate of absorption of diabetes medicines metformin and sulfonylurea Therefore there is no need to change their usual administration time Do not use the preparation if there are visible particles in the solution or if the solution appears cloudy or colored Use a new needle for each injection and discard it after use After completing the injection close the Byetta pen with the cover in order to prevent exposure to light Do not leave the needle you used attached to the pen in order to prevent leakage of the solution from ne pen or entry of air into the cartridge How can you contribute to the success of the treatment Even if there is an improvement in your health do not stop treatment with this medicine without consulting your doctor Avoid poisoning This medicine and all other medicines must be stored in a secured place out of the rea
17. tment The doctor may instruct a change in the dosage of the sulfonylurea and that your blood glucose level be tested Swelling of the face tongue or throat difficulty swallowing rash and breathing difficulties rare stop treatment and refer to the doctor immediately Pancreatitis rare Symptoms that may indicate pancreatitis include severe and persistent abdominal pain which can be accompanied by vomiting Stop treatment and refer to the doctor immediately Altered renal function rare sometimes associated with dehydration In the event that you experience side effects not mentioned in this leaflet or if there is a change in your general health consult your doctor immediately Dosage Dosage is according to doctor s instructions only Do not exceed the recommended dosage Treatment is generally initiated with a dosage of 5 ug twice daily for 30 days Thereafter in accordance with the attending doctor s recommendation the dosage can be raised to 10 ug twice daily The safety and effectiveness of use in children and adolescents under 18 years of age have not yet been established This medicine is to be used at specific time intervals as determined by the attending doctor If you forget to take this medicine at the specified time skip that dose and take the next dose at the scheduled time Never take two doses together If you accidentally take a double dose or a higher dose than that prescribed you may need urgent medical ca
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