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Contains the active ingredient metformin (met-FOR-min) hydrochloride Consumer Medicine Information For a copy of a large print leaflet, Ph: 1800 195 055 What is in this leaflet Read this leaflet carefully before taking your medicine. This leaflet answers some common questions about metformin It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist or diabetes educator. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. Ask your doctor or pharmacist: if there is anything you do not understand in this leaflet, if you are worried about taking your medicine, or to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. What this medicine is used for The name of your medicine is APO-Metformin 500, 850 or 1000 tablets. It contains the active ingredient metformin (as metformin hydrochloride). It is used to treat type 2 diabetes (also called non-insulin dependent diabetes mellitus or maturity onset diabetes) in adults and children over 10 years of age. It is especially useful in those who are overweight, when diet and exercise are not enough to lower high blood glucose levels (hyperglycaemia). For adult patients, metformin can be used alone, or in combination with other oral diabetic medicines or in combination with insulin in insulin requiring type 2 diabetes. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. How it works Metformin belongs to a group of medicines called biguanides. Metformin lowers high blood glucose by helping your body make better use of the insulin produced by your pancreas. If your blood glucose is not properly controlled, you may experience hypoglycaemia (low blood glucose) or hyperglycaemia (high blood glucose). People with type 2 diabetes are unable to make enough insulin or their body does not respond properly to the insulin it does make. This causes a build up of glucose in the blood, which can lead to serious medical problems with your heart, eyes, circulation or kidneys. There is no evidence that this medicine is addictive. Use in children This medicine should not be used in children under 10 years of age. Before you take this medicine When you must not take it Do not take this medicine if: You have or have had any of the following: type 1 diabetes that is well controlled by insulin alone type 2 diabetes that is already well controlled by diet alone diabetic ketoacidosis (a symptom of uncontrolled diabetes, in which substances called ketone bodies build up in the blood - you may notice this as an unusual fruity odour on your breath, difficulty breathing, confusion and frequent urination) severe liver disease excessive alcohol intake, binge drinking, alcohol dependence severe kidney disease or kidney failure dehydration, severe blood loss, shock a severe infection certain heart or blood vessel problems, including a recent heart attack or severe heart failure (when the heart fails to pump blood effectively) severe breathing difficulties blood clots in the lungs (symptoms include coughing, shortness of breath, chest pain and a fast heart rate) gangrene inflammation of the pancreas (pancreatitis), symptoms include severe upper stomach pain, often with nausea and vomiting. You need to have major surgery or an examination such as an X-ray or scan requiring an injection of iodinated contrast (dye). You must stop taking metformin for a certain period of time before and after the examination or the surgery. Your doctor will decide whether you need any other treatment for this time. It is important that you follow your doctor's instructions precisely. You are breast-feeding. Metformin may pass into human breast milk. You are hypersensitive to, or have had an allergic reaction to, metformin, other biguanides or any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms. If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital. The expiry date (EXP) printed on the pack has passed. The packaging is torn, shows signs of tampering or it does not look quite right. Before you start to take it Before you start taking this medicine, tell your doctor if: You have allergies to: any other medicines any other substances, such as foods, preservatives or dyes. You have or have had any medical conditions, especially the following: kidney problems heart failure. Alcohol can affect the control of your diabetes. Drinking excessive amounts of alcohol while you are being treated with metformin may also lead to serious side effects. Your doctor may suggest you stop drinking or reduce the amount of alcohol you drink. You are currently pregnant or you plan to become pregnant. Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved. You are currently breastfeeding or you plan to breast-feed. Do not take this medicine whilst breastfeeding. You are planning to have surgery or an anaesthetic. You are currently receiving or are planning to receive dental treatment. You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop. Some medicines may interact with metformin. These include: other medicines used to treat diabetes, such as sulfonylureas or repaglinide some medicines used to treat high blood pressure and some heart conditions, including beta-blockers, calcium channel blockers and ACE inhibitors; some examples include metoprolol, nifedipine and enalapril medicines used to prevent blood clots such as warfarin diuretics, also called fluid tablets thyroid preparations such as thyroxine cimetidine, a medicine commonly used to treat reflux and ulcers glucocorticoids such as prednisone and cortisone some medicines used to treat asthma such as salbutamol or terbutaline. If you are taking any of these you may need a different dose or you may need to take different medicines. Other medicines not listed above may also interact with metformin. How to take this medicine Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet. How much to take Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines. Do not stop taking your medicine or change your dosage without first checking with your doctor. Adults The usual starting dose for adults is 500mg one to two times a day. Your doctor may increase or decrease the dose, depending on your blood glucose levels. The maximum recommended dose is 1000mg three times a day. People over 65 years of age or those with kidney problems may need smaller doses. Children & Adolescents The usual starting dose for children from 10 years of age and adolescents is one tablet of 500 mg or 850 mg once daily. Your doctor may increase or decrease the dose, depending on your blood glucose levels. The maximum recommended dose is 2000 mg daily, taken as two or three divided doses. How to take it Swallow the tablets with a glass of water. When to take it Take your medicine during or immediately after a meal, at about the same time each day. This will reduce the chance of a stomach upset. Taking your medicine at the same time each day will have the best effect. It will also help you remember when to take it. How long to take it for Continue taking your medicine for as long as your doctor tells you. Metformin will help control your diabetes but will not cure it. Most people will need to take metformin on a long-term basis. Make sure you have enough to last over weekends and holidays. If you forget to take it If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. Otherwise take it as soon as you remember (with or immediately after a meal) and then go back to taking your medicine as you would normally. Do not take a double dose to make up for missed doses. This may increase the chance of you getting low blood sugar levels (hypoglycaemia). If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember. If you take too much (overdose) If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively, go to the Accident and Emergency department at your nearest hospital. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. If you take too much metformin you may feel sleepy, very tired, sick, vomit, have trouble breathing and have unusual muscle pain, stomach pain or diarrhoea. These may be early signs of a serious condition called lactic acidosis (build up of lactic acid in the blood). You may also experience symptoms of hypoglycaemia (low blood glucose). This usually only happens if you take too much metformin together with other medicines for diabetes or with alcohol. While you are taking this medicine Things you must do Make sure that you, your friends, family and work colleagues can recognise the symptoms of hypoglycaemia and hyperglycaemia and know how to treat them. HYPOGLYCAEMIA Metformin does not normally cause hypoglycaemia, although you may experience it if you also take other medicines for diabetes such as sulfonylureas or repaglinide; or if you also use insulin. Hypoglycaemia can occur suddenly. Initial signs may include: weakness, trembling or shaking sweating light-headedness, dizziness, headache or lack of concentration irritability, tearfulness or crying hunger numbness around the lips and tongue. If not treated promptly, these may progress to: loss of co-ordination slurred speech confusion fits or loss of consciousness. If you experience any of the symptoms of hypoglycaemia, you need to raise your blood glucose immediately. You can do this by doing one of the following: eating 5 to 7 jelly beans eating 3 teaspoons of sugar or honey drinking half a can of non-diet soft drink taking 2 to 3 concentrated glucose tablets. Unless you are within 10 to 15 minutes of your next meal or snack, follow up with extra carbohydrates such as plain biscuits, fruit or milk. Taking this extra carbohydrate will prevent a second drop in your blood glucose level. HYPERGLYCAEMIA Hyperglycemia is often asymptomatic (doesn't cause any immediate symptoms) in many people. However some people will develop symptoms. Those people who develop symptoms may experience the following: high levels of sugar in the urine frequent urination increased thirst. If you develop any signs of hyperglycaemia, contact your doctor immediately. Your doctor may need to consider additional or other treatments for your diabetes. The risk of hyperglycaemia is increased in the following situations: uncontrolled diabetes illness, infection or stress taking less metformin than prescribed taking certain other medicines too little exercise eating more carbohydrates than normal. Tell your doctor that you are taking this medicine if: you are about to be started on any new medicine you are pregnant or are planning to become pregnant you are breastfeeding or are planning to breastfeed you are about to have any blood tests You must also tell your doctor if: you become ill you become dehydrated you are injured you have a fever you have a serious infection you are having surgery (including dental surgery) or are going into hospital Your blood glucose may become difficult to control at these times. You may also be more at risk of developing a serious condition called lactic acidosis. At these times, your doctor may replace metformin with insulin. Go to your doctor regularly for a check-up. Your doctor may want to perform blood tests to check your kidneys, liver, heart and vitamin B12 level while you are taking this medicine. Check your blood glucose levels regularly. This is the best way to tell if your diabetes is being controlled properly. Your doctor or diabetes educator will show you how and when to do this. When you start treatment with metformin, it can take up to two weeks for your blood glucose levels to be properly controlled. Carefully follow the advice of your doctor and dietician on diet, drinking alcohol and exercise. Things you must not do Do not skip meals while taking this medicine. Do not give this medicine to anyone else, even if their symptoms seem similar to yours. Do not take your medicine to treat any other complaints unless your doctor or pharmacist tells you to. Do not stop taking your medicine, or change the dosage, without checking with your doctor Things to be careful of If you have to be alert, for example when driving, be especially careful not to let your blood glucose levels fall too low. Low blood glucose levels may slow your reaction time and affect your ability to drive or operate machinery. Drinking alcohol can make this worse. However, metformin by itself is unlikely to affect how you drive or operate machinery. If you become sick with a cold, fever or flu, it is very important to continue taking metformin even if you feel unable to eat your normal meal. Your diabetes educator or dietician can give you a list of foods to use for sick days. If you are travelling, it is a good idea to: wear some form of identification (e.g. bracelet) showing you have diabetes carry some form of sugar to treat hypoglycaemia if it occurs, for example, sugar sachets or jelly beans carry emergency food rations in case of a delay, for example, dried fruit, biscuits or muesli bars bring your medicine with you, so you don't miss any doses. Possible side effects Tell your doctor as soon as possible if you do not feel well while you are taking metformin. Metformin helps most people with diabetes, but it may have unwanted side effects in a few people. If you are over 65 years of age, report any side effects to your doctor immediately. People over his age may have an increased chance of getting side effects. Ask your doctor or pharmacist to answer any questions you may have. Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not. Tell your doctor or pharmacist if you notice any of the following and they worry you: stomach upset such as feeling sick (nausea) vomiting taste disturbance loss of appetite diarrhoea skin reactions such as redness of the skin, itching or an itchy rash (urticaria) These are generally mild side effects. Stomach upset and diarrhoea are common but usually short-lived. Taking your medicine with meals can help reduce nausea and diarrhoea. Skin rash has been reported rarely. Tell your doctor immediately or go to Accident or Emergency at the nearest hospital if you notice any of the following symptoms of Lactic Acidosis (build up of lactic acid in the blood): nausea, vomiting, stomach pain trouble breathing feeling weak, tired or generally unwell unusual muscle pain sleepiness dizziness or light-headedness shivering, feeling extremely cold slow heart beat. Lactic acidosis is a very rare but serious side effect requiring urgent medical attention or hospitalisation. Although rare, if lactic acidosis does occur it can be fatal. The risk of lactic acidosis is higher in the elderly, those whose diabetes is poorly controlled, those with prolonged fasting, those with certain heart conditions, those who drink alcohol and those with kidney and liver problems. Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Allergic reactions If you think you are having an allergic reaction to metformin, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital. Symptoms of an allergic reaction may include some or all of the following: cough, shortness of breath, wheezing or difficulty breathing swelling of the face, lips, tongue, throat or other parts of the body rash, itching or hives on the skin fainting hay fever-like symptoms. Storage and disposal Storage Keep your medicine in its original packaging until it is time to take it. If you take your medicine out of its original packaging it may not keep well. Keep your medicine in a cool dry place where the temperature will stay below 25°C. Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines. Keep this medicine where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines. Disposal If your doctor tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely. Product description What APO-Metformin 500, 850 or 1000 looks like 500 mg tablets: White coloured, film-coated biconvex capsule shaped tablet with central break-line on one side and '500' embossed on the other side. They are packaged in a blister pack of 100 tablets. 850 mg tablets: White coloured, film-coated, round biconvex tablets plain on one side and '850' embossed on the other side. They are packaged in a blister pack of 60 tablets. 1000 mg tablets: White, film-coated, capsule-shaped, biconvex tablet, plain on one side and a breakline on the other. They are packed in a blister pack of 10, 30, 60 and 90 tablets. * Not all strengths and/or pack sizes may be available. Ingredients Each tablet 500 mg, 850 mg or 1000 mg of metformin hydrochloride as the active ingredient. It also contains the following inactive ingredients: hypromellose macrogol 6000 magnesium stearate povidone propylene glycol silica - colloidal anhydrous sodium starch glycollate starch - maize talc- purified colloidal anhydrous silica titanium dioxide. This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes. Australian Registration Numbers APO-Metformin 500 tablets (blister pack): AUST R 174815. APO-Metformin 850 tablets (blister pack): AUST R 174816. APO-Metformin 1000 tablets (blister pack): AUST R 176509. Sponsor Apotex Pty Ltd 16 Giffnock Avenue Macquarie Park NSW 2113 APO and APOTEX are registered trade marks of Apotex Inc. This leaflet was last updated in:
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Lantus – Uputa o lijeku - Budite prvi i komentirajte! - 12 min čitanja Lantus 100 jedinica/ml otopina za injekciju u ulošku inzulin glargin Pažljivo pročitajte cijelu uputu prije nego što poč nete uzimati lijek, jer sadržava važne informacije za Vas. Upute za uporabu inzulinske brizgalice priložene su uz brizgalicu. Proučite ih prije uporabe lijeka. - Sačuvajte ovu uputu. Možda ćete je trebati ponovo pročitati. - Ukoliko imate dodatnih pitanja obratite se svom liječniku, ljekarniku ili medicinskoj sestri. - Ovaj je lijek propisan Vama. Nemojte ga davati drugima. Može im štetiti, čak i ako imaju simptome jednake Vašima. - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. U ovoj uputi: - Što je Lantus i za što se koristi - Prije nego počnete uzimati Lantus - Kako uzimati Lantus - Moguće nuspojave - Kako čuvati Lantus - Dodatne informacije Što je Lantus i za što se koristi Lantus je otopina za injekciju koja sadržava inzulin glargin. Inzulin glargin je modificirani inzulin, vrlo sličan ljudskom inzulinu. Lantus se upotrebljava za liječenje šećerne bolesti u odraslih bolesnika, adolescenata i djece starije od 2 godine. Šećerna bolest (dijabetes) je bolest u kojoj vaše tijelo ne stvara dovoljno inzulina za regulaciju razine šećera u krvi. Inzulin glargin ima dugotrajan i kontinuiran učinak na snižavanje šećera u krvi. Prije nego počnete uzimati Lantus Nemojte uzimati Lantus Ako ste alergični (preosjetljivi) na inzulin glargin ili na bilo koji drugi sastojak Lantusa (za cjeloviti popis pomoćnih tvari vidjeti dio 6.). Budite oprezni s Lantusom Razgovarajte s Vašim liječnikom, ljekarnikom ili medicinskom sestrom prije nego počnete koristiti Lantus. Pažljivo slijedite upute o doziranju, kontroli (pretrage krvi i mokraće), prehrani i fizičkoj aktivnosti (fizički rad i tjelovježba) o kojima ste razgovarali sa svojim liječnikom. Ako vam je šećer u krvi prenizak (hipoglikemija), slijedite upute za hipoglikemiju (vidjeti uokvireni tekst na kraju upute). Putovanje Prije puta posavjetujte se sa svojim liječnikom. Porazgovarajte o: - dostupnosti inzulina u zemlji koju posjećujete, opskrbi inzulinom, štrcaljkama i dr., - ispravnom čuvanju inzulina za vrijeme putovanja, - rasporedu uzimanja obroka i inzulina za vrijeme putovanja, mogućim utjecajima promjene vremenskih zona, - mogućim novim rizicima po zdravlje u zemljama koje namjeravate posjetiti - tome što trebate učiniti u hitnim slučajevima, ako se ne osjećate dobro ili obolite. Bolesti i ozljede Liječenje Vaše bolesti (dijabetesa) može zahtijevati posebnu pozornost (na primjer prilagodbu doze inzulina, pretrage krvi i urina) u sljedećim situacijama: - ako ste bolesni ili jako ozlijeđeni, šećer u krvi Vam može porasti (hiperglikemija), - ako ne jedete dovoljno, šećer u krvi vam može postati prenizak (hipoglikemija). U većini slučajeva trebat ćete liječ Kontaktirajte liječnika na vrijeme. Ako imate dijabetes tipa 1 (šećernu bolest koja je ovisna o inzulinu), nemojte prestati uzimati inzulin i nastavite uzimati dovoljno ugljikohidrata. Uvijek recite osobama koje skrbe o vama ili vas liječe da vam je potreban inzulin. U nekih bolesnika s dugotrajnim dijebetesom tipa 2 i bolešću srca ili prethodnim moždanim udarom koji su liječeni pioglitazonom i inzulinom došlo je do razvoja zatajenja srca. Odmah obavijestite svog liječnika ako uočite znakove srčanog zatajenja, kao što je neuobičajena zadihanost, nagli dobitak na težini ili lokalizirano oticanje (edem). Uzimanje drugih lijekova s Lantusom Neki lijekovi uzrokuju promjenu razine šećera u krvi (smanjenje, povećanje ili oboje, ovisno o situaciji). U svakom slučaju, može biti potrebno prilagoditi dozu inzulina kako biste izbjegli prenisku ili previsoku razinu šećera u krvi. Budite oprezni kad započinjete i kad prestajete uzimati drugi lijek. Obavijestite svog liječ nika ili ljekarnika ako uzimate ili ste nedavno uzimali bilo koji drugi lijek, uključujući i one koje ste kupili bez recepta. Prije uzimanja lijeka upitajte svog liječnika može li taj lijek utjecati na razinu šećera u krvi i što treba poduzeti, bude li potrebno. Lijekovi koji mogu uzrokovati pad razine šećera u krvi (hipoglikemija) uključuju: - sve ostale lijekove za liječenje dijabetesa - ACE inhibitore (koriste se za liječenje nekih bolesti srca ili visokog krvnog tlaka) - dizopiramid (koristi se za liječenje nekih bolesti srca) - fluoksetin (koristi se za liječenje depresije) - fibrate (koriste se za snižavanje visoke razine lipida u krvi) - inhibitore monoaminooksidaze (koriste se za liječenje depresije) - pentoksifilin, propoksifen, salicilate (kao što je acetilsalicilatna kiselina, koja se koristi za ublažavanje boli i snižavanje povišene temperature) - sulfonamidske antibiotike. Lijekovi koji mogu uzrokovati povišenje razine šećera u krvi (hiperglikemija) uključuju: - kortikosteroide (kao što je kortizon, koji se koristi za liječenje upala) - danazol (lijek koji djeluje na ovulaciju) - diazoksid (koristi se za liječenje visokog krvnog tlaka) - diuretike (koriste se za liječenje visokog krvnog tlaka ili prekomjerno zadržavanje tekućine) - glukagon (hormon gušterače, koji se koristi za liječenje teške hipoglikemije) - izoniazid (koristi se za liječenje tuberkuloze) - estrogene i progesterone (primjerice kontracepcijske tablete) - derivate fenotiazina (koriste se za liječenje psihijatrijskih poremećaja) - somatropin (hormon rasta) - simpatomimetike (primjerice adrenalin, salbutamol ili terbutalin za liječenje astme) - tireoidne hormone (koriste se za liječenje poremećaja funkcije štitnjače) - atipične antipsihotike (primjerice klozapin i olanzapin) - inhibitore proteaze (za liječenje infekcija HIV-om) Razina šećera u krvi može se povisiti ili sniziti ako uzimate: - beta-blokatore (koriste se za liječenje visokog krvnog tlaka) - klonidin (koristi se za liječenje visokog krvnog tlaka) - soli litija (koriste se za liječenje psihijatrijskih poremećaja) Pentamidin (koristi se za liječenje nekih infekcija uzrokovanih parazitima) može uzrokovati hipoglikemiju, nakon koje katkad može nastupiti hiperglikemija. Beta blokatori kao i drugi simpatolitici (npr. klonidin, gvanetidin i rezerpin) mogu oslabiti ili čak potpuno potisnuti upozoravajuće simptome hipoglikemije. Ako niste sigurni uzimate li koji od ovih lijekova, upitajte svog liječnika ili ljekarnika. Uzimanje hrane i pića s Lantusom Razina šećera u krvi može se povisiti ili sniziti ako pijete alkohol. Trudnoća i dojenje Prije uzimanja bilo kojeg lijeka, zatražite savjet od svog liječnika ili ljekarnika. Ako ste trudni ili planirate trudnoću, o tome obavijestite svog liječnika. Možda će trebati promijeniti dozu inzulina za vrijeme trudnoć e i nakon poroda. Za zdravlje Vašeg djeteta posebno je važna pažljiva kontrola dijabetesa i sprječavanje hipoglikemije. Ako dojite, posavjetujte se sa svojim liječnikom jer ćete možda trebati prilagoditi dozu inzulina i način prehrane. Upravljanje vozilima i strojevima Vaša sposobnost koncentracije i reagiranja može biti smanjena ako imate: - hipoglikemiju (niska razina šećera u krvi), - hiperglikemiju (visoka razina šećera u krvi), - probleme s vidom. Imajte to na umu u svim situacijama u kojima sebe i druge možete izložiti riziku (primjerice vožnja autom ili upravljanje strojevima). Morate pitati liječnika preporuča li Vam voziti: - ako imate česte epizode hipoglikemije, - ako su Vam smanjeni ili izostaju upozoravajući znakovi hipoglikemije. Važne informacije o nekim pomoćnim tvarima u Lantusu Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija, odnosno praktički ne sadržava natrij. Kako uzimati Lantus Doziranje Uvijek uzimajte ovaj lijek točno onako kako Vam je propisao liječnik. Ako niste sigurni, trebate se savjetovati s liječnikom ili ljekarnikom. Na temelju Vašeg načina života, rezultata pretraga razine šećera u krvi (glukoze), te Vaše ranije uporabe inzulina, Vaš liječnik će: odrediti koliko Vam je Lantusa dnevno potrebno i u koje vrijeme, reći kad ćete provjeriti razinu šećera u krvi i trebate li napraviti pretrage mokraće, reći kad ćete možda trebati injicirati veću ili manju dozu Lantusa. Lantus je inzulin dugog djelovanja. Liječnik će Vam možda reći da ga uzimate u kombinaciji s kratkodjelujućim inzulinom odnosno s tabletama koje snižavaju povišeni šećer u krvi. Mnogi čimbenici mogu utjecati na razinu šećera u krvi. Morate ih poznavati da biste ispravno odgovorili na promjene razine šećera u krvi i spriječili da postane previsoka ili preniska. Za dodatne informacije pogledajte uokvireni tekst na kraju upute. Upotreba u djece i adolescenata Lantus mogu koristiti adolescenti i djeca od 2 godine naviše. Nema podataka o upotrebi Lantusa u djece mlađe od 2 godine. Učestalost primjene Potrebna Vam je jedna injekcija Lantusa svaki dan u isto vrijeme. Način primjene Lantus se daje injekcijom pod kožu. NE ubrizgavajte Lantus u venu, budući da će to promijeniti njegovo djelovanje i može uzrokovati hipoglikemiju. Liječnik će Vas uputiti u koje područje na koži trebate injicirati Lantus. Prilikom svake injekcije promijenite mjesto uboda unutar tih područja na koži. Kako rukovati s ulošcima Lantus ulošci smiju se upotrebljavati samo s brizgalicama OptiPen, ClikSTAR, Tactipen ili Autopen 24 kako bi se osigurala primjena ispravne doze. Moguće je da neke od navedenih brizgalica nisu na tržištu u vašoj zemlji. Brizgalicu treba koristiti sukladno preporukama proizvođača medicinskog proizvoda. Treba pažljivo slijediti upute proizvođa ča za uporabu brizgalice, o umetanju staklenog uloška, pričvršćivanju igle te primjeni injekcije inzulina. Prije stavljanja u brizgalicu, uložak treba držati na sobnoj temperaturi sat do dva. Pregledajte uložak prije nego li ga uporabite. Rabite ga samo ako je otopina bistra, bezbojna i vodenasta, te ako u njoj nema vidljivih čestica. Nemojte mućkati ili miješati otopinu prije uporabe. Upotrijebite novi uložak uvijek kad primijetite da Vam se neočekivano pogoršala regulacija šećera u krvi. To je zbog toga što je stari inzulin možda izgubio na učinkovitosti. Smatrate li da imate poteškoća s Lantusom, provjerite to sa svojim liječnikom ili ljekarnikom. Posebna upozorenja prije primjene lijeka Prije injekcije uklonite mjehuriće zraka (vidi upute za uporabu brizgalice). Pazite da alkohol, druga sredstva za dezinfekciju ili neke druge tvari ne kontaminiraju inzulin. Prazne uloške nemojte ponovno puniti i rabiti. Ne dodavajte u uložak drugi inzulin. Ne miješajte Lantus s drugim inzulinima ili lijekovima. Ne razrjeđujte ga. Miješanje i razrjeđivanje mogu promijeniti djelovanje Lantusa. Problemi s inzulinskom brizgalicom? Pridržavajte se uputa proizvođača za uporabu brizgalice. Ako je inzulinska brizgalica oštećena ili ne radi ispravno (zbog mehaničkih oštećenja), potrebno ju je ukloniti i upotrijebiti novu. Ako brizgalica ne radi ispravno, otopina se može iz uloška uvući u štrcaljku za injekciju. Stoga, uvijek uza se imajte i štrcaljke i igle. Međutim, smijete koristiti samo štrcaljke za injiciranje koje su namijenjene koncentraciji inzulina od 100 jedinica po mililitru.. Ako uzmete više Lantusa nego što ste trebali Ako ste ubrizgali previše Lantusa, razina šećera u krvi može vam postati preniska (hipoglikemija). Često provjeravajte razinu šećera u krvi. Općenito, da spriječite hipoglikemiju, morate više jesti i kontrolirati šećer u krvi. Za informacije o liječenju hipoglikemije pogledajte uokvireni tekst na kraju upute. Ako ste zaboravili uzeti Lantus Ako propustite dozu Lantusa ili injicirate premalu dozu, razina šećera u krvi može postati previsoka (hiperglikemija). Često provjeravajte razinu šećera u krvi. Za dodatne informacije o liječenju hiperglikemije pogledajte uokvireni tekst na kraju upute. Nemojte uzeti dvostruku dozu kako biste nadoknadili propuštenu. Ako prestanete uzimati Lantus To može dovesti do teške hiperglikemije (vrlo visoka razina šećera u krvi) i ketoacidoze (nakupljanje kiseline u krvi zato što tijelo razgrađuje masti umjesto šećera). Nemojte prestati uzimati Lantus, prije nego se posavjetujete s Vašim liječnikom, koji će vam reći što trebate napraviti. Zamjene inzulina Da bi se izbjegle pogreške pri primjeni između Lantusa i ostalih inzulina, potrebno je prije svake injekcije provjeriti označavanje inzulina. U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom Lantusa obratite se svom liječniku ili ljekarniku. Moguće nuspojave Kao i svi drugi lijekovi, Lantus može izazvati nuspojave, iako se one ne javljaju u svih bolesnika. Hipoglikemija (preniska razina šećera u krvi) može biti vrlo ozbiljna. Ako Vam se razina šećera u krvi previše snizi, možete izgubiti svijest. Ozbiljna hipoglikemija može uzrokovati oštećenje mozga te može biti opasna po život. Ako imate simptome niske razine šećera u krvi, odmah poduzmite mjere da povisite razinu šećera u krvi. Ako iskusite sljedeće simptome, odmah obavijestite svog liječnika: raširene kožne reakcije (osip i svrbež po cijelom tijelu), jako oticanje kože ili mukozne membrane (angioedem), zadihanost, pad krvnog tlaka s ubrzanim otkucajima srca i znojenjem. To mogu biti simptomi teške alergije na inzulin, koja može biti opasna po život. Vrlo česte prijavljene nuspojave (pojavljuju se u više od 1 na 10 bolesnika) Hipoglikemija Kao kod svih terapija inzulinom, najčešća nuspojava je hipoglikemija. Hipoglikemija (preniska razina šećera u krvi) znači da u krvi nema dovoljno šećera. Za dodatne informacije o nuspojavama niske ili visoke razine šećera u krvi, pogledajte uokvireni tekst na kraju upute. Česte prijavljene nuspojave (pojavljuju se u najviše 1 od 10 bolesnika) Kožne promjene na mjestu injiciranja Ako prečesto injicirate inzulin u isto mjesto na koži, masno tkivo ispod kože na tom mjestu može se stanjiti (lipoatrofija) ili zadebljati (lipohipertrofija). Do zadebljanja masnog tkiva dolazi u 1-2% bolesnika, dok je stanjivanje manje često. Može se dogoditi da inzulin koji injicirate na tom mjestu ne djeluje dobro. Promjena mjesta na koži prilikom svakog injiciranja može spriječiti takve kožne reakcije. Kožne i alergijske reakcije Kod 3-4% bolesnika mogu se pojaviti reakcije na mjestu injiciranja (crvenilo, neuobičajeno jaka bol prilikom injiciranja, svrbež, koprivnjača, oticanje ili upala). Ove reakcije se mogu proširiti i oko mjesta injiciranja. Većina manjih reakcija na inzulin obično prolazi nakon par dana ili tjedana. Rijetke prijavljene nuspojave (pojavljuju se u najviše 1 od 1000 bolesnika) Teške alergijske reakcije na inzulin Povezani simptomi uključ uju raširene kožne reakcije (osip i svrbež po cijelom tijelu), jako oticanje kože ili mukozne membrane (angioedem), zadihanost, pad krvnog tlaka uz ubrzane otkucaje srca i znojenje. To mogu biti simptomi teške alergijske reakcije na inzulin i mogu biti opasni po život. Poremećaji oka Značajne promjene (poboljšanje ili pogoršanje) u razini Vašeg šećera u krvi mogu uzrokovati prolazno pogoršanje vida. Ako imate proliferativnu retinopatiju (bolest očiju povezana s dijabetesom), teški hipoglikemijski napadi mogu uzrokovati privremeni gubitak vida. Opći poremećaji U rijetkim slučajevima, liječenje inzulinom također može uzrokovati privremeno nakupljanje vode u tijelu, uz oticanje listova i zglobova. Vrlo rijetke prijavljene nuspojave (pojavljuju se u 1 od 10000 bolesnika) U vrlo rijetkim slučajevima mogu se pojaviti disgeuzija (poremećaj okusa) i mijalgija (bol u mišićma). Ostale nuspojave s nepoznatom učestalošću (učestalost se ne može odrediti iz dostupnih podataka): Liječenje inzulinom može uzrokovati nastanak protutijela na inzulin (tvari koje djeluju protiv inzulina). U rijetkim slučajevima to može zahtijevati prilagodbu doze inzulina. Primjena u djece i adolescenata Općenito uzevši, nuspojave u djece i adolescenata u dobi do 18 godina slične su onima koje se javljaju u odraslih bolesnika. Pritužbe na reakcije na mjestu injiciranja (bol i reakcije na mjestu injiciranja) i kožne reakcije (osip, urtikarija) zabilježene su češće u bolesnika mlađih od 18 godina, nego u odraslih bolesnika. Za bolesnike mlađe od 2 godina nema dostupnih kliničkih podataka o sigurnosti primjene lijeka. Ako primijetite bilo koju nuspojavu potrebno je obavijestiti liječnika ili ljekarnika. Kako čuvati Lantus Lantus morate čuvati izvan dohvata i pogleda djece. Nemojte upotrebljavati Lantus nakon isteka roka valjanosti navedenog na pakovanju i na ulošku. Rok valjanosti odnosi se na posljednji dan navedenoga mjeseca. Neotvoreni ulošci Čuvati u hladnjaku (2°C-8 °C). Ne zamrzavati. Nemojte stavljati Lantus blizu zamrzivača ili rashladnog uloška u prijenosnim hladnjacima. Čuvajte uložak u vanjskom pakovanju, radi zaštite od svjetlosti. Ulošci u uporabi Ulošci u uporabi (u inzulinskoj brizgalici) se mogu čuvati do najviše 4 tjedna pri temperaturi do 25°C, zaštićeno od izvora topline ili svjetlosti, ne u hladnjaku. Nemojte koristiti lijek nakon isteka tog perioda. Ne upotrebljavajte Lantus opazite li u njemu čestice. Rabite ga samo ako je otopina bistra, bezbojna i vodenasta. Lijekovi se ne smiju bacati u otpadne vode ili kućni otpad. Upitajte svog ljekarnika kako odložiti lijek koji Vam više nije potreban. Ove mjere pomoći će u zaštiti okoliša. Dodatne informacije Što Lantus sadrži Djelatna tvar je inzulin glargin. Jedan mililitar otopine sadržava 100 jedinica djelatne tvari inzulina glargina (što odgovara količini od 3,64 mg). Pomoćne tvari u Lantusu su: cinkov klorid, metakrezol, glicerol, natrijev hidroksid (vidjeti dio 2 “Važne informacije o nekim pomoćnim tvarima u Lantusu”), kloridna kiselina i voda za injekcije. Kako Lantus izgleda i sadržaj pakovanja Lantus 100 jedinica/ml otopina za injekciju u ulošku bistra je i bezbojna otopina. Lantus dolazi u posebnome ulošku koji se smije koristiti samo s brizgalicama OptiPen, ClikSTAR, Tactipen ili Autopen 24. Jedan uložak sadržava 3 ml otopine (što odgovara količini od 300 jedinica). Dostupno je pakovanje s 5 uložaka. Način i mjesto izdavanja lijeka Na recept, u ljekarni.