PACKAGE LEAFLET: INFORMATION FOR THE USER. Fertin 1mg tablets Fertin 2 mg tablets Fertin 3mg tablets Fertin 4mg tablets {glimepiride}

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER Fertin 1mg tablets Fertin 2 mg tablets Fertin 3mg tablets Fertin 4mg tablets {glimepiride} Read all of this leaflet carefully before you start taking this medicine - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Fertin is and what it is used for 2. Before you take Fertin 3. How to take Fertin 4. Possible side effects 5. How to store Fertin 6. Further information 1. WHAT FERTIN IS AND WHAT IT IS USED FOR Fertin belongs to the group of sulphonylurea derivatives. These are blood sugar lowering medicines. Fertin works by increasing the amount of insulin released from your pancreas. The insulin then lowers your blood sugar levels Fertin. is used to keep blood sugar at the correct level in adults with diabetes (diabetes mellitus type 2), when diet, physical exercise and weight loss alone fail to lower blood sugar (glucose) levels. 2. BEFORE YOU TAKE FERTIN DO NOT take Fertin if you: have insulin dependent diabetes (type 1), this means that you have diabetes that can only be treated with insulin, have ketoacidosis (acid poisoning caused by diabetes), are in a diabetic coma (uncontiousness resulting from not well controlled or untreated diabetes) have severe kidney or liver disease, are allergic (hypersensitive) to glimepiride or related substances (other blood sugar lowering medicines, so-called sulphonylurea derivatives like e.g. glibenclamide) and to medicines that are used for urinary tract infections from the sulphanomide group (e.g. sulphamethizol), are allergic (hypersensitive) to glimepiride or to any of the other ingredients in Fertin. Take special care with Fertin: Tell your doctor if you: have recently had an accident, an acute operation or a severe infection with fever. If so it may be necessary to temporarily use insulin to treat your diabetes, have already been using Fertin for a longer period, then you should let your blood and liver be checked on the possible occurrence of rare side effects (see section 4 Possible side effects ). have G6PD-deficiency. Fertin can lead to a type of anaemia called hemolytic anaemia. A non-sulfonylurea alternative should be considered. 1

2 As with any treatment for diabetes, your blood sugar level may become too low (known as hypoglycaemia) if: your food intake is irregular or reduced or you change your diet meals are delayed, you skip a meal or you are fasting you use alcohol, especially when you skip a meal you are exercising at a higher physical level than usual you are not using the correct dosage of the medicine. have kidney or liver problems, have certain hormonal deviations, e.g. to your thyroid gland or hypophysis (a certain gland at the bottom of the brain), Symptoms of hypoglycaemia include: headache, severe hunger, extreme tiredness, nausea and vomiting, irritability, aggressiveness, depressive mood, agitation, confusion, helplessness, sensory disturbances sleeping disorders, shakiness, severe sweating, dizziness, emotional disorders and decrease of concentration, alertness and increase in reaction time, difficulties speaking, vision problems, breathing difficulties and changed blood pressure. In addition, the following signs may also occur: anxiety, accelerated heartbeat (tachycardia), palpitations, strong pain in the chest (angina pectoris), cardiac arrhythmias loss of self-control or you may fall into unconsiousness. These symptoms usually improve after intake of carbohydrates (e.g. sugar). Artificial sweeteners have no effect. If any of the above symptoms are severe or last a long time, you should get immediate medical attention. It is possible that the treatment must be adjusted. Consult your doctor if one of the above mentioned warnings is applicable to you or has been in the past. The level of sugar in your blood and urine should be checked regularly. Your doctor may also take blood tests to monitor your blood cell levels and liver function. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Simultaneous use of Fertin with other medicine can weaken or strengthen the blood sugar lowering effect of glimepiride. The effect of Fertin and thus the blood sugar lowering effect can be strengthened by: Insulin, metformin, other blood surgar lowering medicines, Phenylbutazone, azapropazon, oxyfenbutazone, salicylates (medicines for e.g. pain and inflammation), Certain long acting sulphonamides (medicine for urinary tract infections), Tetracyclines, clarithromycin, chloramphenicol, quinolones, miconazol, fluconazol (medicines for bacterial and fungal infections), Coumarines (blood-diluting medicines that inhibit blood clotting) Male sex hormones and derivatives of it (namely anabolic steroids), Fluoxetine, MAO-inhibitors (medicines to treat depression), Fibrates (medicine for high lipid level in the blood), 2

3 Medicines for high blood pressure e.g. the type ACE inhibitors, Probenecide, allopurinol (medicine for gout), Phosphamides (medicine for cancer) Sulfinpyrazone (medicine for gout) Cyclophosphamide, ifosfamide, trofosfamide (medicine to treat cancer) Fenfluramine (medicine to reduce weight) Pentoxifyline (medicinal productto increase circulation when given in a high dose intravenous infusion) Tritoqualine (medicinal products to treat nasal allergies such as hay fever) Sympatholytics (to treat high blood pressure, heart failure, or prostate symptoms) The effect of Fertin and thus the blood sugar lowering effect can be weakened by: Female hormones: oestrogens (hormones, mostly used to treat menopause complaints), progestagens, Diuretics (water tablets), Glucocorticoids (adrenocorticotropic hormones, like hydrocortison), Chlorpromazine and other phenothiazine derivatives (medicines for mental illnesses), Substances that stimulate the thyroid gland (thyroid stimulating agents), Adrenaline and other substances with a stimulating effect on a certain part of the nervous system (sympathicomimetics), Nicotinic acid and derivates (e.g. used as medicine for a high fatty acid level in the blood), Long-term use of laxatives, Phenytoin, barbiturates (medicines for falling disease) and acetozolamide (medicine for falling disease or increased eyeball pressure), Glucagon (hormone with effect opposite to insulin), Rifampicin (medicine for infections, like tuberculoses), Diazoxide (anti-hypertensive) The effect of Fertin can be strengthened or weakened by: Betablockers (medicine used in the treatment of high blood pressure, certain heart conditions or increased eyeball pressure), Clonidine (medicine for high blood pressure or migraine), Medicines applied for stomach disorders and gastrointestinal ulcer of the type H2-receptor antagonists. Guanethidine, Reserpine. Further betablockers and clonidine can hide the first symptoms of hypoglycaemia. Additionally, the use of Fertin can influence effect of coumarines on blood clotting. Taking Fertin with food and drink Fertin must always been taken shortly before or during a meal. Alcohol can alter the effect of Fertin and it should be avoided. Your living and eating habits can influence your blood sugar level, see section 2 Take special care with Fertin. Children and adolescents: There are no data on the use of glimepiride in patients under 8 years of age. For children aged 8 to 17 years, there are limited data on the use of glimepiride alone. The available data on safety and efficacy are insufficient in the paediatric population and therefore such use is not recommended. Pregnancy and breastfeeding Ask your doctor or pharmacist for advice before taking any medicine. Fertin should not be used during pregnancy. If you are planning a pregnancy, or become pregnant during the treatment with this medicine, inform your doctor as it will be necessary for you to switch to insulin. You must not take Fertin while you are breastfeeding. Driving and using machines 3

4 Use caution when driving or operating heavy machinery until you re aware of how this drug affects you. Low blood sugar may make your vision blurred or impair your concentration or reaction time. If this happens you should not drive or use machines. You must consult your doctor whether it is wise to drive a car if you: Have frequent attacks of hypoglycaemia (low sugar levels) Are not sure that you can recognize the symptoms of hypoglycaemia. Important information about some of the ingredients of Fertin - Lactose Fertin contains lactose. Take special care if you are lactose intolerant and you cannot tolerate certain sugars because of a rare hereditary problem and discuss it with your doctor before taking this medicine. 3. HOW TO TAKE FERTIN Always take Fertin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Fertin is for oral use. Your doctor will inform you how many tablets you have to take each day and how often. Carefully follow your doctor s advice while taking Fertin. In case of doubt consult your doctor or pharmacist. Regularly check your blood sugar level. A correct diet, regular physical activity and regular examination of blood and urine are important for a successful treatment. If your blood sugar level changes, e.g. because of not following the diet you cannot compensate this with tablets or insulin. The tablets should be swallowed whole with some fluid, e.g. water, shortly before or during the first main meal of the day (usually breakfast). If you do not have breakfast you should take the product on schedule as prescribed by your doctor. It is important not to leave out any meal when you are on Fertin. Do not skip the meal after taking the tablets. Dosage: Starting and maintenance dose: At the beginning your doctor determines the starting dose, depending your blood and urine glucose level. This is usually 1 tablet of Fertin 1 mg per day (containing 1mg glimepiride). If your diabetes is well controlled, the dosage remains the same. If your diabetes is still not sufficiently controlled the dosage can gradually be increased to 2mg, 3mg or 4 mg glimepiride per day (as one tablet of Fertin 2mg, 3mg or 4mg) but only on doctor s order. The maximum dosage is 6 mg glimepiride per day. Combination with metformin (another medicine used to treat diabetes): If your condition (diabetes) can not be controlled with the maximum daily dose of metformin a simultaneous treatment with glimepiride can be started. The dosage of metformin remains the same, and you will take a low dosage of glimepiride, which is gradually increased until your condition is sufficiently controlled. This may only take place under strict doctor s guidance. Combination with insulin: If your condition cannot be fully controlled with Fertin, simultaneous treatment with insulin can be started. The dose of Fertin will remain the same however you will need to take a low dose of insulin which will gradually be increased until your condition is under control. This may only take place under strict doctor s guidance. Switching from other medicines to Fertin: If you are switching from a different blood sugar level lowering medicine to Fertin, you usually start with the lowest dosage of 1 tablet Fertin 1 mg per day. The dosage can, only on doctor s guidance, gradually be increased (just like at the first adjustment) until your condition is well controlled. Fertin should not be used for the treatment of diabetes in children. 4

5 In case you notice that the effect of Fertin is too strong or too weak consult your doctor or pharmacist. If you take more Fertin than you should: If you take too much Fertin you should immediately contact your doctor or pharmacist. As a result of overdose your blood sugar level can drop severely (severe hypoglycaemia), and you can become unconscious (see also Take special care with Fertin ). In such a case, hospitalisation is often necessary. If you forget to take Fertin: Do not worry. Take the dose as soon as you remember and then take your next dose at the right time. However, if it is almost the time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for a missed dose. Keep checking your blood sugar level regularly. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Fertin can cause side effects although not everybody gets them. All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body). A temporary disturbance of the sight can occur especially at the start of the treatment. Rare (more than 1 out of , but less than 1 out of 1000 patients) side effects include: paleness of the skin, exceptional tiredness, increased tendency to bleed and bruise and increase tendency for inflammation of e.g. the mouth, throat, anus and genitals and fever which can indicate changes in the blood picture. Usually these side effects disappear after ceasing the treatment. hypoglycaemia (low blood sugar) after taking Fertin. (see also Take special care with Fertin ). For symptoms of hypoglycaemia please go to Take special care section. Very rare (less than 1 out of patients) side effects include: other less severe allergic reactions, amongst which inflammation of the blood vessels (allergic vasculitis), which can develop to severe reactions with tightness of the chest, low blood pressure and sometimes shock. severe skin reactions (such as nettle-like rash, sensitivity to light); upset stomach (nausea, vomiting, diarrhoea, feeling of fullness, pain); liver disorder (e.g. jaundice- when skin becomes yellowish) hepatitis (inflamed liver), that can cause liver failure If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE FERTIN Keep Fertin out of reach and sight of children. This product does not require any special storage condition. Do not use Fertin after the expiry date which is mentioned on the package after Exp. The expiry date refers to the last day of that month. 5

6 Medicines should not be disposed of via wastewater or household. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the enviroment. 6. FURTHER INFORMATION Fertin contains: The active ingredient is glimepiride. The other ingredients (excipients) are: Lactose monohydrate, Sodium starch glycolate, Povidone (K30), Magnesium stearate. Fertin 1 mg tablet also contains the colouring agent E172 (red iron oxide), Fertin 2 mg contains E172 (yellow iron oxide) and E132 (indigo carmine), Fertin 3 mg contains E172 (yellow iron oxide), Fertin 4 mg contains E132 (indigo-carmine). What Fertin looks like and the contents of the box Fertin 1mg is pink, round, flat, scored on one side tablet with diameter 6mm. Fertin 2mg is green, oval, flat, scored on one side, embossed MC on the other side tablet with dimensions 5x10mm. Fertin 3mg is pale yellow, oval, flat, scored on one side, embossed MC on the other side tablet with dimensions 5x10mm. Fertin 4mg is blue, oval, flat, scored on one side, embossed MC on the other side tablet with dimensions 5x10mm. The score line helps dividing the tablets in two equal halves. The tablets are packed in PVC/PVDC/Aluminum blisters. Packs of 30 tablets are available. Marketing Authorisation Holder and Manufacturer Medochemie Ltd, P. O Box 51409, Limassol, CY-3505, Cyprus This leaflet was last revised in: February