Glimepiride 4mg Tablets
Package leaflet: Information for the patient
GLIMEPIRIDE 1 mg TABLETS GLIMEPIRIDE 2mg TABLETS GLIMEPIRIDE 3 mg TABLETS GLIMEPIRIDE 4 mg TABLETS (glimepiride)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Glimepiride is and what it is used for
2. What you need to know before you take Glimepiride
3. How to take Glimepiride
4. Possible side effects
5. How to store Glimepiride
6. Contents of the pack and other information
1. What Glimepiride is and what it is used for
Glimepiride contains the active substance glimepiride.
Glimepiride belongs to a group of medicines called oral hypoglycaemics. These medicines help to lower your blood sugar (glucose) if you suffer from Type 2 diabetes (diabetes mellitus). Your doctor will prescribe Glimepiride for you if your diabetes cannot be controlled just by good diet, regular exercise or weight loss.
2. What you need to know before you take Glimepiride Do not take Glimepiride:
• if you are allergic to glimepiride or other sulfonylureas (medicines used to lower your blood sugar such as glibenclamide) or sulfonamides (medicines for bacterial infections such as sulfamethoxazole) or to any of the other ingredients of this medicine listed in section 6
• if you suffer from insulin dependent diabetes (also called Type 1 diabetes mellitus)
• if you have diabetic ketoacidosis (a complication of diabetes when your acid level is raised in your body and you may have some of the following signs: fatigue, feeling sick (nausea), frequent urination and muscular stiffness)
• if you have severe kidney or liver problems.
Glimepiride should not be given to patients in a diabetic coma.
Warnings and precautions
Talk to your doctor or pharmacist before taking Glimepiride:
• if you are recovering from an injury, operation, infection with fever, or from other forms of stress, as temporary change of treatment may be necessary
• if you have a liver or kidney disorder.
Lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur in patients missing the enzyme glucose-6-phosphate dehydrogenase.
In the above cases, your doctor may change the number of tablets you should take or he/she may revise your entire treatment plan.
Children and adolescents
The information available on the use of Glimepiride in children and adolescents under 18 years of age is limited. Therefore its use in these patients is not recommended.
Control of your blood sugar levels
During Glimepiride treatment, regular checking of your blood (or urine) sugar levels is necessary. Your doctor may also perform certain blood tests to monitor your blood cell levels and liver function. You should follow the treatment plan prescribed by your doctor in order to control your blood sugar levels. This means that you should continue with your diabetic diet, take regular exercise and if necessary, lose weight.
In the first few weeks of treatment, there is a greater risk of having low blood sugar levels (hypoglycaemia). Your doctor will therefore monitor your progress closely.
The following factors could increase the risk of you getting low blood sugar levels if:
• you are unwilling or unable to co-operate
• you are undernourished, have an irregular meal time, miss or delay meals or are undergoing a period of fasting
• you change your diet
• you increase your physical activity and you do not eat enough or eat food containing less carbohydrate than normal
• you are elderly or in poor health
• you drink alcohol (especially if you also skip meals)
• you have liver or kidney problems
• you suffer from particular hormone-induced disorders (disorders of the thyroid glands, of the pituitary gland or adrenal cortex)
• you take more Glimepiride than needed
• you take certain other medicines at the same time (see “Other medicines and Glimepiride”).
If yo
u suffer from low blood sugar levels, you may have the following signs:
|
headache |
• difficulty concentrating |
• |
sweating |
|
hunger pangs |
• feeling less alert |
• |
clammy skin |
|
exhaustion |
• reduced reaction time |
• |
anxiety |
|
nausea |
• depression |
• |
faster heart beat |
|
vomiting |
• confusion |
• |
high blood pressure |
|
weariness |
• slurred speech |
• |
feeling of an |
|
sleepiness |
• eyesight problems |
abnormally strong or | |
|
problems |
• dizziness |
irregular heartbeat | |
|
sleeping |
• helplessness |
• |
sudden strong pain in |
|
restlessness |
• shaking or tremors |
the breast that may | |
|
aggression |
• sensory disturbances |
• |
radiate into neighbouring areas (angina pectoris and cardiac arrhythmias) loss of self control |
If your blood sugar levels continue to drop, you may suffer from considerable confusion (delirium), you may develop “fits” (convulsions), suffer from paralysis (loss or impaired body movement), have breathing difficulties, your heartbeat may slow down and you may fall into unconsciousness.
In most cases, the signs of reduced blood sugar vanish very quickly when you eat or drink something sugary e.g. sugar cubes, sweet juice, sweetened tea. You should therefore always carry some form of sugar with you. Remember that sweeteners are not effective. Please contact your doctor or go to the hospital if taking sugar does not help or if any of these symptoms return.
Other medicines and Glimepirid Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The following medicines, if taken with Glimepirid Mylan, may lower your blood sugar (glucose) levels too much. This can lead to a risk of hypoglycaemia (low blood sugar):
• insulin or other medicines for diabetes (e.g. metformin)
• medicines to treat pain and inflammation (e.g. phenylbutazone, azapropazone, oxyphenbutazone, salicylates)
• medicines to treat gout (e.g. allopurinol, sulfinpyrazone, probenecid)
• medicines to treat bacterial infections such as tetracyclines (e.g. doxycycline),chloramphenicol, sulfonamides (e.g. trimethoprim, co-trimoxazole, sulfadiazine), quinolones (e.g. ciprofloxacin), clarithromycin
• medicines to treat fungal infections (e.g. fluconazole, miconazole)
• medicines to inhibit blood clotting (coumarin anticoagulants such as warfarin)
• medicinal products that lower high cholesterol levels (fibrates)
• medicinal products that lower high blood pressure (ACE inhibitors)
• disopyramide, an anti-arrhythmic agent used to control abnormal heart beat
• medicinal products to treat depression (fluoxetine, MAO-inhibitors)
• medicinal products that support muscle build up (anabolics)
• medicinal products used for male sex hormone replacement therapy
• medicinal products used to reduce weight (fenfluramine)
• medicinal products to treat nasal allergies such as hay fever (tritoqualine)
• medicinal products to treat cancer (cyclophosphamide, trophosphamide and iphosphamide)
• medicinal products to increase circulation when given in a high dose intravenous infusion (pentoxyfylline)
• medicinal products called sympatholytics to treat high blood pressure, heart failure, or prostate symptoms.
The following medicines, if taken with Glimepiride, may keep the blood sugar (glucose) levels too high. This can lead to a risk of hyperglycaemia (high blood sugar level):
• medicinal products containing female sex hormones oestrogens or progestogens, such as hormone replacement therapy (HRT) or oral contraceptives
• medicinal products for mental illness (e.g. chlorpromazine and other phenothiazine derivatives
• medicinal products that support urine production (thiazide diuretics -water tablets)
• medicines used to stimulate the thyroid gland (such as levothyroxine)
• medicines used to treat allergies and inflammation (e.g. glucocorticoids)
• medicines used to raise heartbeat, to treat asthma or nasal congestion, coughs and colds, to reduce weight, or used in life-threatening emergencies (e.g. adrenaline and sympathomimetics),
• medicinal products to treat high cholesterol level (nicotinic acid)
• medicinal products to treat constipation, when they are used long term (laxatives)
• medicinal products to treat epilepsy (e.g. phenytoin)
• medicines to treat nervousness and sleep problems (e.g. barbiturates)
• medicinal products to treat increased pressure in the eye (acetazolamide)
• medicines used to treat high blood pressure or lowering blood sugar (e.g. diazoxide)
• medicinal products to treat tuberculosis (rifampicin)
• medicines used to treat severe low blood sugar levels (e.g. glucagon).
Other medicines, if taken with Glimepiride, may affect the control of blood glucose levels (causing either high or low levels):
• medicinal products to treat stomach ulcers (called H2 antagonists like cimetidine, ranitidine)
• medicinal products to treat high blood pressure or heart failure such as beta-blockers, clonidine, guanethidine and reserpine. These can also hide the signs of hypoglycaemia, so special care is needed when taking these medicines.
Glimepiride may either increase or weaken the effects of the following medicines:
• medicines inhibiting blood clotting (coumarin derivatives such as warfarin).
Colesevelam, a medicine used to reduce cholesterol, has an effect on the absorption of Glimepiride Mylan. To avoid this effect, you should be advised to take Glimepiride Mylan at least 4 hours before colesevelam.
Glimepiride with alcohol
You should not drink alcohol while being treated with this medicine. Alcohol intake may increase or decrease the blood sugar lowering action of glimepiride in an unpredictable way.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Glimepiride should not be taken during pregnancy.
Glimepiride may pass into breast milk. If you are breast-feeding, you should not take Glimepiride. Driving and using machines
Your ability to concentrate or react may be impaired if your blood sugar is lowered (hypoglycaemia), or raised (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (e.g. when driving a car or using machines).
Please ask your doctor whether you can drive a car if you:
• have frequent episodes of hypoglycaemia
• have fewer or no warning signals of hypoglycaemia.
Glimepiride contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicinal product.
3. How to take Glimepiride
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults
The recommended starting dose is 1 mg of Glimepiride each day. Depending on how your blood glucose level responds, your doctor may increase this dose by 1 mg every 1-2 weeks. The maximum dose is 6 mg a day.
If the lowest dose of 1 mg of Glimepiride a day reduces your blood glucose concentration too far (hypoglycaemia) then your doctor may decide that your blood sugar can be controlled by diet management alone and will discuss this option with you.
During the course of treatment, the dose of Glimepiride may need to be adjusted by your doctor, especially if your weight or lifestyle changes.
Combination therapy
You may already be taking the maximum dose of metformin for diabetes and may, in addition, need to take Glimepiride. Your doctor will start you on a low dose of Glimepiride. Your blood glucose level will need to be monitored closely.
If the maximum daily dose of Glimepiride does not control your blood sugar well enough your doctor may want you to start using insulin. In such cases, your blood glucose level will need to be closely monitored. This is to make sure you do not suffer from hypoglycaemia (low blood sugar).
Switching medication
If your doctor feels it is necessary to change from another antidiabetic medicine to Glimepiride, this must be done under close medical supervision. In some cases, there may need to be a break between the medication so the previous medication does not have an additive effect, leading to hypoglycaemia.
Use in children
Glimepiride is not usually recommended for use in children.
Method of administration
Swallow your tablets whole with a small glass of water
■ Take your tablets shortly before or with your first main meal of the day.
■ Do not stop taking this medicine unless your doctor tells you to.
Regular exercise and a good diet are important to help control your diabetes.
You must check your blood and urine glucose levels regularly. Your doctor will tell you how to do this. If you are unsure check with your doctor.
If you take more Glimepiride than you should
If you have taken too many tablets, this will cause your blood sugar level to drop too low (hypoglycaemia - for symptoms of hypoglycaemia see section 2). You should eat or drink something sugary as soon as you can (e.g. sugar cubes, sweet juice, sweetened tea) and tell your doctor immediately. When treating hypoglycaemia due to accidental intake in children, the quantity of sugar given must be carefully controlled to avoid the possibility of producing dangerous hyperglycaemia. Persons in a state of unconsciousness must not be given food or drink.
Since the state of hypoglycaemia may last for some time it is very important that the patient is carefully monitored until there is no more danger. Admission into hospital may be necessary, also as a measure of precaution. Show the doctor the package or remaining tablets, so the doctor knows what has been taken.
Severe cases of hypoglycaemia accompanied by loss of consciousness and severe neurological failure are cases of medical emergency requiring immediate medical treatment and admission into hospital. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.
If you forget to take Glimepiride
If you forget to take Glimepiride, take the next dose as soon as you remember or feel faint, otherwise your blood sugar level will become too high and you may go into a coma (unconscious). Do not take a double dose to make up for a forgotten dose.
If you stop taking Glimepiride
If you interrupt or stop the treatment you should be aware that the desired blood sugar lowering effect will not be achieved or that the disease will deteriorate again. Keep taking Glimepiride until your doctor tells you to stop.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can sometimes cause side effects, although not everybody gets them. Tell your doctor immediately if you experience any of the following:
Rare (may affect up to 1 in 1,000 people)
• changes in your blood, which can be severe and may make you feel unusually tired and look pale, bruise or bleed more easily or you may suffer from infections with sore throats or mouth ulcers. These effects usually go away if treatment is stopped
• severe hypoglycaemia including loss of consciousness, seizures or coma.
Very rare (may affect up to 1 in 10,000 people)
• abnormal liver function including yellowing of the skin and eyes (jaundice), problems with the bile flow (cholestasis), inflammation of the liver (hepatitis) or liver failure.
• allergic reactions (including inflammation of blood vessels, often with skin rash) which may develop into serious reactions with difficulty in breathing, fall in blood pressure and sometimes progressing to shock
Not known (frequency cannot be estimated from the available data)
• allergy (hypersensitivity) of the skin such as a rash or itchy red swollen skin and increased sensitivity to sun. Some mild allergic reactions may develop into serious reactions.
• Severe decrease in the number of blood platelets (thrombocytopenia) and bleeding into the skin (thrombocytopenic purpura).
Other possible side effects:
Rare (may affect up to 1 in 1,000 people):
• lower blood sugar than normal (hypoglycaemia) (See section 2 - Warnings and precautions).
Very rare (may affect up to 1 in 10,000 people):
• feeling and being sick, diarrhoea, feeling bloated, abdominal discomfort or pain
• decrease in blood sodium levels.
Not known (frequency cannot be estimated from the available data):
• patients allergic to glimepiride may also be allergic to similar antidiabetic medicines or antibiotics called sulfonamides
• change in eyesight at the start of the treatment due to changes in blood sugar levels but this should improve as treatment continues
• raised liver enzymes in the blood.
Your doctor will take blood samples and check your liver is working properly from time to time to make sure that your tablets are not causing side effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Glimepiride
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not store your tablets above 25oC. Store in the original package.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information What Glimepiride contains
The active substance is glimepiride. Each tablet contains either 1 mg, 2 mg, 3 mg or 4 mg of glimepiride. The other ingredients are lactose monohydrate; povidone K25; cellulose, microcrystalline; magnesium stearate; sodium starch glycolate (Type A); iron oxide red E172 (1 mg tablets); iron oxide yellow E172 (2 mg and 3 mg tablets) and indigo carmine E132 (2 mg and 4 mg tablets).
What Glimepiride looks like and contents of the pack
The Glimepiride 1 mg tablet is an oblong shaped pink tablet with ‘GM’ breakline ‘1’ on one side and ‘G’ breakline ‘G’ on the other side.
The 2 mg tablet is an oblong shaped green tablet with ‘GM’ breakline ‘2’ on one side and ‘G’ breakline ‘G’ on the other side.
The 3 mg tablet is an oblong shaped yellow tablet with ‘GM’ breakline ‘3’on one side and ‘G’ breakline ‘G’ on the other.
The 4 mg tablet is an oblong shaped blue tablet with ‘GM’ breakline ‘4’ on one side and ‘G’ breakline ‘G’ on the other side.
Glimepiride is available in blister packs of 30, 50, 60, 90, 100, 120 or 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Generics [UK] Limited, Station Close, Potters Bar, EN6 1TL, UK.
Manufacturer
Generics [UK] Limited, Station Close, Potters Bar, EN6 1TL, UK.
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland