Glimepiride 6 Mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Glimepiride 4mg/6mg 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.
Glimepiride 4mg/6mg Tablets Glimepiride
In this leaflet:
1. What Glimepiride Tablets are and what they are used for
2. Before you take Glimepiride Tablets
3. How to take Glimepiride Tablets
4. Possible side effects
5. How to store Glimepiride Tablets
6. Further information
1. What Glimepiride Tablets are and what they are used for
Glimepiride Tablets are a medicine to reduce blood sugar levels (antidiabetic medicine taken orally).
Glimepiride Tablets are used in a certain form of diabetes (type 2 diabetes mellitus), when diet, exercise and weight loss alone do not have an adequate effect.
2. Before you take Glimepiride Tablets Do not take Glimepiride Tablets
- If you are hypersensitive (allergic) to glimepiride or other drugs of the same group (sulfonylureas and sulfonamides) or one of the other components of the medicine,
- If your kidney or liver function is severely impaired,
- If you have insulin-dependent (type 1) diabetes,
- If the acid level in your body is raised (ketoacidosis),
- In the case of somnolence and loss of consciousness due to a strongly increased blood sugar level (diabetic coma).
In cases of severe renal or hepatic functional disorders, a changeover to insulin is required.
Take special care with Glimepiride Tablets
During glimepiride treatment regular monitoring of your blood sugar level is necessary. Your doctor may also take blood tests to monitor your blood cell levels and liver function.
You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means that, apart from regular tablet intake, you observe the dietary regimen, have physical exercise and, where necessary, reduce weight. Also take care that you have your blood (and possibly urine) sugar levels determined regularly as prescribed by your doctor.
In the first few weeks of treatment the risk of having reduced blood sugar levels (hypoglycaemia) may be increased, therefore it is vital that you are carefully monitored by your doctor.
Reduced blood sugar may occur if:
- you take meals irregularly or skip meals altogether,
- you are fasting,
- you are malnourished,
- you change your diet,
- you increase your physical activity and carbohydrate intake does not come up to this increase,
- you consume alcohol, especially in combination with skipped meals,
- you take other medicines or natural remedies at the same time,
- you take high doses of glimepiride,
- you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, of the pituitary gland or adrenal cortex),
- your renal function is decreased,
- your liver function is seriously decreased,
- you do not observe the instructions given by your doctor or in this patient package insert.
Please inform your doctor of such risks so that he can either adjust the dosage of glimepiride or revise the entire treatment plan to change it where necessary.
If you suffer from low blood sugar (hypoglycaemia) you may have the following signs: headache, hunger, exhaustion, nausea, vomiting, weariness, sleepiness, sleep disorders, restlessness, aggressiveness, impaired concentration, reduced alertness and reaction time, depression, confusion, speech and visual disorders, aphasia, tremor, paresis, sensory disturbances, dizziness, and helplessness.
The following signs may also occur: sweating, clammy skin, anxiety, accelerated heart beat, high blood pressure, palpitations, sudden strong pain in the breast that may radiate into neighbouring areas (angina pectoris), and cardiac arrhythmias.
If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop cerebral convulsions, lose self control, breathing may be shallow and your heart beat slowed down, you may fall into unconsciousness. The clinical picture of a severe reduced blood sugar level may resemble that of a stroke.
In most cases the signs of reduced blood sugar vanish very quickly when you consume some form of sugar, e.g. grape sugar, sugar cubes, sweet juice, sweetened tea.
You should therefore always take some form of sugar with you (grape sugar, sugar cubes). Remember that sweeteners are not effective. Please contact your doctor or the next hospital if taking sugar does not help or if the symptoms recur.
Signals of reduced blood sugar may be absent or less pronounced or develop very slowly. You are not aware in time that your blood sugar level has dropped. This may happen in elderly patients taking certain medicinal products (e.g. those acting on the central nervous system and betablockers). It may also happen when you suffer from certain disorders of the endocrine system (e.g. certain disorders of thyroid function and anterior pituitary or adreneocortical insufficiency). Impaired liver function may affect counter regulation.
In stress-situations (e.g. accidents, acute operations, infections with fever, etc.) a temporary switch to insulin may be indicated.
Signs of raised blood sugar (hyperglycaemia - it may occur when glimepiride has not yet sufficiently reduced the blood sugar, when you have not complied with the treatment plan prescribed by your doctor or in special stress situations) may include thirst, frequent urination, dry mouth and dry itching skin, fungal or skin infections and reduced performance.
In such a case, you must contact your doctor.
Taking other medicines
The activity and safety of this treatment may be affected if this medicine is taken at the same time as certain other medicines. Conversely, other medicines may be affected if they are taken at the same time as Glimepiride Tablets.
The blood sugar lowering effect of glimepiride may be strengthened and signs of low blood sugar levels may occur when one of the following drugs is taken:
- other oral antidiabetic drugs, and insulin,
- antibiotics (e.g. chloramphenicol, quinolone, tetracyclines, sulfonamides),
- painkillers or antirheumatics (pyrazolone-derivates, e.g. phenylbutazone, azapropazone, oxyfenbutazone),
- painkillers (salicylates),
- products to treat tuberculosis (p-amino-salicylic acid),
- products supporting muscle build-up (anabolics and male sex hormones),
- products inhibiting blood clotting (coumarin),
- products to treat fungal infections (miconazole, fluconazole),
- products lowering blood pressure or heart beat (ACE-inhibitors, betablockers, sympatholytics),
- products elevating mood/antidepressants (fluoxetine, MAO-inhibitors),
- products suppressing appetite (fenfluramine),
- products lowering increased fat levels in the blood (fibrates),
- certain products to treat cancer (cyclo- tro- and iphosphamides),
- products to treat allergies (tritoqualine),
- infusion of high dose of products to increase blood flow (pentoxiphylline),
- products to treat gout (probenecid, allopurinol, sulphinpyrazone).
The blood glucose lowering effect of glimepiride may be weakened and raised blood sugar levels may occur when one of the following drugs is taken:
- female sex hormones (oestrogens and progestagens)
- products supporting urine production (saluretics, thiazide diuretics)
- thyroid hormones,
- products inhibiting inflammation (glucocorticoids),
- products to treat cramps or schizophrenia (phenytoin, phenothiazine derivates),
- products lowering blood pressure (diazoxide),
- products to treat tuberculosis (rifampicin),
- products to treat low blood sugar (glucagon),
- sleeping pills (barbiturate),
- products to treat certain eye diseases (acetazolamide),
- products to raise heart beat (adrenaline and sympathicomimetics)
- products lowering increased fat levels in the blood (nicotinic acid derivatives)
- long term use of products relieving evacuation (laxatives)
Alcohol can enhance or diminish the ability of Glimepiride Tablets to reduce blood sugar in an unpredictable manner.
Products to treat ulcers in the stomach or duodenum (H2 receptor-antagonists) or blood pressure lowering products (betablockers, clonidine and reserpine) may either strengthen or weaken the blood sugar lowering effect of glimepiride.
Medicinal products with effects on the central nervous system (betablockers, clonidine, guanethidine or reserpine) may mask or totally suppress the signs of reduced blood sugar.
Glimepiride may either strengthen or weaken the effect of products inhibiting blood clotting (coumarin derivatives).
Consult your doctor before you start taking another medicinal product.
Pregnancy
Glimepiride Tablets must not be taken during pregnancy. If pregnancy is planned you should discuss the treatment plan with your doctor. If you become pregnant during a glimepiride treatment you should instantly inform your doctor.
Breast-feeding
Glimepiride Tablets may pass into breast milk. Glimepiride Tablets must not be taken during breastfeeding.
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.
Important information about some of the ingredients of Glimepiride Tablets
This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Glimepiride Tablets
Dosage
The dose is fixed by the doctor, depending on your blood and urine sugar levels.
Change in external factors (e.g. weight reduction, change in life style, stress) or improvements in the disease may require changed glimepiride doses.
The usual starting dose for adults is 1 mg of glimepiride per day. If good blood sugar control is achieved the dosage should be used for maintenance therapy. Doses of more than 4 mg of glimepiride per day give better results only in exceptional cases. The maximum recommended dose is 6 mg glimepiride per day.
A combination therapy of glimepiride plus metformin or of glimepiride plus insulin may be initiated. In such a case your doctor will determine the proper doses of glimepiride, metformin or insulin individually for you.
Glimepiride must be swallowed with at least half a glass of water. Usually the entire daily dose is taken all at once directly before or during a substantial 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 glimepiride.
Always take Glimepiride Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Please speak with your doctor or pharmacist if you have the impression that Glimepiride Tablets are acting too strongly or not strongly enough.
If you take more Glimepiride Tablets than you should
If you happen to have taken too much glimepiride or an additional dose there is a danger of low sugar levels, (signs of hypoglycaemia see section 2) and therefore you should instantly consume enough sugar (e.g. a small bar of grape sugar cubes, sugar cubes, sweet juice, sweetened tea) and inform a doctor immediately. The same should be done if somebody, e.g. a child, has taken the product unintentionally. Persons in a state of unconsciousness must not be given food or drink.
Since the state of low sugar levels 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. Severe cases of low blood sugar 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 Tablets
If you forget to take a dose, do not take the missed dose, just take the next dose on time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Glimepiride Tablets
If you interrupt or stop the treatment you should be aware that the desired blood sugar lowering effect is not achieved or that the disease will deteriorate again. If any change is necessary it is absolutely important for you to contact your doctor first.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Glimepiride Tablets can cause side effects, although not everybody gets them.
Most side-effects of Glimepiride Tablets are dose-dependent and disappear when the dose is reduced or if the medicine is no longer taken.
Side-effects occur most often at the start of treatment.
Side-effects are generally mild and temporary.
Frequencies of side-effects:
Very common: more than 1 patient in 10
Common: more than 1 patient in 100 and less than 1 patient in 10 Uncommon: more than 1 patient in 1000 and less than 1 patient in 100 Rare: more than 1 patient in 10000 and less than 1 patient in 1000 Very rare: less than 1 patient in 10000
|
Very common and Common |
Uncommon |
Rare |
Very rare | |
|
Blood and lymphatic system disorders |
Changes in hematology 1) | |||
|
Immune system disorders |
Mild hypersensitivity reactions 2), allergic inflammation of blood vessels, cross allergenicity with sulphonylureas, sulphonamides or related substances | |||
|
Metabolism and nutrition disorders |
Low blood sugar (hypoglycae mia) 3) |
|
Eye disorders |
Visual disturbances 4) | |||
|
Gastrointestinal disorders |
Nausea, vomiting, diarrhoea, abdominal enlarging, abdominal discomfort and abdominal pain 5) | |||
|
Liver and biliary tract disorders |
Elevation of liver enzymes |
Abnormal liver function (e.g. with problems with the flow of bile and jaundice), hepatitis and hepatic failure | ||
|
Skin and subcutaneous tissue disorders |
Hypersensitivity reactions of the skin as itching, rash and hives, hypersensitivity to light | |||
|
Investigations |
Decrease in the blood sodium concentrations |
1) Changes in blood values normally vanish when the treatment is discontinued.
2) In isolated cases, mild reactions (e.g. of the skin) may develop into life-threatening situations with breathing difficulties, decreased blood pressure and even shock. Therefore, if you observe skin reactions you should instantly inform your doctor.
3) “Hypoglycaemic reactions” are reactions caused by low blood sugar. These usually occur immediately. They may be dangerous and are not always easy to treat, (see also section 2 and section
3) .
4) Temporary visual disturbances are due to changes in blood sugar concentration and occur particularly at the start of treatment.
5) Gastrointestinal complaints seldom lead to discontinuation of therapy.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor pharmacist.
5. How to store Glimepride Tablets
Keep out of the reach and sight of children.
Store in the original package.
Do not store above 30° C
Do not use this medicine after the expiry date which is stated on the carton.
For environmental and safety reasons, residues of the medicines or out-of-date packs must be removed from the general pharmacy stock and stored separately.
6. Further information What Glimepiride Tablets contains
- The active substance is glimepiride. Each tablet contains 4 mg or 6 mg glimepiride.
- The other ingredients are lactose monohydrate, maize starch, sodium starch glycolate, povidone, polysorbate 80, talc, magnesium stearate and yellow iron oxide (E172).
What Glimepiride Tablets looks like and contents of the pack
Glimepiride 4mg Tablets:
Yellow capsule shaped tablets (10.7 x 5.5mm) with a break line on one side.
Glimepiride 6mg Tablets:
Yellow capsule shaped tablets (12.5 x 6.5mm) with a break line on one side.
Glimepiride Tablets are available in blister packs of 10, 20, 30, 50, 60, 90, 100, 120 and 500 tablets. The Glimepiride 6mg Tablets are also available in blister packs of 28.
Glimepiride Tablets are also available in containers of 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
PLIVA Pharma Ltd.
Vision House Bedford Rd Petersfield
Hampshire GU32 3Q8.
Manufacturer:
Teva Operations Poland Sp Z o.o.
Ul. Mogilska 80 31-546 Krakow Poland