Full Prescribing Info
Each NIKP-Glimepiride tablet 3mg contains active ingredient 3mg of glimepiride.
Excipients/Inactive Ingredients: Lactose, cellulose, sodium starch glycolate, povidone, magnesium stearate, ferric oxide (yellow).
NIKP-Glimepiride tablet 3mg is an orally active blood sugar lowering drug. This drug belongs to a blood sugar lowering group of medicines called sulfonylurea. NIKP-Glimepiride tablet 3mg works by increasing the amount of insulin released from the pancreas. The insulin then lowers blood sugar levels.
NIKP-Glimepiride tablet 3mg is used to treat a certain form of diabetes (type 2 diabetes mellitus) when diet, physical exercise and weight reduction alone have not been able to control blood sugar levels.
Dosage/Direction for Use
Always take NIKP-Glimepiride tablet 3mg exactly as prescribed. The patient should check with the doctor or pharmacist if not sure.
Taking this medicine: Take this medicine by mouth, just before or with the first main meal of the day (usually breakfast). If the patient does not have breakfast he/she should take the product on schedule as prescribed by the doctor. It is important not to leave out any meal when taking NIKP-Glimepiride tablet 3mg.
Swallow the tablets whole with at least half glass of water. Do not crush or chew the tablets.
How much to take: The dose of glimepiride depends on the patient's needs, condition and results of blood and urine sugar tests and is determined by the doctor. Do not take more tablets than the doctor has prescribed.
The usual starting dose is 1 mg of glimepiride once a day.
If necessary, the doctor may increase the dose after each 1-2 weeks of treatment.
The maximum recommended dose is 6 mg of glimepiride per day.
A combination therapy of glimepiride plus metformin or of glimepiride plus insulin may be initiated. In such case the doctor will determine the proper doses of glimepiride, metformin or insulin individually for the patient.
If the patient's weight changes or if the patient changes his/her lifestyle, or the patient is in a stress situation this may require changed glimepiride doses, therefore inform the doctor.
If the patient feels the effect of the medicine is too weak or too strong do not change the dose, but ask the doctor.
If the patient forgets to take NIKP-Glimepiride tablet 3mg: If the patient forgets to take a dose, a double dose should not be taken to make up for forgotten doses.
If the patient stops taking NIKP-Glimepiride tablet 3mg: If the patient interrupts or stops the treatment the patient should be aware that the desired blood sugar lowering effect is not achieved or that the disease will deteriorate again. Keep taking NIKP-Glimepiride tablet 3mg until advised by the doctor to stop.
If there are any further questions on the use of this product, ask the doctor or pharmacist.
If the patient happens to have taken too much NIKP-Glimepiride tablet 3mg or an additional dose there is a danger of hypoglycaemia (see Important information about hypoglycaemia (low blood sugar) under Precautions) and therefore the patient should instantly consume enough sugar (e.g. a small bar of sugar cubes, sweet juice, sweetened tea) and inform a 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.
Do not take NIKP-Glimepiride tablet 3mg and tell the doctor if: The patient is allergic (hypersensitive) to: Glimepiride or other sulfonylureas (medicines used to lower blood sugar such as glibenclamide) or sulfonamides (medicines for bacterial infections such as sulfamethoxazole) or any of the other ingredients of NIKP-Glimepiride tablet 3mg (listed in Description).
The patient has insulin dependent diabetes (type 1 diabetes mellitus).
The patient has diabetic ketoacidosis (a complication of diabetes when acid level is raised in the body and the patient may have some of the following signs: fatigue, feeling sick (nausea), frequent urination and muscular stiffness).
The patient is in diabetic coma.
The patient has severe kidney disease.
The patient has a severe liver disease.
Do not take this medicine if any of the previously mentioned applies. If not sure, talk to the doctor or pharmacist before taking NIKP-Glimepiride tablet 3mg.
Special Precautions
Take special care with NIKP-Glimepiride tablet 3mg: Check with the doctor or pharmacist before taking the medicine if: The patient is recovering from an injury, operation, infections with fever, or from other forms of stress, inform the doctor as temporary change of treatment may be necessary.
The patient has a severe liver or kidney disorder.
If not sure if any of these apply, talk to the doctor or pharmacist before taking NIKP-Glimepiride tablet 3mg.
Lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anemia) can occur in patients missing the enzyme glucose-6-phosphate dehydrogenase.
Important information about hypoglycaemia (low blood sugar): When the patient takes NIKP-Glimepiride tablet 3mg, the patient may get hypoglycaemia (low blood sugar). Please see as follows for additional information about hypoglycaemia, its signs and treatment.
Following factors could increase the risk of getting hypoglycaemia: Undernourishment, irregular meal time, missed or delayed meal or period of fasting; Changes to diet; Taking more NIKP-Glimepiride tablet 3mg than needed; Having decreased kidney function; Having severe liver disease; If the patient suffers from particular hormone-induced disorders (disorders of the thyroid glands, of the pituitary gland or adrenal cortex); Drinking alcohol (especially when the patient skips a meal); Taking certain other medicines (see Taking other medicines under Interactions); If the patient increases body exercise and the patient does not eat enough or eats food containing less carbohydrate than normal.
Signs of hypoglycaemia include: Hunger pangs, headache, nausea, vomiting, sluggishness, sleepiness, disordered sleep, restlessness, aggression, impaired concentration, reduced alertness and reaction time, depression, confusion, speech and visual disorders, slurred speech, shakiness, partial paralysis, sensory disturbances, dizziness, 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 the patient may suffer from considerable confusion (delirium), develop convulsions, lose self control, breathing may be shallow and heart beat slowed down, may fall into unconsciousness. The clinical picture of severe reduced blood sugar level may resemble that of a stroke.
Treating hypoglycaemia: In most cases the signs of reduced blood sugar vanish very quickly when the patient consumes some form of sugar, e.g. sugar cubes, sweet juice, sweetened tea.
The patient should therefore always take some form of sugar with him/her (e.g. sugar cubes). Remember that artificial sweeteners are not effective. Please contact the doctor or go to the hospital if taking sugar does not help or if the symptoms recur.
Laboratory Tests: The level of sugar in the blood or urine should be checked regularly. The doctor may also take blood tests to monitor the blood cell levels and liver function.
Important information about some of the ingredients of NIKP-Glimepiride tablet 3mg: NIKP-Glimepiride tablet 3mg contains lactose. If the patient has been told by the doctor that he/she cannot tolerate some sugars, contact the doctor before taking this medicinal product.
Driving and using machines: The patient's ability to concentrate or react may be impaired if blood sugar is lowered (hypoglycaemia), or raised (hyperglycaemia) or if the patient develops visual problems as a result of such conditions. Bear in mind that the patient could endanger himself/herself or others (e.g. when driving in a car or using machines). Please ask the doctor whether the patient can drive a car if the patient: Has frequent episodes of hypoglycaemia; Has fewer or no warning signals of hypoglycaemia.
Use in Children: The information available on the use NIKP-Glimepiride tablet 3mg in people under 18 years of age is limited. Therefore, its use in these patients is not recommended.
Use In Pregnancy & Lactation
Pregnancy: NIKP-Glimepiride tablet 3mg should not be taken during pregnancy. Tell the doctor if the patient is, the patient thinks she might be or planning to become pregnant.
Breast feeding: NIKP-Glimepiride tablet 3mg may pass into breast milk. NIKP-Glimepiride tablet 3mg should not be taken during breast feeding.
Ask the pharmacist for advice before taking any medicine.
Side Effects
Like all medicines, NIKP-Glimepiride tablet 3mg can cause side effects, although not everybody gets them.
Tell the doctor immediately if the patient experiences any of the following symptoms: 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.
Abnormal liver function including yellowing of the skin and eyes (jaundice), problem with the bile flow (cholestasis), inflammation of the liver (hepatitis) or liver failure.
Allergy (hypersensitivity) of the skin such as itching, rash, hives and increased sensitivity to sun. Some mild allergic reaction may develop into serious reactions.
Severe hypoglycaemia including loss of consciousness, seizures or coma.
Some patients experienced the following side effects whilst taking NIKP-Glimepiride tablet 3mg: Rare side effects (affects more than 1 patient in 10,000 and less than 1 patient in 1000 people): Lower blood sugar than normal (hypoglycaemia) (see Take special care with NIKP-Glimepiride tablet 3mg under Precautions).
Decrease in the number of blood cells: Blood platelets (which increases risk of bleeding or bruising); White blood cells (which makes infections more likely); Red blood cells (which can make the skin pale and cause weakness and breathlessness).
These problems generally get better after the patient stops taking NIKP-Glimepiride tablet 3mg.
Very rare side effects (affects less than 1 patient in 10,000): 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 into shock. If the patient experiences any of these symptoms, tell the doctor immediately.
Feeling of being sick, diarrhea, feeling full or bloated, and abdominal pain.
Decrease in the amount of sodium level in the patient's blood (shown by blood tests).
Other side effects include: Allergy (hypersensitivity) of the skin may occur such as itching, rash, hives and increased sensitivity to sun. Some mild allergic reactions may develop into serious reactions with swallowing or breathing problems, swelling of lips, throat or tongue. Therefore in the event of one of these side effects, tell the doctor immediately.
Allergic reactions with sulfonylureas, sulfonamides, or related drugs may occur.
Problems with sight may occur when beginning treatment with NIKP-Glimepiride tablet 3mg. This is due to changes in blood sugar levels and should soon improve.
Increased liver enzymes.
If any of these side effects gets serious, or if any side effects not listed in this monograph is noticed, please tell the doctor or pharmacist.
Drug Interactions
Taking other medicines: Please tell the doctor or pharmacist if the patient is taking or has recently taken any other medicines, including medicines obtained without prescription.
The doctor may wish to change the dose of NIKP-Glimepiride tablet 3mg if the patient is taking other medicines, which may weaken or strengthen the effect of NIKP-Glimepiride tablet 3mg on the level of sugar in the blood.
The following medicines can increase the blood sugar lowering effect of NIKP-Glimepiride tablet 3mg. This can lead to a risk of hypoglycaemia (low blood sugar): Other medicinal products to treat diabetes mellitus (such as insulin or metformin); Medicinal products to treat pain and inflammation (phenylbutazone, azopropazone, oxyphenbutazone, aspirin-like medicines); Medicinal products to treat urinary infections (such as some long acting sulfonamides); Medicinal products to treat bacterial and fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin); Medicinal products to inhibit blood clotting (coumarin derivatives such as warfarin); Medicinal products supporting muscle build up (anabolics); Medicinal products used for male sex hormone replacement therapy; Medicinal products to treat depression (fluoxetine, MAO-inhibitors); Medicinal products lowering high cholesterol level (fibrates); Medicinal products lowering high blood pressure (ACE inhibitors); Medicinal products to treat gout (allopurinol, probenecid, sulfinpyrazone); Medicinal products to treat cancer (cyclophosphamide, ifosfamide, trofosfamide); Medicinal products used to reduce weight (fenfluramine); Medicinal product to increase circulation when given in a high dose intravenous infusion (pentoxifylline); Medicinal products to treat nasal allergies such as hay fever (tritoqualine); Medicinal products called sympatholytics to treat high blood pressure, heart failure, or prostate symptoms.
The following medicines may decrease the blood sugar lowering effect of NIKP-Glimepiride tablet 3mg. This can lead to a risk of hyperglycaemia (high blood sugar level): Medicinal products containing female sex hormones (oestrogens, progestogens); Medicinal products supporting urine production (thiazide diuretics); Medicinal products used to stimulate the thyroid gland (such as levothyroxine); Medicinal product to treat allergies and inflammation (glucocorticoids); Medicinal products to treat severe mental disorders (chlorpromazine and other phenothiazine derivatives); Medicinal products used to raise heart beat, to treat asthma or nasal congestion, coughs and colds, used to reduce weight, or used in life-threatening emergencies (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 seizures (phenytoin); Medicinal products to treat nervousness and sleep problems (barbiturates); Medicinal products to treat increased pressure in the eye (acetazolamide); Medicinal products to treat high blood pressure or lowering blood sugar (diazoxide); Medicinal products to treat infections, tuberculosis (rifampicin); Medicinal products to treat severe low blood sugar levels (glucagon).
The following medicinal products can increase or decrease the blood sugar lowering effect of NIKP-Glimepiride tablet 3mg: Medicinal products to treat stomach ulcers (called H2 antagonists); 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.
NIKP-Glimepiride tablet 3mg may either increase or weaken the effects of the following medicines: Medicinal products inhibiting blood clotting (coumarin derivatives such as warfarin).
Taking NIKP-Glimepiride tablet 3mg with food and drink: Alcohol intake may increase or decrease the blood sugar lowering action of NIKP-Glimepiride tablet 3mg in an unpredictable way.
Caution For Usage
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
Store below 30°C.
Store in the original package.
Do not use NIKP-Glimepiride tablet 3mg if visible signs of deterioration are noticed.
Shelf-life: 3 years.
MIMS Class
ATC Classification
A10BB12 - glimepiride ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.
Tab 3 mg x 10 x 10's.
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