Glimepiride Tablets USP 1mg

Glimepiride Tablets USP 1mg
Glimepiride Tablets USP 2mg
Glimepiride Tablets USP 3mg
Glimepiride Tablets USP 4mg

Package leaflet: Information for the user

Read this entire leaflet carefully before you starts 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 is one of a group of medicines called oral hypoglycaemics, which are used for the treatment of diabetes (a disease where the body does not produce enough insulin to control the level of blood sugar). Oral hypoglycaemics help control blood sugar level.

The active ingredient in your Glimepiride tablets is Glimepiride.

What Glimepiride used for:

Glimepiride is used in the treatment of non-insulin dependent (Type II) diabetes mellitus. You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Type II diabetes can sometimes be controlled by good diet, physical exercise and weight reduction alone, but where this is not possible, Glimepiride is used in addition.

1. 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 any of the other ingredients of this medicine (listed in section 6)
if you have insulin-dependent diabetes (Type I 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 are in a diabetic coma
if you have severe kidney disease
if you have a severe liver disease

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Glimepiride.

Warnings and precautions:

Talk to your doctor or pharmacist before taking your medicine if:

You are recovering from an injury, operation, infections with fever, or from other forms of stress, inform your doctor as temporary change of treatment may be necessary.You have a severe liver or kidney disorder.

If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Glimepiride .

Lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur in patients missing the enzyme glucose-6-phosphate dehydrogenase.

The information available on the use of Glimepiride in people under 18 years of age is limited. Therefore, its use in these patients is not recommended.

Important information about hypoglycaemia (low blood sugar)

When you take Glimepiride, you may get hypoglycaemia (low blood sugar). Please see below for additional information about hypoglycaemia, its signs and treatment.

Following factors could increase the risk of you getting hypoglycaemia:

Undernourishment, irregular meal time, missed or delayed meal or period of fasting
Changes to your diet
Taking more Glimepiridethan needed
Having kidneys that do not work properly
Having severe liver disease
If you suffer from particular hormone-induced disorders (disorders of the thyroid glands, of the pituitary gland or adrenal cortex)
Drinking alcohol (especially when you skip a meal)
Taking certain other medicines (see below ?Other medicines and Glimepiride ?)

If you increase the amount of exercise you do and you don’t eat enough food or eat food containing less carbohydrate than usual.

Signs of hypoglycaemia include:

Hunger pangs, headache, nausea, vomiting, sluggishness, sleepiness, problems sleeping, restlessness, aggression, problems with concentration, reduced alertness and reaction time, depression, confusion, problems with your speech and sight, slurred speech, shakiness, partial paralysis, dizziness, helplessness
The following signs may also occur: sweating, clammy skin, anxiety, fast or increased heartbeat, high blood pressure, awareness of your heartbeat, 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 fits, lose self-control, breathing may be shallow and your heartbeat slowed down, you may fall into unconsciousness.

The clinical picture of a 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 you consume some form of sugar, e.g. sugar cubes, sweet juice, sweetened tea.

You should therefore always take some form of sugar with you (e.g. sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or go to the hospital if taking sugar does not help or if the symptoms recur.

Laboratory tests

The level of sugar in your blood or urine should be checked regularly. Your doctor may also take blood tests to monitor your blood cell levels and liver function.

Children and adolescents

Glimepiride is not recommended for use in children under 18 years of age.

Other medicines and Glimepiride

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor may wish to change your dose of Glimepiride if you are taking other medicines, which may weaken or strengthen the effect of Glimepiride on the level of sugar in your blood.

The following medicines can increase the blood sugar-lowering the effect of Glimepiride. This can lead to a risk of hypoglycaemia (low blood sugar):

Other medicines to treat diabetes mellitus (such as insulin or metformin)
Medicines to treat pain and inflammation (phenylbutazone, azopropazone, oxyphenbutazone, aspirin-like medicines)
Medicines to treat urinary infections (such as some long-acting sulfonamides)
Medicines to treat bacterial and fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin)
Medicines to inhibit blood clotting (coumarin derivatives such as warfarin)
Medicines supporting muscle build-up (anabolics)
Medicines used for male sex hormone replacement therapy
Medicines to treat depression (fluoxetine, MAOinhibitors)
medicines lowering high cholesterol level (fibrates)
medicines lowering high blood pressure (ACE inhibitors) Medicines called anti-arrhythmic agents used to control abnormal heartbeat (disopyramide)
Medicines to treat gout (allopurinol, probenecid, sulfinpyrazone)

Medicines to treat cancer (cyclophosphamide, ifosfamide, trofosfamide)
Medicines used to reduce weight (fenfluramine)
Medicines to increase circulation when given in a high dose of intravenous infusion (pentoxifylline)
Medicines to treat nasal allergies such as hay fever (tritoqualine)
Medicines called sympatholytics to treat high blood pressure, heart failure, or prostate symptoms

The following medicines may decrease the blood sugar lowering the effect of Glimepiride. This can lead to a risk of hyperglycemia (high blood sugar level):

Medicines containing female sex hormones (oestrogens, progestogens)
Medicines to treat high blood pressure called thiazide diuretics (water tablets)
Medicines used to stimulate the thyroid gland (such as levothyroxine)
Medicines to treat allergies and inflammation (glucocorticoids)
Medicines to treat severe mental disorders (chlorpromazine and other phenothiazine derivatives)
Medicines used to raise heartbeat, to treat asthma or nasal congestion, coughs and colds, used to reduce weight, or used in life-threatening emergencies (adrenaline and sympathomimetics)
Medicines to treat high cholesterol level (nicotinic acid)
Medicines to treat constipation when they are used long term (laxatives)
Medicines to treat fits (phenytoin)
Medicines to treat nervousness and sleep problems (barbiturates)
Medicines to treat increased pressure in the eye (acetazolamide)
Medicines to treat high blood pressure or low blood sugar (diazoxide)
Medicines to treat infections, tuberculosis (rifampicin)
Medicines to treat severe low blood sugar levels (glucagon)

The following medicines can increase or decrease the blood sugar lowering the effect of Glimepiride :

Medicines to treat stomach ulcers (called H2 antagonists)
Medicines to treat high blood pressure or heart failures 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 increases 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. To avoid this effect, you should be advised to take Glimepirideat least 4 hours before colesevelam

Glimepiridewith food, drink and alcohol

Alcohol intake may increase or decrease the blood sugar lowering action of Glimepiride in an unpredictable way.

Pregnancy and breast-feeding

Pregnancy

Glimepiride should not be taken during pregnancy. Tell your doctor if you are, you think you might be or are planning to become pregnant.

Breast-feeding

Glimepiride may pass into breast milk. Glimepiride should not be taken during breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Your ability to concentrate or react may be reduced 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 tablets contain lactose

If you have been told by your doctor that you cannot tolerate some sugars, contact your doctor before taking this medicinal product.

3. How to take Glimepiride tablets

Always take Glimepiridetablets exactly as your doctor has told you. You should check with your doctor if you are not sure.

Taking this medicine

Take this medicine by mouth, just before or with the first main meal of the day (usually breakfast). If you do not have breakfast you should take the medicine on schedule as prescribed by your doctor. It is important not to leave out any meal when you are on Glimepiride
Swallow the tablets with at least half glass of water. Do not crush or chew the tablets.

If you take more Glimepiridethan you should

If you happen to have taken too much Glimepirideor an additional dose there is a danger of hypoglycaemia (signs of hypoglycaemia see section 2) and therefore you 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 the 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 coma are cases of medical emergency requiring immediate medical treatment and admission into hospital. It may be helpful to tell your family and friends to call a doctor immediately if this happens to you.

If you forget to take Glimepiride

If you forget to take a tablet, do not take a double dose to make up for forgotten doses.

If you stop taking Glimepiride

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 get worse again. Keep taking Glimepiride until your doctor tells you to stop.

4. Possible side effects

Like all medicines, Glimepiridecan cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience 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), problems 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 the sun. Some mild allergic reactions may develop into serious reactions

Severe hypoglycaemia including loss of consciousness, seizures or coma

Some patients experienced the following side effects whilst taking Glimepiride :

Rare side effects (may affect up to 1 in 1,000 people)

Lower blood sugar than normal (hypoglycaemia) (see section 2)
A 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 or breathlessness)

These problems generally get better after you stop taking Glimepiride Very rare side effects (may affect up to 1 in 10,000 people)

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. If you experience any of these symptoms, tell your doctor immediately
Abnormal liver function including yellowing of the skin and eyes (jaundice), impairment of the bile flow(cholestasis), inflammation of the liver (hepatitis) or liver failure. If you experience any of these symptoms, tell your doctor immediately
Feeling or being sick, diarrhoea, feeling full or bloated, and abdominal pain
A decrease in the amount of sodium level in your 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 the sun.
Some mild allergic reactions may develop into serious reactions with swallowing or breathing problems, swelling of your
lips, throat or tongue. Therefore in the event of one of these side effects, tell your doctor immediately
Allergic reactions with sulfonylureas, sulfonamides, or related medicines may occur
Problems with your sight may occur when beginning treatment with Glimepiride. This is due to changes in blood sugar levels and should soon improve
Increased liver enzymes
Severe unusual bleeding or bruising under the skin

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

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 label after EXP. The expiry date refers to the last day of that month.
Do not store the tablets above 25? C

Store in the original package in order to protect from moisture.

Do not use this medicine if you notice visible signs of deterioration.

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 protect the environment.

6. Contents of the pack and other information

What Glimepiridetablet contains

The active substance is Glimepiride.

Each uncoated tablet contains:
Glimepiride USP 1mg
Excipients q.s.

The other ingredients are lactose, sodium starch glycolate, povidone, sodium lauryl sulphate, magnesium stearate, microcrystalline cellulose.

What Glimepiridetablets looks like and contents of the pack

PVC/Aluminium Blister Pack.

Pack size: 7, 14, 28, 30, 50, 90, 100 and 500 tablets.

Not All Packs May Be Marketed.

7. Manufactured In India By:

TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)