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TAJ PHARMA INDIA / Product / TYRAEL (GLIMEPIRIDE 1 MG, 2MG, 3MG, 4MG TABLETS)
Glimempride-4mg
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TYRAEL (GLIMEPIRIDE 1 MG, 2MG, 3MG, 4MG TABLETS)

Generic Name

Glimepiride


Brand Name

TYRAEL®


Dosage Form

Tablets


Strength and Dosage

1, 2, 3 and 4 mg


Therapeutic Category


Patient Information Leaflet

Summary of Product Characteristics pdfIcon

Product Description


Active ingredient in TYRAEL is Glimepiride.
Glimepiride is an orally active blood sugar lowering drug. This drug belongs to a blood sugar lowering group of medicines called sulfonylureas. Glimepiride works by increasing the amount of insulin released from your pancreas. The insulin then lowers your blood sugar levels.
TYRAEL 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 your blood sugar levels.



BEFORE YOU TAKE TYRAEL Do not take TYRAEL and tell your doctor if:

• You are allergic (hypersensitive) 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 what TYRAEL contains).
• You have insulin dependent diabetes (type 1 diabetes mellitus)
• 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)
• You are in a diabetic coma.
• You have severe kidney disease.
• 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 TYRAEL.

Warnings and precautions
Talk to your doctor or pharmacist before taking TYRAEL
• 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
• If you have 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 TYRAEL. Lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anemia) can occur in patients missing the enzyme glucose-6-phoshate dehydrogenase.

Important information about hypoglycaemia (low blood sugar)
When you take TYRAEL, 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 TYRAEL than 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 Taking other medicines below)
• If you increase the amount of exercise you do and you don’t eat enough food or eat food containing less carbohydrate than usual.

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, and 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
TYRAEL is not recommended for use in children under 18 years of age.

Other medicines and TYRAEL:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Your doctor may wish to change your dose of TYRAEL if you are taking other medicines, which may weaken or strengthen the effect of TYRAEL on the level of sugar in your blood.

The following medicines can increase the blood sugar lowering effect of TYRAEL. This can lead to a risk of hypoglycaemia (low blood sugar):
• Medicines to treat pain and inflammation (phenylbutazone, azopropazone, oxyphenbutazone, aspirinlike medicines)
• Other medicines to treat diabetes mellitus (such as insulin or metformin)
• Medicines supporting muscle build up (anabolics)
• Medicines to inhibit blood clotting (coumarin derivatives such as warfarin)
• Medicines used to reduce weight (fenfluramine)
• Medicines called anti-arrhythmic agents used to control abnormal heart beat (disopyramide)
• Medicines lowering high cholesterol level (fibrates)
• Medicines lowering high blood pressure (ACE inhibitors)
• Medicines to treat depression (fluoxetine, MAO inhibitors)
• Medicines to treat gout (allopurinol, probenecid, sulfinpyrazone)
• Medicines to treat cancer (cyclophosphamide , ifosfamide, trofosfamide)
• Medicines to treat bacterial and fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin)
• Medicines to treat nasal allergies such as hay fever (tritoqualine)
• Medicines to increase circulation when given in a high dose intravenous infusion (pentoxifylline)
• Medicines to treat urinary infections (such as some long acting sulfonamides)
• Medicines used for male sex hormone replacement therapy
• Medicines called sympatholytics to treat high blood pressure, heart failure, or prostate symptoms

The following medicines may decrease the blood sugar lowering effect of TYRAEL. This can lead to a risk of hyperglycaemia (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 heart beat, 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 high blood pressure or lowering blood sugar (diazoxide)
• Medicines to treat severe low blood sugar levels (glucagon)
• Medicines to treat nervousness and sleep problems (barbiturates)
• Medicines to treat infections, tuberculosis (rifampicine)
• Medicines to treat increased pressure in the eye (azetazolamide)

The following medicinal products can increase or decrease the blood sugar lowering effect of TYRAEL:
• Medicines 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.
• Medicines to treat stomach ulcers (called H2 antagonists)
TYRAEL 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 TYRAEL. To avoid this effect, you should be advised to take TYRAEL at least 4 hours before colesevelam.

TYRAEL with food and drink:
Alcohol intake may increase or decrease the blood sugar lowering action of TYRAEL in an unpredictable way

Pregnancy, breast-feeding and fertility:
Pregnancy
TYRAEL should not be taken during pregancy. 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 breast feeeding.
Ask your doctor or pharmacist for advice before taking this 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

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


HOW TO TAKE TYRAEL

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist 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 product on schedule as prescribed by your doctor. It is important not to leave out any meal when you are on TYRAEL.
• 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 TYRAEL depends on your needs, condition and results of blood and urine sugar tests and is determined by your doctor. Do not take more tablets than your doctor has prescribed.
• The usual starting dose is one Glimepiride 1 mg tablet once a day.
• If necessary, your doctor may increase the dose after each 1 – 2 weeks of treatment.
• The maximum recommended dose is 6 mg Glimepiride tablet per day.
• A combination therapy of glimepiride plus metformin or of glimepiride plus insulin may be started. In such a case your doctor will determine the proper doses of glimepiride, metformin or insulin individually for you
• Your dose of TYRAEL may need to be adjusted if you change weight, change your lifestyle, or if you are under a lot of stress. Please speak to your doctor if any of these situations apply to you.
• If you feel the effect of your medicine is too weak or too strong do not change the dose yourself, but ask your doctor

If you take more TYRAEL than you should
If you happen to have taken too much TYRAEL or an additional dose there is a danger of hypoglycaemia 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 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 & friends to call a doctor immediately if this happens to you.

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

If you stop taking TYRAEL
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 TYRAEL until your doctor tells you to stop.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.


POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can 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 sun.
• Some mild allergic reactions may develop into serious reactions
• Severe hypoglycaemia including loss of consciousness, seizures or coma
Other possible side effects with TYRAEL:

Rare side effects (may affect up to 1 in 1000 people)
• Lower blood sugar than normal (hypoglycaemia) (See Section 2)
• 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 TYRAEL

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
• Decrease in the amount of sodium level in your blood (shown by blood tests)

Not known (frequency cannot be estimated from the available data)
• 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 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 drugs may occur
• Problems with your sight may occur when beginning treatment with TYRAEL. This is due to changes in blood sugar levels and should soon improve
• Increased liver enzymes
• Severe unusual bleeding or bruising under the skin


HOW TO STORE TYRAEL

• Keep this medicine out of the sight and reach of children
• This medicinal product does not require any special temperature storage condition. Store in the original package in order to protect from moisture. Keep the blister in the outer carton.
• Do not use this medicine after the expiry date which is stated on the carton (EXP). The expiry date refers to the last day of that month.
• 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.


FURTHER INFORMATION

The active substance is Glimepiride.
For 1mg: Each tablet contains 1 mg of glimepiride.
For 2mg: Each tablet contains 2 mg of glimepiride.
For 3mg: Each tablet contains 3 mg of glimepiride.
For 4mg: Each tablet contains 4 mg of glimepiride.
The other ingredients are:
Core tablet: lactose monohydrate, sodium starch glycolate(type A), povidone (K-30), magnesium stearate
Coloring agent:
TYRAEL 1 mg: Iron oxide red (E172)
TYRAEL 2 mg: Iron oxide red (E172)
TYRAEL 3 mg: Iron oxide yellow (E172)

What TYRAEL looks like and contents of the pack
TYRAEL 1mg: Pink coloured round, flat uncoated tablets with plain on both side.
TYRAEL 2mg: Light pink coloured oval shaped, uncoated tablets with plain on both side.
TYRAEL 3mg: Pale yellow, oval shaped uncoated tablets with plain on both side.
TYRAEL 4mg: White oval shaped uncoated tablets with plain on both side.
TYRAEL are available in blister packs of 10, 30, 60, 90,120 and 180 tablets.
Not all packs sizes may be marketed.

Additional Information

If you are a distributor, please inquire with us about product , importing and/or marketing our products in your country or region. If you are a consumer, don’t hesitate to contact us about more information for this product.

To inquire more about cost effective Taj Brands products, hospital imports, non-available life saving products, please contact us.

The most common markets for this product include the following state . Please inquire with us if your state is not listed:

North India : Jammu & Kashmir ,Himachal Pradesh,Uttar Pradesh ,Uttaranchal , Punjab ,Haryana.
South India : Kerala, Karnataka ,Tamil Nadu,Andhra Pradesh.
East India : Assam ,Manipur, Meghalaya,West Bengal ,Orissa,Sikkim ,Mizoram, Tripura
West India : Goa ,Gujarat ,Rajasthan ,Maharashtra
Central India : Madhya Pradesh, Chattisgarh

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