1 mg, 2 mg tablets 
glimepiride

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet:
1. What Glimepiride Sandoz is and what it is used for
2. What you need to know before you take Glimepiride Sandoz
3. How to take Glimepiride Sandoz
4. Possible side effects
5. How to store Glimepiride Sandoz
6. Contents of the packaging and other information

What Glimepiride Sandoz is and what it is used for

Glimepiride Sandoz is a blood sugar lowering medicine in tablet form. The drug belongs to the group of sufonureids that lower your blood sugar. Glimepiride Sandoz works by increasing the amount of insulin released from the pancreas. Insulin then lowers your blood sugar level.

What Glimepiride Sandoz is used for

Glimepiride Sandoz is used to treating a special type of diabetes ( type 2 diabetes mellitus ) as diet, exercise and weight reduction alone have not been sufficient.

Glimepiride contained in Glimepiride Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you take Glimepiride Sandoz

Do not take Glimepiride Sandoz:

  • if you are allergic to glimepiride or other sulphonylureas (medicines used to lower your blood sugar such as glibenclamide) or sulphonamides (medicines used to treat bacterial infections such as sulphamethoxazole) or any of the other ingredients of this medicine (listed in section 6)
  • if you have type 1 diabetes mellitus
  • if you have ketoacidosis (a diabetic complication where the acid level in your body is elevated and you may have some of the following symptoms: fatigue, malaise (nausea), increased need to urinate and muscle stiffness)
  • if you are in a diabetic coma
  • if you suffer from severe kidney disease
  • if you suffer from a serious 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 Sandoz.

Warnings and cautions

Talk to your doctor or pharmacist before taking  Glimepiride Sandoz again

  • You are recovering from an injury, surgery, fever infection, or from any other type of stress, it may be necessary to temporarily change the treatment
  • You have severe liver or kidney effects

If you are not sure if you have any of the above, talk to your doctor or pharmacist before taking Glimepiride Sandoz.

In patients who lack the enzyme et glucose ‑6‑ phosphate dehydrogenase, decreased haemoglobin levels and red blood cell degradation ( haemolytic anaemia) may occur.

Treatment of persons under 18 years of age is not recommended as there is insufficient information on the treatment of this patient group.

Important information about hypoglycaemia (low blood sugar)

When you take Glimepiride Sandoz you may get hypoglycaemia (low blood sugar). See below for more information on hypoglycaemia, its symptoms and treatment.

The following factors may increase the risk of hypoglycaemia

  • Malnutrition, irregular mealtimes, missed or delayed food intake or periods of fasting
  • Dietary changes
  • Too high a dose Glimepiride Sandoz
  • Impaired renal function
  • Severe liver disease
  • Certain hormonal disorders (such as thyroid disorders, pituitary gland or adrenal cortex )
  • Alcohol consumption (especially if you skip a meal)
  • Concomitant use of certain other medicines (see below “Other medicines and Glimepiride Sandoz”)
  • If you increase your physical activity and do not eat enough or if you eat foods with less carbohydrate content than usual.

Signs of hypoglycaemia include:

  • Hunger, headache, nausea, vomiting, inertia, fatigue, sleep disturbances, restlessness, aggression, impaired concentration, decreased alertness and reactivity, depression, confusion, speech and vision disorders, slurred speech, tremors, partial paralysis, dizziness, dizziness,
  • The following signs may also occur: sweating, sticky skin, anxiety, increased heart rate (high heart rate ), high blood pressure , palpitations, sudden severe chest pain that may radiate (angina, heart rhythm disturbance)

If your blood sugar levels continue to drop, you may experience pronounced confusion ( delirium ), seizures, loss of self-control, shallow breathing, and slower heart rate (low heart rate ) and you may become unconscious. A severe drop in blood sugar can resemble a stroke.

Treatment of hypoglycaemia:

In most cases, the signs of lowered blood sugar disappear very quickly when you take sugar in some form, e.g. sugar cubes, sweet juice or sugared tea. You should therefore always carry some form of sugar with you (eg pieces of sugar). Remember that artificial sweeteners are not effective. Contact your doctor or see a hospital if you do not improve your sugar intake or if your symptoms return.

Laboratory tests

The sugar level in your blood or urine should be checked regularly. Your doctor may also want to take blood samples to analyze your blood cells and liver function.

Children and young people

Glimepiride Sandoz is not recommended for use in children below 18 years.

Other medicines and Glimepiride Sandoz

Tell your doctor or pharmacist if you have recently taken or might take any other medicines. Your doctor may want to change the dose of one of Glimepiride Sandoz if you are taking other medicines that may weaken or enhance the effect of Glimepiride Sandoz on your blood sugar.

The following medicines may increase the blood sugar-lowering effect of Glimepiride Sandoz and lead

to an increased risk of hypoglycaemia (low blood sugar):

  • Other medicines used to treat diabetes (such as insulin , or metformin )
  • Medicines for the treatment of pain and inflammation (phenylbutazone, azapropazone and oxyfenbutazone and acetylsalicylic acid- like medicines)
  • Drugs used in the treatment of urinary tract infections (such as long-acting sulfonamides )
  • Drugs used in the treatment of bacterial and fungal infections ( tetracyclines , chloramphenicol, fluconazole , miconazole , quinelone antibiotics, clarithromycin)
  • Drugs that inhibit blood coagulation (coumarin derivatives such as warfarin )
  • Drugs that promote muscle building (anabolic steroids )
  • Drugs used in the replacement of male sex hormone 
  • Drugs used to treat depression ( fluoxetine , MAO inhibitors)
  • Medicines for high cholesterol levels (fibrates)
  • Medicines for high blood pressure (ACE inhibitors)
  • Drugs called antiarrhythmics and used to control abnormal heart rhythms ( disopyramide )
  • Medicines for the treatment of gout (allopurinol, probenecid, sulfinpyrazone)
  • Drugs used to treat cancer (cyclophosphamide, ifosphosamide and trophosphamide)
  • Medicines used for weight loss (fenfluramine)
  • Drugs that increase blood circulation when given in high doses by intravenous infusion (pentoxifylline)
  • Drugs used in the treatment of nasal allergy s such as hay fever (tritoqualin)
  • Drugs called sympatholytic drugs used to treat high blood pressure , heart failure or prostate symptoms

The following medicines may lower the blood sugar lowering effect of Glimepiride Sandoz. This may lead to an increased risk of hyperglycaemia (high blood sugar):

  • Medicines containing female sex hormones ( estrogens , progestogens)
  • Drugs acting diuretic ( thiazide you, diuretics )
  • Drugs that stimulate the thyroid gland (such as levothyroxine)
  • Medicines for the treatment of allergies and inflammation ( glucocorticoids )
  • Medicines for the treatment of severe mental disorders (chlorpromazine and other phenothiazine derivatives)
  • Medicines used to increase heart rate , to treat asthma or nasal congestion, coughs and colds , to treat obesity , or medicines used in life-threatening situations ( adrenaline and sympathomimetics )
  • Medicines for the treatment of high cholesterol levels ( nicotinic acid )
  • Medicines for long-term treatment of constipation ( laxatives )
  • Medicines for the treatment of seizures ( phenytoin )
  • Medicines for the treatment of anxiety and sleep problems ( barbiturates )
  • Medicines for the treatment of increased pressure in the eye (acetazolamide)
  • Medicines for the treatment of high blood pressure or for the treatment of low blood sugar (diazoxide)
  • Medicines for the treatment of infections , tuberculosis (rifampicin)
  • Medicines for the treatment of severe low blood sugar (glucagon)

The following medicines may either enhance or weaken the blood-glucose-lowering effect of Glimepiride Sandoz:

  • Medicines for the treatment of stomach ulcers (so-called H2 antagonists )
  • Medicines for the treatment of high blood pressure or heart failure such as beta-blockers , clonidine , guanetidine and reserpine. These medicines can also hide the signs of hypoglycaemia , so special precautions should be taken when using them.

Glimepiride Sandoz may either increase or decrease the effect of the following medicines:

  • Drugs that inhibit blood coagulation (coumarin derivatives such as warfarin )

Kolesevelam, a drug used to lower cholesterol, has an effect on the uptake of Glimepiride Sandoz. To avoid this effect, you should take Glimepiride Sandoz at least 4 hours before cholesevelam.

Glimepiride Sandoz with alcohol

Alcohol can potentially enhance or weaken the blood sugar lowering effect of Glimepiride Sandoz.

Pregnancy and breastfeeding

Pregnancy

Glimepiride Sandoz should not be used during pregnancy.

Breast-feeding

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

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Your ability to concentrate and react may be impaired if your blood sugar is lowered ( hypoglycaemia ) or elevated ( hyperglycaemia ) or if your vision is impaired as a result of these conditions. Always keep in mind that you may expose yourself or others (eg when driving or operating machines) to danger.

Ask your doctor if you can drive if you:

  • often have episodes of hypoglycemia
  • have weak, or no, warning signs of hypoglycaemia

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Glimepiride Sandoz contains lactose and sodium 

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free.

3. How to take Glimepiride Sandoz

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Use of this medicine

  • The medicine is taken orally, just before or in connection with the first meal of the day (usually breakfast). If you do not eat breakfast, take the medicine according to the instructions given to you by your doctor. It is important not to skip any meal while using Glimepiride Sandoz.
  • The tablet can be divided into two equal doses . The tablets should be swallowed together with at least half a glass of water. The tablets must not be crushed or chewed.

Dosage instructions

The dosage of Glimepiride Sandoz depends on your needs, your condition and the 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 Glimepiride Sandoz 1 mg tablet daily.
  • If necessary, your doctor may increase the dose one after 1-2 weeks of treatment.
  • The maximum recommended dose is 6 mg daily.
  • Combination therapy with glimepiride plus metformin or with glimepiride plus insulin may be appropriate. In these cases, your doctor will prescribe the appropriate dose of glimepiride, metformin or insulin for you.
  • If your weight changes or if your lifestyle changes or if you are stressed, you should inform your doctor; it may be necessary to adjust dose one.
  • If you have the impression that the effect of your medicine is too weak or too strong, do not change the dose yourself without first consulting your doctor.

If you take more Glimepiride Sandoz than you should

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital or the Poison Information Center for risk assessment and advice.

If you have taken too much Glimepiride Sandoz or an extra dose, there is a risk of hypoglycaemia (signs of hypoglycaemia see section 2) and therefore you should get enough sugar immediately (eg sugar cubes, sweet juice, sweetened tea) and contact a doctor immediately. When treating hypoglycaemia in children who have accidentally ingested Glimepiride Sandoz, it is important that the amount of sugar is carefully determined to avoid the occurrence of dangerous hyperglycaemia. People who are unconscious should not be given food or drink.

As hypoglycaemia can be persistent, it is important that the patient is closely monitored until the danger is over. Hospitalization may be necessary, if only as a precaution. Bring packing or any remaining tablets so that your doctor knows what you have taken.

Severe cases of hypoglycaemia with unconsciousness and severe effects on the nervous system require immediate medical treatment and hospitalization. There should always be an understanding person who can contact a doctor in an emergency.

If you forget to take Glimepiride Sandoz 

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

If you stop taking Glimepiride Sandoz

If you stop or stop treatment, you should be aware that the desired blood sugar lowering effect can not be achieved and that the disease may worsen again. Continue to use Glimepiride Sandoz until your doctor tells you to stop treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. 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 ( vasculitis , which is inflammation of blood vessels, often with rash) that can develop into severe reactions with difficulty breathing, drop in blood pressure and sometimes even shock
  • Abnormal liver function including yellowing of the skin and whites of the eyes (jaundice), problems with bile secretion (bile stasis), hepatitis ( hepatitis ) or liver failure
  • Allergic skin reactions (hypersensitivity) such as itching , rash, hives and photosensitivity. Some mild allergic reactions can develop into severe reactions.
  • Severe hypoglycaemia with unconsciousness, seizures or coma

Some patients experienced the following side effects during treatment with Glimepiride Sandoz:

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

  • Lower than normal blood sugar ( hypoglycaemia ) (see section 2 Warnings and precautions)
  • Reduction in the number of blood cells:
    • Platelets (increases the risk of bleeding or the risk of bruising)
    • White blood cells (increases the risk of infection)
    • Red blood cells (skin may become pale and weakness or shortness of breath may occur)

These problems usually get better as soon as you stop using Glimepiride Sandoz.

  • Changes in the taste experience
  • Hair loss
  • Weight gain

Very rare (may affect up to 1 in 10,000 people): 

  • Allergic reactions (including vasculitis , which is inflammation of blood vessels, often with rash) that can develop into severe reactions with difficulty breathing, a drop in blood pressure and sometimes even shock . If you experience any of these symptoms, contact your doctor immediately 
  • Abnormal liver function including yellowing of the skin and whites of the eyes (jaundice), problems with bile secretion (bile stasis), hepatitis ( hepatitis ) or liver failure. If you experience any of these symptoms, contact your doctor immediately 
  • Nausea, vomiting, diarrhea, feeling full or bloated, abdominal pain
  • Decrease in sodium levels in the blood (seen during blood tests)

Has been reported (occurs in the unknown number of users):

  • Allergic skin reactions (hypersensitivity) such as itching , rash, hives and photosensitivity. Some mild allergic reactions may develop into severe reactions with difficulty swallowing or breathing, swelling of the lips, throat or tongue. Therefore, if you get any of these symptoms, contact your doctor immediately
  • Allergic reactions to sulphonylureas, sulphonamides or similar medicines may occur
  • Visual disturbances may occur at the beginning of treatment due to changes in blood sugar levels. However, this problem is improving
  • Elevated liver enzyme levels
  • 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 also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Glimepiride Sandoz

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, jar and blister after EXP. The expiration date is the last day of the specified month.

Store below 25 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is glimepiride.
    Each tablet contains 1 mg glimepiride.
    Each tablet contains 2 mg glimepiride.

1 mg tablets:

  • The other ingredients are lactose monohydrate , sodium starch glycolate (type A), povidone K30, red iron oxide (E 172), microcrystalline cellulose and magnesium stearate.

2 mg tablets:

  • The other ingredients are lactose monohydrate , sodium starch glycolate (type A), povidone K30, yellow iron oxide (E 172), indigo carmine (E132), microcrystalline cellulose and magnesium stearate.

What the medicine looks like and contents of the pack

1 mg tablets :

Pink, slightly marbled, oblong, flat tablets with bevelled edges and break notches

on both sides and marked “G1” on one side.

2 mg tablets :

Green, slightly marbled, oblong, flat tablets with bevelled edges and break notches on both sides and marked “G2” on one side.

The tablets are packaged in clear PVC / PE / PVDC / Aluminum blister or packed in a white PP tablet jar with LDPE or MDPE lid and inserted in a carton, or packaged in a white PP tablet jar with LDPE or MDPE lid.

Pack sizes:

Blisters: 7, 14, 15, 28, 30, 56, 60, 90, 98, 100, 120, 180, 200 and 100×1 tablets.

Tablet jar: 100 and 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Manufacturer

Lek Pharmaceuticals dd, Verovkova 57, 1526 Ljubljana, Slovenia

or

LEK SA, Ul. Podlipie 16, 95-010 Stryków, Poland

or

LEK SA, Ul. Domaniewska 50 C, 02-672 Warsaw, Poland.

or

Salutas Pharma GmbH, Otto-von-Guericke- Allee 1, 39179 Barleben, Germany.

This medicinal product is authorized under the European Economic Area under the names:

Belgium Glimepiride Sandoz 2 mg tabletsGlimepiride Sandoz 3 mg tabletsGlimepiride Sandoz 4 mg tablets
Denmark Stapiride
France GLIMEPIRIDE Sandoz 1 mg, compressed securelyGLIMEPIRIDE Sandoz 2 mg, compressed securelyGLIMEPIRIDE Sandoz 3 mg, compressed securelyGLIMEPIRIDE Sandoz 4 mg, compressed securely
Netherlands Glimepiride Sandoz 1, tablets 1 mg glimepiride Sandoz 2, 2 mg tablets glimepiride Sandoz 3, tablets 3 mg glimepiride Sandoz 4, tablets 4 mg
UK Glimepiride 1mg TabletsGlimepiride 2mg TabletsGlimepiride 3mg TabletsGlimepiride 4mg Tablets
Sweden Glimepiride Sandoz 1 mg tabletGlimepiride Sandoz 2 mg tablet

Muhammad Nadeem

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