1 mg, 2 mg, 3 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 STADA is and what it is used for
2. What you need to know before you use Glimepiride STADA
3. How to use Glimepiride STADA
4. Possible side effects
5. How to store Glimepiride STADA 6. Contents of the pack
and other information

What Glimepiride STADA is and what it is used for

Glimepiride is a medicine that lowers blood sugar levels. This medicine belongs to a group of blood sugar-lowering medicines called sulphonylureas. Glimepiride works by increasing the amount of insulin released from your pancreas. Insulin then lowers your blood sugar levels.

What Glimepiride Stada is used for:

Glimepiride Stada is used to treat a specific form of diabetes (type 2 diabetes mellitus ) when diet, physical activity and weight loss alone are not enough to control your blood sugar levels.

Glimepiride contained in Glimepiride Stada 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 use Glimepiride STADA

Do not use Glimepiride STADA

  • 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)
  • you have insulin dependent diabetes (type 1 diabetes mellitus )
  • you have diabetic ketoacidosis (a diabetic complication where the acid level in your body is elevated and you may feel some of the following symptoms: fatigue, feeling sick (nausea), increased need to urinate and muscle stiffness)
  • you have diabetes coma
  • you suffer from a serious kidney disease
  • 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 Stada.

Do not take Glimepiride Stada 2 mg if you are allergic to tartrazine or para-orange (see section 2, Glimepiride Stada contains tartrazine and para-orange).

Warnings and cautions

Talk to your doctor or pharmacist before taking Glimepiride Stada:

  • if you are recovering from an injury, surgery, infection with a fever or any other type of stress, as you may then need to temporarily change your treatment.
  • if you have severe liver or kidney disease.

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

Lowering the hemoglobin levels, and the degradation of red blood cells ( hemolytic anemia) may occur in patients lacking enzyme et glucose 6- phosphate dehydrogenase.

Children and young people

Experience with glimepiride treatment in people under 18 years of age is limited. Therefore, this treatment is not recommended in these patients.

Important information about hypoglycaemia (low blood sugar).

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

The following factors may increase your risk of developing hypoglycaemia:

  • malnutrition, irregular meals, omitted or delayed meals or fasting periods.
  • changes in your diet
  • intake of too much Glimepiride Stada
  • renal impairment
  • severe liver disease
  • if you have certain hormone- causing diseases (diseases of the thyroid gland or pituitary gland or adrenal cortex ).
  • consumption of alcohol (especially if you skip a meal)
  • taking certain other medicines (see “Other medicines and Glimepiride Stada” below)
  • if you increase your physical activity and do not eat enough or if you eat foods that contain less carbohydrates than usual.

Signs of hypoglycaemia are:

  • voracious hunger, headache, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggression, impaired concentration, decreased alertness and reaction, depression, confusion, speech and vision disorders, slurred speech, tremors, partial paralysis, dizziness, numbness.
  • The following symptoms may also occur: sweating, damp skin, anxiety, increased heart rate, high blood pressure , palpitations, sudden severe chest pain that may radiate to surrounding areas (angina and irregular heartbeat).

If your blood sugar level continues to drop, you may experience significant confusion ( delirium ), develop seizures, lose self-control, have shallow breathing and a slower heart rate, and even become unconscious. The clinical picture of a sharp drop in blood sugar may be similar to that of a stroke.

Treatment of hypoglycaemia:

The symptoms almost always disappear immediately after consuming sugar, e.g. in the form of sugar cubes, sweet juice or sweetened tea. Therefore, you should always have some form of sugar with you (eg sugar cubes). Sweeteners have no effect. If sugar intake does not help, consult your doctor or seek medical attention.

Laboratory tests

The sugar level in your blood or urine should be checked regularly. Your doctor may also take blood tests to check your blood counts and liver function.

Other medicines and Glimepiride STADA

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

Your doctor may want to change your dose of Glimepiride Stada if you are taking other medicines that may weaken or enhance the effect of Glimepiride Stada on your blood sugar levels.

The following medicines may increase the blood sugar lowering effect of Glimepirid Stada. This may lead to an increased risk of hypoglycaemia (low blood sugar):

  • other medicines to treat diabetes mellitus (such as insulin or metformin )
  • medicines used to treat pain and inflammation (phenylbutazone, azopropazone, oxyfenbutazone, aspirin-like medicines)
  • medicines used to treat urinary tract infections (such as long-acting sulfonamides )
  • medicines used to treat bacterial and fungal infections ( tetracyclines , chloramphenicol, fluconazole , miconazole , quinolones , clarithromycin)
  • drugs that inhibit blood coagulation (coumarin derivatives such as warfarin )
  • drugs that promote muscle building (anabolic steroids )
  • drugs used for male hormone replacement therapy.
  • medicines used to treat depression ( fluoxetine , MAO inhibitors )
  • drugs that lower high cholesterol levels (fibrates)
  • drugs that lower high blood pressure ( ACE inhibitors )
  • drugs called antiarrhythmics and used to control abnormal heart rhythms ( disopyramide )
  • medicines used to treat gout (allopurinol, probenecid, sulfinpyrazone)
  • drugs used to treat cancer (cyclophosphamide, ifosfamide, trophosphamide)
  • weight loss drug (fenfluramine)
  • drugs to increase circulation when given in high doses intravenously (pentoxifylline)
  • drugs to treat allergy symptoms from the nose, e.g. hay fever (tritoqualin).
  • drugs called sympatholytics to treat high blood pressure , heart weight or prostate symptoms.

The following medicines may reduce the blood sugar lowering effect of Glimepirid Stada. This may lead to a risk of hyperglycaemia (high blood sugar levels):

  • drugs containing female sex hormone ( estrogen , progesterone )
  • diuretics (thiazide diuretics)
  • drugs that stimulate the thyroid gland (such as levothyroxine)
  • medicines used to treat allergies and inflammation ( glucocorticoids )
  • medicines for the treatment of severe mental illness (chlorpromazine or other phenothiazine derivatives)
  • medicines used to increase heart rate, to treat asthma or nasal congestion, coughs and colds, for weight loss or in acute life-threatening situations ( adrenaline and sympathomimetics)
  • drugs to treat high cholesterol levels ( nicotinic acid )
  • medicines for the treatment of constipation when used for a long time ( laxatives )
  • drugs in the treatment of seizures ( phenytoin )
  • medicines for the treatment of anxiety and sleep problems ( barbiturates )
  • medicines used to treat high pressure in the eyes (azetazolamide)
  • medicines used to treat high blood pressure or lower blood sugar (diazoxide)
  • drugs in the treatment of infections , tuberculosis (rifampicin)
  • medicines used to treat very low blood sugar levels (glucagon).

The following medicines may increase or decrease Glimepiride Stada’s blood sugar lowering effect:

  • medicines used to treat stomach ulcers (H 2 – antagonists )
  • medicines used to treat high blood pressure or heart failure such as beta-blockers , clonidine , guanetidine and reserpine. These can also obscure the signs of hypoglycaemia , so special care should be taken when using these medicines.

Glimepiride Stada may either increase or decrease the effect of the following medicines

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

Glimepiride STADA with food, drink and alcohol

Alcohol may potentially enhance or attenuate the hypoglycaemic effect of Glimepiride Stada.

Pregnancy, breastfeeding and fertility

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.

Pregnancy

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

Breast-feeding

Glimepiride Stada may pass into breast milk. Glimepiride Stada should not be taken if you are breastfeeding.

Driving and using machines

Your ability to concentrate and react may be impaired if your blood sugar is low ( hypoglycaemia ), or high ( hyperglycaemia ), or if you suffer from visual disturbances as a result of such conditions. Remember that you can put yourself and others at risk (eg if you drive or use machines). Ask your doctor if you can drive if you:

  • have recurring problems with hypoglycemia
  • may have few 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 sharp 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 STADA 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 sodium (23 mg) per tablet, ie essentially ‘sodium-free. is next to “sodium-free”.

Glimepiride Stada 2 mg tablets contain tartrazine and para-orange

These dyes can cause allergic reactions (see section 4).

How to use Glimepiride STADA

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

The recommended dose is:

The dose of Glimepiride Stada depends on your needs, conditions and the results of blood and urine tests and is determined by your doctor. Do not take more tablets than your doctor has told you to.

  • The recommended starting dose is 1 mg once daily
  • if necessary, your doctor may increase the dose one after each 1-2 weeks of treatment
  • the maximum recommended dose is 6 mg glimepiride daily
  • combination therapy with glimepiride and metformin or with glimepiride and insulin may be started. In such cases, your doctor will decide on the appropriate dose of glimepiride, metformin or insulin for you individually.
  • if your weight changes or if you change your lifestyle, or are in a stressful situation, this may require a change Glimepiride Stada- dose . Talk to your doctor.

Method of administration

  • take the medicine by mouth, just before or with the first meal of the day (usually breakfast). If you do not eat breakfast, take the medicine according to your doctor’s instructions. It is important not to skip meals when taking Glimepiride Stada
  • swallow the tablets with at least half a glass of water. Do not crush or chew the tablets.

If you take more Glimepiride STADA 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 take too much Glimepiride Stada or take an extra dose, there is a risk of hypoglycaemia (see section 2 for signs of hypoglycaemia ) and you should therefore immediately eat enough sugar (eg a piece of sugar, sweet juice, sweetened tea) and consult a doctor. If a child has accidentally ingested the sugar, sugar should be given with caution to avoid causing dangerous hyperglycemia. Unconscious persons must not be given food or drink.

As a condition with hypoglycaemia can last for some time, it is very important that the patient is monitored until the danger is over. Hospitalization may be necessary, even as a precautionary measure. Show the doctor the box with the medicine, so the doctor knows what was taken.

Severe cases of hypoglycaemia accompanied by unconsciousness and severe nerve failure require urgent medical attention and hospitalization. It is important to make sure that at least one person is always informed, and can call a doctor if needed.

If you forget to take Glimepiride STADA

Do not take a double dose to make up for a forgotten dose.

If you stop taking Glimepiride STADA

If you stop or stop treatment, you should be aware that you no longer have the desired blood sugar lowering effect and that the disease may get worse. Continue to take Glimepiride Stada 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.

Contact a doctor immediately if you experience any of the following symptoms;

  • allergic reactions (including inflammation of the blood vessels, often with rash) which can develop into severe reactions with difficulty breathing, drop in blood pressure and sometimes turn into a state of shock.
  • Abnormal liver function, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), hepatitis ( hepatitis ) or liver failure.
  • Allergies (hypersensitivity) of the skin, such as itching , rash, hives and increased sensitivity to sunlight. Some mild allergic reactions can develop into severe reactions.
  • Severe hypoglycaemia including unconsciousness, seizures or coma .

Some patients may experience the following side effects while using Glimepiride Stada:

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

  • lower than normal blood sugar ( hypoglycaemia ) (see section 2 – Warnings and precautions).
  • reduction of blood s
    • Platelets (which increases the risk of bleeding or bruising
    • White blood cells (which increases the risk of infection)
    • Red blood cells (which may cause pale skin and weakness or shortness of breath)

These problems usually get better after you stop taking Glimepiride Stada.

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

  • allergic reactions (including inflammation of the blood vessels, often with rash) which can develop into severe reactions with difficulty breathing, drop in blood pressure and sometimes develop into shock . If you get any of these symptoms, contact a doctor immediately .
  • abnormal liver function with yellowing of the skin and eyes (jaundice), impaired bile flow (cholestasis), hepatitis ( hepatitis ) or liver failure. If you get any of these symptoms, contact a doctor immediately .
  • malaise or nausea, diarrhea, satiety, bloating, and abdominal pain.
  • decrease in sodium levels in the blood (seen in blood tests).

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

  • allergies (hypersensitivity) in the skin can occur as itching , rash, hives and increased sun sensitivity. Some mild allergic reactions can develop into severe reactions with swallowing or breathing problems, swelling of the lips, throat or tongue. If you get any of these symptoms, contact a doctor immediately.
  • allergic reactions to sulphonylureas, sulphonamides or related medicines may occur.
  • vision problems may occur at the beginning of treatment with Glimepiride Stada. This is due to the changes in blood sugar levels and should soon get better.
  • elevated liver enzyme values.
  • severe reduction in platelet counts and unusual bleeding or bruising under the skin.

Glimepiride Stada 2 mg tablets contain dyes tartrazine and para-orange which may cause allergic reactions.

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 STADA

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

Do not store above 30 ° C.

The medicine 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 1 mg, 2 mg and 3 mg respectively.
  • The other ingredients are lactose monohydrate , sodium starch glycolate (type A), magnesium stearate, microcrystalline cellulose, povidone K29-32

Glimepiride Stada 1 mg tablets also contain:

  • red iron oxide (E172)

Glimepiride Stada 2 mg tablets also contain:

  • yellow iron oxide (E172)
  • paraorange (E110)
  • tartrazine (E102)
  • brilliant blue (E133)

Glimepiride Stada 3 mg tablets also contain:

  • yellow iron oxide (E172)

What the medicine looks like and contents of the pack

Glimepiride Stada 1 mg tablets are pink, flat, oblong and 8 x 4 mm in size.

Glimepiride Stada 2 mg tablets are green, flat, oblong and 10 x 5 mm in size.

Glimepiride Stada 3 mg tablets are yellow, flat, oblong and 10 x 5 mm in size.

All tablets are bevelled edges, notched on one side and marked with “G” on the other side.

If half a tablet is needed, the tablet can be divided into two parts by placing it on a hard surface with the notch upwards. Press with your thumb from above and the tablet will be divided into two equal parts.

Glimepiride Stada tablets are packaged in PVC / Aluminum blisters.

Pack sizes: 10, 20, 30, 50, 60, 90, 118, 120, 180 and 195 tablets.

Not all pack sizes may be marketed

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Other manufacturers

Actavis ehf., Reykjavikurvegur 78, PO IS-220 Hafnafjörður, Iceland

Actavis Ltd., BLB016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta

Balkanpharma – Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria

PharmaCoDane Aps, Marielundvej 46 A, 2730 Herlev, Denmark

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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