GLIMEPIRIDE 1 mg Coated Tablet

Содержание инструкции

1. Glimepiride Sandoz GmbH 1 mg tablets, 2 mg tablets, 3 mg tablets
   1. What is Glimepiride Sandoz GmbH and what is it used for
   2. What you need to know before taking Glimepiride Sandoz GmbH
   3. How to take Glimepiride Sandoz GmbH
   4. Possible side effects
   5. How to store Glimepiride Sandoz GmbH
   6. Package Contents and Other Information

Glimepiride Sandoz GmbH 1 mg tablets, 2 mg tablets, 3 mg tablets

Glimepiride Sandoz GmbH 4 mg tablets
Glimepiride
Generic medicine

Read this leaflet carefully before you start to take this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist (see section 4).

Contents of this leaflet:

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

1. What is Glimepiride Sandoz GmbH and what is it used for

Glimepiride Sandoz GmbH is a medicine that reduces blood sugar levels, taken orally. This medicine belongs to a group of medicines that reduce blood sugar levels called sulfonylureas. Glimepiride Sandoz GmbH works by increasing the amount of insulin released by the pancreas. Insulin reduces blood sugar levels.

What is Glimepiride Sandoz GmbH used for:

• Glimepiride Sandoz GmbH is used to treat some forms of diabetes (type 2 diabetes mellitus) when diet, exercise and weight reduction alone are not able to control blood sugar levels.

2. What you need to know before taking Glimepiride Sandoz GmbH

Do not take Glimepiride Sandoz GmbH and consult your doctor if:

• you are allergic (hypersensitive) to glimepiride or other sulfonylureas (medicines used to reduce blood sugar levels such as glibenclamide) or sulfonamides (medicines for bacterial infections such as sulfamethoxazole) or to any of the other ingredients of this medicine (listed in section 6)
• you suffer from insulin-dependent diabetes (type 1)
• you suffer from diabetic ketoacidosis (a complication of diabetes that occurs when acid levels in the body increase and the following symptoms may appear: fatigue, feeling unwell (nausea), frequent urination and muscle stiffness)
• you are in a diabetic coma
• you have a severe kidney disease
• you have a severe liver disease

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

Warnings and precautions
Consult your doctor or pharmacist before taking Glimepiride Sandoz GmbH, if:

• you are recovering from an injury, surgery, an infection with fever or from other forms of stress, inform your doctor as a temporary change in therapy may be necessary
• you have a severe liver or kidney disorder If you are not sure whether any of the above conditions apply to you, talk to your doctor or pharmacist before taking Glimepiride Sandoz GmbH.

In patients deficient in glucose-6-phosphate dehydrogenase enzyme, a decrease in hemoglobin levels and red blood cell breakdown (hemolytic anemia) may occur.
The information available on the use of Glimepiride Sandoz GmbH in patients under 18 years of age is limited. Therefore, use is not recommended in these patients.

Important information about hypoglycemia (low blood sugar levels)
When taking Glimepiride Sandoz GmbH, you may experience hypoglycemia (low blood sugar levels). Refer to the paragraphs below for more information on hypoglycemia, its symptoms and treatments.

The following factors can increase the risk of hypoglycemia:

• malnutrition, irregularity in meal times, missing or delaying a meal or a period of fasting
• changes in diet
• taking more Glimepiride Sandoz GmbH than necessary
• reduced kidney function
• severe liver disease
• if you suffer from particular hormone-induced disorders (thyroid, pituitary or adrenal cortex disorders)
• drinking alcohol (especially when skipping a meal)
• taking certain medicines (see Other medicines and Glimepiride Sandoz GmbH)
• if you increase the amount of physical exercise and do not eat enough or eat foods that contain less carbohydrates than usual

The signs of hypoglycemia include:

• intense hunger, headache, nausea, vomiting, drowsiness, sleepiness, sleep disturbances, agitation, aggressiveness, difficulty concentrating, reduced alertness and reaction time, depression, confusion, speech and vision disorders, difficulty speaking, tremors, partial paralysis, sensory disturbances, dizziness, feeling weak
• the following signs may also occur: sweating, cold and clammy skin, anxiety, rapid heartbeat, high blood pressure, palpitations, sudden severe chest pain that may radiate to nearby areas (angina pectoris and cardiac arrhythmia)

If blood sugar levels continue to decrease, extreme confusion (delirium), development of convulsions, loss of self-control, breathing may be shallow and the heartbeat slowed, you may lose consciousness. The clinical picture of reduced blood sugar levels can resemble that of a stroke.

Treatment of hypoglycemia:
In most cases, the symptoms of hypoglycemia disappear quickly as soon as you consume sugar in any form, for example sugar cubes, sweet fruit juice, sweetened tea.
Therefore, always carry some sugar with you in any form (e.g. sugar cubes).
Remember that sweeteners have no effect. If the sugar intake is not sufficient or if the symptoms should recur, contact your doctor or the nearest hospital.

Laboratory tests
It is necessary to monitor blood and urine sugar levels regularly. Your doctor may also prescribe blood tests to monitor blood cell levels and liver function.

Children and adolescents
Glimepiride Sandoz GmbH is not recommended for use in children under 18 years of age.

Other medicines and Glimepiride Sandoz GmbH
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your doctor may change the dose of Glimepiride Sandoz GmbH if you are taking other medicines that can weaken or strengthen the effect of Glimepiride Sandoz GmbH on blood sugar levels.
The following medicines can increase the blood sugar-lowering effect of Glimepiride Sandoz GmbH. This can lead to a risk of hypoglycemia (low blood sugar levels):

• other medicines used to treat diabetes mellitus(such as insulin or metformin)
• medicines for treating painandinflammation(phenylbutazone, azapropazone, oxyphenbutazone, medicines similar to acetylsalicylic acid)
• medicines used to treat urinary tract infections(such as some long-acting sulfonamides)
• medicines used to treat bacterial and fungal infections(tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin)
• medicines that inhibit blood clotting(coumarin derivatives such as warfarin);
• medicines that promote muscle development(anabolics)
• medicines used for hormone replacement therapyin men
• medicines used to treat depression(fluoxetine, MAO inhibitors)
• medicines that lower high levels of cholesterol(fibrates)
• medicines that lower high blood pressure(ACE inhibitors)
• medicines called anti-arrhythmic agents used to control irregular heartbeat(disopyramide)
• medicines for treating gout(allopurinol, probenecid, sulfinpyrazone)
• medicines used to treat tumors(cyclophosphamide, ifosfamide, trofosfamide)
• medicines used to reduce body weight(fenfluramine)
• medicines used to increase blood flowwhen administered at high doses by intravenous infusion (pentoxifylline)
• medicines used to treat nasal allergies such as hay fever(tritoqualine)
• medicines called sympatholyticsfor treating high blood pressure, heart failure or prostate symptoms

The following medicines can reduce the effect of Glimepiride Sandoz GmbH on blood sugar. This can increase the risk of hyperglycemia (high blood sugar):

• medicines containing female sex hormones(estrogens and progestins)
• medicines that promote urine production(thiazide diuretics)
• medicines used to stimulate the thyroid(such as levothyroxine)
• medicines used to treat allergies and inflammation(glucocorticoids)
• medicines used for the treatment of severe mental disorders(chlorproazine and other phenothiazine derivatives)
• medicines used to increase the heart rate, for treating asthmaor nasal congestion, cough and cold, those used for reducing body weightor used in life-threatening emergencies (adrenaline and sympathomimetics)
• medicines used to lower levels of cholesterol(nicotinic acid)
• medicines used to treat constipationif used for a long time (laxatives)
• medicines used to treat convulsions(phenytoin)
• medicines used to treat nervousnessand sleep disorders(barbiturates)
• medicines used to treat increased pressure in the eye(acetazolamide)
• medicines used to treat high blood pressureor low blood sugar levels (diazoxide)
• medicines for treating infectionsand tuberculosis(rifampicin)
• medicines used to treat low and severe sugar levelsin the blood (glucagon)

The following medicines can intensify or reduce the hypoglycemic effects of Glimepiride Sandoz GmbH:

• medicines used to treat stomach ulcers(called H2 antagonists)
• medicines for treating high blood pressureor heart failuresuch as beta-blockers, clonidine, guanethidine and reserpine. They can also mask the signs of hypoglycemia, so particular caution is recommended when taking them.

Glimepiride Sandoz GmbH can both intensify and reduce the effects of the following medicines:

• medicines that inhibit the formation of blood clots(coumarin derivatives such as warfarin).

Colesevelam, a medicine used to reduce cholesterol, has an effect on the absorption of Glimepiride Sandoz GmbH. To avoid this effect, it is recommended to take Glimepiride Sandoz GmbH at least 4 hours before colesevelam.

Glimepiride Sandoz GmbH with food, beverages and alcohol
Alcohol can unpredictably increase or decrease the ability of Glimepiride Sandoz GmbH to lower blood sugar.

Pregnancy and breastfeeding
Pregnancy
Glimepiride Sandoz GmbH should not be used during pregnancy.

Breastfeeding
Glimepiride Sandoz GmbH can pass into breast milk. Glimepiride Sandoz GmbH should not be used during breastfeeding.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines:
Your ability to concentrate or react may be impaired if your blood sugar levels decrease (hypoglycemia) or increase (hyperglycemia), or if you develop visual disturbances as a result of these conditions. Keep in mind that this may pose a danger to yourself and others (e.g. when driving a car or using machinery). Ask your doctor if it is advisable to drive when:

• you experience frequent episodes of hypoglycemia;
• you have few or no symptoms of hypoglycemia.

Glimepiride Sandoz GmbH contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Glimepiride Sandoz GmbH

Take this medicine following the doctor's instructions exactly. If you have any doubts,
consult your doctor or pharmacist.

Taking the medicine

• Take this medicine by mouth, just before or during the first meal of the day (usually breakfast). If you do not eat breakfast, follow the dosage schedule prescribed by your doctor. It is important not to skip any meals while you are being treated with Glimepiride Sandoz GmbH
• Swallow the tablet whole with at least half a glass of water. Do not break or chew the tablet

How much medicine to take
The dose of Glimepiride Sandoz GmbH is determined by your doctor based on your needs, your
condition, and the results of blood and urine tests. Do not take more tablets than
prescribed by your doctor.

• The usual starting dose is 1 mg of Glimepiride Sandoz GmbH per day.
• If necessary, your doctor may increase the dose after each period of 1-2 weeks of treatment
• The maximum recommended dose is 6 mg per day
• A combination therapy of glimepiride plus metformin or glimepiride plus insulin may be started. In these cases, your doctor will determine the dose of glimepiride, metformin or insulin that is most suitable for your case
• If your body weight changes or if you change your lifestyle, or if you are experiencing a stressful situation, a change in the dosage of Glimepiride Sandoz GmbH may be necessary, so in such cases inform your doctor
• If you feel that the effects of Glimepiride Sandoz GmbH are too strong or too weak, do not change the dose yourself, but consult your doctor.

If you take more Glimepiride Sandoz GmbH than you should
If you have taken an excessive amount of Glimepiride Sandoz GmbH or an extra dose, there is a
risk that your blood sugar levels will drop too low (for signs of hypoglycemia, see
paragraph 2), in which case you should immediately consume an adequate amount of sugar (for
example sugar cubes, sweet fruit juice, sweetened tea) and inform your doctor immediately.
When treating hypoglycemia due to accidental ingestion by a child, the amount of
sugar must be carefully controlled to avoid causing dangerous hyperglycemia. Do not
administer food or drinks to people who are unconscious.
Since the condition of low blood sugar levels can last for some time, it is very
important that the patient is carefully monitored until there is no longer any danger.
Hospitalization may also be necessary, even as a precautionary measure. Show your
doctor the package of the medicine or the remaining tablets so that they know what has been
taken.
The most severe cases of hypoglycemia accompanied by loss of consciousness and severe
neurological insufficiency require immediate and urgent medical treatment and hospitalization. It is finally
advisable to inform another person in advance, so that they can call a doctor in
case of emergency.

If you forget to take Glimepiride Sandoz GmbH
If you forget to take a dose, do not take a double dose to make up for a missed dose.

If you stop taking Glimepiride Sandoz GmbH
If you discontinue or stop treatment, you should be informed that you may not achieve the desired
effects of reducing blood sugar, or your condition may worsen again.
Continue taking Glimepiride Sandoz GmbH until your doctor tells you to stop.
If you have doubts about the use of this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Immediately inform your doctor if you experience any of the following symptoms:

• Allergic reactions (including inflammation of blood vessels, often accompanied by skin rash) which may develop into a severe reaction with difficulty breathing, low blood pressure sometimes leading to shock
• Abnormalities in liver function including yellowing of the skin and eyes (jaundice), problems with 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 worsen.
• Severe hypoglycemia including loss of consciousness, convulsions or coma

Some patients experience the following side effects while taking glimepiride:

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

• Lower than normal blood sugar levels (hypoglycemia - see section 2)
• Decreased blood cell counts:
• Platelets (may increase the risk of bleeding or bruising)
• White blood cells (may increase the risk of infections)
• Red blood cells (may cause paleness, weakness or shortness of breath) These problems usually decrease after stopping treatment with Glimepiride Sandoz GmbH.

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 evolve into severe reactions with difficulty breathing, low blood pressure, sometimes causing shock. If you experience any of these symptoms, inform your doctor immediately
• Abnormal liver function including yellowing of the skin and eyes (jaundice), impaired bile flow (cholestasis), inflammation of the liver (hepatitis) or liver failure. If you experience any of these symptoms, inform your doctor immediately
• Feeling or being unwell, diarrhea, a sensation of fullness or bloating and abdominal pain
• Decreased levels of sodium in the blood (demonstrated by blood tests)

Side effects with unknown frequency (frequency cannot be estimated from available data).

• Allergy (hypersensitivity) at skin level manifesting as itching, rash, hives and increased sensitivity to the sun. Some mild allergic reactions may worsen and cause breathing or swallowing problems, swelling of the lips, throat or tongue. Therefore, if any of these side effects occur, contact your doctor immediately
• Allergic reactions to sulfonylureas, sulfonamides or other related medicines
• Vision problems at the beginning of treatment with Glimepiride Sandoz GmbH. These are related to changes in blood sugar levels and should improve soon
• Increased liver enzymes
• Unusual severe bleeding or bruising under the skin

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the
national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store Glimepiride Sandoz GmbH

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 packaging, after the wording
EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Glimepiride Sandoz GmbH contains
The active ingredient is glimepiride. Each tablet contains 1, 2, 3 or 4 mg of glimepiride.
The other ingredients are:
Glimepiride Sandoz GmbH 1 mg tablets
lactose monohydrate, sodium carboxymethylcellulose (type A), povidone K30, red iron oxide (E172),
microcrystalline cellulose, magnesium stearate.
Glimepiride Sandoz GmbH 2 mg tablets
lactose monohydrate, sodium carboxymethylcellulose (type A), povidone K30, yellow iron oxide (E172),
indigotine (E132), microcrystalline cellulose, magnesium stearate.
Glimepiride Sandoz GmbH 3 mg tablets
lactose monohydrate, sodium carboxymethylcellulose (type A), povidone K30, yellow iron oxide (E172),
microcrystalline cellulose, magnesium stearate.
Glimepiride Sandoz GmbH 4 mg tablets
lactose monohydrate, sodium carboxymethylcellulose (type A), povidone K30, indigotine (E132),
microcrystalline cellulose, magnesium stearate.

Description of the appearance of Glimepiride Sandoz GmbH and package contents
Glimepiride Sandoz GmbH 1 mg tablets.
Pink tablets, slightly mottled, oblong, flat, with beveled edges, with a fracture line
on both sides and the embossed inscription “G1” on one side.
Transparent PVC/PE/PVDC//Aluminum blisters containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98,
100, 112, 120, 280 and 100x1 tablets.
White, opaque PP container with an LDPE or MDPE cap containing 20, 30, 90, 100, 120 and 250
tablets.
Glimepiride Sandoz GmbH 2 mg tablets.
Green tablets, slightly mottled, oblong, flat, with beveled edges, with a fracture line
on both sides and the embossed inscription “G2” on one side.
Transparent PVC/PE/PVDC//Aluminum blisters containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98,
100, 112, 120, 280 and 100x1 tablets.
White, opaque PP container with an LDPE or MDPE cap containing 20, 30, 90, 100, 120 and 250
tablets.
Glimepiride Sandoz GmbH 3 mg tablets.
Light yellow tablets, slightly mottled, oblong, flat, with beveled edges, with a fracture line
on both sides and the embossed inscription “G3” on one side.
Transparent PVC/PE/PVDC//Aluminum blisters containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98,
100, 112, 120, 280 and 100x1 tablets.
White, opaque PP container with an LDPE or MDPE cap containing 20, 30, 90, 100, 120 and 250
tablets.
Glimepiride Sandoz GmbH 4 mg tablets.
Blue tablets, slightly mottled, oblong, flat, with beveled edges, with a fracture line on
both sides and the embossed inscription “G4” on one side.
Transparent PVC/PE/PVDC//Aluminum blisters containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98,
100, 112, 120, 280 and 100x1 tablets.
White, opaque PP container with an LDPE or MDPE cap containing 20, 30, 90, 100, 120 and 250
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz GmbH – Biochemiestrasse, 10 – 6250 Kundl (Austria)
Representative for Italy: Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Manufacturers
Lek SA - ul. Podlipie 16 95-010 Stryków, Poland
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany.
Salutas Pharma GmbH, Dieselstrasse 5 70839 Gerlingen, Germany.
Lek Pharmaceuticals d.d., Verovśkova 57, 1526 Ljubljana, Slovenia.
Lek SA - ul. Domaniewska 50 C, 02-672 Warszawa, Poland

This medicinal product is authorised in the member states of the EEA under the following designations:
Cyprus Glimepirid HEXAL
Denmark Glimeprisan
Italy GLIMEPIRIDE Sandoz GmbH 1 mg tablets
GLIMEPIRIDE Sandoz GmbH 2 mg tablets
GLIMEPIRIDE Sandoz GmbH 3 mg tablets
GLIMEPIRIDE Sandoz GmbH 4 mg tablets
Luxembourg Glimepirid HEXAL 1 mg Tabletten
Glimepirid HEXAL 2 mg Tabletten
Glimepirid HEXAL 3 mg Tabletten
Glimepirid HEXAL 4 mg Tabletten
Spain Glimepirida Bexal1 mg comprimidos EFG
Glimepirida Bexal2 mg comprimidos EFG
Glimepirida Bexal3 mg comprimidos EFG
Glimepirida Bexal4 mg comprimidos EFG