Glimepiride Sandoz GmbH

Patient Information Leaflet

Glimepiride Sandoz GmbH 1 mg tablets, 2 mg tablets, 3 mg tablets, 4 mg tablets

Glimepiride
Generic medicine
Please read all of this leaflet carefully before taking 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 experience any side effects, including 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 taking 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 Glimepiride Sandoz GmbH is and what it is used for

Glimepiride Sandoz GmbH is a medicine that reduces blood sugar levels, taken by oral route. This medicine belongs to a group of medicines that lower 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 Glimepiride Sandoz GmbH is used for:

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

2. What you should know before taking Glimepiride Sandoz GmbH

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

• you are allergic (hypersensitive) to glimepiride or to other sulfonylureas (medicines used to lower 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 have insulin-dependent diabetes (type 1)
• you have diabetic ketoacidosis (a complication of diabetes that occurs when acid levels in the body rise and may cause symptoms such as fatigue, feeling unwell (nausea), frequent urination, and muscle stiffness)
• you are in diabetic coma
• you have severe kidney disease
• you have severe liver disease

Do not take this medicine if any of the above conditions apply to you. If you are unsure, speak with 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 other forms of stress; inform your doctor, as temporary changes in therapy may be necessary
• you have severe liver or kidney disease

If you are unsure whether any of the above conditions apply to you, speak with your doctor or pharmacist before taking Glimepiride Sandoz GmbH.

In patients deficient in the enzyme glucose-6-phosphate dehydrogenase, reduced hemoglobin levels and breakdown of red blood cells (hemolytic anemia) may occur.

Available data on the use of Glimepiride Sandoz GmbH in patients under 18 years of age are 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 sections below for further information on hypoglycemia, its symptoms, and treatment.

The following factors may increase the risk of hypoglycemia:

• malnutrition, irregular meal times, skipping or delaying meals, or periods of fasting
• changes in diet
• taking more Glimepiride Sandoz GmbH than required
• reduced kidney function
• severe liver disease
• if you have certain hormone-related disorders (thyroid, pituitary, or adrenal cortex disorders)
• alcohol consumption (especially when skipping a meal)
• taking certain medicines (see section "Other medicines and Glimepiride Sandoz GmbH")
• if you increase physical activity without adequate nutrition or eat foods containing fewer carbohydrates than usual

Signs of hypoglycemia include:

• intense hunger, headache, nausea, vomiting, numbness, drowsiness, sleep disturbances, agitation, aggression, difficulty concentrating, reduced alertness and reaction time, depression, confusion, speech and vision disturbances, 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 radiating to nearby areas (angina pectoris and cardiac arrhythmia)

If blood sugar levels continue to drop, severe confusion (delirium), seizures, loss of self-control, shallow breathing, and slowed heartbeat may occur, potentially leading to loss of consciousness. The clinical picture of low blood sugar may resemble that of a stroke.

Treatment of hypoglycemia:

In most cases, symptoms of hypoglycemia disappear rapidly after consuming sugar in any form, such as sugar cubes, sweet fruit juice, or sugared tea.

Always carry sugar in some form (e.g., sugar cubes) with you. Remember that artificial sweeteners have no effect. If sugar intake is insufficient or symptoms recur, contact your doctor or the nearest hospital.

Laboratory tests

Regular monitoring of blood and urine sugar levels is necessary. Your doctor may also order 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

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

Your doctor may adjust the dose of Glimepiride Sandoz GmbH if you are taking other medicines that may weaken or enhance its blood sugar-lowering effect.

The following medicines may enhance the blood sugar-lowering effect of Glimepiride Sandoz GmbH. This may increase the risk of hypoglycemia (low blood sugar levels):

• other medicines used to treat diabetes mellitus (such as insulin or metformin)
• medicines used to treat pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone, medicines similar to acetylsalicylic acid)
• 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)
• medicines that inhibit blood clotting (coumarin derivatives such as warfarin)
• medicines that promote muscle development (anabolic agents)
• medicines used for hormone replacement therapy in men
• medicines used to treat depression (fluoxetine, MAO inhibitors)
• medicines that lower high cholesterol levels (fibrates)
• medicines that lower high blood pressure (ACE inhibitors)
• antiarrhythmic agents used to control irregular heartbeat (disopyramide)
• medicines used to treat gout (allopurinol, probenecid, sulfinpyrazone)
• medicines used to treat tumors (cyclophosphamide, ifosfamide, trofosfamide)
• medicines used for weight reduction (fenfluramine)
• medicines used to increase blood flow when administered at high doses by intravenous infusion (pentoxifylline)
• medicines used to treat nasal allergies such as hay fever (tritoqualine)
• medicines called sympatholytics used to treat high blood pressure, heart failure, or prostate symptoms

The following medicines may reduce the blood sugar-lowering effect of Glimepiride Sandoz GmbH. This may increase the risk of hyperglycemia (high blood sugar levels):

• medicines containing female sex hormones (estrogens and progestogens)
• medicines that promote urine production (thiazide diuretics)
• medicines used to stimulate the thyroid gland (such as levothyroxine)
• medicines used to treat allergies and inflammations (glucocorticoids)
• medicines used to treat severe mental disorders (chlorprothixene and other phenothiazine derivatives)
• medicines used to increase heart rate, treat asthma or nasal congestion, cough and cold, those used for weight reduction, or used in life-threatening emergencies (adrenaline and sympathomimetics)
• medicines used to lower cholesterol levels (nicotinic acid)
• medicines used to treat constipation when used long-term (laxatives)
• medicines used to treat seizures (phenytoin)
• medicines used to treat nervousness and sleep disorders (barbiturates)
• medicines used to treat increased eye pressure (acetazolamide)
• medicines used to treat high blood pressure or low blood sugar levels (diazoxide)
• medicines used to treat infections and tuberculosis (rifampicin)
• medicines used to treat low and severe blood sugar levels (glucagon)

The following medicines may enhance or reduce the hypoglycemic effects of Glimepiride Sandoz GmbH:

• medicines used to treat stomach ulcers (called H2 antagonists)
• medicines used to treat high blood pressure or heart failure, such as beta-blockers, clonidine, guanethidine, and reserpine. These may also mask signs of hypoglycemia; therefore, particular caution is advised during their use.

Glimepiride Sandoz GmbH may either enhance or reduce the effects of the following medicines:

• medicines that inhibit blood clot formation (coumarin derivatives such as warfarin).

Colesevelam, a medicine used to lower cholesterol, affects the absorption of Glimepiride Sandoz GmbH. To avoid this interaction, it is recommended to take Glimepiride Sandoz GmbH at least 4 hours before colesevelam.

Glimepiride Sandoz GmbH with food, drinks, and alcohol

Alcohol may unpredictably increase or decrease the blood sugar-lowering effect of Glimepiride Sandoz GmbH.

Pregnancy and breastfeeding

Pregnancy

Glimepiride Sandoz GmbH must not be used during pregnancy.

Breastfeeding

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

If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines:

Your ability to concentrate or react may be impaired if your blood sugar levels drop (hypoglycemia) or rise (hyperglycemia), or if you develop visual disturbances as a result of these conditions. Be aware that this may pose a risk to yourself and others (e.g., when driving a car or operating machinery). Ask your doctor whether you should drive if:

• you frequently experience 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, consult them before taking this medicine.

3. How to take Glimepiride Sandoz GmbH

Take this medicine exactly as your doctor has told you. If you have any doubts,
consult your doctor or pharmacist.
Taking the medicine

• Take this medicine by mouth, just before or during your first meal of the day (usually breakfast). If you do not eat breakfast, follow the dosing 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 will be determined by your doctor according to your needs,
your condition, and the results of blood and urine tests. Do not take more tablets than your doctor has prescribed.

• The usual starting dose is 1 mg of Glimepiride Sandoz GmbH daily.
• If necessary, your doctor may increase the dose after each 1- to 2-week treatment period.
• The maximum recommended dose is 6 mg daily.
• Combination therapy with glimepiride plus metformin or glimepiride plus insulin may be started. In such cases, your doctor will determine the appropriate dose of glimepiride, metformina or insulin for your condition.
• If your body weight changes, if you change your lifestyle, or if you are under stress, your dose of Glimepiride Sandoz GmbH may need to be adjusted; therefore, inform your doctor in such cases.
• If you think that the effects of Glimepiride Sandoz GmbH are too strong or too weak, do not change the dose on your own, 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 may drop too low (for symptoms of hypoglycaemia, see section 2). In this case, you must immediately consume an adequate amount of sugar (for example, sugar cubes, sweet fruit juice, sugared tea) and contact your doctor immediately.
When treating hypoglycaemia due to accidental ingestion by a child, the amount of sugar administered must be carefully controlled to avoid causing dangerous hyperglycaemia. Do not give food or drink to unconscious people.
Since low blood sugar levels may last for some time, it is very important that the patient is closely monitored until there is no longer any danger. Hospitalisation may also be necessary, even as a precautionary measure. Show the doctor the medicine packaging or the remaining tablets so that he or she knows what has been taken.
Severe cases of hypoglycaemia accompanied by loss of consciousness and severe neurological impairment require immediate and urgent medical treatment and hospitalisation. It is also 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 the missed dose.

If you stop taking Glimepiride Sandoz GmbH
If you stop or interrupt treatment, you should be aware that you may not achieve the desired blood sugar-lowering effects, or your condition may worsen again. Continue taking Glimepiride Sandoz GmbH until your doctor tells you to stop.
If you have any doubts about using 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 contact your doctor if you experience any of the following symptoms:

• Allergic reactions (including inflammation of blood vessels, often accompanied by skin rash), which may progress to a severe reaction with breathing difficulties, drop in blood pressure that sometimes leads to shock
• Liver function abnormalities, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), liver inflammation (hepatitis), or liver failure
• Skin allergy (hypersensitivity), such as itching, skin rash, hives, and increased sensitivity to sunlight. Some mild allergic reactions may worsen.
• Severe hypoglycaemia, including loss of consciousness, seizures, 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 (hypoglycaemia – see section 2)
• Decrease in 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 improve 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), progressing to severe reactions with breathing difficulties, drop in blood pressure, sometimes leading to shock. If you experience any of these symptoms, contact your doctor immediately
• Abnormal liver function, including yellowing of the skin and eyes (jaundice), impaired bile flow (cholestasis), liver inflammation (hepatitis), or liver failure. If you experience any of these symptoms, contact your doctor immediately
• Feeling unwell, diarrhoea, sensation of fullness or bloating, and abdominal pain
• Decreased levels of sodium in the blood (shown by blood tests)

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

• Skin allergy (hypersensitivity) manifesting as itching, skin rash, hives, and increased sensitivity to sunlight. Some mild allergic reactions may worsen and cause breathing or swallowing difficulties, or swelling of the lips, throat, or tongue. Therefore, if any of these side effects occur, contact your doctor immediately
• Allergic reactions to sulphonylureas, 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 quickly
• Increased liver enzymes
• Unusual severe bleeding or bruising under the skin

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 stated on the packaging after the word
EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

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

Description of the appearance of Glimepiride Sandoz GmbH and pack sizes
Glimepiride Sandoz GmbH 1 mg tablets.
Pink, slightly mottled, elongated, flat tablets with bevelled edges, a break line on both sides and the embossed characters “G1” on one side.
Transparent blisters in PVC/PE/PVDC//Aluminium 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 LDPE or MDPE cap containing 20, 30, 90, 100, 120 and 250 tablets.

Glimepiride Sandoz GmbH 2 mg tablets.
Green, slightly mottled, elongated, flat tablets with bevelled edges, a break line on both sides and the embossed characters “G2” on one side.
Transparent blisters in PVC/PE/PVDC//Aluminium 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 LDPE or MDPE cap containing 20, 30, 90, 100, 120 and 250 tablets.

Glimepiride Sandoz GmbH 3 mg tablets.
Light yellow, slightly mottled, elongated, flat tablets with bevelled edges, a break line on both sides and the embossed characters “G3” on one side.
Transparent blisters in PVC/PE/PVDC//Aluminium 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 LDPE or MDPE cap containing 20, 30, 90, 100, 120 and 250 tablets.

Glimepiride Sandoz GmbH 4 mg tablets.
Blue, slightly mottled, elongated, flat tablets with bevelled edges, a break line on both sides and the embossed characters “G4” on one side.
Transparent blisters in PVC/PE/PVDC//Aluminium 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 LDPE or MDPE cap containing 20, 30, 90, 100, 120 and 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH – Biochemiestrasse, 10 – 6250 Kundl (Austria)
Representative in 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., Verovškova 57, 1526 Ljubljana, Slovenia.
Lek SA - ul. Domaniewska 50 C, 02-672 Warszawa, Poland

This medicinal product has been authorised in EEA Member States under the following names:
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 Bexal 1 mg comprimidos EFG
Glimepirida Bexal 2 mg comprimidos EFG
Glimepirida Bexal 3 mg comprimidos EFG
Glimepirida Bexal 4 mg comprimidos EFG

This patient information leaflet was last approved on