Glimepiride aurovitas: detailed information

Package leaflet: Information for the user

Glimepiride Aurovitas, 2 mg, tablets
Glimepiride Aurovitas, 3 mg, tablets
Glimepiride Aurovitas, 4 mg, tablets
Glimepiridum
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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

What Glimepiride Aurovitas is and what it is used for
What you need to know before taking Glimepiride Aurovitas
How to take Glimepiride Aurovitas
Possible side effects
How to store Glimepiride Aurovitas
Contents of the pack and other information

1. What Glimepiride Aurovitas is and what it is used for

Glimepiride Aurovitas is an oral medicine that lowers blood glucose (sugar) levels.
It belongs to a group of medicines that reduce blood glucose levels known as
sulfonylurea derivatives. Glimepiride Aurovitas works by increasing the amount of
insulin released by the pancreas. Insulin reduces blood glucose levels.
For what purpose is Glimepiride Aurovitas used:
Glimepiride Aurovitas is used to treat type 2 diabetes when blood glucose levels cannot be controlled by diet,
physical activity and weight reduction alone.

2. What you need to know before taking Glimepiride Aurovitas
Do not take Glimepiride Aurovitas:

if you are allergic to glimepiride or to any other sulfonylurea derivative (medicines used to reduce blood glucose levels, e.g. glibenclamide) or sulfonamides (medicines used for bacterial infections, e.g. sulfamethoxazole), or to any of the other ingredients of this medicine (listed in section 6),
if you have insulin-dependent diabetes (type 1 diabetes),
if you have diabetic ketoacidosis (a complication of diabetes causing increased acid levels in the body; symptoms may include fatigue, nausea, frequent urination and muscle stiffness),
if you are in a state of diabetic coma,
if you have severe kidney function impairment,
if you have severe liver function impairment.

Do not take this medicine if any of the above conditions apply to you.
If you have any doubts, consult your doctor or pharmacist before taking Glimepiride Aurovitas.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if:

you have experienced trauma, surgery, infection with fever, or any other stressful condition; inform your doctor, as temporary changes in treatment may be necessary,
you have impaired liver or kidney function.

If you have any doubts, discuss this with your doctor or pharmacist before taking Glimepiride Aurovitas.
In patients with glucose-6-phosphate dehydrogenase deficiency, a decrease in haemoglobin levels and breakdown of red blood cells (haemolytic anaemia) may occur.
Information on the use of Glimepiride Aurovitas in patients under 18 years of age is limited.
Its use is not recommended in this patient group.
Important information about hypoglycaemia (low blood sugar)
While taking Glimepiride Aurovitas, you may experience hypoglycaemia (low blood sugar). Below are additional details about hypoglycaemia, its symptoms and treatment.
The following factors may increase the risk of hypoglycaemia:

reluctance (more common in elderly patients) or inability to cooperate,
undernutrition, irregular meals or skipping meals,
changes in diet,
taking a higher dose of Glimepiride Aurovitas than required,
kidney function impairment,
severe liver function impairment,
certain conditions caused by hormonal disorders (e.g. thyroid, pituitary or adrenal gland dysfunction),
alcohol consumption, especially when combined with skipped meals,
concomitant use of certain other medicines (see below: Glimepiride Aurovitas and other medicines),
increased physical exertion beyond usual levels, especially if meals are insufficient or contain less carbohydrate than usual.

Symptoms of hypoglycaemia include:
Hunger attacks, headache, nausea, vomiting, fatigue, drowsiness, sleep disturbances,
restlessness, aggression, difficulty concentrating, impaired attention and reaction time, depression, confusion,
speech and vision disturbances, slurred speech, trembling, partial paralysis, sensory disturbances, dizziness,
and feelings of helplessness.
Additional symptoms may include: sweating, clammy skin, anxiety, rapid heartbeat, elevated blood pressure,
palpitations, sudden and severe chest pain radiating to adjacent areas (angina pectoris and cardiac arrhythmias).
If blood glucose levels continue to fall, symptoms may progress to confusion (delirium), seizures, loss of self-control,
shallow breathing and slowed heart rate, and may lead to loss of consciousness or coma. Low blood sugar levels may produce
symptoms similar to those of a stroke.
Treatment of hypoglycaemia:
In many cases, symptoms of low blood glucose resolve rapidly after consuming sugar in some form, e.g. sugar cubes, sweet juice, or sweetened tea.
Always carry sugar with you (e.g. sugar cubes).
Remember that artificial sweeteners are not effective in treating hypoglycaemia. Contact your doctor or go to hospital if symptoms of hypoglycaemia do not resolve after consuming sugar.
Laboratory tests
You should regularly monitor your blood or urine glucose levels. Your doctor may also perform regular blood tests. These are necessary to check liver function and blood cell counts.
Children and adolescents
Glimepiride Aurovitas is not recommended for use in children under 18 years of age.
Glimepiride Aurovitas and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Your doctor may decide to adjust the dose of Glimepiride Aurovitas if you are taking other medicines that may weaken or enhance its effect on blood glucose levels.
The following medicines may enhance the effect of Glimepiride Aurovitas on blood glucose levels, potentially leading to hypoglycaemia (low blood sugar):

other antidiabetic medicines (e.g. insulin or metformin),
medicines used to treat pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone, medicines with actions similar to acetylsalicylic acid),
medicines used to treat urinary tract infections (including some long-acting sulfonamides),
medicines used to treat bacterial and fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolone antibiotics, clarithromycin),
anticoagulant medicines (coumarin derivatives, e.g. warfarin),
medicines supporting muscle mass development (anabolic steroids),
medicines used in testosterone replacement therapy,
medicines used to treat depression [fluoxetine, monoamine oxidase inhibitors (MAO inhibitors)],
medicines that lower high cholesterol levels (fibrates),
medicines that lower high blood pressure [angiotensin-converting enzyme (ACE) inhibitors],
antiarrhythmic medicines used to prevent cardiac rhythm disturbances (disopyramide),
medicines used to treat gout (allopurinol, probenecid, sulfinpyrazone),
medicines used to treat cancer (cyclophosphamide, ifosfamide, trofosfamide),
medicines used for weight reduction (fenfluramine),
medicines used to improve circulation, administered intravenously in high doses (pentoxifylline),
medicines used to treat nasal allergies, e.g. hay fever (tritoqualine),
medicines known as sympatholytics used to treat high blood pressure, heart failure or symptoms of prostate disease,

The following medicines may reduce the effect of Glimepiride Aurovitas on blood glucose levels, potentially leading to hyperglycaemia (high blood sugar):

medicines containing female sex hormones (oestrogens, progestogens),
medicines promoting urine production (thiazide diuretics),
medicines stimulating the thyroid gland (e.g. levothyroxine),
medicines used to treat allergies and inflammatory conditions (glucocorticoids),
medicines used to treat severe psychiatric disorders (chlorpromazine and phenothiazine derivatives),
medicines used for rapid heartbeat, asthma, nasal congestion, cough and colds, for weight reduction, or in life-threatening emergencies (adrenaline and sympathomimetics),
medicines used to treat high cholesterol levels (nicotinic acid and its derivatives),
long-term use of medicines for constipation (laxatives),
medicines used to treat epilepsy (phenytoin),
medicines used to treat anxiety and sleep disorders (barbiturates),
medicines used to treat increased intraocular pressure (acetazolamide),
medicines used to treat high blood pressure and low blood sugar (diazoxide),
medicines used to treat infections, tuberculosis (rifampicin),
medicines used to treat life-threatening very low blood sugar (glucagon).

The following medicines may increase or decrease the effect of Glimepiride Aurovitas on blood glucose levels:

medicines used to treat stomach ulcers (H2-receptor antagonists),
medicines used to treat high blood pressure or heart failure, e.g. beta-blockers, clonidine and reserpine. These medicines may also mask the symptoms of hypoglycaemia; therefore, caution is required when using them.

Glimepiride Aurovitas may increase or decrease the effect of the following medicines:

anticoagulant medicines (coumarin derivatives, e.g. warfarin).

Colesevelam, a medicine used to lower cholesterol levels, affects the absorption of Glimepiride Aurovitas. This interaction has not been observed when Glimepiride Aurovitas is administered at least 4 hours before colesevelam. To avoid this interaction, Glimepiride Aurovitas should be taken at least 4 hours before colesevelam.
Glimepiride Aurovitas with food, drink and alcohol
Alcohol consumption may unpredictably enhance or weaken the effect of Glimepiride Aurovitas.
Pregnancy, breastfeeding and fertility
Pregnancy
Do not take Glimepiride Aurovitas during pregnancy or while breastfeeding. If you are pregnant or breastfeeding, suspect you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Breastfeeding
Glimepiride Aurovitas may pass into breast milk.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Your ability to concentrate or react quickly may be reduced due to low blood glucose (hypoglycaemia) or high blood glucose (hyperglycaemia). Be aware that you may put yourself or others at risk (e.g. when driving or operating machinery). Patients should consult their doctor whether they can drive or operate machinery if:

they frequently experience hypoglycaemia,
warning symptoms of hypoglycaemia are weakened or absent.

Glimepiride Aurovitas contains lactose
If you have previously been diagnosed with an intolerance to certain sugars, you should consult your doctor before taking this medicine.
Glimepiride Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is essentially "sodium-free".
3. How to take Glimepiride Aurovitas
Always take this medicine exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.
How to take the medicine
Take the medicine orally, just before or during the first meal of the day (usually breakfast). If you do not eat breakfast, take the medicine as directed by your doctor.
It is important not to skip meals while taking Glimepiride Aurovitas.
Swallow the tablet whole without chewing or crushing it, with at least half a glass of water.
Each tablet can be divided into equal doses.
Recommended dose
The dose of Glimepiride Aurovitas depends on your condition and the results of blood and urine glucose tests, and is determined by your doctor. Do not take more tablets than prescribed by your doctor.

The starting dose is one Glimepiride Aurovitas tablet - 1 mg once daily.
Your doctor may increase the dose after 1-2 weeks of treatment if necessary.
The maximum recommended dose is 6 mg of Glimepiride Aurovitas per day.
Your doctor may recommend concomitant use of glimepiride with metformin or glimepiride with insulin. In such cases, your doctor will prescribe appropriate, individually determined doses of glimepiride with metformin or insulin.
If you experience changes in body weight, lifestyle, or are under stress, inform your doctor so they can adjust the dose if necessary.
If you feel the medicine's effect is too weak or too strong, do not change the dose on your own; contact your doctor.

Taking more Glimepiride Aurovitas than recommended
Taking too many tablets of Glimepiride Aurovitas or taking an extra dose is dangerous for the patient, as there is a risk of hypoglycaemia (symptoms of hypoglycaemia are described in section 2. Warnings and precautions). In such a case, immediately consume an adequate amount of sugar (e.g. small sugar cubes, sweet juice, sweetened tea) and contact your doctor as soon as possible. Treatment of hypoglycaemia in children who have accidentally taken the medicine requires careful sugar administration to avoid the risk of hyperglycaemia. Do not give food or drinks to unconscious individuals.
In cases of prolonged hypoglycaemia, it is very important that the patient remains under strict medical supervision until the risk has passed. Hospitalisation may be necessary as a precaution. Show the doctor the packaging or remaining tablets so they know which medicine was taken.
Severe cases of hypoglycaemia with loss of consciousness and severe neurological impairment require immediate medical assistance, usually in a hospital setting. Ensure that someone nearby has been informed in advance and can call a doctor in emergencies.
If you miss a dose of Glimepiride Aurovitas
Do not take a double dose to make up for a missed dose.
Stopping Glimepiride Aurovitas
After stopping treatment, the achieved reduction in blood glucose levels will not be maintained and the condition may worsen. Continue taking Glimepiride Aurovitas for as long as your doctor recommends.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact your doctor immediately if any of the following symptoms occur:

Allergic reactions (including inflammation of blood vessels, often with a rash), which may progress to severe reactions with difficulty breathing, drop in blood pressure, and even shock.
Liver function disorders, including yellowing of the skin and eyes (jaundice), impaired bile flow (cholestasis), inflammation or liver failure.
Skin allergy (hypersensitivity), manifesting as itching, rash, urticaria, or increased sensitivity to sunlight. Some mild allergic reactions may progress to severe reactions with difficulty swallowing or breathing, or swelling of the lips, throat, or tongue.
Severe hypoglycaemia, including loss of consciousness, seizures, or coma.

The following adverse reactions have been reported in some patients treated with Glimepiride Aurovitas:
Uncommon (may occur in up to 1 in 1,000 patients)

Lower than normal blood glucose levels (hypoglycaemia, see section 2. Important information before taking Glimepiride Aurovitas, subsection Warnings and precautions).
Decreased number of blood cells, such as:
- platelets, increasing the risk of bleeding or bruising (thrombocytopenia),
- white blood cells, increasing the likelihood of infections,
- red blood cells, which may cause paleness, weakness, or shortness of breath.

These disorders usually resolve after discontinuation of Glimepiride Aurovitas.

Weight gain,
Hair loss,
Taste disturbances.

Very rare (may occur in up to 1 in 10,000 patients)

Allergic reaction (including vasculitis, often with skin rash), which may progress to a severe reaction with breathing difficulties, drop in blood pressure, and sometimes shock. If any of these symptoms occur, inform your doctor immediately.
Liver dysfunction, manifesting as yellowing of the skin and eyes (jaundice), problems with bile secretion (cholestasis), liver inflammation or failure. If any of these symptoms occur, inform your doctor immediately.
Nausea or vomiting, diarrhoea, feeling of abdominal fullness or bloating, and abdominal pain.
Decreased sodium concentration in blood (detected by laboratory tests).

Frequency not known, cannot be estimated from available data:

Skin allergy (hypersensitivity) with itching, rash, urticaria, and increased sensitivity to sunlight. Some mild reactions may progress to severe reactions with swelling or breathing difficulties, or swelling of the lips, throat, or tongue. If any of these symptoms occur, inform your doctor immediately.
Allergic reactions to sulfonylurea derivatives, sulfonamides, or similar medicines may occur.
Visual disturbances may occur at the beginning of treatment with Glimepiride Aurovitas. These disturbances are caused by changes in blood sugar levels and should resolve quickly.
Increased liver enzyme activity.
Severe bleeding or subcutaneous bruising.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, al. Jerozolimskie 181c, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Glimepiride Aurovitas
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following the word "EXP". The expiry date refers to the last day of the stated month.
No special storage precautions are required for this medicinal product.
Do not use this medicine if there are visible signs of deterioration.
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 protect the environment.

6. Contents of the pack and other information

What Glimepiride Aurovitas contains

The active substance is glimepiride. Each tablet contains 2 mg, 3 mg or 4 mg of glimepiride.
Other ingredients: microcrystalline cellulose (PH-101), lactose monohydrate, povidone (K 25), sodium carboxymethyl starch (type A), magnesium stearate.
Additionally, the tablets contain colouring agents:
3 mg tablets also contain iron oxide yellow (E 172),
4 mg tablets also contain indigo carmine, aluminium lake (E 132).

What Glimepiride Aurovitas looks like and contents of the pack
Tablet
Glimepiride Aurovitas 2 mg tablets:
White or almost white, flat, elongated, uncoated tablets with a dividing score line. On one side, the characters "Y" and "32" are embossed on both sides of the score line; the other side is smooth. Dimensions: 10 mm x 5 mm. The tablet can be divided into equal doses.
Glimepiride Aurovitas 3 mg tablets:
Light yellow, flat, elongated, uncoated tablets with a dividing score line. On one side, the characters "Y" and "33" are embossed on both sides of the score line; the other side is smooth. Dimensions: 10 mm x 5 mm. The tablet can be divided into equal doses.
Glimepiride Aurovitas 4 mg tablets:
Light blue or almost blue, flat, elongated, uncoated tablets with a dividing score line. On one side, the characters "Y" and "34" are embossed on both sides of the score line; the other side is smooth. Dimensions: 10 mm x 5 mm. The tablet can be divided into equal doses.
Glimepiride Aurovitas tablets are available in blisters made of PVC/PE/PVDC/Aluminium and in HDPE bottles with PP closure, packed in a cardboard box.
Pack sizes:
Blisters: 15, 30, 50, 60, 90 and 120 tablets.
HDPE bottle: 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D, lok. 27
01-909 Warsaw
Poland

Manufacturer / Importer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Glimepirid Aurovitas
Italy: GLIMEPIRIDE AUROBINDO
Netherlands: Glimepiride Aurobindo 1 mg/2 mg /3 mg /4 mg, tabletten
Poland: Glimepiride Aurovitas
Portugal: Glimepirida Aurovitas
Spain: GLIMEPIRIDA AUROVITAS 2 mg/ 4 mg comprimidos EFG