Metformin Aurobindo

Patient Information Leaflet: Information for the User

Metformin Aurobindo 500 mg film-coated tablets, 850 mg film-coated tablets, 1000 mg film-coated tablets

Generic medicine
Please read 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 give it 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Metformina Aurobindo is and what it is used for

Metformina Aurobindo contains metformin, a medicine used to treat diabetes. It belongs to a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas that enables the human body to absorb glucose (sugar) from the blood. Your body uses glucose for energy production or stores it for future use.
If you have diabetes, your pancreas does not produce enough insulin, or your body is unable to use the insulin it produces effectively. This leads to high levels of glucose in your blood. Metformina Aurobindo helps lower blood glucose levels to values as close as possible to normal.
If you are an overweight adult, long-term use of Metformina Aurobindo also helps reduce the risk of diabetes-related complications. Metformina Aurobindo is associated with both stable body weight and modest weight loss.
Metformina Aurobindo is used to treat patients with type 2 diabetes (also called "non-insulin-dependent diabetes") when diet and exercise alone have not been sufficient to control blood glucose levels. It is particularly used in overweight patients.
Adults may take Metformina Aurobindo alone or in combination with other antidiabetic medicines (oral medications or insulin).
Children from the age of 10 years and adolescents may take Metformina Aurobindo alone or in combination with insulin.

2. What you need to know before taking Metformina Aurobindo

Do not take Metformina Aurobindo

• If you are allergic (hypersensitive) to metformin or to any of the other ingredients of this medicine (see “What Metformina Aurobindo contains” in section 6).
• If you have liver problems.
• If you have severely reduced kidney function.
• If you have uncontrolled diabetes associated, for example, with severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood and may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, and breath with an unusual fruity odour.
• If you have lost too much fluid from your body (dehydration), such as after prolonged or severe diarrhoea, or repeated vomiting. Dehydration can lead to kidney failure, which may put you at risk of lactic acidosis (see “Warnings and precautions”).
• If you have a severe infection, such as infections of the lungs, bronchi, or kidneys. Severe infections can lead to kidney failure, which may put you at risk of lactic acidosis (see “Warnings and precautions”).
• If you are being treated for heart failure or have recently had a myocardial infarction, if you have serious circulation problems (such as shock) or breathing difficulties. These conditions can lead to poor oxygen supply to tissues, which may put you at risk of lactic acidosis (see “Warnings and precautions”).
• If you consume large amounts of alcohol.

If you have any of the conditions listed above, consult your doctor before starting to take this medicine.

Ask your doctor for advice if:

• you are due to have a test such as an X-ray or a scan that requires injection into the bloodstream of an iodine-containing contrast medium;
• you are due to have surgery.

You must stop taking Metformina Aurobindo for a certain period of time before and after the diagnostic test or surgical procedure. Your doctor will decide whether you will need another treatment during this time. It is important that you follow your doctor’s instructions exactly.

Warnings and precautions

Risk of lactic acidosis

Metformina Aurobindo may cause a very rare but very serious side effect called lactic acidosis, particularly if the kidneys are not functioning properly. The risk of developing lactic acidosis is higher in the presence of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for further information), liver problems, or any other medical condition characterised by reduced oxygen supply to part of the body (such as severe heart disease).

If you have any of the medical conditions described above, consult your doctor for further instructions.

Stop taking Metformina Aurobindo for a short period of time if you have a medical condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, exposure to heat, or if you are drinking less fluid than usual. Consult your doctor for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking Metformina Aurobindo and contact your doctor or go immediately to the nearest hospital, because lactic acidosis can lead to coma.

Symptoms of lactic acidosis include:

• vomiting;
• stomach ache (abdominal pain);
• muscle cramps;
• a general feeling of malaise associated with severe fatigue;
• difficulty breathing;
• reduced body temperature and slower heartbeat.

Lactic acidosis is a medical emergency and must be treated in hospital.

If you are undergoing major surgery, you must stop taking Metformina Aurobindo during the operation and for a certain period of time afterwards. Your doctor will decide when you should stop and when you should restart treatment with Metformina Aurobindo.

Metformina Aurobindo alone does not cause hypoglycaemia (low blood glucose levels). However, if you take Metformina Aurobindo together with other medicines for treating diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides), there is a risk of hypoglycaemia. If you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances or difficulty concentrating, it is usually helpful to eat or drink something containing sugar.

During treatment with Metformina Aurobindo, your doctor will check your kidney function at least once a year, or more frequently if you are elderly and/or if kidney function worsens.

Other medicines and Metformina Aurobindo

If you are due to receive an injection of an iodinated contrast medium into the bloodstream, for example for an X-ray, you must stop taking Metformina Aurobindo before or during the injection. Your doctor will decide when you should stop and when you should restart treatment with Metformina Aurobindo.

Inform your doctor if you are taking, have recently taken, or might take any other medicines. You may need to have your blood glucose and kidney function tested more frequently, or your doctor may decide to adjust the dose of Metformina Aurobindo. It is particularly important to mention the following:

• medicines that increase urine production (diuretics);
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib);
• some medicines for treating high blood pressure (ACE inhibitors and angiotensin II receptor antagonists);
• beta-2 agonists such as salbutamol or terbutaline (used to treat asthma);
• corticosteroids (used to treat a range of conditions, such as severe skin inflammation or asthma);
• medicines that may alter the amount of Metformina Aurobindo in the blood, especially if kidney function is reduced (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib);
• other medicines used to treat diabetes.

Metformina Aurobindo and alcohol

Avoid excessive alcohol consumption during treatment with Metformina Aurobindo, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, talk to your doctor about whether changes to your treatment or monitoring of your blood glucose levels are needed.

This medicine is not recommended if you are breastfeeding or planning to breastfeed your baby.

Driving and using machines

Metformina Aurobindo alone does not cause hypoglycaemia (low blood glucose levels). This means it does not affect your ability to drive or use machines.

However, take particular care if you are taking Metformina Aurobindo together with other medicines for treating diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances or difficulty concentrating. Do not drive or use machines if you experience these symptoms.

3. How to take Metformina Aurobindo

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Metformina Aurobindo cannot replace the benefits derived from a healthy lifestyle. Continue to follow all dietary advice provided by your doctor and maintain regular physical activity.

Recommended dose:
Children from 10 years of age and adolescents usually start with 500 mg or 850 mg of Metformina Aurobindo once daily. The maximum daily dose is 2000 mg, taken in 2 or 3 divided doses.
Treatment of children between 10 and 12 years of age is recommended only under specific medical indication, as experience in this age group is limited.
Adults generally start with 500 mg or 850 mg of Metformina Aurobindo 2 or 3 times daily. The maximum daily dose is 3000 mg, taken in 3 divided doses.
If you have reduced kidney function, your doctor may prescribe a lower dose.
If you are also taking insulin, your doctor will advise you on how to start Metformina Aurobindo.

Monitoring

• Your doctor will adjust your dose of Metformina Aurobindo based on your blood glucose levels. Make sure to consult your doctor regularly. This is particularly important for children and adolescents, or if you are elderly.
• Your doctor will also check your kidney function at least once a year. You may need more frequent monitoring if you are elderly or have impaired kidney function.

How to take Metformina Aurobindo
Take the tablets during or after meals. This will help you avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow each tablet with a glass of water.

• If you take one dose per day, take it in the morning (with breakfast).
• If you take two doses per day, take them in the morning (with breakfast) and in the evening (with dinner).
• If you take three doses per day, take them in the morning (with breakfast), at midday (with lunch), and in the evening (with dinner).

If, after some time, you feel that the effect of Metformina Aurobindo is too strong or too weak, consult your doctor or pharmacist.

If you take more Metformina Aurobindo than you should
If you have taken more Metformina Aurobindo than prescribed, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and may include vomiting, stomach pain (abdominal pain) with muscle cramps, a general feeling of malaise with severe fatigue and difficulty breathing. Further symptoms include lowered body temperature and slowed heart rate.
If you experience any of these symptoms, seek immediate medical attention, as lactic acidosis can lead to coma. Stop taking Metformina Aurobindo immediately and contact a doctor or go to the nearest hospital straight away.

If you forget to take Metformina Aurobindo
Do not take a double dose to make up for the missed dose. Take the next dose at your usual scheduled time.

If you have any further questions 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 everyone gets them. The following side effects may occur:
Metformin Aurobindo may cause a very rare (may affect up to 1 in 10,000 people) but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Metformin Aurobindo and must contact your doctor or go to the nearest hospital immediately, because lactic acidosis can lead to coma.

Very common side effects (may affect more than 1 in 10 people):

• Gastrointestinal problems such as nausea, vomiting, diarrhoea, stomach ache (abdominal pain), and loss of appetite. These side effects mostly occur at the beginning of treatment with Metformin Aurobindo. It may help to spread the doses throughout the day and to take the tablets during or after a meal. If symptoms persist, stop taking Metformin Aurobindo and consult your doctor.

Common side effects (may affect 1 in 10 people):

• Altered taste.

• Low or reduced levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), red and sore tongue (glossitis), tingling sensations (paraesthesiae), or pale or yellowish skin). Your doctor may order some tests to determine the cause of these symptoms, as some of them may also be caused by diabetes or other unrelated health problems.

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

• Lactic acidosis. This is a very rare but serious complication, particularly if the kidneys are not working properly. The symptoms of lactic acidosis are non-specific (see section “Warnings and precautions”).

• Abnormal liver function tests or hepatitis (liver inflammation; may cause tiredness, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If you experience such symptoms, stop taking Metformin Aurobindo and contact your doctor.

• Skin reactions such as redness of the skin (erythema), itching, or itchy rash (urticaria).

Children and adolescents
Limited data in children and adolescents have shown that adverse events were similar in nature and severity to those reported in adults.

Reporting of side effects
If you get any side effects, 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.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metformina Aurobindo

Keep this medicine out of the sight and reach of children.
If a child is being treated with Metformina Aurobindo, it is recommended that parents and caregivers supervise how this medicine is used.
This medicine does not require any special storage conditions.
Do not use Metformina Aurobindo after the expiry date stated on the carton or blister pack after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Metformina Aurobindo contains

• The active substance is metformin, present in the form of metformin hydrochloride.

Metformina Aurobindo 500 mg:
Each film-coated tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg
of metformin.
Metformina Aurobindo 850 mg:
Each film-coated tablet contains 850 mg of metformin hydrochloride, equivalent to 663 mg
of metformin.
Metformina Aurobindo 1000 mg:
Each film-coated tablet contains 1000 mg of metformin hydrochloride, equivalent to 780 mg
of metformin.

• Other components are: Tablet core: Povidone, magnesium stearate. Coating: Hypromellose, macrogol.

Description of the appearance of Metformina Aurobindo and package contents
Film-coated tablets.
Metformina Aurobindo 500 mg:
White, round film-coated tablets [11 mm in diameter], biconvex, with an "A" engraved on one side and "60" engraved on the other side.
Metformina Aurobindo 850 mg:
White, round film-coated tablets [12.70 mm in diameter], biconvex, with an "A" engraved on one side and "61" engraved on the other side.
Metformina Aurobindo 1000 mg:
White, capsule-shaped, biconvex film-coated tablets with a score line on one side and "A" and "90" engraved on the other side, separated by a score line. Dimensions are 20.5 mm x 8.6 mm. The tablet can be divided into equal doses.
Metformina Aurobindo is packaged in blisters.
Metformina Aurobindo 500 mg:
30 or 50 film-coated tablets in blisters (PVC/PVdC/aluminium) or (PVC/Aluminium), each containing 10 film-coated tablets.
Metformina Aurobindo 850 mg:
30 or 40 film-coated tablets in blisters (PVC/PVdC/aluminium) or (PVC/Aluminium), each containing 10 film-coated tablets.
Metformina Aurobindo 1000 mg:
60 film-coated tablets in blisters (PVC/PVdC/aluminium) or (PVC/Aluminium), each containing 10 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 - Saronno (VA)
Italy

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

This medicinal product is authorized in the European Economic Area countries under the
following names:
Italy: Metformina Aurobindo