500 mg, 850 mg, 1000 mg film-coated tablets
metformin hydrochloride

What Metformin Aurobindo is and what it is used for

What Metformin Aurobindo is

Metformin Aurobindo contains metformin, a medicine used to treat diabetes. It belongs to a group of drugs called biguanides.

Insulin is a hormone produced in the pancreas that helps the body absorb glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for future needs. If you have diabetes, the pancreas does not produce enough insulin or the body cannot use the insulin that is produced well enough. This leads to high glucose levels in the blood. Metformin Aurobindo helps lower blood glucose levels to a level that is as close to normal as possible.

If you are an adult and overweight, taking Metformin Aurobindo for a long time can also help reduce the risk of complications associated with diabetes. Metformin Aurobindo is associated with either stable body weight or a slight weight loss.

What Metformin Aurobindo is used for

Metformin Aurobindo is used to treat patients with type 2 diabetes (also known as “non-insulin-dependent diabetes”) when diet and exercise alone are not sufficient to control blood glucose levels, especially for obese patients.

Adults can take Metformin Aurobindo as the sole treatment or with other medicines to treat diabetes (medicines taken by mouth or insulin ). Children 10 years of age or older and adolescents can take Metformin Aurobindo as their only treatment or with insulin.

Metformin contained in Metformin Aurobindo may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

Before you take Metformin Aurobindo

Do not take Metformin Aurobindo

  • if you are allergic (hypersensitive) to metformin or any of the other ingredients of this medicine (listed in section 6)
  • if you have liver problems
  • if you have severe renal impairment.
  • if you have uncontrolled diabetes with, for example, severe hyperglycaemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis. Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness or that your breath gets a different, fruity smell. If the body has lost too much water (dehydration), e.g. due to prolonged or severe diarrhea, or if you have vomited several times in a row. Dehydration can lead to kidney problems which can cause lactic acidosis (see “Warnings and Cautions” below)
  • if you have a severe infection , e.g. an infection that affects the lungs, trachea or kidneys. Severe infections can lead to kidney problems which can cause lactic acidosis (see “Warnings and precautions” below)
  • if you are being treated for acute heart failure or have recently had a heart attack, if you have severe circulatory problems (such as shock ) or difficulty breathing. This can lead to a lack of oxygen in tissue one, which can cause lactic acidosis (see “Warnings and Precautions” below)
  • if you drink a lot of alcohol

If any of these apply to you, do not take this medicine without talking to a doctor first.

You need to consult a doctor about

• you need to undergo an examination, such as an X-ray examination or computed tomography, which means that you receive contrast agents that contain iodine injected into the blood

• you are going to undergo a major operation

You must stop taking Metformin Aurobindo for a certain period before and after the examination or operation. Your doctor will decide if you need any other treatment during this time. You must follow your doctor’s instructions carefully.

Warnings and cautions

Risk of lactic acidosis

Metformin Aurobindo can cause the very rare, but very serious, side effect of lactic acidosis, especially if your kidneys are not working properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, severe infections, prolonged fasting or alcohol intake, dehydration (see more information below), liver problems, and conditions where part of the body has reduced oxygen supply (including acute severe heart disease).

If any of the above apply to you, talk to your doctor for further information.

Stop taking Metformin Aurobindo for a short time if you have a condition that may be associated with dehydration, such as severe vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. Talk to a doctor for further instructions.

Stop taking Metformin Aurobindo and contact your doctor or nearest hospital immediately if you experience any of the symptoms of lactic acidosis as the condition may lead to coma.

The symptoms of lactic acidosis include:

  • vomiting
  • abdominal pain (stomach pain)
  • muscle cramps
  • a general feeling of not feeling well and pronounced fatigue
  • hard to breathe
  • lowered body temperature and heart rate .

Lactic acidosis is an acute medical condition that must be treated in a hospital.

If you are going to have a major operation, you must stop taking Metformin Aurobindo during the operation and for a certain time after it. Your doctor will decide when you need to stop taking Metformin Aurobindo and when you should start taking it again.

Metformin Aurobindo itself does not cause hypoglycemia (too low blood sugar) but if you take Metformin Aurobindo with other antidiabetic medicines that can cause hypoglycemia (eg sulphonylureas, insulin, meglitinides) there is a risk of hypoglycemia. If you experience symptoms of hypoglycemia, such as weakness, dizziness, sweating, rapid heartbeat, visual disturbances, or difficulty concentrating, eating or drinking something containing sugar usually helps.

During treatment with Metformin Aurobindo, your doctor will check your kidney function at least once a year or more often if you are older and/or if your kidney function is deteriorating.

Other medicines and Metformin Aurobindo

If you need to get an injection into your blood with a contrast agent that contains iodine, for example in connection with X-rays or computed tomography, you must stop taking Metformin Aurobindo before or at the time of injection. Your doctor will decide when you need to stop taking Metformin Aurobindo and when you should start taking it again.

Tell your doctor if you are taking, have recently taken, or might take any other medicines. You may need to do more blood sugar and kidney function tests, or your doctor may need to adjust the dose of Metformin Aurobindo. You must mention the following:

  • drugs that increase urine production ( diuretics )
  • drugs used to treat pain and inflammation ( NSAIDs and COX 2 inhibitors, such as ibuprofen and celecoxib)
  • certain medicines for the treatment of high blood pressure ( ACE inhibitors and angiotensin II receptor antagonists).
  • beta-2 agonists such as salbutamol or terbutaline (used for asthma )
  • corticosteroids (used to treat a variety of conditions, such as severe dermatitis or asthma )
  • drugs that can change the amount of metformin in your blood, especially if you have a decrease
  • renal function (eg verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim,vandetanib, isavuconazole, crizotinib, olaparib)
  • other drugs used to treat diabetes

Metformin Aurobindo with food, drink and alcohol

Avoid high alcohol intake while taking Metformin Aurobindo as alcohol may increase the risk of lactic acidosis (see section “Warnings and precautions”).

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.

During pregnancy, you need insulin to treat your diabetes. Tell your doctor if you are or think you may be pregnant or are planning to have a baby so that he or she can change your treatment.

Do not take this medicine if you are breastfeeding or if you are planning to breastfeed your baby.

Driving and using machines

Metformin Aurobindo alone does not cause hypoglycemia ( too low a blood glucose level). This means that it does not affect your ability to drive or use machines.

However, you should be especially careful if you take Metformin Aurobindo with other antidiabetic medicines that can cause hypoglycemia (eg sulphonylureas, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, sweating, rapid heartbeat, visual disturbances, or difficulty concentrating. Do not drive or use machines if you experience such symptoms.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.

How to take Metformin Aurobindo

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

Metformin Aurobindo cannot replace the beneficial effects of a healthy lifestyle. Continue to follow any dietary advice your doctor has given you and exercise regularly.

The recommended dose is

Children 10 years of age or older and adolescents usually start with 500 mg or 850 mg Metformin Aurobindo once a day. The maximum daily dose is 2,000 mg divided into two or three doses. Treatment of children aged 10-12 years is only recommended according to your doctor’s instructions, as experience in this age group is limited.

Adults usually start with 500 mg or 850 mg Metformin Aurobindo two or three times a day. The maximum daily dose is 3,000 mg divided into three doses.

If you have impaired kidney function, your doctor may prescribe a lower dose.

If you are also taking insulin, your doctor will tell you how to start treatment with Metformin Aurobindo.

Check

  • Your doctor will take regular blood glucose tests and adjust your dose of Metformin Aurobindo to your blood glucose level. You need to talk to your doctor regularly. This is especially important for children and adolescents or if you are older.
  • Your doctor will also examine your kidney function at least once a year. You may need more frequent check-ups if you are older or if your kidneys are not working properly.

How to take Metformin Aurobindo

Take the tablets with or after a meal. This way you avoid side effects that affect digestion.

The tablets must not be crushed or chewed. Swallow each tablet with a glass of water.

  • If you take one dose a day, take it in the morning (breakfast).
  • If you take two doses a day, take one dose in the morning (breakfast) and one in the evening (dinner).
  • If you take three doses a day, take one in the morning (breakfast), one in the middle of the day (lunch) and one in the evening (dinner).

If after a while you think that the effect of Metformin Aurobindo is too strong or too weak, talk to your doctor or pharmacist.

If you take more Metformin Aurobindo than you should

If you take more Metformin Aurobindo than you should, lactic acidosis may occur. The symptoms of lactic acidosis are vomiting, stomach pain with muscle cramps, general malaise with great fatigue, and difficulty breathing. Additional symptoms are decreased body temperature and decreased heart rate.

If you experience any of these symptoms, seek immediate medical attention as lactic acidosis may lead to coma. Stop taking Metformin Aurobindo immediately and contact your doctor or nearest hospital immediately.

If you forget to take Metformin Aurobindo

Do not take a double dose to make up for a forgotten dose. Take the next dose at the time you would normally take it.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur:

Metformin Aurobindo can cause it very rarely (may affect up to 1 user in 10,000), but very serious side effects include lactic acidosis (see section “Warnings and precautions”). If this happens to you, you must stop taking Metformin Aurobindo and contact your doctor or nearest hospital immediately as lactic acidosis may lead to coma.

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

  • Digestive problems, e.g. nausea, vomiting, diarrhea, stomach pain and loss of appetite. These side effects usually occur at the beginning of treatment with Metformin Aurobindo. It helps if you distribute the doses throughout the day and if you take the tablets with or immediately after a meal. If symptoms persist, stop taking Metformin Aurobindo and talk to your doctor.

Common side effects ( may affect up to 1 in 10 people)

  • Taste changes.

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

  • Lactic acid . This is a very rare but serious complication, which can occur especially if the kidneys are not functioning properly. Symptoms of lactic acidosis are nonspecific (see section “Warnings and precautions”).
  • Deviations in liver function tests or hepatitis (this may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this happens to you, stop taking Metformin Aurobindo and contact your doctor.
  • Skin reactions such as redness of the skin ( erythema ), itching or hives .
  • Low levels of vitamin B12 in the blood.

Children and young people

Limited information shows that the type and severity of side effects are similar for children and adolescents as for adults.


If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

How to store Metformin Aurobindo

Keep this medicine out of the sight and reach of children. If a child is being treated with Metformin Aurobindo, parents and caregivers should monitor the use of this medicine.

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the label, carton, or blister after “EXP”. The expiration date is the last day of the specified month.

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 to protect the environment.

6. Contents of the pack and other information

Content declaration

The active substance is metformin hydrochloride

500 mg tablets: A film-coated tablet contains 500 mg metformin hydrochloride equivalent to 390 mg metformin.

850 mg tablets: One film-coated tablet contains 850 mg metformin hydrochloride equivalent to 663 mg metformin.

1000 mg tablets: A film-coated tablet contains 1000 mg metformin hydrochloride equivalent to 780 mg metformin.

The other ingredients are

Tablet core: povidone, magnesium stearate

Film coating: hypromellose, macrogol.

What the medicine looks like and contents of the pack

Film-coated tablet.

Metformin Aurobindo 500 mg White, round [diameter 11mm], biconvex, film-coated tablets with “A” debossed on one side and “60” debossed on the other side.

Metformin Aurobindo 850 mg White, round [diameter 12.70 mm], biconvex, film-coated tablets with “A” debossed on one side and “61” debossed on the other side.

Metformin Aurobindo 1000 mg

White, biconvex, capsule-shaped film-coated tablets with a scoreline on both sides. The size is 20.5 mm x 8.6 mm. The tablet can be divided into two equal doses.

Metformin Aurobindo is packaged in a blister pack (Clear PVC / PVDC / aluminum) or (Clear PVC / aluminum) or white opaque HDPE can pack with polypropylene closure.

Metformin Aurobindo 500 mg / 850 mg:

20, 28, 30, 40, 42, 50, 56, 60, 70, 80, 84, 90, 98, 100, 120, 180, 200, 300 and 400 film-coated tablets in blister packs, each blister containing 10 or 14 film-coated tablets . White opaque HDPE jar pack containing 90, 100, 400 or 500 film-coated tablets.

Metformin Aurobindo 1000 mg:

20, 30, 40, 50, 60, 70, 80, 90, 100, 120 and 180 film-coated tablets in blister packs, each blister containing 10 film-coated tablets. White opaque HDPE jar pack containing 60, 90, 100 or 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Aurobindo Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana FRN 1913

Malta

Manufacturer

Milpharm Limited

Ares, Odyssey Business Park

West End Road

South Ruislip HA4 6QD

UK

or

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000.

Malta

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd
medinfo@orionpharma.com

This medicinal product is authorized under the European Economic Area under the names:

Austria Diabetormin 850 mg / 1000 mg Film tablets
Denmark Metformin “Aurobindo”
France METFORMINE AUROBINDO 500 mg / 850 mg / 1000 mg, compressed pill
Germany Metformin Aurobindo 500 mg / 850 mg / 1000 mg Film tablets
Ireland Metformin Aurobindo 500 mg / 850 mg / 1000 mg film-coated tablets
Italy METFORMINA DOC Generic 500 mg / 850 mg / 1000 mg, compressed rivestite with film
Latvia Metformin Aurobindo 500 mg / 850 mg / 1000 mg, tablets are recommended
Netherlands Metformin HCl Aurobindo 500 mg / 850 mg / 1000 mg, film-coated tablets
Portugal Metformina Aurobindo
Romania Metformin Aurobindo 500 mg / 850 mg / 1000 mg compress filmate
Spain Metformina Ratiopharm 850 mg compresses recovered with film
Sweden Metformin Aurobindo
UK Metformin 500 mg / 850 mg film-coated tablets

Muhammad Nadeem

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