Metformin Mylan Generics: detailed information

Package leaflet: Information for the patient

METFORMIN MYLAN GENERICS 500 mg film-coated tablets, 850 mg film-coated tablets, 1000 mg film-coated tablets

metformin hydrochloride
Generic medicine
Read all of this leaflet carefully before you start 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 they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Metformina Mylan Generics is and what it is used for

What Metformina Mylan Generics is
Metformina Mylan Generics contains metformin hydrochloride, a medicine used in the treatment of
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 to produce energy 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 properly. This leads to high levels of glucose in the blood.
Metformina Mylan Generics helps lower your blood glucose levels to as close to normal as possible.
If you are overweight, taking Metformina Mylan Generics over a long period of time also helps
reduce the risk of diabetes-related complications.
Metformina Mylan Generics is associated with stable body weight or a modest weight loss.

What Metformina Mylan Generics is used for
Metformina Mylan Generics is used to treat patients with type 2 diabetes (also known as
"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 can take Metformina Mylan Generics alone or in combination with other antidiabetic medicines
(oral medications or insulin).
Children aged 10 years and older and adolescents can take Metformina Mylan Generics alone or in
combination with insulin.

2. What you need to know before taking Metformina Mylan Generics

Do not take Metformina Mylan Generics

If you are allergic to metformin or to any of the other ingredients of this medicine (listed in section 6).
If you have liver disorders.
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, laboured breathing, drowsiness, or breath with an unusually fruity odour.
If you have lost too much fluid from your body (dehydration), such as following prolonged or severe diarrhoea, or if you have vomited repeatedly. Dehydration may lead to kidney problems, which may put you at risk of lactic acidosis (see “Warnings and Precautions” below).
If you have a severe infection, such as infections of the lungs, bronchi, or kidneys. Severe infections may lead to kidney problems, which may put you at risk of lactic acidosis (see “Warnings and Precautions” below).
If you are being treated for heart failure or have recently had a myocardial infarction, if you have severe circulatory problems (such as shock) or respiratory failure. These conditions may lead to inadequate oxygen supply to tissues, which may put you at risk of lactic acidosis (see “Warnings and Precautions” below).
If you consume large amounts of alcohol. If you have any of the conditions listed above, consult your doctor before starting this medicine.

Warnings and Precautions
Inform your doctor or pharmacist before taking Metformina Mylan Generics.
Risk of lactic acidosis
Metformina Mylan Generics may cause a very rare but serious side effect called lactic acidosis, particularly if your 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 disorders, 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.
Temporarily stop taking Metformina Mylan Generics if you have a medical condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, heat exposure, 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 Mylan Generics and contact your doctor or the nearest hospital immediately, as 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 heart rate.

Lactic acidosis is a medical emergency and must be treated in hospital.
Contact your doctor immediately for further advice if:

you know you have a hereditary genetic disease affecting mitochondria (the components that produce energy within cells), such as MELAS syndrome (Mitochondrial Encephalopathy, myopathy, Lactic Acidosis and Stroke-like episodes) or Maternal Inherited Diabetes and Deafness (MIDD)
you experience any of the following symptoms after starting metformin: seizures, reduced cognitive abilities, movement difficulties, symptoms indicating nerve damage (e.g. pain or numbness), headache, or deafness.

Your doctor should check how well your kidneys are functioning before starting treatment with this medicine, especially if you have heart failure being managed with medication.
During treatment with Metformina Mylan Generics, your doctor will monitor your kidney function at least once a year, or more frequently if you are elderly and/or if kidney function worsens.
You should eat carbohydrates regularly throughout the day. If your doctor has given you dietary advice, continue to follow it.
Metformina Mylan Generics alone does not cause hypoglycaemia (low blood glucose levels). However, if Metformina Mylan Generics is taken together with other antidiabetic medicines that may 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, tachycardia, visual disturbances, or difficulty concentrating, it is usually helpful to eat or drink something containing sugar.
If you are undergoing major surgery, you must stop taking Metformina Mylan Generics during the procedure and for a certain period afterwards. Your doctor will decide when to stop and when to restart treatment with Metformina Mylan Generics.
Children and adolescents
Metformina Mylan Generics is not recommended for children under 10 years of age. Treatment in children aged between 10 and 12 years is recommended only on the specific advice of a doctor, due to limited experience in this age group.
Other medicines and Metformina Mylan Generics
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 Mylan Generics. 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 used to treat 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 metformin in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib)
Other medicines used to treat diabetes.

If you are scheduled to receive an injection of iodinated contrast medium into the bloodstream, for example for an X-ray, you must stop taking Metformina Mylan Generics before or during the injection. Your doctor will decide when to stop and when to restart treatment with Metformina Mylan Generics.
Metformina Mylan Generics and alcohol
Avoid excessive alcohol consumption during treatment with Metformina Mylan Generics, as this may increase the risk of lactic acidosis (see section “Warnings and Precautions”).
Pregnancy and breastfeeding
During pregnancy, insulin is required for the treatment of diabetes. Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy, so that your treatment can be adjusted. This medicine is not recommended during breastfeeding or if you are planning to breastfeed your baby.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Metformina Mylan Generics alone does not cause hypoglycaemia (low blood glucose levels). This means it does not affect your ability to drive or use machines.
However, exercise particular caution if you are taking Metformina Mylan Generics together with other antidiabetic medicines that may cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, tachycardia, visual disturbances, or difficulty concentrating. Do not drive or use machines if these symptoms occur.

3. How to take Metformina Mylan Generics

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Metformina Mylan Generics cannot replace the benefits derived from a healthy lifestyle. Continue to
follow all dietary advice provided by your doctor and maintain regular physical activity.
The recommended dose in adults is 500 mg or 850 mg two or three times daily. The maximum daily
dose is 3000 mg, taken in three separate doses.
If you are also taking insulin, your doctor will advise you on how to start.

Use in children aged 10 years and older and adolescents
Children aged 10 years and older and adolescents usually start with 500 mg or 850 mg of Metformina
Mylan Generics once daily. The maximum daily dose is 2000 mg, taken in 2 or 3 divided doses.
Treatment of children aged between 10 and 12 years is recommended only on specific medical advice, as experience in this age group is limited.

Monitoring

Your doctor will regularly monitor your blood glucose levels and adjust your dose of Metformina Mylan Generics accordingly. 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 checks if you are elderly or if your kidneys do not function normally.

Method of administration
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). The 1000 mg tablets may be divided into two equal halves.

If, after some time, you feel that the effect of Metformina Mylan Generics is too strong or too weak, consult your doctor or pharmacist.
If you take more Metformina Mylan Generics than you should
If you have taken more Metformina Mylan Generics than you should, lactic acidosis may occur. Symptoms of lactic acidosis include vomiting, stomach pain (abdominal pain) with muscle cramps, a general feeling of being unwell with severe tiredness, and difficulty breathing. If this happens, you may require immediate hospital treatment, as lactic acidosis can lead to coma. Contact a doctor or the nearest hospital immediately.
If you forget to take Metformina Mylan Generics
Do not take a double dose to make up for the forgotten dose. Take the next dose at your usual time.
If you stop taking Metformina Mylan Generics
If you suddenly stop taking Metformina Mylan Generics, your blood glucose levels may rise. Talk to your doctor before stopping this medicine.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you think you are experiencing any of the following side effects, stop taking this medicine immediately
and go to the nearest emergency room.
These side effects are very rare (may affect up to 1 in 10,000 people)

Lactic acidosis. This is a very rare but serious side effect (see section “Warnings and precautions”). Lactic acidosis may lead to coma.
Abnormal liver function tests or hepatitis (inflammation of the liver; this may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes).

Very common side effects (in more than 1 out of 10 people)

Digestive 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 Metformina Mylan Generics. It may help to spread the doses throughout the day and to take the tablets during or immediately after a meal. If symptoms persist, stop taking Metformina Mylan Generics and consult your doctor.

Common side effects (up to 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 prescribe certain tests to determine the cause of your symptoms, as some of these may also be caused by diabetes or other unrelated health problems.

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

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

Additional side effects in 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 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 https://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 Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via 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 Metformina Mylan Generics contains
The active substance is metformin (as metformin hydrochloride).
Each 500 mg film-coated tablet contains 500 mg of metformin hydrochloride, equivalent to
390 mg of metformin base.
Each 850 mg film-coated tablet contains 850 mg of metformin hydrochloride, equivalent to
662.9 mg of metformin base.
Each 1000 mg film-coated tablet contains 1000 mg of metformin hydrochloride, equivalent to
780 mg of metformin base.
The other excipients are:
Tablet core: povidone K30, magnesium stearate.
Film coating: hypromellose, hydroxypropylcellulose, and polyethylene glycol 400 and 8000.

Description of the appearance of Metformina Mylan Generics and the contents of the pack
METFORMINA MYLAN GENERICS 500 mg:
Film-coated tablets, white, round, convex, smooth on both sides.
METFORMINA MYLAN GENERICS 850 mg:
Film-coated tablets, white, round, convex, smooth on both sides.
METFORMINA MYLAN GENERICS 1000 mg:
Film-coated tablets, white, oval, with "MF" and a score line "3" imprinted on one side of the tablet and "G" on the other side. The tablet can be divided into two equal parts.
Metformina Mylan Generics tablets are packed in blisters (PVC/aluminum) containing 20, 30, 40, 50, 60, and 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano, Italy

Manufacturer
Mylan Hungary Kft., Mylan utca 1., Komárom, H-2900, Hungary

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