Package leaflet: Information for the patient

METFORMIN EG STADA 500 mg prolonged-release tablets, 750 mg prolonged-release tablets, 1000 mg prolonged-release tablets

Generic medicine
Please read this leaflet carefully before you start taking this medicine, as 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 other people, even if their symptoms are the same as yours, as it may 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

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

1. What Metformina EG STADA is and what it is used for

Metformina EG STADA tablets contain the active substance metformin hydrochloride, which belongs to a group of medicines called biguanides. Metformin is used in the treatment of type 2 diabetes mellitus (non-insulin-dependent diabetes) when diet and exercise alone have not been sufficient to control blood glucose (sugar) levels. It is particularly used in overweight patients.
Insulin is a hormone produced in the pancreas and helps the body to remove glucose (sugar) from the blood and to use it for energy production or to store it for later use.
If you have type 2 diabetes, your pancreas does not produce enough insulin or your body is unable to respond properly to the insulin it produces. This leads to an accumulation of glucose in the blood, possibly resulting in a series of serious long-term complications. It is therefore important that you continue taking the medicine, even in the absence of obvious symptoms. Metformina EG STADA makes your body more sensitive to insulin and helps normalize the way your body uses glucose.
If you are an overweight adult, long-term use of Metformina EG STADA will help you reduce the risk of diabetes-related complications. Metformina EG STADA is associated with stabilization of body weight and/or modest weight loss.
Metformina EG STADA is specially formulated to release the drug slowly into the body, thereby differentiating it from many other types of metformin-containing tablets. Adults may take Metformina EG STADA alone or in combination with other antidiabetic medicines (oral medications or insulin).

2. What you should know before taking Metformina EG STADA

Do NOT take Metformina EG STADA if:

you are allergic to metformin or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include rash, itching or shortness of breath;
you have liver problems;
you have severely reduced kidney function;
you have uncontrolled diabetes associated, for example, with severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see "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 unusually fruity odour;
you have lost too much fluid from your body (dehydration), for example due to severe or prolonged diarrhoea, or if you have vomited repeatedly. Dehydration can cause kidney problems, with a possible risk of lactic acidosis occurring (see "Warnings and precautions");
you have a severe infection, for example affecting the lungs, bronchial system or kidneys. Severe infections can cause kidney problems, with a possible risk of lactic acidosis occurring (see "Warnings and precautions");
you have been treated for acute heart problems or have recently had a heart attack or have serious circulatory problems (such as shock) or breathing difficulties. This may lead to insufficient oxygen supply to tissues, with a possible risk of lactic acidosis occurring (see "Warnings and precautions");
you consume large amounts of alcohol.

Warnings and precautions
Risk of lactic acidosis
Metformina EG STADA 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 in the case of severe heart disease).
If you have any of the medical conditions listed above, consult your doctor for further instructions.
If you experience any of the symptoms of lactic acidosis, stop taking Metformina EG STADA immediately and
contact your doctor or go to the nearest hospital, as lactic acidosis can lead to coma.
Symptoms of lactic acidosis include:

vomiting
stomach ache (abdominal pain)
muscle cramps
a general feeling of being unwell 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.
Temporarily stop taking Metformina EG STADA 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 fluids than normal. Consult your doctor for further instructions.

Pay attention to the following:

If you are undergoing major surgery, you must stop taking Metformina EG STADA during the procedure and for a certain period afterwards. Your doctor will decide when to stop and when to restart treatment with Metformina EG STADA.
Metformina EG STADA by itself does not cause hypoglycaemia (low blood glucose level). However, if you take metformin hydrochloride together with other medicines for the treatment of diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides), there is a risk that hypoglycaemia may occur.

If symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances or difficulty concentrating occur, eating or drinking something containing sugar usually helps.

During treatment with Metformina EG STADA, 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.

You may find remnants of the tablets in your stools. Do not worry: this is normal with this type of tablet.
Metformina EG STADA cannot replace the benefits of a healthy lifestyle. Continue to follow all dietary advice given by your doctor and engage in regular physical activity.
Do not stop treatment with this medicine without first consulting your doctor.

Other medicines and Metformina EG STADA
If you are due to receive an injection of an iodinated contrast agent into the bloodstream, for example to undergo an X-ray or ultrasound, you must stop taking Metformina EG STADA before or at the time of the injection. Your doctor will decide when to stop and when to restart treatment with Metformina EG STADA.
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 need to adjust the dose of Metformina EG STADA. It is particularly important to mention the following medicines:

medicines that increase urine production (diuretics (water tablets) such as furosemide);
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);
some medicines used to treat asthma (beta-2 agonists such as salbutamol or terbutaline);
medicines used to treat heart attacks and low blood pressure (sympathomimetic medicines including epinephrine and dopamine). Epinephrine is also included in some anaesthetics used in dentistry;
anti-inflammatory medicines (corticosteroids, such as prednisolone, mometasone, beclometasone);
medicines that may alter the amount of Metformina EG STADA in the blood, especially in case of reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib);
other medicines used to treat diabetes.

Metformina EG STADA and alcohol
Avoid excessive alcohol consumption while being treated with Metformina EG STADA, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant or are planning to become pregnant, inform your doctor so that they can change your treatment or monitor your blood glucose levels.
You must not take this medicine if you are breastfeeding or intend to breastfeed.

Driving and using machines
Metformina EG STADA by itself does not cause hypoglycaemia (low blood glucose level).
Therefore, this medicine should not affect your ability to drive or use machines.
However, exercise particular caution if you take Metformina EG STADA together with other medicines used to treat diabetes that may cause hypoglycaemia (e.g. sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances or difficulty concentrating. If you experience these symptoms, do not drive or operate machinery.

Metformina EG STADA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Metformina EG STADA

Your doctor may prescribe Metformina EG STADA to be taken alone or in combination with other
oral antidiabetic medicines or with insulin.
Take this medicine exactly as your doctor has told you. If you are not sure, consult your
doctor or pharmacist.
Recommended dose
Normally, treatment starts with 500 milligrams of Metformina EG STADA per day. After Metformina EG STADA has been taken for about 2 weeks, your doctor may measure your blood glucose and adjust the dose accordingly.
The maximum daily dose is 2000 milligrams of Metformina EG STADA.
If your kidney function is impaired, your doctor will prescribe a lower dose of the medicine.
Your doctor will regularly monitor your blood glucose levels and adjust the dose of Metformina EG STADA according to your blood glucose levels. Consult your doctor regularly. This is particularly important if you are elderly.
Method of administration
The tablets are for oral use.
Normally, you should take the tablets once daily with the evening meal. Swallow the tablets whole
with a glass of water; do not chew or crush them.
The tablets are formulated to provide prolonged release of the medicine during administration.
The medicine is thus released slowly into the body, and therefore it is necessary to take the tablets only
once daily.
In some cases, your doctor may recommend taking the tablets twice daily.
If you take more Metformina EG STADA than you should
If you take more tablets than prescribed, lactic acidosis may occur. Symptoms of lactic acidosis are
non-specific and include vomiting, stomach pain (abdominal pain), muscle cramps, general feeling of
malaise with severe fatigue and difficulty in breathing. Other symptoms are lowered body temperature and
slower heart rate.
If you experience any of these symptoms, stop taking Metformina EG STADA immediately and seek
urgent medical advice from your doctor or go to the nearest hospital, because lactic acidosis can lead to
coma.
If you forget to take Metformina EG STADA
Take it as soon as you remember, together with food. Do not take a double dose to make up for the missed
dose.
If you have any doubts about how to use 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.
The following side effects may occur:
Metformina EG STADA 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 Metformina EG STADA and contact your doctor or go to the nearest hospital immediately, because lactic acidosis can lead to coma.
Symptoms of lactic acidosis include:

vomiting
stomach ache (abdominal pain)
muscle cramps
a general feeling of being unwell associated with severe tiredness
difficulty breathing
reduced body temperature and slower heartbeat

Very rarely (up to 1 in 10,000 people), Metformina EG STADA may cause changes in liver function tests and hepatitis (liver inflammation, with fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If you develop these symptoms, stop taking Metformina EG STADA and contact your doctor immediately.
Other possible side effects are listed below by frequency:
Very common (may affect more than 1 in 10 people)

digestive problems such as feeling sick (nausea), sickness (vomiting), diarrhoea, stomach ache (abdominal pain) and loss of appetite. If these symptoms occur, do not stop taking the tablets, as these symptoms usually disappear within about 2 weeks. These side effects mostly occur at the beginning of treatment with Metformina EG STADA. It is helpful to take Metformina EG STADA with a meal. If symptoms persist, stop taking Metformina EG STADA and consult your doctor.
Common (may affect up to 1 in 10 people)
Altered sense of taste
Decreased levels of vitamin B_{12} in the blood: symptoms may include extreme tiredness (fatigue), sore and red tongue (glossitis), tingling (paraesthesiae), or pale or yellowish skin. Your doctor may carry out certain tests to determine the cause of the symptoms, as some of these may also be caused by diabetes or other health problems unrelated to this medicine.

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

Skin reactions such as redness of the skin, itching or skin rash/urticaria.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the website 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 Metformin EG STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after the word “Exp.” The expiry date refers to the last day of that month.
Store below 25°C.
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 EG STADA contains
Metformin hydrochloride
Metformina EG STADA 500 mg prolonged-release tablets
One prolonged-release tablet contains 500 mg of metformin hydrochloride, equivalent to 389.938 mg
of metformin base.
Metformina EG STADA 750 mg prolonged-release tablets
One prolonged-release tablet contains 750 mg of metformin hydrochloride, equivalent to 584.907 mg
of metformin base.
Metformina EG STADA 1000 mg prolonged-release tablets
One prolonged-release tablet contains 1000 mg of metformin hydrochloride, equivalent to 779.876 mg
of metformin base.

Other components:
Povidone K-90F
Anhydrous colloidal silica
Sodium carboxymethylcellulose 2,500–3,500 mPa·s
Hypromellose 100000 cps
Microcrystalline cellulose
Magnesium stearate

Description of the appearance of Metformina EG STADA and contents of the pack
Description
Metformina EG STADA 500 mg prolonged-release tablets: Tablets from white to almost white, round, biconvex, with "500" engraved on one side and smooth on the other. The tablets have a diameter of approximately 12.15 mm.
Metformina EG STADA 750 mg prolonged-release tablets: Tablets from white to almost white, capsule-shaped, biconvex, smooth on both sides. The tablets are approximately 20.0 mm long and 9.6 mm wide.
Metformina EG STADA 1000 mg prolonged-release tablets: Tablets from white to almost white, capsule-shaped, biconvex, smooth on both sides. The tablets are approximately 22.6 mm long and 10.6 mm wide.

Pack contents
The tablets are available in blisters [rigid PVC film, coated with PVdC 90 gsm pharmaceutical grade (transparent) and aluminium foil] containing 30, 60 and 100 tablets.
Not all pack sizes may be marketed.
The tablets are available in blisters [rigid PVC film, coated with PVdC 90 gsm pharmaceutical grade (transparent) and aluminium foil] containing 30, 60 and 100 tablets.
Not all pack sizes may be marketed.
The tablets are available in blisters [rigid PVC film, coated with PVdC 90 gsm pharmaceutical grade (clear) and aluminium foil] containing 30 and 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milano
Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel, Germany

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
DE Metformin STADA 500 mg Retardtabletten
Metformin STADA 750 mg Retardtabletten
Metformin STADA 1000 mg Retardtabletten
CZ Stadamet Prolong
FI Metformin STADA 500 mg depottabletti
Metformin STADA 750 mg depottabletti
Metformin STADA 1000 mg depottabletti
HU Diaform XR 500 mg retard tabletta
Diaform XR 750 mg retard tabletta
Diaform XR 1000 mg retard tabletta
Melliform XR 500 mg retard tabletta
Melliform XR 750 mg retard tabletta
Melliform XR 1000 mg retard tabletta
Diastart XR 500 mg retard tabletta
Diastart XR 750 mg retard tabletta
Diastart XR 1000 mg retard tabletta
IT METFORMINA EG STADA
PL Metformin hydrochloride STADA
SK STADAMET retard 500 tablety s predĺženým uvoľňovaním
STADAMET retard 750 mg tablety s predĺženým uvoľňovaním
STADAMET retard 1000 mg tablety s predĺženým uvoľňovaním