METFORMINA 500 mg Tabletki O Przedłużonym Uwalnianiu

Treść ulotki

1. METFORMINA EG STADA 500 mg prolonged-release tablets, 750 mg prolonged-release tablets, 1000 mg prolonged-release tablets
   1. What is Metformina EG STADA and what is it used for
   2. What you need to know before taking Metformina EG STADA
   3. How to take Metformina EG STADA
   4. Possible side effects
   5. How to store Metformina EG STADA
   6. Package contents and other information

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

Generic medicine

Read this leaflet carefully before 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Metformina EG STADA tablets contain the active ingredient 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) when changes in diet and exercise alone have not been
sufficient to control blood glucose (sugar) levels. It is used in particular in
overweight patients.
Insulin is a hormone produced by the pancreas and helps the body to take glucose (sugar)
from the blood and use it to produce energy or store it for later use.
If you suffer from type 2 diabetes, your pancreas does not produce enough insulin or your body is not
able to respond properly to the insulin it produces. This causes a build-up of glucose in the blood
with possible appearance of a number of serious long-term problems. It is therefore important that you continue
to take the medicine, even in the absence of evident symptoms. Metformina EG STADA makes the body
more sensitive to insulin and helps to normalise the way it uses glucose.
If you are an overweight adult, long-term use of Metformina EG STADA will help you reduce
the risk of complications related to diabetes. Metformina EG STADA is associated with stabilisation of body
weight or/and modest weight loss.
Metformina EG STADA is specially formulated to release the drug slowly into the body and in
this differs therefore from many other types of metformin-based tablets. Adults can take
Metformina EG STADA alone or together with other medicines for the treatment of diabetes (medicines
taken orally or insulin).

2. What you need to 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 skin rash, itching or shortness of breath;
• you have liver problems;
• you have severely reduced kidney function;
• you have uncontrolled diabetes associated with, for example, severe high blood sugar (high levels of glucose in the blood), 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 can 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 (see “Warnings and precautions”);
• you have a severe infection, for example affecting the lungs or bronchial system or the kidneys. Severe infections can cause kidney problems, with a possible risk of lactic acidosis (see “Warnings and precautions”);
• you have been treated for acute heart problems or have recently had a heart attack or have severe circulatory problems (such as shock) or difficulty breathing. This can lead to a lack of oxygen supply to the tissues with a possible risk of lactic acidosis (see “Warnings and precautions”);
• you consume large amounts of alcohol.

Warnings and precautions
Risk of lactic acidosis
Metformina EG STADA can cause a very rare but very serious side effect called lactic acidosis, particularly if your kidneys do not function properly. The risk of developing lactic acidosis is greater in the presence of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for more information), liver problems and any other medical condition characterised by a reduced supply of oxygen to a part of the body (such as in the case of severe heart disease).
If you have any of the medical conditions described above, consult your doctor for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking Metformina EG STADA and
seek immediate medical attention or go to the nearest hospital,because lactic acidosis can lead to coma.
Symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• a general feeling of unwellness with severe tiredness
• difficulty breathing
• reduced body temperature and slower heartbeat

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 drink less fluid than usual. Consult your doctor for further instructions.
Pay attention to the following:

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

Hypoglycaemia symptoms such as weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances or difficulty concentrating are usually helped by eating or drinking something containing sugar.

• 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 your kidney function worsens.

Remnants of the tablets may be found 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 the dietary advice your doctor has given you and take regular exercise.
Do not stop treatment with this medicine without first consulting your doctor.

Other medicines and Metformina EG STADA
If you are to be injected with an iodinated contrast agentinto your bloodstream, for example
to perform an X-ray or ultrasound, you must stoptaking Metformina EG STADA
before or at the time of the injection. Your doctor will decide when you should stop and when you should resume
treatment with Metformina EG STADA.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
You may need to have your blood sugar and kidney function checked more frequently, or your
doctor may need to adjust your dose of Metformina EG STADA. It is particularly
important to mention the following drugs:

• medicines that increase urine production (diuretics (water tablets)such as furosemide);
• medicines used to treat pain and inflammation (NSAIDsand COX-2 inhibitors, such as ibuprofen and celecoxib);
• some medicines for treating high blood pressure (ACE inhibitorsand 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 dental anaesthetics;
• anti-inflammatory medicines (corticosteroids, such as prednisolone, mometasone, beclometasone);
• medicines that can change the amount of Metformina EG STADA in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimetoprim, vandetanib, isavuconazole, crizotinib, olaparib);
• other medicines used to treat diabetes.

Metformina EG STADA with alcohol
Avoid excessive alcohol consumption during treatment 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, suspect you may be pregnant or are planning to become pregnant, tell your doctor so
that they can change your treatment or monitor your blood glucose levels.
You should not take this medicine if you are breastfeeding or intend to breastfeed.

Driving and using machines
Metformina EG STADA itself does not cause hypoglycaemia (a level of glucose in the blood that is too low).
Therefore, this medicine should not affect your ability to drive or operate
machinery.
However, be particularly careful if you are taking Metformina EG STADA with other medicines used to
treat diabetes that can cause hypoglycaemia (e.g. sulfonylureas, insulin, meglitinides). Symptoms
of hypoglycaemia include weakness, dizziness, increased sweating, rapid heartbeat,
visual disturbances or difficulty concentrating. If you notice 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 following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.

Recommended dose
Normally, treatment is started 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 sugar and
adjust the dose.
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 medicine.
Your doctor will perform regular blood sugar tests and adjust the dose of Metformina EG STADA to blood
glucose levels. Consult your doctor regularly. This is especially important if you are an elderly person.

Method of administration
The tablets are for oral use.
Normally you should take the tablets once a day, with the evening meal. Swallow the tablets whole
with a glass of water, do not chew or crush them.
The tablets are made in such a way that there is a prolonged release of the medicine during intake.
The medicine is thus released slowly into the body and it is therefore necessary to take the tablets only
once a day.
In some cases, your doctor may recommend taking the tablets twice a day.

If you take more Metformina EG STADA than you should
If you take more tablets than you should, lactic acidosis may occur. The symptoms of lactic acidosis are
non-specific, such as vomiting, stomach pain (abdominal pain), muscle cramps, general feeling of
illness with severe fatigue and difficulty breathing. Other symptoms are reduced body temperature and
slower heartbeat.

If you experience any of these symptoms, stop taking Metformina EG
STADA immediately and seek immediate medical attention 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 with food. Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

The following side effects may occur:
Metformina EG STADA may cause a very rare (may affect up to 1 in

• 10,000) but very serious effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Metformina EG STADA and seek immediate medical attentionor go to the nearest hospital,because lactic acidosis can lead to coma. The symptoms of lactic acidosis include:
• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• a general feeling of unwellness associated with severe fatigue
• difficulty breathing
• reduced body temperature and slower heartbeat

Very rarely (up to 1 in 10,000) Metformina EG STADA may cause changes in liver function tests and hepatitis (inflammation of the liver, 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 by frequency as follows:
Very common(may affect more than 1 in 10 people)

• digestive problems, such as feeling unwell (nausea), discomfort (vomiting), diarrhoea, stomach pain (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 occur mostly at the beginning of treatment with Metformina EG STADA. It is helpful to take Metformina EG STADA with a meal. If thesymptoms persist, stop taking Metformina EG STADA and see your doctor.Common(may affect up to 1 in 10 people)
• Changes in taste
• Decreased levels of vitamin B in the blood: symptoms may include extreme fatigue, sore and red tongue (glossitis), tingling (paresthesia) or pale or yellowish skin. Your doctor may prescribe some tests to find out the cause of the symptoms because some of these may also be caused by diabetes or other health problems not related to this medication.

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through 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 EG STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging and on the blister pack after the
wording “Exp.” The expiry date refers to the last day of that month.
Store at a temperature below 25°C.
Do not dispose of any medicine in 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 corresponding 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 corresponding 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 corresponding to 779.876
mg of metformin base.

Other ingredients:
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 package contents
Description
Metformina EG STADA 500 mg prolonged-release tablets: Tablets from white to almost white,
round, biconvex, with "500" imprinted on one side and smooth on the other side. 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.
Package contents
The tablets are available in blisters [rigid PVC film, coated with 90 gsm pharmaceutical grade PVdC (transparent) and aluminum foil] of 30, 60 and 100 tablets.
Not all pack sizes may be marketed.
The tablets are available in blisters [rigid PVC film, coated with 90 gsm pharmaceutical grade PVdC (transparent) and aluminum foil] of 30, 60 and 100 tablets.
Not all pack sizes may be marketed.
The tablets are available in blisters [rigid PVC film, coated with 90 gsm pharmaceutical grade PVdC (clear) and aluminum foil] of 30 and 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., via Pavia 6, 20136 Milan

Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel, Germany

This medicinal product is authorised in the Member States of the European Economic Area (EEA) with the
following denominations:
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