Metformin EG

Package leaflet: Information for the user

Metformin EG 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Insulin is a hormone produced by the pancreas that enables the human body to absorb glucose (sugar) from the blood. The 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 properly use the insulin it produces. This leads to high levels of glucose in the blood. Metformina EG helps lower blood glucose levels to as near normal as possible. If you are an overweight adult, taking Metformina EG over a long period of time also helps reduce the risk of diabetes-related complications.

What Metformina EG is used for
Metformina EG is used in the treatment of 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 EG alone or in combination with other antidiabetic medicines (oral medications or insulin).
Children from the age of 10 years and adolescents may take Metformina EG alone or in combination with insulin.

2. What you need to know before taking Metformina EG

DO NOT take Metformina EG

• if you are allergic to metformin or to any of the other ingredients of this medicine (listed in section 6);
• if you have severely reduced kidney function;
• if you have liver problems;
• 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 if you have vomited repeatedly. Dehydration may lead to kidney problems, which could put you at risk of lactic acidosis (see “Warnings and precautions” below);
• if you have a severe infection, such as one affecting your lungs, bronchi, or kidneys. Severe infections may lead to kidney problems, which could put you at risk of lactic acidosis (see “Warnings and precautions” below);
• if you are being treated for heart failure, have recently had a heart attack, or suffer from severe circulatory or respiratory problems. These conditions may lead to inadequate oxygen supply to tissues, which could put you at risk of lactic acidosis (see “Warnings and precautions” below);
• if you consume large amounts of alcohol.

If any of the above conditions apply to you, consult your doctor before starting to
take this medicine.
Make sure to seek medical advice if

• you are scheduled for tests such as X-rays or scans involving injection of iodinated contrast agents into your bloodstream;
• you are scheduled for surgery.

You must stop taking Metformina EG for a certain period of time before and after the test or
surgery. Your doctor will determine whether you need alternative treatment during this time. It is important that you strictly follow your doctor’s instructions.

Warnings and precautions
Talk to your doctor or pharmacist before taking Metformina EG.

Risk of lactic acidosis
Metformina EG may cause a very rare but very 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 problems, or any other medical condition characterized by reduced oxygen supply to part of the body (such as severe heart disease).
If you have any of the above-mentioned medical conditions, consult your doctor for further instructions.

Stop taking Metformina EG temporarily if you develop 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 EG immediately and contact your doctor or go to the nearest hospital, as lactic acidosis may 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
• low body temperature and slow heart rate

Lactic acidosis is a medical emergency and must be treated in hospital.
If you are undergoing major surgery, you must stop taking Metformina EG during the procedure and for a certain period afterwards. Your doctor will decide when to stop and when to restart treatment with Metformina EG.
During treatment with Metformina EG, 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.

Metformina EG alone does not cause hypoglycaemia (low blood glucose levels). However, if you take Metformina EG together with other antidiabetic medicines that may cause hypoglycaemia (such as sulphonylureas, insulin, glinides), 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.

Other medicines and Metformina EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are scheduled to receive an injection of an iodinated contrast agent into your bloodstream, for example for an X-ray, you must stop taking Metformina EG before or during the injection.
Your doctor will decide when to stop and when to restart treatment with Metformina EG.
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 monitored more frequently, or your doctor may decide to adjust your dose of Metformina EG. It is particularly important to mention the following:

• 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 increase urine production (diuretics);
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib);
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).

Metformina EG with food, drinks, and alcohol
Avoid excessive alcohol consumption during treatment with Metformina EG, 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. If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor may change your treatment.
Metformina EG is not recommended during breastfeeding or if you are planning to breastfeed your baby.

Driving and using machines
Metformina EG alone does not cause hypoglycaemia (low blood glucose levels). This means it does not affect your ability to drive or operate machinery.
However, be especially cautious if you are taking Metformina EG together with other antidiabetic medicines that may cause hypoglycaemia (such as sulphonylureas, insulin, glinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances, or difficulty concentrating. Do not drive or operate machinery if these symptoms occur.

3. How to take Metformina EG

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

Usual dose
Children from 10 years of age and adolescents usually start with 500 mg or 850 mg of metformin hydrochloride once daily. The maximum daily dose is 2000 mg, taken in 2 or 3 separate doses. Treatment of children aged between 10 and 12 years is recommended only under specific medical guidance, as experience in this age group is limited.
Adults generally start with 500 mg or 850 mg of metformin hydrochloride 2 or 3 times daily. The maximum daily dose is 3000 mg, taken in 3 separate 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 the appropriate starting dose of Metformina EG.

Monitoring

• Your doctor will adjust your dose of Metformina EG according to your blood glucose levels. Regularly consult your doctor. 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. More frequent monitoring may be needed if you are elderly or if your kidneys do not function normally.

How to take Metformina EG
Take the tablets during or after meals. This will help you avoid gastrointestinal side effects.

Method of administration
Thanks to the snap-tab design, Metformina EG tablets can be divided either by hand or by placing the tablet with the smaller break line downwards on a hard, flat surface and simultaneously applying pressure with both thumbs on the right and left sides of the break line.
Do not crush or chew the tablet. Swallow each tablet whole 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 EG is too strong or too weak, consult your doctor or pharmacist.

If you take more Metformina EG than you should
If you have taken more Metformina EG than prescribed, lactic acidosis may occur. Symptoms of lactic acidosis include vomiting, stomach pain (abdominal pain) associated with muscle cramps, a general feeling of being unwell with severe tiredness, and difficulty breathing. Seek immediate medical advice from your doctor or pharmacist.

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

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 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 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) associated with muscle cramps, a general feeling of being unwell with severe tiredness, and difficulty breathing.

Very common side effects (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. These side effects mostly occur at the beginning of treatment with Metformina EG. Spreading the daily dose throughout the day and taking the tablets during or immediately after meals may help reduce these effects. If symptoms persist, stop taking Metformina EG and consult your doctor.

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

• Altered sense of taste.

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

• Skin rashes such as redness of the skin (erythema), itching, or itchy rash (urticaria);
• Decreased levels of vitamin B in the blood;
• Abnormalities in liver function tests or hepatitis (inflammation of the liver which may cause tiredness, loss of appetite, weight loss, with or without yellowing of the skin and whites of the eyes). If any of these occur to you, stop taking this medicine.

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 ones 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 EG

Keep this medicine out of the sight and reach of children. If a child is being treated with
Metformina EG, it is advisable for parents and caregivers to supervise how this medicine is used.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack, bottle, or blister after the words “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 you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Metformina EG Contains
The active substance is metformin hydrochloride. One 1000 mg film-coated tablet of Metformina EG contains 780 mg of metformin as metformin hydrochloride 1000 mg.
The other components are hypromellose, macrogol 6000, magnesium stearate, povidone K25, titanium dioxide (E171).

Description of the Appearance of Metformina EG and Contents of the Pack
The 1000 mg film-coated tablets of Metformina EG are white, elongated tablets with score lines on both sides (snab-tab shape).
Metformina EG is available in packs containing 15, 20, 30, 50, 60, 90, 100, 118, 120, 150, 180, 200 or 600 film-coated tablets in blister packs (PVC-aluminum or PVC/PVDC-aluminum).
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy

Manufacturer
Stada Arzneimittel AG, Stadastrasse, 2-18 - 61118 Bad Vilbel (Germany)
DOPPEL Farmaceutici S.r.l., Via Volturno, 48 - 20089 Quinto De Stampi - Rozzano - MI (Italy)
COSMO S.p.A., Via C. Colombo, 1- 20020 Lainate - MI (Italy)

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
DE Metformin STADA 1000 mg Filmtabletten
AT: Metformin Stada 1000 mg - Filmtabletten
CZ Stadamet 1000
DK: Metformin Stada
FI Metformin STADA 1000 mg tabletti, kalvopäällysteinen
HU Stadamet 1000 mg filmtabletta
IT Metformina EG 1000 mg compresse rivestite con film
NL Metformine HCI CF 1000 mg filmomhulde tabletten
SE Metformin Stada 1000 mg, filmdragerad tablett
SK Stadamet