Metformin Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

METFORMINA DOC Generici 500 mg/850 mg/1000 mg film-coated tablets

Equivalent 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 other people, even if their symptoms are the same as yours, because it could 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:

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

1. What METFORMINA DOC Generici is and what it is used for

METFORMINA DOC Generici contains metformin, a medicine used to treat
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 properly use the insulin it produces. This leads to high levels of
glucose in the blood. METFORMINA DOC Generici helps lower your blood glucose levels to
as close to normal as possible.
If you are overweight, taking METFORMINA DOC Generici over a long period of time may also
help reduce the risk of diabetes-related complications.
METFORMINA DOC Generici is associated with stable body weight or modest weight loss.

What METFORMINA DOC Generici is used for
METFORMINA DOC Generici 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 glucose levels in your blood. It is used particularly in overweight patients.
Adults may take METFORMINA DOC Generici alone or in combination with other antidiabetic
medicines (oral medications or insulin).
Children from 10 years of age and adolescents may take METFORMINA DOC Generici alone or
in combination with insulin.

2. What you need to know before taking METFORMINA DOC Generici

Do not take METFORMINA DOC Generici

• 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 unusually fruity odour.
• If you have lost too much fluid from your body (dehydration), such as after prolonged or severe diarrhoea, or repeated vomiting. Dehydration may lead to kidney problems, which could put you at risk of lactic acidosis (see “Warnings and precautions”).
• If you have a severe infection, such as infections of the lungs, bronchi, or kidneys. Severe infections may lead to kidney failure, which could put you at risk of lactic acidosis (see “Warnings and precautions”).
• If you are being treated for heart failure or have recently had a myocardial infarction, or if you have severe circulation problems (such as shock) or breathing difficulties. These conditions may lead to inadequate oxygen supply to tissues, which could put you at risk of lactic acidosis (see “Warnings and precautions”).
• If you consume large amounts of alcohol.

If you have any of the conditions listed above, consult your doctor before starting to take this medicine.
Pay attention to the following specific risk of lactic acidosis: Be sure to seek medical advice

• If you are scheduled for a diagnostic test such as X-rays or scanning that requires injection of an iodine-containing contrast agent into your bloodstream.
• If you are scheduled for surgery.

Stop taking METFORMINA DOC Generici for a certain period of time before and after the diagnostic test or surgical procedure. Your doctor will decide whether you need alternative treatment during this time. It is important that you follow your doctor’s instructions exactly.

Warnings and precautions
Talk to your doctor or pharmacist before taking METFORMINA DOC Generici.

Risk of lactic acidosis
METFORMINA DOC Generici 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 medical conditions described above, consult your doctor for further instructions.
METFORMINA DOC Generici alone does not cause hypoglycaemia (low blood glucose levels). However, if you take METFORMINA DOC Generici together with other diabetes medicines that can cause hypoglycaemia (such as sulfonylureas, 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.

Stop taking METFORMINA DOC Generici for a short period 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 fluid than normal. Consult your doctor for further instructions.

If you develop any of the symptoms of lactic acidosis, stop taking METFORMINA DOC Generici and contact your doctor or the nearest hospital immediately, because 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
• lowered body temperature and slower heartbeat

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

Other medicines and METFORMINA DOC Generici
If you are scheduled to receive an injection of iodinated contrast medium into your bloodstream, for example for an X-ray, you must stop taking METFORMINA DOC Generici before or during the injection. Your doctor will decide when to stop and when to restart treatment with METFORMINA DOC Generici.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You may need to have more frequent blood glucose and kidney function tests, or your doctor may decide to adjust the dose of METFORMINA DOC Generici. 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)
• certain medicines for treating 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)
• Other medicines used to treat diabetes

METFORMINA DOC Generici with food, drinks and alcohol
Avoid excessive alcohol consumption during treatment with METFORMINA DOC Generici, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy, insulin is required for the treatment of diabetes. Inform your doctor if you are, or think you may be, pregnant, or if you are planning a pregnancy, so that your treatment can be changed. Do not take this medicine while breastfeeding or if you are planning to breastfeed your baby.

Driving and using machines
METFORMINA DOC Generici alone does not cause hypoglycaemia (low blood glucose levels). This means it does not affect your ability to drive or operate machinery.
However, exercise particular caution if you are taking METFORMINA DOC Generici together with other diabetes medicines that can cause hypoglycaemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, tachycardia, visual disturbances, or difficulty concentrating. Do not drive or operate machinery if these symptoms occur.

3. How to take METFORMINA DOC Generici

Take this medicine exactly as instructed by your doctor. If you have any
doubts, consult your doctor or pharmacist.
METFORMINA DOC Generici cannot replace the benefits of a healthy lifestyle. Continue to
follow all dietary advice provided by your doctor and maintain regular physical activity.
The recommended dose is:
Children from 10 years of age and adolescents usually start with 500 mg or 850 mg of
METFORMINA DOC Generici once daily. The maximum daily dose is 2000 mg, taken in 2 or 3 divided doses. Treatment of children aged 10 to 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 METFORMINA DOC Generici 2 or 3 times daily. The maximum daily dose is 3000 mg, taken in 3 divided doses.
If you are also taking insulin, your doctor will advise you on how to start METFORMINA DOC Generici.

Monitoring

• Your doctor will carry out regular blood glucose tests and adjust your dose of METFORMINA DOC Generici according to your blood glucose levels. Make sure you 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.

How to take METFORMINA DOC Generici
Take the tablets during or after meals. This will help you avoid unwanted digestive 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). If, after some time, you feel that the effect of METFORMINA DOC Generici is too strong or too weak, consult your doctor or pharmacist.

If you take more METFORMINA DOC Generici than you should
If you have taken more METFORMINA DOC Generici than you should, lactic acidosis may occur.
Symptoms of lactic acidosis include vomiting, stomach ache (abdominal pain) with muscle cramps, a general feeling of discomfort with severe tiredness, and difficulty breathing.
If this happens, you may need immediate hospital treatment, as lactic acidosis can lead to coma. Contact your doctor or pharmacist immediately.

If you forget to take METFORMINA DOC Generici
Do not take a double dose to make up for a forgotten dose. Take the next dose at your usual time.
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.
The following side effects may occur:
METFORMINA DOC Generici 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 DOC Generici and contact your doctor or go immediately to the nearest hospital, because lactic acidosis can lead to coma.
Very common (may affect more than 1 in 10 people)

• Gastrointestinal 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 DOC Generici. It may help to spread the doses throughout the day and to take the tablets during or after a meal. If symptoms persist, stop taking METFORMINA DOC Generici and consult your doctor.
  Common side effects (may affect up to 1 in 10 people)
• Altered taste.
  Rare side effects (may affect up to 1 in 10,000 people)
• Lactic acidosis. This is a very rare but serious complication, especially if your kidneys are not functioning properly. 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.
• Skin reactions such as redness of the skin (erythema), itching, or skin rash (urticaria).
• Low levels of vitamin B12 in the blood.
• Changes in liver function tests or hepatitis (inflammation of the liver; this may cause tiredness, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this happens 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 experience any side effects, 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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store METFORMINA DOC Generici

Keep this medicine out of the sight and reach of children.
If a child is being treated with METFORMINA DOC Generici, parents and caregivers must supervise the use of this medicine.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the label, carton or blister after “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 no longer required. This will help protect the environment.

6. Package contents and other information

What METFORMINA DOC Generici 500 mg/850 mg/1000 mg contains
The active substance is metformin; it is present in the form of metformin hydrochloride.
METFORMINA DOC Generici 500 mg:
Each film-coated tablet contains 500 mg of metformin hydrochloride, equivalent to
390 mg of metformin.
METFORMINA DOC Generici 850 mg:
Each film-coated tablet contains 850 mg of metformin hydrochloride, equivalent to
663 mg of metformin.
METFORMINA DOC Generici 1000 mg:
Each film-coated tablet contains 1000 mg of metformin hydrochloride, equivalent to
780 mg of metformin.
Other components are:
Tablet core: povidone, magnesium stearate.
Coating: hypromellose, macrogol.

Description of the appearance of METFORMINA DOC Generici 500 mg/850 mg/1000 mg and
packaging contents
Film-coated tablets.
METFORMINA DOC Generici 500 mg:
White, round, biconvex film-coated tablets, 11 mm in diameter, with an "A" engraved on one side and "60" on the other.
METFORMINA DOC Generici 850 mg:
White, round, biconvex film-coated tablets, 12.70 mm in diameter, with an "A" engraved on one side and "61" on the other.
METFORMINA DOC Generici 1000 mg:
White, capsule-shaped, biconvex film-coated tablets, with a score line on both sides. Size: 20.5 x 8.6 mm. The tablet can be divided into equal parts.

METFORMINA DOC Generici 500 mg/850 mg/1000 mg is packaged in blisters (PVC/PvDC/Al transparent) or (PVC/Al transparent), or in opaque white HDPE bottles with polypropylene closure.
METFORMINA DOC Generici 500 mg/850 mg:
Each package contains
20/28/30/40/42/50/56/60/70/80/84/90/98/100/120/180/200/300/400 film-coated tablets, in blisters containing 10 or 14 film-coated tablets each, or in opaque white HDPE bottles containing 90, 100, 400 or 500 film-coated tablets.
METFORMINA DOC Generici 1000 mg:
Each package contains 20/30/40/50/60/70/80/90/100/120/180 film-coated tablets in blisters, each blister containing 10 film-coated tablets, or in opaque white HDPE bottles containing 60, 90, 100 or 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 - Milan
Italy

Manufacturer
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
or
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
or
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
or
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
14th National Road 1
GR-14564, Kifisia, Athens
Greece

This medicinal product is authorized in the European Economic Area countries under the
following names:
Austria Diabetormin 850 mg / 1000 mg-Filmtabletten
Denmark Metformin “Aurobindo”
Estonia Metformin Aurobindo
Finland Metformin Aurobindo 500 mg/ 850 mg/ 1000 mg tabletti, kalvopäällysteinen
France METFORMINE ARROW LAB 500 mg/ 850 mg comprimés pelliculés
METFORMINE ARROW LAB 1000 mg, comprimé pelliculé sécable
Germany Metformin Aurobindo 500 mg/ 850 mg/ 1000 mg Filmtabletten
Greece GLYCOFREN 850 mg/1000 mg επικαλυμμένο με λεπτό υμένιο δισκία
Ireland Metformin Aurobindo 500 mg/ 850 mg/ 1000 mg film-coated tablets
Italy METFORMINA DOC Generici 500 mg/850 mg/ 1000 mg compresse rivestite con film
Latvia Metformin Aurobindo 500 mg/ 850 mg/ 1000 mg, apvalkotās tabletes
Netherlands Metformine HCl Aurobindo 500 mg/ 850 mg/ 1000 mg, filmomhulde tabletten
Poland Metformin Aurobindo
Portugal Metformina Aurobindo
Romania Metformin Aurobindo 500 mg/ 850 mg/ 1000 mg comprimate filmate
Spain Metformina ratiopharm 850 mg comprimidos recubiertos con película
Sweden Metformin Aurobindo
United Kingdom Metformin hydrochloride 500 mg/ 850 mg film-coated tablets