METFORMIN TEVA ITALIA

Package leaflet: Information for the patient

Metformina Teva Italia 1000 mg film-coated tablets

metformin hydrochloride
Equivalent medicinal product
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 adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Metformina Teva Italia is and what it is used for

Metformina Teva Italia contains metformin hydrochloride, a substance belonging to a group of
medicines called biguanides, which reduce excess sugar (glucose) in the blood and are used in the
treatment of diabetes.
This medicine is used in adult patients, particularly those who are overweight, who have a type of
diabetes known as type 2 diabetes mellitus, when diet and physical exercise are not sufficient to
maintain blood glucose levels under control.
In overweight adult patients, taking metformin hydrochloride as first-line therapy after failure of diet
reduces the risk of complications associated with diabetes.
Metformina Teva Italia may be prescribed by your doctor alone or in combination with other medicines
for the treatment of diabetes (oral antidiabetics or insulin).
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Metformina Teva Italia

Do not take Metformina Teva Italia

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• 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 your liver function is impaired (hepatic insufficiency);
• if you have severely reduced kidney function;
• if you are in a condition that may alter your kidney function such as excessive fluid loss (dehydration), a severe ongoing infection, serious circulatory problems (shock), or if you need to undergo a diagnostic examination involving administration of an iodine-containing contrast agent;
• if you suffer or have suffered from diseases that may cause poor oxygen supply to tissues (tissue hypoxia), such as impaired heart function (heart failure, myocardial infarction), serious circulatory problems (shock) or respiratory failure;
• if you are in a state of intoxication (acute alcohol intoxication);
• if you chronically and excessively consume alcohol (alcoholism).

Warnings and precautions
Talk to your doctor or pharmacist before taking Metformina Teva Italia.
If you are being treated with Metformina Teva Italia, you should:

• follow a balanced diet and spread carbohydrate intake throughout the day; in particular, if you are overweight, you should follow a low-calorie (hypocaloric) diet;
• regularly perform tests to monitor your blood glucose levels;
• monitor blood vitamin B12 levels if you suspect vitamin B12 deficiency (such as anaemia or neuropathy);
• be cautious if you are taking other antidiabetic medicines (insulin or sulphonylureas), as their combination with this medicine may cause hypoglycaemia (low blood sugar levels).

Risk of lactic acidosis
Metformina Teva Italia 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 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.
Contact your doctor immediately for further instructions if:

• you know you have a hereditary genetic disease affecting mitochondria (the components producing energy within cells), such as MELAS syndrome (Mitochondrial Encephalopathy, myopathy, Lactic Acidosis and Stroke-like episodes, mitochondrial encephalomyopathy with lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD, Maternal Inherited Diabetes and Deafness);
• 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 and deafness.

Temporarily stop taking Metformina Teva Italia 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 Teva Italia and
contact your doctor or nearest hospital immediately, 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;
• reduced body temperature and slower heart rate.

The incidence of lactic acidosis can be reduced by:

• avoiding prolonged fasting and carefully monitoring your blood glucose levels, thereby preventing the onset of ketosis (production of fatty acids due to excessively low glucose levels);
• monitoring your clinical condition; in particular, your doctor should pay special attention to any condition that may impair liver function (hepatic insufficiency) or cause poor oxygen supply to your tissues.

Lactic acidosis is a medical emergency and must be treated in hospital.
Renal function
Metformin hydrochloride is eliminated from your body via the kidneys; therefore, your doctor will prescribe specific blood tests (creatinine clearance) to check whether your kidneys are functioning normally. During treatment with Metformina Teva Italia, 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. Additionally, you should be particularly cautious and consult your doctor if you are taking or are about to start treatment with medicines that may affect your kidney function, such as antihypertensive drugs (blood pressure-lowering medicines), diuretics (medicines that increase urine elimination) or non-steroidal anti-inflammatory drugs (NSAIDs).
Radiological examination
If you need to undergo a diagnostic examination involving administration of an iodine-containing contrast agent, inform your doctor that you are taking metformin hydrochloride, as your kidney function is more likely to be impaired (risk of renal failure), leading to excessive accumulation of metformin hydrochloride in your body and possible development of lactic acidosis.
Your doctor will instruct you to stop treatment before or at the time of the examination and will allow you to restart treatment no sooner than 48 hours after the examination, and only after confirming normal kidney function.
Surgery
Inform your doctor if you are taking Metformina Teva Italia and are scheduled for surgery requiring anaesthesia (general, spinal or epidural). If you are undergoing major surgery, you must stop taking Metformina Teva Italia during the procedure and for a certain period afterwards. Your doctor will decide when to stop and when to restart treatment with Metformina Teva Italia.
Other medicines and Metformina Teva Italia
If you are scheduled to receive an injection of an iodinated contrast agent into the bloodstream, for example for an X-ray, you must stop taking Metformina Teva Italia before or during the injection. Your doctor will decide when to stop and when to restart treatment with Metformina Teva Italia.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. You may need to have more frequent blood glucose and kidney function tests, or your doctor may decide to adjust the dose of Metformina Teva Italia. It is particularly important to mention the following:

• systemically or locally administered glucocorticoid medicines (used, for example, as anti-inflammatory agents or in asthma treatment) and sympathomimetic medicines (with various therapeutic applications): these medicines may increase your blood glucose levels (intrinsic hyperglycaemic effect), so you should monitor your blood glucose levels more frequently, especially at the beginning of treatment. Moreover, if necessary, your doctor will need to adjust the dose of Metformina Teva Italia you are taking during treatment with the other medicine and after stopping it;

• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists): these medicines may reduce blood glucose levels. Therefore, if necessary, your doctor will need to adjust the dose of Metformina Teva Italia you are taking during treatment with the other medicine and after stopping it;

• medicines that increase urine production (diuretics): these medicines may increase the risk of lactic acidosis;

• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib);

• medicines that may alter the amount of medicine in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Metformina Teva Italia and alcohol
Avoid excessive alcohol consumption during treatment with Metformina Teva Italia, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Uncontrolled diabetes during pregnancy or before conception may cause congenital malformations, pregnancy loss, pregnancy-induced hypertension, pre-eclampsia (excessive increase in blood pressure accompanied by excess protein in the urine) and perinatal mortality (stillbirth or death within the first week of life).
If strictly necessary, to reduce risks associated with excessively high blood glucose levels, the use of metformin may be considered during pregnancy or before conception, either in addition to or instead of insulin.
Breastfeeding
It is recommended not to use Metformina Teva Italia during breastfeeding, as metformin hydrochloride passes into breast milk.
Driving and using machines
Metformina Teva Italia does not impair the ability to drive vehicles or operate machinery.
However, you should be cautious if you take Metformina Teva Italia together with other antidiabetic medicines (sulphonylureas, insulin, meglitinides), as an excessive reduction in your blood glucose levels (hypoglycaemia) may cause symptoms that interfere with your ability to drive or operate machinery.

3. How to take Metformina Teva Italia

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.
Metformina Teva Italia alone or in combination with other oral antidiabetic medicines
The recommended starting dose is one 500 mg or 850 mg tablet, taken 2 or 3 times a day (metformine hydrochloride tablets of 500 mg and 850 mg are available on the market).
After 10–15 days of treatment, your doctor will adjust the dose based on your blood glucose levels.
If you have reduced kidney function, your doctor may prescribe you a lower dose.
The maximum recommended dose is 3 g per day (in 3 divided doses).
If you are a patient taking a high dose of metformin (from 2 to 3 g per day), it is recommended to take one 1000 mg tablet instead of two 500 mg tablets.
The tablets should be taken during or immediately after meals. This helps prevent possible stomach or intestinal disturbances such as nausea, vomiting, etc. (see section “Possible side effects”).
Metformina Teva Italia with insulin
The recommended starting dose of metformine hydrochloride is 500 mg or 850 mg, 2 or 3 times a day, while the insulin dose will be adjusted accordingly based on blood glucose levels.
Use in the elderly
If you are elderly, your doctor will evaluate the most appropriate dose for you, particularly based on your kidney condition, and will regularly monitor their proper function.
Use in children
The use of metformine hydrochloride is not recommended in children.
If you take more Metformina Teva Italia than you should
Inform your doctor or go to the nearest hospital if you have taken an excessive amount of this medicine.
Taking very high doses of this medicine may lead to lactic acidosis.
If you forget to take Metformina Teva Italia
Do not take a double dose to make up for the forgotten dose.
If you stop taking Metformina Teva Italia
Ask your doctor for advice if you intend to stop treatment.
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.
Metformina Teva Italia 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 Teva Italia and must immediately contact your doctor or go to the nearest hospital, because lactic acidosis can lead to coma.

Very common (may affect more than 1 in 10 people)

• nausea and vomiting;
• diarrhoea;
• abdominal pain;
• loss of appetite.
  These effects occur most frequently at the beginning of treatment and in most cases resolve spontaneously. To help prevent these side effects, it is recommended to take the tablets during or immediately after meals.

Common (may affect up to 1 in 10 people)

• altered taste;
• reduced absorption of Vitamin B12.

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

• erythema, itching and urticaria;
• decreased blood pH value due to increased acid levels (lactic acidosis);
• altered results of liver function laboratory tests;
• inflammation of the liver.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following 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 Metformina Teva Italia

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Metformina Teva Italia contains

• The active substance is metformin hydrochloride. One film-coated tablet contains 1000 mg of metformin hydrochloride, equivalent to 780 mg of metformin base.
• The other components are:
  • within the tablet: povidone, anhydrous colloidal silica and magnesium stearate;
  • in the tablet coating: hypromellose, titanium dioxide and macrogols.

Description of the appearance of Metformina Teva Italia and contents of the pack
Film-coated tablets, white or almost white, oval-shaped, with a score line on both sides.
"9" is engraved on the left side and "3" on the right side on one face; "72" is engraved on the left side and "14" on the right side on the other face.
Metformina Teva Italia is supplied in a box containing a blister pack of 60 tablets.
Marketing Authorization Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy
Manufacturer
Pharmachemie B.V. - Swensweg 5, Postbus 552, 2003 RN Haarlem (The Netherlands)
Teva Pharmaceutical Works Private Limited Company - Pallagi út 13 - 4042 Debrecen (Hungary)