Metformin Sandoz

Package leaflet: Information for the patient

Metformina Sandoz 500 mg prolonged-release tablets, 750 mg prolonged-release tablets, 1000 mg prolonged-release 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Metformina Sandoz prolonged-release tablets contain the active substance metformin hydrochloride and belong to a group of medicines called biguanides, used in the treatment of type 2 diabetes mellitus (non-insulin-dependent diabetes).
Metformina Sandoz is used to treat type 2 diabetes in adults when diet and exercise alone have not been sufficient to control blood glucose (sugar) levels, particularly in overweight patients.
Metformina Sandoz may be used alone or in combination with other antidiabetic medicines (oral medications or insulin).
Insulin is a hormone that enables the body's tissues to take up glucose from the blood and use it to produce energy or store it for later use. People with type 2 diabetes either do not produce enough insulin in the pancreas or their body does not respond properly to insulin. This leads to an accumulation of glucose in the blood, which over time may cause a range of serious complications. Therefore, it is important to continue taking Metformina Sandoz even if you do not have any obvious symptoms.
Metformina Sandoz makes the body more sensitive to insulin and helps normalize the way the body uses glucose.
Metformina Sandoz is associated with stable body weight or a modest weight loss.
In overweight adults, long-term use of Metformina Sandoz also reduces the risk of diabetes-related complications.
Metformina Sandoz prolonged-release tablets are specially formulated to release the active substance slowly into the body and are therefore different from other types of tablets containing metformin.

2. What you need to know before taking Metformina Sandoz

Do not take Metformina Sandoz if:

• you are allergic to metformin or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include a skin 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 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
• you have lost excessive amounts of body water (dehydration), for example due to prolonged or severe diarrhoea or repeated vomiting. Dehydration may lead to kidney problems, which can increase the risk of lactic acidosis (see “Warnings and precautions” below)
• you have a severe infection, such as a lung or bronchial infection or a kidney infection. Severe infections may cause kidney problems, which can increase the risk of lactic acidosis (see “Warnings and precautions” below)
• you are being treated for acute heart problems or have recently had a heart attack, severe circulatory disorders (e.g. shock), or breathing difficulties. These conditions may cause reduced oxygen supply to tissues, which in turn may increase the risk of lactic acidosis (see “Warnings and precautions” below)
• you consume large amounts of alcohol
• you are under 18 years of age

If any of these conditions apply to you, consult your doctor before taking this medicine.
Make sure to consult your doctor if:

• you need to undergo a radiological examination or test requiring injection of an iodine-containing contrast medium into the bloodstream
• you need to undergo major surgery
  Metformina Sandoz must be temporarily discontinued before and after such an examination or surgery. Your doctor will decide whether you need alternative treatment during this period. It is essential to follow your doctor’s instructions carefully.

Warnings and precautions
Talk to your doctor or pharmacist before taking Metformina Sandoz.
Risk of lactic acidosis
Metformina Sandoz 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, and any other medical condition characterized by reduced oxygen supply to part of the body (such as severe acute heart disease).
If you have any of the medical conditions listed above, contact your doctor for further instructions.
Temporarily stop taking Metformina Sandoz 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.
Stop taking Metformina Sandoz and contact your doctor or the nearest hospital immediately if you experience any of the symptoms of lactic acidosis, 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 slower 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 Sandoz during and for a certain period after the procedure. Your doctor will decide when to stop and when to restart treatment with Metformina Sandoz.
During treatment with Metformina Sandoz, 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 Sandoz by itself does not cause hypoglycaemia (low blood glucose levels). However, if you take Metformina Sandoz together with other antidiabetic medicines that may 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, rapid heartbeat, blurred vision, or difficulty concentrating, eating or drinking something containing sugar usually helps.
It is possible that parts of the tablet may appear in the stool. Do not be concerned: this is normal for this type of tablet.
Continue to follow any dietary advice given by your doctor; consume carbohydrates regularly throughout the day.
Do not stop taking this medicine without consulting your doctor.
Other medicines and Metformina Sandoz
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 iodinated contrast medium into the bloodstream, for example for an X-ray or scan, you must temporarily stop taking Metformina Sandoz before and during the injection. Your doctor will decide when to stop and when to restart treatment with Metformina Sandoz.
You may need to have more frequent blood glucose and kidney function tests, or your doctor may decide to adjust your dose of Metformina Sandoz. It is particularly important to mention the following:

• medicines that increase urine production (diuretics 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)
• beta-2 adrenergic receptor agonists, such as salbutamol or terbutaline (used to treat asthma)
• steroids (prednisolone, mometasone, beclometasone) used to treat various conditions such as severe dermatitis or asthma
• sympathomimetic medicines including epinephrine and dopamine, used to treat heart attacks and low blood pressure. Epinephrine is also used in some dental anaesthetics
• medicines that may alter the amount of Metformina Sandoz in the blood, especially if kidney function is reduced (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib)
• other medicines used to treat diabetes

Metformina Sandoz and alcohol
Avoid excessive alcohol consumption during treatment with Metformina Sandoz, 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, or are planning to become pregnant, talk to your doctor about whether changes to your treatment or monitoring of blood sugar levels are needed.
This medicine is not recommended if you are breastfeeding or planning to breastfeed your baby.
Driving and using machines
Metformina Sandoz taken alone does not cause hypoglycaemia (symptoms of low blood sugar such as weakness, confusion, and increased sweating) and therefore should not affect your ability to drive or use machines.
However, you should exercise particular caution if Metformina Sandoz is used together with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, tachycardia, blurred vision, or difficulty concentrating.
If you begin to experience these symptoms, do not drive or operate machinery.

3. How to take Metformina Sandoz

Take this medicine exactly as directed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Your doctor may prescribe Metformina Sandoz alone or in combination with other
oral antidiabetic medicines or insulin.
Metformina Sandoz does not replace the benefits of a healthy lifestyle. Follow all
your doctor's advice regarding diet and regular physical activity.
Recommended dose
Treatment of diabetes with metformin alone or in combination with other medicines
Adults: You will usually start treatment with 500 mg of Metformina Sandoz once daily with
the evening meal. After approximately 2 weeks of treatment with Metformina Sandoz, your doctor will assess your blood sugar levels and, if necessary, adjust the dose.
The maximum daily dose is 2000 mg of Metformina Sandoz.
For patients already treated with metformin, the initial dose of Metformina Sandoz should be
equivalent to the daily dose of immediate-release metformin tablets.
If you have reduced kidney function, your doctor may prescribe you a lower dose.
Switching from antidiabetic treatment to Metformina Sandoz is not recommended in
patients treated with metformin at doses exceeding 2000 mg daily in the form of
immediate-release tablets.
If you are also using insulin, your doctor will advise you on how to start taking Metformina Sandoz.
Usually, you should take the tablet once daily with the evening meal.
In some cases, your doctor may recommend taking the tablets twice daily with lunch and dinner. Always take the tablets with food.
Swallow the tablets whole with a glass of water; do not chew, divide, or crush them.
Monitoring of treatment

• Your doctor will prescribe regular blood glucose tests and adjust the dose of Metformina Sandoz based on your blood glucose levels. It is advisable that your doctor sees you regularly for check-ups. This is particularly important for elderly patients.
• Your doctor will check your kidney function at least once a year. More frequent monitoring may be necessary if you are elderly or if your kidneys are not functioning properly.

Use in children
Metformina Sandoz must not be used in children due to insufficient safety data.
If you take more Metformina Sandoz than you should
If you have accidentally taken more tablets than prescribed, you do not need to worry unless
you experience unusual symptoms. In such a case, contact your doctor. If the overdose is
significant, there is a higher risk of lactic acidosis. Symptoms of lactic acidosis
are non-specific and include vomiting, stomach pain (abdominal pain) with muscle cramps, a
general feeling of being unwell with severe fatigue and difficulty breathing. Further
symptoms include reduced body temperature and heart rate. If you experience any of
these symptoms, you may require immediate hospital treatment, as lactic acidosis
can lead to coma. Stop taking Metformina Sandoz immediately and contact your
doctor or the nearest hospital immediately.
If you forget to take Metformina Sandoz
Take it as soon as you remember, with some food. Do not take a double dose to make up
for a forgotten dose. Take the next dose at your usual time.
If you stop taking Metformina Sandoz
Do not stop taking this medicine without first consulting your doctor.
If you stop treatment with Metformina Sandoz, your blood sugar levels may rise again.
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 Sandoz 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 Sandoz and must immediately contact your doctor or go to the nearest hospital, because lactic acidosis can lead to coma.
Other possible side effects listed below are categorized by frequency:

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

• gastrointestinal problems including diarrhoea, nausea, vomiting, stomach pain or loss of appetite. If you experience these, do not stop taking the tablets, as these symptoms usually disappear within about 2 weeks. It may help to take the tablets with a meal or immediately after a meal. If symptoms persist, stop taking Metformina Sandoz and contact your doctor.

Common (may affect up to 1 in 10 people):

• taste disturbances.
  Low or reduced levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), red and sore tongue (glossitis), tingling sensations (paraesthesiae), or pale or yellowish skin). Your doctor may prescribe certain tests to determine the cause of your symptoms, as some of these may also be caused by diabetes or other unrelated health problems.

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

• lactic acidosis. This is a very rare but dangerous complication, especially when the kidneys are not functioning properly. Symptoms of lactic acidosis are non-specific (see section "Warnings and precautions").
• abnormal liver function test results or hepatitis (inflammation of the liver; which may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). Stop taking Metformina Sandoz immediately and contact your doctor if you experience such symptoms.
• skin reactions such as redness of the skin (erythema), itching or itchy rash (urticaria).

Reporting of side effects
If you experience any side effect, 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 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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, on the bottle label, and on the blister after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Bottle: the shelf life after first opening is 4 months.
Do not dispose of any medicine 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 Sandoz Contains
The active substance is metformin hydrochloride.
Metformina Sandoz 500 mg prolonged-release tablets:
Each tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of
metformin.
Metformina Sandoz 750 mg prolonged-release tablets:
Each tablet contains 750 mg of metformin hydrochloride, equivalent to 585 mg of
metformin.
Metformina Sandoz 1000 mg prolonged-release tablets:
Each tablet contains 1000 mg of metformin hydrochloride, equivalent to 780 mg of
metformin.

• Other components are: Tablet core: stearic acid, shellac, povidone (Kollidon 30), anhydrous colloidal silica, magnesium stearate. Coating: hypromellose, hydroxypropylcellulose, titanium dioxide (E 171), propylene glycol, macrogol 6000, talc.

Description of the Appearance of Metformina Sandoz and Contents of the Package
Metformina Sandoz 500 mg prolonged-release tablets:
White to off-white, oval, biconvex, film-coated tablets, smooth on both sides.
Approximate dimensions: 15 mm x 8.5 mm.
Metformina Sandoz 750 mg prolonged-release tablets:
White to off-white, capsule-shaped, biconvex, film-coated tablets, smooth on both sides.
Approximate dimensions: 19.1 mm x 9.3 mm.
Metformina Sandoz 1000 mg prolonged-release tablets:
White to off-white, oval, biconvex, film-coated tablets, smooth on both sides.
Approximate dimensions: 20.4 mm x 9.7 mm.
PVC/PVDC//aluminum blisters
Pack sizes of 30, 60 and 100 tablets in blister
HDPE bottle with PP cap with child-resistant closure
500 mg, 1000 mg: pack sizes of 30, 60, 100 and 120 tablets
HDPE bottle with PP cap with child-resistant closure
750 mg: pack sizes of 30, 60 and 120 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.,
Viale Luigi Sturzo, 43
20154 Milan
Italy

Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Saxony-Anhalt, Barleben
Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Finland Metformin Sandoz 500 mg depottabletit
Metformin Sandoz 750 mg depottabletit
Metformin Sandoz 1000 mg depottabletit
Italy Metformina Sandoz
Poland Metformin hydrochloride Sandoz
Czech Republic Metformin Sandoz
Slovakia Metformin Sandoz 500 mg tablety s predĺženým uvolňovaním
Metformin Sandoz 750 mg tablety s predĺženým uvolňovaním
Metformin Sandoz 1000 mg tablety s predĺženým uvolňovaním
Slovenia Mikubrel SR 500 mg tablete s podaljšanim sproščanjem
Mikubrel SR 750 mg tablete s podaljšanim sproščanjem
Mikubrel SR 1000 mg tablete s podaljšanim sproščanjem