METFORMINA 500 mg Extended-Release Tablet

Зміст інструкції

1. Metformina Sandoz 500 mg prolonged-release tablets, 750 mg prolonged-release tablets, 1000 mg prolonged-release tablets
   1. What is Metformina Sandoz and what is it used for
2. Metformina Sandoz is associated with a stable body weight or a modest weight loss.
   1. What you need to know before you take Metformina Sandoz
   2. How to take Metformina Sandoz
   3. Possible side effects
   4. How to store Metformina Sandoz
   5. Package contents and other information

Metformina Sandoz 500 mg prolonged-release tablets, 750 mg prolonged-release tablets, 1000 mg prolonged-release tablets

Generic medicine

Read this leaflet carefully before you start 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 Sandoz is and what it is used for
• 2. What you need to know before you take 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 is Metformina Sandoz and what is it used for

Metformina Sandoz prolonged-release tablets contain the active ingredient metformin
hydrochloride, and belong to a group of medicines called biguanides, used in the
treatment of type 2 diabetes mellitus (non-insulin-dependent).
Metformina Sandoz is used for the treatment of 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 can be used alone or in combination with other medicines used for
the treatment of diabetes (medicines taken by mouth or insulin).
Insulin is a hormone that allows the body's tissues to take glucose from the blood and
use it to produce energy or store it for future use. People with
type 2 diabetes do not produce enough insulin in the pancreas or their body does not
respond properly to insulin. This causes an accumulation of glucose in the blood which
can cause, in the long term, a number of serious problems. Therefore it is important to continue
to take Metformina Sandoz, even if you have no obvious symptoms.
Metformina Sandoz makes the body more sensitive to insulin and helps to normalize the
way the body uses glucose.

Metformina Sandoz is associated with a stable body weight or a modest weight loss.

In overweight adults, long-term use of Metformina Sandoz also reduces the
risk of complications related to diabetes.
Metformina Sandoz extended-release tablets are specially designed to
release the active ingredient slowly into the body and are therefore different from other types of
tablets that contain metformin.

2. What you need to know before you take Metformina Sandoz

Do not take Metformina Sandoz if:

• you are allergic to metformin or 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 with, for example, severe high blood sugar (high levels of glucose in the blood), nausea, vomiting, diarrhea, 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 can lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness and breath with an unusually fruity odor
• you have lost a large amount of water from your body (dehydration), for example due to prolonged or severe diarrhea or repeated vomiting. Dehydration can cause kidney problems, which can determine the risk of lactic acidosis (see “Warnings and precautions” below)
• you suffer from a severe infection, for example an infection affecting the lungs or airways or the kidney. Severe infections can cause kidney problems, which can determine 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 difficulty breathing. This could cause a reduction in oxygen supply to the tissues, which in turn can determine 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 occur, consult your doctor before taking this medicine
Make sure to consult your doctor if you need:

• to undergo an X-ray examination or a test that requires the injection of an iodine-containing contrast agent into the blood
• to undergo major surgery
• Metformina Sandoz must be discontinued for a while before and after an examination or surgery. Your doctor will decide if another treatment is necessary during this period. It is essential to carefully follow your doctor's instructions.

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

Risk of lactic acidosis
Metformina Sandoz can cause a very rare, but very serious, side effect
called lactic acidosis, especially if your kidneys do not work 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 characterized by a reduced
supply of oxygen to a part of the body (as in the case of severe acute heart disease
).
If you have any of the medical conditions described above, contact your doctor for further
instructions.

Stop taking Metformina Sandoz for a short period of time if you have a
medical condition that may be associated with dehydration(loss of significant fluids
organic) such as severe vomiting, diarrhea, fever, exposure to heat or if you drink less fluids than
usual. Consult your doctor for further instructions.

Stop taking Metformina Sandoz and immediately contact your doctor or the nearest
hospital if you experience any of the symptoms of lactic acidosis,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 heart rate

Lactic acidosis is a medical emergency and must be treated in hospital.
If you are to undergo major surgery, you must stop taking
Metformina Sandoz during the surgery and for a certain period of time thereafter. The doctor will decide when you should stop and when you should resume
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 itself does not cause hypoglycemia (a blood glucose level that is too
low). However, if you take Metformina Sandoz together with other antidiabetic drugs that
can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides), there is a risk of
hypoglycemia. If you experience symptoms of hypoglycemia, such as weakness, dizziness, increased
sweating, rapid heartbeat, vision disturbances or difficulty concentrating, it is generally helpful to eat or drink something containing sugar.
Parts of the tablet may appear in your stool. Do not worry: this is normal for
this type of tablet.
Continue to follow any dietary advice your doctor has given you; eat 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 to be injected with an iodine-containing contrast agent into the bloodstream,
for example to have an X-ray or scan, you must stop taking
Metformina Sandoz for a certain period of time before and during the injection. The doctor
will decide when you should stop and when you should resume treatment with Metformina
Sandoz.
. You may need to have your blood sugar and kidney function checked more often, 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 for treating 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 anesthetics
• medicines that can change the amount of Metformina Sandoz in your 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 with alcohol
Avoid excessive alcohol consumption during treatment with Metformina Sandoz as
this can increase the risk of lactic acidosis (see section “Warnings and
precautions”).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, consult your doctor
if changes to your treatment or monitoring of your blood sugar levels are necessary.
This medicine is not recommended if you are breastfeeding or if you plan to
breastfeed your baby.

Driving and using machines
Metformina Sandoz taken alone does not cause hypoglycemia (symptoms of low blood sugar
such as weakness, confusion and increased sweating) and therefore should not
affect your ability to drive or operate machinery.
However, you should be particularly careful if Metformina Sandoz is used
at the same time as other antidiabetic drugs that can cause hypoglycemia (such as
sulfonylureas, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness,
increased sweating, rapid heartbeat, blurred vision or difficulty concentrating.
If you start to experience these symptoms, do not drive or operate machinery.

3. How to take Metformina Sandoz

Take this medicine following exactly the instructions of your doctor. If you have
any doubts, consult your doctor or pharmacist.
Your doctor may prescribe Metformina Sandoz alone or together with other oral antidiabetic medicines or insulin.
Metformina Sandoz does not replace the benefits of a healthy lifestyle. Follow all the advice
of your doctor regarding diet and regular physical activity.
Recommended dose

Treatment of diabetes with metformin alone or in combination with other medicines
Adults: Usually, you will start treatment with 500 mg per day of Metformina Sandoz with the
evening meal. After about 2 weeks of therapy with Metformina Sandoz, your doctor may
evaluate blood sugar levels and, if necessary, adjust the dose.
The maximum daily dose is 2000 mg of Metformina Sandoz.
In patients already treated with metformin, the initial dose of Metformina Sandoz must be
equivalent to the daily dose of immediate-release metformin tablets.
If you have reduced kidney function, your doctor may prescribe a lower dose.
Switching from antidiabetic treatment to Metformina Sandoz is not recommended in
patients treated with metformin at doses higher than 2000 mg per day in the form of
immediate-release tablets.
If you are also using insulin, your doctor will tell you how to start taking Metformina Sandoz.
Usually, you should take the tablet once a day, with the evening meal.
In some cases, your doctor may recommend taking the tablets twice a day, at lunch and dinner. Always take the tablets with food.
Swallow the tablets whole with a glass of water, do not chew, divide or
crush.

Treatment control

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

Use in children
Metformina Sandoz should not be used in children due to inadequate safety data.

If you take more Metformina Sandoz than you should
If you have accidentally taken more tablets, you do not need to worry unless
you experience unusual symptoms. In such a case, contact your doctor. If the overdose is
excessive, it is more likely that lactic acidosis may occur. The symptoms of lactic acidosis
are nonspecific such as vomiting, stomach pain (abdominal pain) with muscle cramps, a
general feeling of unwellness with severe fatigue and difficulty breathing. Further
symptoms are a reduction in 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.
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 missed dose. Take the next dose at the usual time.

If you stop taking Metformina Sandoz
You should not stop taking this medicine without consulting your doctor first.
If you stop taking Metformina Sandoz, blood sugar levels
may rise again.
If you have any questions 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.
The following side effects can occur:
Metformina Sandoz can 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 Sandozand
immediately contact your doctor or the nearest hospital,because lactic acidosis
can lead to coma.
Below are listed other possible side effects, ordered by frequency:
Very common (may affect more than 1 in 10 people):
o loss of appetite. If you experience these, do not stop taking the tablets
because these symptoms will usually disappear within about 2 weeks. It may help
to take the tablets with a meal or immediately after. If symptoms persist,
stop taking Metformina Sandoz and inform your doctor.
Common (may affect up to 1 in 10 people):

• taste alterations. Reduced or low levels of vitamin B12 in the blood (symptoms may include extreme fatigue, sore and red tongue (glossitis), tingling (paresthesia) or pale or yellowish skin). Your doctor may order some tests to find out the cause of your symptoms because some of these may also be caused by diabetes or other health problems not related to this medicine.

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 results of liver function tests 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). Immediately stoptaking Metformina Sandoz and inform your doctorif you experience such symptoms.
• skin reactions such as skin redness (erythema), itching or itchy rash (urticaria).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet,
tell your doctor or pharmacist. 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 Sandoz

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 package,
on the label of the bottle and on the blister after “Exp.”. The expiry date refers to the last
day of that month.
This medicine does not require any particular storage conditions.
Bottle: the period of validity after first opening is 4 months.
Do not dispose of any medicine in the wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. Package contents and other information

What Metformina Sandoz contains
The active ingredient 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 ingredients 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 pack
Metformina Sandoz 500 mg prolonged-release tablets:
Whitish, oval, biconvex tablets, film-coated, smooth on both sides.
Approximate dimensions: 15 mm x 8.5 mm.
Metformina Sandoz 750 mg prolonged-release tablets:
Whitish, capsule-shaped, biconvex tablets, film-coated, smooth on both
sides.
Approximate dimensions: 19.1 mm x 9.3 mm.
Metformina Sandoz 1000 mg prolonged-release tablets:
Whitish, oval, biconvex tablets, film-coated, smooth on both sides.
Approximate dimensions: 20.4 mm x 9.7 mm.
PVC/PVDC//aluminium blister
Packs of 30, 60 and 100 tablets in blisters
HDPE bottle with a child-resistant closure
500mg, 1000mg: packs of 30, 60, 100 and 120 tablets
HDPE bottle with a child-resistant closure
750mg: packs of 30, 60 and 120 tablets
Not all pack sizes may be marketed.

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

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

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
n>
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 predlženým uvolnovaním
Metformin Sandoz 750 mg tablety s predlženým uvolnovaním
Metformin Sandoz 1000 mg tablety s predlženým uvolnovaním
Slovenia Mikubrel SR 500 mg tablete s podaljšanim sprošcanjem
Mikubrel SR 750 mg tablete s podaljšanim sprošcanjem
Mikubrel SR 1000 mg tablete s podaljšanim sprošcanjem