Metformin hydrochloride sandoz gmbh

Package leaflet: Information for the patient

Metformin hydrochloride Sandoz GmbH, 500 mg, prolonged-release tablets
Metformin hydrochloride Sandoz GmbH, 750 mg, prolonged-release tablets
Metformin hydrochloride Sandoz GmbH, 1000 mg, prolonged-release tablets
Metformini hydrochloridum
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Leaflet contents

1. What Metformin hydrochloride Sandoz GmbH is and what it is used for
2. Important information before taking Metformin hydrochloride Sandoz GmbH
3. How to take Metformin hydrochloride Sandoz GmbH
4. Possible side effects
5. How to store Metformin hydrochloride Sandoz GmbH
6. Contents of the pack and other information

1. What Metformin hydrochloride Sandoz GmbH is and what it is used for

Metformin hydrochloride Sandoz GmbH 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 (non-insulin-dependent) diabetes.
Metformin hydrochloride Sandoz GmbH is used together with diet and physical exercise to reduce the risk of developing type 2 diabetes in overweight adults when diet and physical exercise alone for 3 to 6 months have not been sufficient to control blood glucose (sugar) levels. There is a high risk of developing type 2 diabetes if additional risk factors are present, such as high blood pressure, age over 40 years, abnormal blood lipid (fat) levels, or a history of gestational diabetes.
The medicine is particularly effective if the patient is under 45 years of age, has significant overweight, high post-meal blood glucose levels, or if the patient is a woman with a history of gestational diabetes.
Metformin hydrochloride Sandoz GmbH is used in the treatment of adult patients with type 2 diabetes when diet and physical exercise alone are not sufficient to achieve adequate control of blood glucose (sugar) levels. It is especially indicated for overweight patients.
Insulin is a hormone that enables body tissues to take up glucose from the blood and use it for energy or store it for later use.
In people with type 2 diabetes, the pancreas does not produce enough insulin or the body cannot properly use the insulin that is produced. This leads to accumulation of glucose in the blood, which may cause a range of serious, long-term complications. Therefore, it is important to continue taking the medicine regularly, even if no obvious symptoms are present.
Metformin hydrochloride Sandoz GmbH increases the body's sensitivity to insulin and helps restore the normal way the body uses glucose.
Treatment with Metformin hydrochloride Sandoz GmbH is associated either with stable body weight or with a slight reduction in body weight.
The prolonged-release tablets of Metformin hydrochloride Sandoz GmbH are specially formulated to slowly release the medicine in the body, thus differing from many other types of metformin-containing tablets.

2. Important information before using Metformin hydrochloride Sandoz GmbH

When not to use Metformin hydrochloride Sandoz GmbH

• if the patient is allergic to metformin or to any of the other ingredients of this medicine (listed in section 6). Allergic reaction may cause rash, itching or difficulty breathing.
• if the patient has liver function disorders.
• if the patient has significantly reduced kidney function.
• if the patient has uncontrolled diabetes, e.g. with severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden weight loss or 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 which may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness or unusual fruity odour of breath.
• if the patient has lost too much body fluid (dehydration). Dehydration may lead to kidney dysfunction, which may increase the risk of lactic acidosis (see below "Warnings and precautions").
• if the patient has a severe infection, e.g. affecting the lungs, bronchi or kidneys. Severe infections may cause kidney dysfunction with risk of lactic acidosis (see below "Warnings and precautions").
• if the patient has been treated for acute heart failure or recently suffered a heart attack, or has severe circulatory disorders or breathing difficulties. These conditions may lead to tissue hypoxia, which may increase the risk of lactic acidosis (see below "Warnings and precautions").
• if the patient drinks large amounts of alcohol.
• if the patient is under 18 years of age.

Warnings and precautions
Before starting treatment with Metformin hydrochloride Sandoz GmbH, discuss this with your
doctor or pharmacist.
Risk of lactic acidosis
Metformin hydrochloride Sandoz GmbH may cause a very rare but serious adverse effect called
lactic acidosis, especially in patients with impaired kidney function.
The risk of lactic acidosis increases also in cases of uncontrolled diabetes, severe infections, prolonged
fasting or alcohol consumption, dehydration (more details below), liver dysfunction, and any
medical conditions in which part of the body is inadequately supplied with oxygen (e.g. acute,
severe heart diseases).
If any of the above conditions apply to the patient, consult a doctor for further instructions.
Contact a doctor immediately for further instructions if:
the patient has a genetically inherited mitochondrial disorder (energy-producing structures in
cells), such as MELAS (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like
episodes) or maternally inherited diabetes and deafness (MIDD).
after starting metformin treatment, the patient develops any of the following symptoms:
seizures, worsening of cognitive abilities, movement difficulties, symptoms indicating nerve
damage (e.g. pain or numbness), migraine and deafness.
The use of Metformin hydrochloride Sandoz GmbH should be temporarily discontinued
if the patient develops a medical condition that may lead to dehydration (significant loss of
body fluids), such as severe vomiting, diarrhoea, fever, or exposure to high temperatures, or if the
patient drinks less fluid than usual. Consult a doctor for further instructions.
Discontinue Metformin hydrochloride Sandoz GmbH and contact a doctor or the nearest
hospital immediately if the patient experiences any symptoms of lactic acidosis, as this
condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general malaise combined with severe fatigue
• difficulty breathing
• low body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring hospital treatment.
If the patient is to undergo major surgery, treatment with Metformin hydrochloride Sandoz GmbH
must be discontinued during the procedure and for some time afterwards. The doctor will decide
when the patient should stop and when to resume treatment with Metformin hydrochloride Sandoz
GmbH.
During treatment with Metformin hydrochloride Sandoz GmbH, the doctor will monitor the
patient's kidney function at least once a year, or more frequently if the patient is elderly and/or has
worsening kidney function.
Metformin hydrochloride Sandoz GmbH does not cause hypoglycaemia (low blood glucose
levels). However, if the patient takes Metformin hydrochloride Sandoz GmbH in combination with
other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylurea derivatives,
insulin, meglitinides), there is a risk of hypoglycaemia. If symptoms of hypoglycaemia occur, such
as weakness, dizziness, increased sweating, rapid heartbeat, blurred vision or difficulty concentrating,
consuming food or a drink containing sugar usually helps.
Metformin hydrochloride Sandoz GmbH should not be initiated in patients aged 75 years and
older for the purpose of reducing the risk of type 2 diabetes.
Tablet remnants may be visible in the stool. This is normal with this type of tablet and should not be
a cause for concern.
Continue to follow all dietary recommendations provided by the doctor and ensure regular intake
of carbohydrates throughout the day.
Do not stop taking this medicine without consulting your doctor.
Metformin hydrochloride Sandoz GmbH and other medicines
If the patient is to receive an iodine-containing contrast agent injected into the bloodstream, e.g.
for an X-ray or CT scan, treatment with Metformin hydrochloride Sandoz GmbH must be
discontinued before or at the latest during the administration of the contrast agent. The doctor will
decide when the patient should stop and when to resume taking Metformin hydrochloride Sandoz
GmbH.
Inform the doctor about all medicines currently or recently taken, as well as any medicines the
patient plans to take. The patient may require more frequent monitoring of blood glucose levels and
kidney function assessments, or dose adjustments of Metformin hydrochloride Sandoz GmbH. It is
particularly important to inform the doctor about the use of:
diuretics (water tablets) that increase urine production, such as furosemide
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)
steroids, such as prednisolone, mometasone, beclomethasone
sympathomimetics, including epinephrine and dopamine, used to treat heart attack and low
blood pressure. Epinephrine is also an ingredient in some local anaesthetics used in dentistry.
medicines that may alter the blood levels of Metformin hydrochloride Sandoz GmbH, especially
in patients with reduced kidney function (e.g. verapamil, rifampicin, cimetidine, dolutegravir,
ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib)
beta-2 adrenergic receptor agonists, such as salbutamol or terbutaline (used in asthma treatment)
other antidiabetic medicines.
Metformin hydrochloride Sandoz GmbH and alcohol
Avoid excessive alcohol consumption while taking Metformin hydrochloride Sandoz GmbH, as
this may increase the risk of lactic acidosis (see section "Warnings and precautions").
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she
should talk to her doctor, as changes in treatment or monitoring of blood glucose levels may be
necessary.
This medicine is not recommended for breastfeeding women or those planning to breastfeed.
Driving and using machines
Metformin hydrochloride Sandoz GmbH used as monotherapy does not cause hypoglycaemia
(symptoms of low blood glucose (sugar) levels such as fainting, confusion and excessive sweating),
and therefore should not affect the ability to drive or operate machinery.
However, bear in mind that Metformin hydrochloride Sandoz GmbH taken together with other
antidiabetic medicines may cause hypoglycaemia. In such cases, special caution should be taken
when driving or operating machinery.
Do not drive or operate machinery if the patient begins to experience symptoms of hypoglycaemia.

3. How to use Metformin hydrochloride Sandoz GmbH

This medicine should always be taken exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor may prescribe Metformin hydrochloride Sandoz GmbH to be used as monotherapy or in combination with other oral antidiabetic medicines or insulin.
The tablets should be swallowed whole with a glass of water. Do not chew, divide or crush them.

Recommended dose
Treatment is usually initiated with 500 mg of Metformin hydrochloride Sandoz GmbH once daily.
After approximately 2 weeks of treatment with Metformin hydrochloride Sandoz GmbH, your doctor may adjust the dose based on blood glucose measurements. The maximum daily dose of Metformin hydrochloride Sandoz GmbH is 2000 mg.
If you have reduced kidney function, your doctor may prescribe a lower dose.
Tablets are usually taken once daily with the evening meal.
In some cases, your doctor may advise taking the tablets twice daily, with the morning and evening meals. Tablets should always be taken with meals.

Taking more Metformin hydrochloride Sandoz GmbH than prescribed
If you accidentally take extra tablets, do not worry, but if any unusual symptoms occur, inform your doctor. In the case of a large overdose, there is an increased risk of lactic acidosis. Symptoms of lactic acidosis are non-specific, such as vomiting, abdominal pain with muscle cramps, general malaise with severe fatigue and difficulty breathing. Later symptoms may include lowered body temperature and slowed heart rate. If any of these symptoms occur, seek immediate medical help, as lactic acidosis may lead to coma. You should stop taking Metformin hydrochloride Sandoz GmbH immediately and contact your doctor or go to the nearest hospital without delay.

Missing a dose of Metformin hydrochloride Sandoz GmbH
Take the next dose as soon as possible with a meal. Do not take a double dose to make up for a missed dose.

Stopping Metformin hydrochloride Sandoz GmbH
Do not stop taking this medicine without consulting your doctor. If you stop taking Metformin hydrochloride Sandoz GmbH, your blood glucose levels may rise again.

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 will get them.
The following side effects may occur:
Metformin hydrochloride Sandoz GmbH may very rarely (less than 1 in 10,000 people) cause a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs in a patient, treatment with Metformin hydrochloride Sandoz GmbH must be stopped immediately and the doctor or nearest hospital must be contacted immediately, as lactic acidosis may lead to coma.
Metformin hydrochloride Sandoz GmbH may cause abnormal liver function tests and hepatitis, which may lead to jaundice (may occur in less than 1 in 10,000 people). If yellowing of the eyes and/or skin occurs in a patient, medical advice should be sought immediately.
Other possible side effects are listed below according to their frequency of occurrence:
Very common side effects (may affect more than 1 in 10 people):
diarrhoea, nausea, vomiting, stomach pain or loss of appetite. Do not stop taking the tablets if these symptoms occur, as they usually resolve after about 2 weeks. It is helpful to take the tablet during or immediately after a meal.
Common side effects (may affect less than 1 in 10 people):
taste disturbances
low or reduced vitamin B12 blood levels (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling sensations (paraesthesiae), or pale or yellowish skin). The doctor may order several tests to determine the cause of symptoms, as some of them may also be caused by diabetes or other health problems unrelated to diabetes.
Very rare side effects (may affect less than 1 in 10,000 people):
skin rash, including redness, itching and urticaria.
Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Metformin hydrochloride Sandoz GmbH

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging or
blister pack after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via household waste or sewage.
Ask your pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Metformin hydrochloride Sandoz GmbH contains
The active substance is metformin hydrochloride (Metformini hydrochloridum).
Metformin hydrochloride Sandoz GmbH, 500 mg
Each tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.
Metformin hydrochloride Sandoz GmbH, 750 mg
Each tablet contains 750 mg of metformin hydrochloride, equivalent to 585 mg of metformin.
Metformin hydrochloride Sandoz GmbH, 1000 mg
Each tablet contains 1000 mg of metformin hydrochloride, equivalent to 780 mg of metformin.

Other ingredients are:
Tablet core: stearic acid, gelatin, povidone (K-30), anhydrous colloidal silicon dioxide, magnesium stearate.
Coating: hypromellose, hydroxypropylcellulose, titanium dioxide (E 171), propylene glycol, macrogol 6000, talc.

What Metformin hydrochloride Sandoz GmbH looks like and contents of the pack
Metformin hydrochloride Sandoz GmbH, 500 mg, prolonged-release tablets
Almost white, oval, biconvex coated tablets, smooth on both sides. Approximate dimensions: 15 mm x 8.5 mm.

Metformin hydrochloride Sandoz GmbH, 750 mg, prolonged-release tablets
Almost white, biconvex, capsule-shaped coated tablets, smooth on both sides. Approximate dimensions: 19.1 mm x 9.3 mm.

Metformin hydrochloride Sandoz GmbH, 1000 mg, prolonged-release tablets
Almost white, oval, biconvex coated tablets, smooth on both sides. Approximate dimensions: 20.4 mm x 9.7 mm.

Blister packs made of PVC/PVDC/Aluminium
Pack sizes: 30 tablets.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer/Importer
Salutas Pharma GmbH
Otto-Von-Guericke-Allee 1
39179 Barleben, Germany
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana, Slovenia

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Metformin hydrochloride Sandoz GmbH
Hungary: Metformin Sandoz 500 mg retard tabletta
Metformin Sandoz 750 mg retard tabletta
Metformin Sandoz 1000 mg retard tabletta
Croatia: Meglucon 500 mg tablete s produljenim oslobađanjem
Meglucon 750 mg tablete s produljenim oslobađanjem
Meglucon 1000 mg tablete s produljenim oslobađanjem

Logo of the Marketing Authorisation Holder