Metformin hydrochloride sandoz

Package leaflet: Information for the patient

Metformin hydrochloride Sandoz, 500 mg, prolonged-release tablets
Metformin hydrochloride Sandoz, 750 mg, prolonged-release tablets
Metformin hydrochloride Sandoz, 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.
It may harm someone else, even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

Metformin hydrochloride 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 (non-insulin-dependent) diabetes.
Metformin hydrochloride Sandoz is used in the treatment of adult patients with type 2 diabetes when diet and exercise alone are insufficient to achieve adequate control of blood glucose (sugar) levels. It is particularly used in patients who are overweight.
Insulin is a hormone that enables the body's 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 it produces. This leads to a build-up of glucose in the blood, which may cause a number of serious, long-term complications. It is therefore important to continue taking the medicine regularly, even if you do not have obvious symptoms.
Metformin hydrochloride Sandoz increases the body's sensitivity to insulin and helps restore the normal way the body uses glucose.
Treatment with Metformin hydrochloride Sandoz is associated either with stable body weight or with slight weight reduction.
The prolonged-release tablets of Metformin hydrochloride Sandoz are specially formulated to release the medicine slowly in the body and therefore differ from many other types of tablets containing metformin.

2. Information before using Metformin hydrochloride Sandoz

When not to use Metformin hydrochloride Sandoz

• if the patient is allergic to metformin or to any of the other ingredients of this medicine (listed in section 6). An 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 water from the body (dehydration). Dehydration may lead to kidney function disorders, which may result in 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 function disorders 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. This may lead to tissue hypoxia, which may result in 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, discuss this with your doctor or pharmacist.
Risk of lactic acidosis
Metformin hydrochloride Sandoz may cause a very rare but serious adverse effect called lactic acidosis, especially in patients with kidney function disorders.
The risk of lactic acidosis is also increased in cases of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (more information below), liver function disorders and any medical conditions in which a 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 disease affecting mitochondria (cellular energy-producing structures), such as MELAS (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
the patient develops any of the following symptoms after starting metformin:
seizures, worsening of cognitive abilities, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine or deafness.
The patient should temporarily stop taking Metformin hydrochloride Sandoz if experiencing a medical condition that may lead to dehydration (significant loss of water from the body), such as severe vomiting, diarrhoea, fever, exposure to high temperatures or if the patient drinks less fluids than usual. Consult a doctor for further instructions.
The patient should stop taking Metformin hydrochloride Sandoz and contact a doctor or the nearest hospital immediately if any symptoms of lactic acidosis occur, 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 and must be treated in hospital.
If the patient is to undergo major surgery, treatment with Metformin hydrochloride Sandoz 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.
During treatment with Metformin hydrochloride Sandoz, 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 deteriorating kidney function.
Metformin hydrochloride Sandoz does not cause hypoglycaemia (low blood glucose levels). However, if the patient takes Metformin hydrochloride Sandoz 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, vision disturbances or difficulty concentrating, eating or drinking a sugary food or drink usually helps.
Undissolved tablet residue 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 given 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 and other medicines
If the patient is to receive an iodine-containing contrast agent injected into the bloodstream, for example for an X-ray or CT scan, the patient must stop taking Metformin hydrochloride Sandoz before or at the latest during the injection. The doctor will decide when the patient should stop and when to resume taking Metformin hydrochloride Sandoz.
Tell the doctor about all medicines the patient is currently taking or has 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 or dose adjustments of Metformin hydrochloride Sandoz by the doctor. It is especially important to inform the doctor about the use of:
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)
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 a component of some local anaesthetics used in dentistry.
medicines that may alter the levels of Metformin hydrochloride Sandoz in the blood, especially in patients with reduced kidney function (i.e. 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 medicines used in the treatment of diabetes.
Metformin hydrochloride Sandoz and alcohol
Avoid excessive alcohol consumption while taking Metformin hydrochloride Sandoz, 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 a pregnancy, 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 patients who are breastfeeding or planning to breastfeed.
Driving and using machines
Metformin hydrochloride Sandoz used as monotherapy does not cause hypoglycaemia (symptoms of low blood glucose (sugar) levels such as fainting, confusion and excessive sweating), therefore it should not affect the ability to drive or operate machinery.
However, bear in mind that Metformin hydrochloride Sandoz taken together with other antidiabetic medicines may cause hypoglycaemia. In such cases, special caution should be exercised 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

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Your doctor may prescribe Metformin hydrochloride Sandoz 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 once daily. After approximately 2 weeks of treatment with Metformin hydrochloride Sandoz, your doctor may adjust the dose based on blood glucose measurements. The maximum daily dose of Metformin hydrochloride Sandoz is 2000 mg.
If the patient has impaired kidney function, the doctor may prescribe a lower dose.
Tablets are usually taken once daily with the evening meal.
In some cases, the doctor may recommend taking the tablets twice daily, with the morning and evening meals. The tablets should always be taken with food.

Taking more Metformin hydrochloride Sandoz than recommended
If additional tablets are accidentally taken, do not panic, but if 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 nonspecific, such as vomiting, abdominal pain with muscle cramps, general malaise with severe fatigue, and difficulty breathing. Later symptoms 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. Immediately discontinue use of Metformin hydrochloride Sandoz and contact your doctor or go to the nearest hospital without delay.

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

Stopping treatment with Metformin hydrochloride Sandoz
Do not stop taking this medicine without consulting your doctor. Discontinuing treatment with Metformin hydrochloride Sandoz may result in increased blood glucose levels.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur:
Metformin hydrochloride Sandoz may very rarely (less than 1 in 10,000 people) cause a very serious adverse effect known as lactic acidosis (see "Warnings and precautions"). If a patient develops lactic acidosis, Metformin hydrochloride Sandoz must be discontinued and immediate contact must be made with a doctor or the nearest hospital, as lactic acidosis may lead to coma.
Metformin hydrochloride Sandoz may cause abnormal liver function test results and hepatitis, which may lead to jaundice (may occur less than 1 in 10,000 people). If a patient develops yellowing of the eyes and/or skin, medical advice should be sought immediately.
Other possible adverse effects are listed below by frequency of occurrence:
Very common adverse effects (may affect more than 1 in 10 people):
diarrhoea, nausea, vomiting, abdominal 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 adverse effects (may affect less than 1 in 10 people):
taste disturbances
reduced or low blood levels of vitamin B12 (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling sensations (paraesthesiae) or pale or yellowish skin). Your 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 adverse effects (may affect less than 1 in 10,000 people):
skin rashes, including redness, itching and urticaria.
Reporting of adverse effects
If any adverse effects occur, including any unlisted adverse effects not mentioned in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring 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
Adverse effects can also be reported to the marketing authorisation holder. Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Metformin hydrochloride Sandoz

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box 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 wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
Doing so helps protect the environment.

6. Contents of the packaging and other information

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

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

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

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

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

PVC/PVDC/Aluminium blisters
Pack size: 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 about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Tel: 22 209 70 00

This medicine is authorised for sale in the European Economic Area countries under the following names:
Poland: Metformin hydrochloride Sandoz
Czech Republic: Metformin Sandoz
Finland: Metformin Sandoz 500 mg depottabletit
    Metformin Sandoz 750 mg depottabletit
    Metformin Sandoz 1000 mg depottabletit
Italy: Metformina Sandoz
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
Slovakia: Metformin Sandoz 500 mg tablety s predĺženým uvoľňovaním
     Metformin Sandoz 750 mg tablety s predĺženým uvoľňovaním
     Metformin Sandoz 1000 mg tablety s predĺženým uvoľňovaním

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