Metformin hydrochloride stada

Package leaflet: Information for the user

Metformin hydrochloride STADA, 500 mg, prolonged-release tablets
Metformin hydrochloride STADA, 750 mg, prolonged-release tablets
Metformin hydrochloride STADA, 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. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Metformin hydrochloride STADA contains metformin hydrochloride as the active substance, which belongs to a group of medicines called biguanides. Metformin hydrochloride STADA is used to treat patients with type 2 diabetes (also known as "non-insulin-dependent diabetes") when proper control of blood glucose (sugar) levels cannot be achieved by diet and physical exercise alone. It is particularly used in overweight patients.
Insulin is a hormone produced by the pancreas that enables the body to take up glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for later use.
In patients with type 2 diabetes, the pancreas does not produce enough insulin or the body cannot properly use the insulin it produces. This leads to excessively high blood glucose levels, which may cause a range of serious and long-term complications.
Therefore, it is important to continue taking the medicine even if you do not have any obvious symptoms.
Metformin hydrochloride STADA increases the body's sensitivity to insulin and helps restore the body's proper use of glucose.
In overweight adults, long-term use of Metformin hydrochloride STADA also reduces the risk of diabetes-related complications. Treatment with Metformin hydrochloride STADA is associated with maintenance of body weight or even moderate weight reduction.
The prolonged-release tablets of Metformin hydrochloride STADA are specially designed to slowly release the medicine in the body and therefore differ from many other types of tablets containing metformin.
Adults may take Metformin hydrochloride STADA alone or in combination with other antidiabetic medicines (oral medications or insulin).

2. Important information before taking Metformin hydrochloride STADA

DO NOT take Metformin hydrochloride STADA 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 shortness of breath
• the patient has impaired liver function
• the patient has significantly reduced kidney function
• the patient has uncontrolled diabetes, for example severe hyperglycaemia (high blood sugar levels), nausea, vomiting, diarrhoea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) 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 abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odour on the breath
• the patient has experienced excessive fluid loss (dehydration), for example due to prolonged or severe diarrhoea or repeated vomiting. Dehydration may lead to impaired kidney function, which may increase the risk of lactic acidosis (see below "Warnings and precautions")
• the patient has a serious infection, such as an infection of the lungs, bronchi or kidneys. Serious infections may lead to impaired kidney function, which may increase the risk of lactic acidosis (see below "Warnings and precautions")
• the patient is being treated for acute heart problems, has recently had a heart attack, has severe circulatory problems (such as shock) or breathing difficulties. These conditions may cause tissue hypoxia, which may increase the risk of lactic acidosis (see below "Warnings and precautions")
• the patient consumes large amounts of alcohol

Warnings and precautions
Before starting treatment with Metformin hydrochloride STADA, discuss this with your doctor or pharmacist.
Risk of lactic acidosis
Metformin hydrochloride STADA may cause a very rare but serious side effect called lactic acidosis, especially if the patient has impaired kidney function.
The risk of lactic acidosis is also increased in cases of uncontrolled diabetes, serious infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), impaired liver function, and any medical conditions in which a part of the body is inadequately supplied with oxygen (e.g. acute severe heart disease).
If any of the above conditions apply to the patient, consult a doctor for further instructions.
Stop taking Metformin hydrochloride STADA immediately 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
• abdominal pain
• muscle cramps
• general malaise accompanied by profound fatigue
• difficulty breathing
• decreased body temperature and heart rate

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.
Contact a doctor immediately for further instructions if:

• the patient has a genetically inherited disease affecting mitochondria (cellular energy-producing structures), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• the patient experiences any of the following symptoms after starting metformin: seizures, worsening cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine or deafness.

Temporarily discontinue taking Metformin hydrochloride STADA if the patient has a medical condition that may lead to dehydration (significant fluid loss from the body), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient is drinking less fluid than usual. Consult a doctor for further instructions.
Consider the following:

• If the patient is undergoing major surgery, must not take Metformin hydrochloride STADA during the procedure and for some time afterwards. The doctor will decide when the patient should stop and restart treatment with Metformin hydrochloride STADA.
• Metformin hydrochloride STADA, when used alone, does not cause hypoglycaemia (low blood glucose levels). However, if Metformin hydrochloride STADA is used in combination with other antidiabetic medicines that may cause hypoglycaemia (such as sulphonylureas, 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, eating or drinking a sugary food or drink usually helps.
• During treatment with Metformin hydrochloride STADA, 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.

It is common for the tablet shell to be visible in the faeces. This is normal with this type of tablet and should not be a cause for concern.
Metformin hydrochloride STADA does not replace the benefits of a healthy lifestyle. The patient should continue to follow the doctor's advice regarding diet and regular physical activity.
Do not stop taking this medicine without consulting your doctor.
Metformin hydrochloride STADA 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, must stop taking Metformin hydrochloride STADA before or at the latest at the time of injection. The doctor will decide when the patient should stop and restart treatment with Metformin hydrochloride STADA.
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 a dose adjustment of Metformin hydrochloride STADA by the doctor. It is especially important to inform the doctor about the following medicines:

• medicines that increase urine production [diuretics (water tablets), 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)
• some medicines used to treat asthma (beta-adrenergic receptor agonists, such as salbutamol or terbutaline)
• medicines used to treat heart attack or low blood pressure (sympathomimetic agents, including epinephrine and dopamine). Epinephrine is also contained in certain dental anaesthetics.
• anti-inflammatory medicines (corticosteroids, such as prednisolone, mometasone, beclometasone)
• medicines that may alter the blood concentration of Metformin hydrochloride STADA, especially if the patient has impaired kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib)
• other medicines used to treat diabetes.

Metformin hydrochloride STADA and alcohol
Avoid consuming excessive amounts of alcohol while taking Metformin hydrochloride STADA, 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 have a baby, she should consult 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 operating machinery
Metformin hydrochloride STADA, when used alone, does not cause hypoglycaemia (low blood glucose levels). This means it should not affect the patient's ability to drive or operate machinery.
However, exercise particular caution if Metformin hydrochloride STADA is used together with other antidiabetic medicines that may cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, rapid heartbeat, blurred vision or difficulty concentrating. If such symptoms occur, the patient should not drive or operate machinery.
Metformin hydrochloride STADA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Metformin hydrochloride STADA

Your doctor may prescribe Metformin hydrochloride STADA as the only medication or in combination with other oral antidiabetic drugs or insulin.
This medicine should always be taken exactly as your doctor has instructed. If in doubt, consult your doctor or pharmacist.
Recommended dose
The usual starting dose is 500 mg of Metformin hydrochloride STADA per day. After approximately 2 weeks of treatment with Metformin hydrochloride STADA, your doctor may order blood glucose tests and adjust the dose accordingly.
The maximum daily dose is 2000 mg of Metformin hydrochloride STADA.
If you have impaired kidney function, your doctor may prescribe a lower dose.
Your doctor will order regular blood glucose tests and adjust the dose of Metformin hydrochloride STADA based on blood glucose levels. You should attend regular check-ups with your doctor. This is particularly important for elderly patients.
Method of administration
The tablets should be taken orally.
Usually, the tablets should be taken once daily with the evening meal. Swallow the tablets whole with a glass of water. Do not crush or chew the tablets.
The tablets are formulated to provide prolonged release of the active substance after ingestion. This means that the drug is slowly released into the body, so taking the tablets once daily is sufficient.
In some cases, your doctor may advise taking the tablets twice daily.
Overdose of Metformin hydrochloride STADA
If you take more tablets than recommended, lactic acidosis may occur.
Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (pain in the abdominal cavity) with muscle cramps, general malaise accompanied by severe fatigue and difficulty breathing. Other symptoms include decreased body temperature and heart rate.
If any of these symptoms occur, stop taking Metformin hydrochloride STADA immediately and contact your doctor or go to the nearest hospital, as lactic acidosis may lead to coma.
Missed dose of Metformin hydrochloride STADA
Take the next dose as soon as possible, during a meal. Do not take a double dose to make up for a missed dose.
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 STADA may very rarely (may occur in no more than 1 in 10,000 people) cause a very serious adverse effect known as lactic acidosis (see section "Warnings and precautions"). If this occurs in a patient, treatment with Metformin hydrochloride STADA must be discontinued and immediate contact must be made with a doctor or the nearest hospital, as lactic acidosis may lead to coma.
Symptoms of lactic acidosis include:

• vomiting
• abdominal pain
• muscle cramps
• general feeling of being unwell accompanied by severe fatigue
• difficulty breathing
• decreased body temperature and heart rate

Metformin hydrochloride STADA may very rarely (may occur in no more than 1 in 10,000 people) cause abnormal liver function test results and hepatitis (which may result in fatigue, loss of appetite, weight loss, with or without yellowing of the skin and whites of the eyes). If such symptoms occur, treatment with Metformin hydrochloride STADA must be stopped immediately and a doctor must be contacted.
Other possible adverse effects are listed below, according to their frequency of occurrence:
Very common (may affect more than 1 in 10 people)

• gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain (pain in the abdominal cavity), loss of appetite. If the above symptoms occur, do not stop taking the tablets, as these symptoms usually resolve within about 2 weeks. These adverse effects most commonly occur at the beginning of treatment with Metformin hydrochloride STADA. It may be helpful to take Metformin hydrochloride STADA with a meal. If symptoms do not resolve, discontinue use of Metformin hydrochloride STADA and inform your doctor.

Common (may affect up to 1 in 10 people)

• taste disturbances
• reduced or low levels of vitamin B in the blood (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling sensation (paraesthesiae), or pale or yellow skin). Your doctor may order several tests to determine the cause of the symptoms, as some of these may also be caused by diabetes or other health disorders unrelated to diabetes.

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

• skin reactions such as redness of the skin (erythema), itching of the skin, or itchy rash (urticaria).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Metformin hydrochloride STADA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging and
blister pack following “Expiry” or “EXP”. The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such practices help protect
the environment.

6. Contents of the Packaging and Other Information

What Metformin hydrochloride STADA contains
The active substance is metformin hydrochloride.
Metformin hydrochloride STADA 500 mg, prolonged-release tablets
Each prolonged-release tablet contains 500 mg of metformin hydrochloride,
corresponding to 389.938 mg of metformin.
Metformin hydrochloride STADA 750 mg, prolonged-release tablets
Each prolonged-release tablet contains 750 mg of metformin hydrochloride,
corresponding to 584.907 mg of metformin.
Metformin hydrochloride STADA 1000 mg, prolonged-release tablets
Each prolonged-release tablet contains 1000 mg of metformin hydrochloride,
corresponding to 779.876 mg of metformin.

Other ingredients are:
Povidone K-90F
Anhydrous colloidal silica
Carboxymethylcellulose
Hypromellose type 100000 cps
Microcrystalline cellulose
Magnesium stearate

What Metformin hydrochloride STADA looks like and contents of the pack
Description
Metformin hydrochloride STADA 500 mg: White to off-white, round, biconvex tablets,
with an embossed "500" on one side and plain on the other. The tablet diameter is approximately
12.15 mm.
Metformin hydrochloride STADA 750 mg: White to off-white, biconvex, capsule-shaped tablets,
with an embossed "750" on one side and plain on the other. The tablet length is approximately
20 mm and width approximately 9.6 mm.
Metformin hydrochloride STADA 1000 mg: White to off-white, biconvex, capsule-shaped tablets,
with an embossed "1000" on one side and plain on the other. The tablet length is approximately
22.6 mm and width approximately 10.6 mm.

Contents of the pack
Metformin hydrochloride STADA 500 mg, prolonged-release tablets
Tablets are available in PVC/PVdC/Aluminium blister packs in cardboard cartons containing
30, 60 or 100 tablets.
Metformin hydrochloride STADA 750 mg, prolonged-release tablets
Tablets are available in PVC/PVdC/Aluminium blister packs in cardboard cartons containing
30, 60 or 100 tablets.
Metformin hydrochloride STADA 1000 mg, prolonged-release tablets
Tablets are available in PVC/PVdC/Aluminium blister packs in cardboard cartons containing
30 or 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer/Importer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Finland: Metformin STADA 500 mg depottabletti
Metformin STADA 750 mg depottabletti
Metformin STADA 1000 mg depottabletti
Germany: Metformin STADA 500 mg Retardtabletten
Metformin STADA 750 mg Retardtabletten
Metformin STADA 1000 mg Retardtabletten
Poland: Metformin hydrochloride STADA
Czech Republic: Stadamet Prolong
Slovakia: STADAMET retard 500 tablety s predĺženým uvoľňovaním
STADAMET retard 750 mg tablety s predĺženým uvoľňovaním
STADAMET retard 1000 mg tablety s predĺženým uvoľňovaním
Hungary: Diaform XR 500 mg retard tabletta
Diaform XR 750 mg retard tabletta
Diaform XR 1000 mg retard tabletta
Melliform XR 500 mg retard tabletta
Melliform XR 750 mg retard tabletta
Melliform XR 1000 mg retard tabletta
Diastart XR 500 mg retard tabletta
Diastart XR 750 mg retard tabletta
Diastart XR 1000 mg retard tabletta
Italy: METFORMINA EG STADA

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
STADA Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20