Package leaflet: Information for the user

NORMOTON, 500 mg, coated tablets
Metformini hydrochloridum
Please read all of 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, pharmacist, or nurse.
This medicine has been prescribed for you personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Normoton is and what it is used for
What you need to know before taking Normoton
How to take Normoton
Possible side effects
How to store Normoton
Contents of the pack and other information

1. What Normoton is and what it is used for

Normoton is a medicine containing metformin, an active substance belonging to a group of medicines called biguanides. It is used in the treatment of type 2 diabetes and prediabetes.
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 people with diabetes or prediabetes, blood glucose levels are elevated because the pancreas does not produce enough insulin or the body cannot properly use the insulin it produces.
Normoton helps lower blood glucose levels to values as close to normal as possible.
Normoton is used in the treatment of adult patients with type 2 diabetes whose blood glucose levels cannot be adequately controlled by diet and physical activity alone. It is particularly used in patients who are overweight.
In adult patients, the doctor may prescribe Normoton as the sole antidiabetic treatment (monotherapy) or in combination with other antidiabetic medicines (oral medications or insulin).
In overweight adults with type 2 diabetes treated with metformin as first-line therapy when diet fails, a reduction in diabetes-related complications has been demonstrated.
Normoton is also used in a condition called prediabetes, when blood sugar levels cannot be properly controlled by diet and physical activity alone.
While being treated with Normoton, you must follow a diet and engage in physical activity.

2. Important information before taking Normoton

When not to take Normoton

if the patient is allergic to metformin or any of the other ingredients of this medicine (listed in section 6),
if the patient has impaired liver function,
if the patient has significantly reduced kidney function,
if the patient has uncontrolled diabetes, for example severe hyperglycaemia (high blood glucose 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 may lead to diabetic pre-coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odour of the breath,
if the patient has excessive loss of body water (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"),
if the patient has a severe infection, such as pneumonia, bronchitis or kidney infection. Severe infections may lead to impaired kidney function, which may increase the risk of lactic acidosis (see below "Warnings and precautions"),
if the patient has been treated for acute heart failure or recent myocardial infarction, severe circulatory disorders (e.g. shock) or breathing difficulties. These conditions may cause tissue hypoxia, which may increase the risk of lactic acidosis (see below "Warnings and precautions"),
if the patient abuses alcohol,
in patients under 18 years of age.

If any of the above situations apply, the patient should consult a doctor before taking this medicine.
It is essential to consult a doctor if:

a radiological examination or a procedure requiring injection of an iodine-containing contrast agent into the blood is necessary,
a major surgical procedure is planned. Normoton must be discontinued for a certain period before and after the examination or surgical procedure. The doctor will decide whether alternative treatment is necessary during this time. It is important to strictly follow the doctor's instructions.

Warnings and precautions
Risk of lactic acidosis
Normoton may cause a very rare but serious adverse effect called lactic acidosis, especially if the patient has impaired kidney function. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), impaired liver function, and any medical conditions in which 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, the patient should consult a doctor for further instructions.
The use of Normoton should be temporarily discontinued if the patient develops a medical condition that may be associated with dehydration (significant loss of body water), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. The patient should consult a doctor for further instructions.
The use of Normoton should be discontinued and the patient should immediately contact a doctor or the nearest hospital if any symptoms of lactic acidosis occur, as this condition may lead to coma.
Symptoms of lactic acidosis include:

vomiting,
abdominal pain,
muscle cramps,
general malaise associated with severe fatigue,
difficulty breathing,
decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.
If the patient is scheduled for a major surgical procedure, Normoton must not be used during and for a certain time after the procedure. The doctor will decide when the patient should stop and resume treatment with Normoton.
Normoton does not cause hypoglycaemia (low blood glucose levels). However, if Normoton is used in combination with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylureas, insulin, meglitinides), there is a risk of hypoglycaemia. If symptoms of hypoglycaemia occur, such as weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances or difficulty concentrating, eating a meal or drinking a sugary beverage usually helps.
While taking Normoton, the doctor will monitor kidney function at least once a year. In patients at increased risk of further deterioration of kidney function and in elderly patients, more frequent monitoring (e.g. every 3–6 months) may be necessary.
If starting treatment with medicines that may impair kidney function (e.g. antihypertensive medicines or non-steroidal anti-inflammatory drugs), the doctor should be informed about the use of Normoton.
In case of bacterial or viral infection (e.g. influenza, respiratory or urinary tract infection), the doctor should be informed about the use of Normoton.
The patient should continue their diet while taking Normoton, with regular intake of carbohydrates during the day (starchy foods such as rice, pasta, potatoes, fruit).
Overweight patients should additionally follow a low-calorie diet under the supervision of a dietitian.
The patient should immediately contact a doctor to obtain further instructions if:

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

Children and adolescents
Normoton should not be used in individuals under 18 years of age.
Interaction of Normoton with other medicines
The patient should inform their doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.
It is especially important to inform the doctor about the use of the following medicines:

diuretics (medicines that increase urine production, used to remove excess fluid from the body),
medicines used to treat pain and inflammation (non-steroidal anti-inflammatory drugs - NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib),
medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
medicines used to treat asthma (beta-2 adrenergic receptor agonists, such as salbutamol or terbutaline),
corticosteroids (used to treat various conditions, such as severe skin inflammation or asthma),
medicines that may alter the blood concentration of Normoton, especially if the patient has impaired kidney function, such as:
verapamil (used to treat high blood pressure, coronary artery disease and cardiac arrhythmias),
rifampicin, trimethoprim (used to treat bacterial infections),
cimetidine (used to treat peptic ulcer disease and gastroesophageal reflux disease),
dolutegravir (used to treat HIV infection),
ranolazine (used to treat angina pectoris – chest pain or discomfort in the upper body between the neck and the abdomen, often caused by physical exertion or excessive physical activity),
vandetanib, crizotinib, olaparib (used to treat cancer),
isavuconazole (used to treat fungal infections),
other medicines used to treat diabetes. In some cases, the patient may require more frequent monitoring of blood glucose levels and kidney function or dose adjustments.

If the patient is to receive an intravenous iodine-containing contrast agent, for example for an X-ray examination or computed tomography, the patient must stop taking Normoton before or at the latest at the time of administration of such an agent.
The doctor will decide when the patient should stop and resume treatment with Normoton.
Normoton and alcohol
The patient should avoid excessive alcohol consumption while taking Normoton, 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 plans to become pregnant, she should consult her doctor, as changes in treatment or monitoring of blood glucose levels may be necessary.
This medicine is not recommended for breastfeeding women or women planning to breastfeed.
Driving and operating machinery
Normoton does not cause hypoglycaemia (low blood glucose levels). This means it does not affect the patient's ability to drive or operate machinery.
However, special caution is required if Normoton is used together with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include: weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances or difficulty concentrating. If such symptoms occur, the patient should not drive or operate machinery.
Normoton contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
3. How to take Normoton
This medicine should always be taken as directed by the doctor. If in doubt, the patient should consult a doctor or pharmacist.
Taking Normoton 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.
Recommended dose
Prediabetes
Adults
The usual dose is 500 mg twice daily. The medicine can be taken during or after a meal.
The dose should not be changed without consulting a doctor.
Treatment of type 2 diabetes
Adults
The usual initial dose is 500 mg of metformin hydrochloride, taken 2 or 3 times daily (corresponding to 1000 mg or 1500 mg of metformin hydrochloride) during or after a meal.
The maximum daily dose of metformin hydrochloride is 3000 mg, taken in three divided doses.
The doctor may gradually increase the dose. The dose should not be increased without consulting a doctor.
If the patient has impaired kidney function, the doctor may prescribe a lower dose.
If the patient is also using insulin, the doctor will advise on how to start taking Normoton.
Use in children and adolescents
Normoton is not indicated for use in individuals under 18 years of age.
Monitoring of treatment

The doctor will order regular blood glucose tests and adjust the dose of Normoton according to blood glucose levels. The patient should attend regular follow-up visits. This is particularly important for elderly patients.
The doctor will check the patient's kidney function at least once a year. More frequent checks may be necessary in elderly patients or if the patient's kidneys do not function properly.

How to take Normoton
Normoton should be taken during or immediately after a meal. This helps to avoid gastrointestinal adverse effects.
Tablets should not be crushed or chewed. The tablet should be swallowed with a glass of water.
If two doses are taken daily, the medicine should be taken in the morning (breakfast) and evening (dinner). If three doses are taken daily, it should be taken in the morning (breakfast), at noon (lunch) and in the evening (dinner). If the doctor recommends a different dosing schedule, the medicine should be taken as directed.
If, after some time of treatment, the patient feels that the effect of the medicine is too strong or too weak, the patient should consult a doctor or pharmacist.
Taking more Normoton than recommended
If more Normoton is taken 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 associated with severe fatigue and difficulty breathing. Other symptoms include decreased body temperature and slowed heart rate. If any of these symptoms occur, the patient should immediately seek medical help, as lactic acidosis may lead to coma.
Normoton should be discontinued immediately and the patient should contact a doctor or go to the nearest hospital.
Missed dose
The patient should not take a double dose to make up for a missed dose. The next dose should be taken at the usual time.
If the patient has any further doubts about the use of this medicine, the patient should consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Normoton may very rarely (in no more than 1 in 10,000 patients) cause a very serious adverse reaction known as lactic acidosis (see section "Warnings and precautions"). If this occurs in a patient, Normoton must be discontinued immediately and the patient should contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.

Other adverse reactions are listed below according to their frequency of occurrence:

Very common adverse reactions (occurring in more than 1 in 10 people)

Gastrointestinal disturbances such as nausea, vomiting, diarrhoea, abdominal pain, and loss of appetite. These adverse reactions most commonly occur at the beginning of Normoton treatment. It may be helpful to divide the daily dose into several smaller doses taken throughout the day and to take Normoton with food or immediately after a meal. If symptoms do not resolve, Normoton should be discontinued and the patient should contact a doctor.

Common adverse reactions (occurring in fewer 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). 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 adverse reactions (occurring in fewer than 1 in 10,000 people)

Lactic acidosis. This is a very rare but serious complication, particularly when kidneys are not functioning properly. Symptoms of lactic acidosis are non-specific: vomiting and abdominal pain, shortness of breath, accompanied by muscle pain and cramps, severe fatigue, lowered body temperature, acute kidney failure, or disturbances in consciousness (see section "Warnings and precautions"). Lactic acidosis requires immediate hospital treatment. If a patient suspects lactic acidosis has occurred, they should immediately seek medical attention and stop taking Normoton.
Abnormal liver function test results or symptoms of hepatitis (accompanied by fatigue, loss of appetite, and weight loss, with or without yellowing of the skin or whites of the eyes). If such symptoms occur, Normoton should be discontinued and the patient should contact a doctor.
Skin reactions such as skin redness (flushing), itching, or itchy rash (urticaria).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows additional information on the safety of the medicine to be collected.

5. How to store Normoton

Normoton should be stored in a place inaccessible and out of sight of children.
Store below 25°C. Keep in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the carton and blister pack following the
"EXP" label. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Normoton contains
The active substance in Normoton is metformin hydrochloride.
Each coated tablet of Normoton contains 500 mg of metformin (as metformin hydrochloride), equivalent to 390 mg of metformin.
The other ingredients are:
Tablet core: copovidone, povidone K-29/32, siliconized microcrystalline cellulose, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol, triacetin.
What Normoton looks like and contents of the pack
Normoton is white, round, biconvex coated tablets.
Available pack:
30 tablets in PVC/PVDC/Aluminium blisters, in a cardboard box.
Marketing Authorization Holder
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Manufacturer
Gedeon Richter România S.A.
Str. Cuza Vodă nr. 99–105, 540306 Târgu-Mureş, România