Normoton

Package Leaflet: Information for the User

NORMOTON, 500 mg, Film-Coated Tablets

Metformin Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What Normoton is and what it is used for

Normoton contains the active substance metformin, which belongs to a group of medicines called biguanides.
It is used to treat type 2 diabetes and pre-diabetic conditions.
Insulin is a hormone produced by the pancreas that allows the body to take up glucose (sugar) from the blood.
The body uses glucose to produce energy or stores it for future use.
In patients with diabetes or pre-diabetic conditions, the blood glucose level is elevated because the pancreas does not produce enough insulin or the patient's body is unable to use the insulin produced.
Normoton helps to lower the blood glucose level to as close to normal as possible.
Normoton is used to treat type 2 diabetes in adults who are unable to control their blood glucose levels with diet and exercise alone.
It is particularly used in patients who are overweight.
In adults, the doctor may prescribe Normoton as the only anti-diabetic medicine (monotherapy) or in combination with other anti-diabetic medicines (oral or insulin).
In adults with type 2 diabetes and overweight treated with metformin as a first-line treatment, a reduction in diabetes complications has been shown.
Normoton is used in a condition called pre-diabetic state, when diet and physical activity alone are not enough to control blood sugar levels.
During treatment with Normoton, you should continue to follow a diet and exercise regularly.

2. Important information before taking Normoton

When not to take Normoton

• if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6),
• if you have liver disease,
• if you have severely reduced kidney function,
• if you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, 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 can lead to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odor from the mouth,
• if you have excessive loss of water from the body (dehydration), for example, due to prolonged or severe diarrhea or repeated vomiting. Dehydration can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• if you have a severe infection, for example, pneumonia, bronchitis, or kidney infection. Severe infections can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• if you have been treated for acute heart failure or have recently had a heart attack, severe circulatory problems (e.g., shock) or breathing difficulties. This can cause tissue hypoxia, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• if you drink a lot of alcohol,
• in children under 18 years of age.

If any of the above conditions apply to you, you should consult your doctor before taking this medicine.
It is essential to consult your doctor if:

• a radiological examination or a test that requires the injection of a contrast agent containing iodine into the blood is necessary,
• a major surgical procedure is to be performed. Normoton should be discontinued for a period before and after the examination or surgical procedure. The doctor will decide whether other treatment is necessary during this time. It is crucial to follow the doctor's instructions carefully.

Warnings and precautions

Risk of lactic acidosis

Normoton may cause a very rare but very serious side effect called lactic acidosis, especially if you have kidney problems. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver disease, and any conditions that may cause tissue hypoxia (e.g., acute heart failure).
If any of these conditions apply to you, you should consult your doctor for more detailed instructions.

Temporary discontinuation of Normoton is recommended if you have a condition that may lead to dehydration

(significant loss of water from the body), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if you drink less fluid than usual. You should consult your doctor for more detailed instructions.
You should stop taking Normoton and contact your doctor or the nearest hospital immediately if you experience any symptoms of lactic acidosis, as this condition can lead to coma.
Symptoms of lactic acidosis include:

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

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.
If you are to undergo a major surgical procedure, you should not take Normoton during the procedure and for a period after it. Your doctor will decide when you should stop and restart Normoton treatment.
Normoton does not cause hypoglycemia (low blood sugar). However, if Normoton is taken with other anti-diabetic medicines 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, eating a meal or drinking a sugary drink usually helps.
During treatment with Normoton, your doctor will check your kidney function at least once a year. More frequent checks may be necessary for patients with increased risk of further kidney function deterioration and for elderly patients.

Other medicines and Normoton

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
It is particularly important to inform your doctor about the following medicines:

• diuretics (used to remove excess water 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 diseases, such as severe skin inflammation or asthma),
• medicines that may change the level of Normoton in the blood, especially if you have kidney problems, such as:
• verapamil (used to treat high blood pressure, coronary heart disease, and arrhythmias),
• rifampicin, trimethoprim (used to treat bacterial infections),
• cimetidine (used to treat stomach and duodenal ulcers and gastroesophageal reflux disease),
• dolutegravir (used to treat HIV infections),
• ranolazine (used to treat angina pectoris - a condition characterized by chest pain or discomfort in the upper body, often caused by physical exertion),
• vandetanib, crizotinib, olaparib (used to treat cancer),
• isavuconazole (used to treat fungal infections),
• other medicines used to treat diabetes. In some cases, you may need more frequent blood glucose checks or kidney function tests, or your Normoton dose may need to be adjusted.

If you are to be injected with a contrast agent containing iodine into the bloodstream, for example, for an X-ray examination or computed tomography, you should stop taking Normoton before or at the time of the injection. Your doctor will decide when you should stop and restart Normoton treatment.

Normoton with alcohol

Avoid excessive alcohol consumption while taking Normoton, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, you should consult your doctor, as changes in treatment or blood glucose monitoring may be necessary.
This medicine is not recommended for breastfeeding women or those planning to breastfeed.

Driving and using machines

Normoton does not cause hypoglycemia (low blood sugar). This means it does not affect your ability to drive or use machines.
However, you should be careful if you are taking Normoton with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating. If you experience these symptoms, do not drive or operate machinery.

Normoton contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Normoton

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Taking Normoton does not replace the benefits of a healthy lifestyle.
You should continue to follow your doctor's recommendations regarding diet and regular physical activity.

Recommended dose

Pre-diabetic state

Adults

The usual dose is 500 mg twice a day. The medicine can be taken with or after a meal.
Do not change the dose without consulting your doctor.
Treatment of type 2 diabetes

Adults

The usual starting dose is 500 mg of metformin hydrochloride, taken 2 or 3 times a day (corresponding to 1000 mg or 1500 mg of metformin hydrochloride) with or after a meal.
The maximum daily dose of metformin hydrochloride is 3000 mg, taken in 3 divided doses.
Your doctor may gradually increase the dose of Normoton. Do not increase the dose without consulting your doctor.
If you have kidney problems, your doctor may prescribe a lower dose.
If you are also taking insulin, your doctor will tell you how to start taking Normoton.

Use in children and adolescents

Normoton is not indicated for use in children under 18 years of age.

Monitoring of treatment

• Your doctor will prescribe regular blood glucose tests and adjust the dose of Normoton according to your blood glucose levels. You should regularly visit your doctor for check-ups. This is especially important for elderly patients.
• Your doctor will check your kidney function at least once a year. More frequent checks may be necessary for elderly patients or if your kidneys are not working properly.

How to take Normoton

Normoton should be taken with a meal or immediately after a meal to avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablet with a glass of water.
If you take two doses a day, take the medicine in the morning (breakfast) and evening (dinner). If you take three doses a day, take the medicine in the morning (breakfast), at noon (lunch), and evening (dinner). If your doctor recommends a different dosing schedule, follow the doctor's instructions.
If, after some time, you feel that the effect of Normoton is too strong or too weak, you should consult your doctor or pharmacist.

Overdose of Normoton

In case of overdose, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain with muscle cramps, general feeling of being unwell, accompanied by severe fatigue, and breathing difficulties. Other symptoms include decreased body temperature and slowed heart rate. If you experience any of these symptoms, you should seek medical attention immediately, as lactic acidosis can lead to coma.

Stop taking Normoton and contact your doctor or the nearest hospital immediately.

Missed dose of Normoton

Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Normoton can cause side effects, although not everybody gets them.
Normoton may very rarely (affecting less than 1 in 10,000 people) cause a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to you, stop taking Normoton and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.
Other side effects are listed below by frequency:

Very common side effects (affecting more than 1 in 10 people)

• Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, loss of appetite. These side effects usually 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 take Normoton with a meal or immediately after a meal. If the symptoms do not disappear, stop taking Normoton and contact your doctor.

Common side effects (affecting less than 1 in 10 people)

• Taste disorders.
• Decreased or low levels of vitamin B12 in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, numbness or tingling, or pale or yellowish skin). Your doctor may prescribe some tests to find the cause of the symptoms, as some of them may also be caused by diabetes or other health problems unrelated to diabetes.

Rare side effects (affecting less than 1 in 10,000 people)

• Lactic acidosis. This is a very rare but serious complication, especially if the kidneys are not working properly. Symptoms of lactic acidosis are non-specific: vomiting and abdominal pain, rapid and deep breathing, muscle cramps, severe fatigue, decreased body temperature, acute kidney failure, or changes in consciousness (see "Warnings and precautions"). Lactic acidosis requires immediate hospital treatment.

If you suspect that you have lactic acidosis, you should stop taking Normoton and seek medical attention immediately.

• Abnormal liver function test results or symptoms of liver inflammation (accompanied by fatigue, loss of appetite, and weight loss, as well as jaundice or non-jaundice of the skin and whites of the eyes). If such symptoms occur, stop taking Normoton and contact your doctor.
• Skin reactions, such as redness, itching, or itchy rash (hives).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring, 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 4921 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Normoton

Normoton should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store in the original package to protect from moisture.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
Medicines should 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 is metformin hydrochloride.
Each film-coated tablet of Normoton contains 500 mg of metformin (in the form of metformin hydrochloride), which corresponds to 390 mg of metformin.
The other ingredients are:
Core:copovidone, povidone K-29/32, microcrystalline cellulose silanized, magnesium stearate.
Coating:hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol, triacetin.

What Normoton looks like and contents of the pack

Normoton is a white, round, biconvex film-coated tablet.
Available pack sizes:
30 tablets in PVC/PVDC/Aluminum blisters and 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, Romania

Date of last revision of the leaflet: April 2025