Valimar

Package Leaflet: Information for the Patient

VALIMAR, 500 mg, prolonged-release 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 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 experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is VALIMAR and what is it used for

VALIMAR contains metformin hydrochloride, a medicine used to treat diabetes. It belongs to a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas that allows the body to take glucose (sugar) from the blood and use it for energy or store it for future use.
In a patient with type 2 diabetes, the pancreas does not produce enough insulin or the body is unable to use the insulin produced. This leads to high blood glucose levels.
VALIMAR helps lower blood glucose levels to as close to normal as possible.
In adults with overweight, long-term use of VALIMAR also reduces the risk of complications associated with diabetes. Taking VALIMAR is associated with either weight loss or no change in body weight.
VALIMAR is used in adults:

• with type 2 diabetes (also called non-insulin-dependent diabetes), especially in patients with overweight. Adults can take VALIMAR alone or in combination with other anti-diabetic medicines (oral or insulin);
• to prevent type 2 diabetes in patients with pre-diabetic conditions.

2. Important information before taking VALIMAR

When not to take VALIMAR:

• if you are allergic to metformin hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you have liver problems;
• 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 diabetic ketoacidosis. Diabetic 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 breath odor.
• in case of excessive fluid loss 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, or have severe circulatory problems, shock, or breathing difficulties. This can cause tissue hypoxia, which can increase the risk of lactic acidosis (see "Warnings and precautions" below);
• if you abuse alcohol;
• if you are under 18 years old.

You must consult your doctor if necessary:

• if you need to undergo a radiological examination or other examination that requires the injection of a contrast agent containing iodine into your bloodstream;
• if you are going to have a major surgical procedure. VALIMAR must be discontinued for a period before and after the examination or surgical procedure. Your doctor will decide if other treatment is necessary during this time. It is essential to follow your doctor's instructions carefully.

Warnings and precautions

Before starting treatment with VALIMAR, discuss it with your doctor or pharmacist.
Diabetic patients should regularly check their blood or urine sugar levels.

Risk of lactic acidosis

VALIMAR 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 case of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver problems, and any conditions in which a part of the body is not adequately supplied with oxygen (e.g., severe heart disease).
If any of the above circumstances apply to you, you should consult your doctor for more detailed instructions.

You should temporarily stop taking VALIMAR if you have a condition that may lead to dehydration

(significant loss of body water), 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 VALIMAR and contact your doctor or the nearest hospital immediately if you experience any symptoms of lactic acidosis

because this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell with severe fatigue,
• breathing difficulties,
• lowered body temperature and slowed heart rate. Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.

If you are going to have a major surgical procedure, you should not take VALIMAR during and for some time after the procedure. Your doctor will decide when you should stop and restart treatment with VALIMAR.
During treatment with VALIMAR, your doctor will check your kidney function at least once a year or more often if you are elderly and/or have impaired kidney function.
VALIMAR itself does not cause hypoglycemia (low blood sugar).
However, if VALIMAR is taken with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, meglitinides), there is a risk of hypoglycemia. If symptoms of hypoglycemia occur, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating, eating or drinking a sugary drink usually helps.
Tablet residues may appear in the stool. Do not worry, this is normal when taking this type of tablet.
You should follow any dietary advice given by your doctor and make sure you eat carbohydrates regularly throughout the day.
You should contact your doctor immediately for further instructions if:

• you have a genetically inherited disease affecting mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness.
• you experience any of the following symptoms after starting metformin: seizures, impaired cognitive function, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and hearing loss.

VALIMAR with other medicines

Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
If you are going to have a contrast agent containing iodine injected into your bloodstream, for example, for an X-ray examination or computed tomography, you must stop taking VALIMAR before or at the latest at the time of injection. Your doctor will decide when you should stop and restart treatment with VALIMAR.
Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood sugar checks and kidney function tests or your doctor may need to adjust your VALIMAR dose. It is especially important to inform your doctor about the following medicines:

• corticosteroids (used to treat various diseases, such as severe skin inflammation or asthma),
• diuretics (medicines that increase urine production),
• 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), beta-2 adrenergic receptor agonists, such as salbutamol or terbutaline (used to treat asthma),
• other medicines used to treat diabetes.

VALIMAR with food, drink, and alcohol

VALIMAR should be taken with a meal or immediately after a meal. You should avoid drinking alcohol while taking VALIMAR, as it may increase the risk of lactic acidosis (see "Warnings and precautions"). Alcohol can increase the risk of lactic acidosis, especially in patients with liver failure or malnutrition. This also applies to medicines containing alcohol.

Pregnancy, breastfeeding, and fertility

During pregnancy, diabetes treatment requires the use of insulin. You should not take VALIMAR if you are pregnant, planning to have a baby, or breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice to change your treatment.

Driving and using machines

VALIMAR used alone does not cause hypoglycemia (low blood sugar), which means it does not affect your ability to drive or use machines.
However, you should be careful when taking VALIMAR with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating. If such symptoms occur, do not drive or operate machinery.

3. How to take VALIMAR

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
VALIMAR 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 dosage
Children:
Due to the lack of appropriate safety data, VALIMAR should not be used in children.
Adults:
The usual initial dose is 1 tablet of VALIMAR 500 mg, taken once a day during the evening meal. After 10-15 days, the dose is adjusted by the doctor based on blood sugar measurements. Gradual dose increase may improve gastrointestinal tolerance.
Your doctor may increase the dose to a maximum of 4 tablets per day (2000 mg), taken once a day during the evening meal.
In patients already treated with metformin, the initial dose of VALIMAR 500 mg should be equivalent to the daily dose of metformin in the form of immediate-release tablets.
In the case of switching from another oral anti-diabetic medicine to VALIMAR 500 mg, the doctor should discontinue the previously used medicine and use VALIMAR 500 mg in the dose specified above.
In patients treated with metformin in a dose above 2000 mg per day in the form of immediate-release tablets, it is not recommended to switch the anti-diabetic treatment to VALIMAR 500 mg.
If you are also taking insulin, your doctor will tell you how to start taking VALIMAR.
VALIMAR used alone (pre-diabetic state)
Usually, a dose of 1000 mg to 1500 mg of metformin is taken once a day with a meal or after a meal. The doctor will assess whether treatment should be continued based on regular blood sugar checks and risk factors.
Treatment monitoring

• Your doctor will prescribe regular blood sugar checks and adjust the VALIMAR dose based on blood sugar 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 you have impaired kidney function. If you have kidney problems, your doctor may prescribe a lower dose.

How to take VALIMAR
VALIMAR should be taken orally with a meal or immediately after a meal. This will help avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow them whole with a glass of water.
If after some time you feel that the effect of the medicine is too strong or too weak, you should consult your doctor.

Taking a higher dose of VALIMAR than recommended

In case of taking a higher dose of VALIMAR than recommended, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (abdominal cramps), general feeling of being unwell with severe fatigue, and breathing difficulties. Other symptoms include lowered body temperature and slowed heart rate. If any of these symptoms occur, you should seek medical help immediately, as lactic acidosis can lead to coma. You should stop taking VALIMAR and contact your doctor or the nearest hospital.

Missing a dose of VALIMAR

If you forget to take VALIMAR, you should take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with VALIMAR

Do not stop taking VALIMAR without consulting your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, stop taking the medicine and seek medical help immediately.

VALIMAR may very rarely cause (may affect up to 1 in 10,000 people) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to you, you should stop takingVALIMAR and contact your doctor or the nearest hospitalimmediately, as lactic acidosis can lead to coma.
Very common side effects (affecting more than 1 in 10 people):

• gastrointestinal disorders, such as diarrhea, nausea, vomiting, abdominal pain (abdominal cramps), loss of appetite; usually occur at the beginning of treatment. To avoid these symptoms, you should take VALIMAR with a meal or immediately after a meal. If the symptoms do not disappear, you should stop taking VALIMAR and tell your doctor.

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

• taste disorders.

Very rare side effects (affecting less than 1 in 10,000 people):

• lactic acidosis. This is a very rare but serious complication, especially when the kidneys are not working properly. Symptoms of lactic acidosis include vomiting, abdominal pain (abdominal cramps), general feeling of being unwell with severe fatigue, and breathing difficulties. If such symptoms occur, you may need immediate hospital treatment, as lactic acidosis can lead to coma. You should stop taking VALIMAR and contact your doctor or the nearest hospital immediately.
• abnormal liver function test results or symptoms of liver inflammation (with accompanying fatigue, loss of appetite, weight loss, and jaundice or without jaundice of the skin and whites of the eyes). If such symptoms occur, you should stop taking VALIMAR and tell your doctor immediately.
• skin reactions, such as skin redness (rash), itching, or itchy hives (urticaria).
• reduced vitamin B levels in the blood.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug 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 49 21 309, 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 VALIMAR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
There are no special precautions for storage of the medicinal product.
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 VALIMAR contains

• The active substance of VALIMAR is metformin hydrochloride. Each prolonged-release tablet contains 500 mg of metformin hydrochloride.
• The other ingredients are: magnesium stearate; colloidal silica, anhydrous; povidone K30; hypromellose K 100M.

What VALIMAR looks like and contents of the pack

VALIMAR 500 mg is a white or almost white capsule-shaped tablet, 16.5 mm x 8.2 mm in size, with the inscription "XR500" on one side and smooth on the other.
Packaging: 30 or 60 tablets in aluminum/PVC blisters, placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fairmed Healthcare GmbH
Dorotheenstraße 48
22301 Hamburg, Germany
pv@fair-med.com

Manufacturer/Importer

Zakłady Farmaceutyczne POLPHARMA SA
ul. Pelplińska 19
83-200 Starogard Gdański
Poland
To obtain more detailed information, please contact the local representative of the marketing authorization holder:
Date of last revision of the leaflet:03/2025