Valimar

Package Leaflet: Information for the Patient

VALIMAR, 750 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package 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 patients 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 sugar levels.
VALIMAR helps lower blood sugar 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 known as non-insulin-dependent diabetes), especially in patients with overweight. Adults can take VALIMAR either 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:

You must consult your doctor if necessary:

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 cases 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 conditions 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

(excessive 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,
• decreased body temperature and slower heart rate. Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.

If you are to undergo major surgery, you should not take VALIMAR during and for some time after the surgery. 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 hypoglycemic symptoms occur, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating, usually eating or drinking a sugary drink helps.
Tablet residues may appear in the stool. Do not be concerned, as this is normal when taking this type of tablet.
You should follow any dietary advice given by your doctor and ensure that carbohydrates are consumed regularly throughout the day.
You should contact your doctor immediately for further instructions if:

• you have a genetically inherited disease affecting the 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.
• after starting metformin, you experience any of the following symptoms: seizures, impaired cognitive function, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or 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 to be injected with a contrast agent containing iodine into the 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 the 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 or kidney function tests, or your doctor may need to adjust the dose of VALIMAR. 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 consuming 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 the 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 use machines.

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 starting dose is 1 tablet of VALIMAR 750 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 2 tablets of VALIMAR 750 mg per day, taken during the evening meal.
In patients already treated with metformin, the starting dose of VALIMAR 750 mg should be equivalent to the daily dose of metformin in the form of immediate-release tablets.
When switching from another oral anti-diabetic medicine to VALIMAR 750 mg, the doctor should discontinue the previously used medicine and use VALIMAR 750 mg in the dose specified above.
In patients treated with metformin at 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 750 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 dose of VALIMAR 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 the tablets 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.

Overdose of VALIMAR

In case of overdose, 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 decreased body temperature and slower heart rate. If any of these symptoms occur, you should immediately seek medical attention, 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following symptoms, stop taking the medicine and seek medical attention 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 hospital immediately, 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; these 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) with muscle 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 redness of the skin (rash), itching, or itchy hives (urticaria).
• decreased vitamin B12 levels in the blood.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can 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 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 stated.
The packaging is marked with "EXP" for the expiry date and "Lot/LOT" for the batch number.
There are no special storage instructions for this medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What VALIMAR contains

• The active substance is metformin hydrochloride. Each prolonged-release tablet contains 750 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 750 mg is a white or almost white capsule-shaped tablet, 19.6 mm x 9.3 mm in size, with "XR750" embossed 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
[email protected]

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