Valimar

Patient Information Leaflet

VALIMAR 500 mg, prolonged-release 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.
• Talk to your doctor or pharmacist if you have any questions.
• This medicine has been prescribed for you personally. 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.

Leaflet Contents

1. What VALIMAR is and what it is used for
2. What you need to know before you take 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 VALIMAR is and what it is used for

VALIMAR contains metformin hydrochloride, a medicine used in diabetes. It belongs to a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas that enables the body to take glucose (sugar) from the blood and use it for energy or store 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 an abnormally high level of glucose in the blood.
VALIMAR helps to lower blood glucose levels to values as close to normal as possible.
In overweight adults, long-term use of VALIMAR also reduces the risk of diabetes-related complications. Treatment with VALIMAR is associated with stable body weight or a slight reduction in body weight.
VALIMAR is used in adults:

• with type 2 diabetes (also known as non-insulin-dependent diabetes), particularly in overweight patients. Adults may take VALIMAR as monotherapy or in combination with other antidiabetic medicines (oral medications or insulin);
• for prevention of type 2 diabetes in patients with prediabetes.

2. Important information before using VALIMAR

When not to use VALIMAR:

• if the patient is allergic to metformin hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the patient has liver function disorders;
• 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 an unusual fruity odour of the breath.
• in case of excessive fluid loss from the body (dehydration), e.g. due to prolonged or severe diarrhoea, or repeated vomiting. Dehydration may lead to kidney dysfunction, which in turn may result in lactic acidosis (see below under "Warnings and precautions");
• if the patient has a severe infection, e.g. pneumonia, bronchitis, or kidney infection. Severe infections may lead to kidney dysfunction, which may result in lactic acidosis (see below under "Warnings and precautions");
• if the patient has been treated for acute heart failure or recently suffered a heart attack, or has severe circulatory disorders, shock, or breathing difficulties. These conditions may cause tissue hypoxia, which may result in lactic acidosis (see below under "Warnings and precautions");
• if the patient abuses alcohol;
• if the patient is under 18 years of age.

It is essential to consult a doctor if any of the following procedures are required:

• radiological examination or other procedures requiring intravenous injection of an iodine-containing contrast agent;
• major surgical procedure. VALIMAR must be discontinued for a certain period before and after the examination or surgery. 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
Before starting treatment with VALIMAR, discuss it with your doctor or pharmacist.
Patients with diabetes should regularly monitor blood or urine glucose levels.
Risk of lactic acidosis
VALIMAR may cause a very rare but serious adverse effect called lactic acidosis, especially if the patient has kidney dysfunction. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), liver dysfunction, or any medical condition involving inadequate oxygen supply to body tissues (e.g. acute severe heart disease).
If any of the above conditions apply to the patient, consult a doctor for further instructions.
VALIMAR should be temporarily discontinued if the patient develops any illness associated with dehydration (significant fluid loss from the body), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. Consult a doctor for further instructions.
VALIMAR 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 accompanied by profound fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.

If the patient is undergoing major surgery, VALIMAR must not be taken during the procedure and for a period afterwards. The doctor will decide when the patient should stop and restart treatment with VALIMAR.
During treatment with VALIMAR, the doctor will monitor kidney function at least once a year, or more frequently if the patient is elderly and/or has worsening kidney function.
VALIMAR alone does not cause hypoglycaemia (low blood glucose levels).
However, if VALIMAR is used in combination with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylureas, insulin, or meglitinides), there is a risk of hypoglycaemia. If symptoms of hypoglycaemia occur, such as weakness, dizziness, excessive sweating, rapid heartbeat, visual disturbances, or difficulty concentrating, consuming sugar-containing food or drink usually helps.
Undissolved tablet residues may appear in the stool. This is normal with this type of tablet and should not be a cause for concern.
Follow all dietary advice provided by the doctor and ensure carbohydrates are consumed regularly throughout the day.
Contact the doctor immediately for further instructions if:

• the patient has a genetically inherited disorder 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);
• after starting metformin, the patient experiences any of the following symptoms: seizures, worsening cognitive function, difficulty moving, signs of nerve damage (e.g. pain or numbness), migraine, or hearing loss.

VALIMAR and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
If an iodine-containing contrast agent is to be injected intravenously, for example during an X-ray or CT scan, the patient must stop taking VALIMAR before or at the latest at the time of injection. The doctor will decide when to stop and restart VALIMAR treatment.
Inform the doctor about all medicines currently or recently taken, as well as any planned medications. The patient may require more frequent blood glucose monitoring and kidney function assessments, or dose adjustments of VALIMAR. It is particularly important to inform the doctor about the following medicines:

• corticosteroids (used to treat various conditions, e.g. 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), and beta-2 adrenergic receptor agonists such as salbutamol or terbutaline (used in asthma treatment);
• other medicines used to treat diabetes.

VALIMAR, food, drink, and alcohol
VALIMAR should be taken with a meal or immediately after a meal. Avoid alcohol consumption during treatment with VALIMAR, as it may increase the risk of lactic acidosis (see "Warnings and precautions"). Alcohol may increase the risk of lactic acidosis, especially in patients with liver impairment or in malnourished individuals. This also applies to medicines containing alcohol.

Pregnancy, breastfeeding, and fertility
During pregnancy, diabetes treatment requires insulin. VALIMAR should not be used if the patient is pregnant, planning to become pregnant, or breastfeeding.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor, who will adjust the treatment accordingly.

Driving and operating machinery
VALIMAR, when used alone, does not cause hypoglycaemia (low blood sugar levels), meaning it does not affect the ability to drive or operate machinery.
However, particular caution is required when VALIMAR is used in combination with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylureas, insulin, or meglitinides). Symptoms of hypoglycaemia include: weakness, dizziness, excessive sweating, rapid heartbeat, visual disturbances, or difficulty concentrating. If such symptoms occur, the patient should not drive or operate machinery.

3. How to use VALIMAR

This medicine should always be taken exactly as prescribed by your doctor. In case of doubt, consult your doctor or pharmacist.
VALIMAR does not replace the benefits of a healthy lifestyle. You should continue to follow any dietary and regular physical activity recommendations given by your doctor.

Recommended dosage
Children:
Due to lack of adequate safety data, VALIMAR should not be used in children.

Adults:
The usual starting dose is 1 tablet of VALIMAR 500 mg, taken once daily with the evening meal. After 10–15 days, the dose will be adjusted by the doctor based on blood glucose measurements. Gradual dose escalation may improve gastrointestinal tolerance.

Your doctor may increase the dose up to a maximum of 4 tablets per day (2000 mg), taken once daily with the evening meal.

For patients already treated with metformin, the starting dose of VALIMAR 500 mg should correspond to the daily dose of metformin in immediate-release tablets.

When switching from another oral antidiabetic medicine to VALIMAR 500 mg, your doctor should discontinue the previously used medicine and initiate VALIMAR 500 mg at the dose specified above.

Switching antidiabetic treatment to VALIMAR 500 mg is not recommended for patients currently taking metformin at doses exceeding 2000 mg per day in the form of immediate-release tablets.

If the patient is also using insulin, the doctor will advise on how to start treatment with VALIMAR.

VALIMAR used as the sole medicine (prediabetes state)
The usual dose is 1000 mg to 1500 mg of metformin once daily with or after a meal. The doctor will assess whether treatment should continue based on regular blood glucose monitoring and risk factors.

Monitoring of treatment

• Your doctor will order regular blood glucose tests and adjust the dose of VALIMAR according to blood glucose levels. You should attend regular follow-up visits with your doctor. This is particularly important for elderly patients.
• Your doctor will check kidney function at least once a year. More frequent monitoring may be necessary for elderly patients or if kidney function is impaired. If kidney function is reduced, 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 helps avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablets whole with a glass of water.
If at any time the patient feels that the medicine’s effect is too strong or too weak, they should consult their doctor.

Taking more VALIMAR than recommended
If more VALIMAR is taken than prescribed, 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 lowered body temperature and slower heartbeat. If any of these symptoms occur, the patient should seek immediate medical help, as lactic acidosis can lead to coma. VALIMAR should be discontinued and the patient should contact their doctor or go to the nearest hospital immediately.

Missing a dose of VALIMAR
If the patient forgets to take VALIMAR, they should take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

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

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following symptoms occur, stop taking the medicine
and seek immediate medical help.
VALIMAR may very rarely (in up to 1 in 10,000 patients) cause a very serious adverse reaction known as lactic acidosis (see section "Warnings and precautions"). If a patient develops lactic acidosis, VALIMAR must be discontinued immediately and the patient should contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.

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

• Gastrointestinal disorders such as diarrhoea, nausea, vomiting, abdominal pain (pain in the abdominal cavity), loss of appetite; these most commonly occur at the beginning of treatment. To help prevent these symptoms, VALIMAR should be taken with food or immediately after a meal. If symptoms do not resolve, VALIMAR should be discontinued and the doctor informed.

Common adverse reactions (occurring in less than 1 in 10 people):

• Taste disturbances.

Very rare adverse reactions (occurring in less 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 include: vomiting, abdominal pain (pain in the abdominal cavity) with muscle cramps, general feeling of malaise with severe fatigue and difficulty breathing. If such symptoms occur, the patient may require immediate hospital treatment, as lactic acidosis may lead to coma. VALIMAR must be stopped immediately and the doctor contacted or the nearest hospital contacted without delay.
• Abnormal liver function test results or symptoms of hepatitis (accompanied by fatigue, loss of appetite, weight loss, and with or without yellowing of the skin and whites of the eyes). If such symptoms occur, VALIMAR must be discontinued and the doctor informed immediately.
• Skin reactions such as skin redness (erythema), skin itching, or itchy rash (urticaria).
• Decreased blood levels of vitamin B.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor or pharmacist. Adverse reactions 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the 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 stated month.
The marking on the package following "EXP" indicates the expiry date, and following "Lot/LOT" indicates the batch number.
No special storage conditions are required for this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 500 mg of metformin hydrochloride.
• Other ingredients are: magnesium stearate; colloidal anhydrous silica; povidone K30; hypromellose K 100M.

What Valimar looks like and contents of the pack
Valimar 500 mg are white or almost white, capsule-shaped tablets, 16.5 mm x 8.2 mm in size, embossed with "XR500" on one side and plain on the reverse.
Pack sizes: 30 or 60 tablets in aluminium/PVC blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

Fairmed Healthcare GmbH
Maria-Goeppert-Straße 3
23562 Lübeck
Germany

For further information, please contact the local representative of the Marketing Authorisation Holder: