Valimar

Package leaflet: Information for the patient

VALIMAR, 750 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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

VALIMAR contains metformini hydrochloridum, 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 abnormally high levels of glucose in the blood.
VALIMAR helps 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 maintenance of body weight or slight weight reduction.
VALIMAR is used in adults:

• with type 2 diabetes (also known as insulin-independent diabetes), particularly in overweight patients. Adults may take VALIMAR as the only antidiabetic medicine or in combination with other antidiabetic medicines (oral agents 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 sugar 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 which may lead to diabetic pre-coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness, or unusual fruity odour of the breath.
• in case of excessive loss of body fluids (dehydration), e.g. due to prolonged or severe diarrhoea, or repeated vomiting. Dehydration may lead to kidney dysfunction, which in turn may increase the risk of lactic acidosis (see section "Warnings and precautions" below);
• if the patient has a severe infection, e.g. pneumonia, bronchitis, or kidney infection. Severe infections may lead to kidney dysfunction, which may increase the risk of lactic acidosis (see section "Warnings and precautions" below);
• 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 increase the risk of lactic acidosis (see section "Warnings and precautions" below);
• 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 test 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 function disorders. 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, and any medical conditions in which a 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, seek further instructions from a doctor.
Temporarily discontinue VALIMAR if the patient develops any illness associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, or exposure to high temperatures, or if the patient drinks less fluid than usual. Consult a doctor for further instructions.
Discontinue VALIMAR and contact a doctor or the nearest hospital immediately if the patient experiences any symptoms of lactic acidosis, as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general malaise combined 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 undergoing major surgery, VALIMAR must not be taken during the procedure and for some time 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 sulfonylurea derivatives, insulin, meglitinides), there is a risk of hypoglycaemia. If symptoms of hypoglycaemia occur, such as weakness, dizziness, excessive sweating, rapid heartbeat, blurred vision, or difficulty concentrating, eating or drinking a sugary food or drink usually helps.

Undigested 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 that carbohydrates are consumed regularly throughout the day.
Contact the doctor immediately for 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 cognitive function, movement difficulties, signs indicating nerve damage (e.g. pain or numbness), migraine, or deafness.

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 treatment with VALIMAR.
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take. The patient may require more frequent monitoring of blood glucose levels and kidney function, or a dose adjustment of VALIMAR by the doctor. It is especially 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), 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. Avoid consuming alcohol while taking VALIMAR, as this may increase the risk of lactic acidosis (see section "Warnings and precautions"). Alcohol may increase the risk of lactic acidosis, particularly in patients with liver failure or in undernourished 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 a doctor so that treatment can be appropriately adjusted.
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, special caution is required when VALIMAR is used in combination with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylurea derivatives, insulin, meglitinides). Symptoms of hypoglycaemia include: weakness, dizziness, excessive sweating, rapid heartbeat, blurred vision, 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 used as directed by the physician. If in doubt, consult a doctor or pharmacist.
VALIMAR does not replace the benefits of a healthy lifestyle. Any recommendations from the doctor regarding diet and regular physical activity should be continued.

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

Adults:
The usual initial dose is 1 tablet of VALIMAR 750 mg, taken once daily with the evening meal. After 10–15 days, the dose will be adjusted by the physician based on blood glucose measurements. Gradual dose escalation may improve gastrointestinal tolerance.
The physician may increase the dose up to a maximum of 2 tablets of VALIMAR 750 mg per day, taken with the evening meal.

For patients already receiving metformin, the initial dose of VALIMAR 750 mg should correspond to the daily dose of metformin in immediate-release tablets.

When switching from another oral antidiabetic medicine to VALIMAR 750 mg, the physician should discontinue the previously used medicine and initiate VALIMAR 750 mg at the dose specified above.

Switching antidiabetic treatment to VALIMAR 750 mg is not recommended for patients currently receiving more than 2000 mg of metformin per day in immediate-release tablets.

If the patient is also using insulin, the physician will provide instructions on how to start using VALIMAR.

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

Monitoring of treatment

• The physician will order regular blood glucose tests and adjust the dose of VALIMAR according to blood glucose levels. Regular follow-up visits to the physician are essential. This is particularly important for elderly patients.
• The physician will check kidney function at least once a year. More frequent monitoring may be necessary for elderly patients or in patients with impaired kidney function. If kidney function is impaired, the physician may prescribe a lower dose.

How to use VALIMAR
VALIMAR should be taken orally with a meal or immediately after a meal. This helps avoid gastrointestinal adverse effects.
Do not crush or chew the tablets. Swallow the tablets whole with a glass of water.
If, after some time, the patient feels that the medicine’s effect is too strong or too weak, they should consult the physician.

Taking more VALIMAR than prescribed
If a higher than prescribed dose of VALIMAR is taken, 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 heart rate. If any of these symptoms occur, the patient should seek immediate medical help, as lactic acidosis may lead to coma. VALIMAR should be discontinued and the patient should contact a physician or go to the nearest hospital.

Missing a dose of VALIMAR
If the patient forgets to take VALIMAR, the next dose should be taken 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 the physician. If there are any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following symptoms occur, you must stop taking the medicine
and seek immediate medical help.
VALIMAR may very rarely (may occur in up to 1 patient in
10,000) cause a very serious adverse reaction known as lactic acidosis
(see section “Warnings and precautions”). If this occurs in a patient, treatment with VALIMAR must be stopped
and you must contact your doctor or nearest hospital immediately,
as lactic acidosis may lead to coma.

Very common adverse reactions (occur 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 avoid these symptoms, VALIMAR should be taken with food or immediately after a meal. If symptoms do not resolve, VALIMAR should be discontinued and your doctor should be informed.

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

• Taste disturbances.

Very rare adverse reactions (occur in less than 1 in 10,000 people):

• Lactic acidosis. This is a very rare but serious complication, particularly if the kidneys are not functioning properly. Symptoms of lactic acidosis include: vomiting, abdominal pain (abdominal cavity pain) with muscle cramps, general feeling of being unwell with severe fatigue and difficulty breathing. If such symptoms occur, the patient may require immediate hospital treatment, as lactic acidosis can lead to coma. VALIMAR must be discontinued immediately and you must contact your doctor or go to the nearest hospital without delay.
• Abnormal liver function test results or symptoms of hepatitis (associated with 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 your doctor must be informed immediately.
• Skin reactions such as skin redness (erythema), 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 your 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine 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 the abbreviation EXP indicates the expiry date, and following the abbreviation 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 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.
• Other ingredients are: magnesium stearate; colloidal anhydrous silica; povidone K30; hypromellose K 100M.

What VALIMAR looks like and contents of the pack
VALIMAR 750 mg are white or almost white capsule-shaped tablets, 19.6 mm x 9.3 mm in size, embossed with "XR750" on one side and plain on the other.
Pack sizes: 30 or 60 tablets in aluminium/PVC blisters, placed in a cardboard carton.
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 more detailed information, please contact the local representative of the Marketing Authorisation Holder: