Valimar

Package leaflet: Information for the patient

VALIMAR, 1000 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, as 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 other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What VALIMAR is and what it is 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 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 up 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 blood glucose levels.
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 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 a single therapy 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 which 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 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 below "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 increase the risk of lactic acidosis (see section below "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 increase the risk of lactic acidosis (see section below "Warnings and precautions");
• if the patient abuses alcohol;
• if the patient is under 18 years of age.

You must consult your doctor if:

• a radiological examination or another procedure requiring intravenous injection of an iodine-containing contrast agent is required;
• a major surgical procedure is planned. VALIMAR must be discontinued for a certain period before and after the examination or surgery. Your doctor will decide whether alternative treatment is necessary during this time. It is important to strictly follow your doctor's instructions.

Warnings and precautions
Before starting treatment with VALIMAR, discuss this with your doctor or pharmacist.
Patients with diabetes should regularly monitor their 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, and any medical conditions in which part of the body is inadequately oxygenated (e.g. acute severe heart disease).
If any of the above conditions apply to the patient, consult your doctor for further instructions.
Temporarily discontinue VALIMAR if the patient develops any medical condition associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. Consult your doctor for further instructions.
Discontinue VALIMAR immediately and contact your doctor or the nearest hospital immediately 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 associated with 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 used during the procedure and for some time afterwards. Your doctor will decide when to stop and restart treatment with VALIMAR.
During treatment with VALIMAR, your 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 itself 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, increased sweating, rapid heartbeat, blurred vision, or difficulty concentrating, it usually helps to eat or drink something containing sugar.
Undigested tablet remnants may appear in the stool. This is normal when taking this type of tablet and should not be a cause for concern.
Follow all dietary advice provided by your doctor and ensure that carbohydrates are consumed regularly throughout the day.
Contact your doctor immediately for further instructions if:

• the patient has a genetically inherited mitochondrial disorder (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, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine, or hearing loss.

VALIMAR and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
If the patient is to receive an intravenous iodine-containing contrast agent, for example for an X-ray examination or computed tomography, the patient must stop taking VALIMAR before or at the latest at the time of injection. Your doctor will decide when to stop and restart treatment with VALIMAR.
Inform your doctor about all medicines currently or recently taken, as well as any planned medications. The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of VALIMAR by the doctor.
It is especially important to inform your 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 impairment or in malnourished individuals. This also applies to medicines containing alcohol.

Pregnancy, breastfeeding and fertility
During pregnancy, diabetes treatment requires insulin. Do not use VALIMAR if the patient is pregnant, planning to become pregnant, or breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her 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, increased sweating, rapid heartbeat, blurred vision, or difficulty concentrating. If such symptoms occur, do not drive or operate machinery.

3. How to use VALIMAR

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.
VALIMAR does not replace the benefits of a healthy lifestyle. You should continue to follow any advice from your doctor regarding diet and regular physical activity.
Your doctor may prescribe VALIMAR to be used alone or in combination with other oral antidiabetic medicines, or with insulin.

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 your doctor based on blood glucose measurements. After the dose has been established, your doctor may consider switching to VALIMAR 1000 mg. Your doctor may increase the dose up to a maximum of 2 tablets of VALIMAR 1000 mg (2000 mg) once daily with the evening meal.
For patients already treated with metformin, the starting dose of VALIMAR should be equivalent to the daily dose of metformin in immediate-release tablets.
When switching from another oral antidiabetic medicine to VALIMAR 1000 mg, your doctor should discontinue the previously used medicine and initiate VALIMAR 1000 mg at the dose specified above.
Switching antidiabetic treatment to VALIMAR is not recommended for patients currently taking more than 2000 mg of metformin daily in 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 only medicine (prediabetes state)
The usual dose is 1000 mg to 1500 mg of metformin once daily with or after a meal. Your doctor will assess whether treatment should continue based on regular blood glucose testing 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 use 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 you feel that the medicine's effect is too strong or too weak, consult your doctor.

Taking more VALIMAR than prescribed
If you take more VALIMAR than prescribed, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (abdominal discomfort) 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, seek immediate medical attention, as lactic acidosis can lead to coma. Discontinue VALIMAR and contact your doctor or go to the nearest hospital immediately.

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

Stopping VALIMAR
Do not stop taking this medicine 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 medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur, stop taking the medicine
and seek medical help immediately.
VALIMAR may very rarely cause (may occur in up to 1 patient in 10,000)
a very serious adverse reaction known as lactic acidosis (see section
"Warnings and precautions"). If this occurs in a patient, VALIMAR must be discontinued
and a doctor or the nearest hospital must be contacted immediately, as lactic acidosis
can 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 avoid 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, especially if the kidneys are not functioning properly. Symptoms of lactic acidosis include: vomiting, abdominal pain (abdominal pain) with muscle cramps, general malaise with a feeling of 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 a doctor or the nearest hospital must be 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 redness of the skin (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 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
Phone: +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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store VALIMAR

Keep the 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 label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot/LOT.
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. This will help protect the environment.

6. Contents of the packaging and other information

What VALIMAR contains

• The active substance is metformin hydrochloride. Each prolonged-release tablet contains 1000 mg of metformin hydrochloride.
• Other components: magnesium stearate; colloidal anhydrous silica; povidone K30; hypromellose K 100M.

What VALIMAR looks like and contents of the pack
VALIMAR 1000 mg are white or almost white capsule-shaped tablets, measuring 21.1 mm x 10.1 mm, with an imprint "XR1000" 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: