Metformin hydrochloride interdos pharma

Package leaflet: information for the user

Metformin hydrochloride Interdos Pharma, 500 mg, prolonged-release tablets
Metformin hydrochloride Interdos Pharma, 750 mg, prolonged-release tablets
Metformin hydrochloride Interdos Pharma, 1000 mg, prolonged-release tablets
Metformini hydrochloridum
Please read 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 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, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Metformin hydrochloride Interdos Pharma is and what it is used for
2. What you need to know before taking Metformin hydrochloride Interdos Pharma
3. How to take Metformin hydrochloride Interdos Pharma
4. Possible side effects
5. How to store Metformin hydrochloride Interdos Pharma
6. Contents of the pack and other information

1. What Metformin hydrochloride Interdos Pharma is and what it is used for

Metformin hydrochloride Interdos Pharma contains the active substance metformin hydrochloride
and belongs to a group of medicines called biguanides, used in the treatment of type 2
(insulin-independent) diabetes.
Metformin hydrochloride is used to treat type 2 diabetes when diet and exercise alone are not
sufficient to control blood glucose (sugar) levels. Insulin is a hormone that enables body tissues
to take up glucose from the blood and use it to produce energy or store it for later use. In people
with type 2 diabetes, the pancreas does not produce enough insulin or the body cannot properly
use the insulin that is produced. This leads to glucose accumulating in the blood, which may cause
a number of serious, long-term health problems. Therefore, it is important to continue taking the
medicine, even if you have no noticeable symptoms. Metformin hydrochloride increases the body's
sensitivity to insulin and helps restore the normal way the body uses glucose.
Treatment with Metformin hydrochloride Interdos Pharma is associated with weight maintenance
or moderate weight loss.
The tablets of Metformin hydrochloride Interdos Pharma have been specially designed to slowly
release the medicine in the body and therefore differ from many other types of tablets containing
metformin.

2. Important information before taking Metformin hydrochloride Interdos Pharma

When not to take Metformin hydrochloride Interdos Pharma:

• if the patient is allergic to metformin hydrochloride or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may cause rash, itching or shortness of breath.
• if the patient has liver function disorders.
• if the patient has significantly reduced kidney function.
• if the patient has uncontrolled diabetes associated, for example, with severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, rapid 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, which may lead to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or an unusual fruity odour of the breath.
• if the patient has lost too much fluid from the body (dehydration), which may occur in case of prolonged or severe diarrhoea or repeated vomiting. Dehydration may lead to kidney function disorders, which may expose the patient to the risk of lactic acidosis (see "Warnings and precautions").
• if the patient has a severe infection, for example, of the lungs, bronchi or kidneys. Severe infections may lead to kidney function disorders, which may expose the patient to the risk of lactic acidosis (see "Warnings and precautions").
• if the patient has been treated for acute heart diseases, recently suffered a heart attack, has severe symptoms of circulatory failure or breathing difficulties. This may lead to tissue hypoxia, which may expose the patient to the risk of lactic acidosis (see "Warnings and precautions").
• if the patient consumes large amounts of alcohol.
• if the patient is under 18 years of age.

Warnings and precautions
Before starting treatment with Metformin hydrochloride Interdos Pharma, discuss this with your doctor.
Risk of lactic acidosis.
Metformin hydrochloride Interdos Pharma may cause a very rare but very serious adverse reaction called lactic acidosis, especially if the patient has kidney function disorders. The risk of lactic acidosis increases also in case of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), liver function disorders and any disease states in which a part of the body is inadequately supplied with oxygen (such as acute, severe heart disease).
If any of the above statements apply to the patient, consult a doctor for further instructions.
The patient should temporarily stop taking Metformin hydrochloride Interdos Pharma if the patient experiences a condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, exposure to high temperature, or if the patient drinks less fluids than usual. Consult a doctor for further instructions.
If any of the symptoms of lactic acidosis occur, the patient must stop taking Metformin hydrochloride Interdos Pharma and immediately contact a doctor or the nearest hospital, because this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting
• abdominal pain
• muscle cramps
• general malaise associated with severe fatigue
• difficulty breathing
• low body temperature and slowed heart rate

Lactic acidosis is an acute, life-threatening condition requiring hospital treatment.
If the patient is to undergo major surgery, the patient must stop taking Metformin hydrochloride Interdos Pharma during the procedure and for some time afterwards. The doctor will decide when the patient should stop and resume treatment with Metformin hydrochloride Interdos Pharma.
During treatment with Metformin hydrochloride Interdos Pharma, the doctor will check the patient's kidney function at least once a year, or more frequently if the patient is elderly and/or has worsening kidney function.
Undigested tablet residues may be present in the stool. Do not worry – this is normal for this type of tablet.
The patient should continue to follow all dietary recommendations provided by the doctor and regularly consume carbohydrates throughout the day.
Do not stop taking this medicine without consulting a doctor.
Metformin hydrochloride Interdos Pharma and other medicines
If an intravascular iodine-containing contrast agent needs to be administered, for example during an X-ray examination, ultrasound or computed tomography, the patient must stop taking Metformin hydrochloride Interdos Pharma before or at the latest at the time of injection. The doctor will decide when the patient should stop and resume treatment with Metformin hydrochloride Interdos Pharma.
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. More frequent monitoring of blood glucose levels and kidney function may be necessary, or the doctor may adjust the dose of Metformin hydrochloride Interdos Pharma. It is especially important to inform the doctor about the following medicines:

• Medicines that increase urine production (diuretics (water tablets), such as furosemide).
• Medicines used to treat pain and inflammatory conditions (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
• Some medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
• Steroids, such as prednisolone, mometasone, beclomethasone.
• Sympathomimetic medicines, including epinephrine and dopamine, used to treat heart attack and low blood pressure. Epinephrine is also contained in some dental anaesthetic medicines.
• Medicines that may alter the blood concentration of Metformin hydrochloride Interdos Pharma, especially in patients with kidney function disorders (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Metformin hydrochloride Interdos Pharma and alcohol
While taking Metformin hydrochloride Interdos Pharma, avoid consuming excessive amounts of alcohol, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor, as changes in treatment or monitoring of blood glucose levels may be necessary.
Use of this medicine is not recommended if the patient is breastfeeding or plans to breastfeed.
Driving and operating machinery
Metformin hydrochloride Interdos Pharma, when used alone as an antidiabetic medicine, does not cause hypoglycaemia (symptoms of low blood sugar or hypoglycaemia, such as fainting, confusion and excessive sweating), and therefore should not affect the ability to drive or operate machinery.
However, it should be noted that Metformin hydrochloride Interdos Pharma, when taken together with other antidiabetic medicines, may cause hypoglycaemia; therefore, in such cases, special caution should be exercised when driving or operating machinery.

3. How to take Metformin hydrochloride Interdos Pharma

Your doctor may prescribe you Metformin hydrochloride Interdos Pharma as the only antidiabetic medicine or in combination with other oral antidiabetic medicines or insulin.
This medicine should always be taken exactly as your doctor has instructed. If in doubt, consult your doctor or pharmacist.
The tablets should be swallowed whole with a glass of water, without chewing.

Recommended dose
Treatment usually starts with a dose of 500 milligrams of Metformin hydrochloride Interdos Pharma per day. After approximately 2 weeks of taking Metformin hydrochloride Interdos Pharma, your doctor may adjust the dose based on blood glucose measurements. The maximum daily dose is 2,000 milligrams of Metformin hydrochloride Interdos Pharma.
If you have impaired kidney function, your doctor may prescribe a lower dose.
Usually, the tablets should be taken once daily during the evening meal.
In some cases, your doctor may recommend taking the tablets twice daily. The tablets should always be taken with food.

Taking more Metformin hydrochloride Interdos Pharma than prescribed
If you accidentally take extra tablets, do not worry, but if unusual symptoms occur, contact your doctor. If the overdose is significant, lactic acidosis is more likely to occur. Symptoms of lactic acidosis are nonspecific and include vomiting, abdominal pain with muscle cramps, general malaise with severe fatigue, and difficulty breathing. Other symptoms include lowered body temperature and slowed heart rate. If any of these symptoms occur, seek immediate medical help, as lactic acidosis may lead to coma. You must immediately stop taking Metformin hydrochloride Interdos Pharma and contact your doctor or the nearest hospital without delay.

If you forget to take Metformin hydrochloride Interdos Pharma
As soon as you remember, take the missed dose with food. Do not take a double dose to make up for a forgotten tablet.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur:
The medicine Metformin hydrochloride Interdos Pharma may cause a very rare (may occur in no
more than 1 in 10,000 patients), but very serious adverse reaction called lactic acidosis (see section
"Warnings and precautions"). If any symptoms of lactic acidosis occur, the patient must stop taking
Metformin hydrochloride Interdos Pharma and immediately contact a doctor or the nearest
hospital, as this condition may lead to coma.
Metformin hydrochloride Interdos Pharma may cause abnormal liver function test results and hepatitis,
which may lead to jaundice (may occur in no more than 1 in 10,000 people). If yellowing of the eyes
and/or skin occurs, the patient should immediately contact a doctor.
Other possible adverse reactions are listed below according to frequency of occurrence as follows:
Very common (may affect more than 1 in 10 people):

• Diarrhoea, nausea, vomiting, abdominal pain or loss of appetite. If these occur, the patient should not stop taking the tablets, as these symptoms usually resolve within about 2 weeks. It is helpful to take the tablets during or immediately after a meal.

Common (may affect up to 1 in 10 people)

• Altered taste
• Decreased or low blood levels of vitamin B12 (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling sensations (paraesthesiae), or paleness or yellowing of the skin). The doctor may order tests to determine the cause of symptoms, as some of them may also be caused by diabetes or other health problems unrelated to diabetes.

Very rare (may affect up to 1 in 10,000 people):

• Skin rashes, including redness, itching and urticaria

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, the patient should
inform their doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department
of Monitoring of 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,
Faks: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Metformin hydrochloride Interdos Pharma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following "EXP:".
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines should 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 Metformin hydrochloride Interdos Pharma contains

• The active substance is metformin hydrochloride.
• The other ingredients are: microcrystalline cellulose, hypromellose, colloidal anhydrous silica, sodium stearyl fumarate.

What Metformin hydrochloride Interdos Pharma looks like and contents of the pack
Metformin hydrochloride Interdos Pharma 500 mg, prolonged-release tablets are white or
almost white, round, biconvex tablets, with the imprint "500" on one side and smooth on the
other side.
Metformin hydrochloride Interdos Pharma 750 mg, prolonged-release tablets are white or
almost white, capsule-shaped, biconvex tablets, with the imprint "750" on one side and smooth on the
other side.
Metformin hydrochloride Interdos Pharma 1000 mg, prolonged-release tablets are white or
almost white, modified capsule-shaped, biconvex tablets, with the imprint "1000" on one side and
smooth on the other side.
Metformin hydrochloride Interdos Pharma may be supplied in various pack sizes.
500 mg: 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 180, 600 tablets.
750 mg: 14, 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 180 or 600 tablets.
1000 mg: 14, 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 180 or 600 tablets.
Not all pack sizes may be marketed.
Metformin hydrochloride Interdos Pharma 500 mg, 750 mg and 1000 mg, prolonged-release tablets are manufactured for
Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
Sohan Healthcare sro
Milady Horakove 75/105,
Hradcany, 160 00 Prague 6
Czech Republic
Importer
Basic Pharma Manufacturing B.V.
Burgemeester Lemmensstraat 352
6163 JT Geleen
The Netherlands
This medicinal product is authorised for marketing in the Member States of the European Economic Area under the following names:
Germany Metformin 500 mg prolonged release tablets
Metformin 750 mg prolonged release tablets
Metformin 1 000 mg prolonged release tablets
Bulgaria Metformin 500 mg prolonged release tablets
Metformin 750 mg prolonged release tablets
Metformin 1 000 mg prolonged release tablets
Poland Metformin hydrochloride Interdos Pharma

Useful advice

• If the patient smokes, they should try to stop smoking.
• Regular physical exercise is recommended.
• Alcohol consumption should be limited to the minimum necessary.
• The patient should take care of their feet. For information on foot care, the patient should contact a clinic or hospital.
• The patient should carry a card, bracelet, or other item indicating that they have diabetes.
• The patient should visit a diabetes clinic regularly.

If the patient would like more information about diabetes, they should contact their nearest diabetes clinic or doctor.