METFORMINA 500 mg Таблетки С Пролонгированным Высвобождением

Содержание инструкции

1. Metformina Accordpharma 500 mg prolonged-release tablets, 700 mg prolonged-release tablets, 1000 mg prolonged-release tablets
   1. What is Metformina Accordpharma and what is it used for
   2. What you need to know before taking Metformina Accordpharma
   3. How to take Metformina Accord
   4. Possible side effects
   5. How to store Metformina Accordpharma
   6. Package Contents and Other Information

Metformina Accordpharma 500 mg prolonged-release tablets, 700 mg prolonged-release tablets, 1000 mg prolonged-release tablets

metformin hydrochloride

Generic Medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section
• 4.

Contents of this leaflet

• 1. What Metformina Accordpharma is and what it is used for
• 2. What you need to know before you take Metformina Accordpharma
• 3. How to take Metformina Accordpharma
• 4. Possible side effects
• 5. How to store Metformina Accordpharma
• 6. Contents of the pack and other information

1. What is Metformina Accordpharma and what is it used for

Metformina Accordpharma contains metformin, a medicine used to treat diabetes. It belongs to a
group of active substances called biguanides.
Insulin is a hormone produced by the pancreas that allows the body to absorb glucose
(sugar) from the blood. The body uses glucose to produce energy or stores it for future
use.
If you have diabetes, the pancreas does not produce enough insulin or your body is not able to use
the insulin that the pancreas produces correctly. This causes high levels of glucose
in the blood. Metformina Accordpharma helps to lower blood glucose, bringing it to a
level as close to normal as possible.
If you are an overweight adult, taking Metformina Accordpharma for a long period of time
also helps to reduce the risk of complications associated with diabetes. Metformina
Accordpharma has been associated with both stabilization and modest weight loss.
Metformina Accordpharma is used to treat patients with type 2 diabetes (also called “non-insulin-dependent
diabetes”) when diet and exercise alone have not been sufficient to
control blood glucose levels. It is used in particular in overweight patients.
Adults can take Metformina Accordpharma alone or in combination with other medicines
to treat diabetes (drugs administered orally or insulin).

2. What you need to know before taking Metformina Accordpharma

Do not take Metformina Accordpharma

• if you are allergic to metformin or any of the other ingredients of this medicine (see section 6)
• if you have liver problems
• if you have severely reduced kidney function
• if you have uncontrolled diabetes, for example, severe hyperglycemia (high blood glucose levels), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called 'ketone bodies' accumulate in the blood and can lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness and breath with an unusually fruity odor
• if your body has lost too much water (dehydration), for example, due to prolonged or severe diarrhea, or if you have vomited many times in a row. Dehydration can cause kidney problems that may expose you to the risk of lactic acidosis (see section “Warnings and precautions”)
• if you have a serious infection, such as an infection affecting the lungs or bronchial system or the kidneys. Serious infections can cause kidney problems, which may expose you to the risk of lactic acidosis (see section “Warnings and precautions”)
• if you are being treated for acute heart failure or have recently had a heart attack, if you have severe circulatory problems (such as shock) or difficulty breathing. This can cause oxygen deficiency in the tissues, which may expose you to the risk of lactic acidosis (see section “Warnings and precautions”)
• if you drink a lot of alcohol
• if you are a child

Warnings and precautions
Risk of lactic acidosis
Metformina Accordpharma can cause a very rare, but very serious side effect called
lactic acidosis, especially if your kidneys do not function properly. The risk of developing lactic
acidosis is also increased by the presence of uncontrolled diabetes, serious infections, prolonged
fasting or alcohol consumption, dehydration (see below for more
information), liver problems and any other medical condition in which an area of the body
is deprived of oxygen supply (such as severe acute heart disease).
If you have any of the medical conditions described above, consult your doctor for further
instructions.

Stop taking Metformina Accordpharma for a short period of time if you have a
medical condition that may be associated with dehydration(significant loss of body fluids)
such as severe vomiting, diarrhea, fever, exposure to heat or if you drink less fluids than usual. Consult your
doctor for further instructions.

Stop taking Metformina Accordpharma and immediately consult your doctor or
the nearest hospital if you experience any of the symptoms of lactic acidosis,because lactic acidosis
can lead to coma.
The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• a general feeling of unwellness associated with severe fatigue
• difficulty breathing
• reduced body temperature and slower heart rate

Lactic acidosis is a medical emergency and must be treated in hospital.
If you are going to have major surgery, you should stop taking
Metformina Accordpharma during the surgery and for a certain period of time afterwards. Your doctor will decide when you should stop and when to resume treatment with
Metformina Accordpharma.
Metformina Accordpharma alone does not cause hypoglycemia (blood glucose levels too low).
However, if you take Metformina Accordpharma together with other medicines to treat diabetes, which
can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides), there is a risk of hypoglycemia.
If you experience symptoms of hypoglycemia such as weakness, dizziness, increased sweating, rapid
heartbeat, vision disturbances or difficulty concentrating, it is usually helpful to eat or
drink something containing sugar.
During treatment with Metformina Accordpharma, your doctor will check your kidney function
at least annually or more frequently if you are elderly and/or if your kidney function worsens.

Other medicines and Metformina Accord
If you are to receive an injection of iodine-containing contrast agents into your bloodstream, for example
as part of X-rays or diagnostic scans, you must stop taking Metformina
Accordpharma before and during the injection. Your doctor will decide when you should stop and
when to resume treatment with Metformina Accordpharma.
Tell your doctor if you are taking, have recently taken or might take any other
medicines. You may need to have your blood sugar levels and kidney function tests more
frequently, or your doctor may decide to adjust the dose of Metformina
Accordpharma. It is particularly important to mention the use of:

• medicines that increase urine production (diuretics).
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
• some medicines for treating high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
• beta-2 agonists, such as salbutamol or terbutaline (used to treat asthma)
• corticosteroids and tetracosactide (used to treat various conditions, such as severe skin inflammation or asthma).
• medicines that can change the amount of Metformina Accordpharma in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).
• other medicines used to treat diabetes.

Metformina Accordpharma with alcohol
Avoid excessive alcohol consumption during treatment with Metformina Accordpharma as
this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to have a baby, talk to your
doctor, as changes to your treatment or monitoring of your blood glucose levels may be necessary.
This medicine is not recommended if you are breastfeeding or intend to breastfeed your baby.

Driving and using machines
Metformina Accordpharma alone does not cause hypoglycemia (blood glucose levels too low).
This means that it does not impair your ability to drive vehicles or use machines.
However, be particularly careful if you take Metformina Accordpharma together with other
medicines to treat diabetes that can cause hypoglycemia (such as sulfonylureas, insulin,
meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating,
rapid heartbeat, vision disturbances or difficulty concentrating. Do not drive vehicles and do not
use machines if you start to experience these symptoms.

3. How to take Metformina Accord

Always take Metformina Accordpharma exactly as your doctor has told you. If you have any doubts
ask your doctor or pharmacist.
Metformina Accordpharma cannot replace the benefits of a healthy lifestyle. Continue to follow
all the dietary advice given to you by your doctor and exercise regularly.

Recommended dose
You should take the tablets once a day during the evening meal. Swallow the
tablets whole, do not chew or crush them.
If you have reduced kidney function, your doctor may prescribe a lower dose.
Metformina Accordpharma 500 mg
The usual starting dose is one 500 mg tablet once a day. After about 2 weeks
of taking 500 mg, your doctor may measure your blood sugar level and adjust the
dose. The maximum daily dose is 2000 mg (4 tablets).
Metformina Accordpharma 750 mg
The usual starting dose is one 750 mg tablet once a day.
After about 2 weeks of taking 750 mg, your doctor may measure your blood sugar level and adjust the dose. The highest daily dose is 2 tablets of Metformina
Accordpharma 750 mg.
Metformina Accordpharma 1000 mg
The usual daily dose is one 1000 mg tablet once a day.
After about 2 weeks of taking 1000 mg, your doctor may measure your blood sugar level and adjust the dose. The highest daily dose is 2 tablets of Metformina
Accordpharma 1000 mg.

Medical monitoring

• Your doctor will perform regular blood glucose tests and adjust the dose of Metformina Accordpharma according to your blood sugar levels. See your doctor regularly. This is particularly important for children and adolescents or if you are an elderly person.
• Your doctor will also check how your kidneys are functioning at least once a year. You may need more frequent checks if you are an elderly person or if your kidneys do not function normally.

How to take Metformina Accordpharma
Take the tablets during or after a meal. The tablets are designed to provide a
prolonged release of the active ingredient. This means that the active ingredient is released slowly
into the body, therefore the tablets should only be taken once a day.
Residues of tablets may appear in the stool. Do not worry, this is not uncommon.

If you take more Metformina Accordpharma than you should
If you have taken more Metformina Accordpharma than you should, you may develop lactic acidosis. The
symptoms of lactic acidosis are non-specific, such as vomiting, stomach pain (abdominal pain) with
muscle cramps, a general feeling of unwellness with extreme fatigue and difficulty breathing.
Further symptoms include a decrease in body temperature and heart rate. If you experience
any of these symptoms, you should seek medical attention immediately, as lactic acidosis
can lead to coma. Stop taking Metformina Accordpharma and contact
your doctor or the nearest hospital immediately.
If you forget to take Metformina Accordpharma
Do not take a double dose to make up for a forgotten dose. Take the next dose
at the scheduled time.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Metformina Accordpharma may cause a very rare (may affect up to 1 in 10,000 people), but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Metformina Accordpharma and immediately contact your doctor or the nearest hospital, because lactic acidosis can lead to coma.

Very common side effects (may affect more than 1 in 10 people):

• digestive problems such as feeling unwell (nausea), vomiting, diarrhoea, stomach pain (abdominal pain) and loss of appetite. These side effects are more likely to occur at the beginning of treatment with Metformina Accordpharma. It may be helpful to divide the doses throughout the day and take Metformina Accordpharma during or immediately after a meal. If the symptoms persist, stop taking Metformina Accordpharma and consult your doctor.

Common side effects (may affect up to 1 in 10 people):

• taste alteration.
• reduced or low levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), red and sore tongue (glossitis), tingling (paresthesia) or pale or yellowish skin). Your doctor may arrange some tests to find out the cause of the symptoms because some of these may also be caused by diabetes or other health problems not related to this medication.

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

• lactic acidosis. This is a very rare, but serious complication, particularly if the kidneys are not functioning properly. The symptoms of lactic acidosis are non-specific (see the “Warnings and precautions” section).
• abnormalities in liver function tests or hepatitis (inflammation of the liver; may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If you experience such symptoms, stop taking Metformina Accordpharma and contact your doctor.
• skin reactions such as skin redness (erythema), itching or itchy rash (urticaria).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Metformina Accordpharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister, bottle and the outer packaging
after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Metformina Accordpharma contains
The active ingredient is metformin hydrochloride.
Metformina Accordpharma 500 mg: Each prolonged-release tablet of Metformina
Accordpharma 500 mg contains 500 mg of metformin hydrochloride which is equivalent to 390 mg of
metformin.
Other ingredients are: Microcrystalline cellulose, Hypromellose K 100M, Anhydrous colloidal silica and
Magnesium stearate.
Metformina Accordpharma 750 mg: a prolonged-release tablet of Metformina
Accordpharma 750 mg contains 750 mg of metformin hydrochloride, which is equivalent to 585 mg of
metformin.
Other ingredients are microcrystalline cellulose, hypromellose K 100M premium CR, anhydrous colloidal
silica and magnesium stearate.
Metformina Accordpharma 1000 mg: a prolonged-release tablet of Metformina
Accordpharma 1000 mg contains 1000 mg of metformin hydrochloride, which is equivalent to 780 mg
of metformin.
Other ingredients are microcrystalline cellulose, hypromellose K 100M premium CR, anhydrous colloidal
silica and magnesium stearate.

Description of the appearance of Metformina Accordpharma and contents of the pack
Metformina Accordpharma 500 mg are uncoated tablets, white to off-white in colour,
biconvex, capsule-shaped, approximately 19.2 mm × 9.3 mm, with “FN1” imprinted on one side and smooth
on the other side.
Metformina Accordpharma 750 mg are uncoated tablets, white to off-white in colour,
biconvex, oblong-shaped, approximately 19.2 mm × 9.3 mm, with “FN2” imprinted on one side and smooth
on the other side.
Metformina Accordpharma 1000 mg are uncoated tablets, white to off-white in colour,
biconvex, oblong-shaped, approximately 22.2 mm × 11.0 mm, with “FN3” imprinted on one side and smooth
on the other side.
For 500 mg: The tablets are supplied in HDPE bottles in the following pack sizes: 30 and 100.
For 750 mg and 1000 mg: The tablets are supplied in HDPE bottles in the following pack sizes: 30 and

• 100.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare B.V.
Winthontlaan 200,
Utrecht 3526KV, Paola,
Netherlands
Accord Healthcare Polska Sp. Z.o.o.
Ul. Lutomierska 50
Pabianice 95-200,
Poland
Accord Healthcare Single Member S.A.,
64th Km National Road Athens,
Lamia, 32009,
Greece