Metformin Accord Pharma: detailed information

Patient Information Leaflet: Information for the User

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

metformin hydrochloride
Generic Medicine
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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Metformina Accordpharma is and what it is used for
What you need to know before taking Metformina Accordpharma
How to take Metformina Accordpharma
Possible side effects
How to store Metformina Accordpharma
Package contents and other information

1. What Metformina Accordpharma is and what it is 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 enables 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, your pancreas does not produce enough insulin, or your body is unable to
use insulin properly. This leads to high levels of glucose in the blood. Metformina Accordpharma helps
lower blood glucose to a level as close to normal as possible.
If you are an overweight adult, taking Metformina Accordpharma over a long period of time also
helps reduce the risk of diabetes-related complications. Metformina Accordpharma has been
associated with both weight stabilization and modest weight loss.
Metformina Accordpharma is used to treat patients with type 2 diabetes (also known as
“non-insulin-dependent diabetes”) when diet and exercise alone have not been sufficient to control
blood glucose levels. It is particularly used in overweight patients.
Adults may take Metformina Accordpharma alone or in combination with other diabetes medicines
(oral antidiabetic agents or insulin).

2. What you need to know before taking Metformina Accordpharma

Do not take Metformina Accordpharma

if you are allergic to metformin or to 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 with severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, 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 may lead to diabetic pre-coma. Symptoms include stomach pain, deep and rapid breathing, drowsiness and breath with an unusual fruity odour
if your body has lost too much water (dehydration), for example due to prolonged or severe diarrhoea, or if you have vomited repeatedly. Dehydration can cause kidney problems which may increase your risk of lactic acidosis (see section “Warnings and precautions”)
if you have a severe infection, such as an infection affecting the lungs, bronchial system or kidneys. Severe infections can cause kidney problems which may increase your 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 serious circulatory problems (such as shock) or breathing difficulties. These conditions may cause insufficient oxygen supply to tissues, increasing your risk of lactic acidosis (see section “Warnings and precautions”)
if you drink large amounts of alcohol
if you are a child

Warnings and precautions
Risk of lactic acidosis
Metformina Accordpharma may cause a very rare but very serious side effect called
lactic acidosis, particularly if the kidneys are not functioning properly. The risk of developing lactic
acidosis is also increased by uncontrolled diabetes, severe infections, prolonged fasting, alcohol consumption, dehydration (see below for further 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.
Temporarily stop taking Metformina Accordpharma if you develop a medical condition that may be associated with dehydration (significant loss of body fluids),
such as severe vomiting, diarrhoea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.
Stop taking Metformina Accordpharma and contact your doctor or go immediately to the nearest hospital if you experience any of the symptoms of lactic acidosis, because lactic acidosis can lead to coma.
Symptoms of lactic acidosis include:

vomiting
stomach ache (abdominal pain)
muscle cramps
a general feeling of discomfort associated with severe fatigue
difficulty breathing
reduced body temperature and slower heartbeat

Lactic acidosis is a medical emergency and must be treated in hospital.
If you are scheduled for major surgery, you must stop taking
Metformina Accordpharma during the procedure and for a certain period afterwards. Your doctor will decide when you should stop and when you can restart treatment with Metformina Accordpharma.
Metformina Accordpharma alone does not cause hypoglycaemia (low blood glucose levels).
However, if you take Metformina Accordpharma together with other medicines for treating diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides), there is a risk of hypoglycaemia.
If you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances or difficulty concentrating, it is usually helpful to eat or drink something containing sugar.
During treatment with Metformina Accordpharma, your doctor will monitor your kidney function
at least once a year, or more frequently if you are elderly and/or if you have worsening kidney function.
Other medicines and Metformina Accordpharma
If you are due to receive an intravenous injection of iodine-containing contrast agents, for example
during 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 you can restart treatment with Metformina Accordpharma.
Inform your doctor if you are taking, have recently taken, or might take any other
medicine. You may need to have your blood glucose 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)
certain medicines used to treat 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 may alter the amount of Metformina Accordpharma in the 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 and 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 might be pregnant, or are planning to have a baby, discuss this with your
doctor, as treatment adjustments or monitoring of 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 hypoglycaemia (low blood glucose levels).
This means it does not impair your ability to drive or operate machinery.
However, take particular care if you take Metformina Accordpharma together with other
medicines for treating diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin,
meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating,
rapid heartbeat, visual disturbances or difficulty concentrating. Do not drive or operate machinery if you start experiencing these symptoms.

3. How to take Metformina Accord

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

Recommended dose
You should take the tablets once daily during an 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 Accord 500 mg
The usual starting dose is one 500 mg tablet once daily. After approximately 2 weeks of taking 500 mg, your doctor may measure your blood sugar levels and adjust the dose accordingly. The maximum daily dose is 2000 mg (4 tablets).

Metformina Accord 750 mg
The usual starting dose is one 750 mg tablet once daily.
After approximately 2 weeks of taking 750 mg, your doctor may measure your blood sugar levels and adjust the dose accordingly. The maximum daily dose is 2 tablets of Metformina Accord 750 mg.

Metformina Accord 1000 mg
The usual daily dose is one 1000 mg tablet once daily.
After approximately 2 weeks of taking 1000 mg, your doctor may measure your blood sugar levels and adjust the dose accordingly. The maximum daily dose is 2 tablets of Metformina Accord 1000 mg.

Medical monitoring

Your doctor will carry out regular blood glucose tests and adjust your dose of Metformina Accord according to your blood sugar levels. You should consult your doctor regularly. This is particularly important for children and adolescents, or if you are elderly.
Your doctor will also check your kidney function at least once a year. You may need more frequent checks if you are elderly or if your kidneys do not function normally.

How to take Metformina Accord
Take the tablets during or after a meal. The tablets are designed to provide prolonged release of the active substance. This means that the active ingredient is released slowly into the body, so the tablets need to be taken only once daily.
Pieces of the tablet may appear in the stool. Do not be concerned; this is not uncommon.

If you take more Metformina Accord than you should
If you take more Metformina Accord than you should, you may develop lactic acidosis. Symptoms of lactic acidosis are non-specific and may include vomiting, stomach pain (abdominal pain) with muscle cramps, general feeling of malaise with extreme tiredness, and breathing difficulties. Further symptoms include lowered body temperature and heart rate. If you experience any of these symptoms, you must seek immediate medical attention, as lactic acidosis can lead to coma. Stop taking Metformina Accord and contact a doctor or the nearest hospital immediately.

If you forget to take Metformina Accord
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 the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Metformina Accordpharma may cause a very rare (may occur in 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 seek immediate medical advice from your doctor or the nearest hospital, as lactic acidosis can lead to coma.

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

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

Common side effects (occur in less than 1 in 10 people):

Altered taste.
Reduced or low levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), red and sore tongue (glossitis), tingling sensations (paraesthesiae), or pale or yellowish skin). Your doctor may arrange some tests to determine the cause of these symptoms, as some of them may also be caused by diabetes or other unrelated health conditions.

Rare side effects (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. The symptoms of lactic acidosis are non-specific (see section “Warnings and precautions”).
Abnormal 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 redness of the skin (erythema), itching, or itchy skin rash (urticaria).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 carton after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater 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 substance is metformin hydrochloride.
Metformina Accordpharma 500 mg: Each prolonged-release tablet of Metformina Accordpharma 500 mg contains 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.
Other ingredients are: microcrystalline cellulose, hypromellose K 100M, anhydrous colloidal silica, and magnesium stearate.
Metformina Accordpharma 750 mg: Each prolonged-release tablet of Metformina Accordpharma 750 mg contains 750 mg of metformin hydrochloride, 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: Each prolonged-release tablet of Metformina Accordpharma 1000 mg contains 1000 mg of metformin hydrochloride, 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, biconvex, capsule-shaped, approximately 19.2 mm × 9.3 mm, with "FN1" engraved on one side and smooth on the other.
Metformina Accordpharma 750 mg are uncoated tablets, white to off-white, biconvex, oblong-shaped, approximately 19.2 mm × 9.3 mm, with "FN2" engraved on one side and smooth on the other.
Metformina Accordpharma 1000 mg are uncoated tablets, white to off-white, biconvex, oblong-shaped, approximately 22.2 mm × 11.0 mm, with "FN3" engraved on one side and smooth on the other.
For 500 mg: Tablets are supplied in HDPE bottles in the following pack sizes: 30 and 100.
For 750 mg and 1000 mg: Tablets are supplied in HDPE bottles in the following pack sizes: 30 and 100.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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,
The 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