Metformin Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

METFORMIN DOC GENERICS 500 mg prolonged-release tablets, 750 mg prolonged-release tablets, 1000 mg prolonged-release tablets

Generic medicine
Please read all of this leaflet carefully before you start 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 other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet
  1. What METFORMIN DOC GENERICS is and what it is used for
  2. What you need to know before taking METFORMIN DOC GENERICS
  3. How to take METFORMIN DOC GENERICS
  4. Possible side effects
  5. How to store METFORMIN DOC GENERICS
  6. Contents of the pack and other information

1. What METFORMINA DOC GENERICS is and what it is used for

METFORMINA DOC GENERICS contains metformin, a medicine used to treat diabetes.
It belongs to a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas that enables the body to absorb glucose
(sugar) from the blood. Your body uses glucose to produce energy or stores it for future use.
In diabetic patients, the pancreas does not produce enough insulin or the body is unable
to use the insulin it produces effectively. This leads to high levels of glucose in the blood.
METFORMINA DOC GENERICS helps lower the level of glucose in your blood to as close to normal as possible.
In overweight adults, long-term use of METFORMINA DOC GENERICS also helps reduce the risk of diabetes-related complications.
METFORMINA DOC GENERICS is used in the treatment of patients with type 2 diabetes
(also known as "non-insulin-dependent diabetes") when diet and exercise alone are not sufficient to achieve adequate blood glucose control.
Adults may take METFORMINA DOC GENERICS alone or in combination with other antidiabetic medicines (oral medications or insulin).

2. What you need to know before taking METFORMINA DOC GENERICS

Do not take METFORMINA DOC GENERICS
if you are allergic (hypersensitive) to metformin or to any of the other ingredients of this
medicinal product (listed in section 6),
if you have liver problems,
if you have severely reduced kidney function,
if you have uncontrolled diabetes associated, 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, rapid and deep breathing, drowsiness or breath with an unusually fruity odour,
if you have lost too much fluid from your body (dehydration), such as after prolonged or severe diarrhoea, or if you have vomited several times in succession. Dehydration may lead to kidney problems, which could put you at risk of lactic acidosis (see “Warnings and precautions”),
if you have a serious infection, such as pneumonia, bronchitis or kidney inflammation. Serious infections may lead to kidney failure, which could put you at risk of lactic acidosis (see “Warnings and precautions”),
if you are being treated for heart failure or have recently had a myocardial infarction, if you have serious circulation problems (such as shock) or breathing difficulties. These conditions may lead to reduced oxygen supply to tissues, which could put you at risk of lactic acidosis (see “Warnings and precautions”),
if you consume large amounts of alcohol,
if the patient is under 18 years of age.

If you have any of the conditions listed above, consult your doctor before starting to take this medicinal product.

Make sure to seek medical advice if:
you are scheduled for a radiological examination or any procedure requiring injection of an iodine-containing contrast agent into your bloodstream,
you are scheduled for major surgery.

Stop taking METFORMINA DOC GENERICS for a certain period before and after the diagnostic test or surgical procedure. Your doctor will decide whether you will need alternative treatment during this time. It is important that you follow your doctor’s instructions exactly.

Warnings and precautions
Talk to your doctor or pharmacist before taking METFORMINA DOC GENERICS

Risk of lactic acidosis
METFORMINA DOC GENERICS may cause a very rare but serious side effect called lactic acidosis, particularly if the kidneys are not functioning properly. The risk of developing lactic acidosis is higher in the presence of uncontrolled diabetes, serious infections, prolonged fasting or alcohol consumption, dehydration (see below for further information), liver problems, or any other medical condition characterised by reduced oxygen supply to any part of the body (such as severe heart disease).

If you have any of the medical conditions listed above, consult your doctor for more detailed instructions.

Temporarily stop taking METFORMINA DOC GENERICS if
you have a medical condition that may lead to dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, exposure to heat, or if you are drinking less fluid than normal.
Contact your doctor for further instructions.

Stop taking METFORMINA DOC GENERICS and contact your doctor or the nearest hospital immediately
if you experience any of the symptoms of lactic acidosis, because lactic acidosis may lead to coma.
Symptoms of lactic acidosis include:

• vomiting
• abdominal pain
• muscle cramps
• a general feeling of malaise associated with severe fatigue
• difficulty breathing
• lowered body temperature and slower heart rate

Lactic acidosis is a medical emergency requiring immediate hospital treatment. If you are undergoing major surgery, you must stop taking METFORMINA DOC GENERICS during the procedure and for a certain period afterwards. Your doctor will decide when to stop and when to restart treatment with METFORMINA DOC GENERICS.

METFORMINA DOC GENERICS does not cause hypoglycaemia (low blood sugar level). However, if you take METFORMINA DOC GENERICS together with other antidiabetic medicines that can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides), there is a risk of hypoglycaemia. If symptoms of hypoglycaemia occur, such as weakness, dizziness, increased
sweating, rapid heartbeat, visual disturbances or difficulty concentrating, eating or drinking something containing sugar usually helps.

During treatment with METFORMINA DOC GENERICS, your doctor will check your kidney function at least once a year, or more frequently if you are elderly and/or if kidney function worsens.

Follow the dietary advice provided by your doctor.

Occasionally, the tablet coating may be visible in the faeces. This should not be a cause for concern, as it is normal for this type of tablet.

Children
METFORMINA DOC GENERICS must not be used in children (age <18 years).

Other medicines and METFORMINA DOC GENERICS
If you are scheduled to receive an injection of an iodinated contrast agent into the bloodstream, for example for an X-ray or CT scan, you must stop taking METFORMINA DOC GENERICS before or at least during the injection. Your doctor will decide when to stop and when to restart treatment with METFORMINA DOC GENERICS.

Inform your doctor if you are taking, have recently taken, or might take any other medicines. You may need to have your blood glucose and kidney function monitored more frequently, or your doctor may decide to adjust the dose of METFORMINA DOC GENERICS. It is particularly important to mention the following:
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 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 (used to treat a range of conditions, such as severe skin inflammation or asthma),
medicines that may alter the amount of METFORMINA DOC GENERICS 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 DOC GENERICS and alcohol
Avoid excessive alcohol consumption during treatment with METFORMINA DOC GENERICS, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding
During pregnancy, insulin is required for the treatment of diabetes. If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicinal product.

This medicine is not recommended during breastfeeding or if you are planning to breastfeed your baby.

Driving and using machines
METFORMINA DOC GENERICS does not cause hypoglycaemia (low blood glucose levels). This means it does not affect your ability to drive or use machinery.
However, exercise particular caution if you are taking METFORMINA DOC GENERICS together with other antidiabetic medicines that may cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, tachycardia, visual disturbances or difficulty concentrating. Do not drive or operate machinery if these symptoms occur.

This medicine contains less than 1 mmol of sodium (23 mg) per prolonged-release tablet, i.e. essentially ‘sodium-free’.

3. How to take METFORMINA DOC GENERICS

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
METFORMINA DOC GENERICS cannot replace the benefits of a healthy lifestyle. Continue to follow all dietary advice provided by your doctor and maintain regular physical activity.
METFORMINA DOC GENERICS must be swallowed whole with sufficient fluid. The tablets must not be cut, crushed, or chewed.

Recommended use
Children: due to lack of adequate safety studies, METFORMINA DOC GENERICS must not be administered to children.
Adults: treatment generally starts with one 500 mg tablet of METFORMINA DOC GENERICS once daily during the evening meal. After 10–15 days, dose adjustment is recommended based on blood glucose levels. Gradual increases in dose may improve gastrointestinal tolerance to the medicine.
Your doctor may increase the dose up to a maximum of 2000 mg taken daily.
METFORMINA DOC GENERICS 750 mg and 1000 mg tablets should be used if you have already been treated with metformin (either immediate-release or prolonged-release formulations).
In patients already treated with metformin, the initial dose of METFORMINA DOC GENERICS should be equivalent to the daily dose of metformin tablets (immediate-release or prolonged-release).
If switching from another oral antidiabetic medicine to METFORMINA DOC GENERICS, the previous medicine should be discontinued and METFORMINA DOC GENERICS started at the dose indicated above.
If you have reduced kidney function, your doctor may prescribe a lower dose.
In patients treated with a metformin dose exceeding 2000 mg per day of immediate-release tablets, switching to METFORMINA DOC GENERICS is not recommended.
If you are also taking insulin, your doctor will advise you on how to start taking METFORMINA DOC GENERICS.
Adults: treatment generally starts with one 500 mg tablet of METFORMINA DOC GENERICS once daily, while the insulin dose is adjusted by the doctor according to blood glucose levels.
If you are already being treated with metformin and insulin in combination, the dose of METFORMINA DOC GENERICS 750 mg or 1000 mg should be equivalent to the daily dose of metformin tablets, up to a maximum of 2000 mg per day.

Elderly
Due to the potential decline in kidney function in elderly patients, the dose of METFORMINA DOC GENERICS should be adjusted according to kidney function. Regular monitoring of kidney function is necessary.

Monitoring of treatment
Your doctor will perform regular blood glucose tests and adjust your dose of METFORMINA DOC GENERICS according to your blood glucose levels. Make sure to consult your doctor regularly for check-ups. This is particularly important if you are elderly.
Your doctor will also check your kidney function at least once a year. You may require more frequent checks if you are elderly or if your kidneys are not functioning properly.

How to take METFORMINA DOC GENERICS
METFORMINA DOC GENERICS should be taken during or immediately after a meal. This will help you avoid gastrointestinal side effects. Do not crush or chew the tablets. Swallow each tablet with a glass of water.
If, after some time, you feel that the effect of METFORMINA DOC GENERICS is too strong or too weak, consult your doctor or pharmacist.

If you take more METFORMINA DOC GENERICS than you should
If you have taken more METFORMINA DOC GENERICS than prescribed, lactic acidosis may occur.
Symptoms of lactic acidosis are non-specific and include: vomiting, stomach ache (abdominal pain) with muscle cramps, a general feeling of being unwell with severe fatigue and difficulty breathing. Other symptoms include lowered body temperature and slowed heart rate. If any of these symptoms occur, you must seek immediate medical attention, as lactic acidosis can lead to coma. Stop taking METFORMINA DOC GENERICS immediately and contact a doctor or the nearest hospital without delay.

If you forget to take METFORMINA DOC GENERICS
Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

METFORMINA DOC GENERICS may very rarely (affecting up to 1 in 10,000 people) cause a very serious side effect called lactic acidosis (see section "Warnings and precautions"). If this occurs, you must stop taking METFORMINA DOC GENERICS and contact your doctor or go to the nearest hospital immediately, as lactic acidosis can lead to coma.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The adverse reactions that may occur are listed below.

Very common side effects (more than 1 in 10 people)
Gastrointestinal problems such as nausea, vomiting, diarrhoea, stomach ache (abdominal pain), and loss of appetite. These side effects mostly occur at the beginning of treatment with METFORMINA DOC GENERICS and usually resolve spontaneously in most cases. It may help to take the tablets during or immediately after a meal. If symptoms persist, stop taking METFORMINA DOC GENERICS and consult your doctor.

Common side effects (up to 1 in 10 people)
Altered taste.

Very rare side effects (up to 1 in 10,000 people)
Lactic acidosis. This is a very rare but serious complication, especially if your kidneys are not functioning properly.
For symptoms of lactic acidosis, see section "Warnings and precautions".
Abnormal liver function tests or symptoms of hepatitis (accompanied by fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this happens to you, stop taking METFORMINA DOC GENERICS and consult your doctor.
Skin reactions such as redness of the skin (erythema), itching, or skin rash (urticaria).
Decreased levels of vitamin B12 in the blood.

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 METFORMIN DOC GENERICS

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton, bottle, or blister after "EXP". The expiry date refers to the last day of that month.
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 DOC GENERICS contains
METFORMINA DOC GENERICS 500 mg prolonged-release tablets
The active substance is metformin hydrochloride.
Each tablet of METFORMINA DOC GENERICS contains 500 mg of metformin
hydrochloride, equivalent to 390 mg of metformin.
The other components are: Croscarmellose sodium, Hypromellose 2208, Microcrystalline
Cellulose PH 101, Anhydrous colloidal silicon dioxide, Magnesium stearate.

METFORMINA DOC GENERICS 750 mg prolonged-release tablets
The active substance is metformin hydrochloride.
Each tablet of METFORMINA DOC GENERICS contains 750 mg of metformin
hydrochloride, equivalent to 585 mg of metformin.
The other components are: Croscarmellose sodium, Hypromellose 2208, Microcrystalline
Cellulose PH 101, Anhydrous colloidal silicon dioxide, Magnesium stearate.

METFORMINA DOC GENERICS 1000 mg prolonged-release tablets
The active substance is metformin hydrochloride.
Each tablet of METFORMINA DOC GENERICS contains 1000 mg of metformin
hydrochloride, equivalent to 780 mg of metformin.
The other components are: Croscarmellose sodium, Hypromellose 2208, Anhydrous colloidal
silicon dioxide, Magnesium stearate, Anhydrous calcium hydrogen phosphate, Povidone K 90,
and isopropyl alcohol.

Description of the appearance of METFORMINA DOC GENERICS and contents of the pack
METFORMINA DOC GENERICS 500 mg prolonged-release tablets
METFORMINA DOC GENERICS tablets are white to off-white, round (12.10 mm - 12.50 mm),
with the imprint “16” and “C”.

METFORMINA DOC GENERICS 750 mg prolonged-release tablets
METFORMINA DOC GENERICS tablets are white to off-white, capsule-shaped
(18.80 mm x 9.30 mm - 19.20 mm x 9.70 mm), with the imprint “15” and “C”.

METFORMINA DOC GENERICS 1000 mg prolonged-release tablets
METFORMINA DOC GENERICS tablets are white to off-white, capsule-shaped
(22.30 mm x 10.30 mm – 22.70 mm x 10.70 mm), with the imprint “14” and “C”.
Each pack contains 60 tablets.

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 - Milan
Italy

Manufacturer
PharmaS d.o.o.
Industrijska cesta 5
44317 Potok, Popovača, Croatia

This medicinal product is authorized in the European Economic Area countries under the
following names:
Malta: METFORMIN DOC GENERICS 500 mg – 750 mg – 1000 mg prolonged release tablets
Italy: METFORMINA DOC GENERICS