Metformin Hexal: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Metformina Hexal 1000 mg film-coated tablets

Generic medicine
Read 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. Never give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Metformina Hexal is and what it is used for
What you need to know before taking Metformina Hexal
How to take Metformina Hexal
Possible side effects
How to store Metformina Hexal
Contents of the pack and other information

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

Metformina Hexal contains metformin, a medicine used to treat diabetes.
It belongs to a class of drugs 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
to store it for later use.
If you have diabetes, your pancreas does not produce enough insulin or your
body is unable to properly use the insulin it produces. This
leads to high levels of glucose in the blood. Metformina Hexal helps
lower blood glucose levels to as near normal as possible.
If you are an overweight adult, long-term use of Metformina Hexal also
helps reduce the risk of diabetes-related complications.
Metformina Hexal is associated with both stable body weight and modest
weight loss.
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Metformina Hexal 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 Hexal alone or in combination with other antidiabetic medicines (oral medications or insulin).
Children aged 10 years and older and adolescents may take Metformina Hexal alone or together with insulin.

2. What you need to know before taking Metformina Hexal

Do not take Metformina Hexal

if you are allergic to metformin or to any of the other ingredients of this medicine (listed in section 6);
if you have severely reduced kidney function;
if you have liver disorders;
if you have uncontrolled diabetes , for example with severe hyperglycaemia (high blood sugar levels), nausea, vomiting, diarrhoea, rapid weight loss, or 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 ache, rapid and deep breathing, drowsiness, or your breath develops an unusual fruity odour;
if you have lost excessive amounts of water from your body (dehydration), for example due to severe or persistent diarrhoea, or if you have vomited repeatedly. Dehydration may lead to kidney problems, which can increase the risk of lactic acidosis (see “Warnings and precautions” below);
if you have a severe infection , for example an infection affecting the lungs or bronchi or the kidney. Severe infections may cause kidney problems, which can increase the risk of lactic acidosis (see “Warnings and precautions” below);
if you are being treated for acute heart failure or have recently had a heart attack , serious circulatory disorders (such as shock), or breathing difficulties. These conditions may cause reduced oxygen supply to tissues, which in turn may increase the risk of lactic acidosis (see “Warnings and precautions” below);
if you consume large amounts of alcohol.

If any of the above conditions apply to you, consult your doctor
before starting to take this medicine.
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Consult your doctor if

you are scheduled for an examination such as X-ray or diagnostic tests requiring injection into the bloodstream of contrast agents containing iodine;
you are scheduled for major surgery.

You must stop taking Metformina Hexal for a certain period of time
before and after the examination or surgery. Your doctor will decide whether you need
another treatment during this time. It is important that you follow your doctor’s
instructions precisely.
Warnings and precautions
Risk of lactic acidosis
Metformina Hexal 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 higher in the presence of uncontrolled diabetes, severe infections, prolonged
fasting or alcohol consumption, dehydration (see below for further information), liver
problems, and any other medical condition characterised by reduced oxygen supply to
part of the body (such as in the case of severe acute heart disease).
If you have any of the medical conditions described above, contact your doctor for further
instructions.
Stop taking Metformina Hexal temporarily if you have 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 fluids than usual. Contact your
doctor for further instructions.
If you experience any of the symptoms of lactic acidosis, stop taking Metformina Hexal
immediately and contact your doctor or go to the nearest hospital , as 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.
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If you are undergoing major surgery, you must stop taking Metformina Hexal during the
procedure and for a certain period afterwards. Your doctor will decide when you should
stop and when you should restart treatment with Metformina Hexal.
During treatment with Metformina Hexal, your doctor will monitor your kidney function
at least once a year, or more frequently if you are elderly and/or if kidney function
worsens.
Metformina Hexal itself does not cause hypoglycaemia (low blood glucose level).
However, if you take Metformina Hexal together with other antidiabetic medicines that
can cause hypoglycaemia (such as sulfonylureas, 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, eating or drinking something containing sugar usually helps.
Other medicines and Metformina Hexal
If you are scheduled to receive an injection of an iodinated contrast agent into the
bloodstream, for example for an X-ray or scan, you must stop taking Metformina Hexal
for a certain period before and during the injection. Your doctor will decide when you
should stop and when you should restart treatment with Metformina Hexal.
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 tested more
frequently, or your doctor may decide to adjust the dose of Metformina Hexal. 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 variety of disorders, such as severe skin inflammation or asthma);
medicines that may alter the amount of metformin in the blood, especially if kidney function is reduced (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib);
other medicines used to treat diabetes.

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Metformina Hexal and alcohol
Avoid excessive alcohol consumption during treatment with Metformina Hexal, as this
may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Pregnancy and breastfeeding
During pregnancy, insulin is required to treat diabetes. If you are pregnant, think you
may be pregnant, are planning to become pregnant, or are breastfeeding, consult your
doctor before taking this medicine.
This medicine is not recommended if you are breastfeeding or intend to breastfeed your
baby.
Driving and using machines
Metformina Hexal itself does not cause hypoglycaemia (low blood glucose level). This
means it does not impair your ability to drive or use machines.
However, pay particular attention if you take Metformina Hexal together with other
antidiabetic medicines that can cause hypoglycaemia (such as sulfonylureas, insulin,
meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased
sweating, rapid heartbeat, visual disturbances, or difficulty concentrating. If you start
experiencing these symptoms, do not drive or operate machinery.

3. How to take Metformina Hexal

Take this medicine exactly as prescribed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Metformina Hexal cannot replace the benefits of a healthy lifestyle. Continue to
follow all dietary advice provided by your doctor and engage in regular physical activity.

The recommended dose is:
Children from 10 years of age and adolescents usually start with 500 mg or 850 mg of
Metformina Hexal* once daily. The maximum daily dose is 2000 mg,
administered in 2 or 3 divided doses. Treatment of children aged 10 to 12 years
is recommended only under specific guidance from the treating physician, as experience in this age group is limited.
Adults usually start with 500 mg or 850 mg of Metformina Hexal* two or three times
daily. The maximum daily dose is 3000 mg, administered in 3 divided doses.
*For individual dose adjustments, tablets containing 500 mg and 850 mg of the active substance metformin hydrochloride are also available.
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If you are also taking insulin, your doctor will advise you on how to start treatment with
Metformina Hexal.
If you have reduced kidney function, your doctor may prescribe a lower dose.

Monitoring

Your doctor will perform regular blood glucose tests and adjust your Metformina Hexal dose according to your blood glucose levels. Make sure to consult your doctor regularly. This is particularly important for children, adolescents, and elderly patients.
Your doctor will also check your kidney function at least once a year. More frequent monitoring may be necessary if you are elderly or if your kidneys do not function normally.

How to take Metformina Hexal
Take Metformina Hexal during or after a meal. This will help you avoid gastrointestinal
side effects.
Do not crush or chew the tablets. Swallow each tablet whole with a glass of water.

If you take one dose per day, take it in the morning (with breakfast).
If you take two doses per day, take them in the morning (with breakfast) and in the evening (with dinner).
If you take three doses per day, take them in the morning (with breakfast), at midday (with lunch), and in the evening (with dinner).

The score line on the tablet is intended to facilitate breaking the tablet if you have
difficulty swallowing it whole.
If after some time you feel that the effect of Metformina Hexal is too strong or
too weak, consult your doctor or pharmacist.

If you take more Metformina Hexal than you should
If you have taken more Metformina Hexal than prescribed, lactic acidosis may occur.
Symptoms of lactic acidosis are nonspecific and include vomiting, stomach pain (abdominal pain) with muscle cramps, a general feeling of discomfort accompanied by severe fatigue and difficulty breathing. Additional symptoms may include lowered body temperature and slowed heart rate. If you experience these symptoms, you may require immediate hospital treatment, as lactic acidosis can lead to coma.
Contact your doctor immediately or go to the nearest hospital.

If you forget to take Metformina Hexal
Do not take a double dose to make up for the missed dose. Take the next dose at your usual scheduled time.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets
them. The following side effects may occur:
Metformin 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 Hexal and contact your doctor or go to the nearest
hospital immediately, as lactic acidosis can lead to coma.
Very common – may affect more than 1 in 10 people

Gastrointestinal problems such as feeling sick (nausea), sickness (vomiting), diarrhoea, stomach ache (abdominal pain), and loss of appetite. These side effects are more frequent at the beginning of treatment with Metformina Hexal. It may help to divide the dose throughout the day and take the tablets during or immediately after meals. If these symptoms persist, stop treatment with Metformina Hexal and consult your doctor.

Common – may affect up to 1 in 10 people

taste disturbances.

Very rare – 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 section "Warnings and precautions").
abnormalities in liver function tests or hepatitis (inflammation of the liver; this may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes).
skin reactions such as redness of the skin (erythema), itching or itchy rash (urticaria).
low levels of vitamin B12 in the blood.

If any of these occur, stop taking Metformina Hexal and consult your doctor.

Children and adolescents
Limited data in children and adolescents have shown that adverse effects were similar in nature and severity to those reported in adults.
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
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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 Hexal

Keep this medicine out of the reach and sight of children. If
Metformina Hexal is being used to treat a child, parents and healthcare providers
are advised to check the instructions for use of this medicine.
This medicine does not require any special storage conditions.
Do not use Metformina Hexal after the expiry date which is stated on the packaging and
on the blister after the term “Exp”. The expiry date refers to the last day of
that month.
Do not dispose of any medicine 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 Hexal contains
The active substance is metformin hydrochloride.
Each film-coated tablet contains 1000 mg of metformin hydrochloride,
equivalent to 780 mg of metformin.
The other components are:
Povidone K90, magnesium stearate, hypromellose, macrogol 4000, colouring agent titanium
dioxide (E171).
Description of the appearance of Metformina Hexal and pack sizes
Metformina Hexal 1000 mg film-coated tablets are white, oval, film-coated tablets,
with a break line on both sides, marked “M 1G” on one side and
smooth on the reverse; the tablets are available in packs of

PVC/aluminum blisters containing 20, 30, 60, 90, 120, 180 and 300 tablets
HDPE bottles with LDPE caps containing 100 and 200 tablets.

Dimensions: approximately 19 mm x 10 mm.
Not all pack sizes may be marketed.
Marketing Authorization Holder
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Sandoz Spa – Largo U. Boccioni, 1 - 21040 Origgio (VA)
Manufacturers responsible for batch release:
Salutas Pharma GmbH - Otto-Von-Guericke-Allee 1 - D-39179 Barleben – Germany
LEK S.A. – Ul. Domaniewska 50c – 02-672 Warszawa – Poland
LEK Pharmaceuticals d.d. – Verovskova 57 -1526 Ljubljana – Slovenia
LEK S.A. – ul. Podlipie, 16 – 95-010 Strykow – Poland
This medicinal product has been authorised in EEA member states under the
following names:
Italy: METFORMINA HEXAL 1000 mg film-coated tablets
Netherlands: Metformine HCl Sandoz 1000 mg filmomhulde tabletten
Portugal: Metformina SANDOZ 1000 mg Comprimidos Revestidos
United Kingdom: Metformin 1000mg Tablets
This patient information leaflet was last approved on
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