Metformin Hexal AG

Package leaflet: Information for the patient

Metformina Hexal AG 500 mg film-coated tablets, 850 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before using 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 they have the same symptoms as yours, because it may 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 Metformina Hexal AG is and what it is used for
2. What you need to know before taking Metformina Hexal AG
3. How to take Metformina Hexal AG
4. Possible side effects
5. How to store Metformina Hexal AG
6. Contents of the pack and other information

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

Metformina Hexal AG 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. The body uses glucose for energy production or stores it for future 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. Metformin helps lower blood glucose to bring it as close as possible to normal levels.
If you are an overweight adult, taking Metformina Hexal AG over a long period of time also helps reduce the risk of diabetes-related complications. Metformina Hexal AG has been associated with both stabilization and modest reduction in body weight.
Metformina Hexal AG 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 particularly used in overweight patients.
Adults may take Metformina Hexal AG alone or in combination with other antidiabetic medicines (oral medications or insulin).
Children aged 10 years and older and adolescents may take Metformina Hexal AG alone or in combination with insulin.

2. What you should know before taking Metformina Hexal AG

Do not take Metformina Hexal AG:

• 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 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, and breath with an unusually fruity odour;
• if you have liver disorders;
• if you drink large amounts of alcohol;
• if your body has lost too much water (dehydration), for example due to prolonged or severe diarrhoea or repeated vomiting. Dehydration may cause kidney problems, which could increase your risk of lactic acidosis (see section “Warnings and precautions” below);
• if you have a severe infection, such as an infection affecting the lungs, bronchial system or kidneys. Severe infections may cause kidney problems, which could 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, or if you have serious circulatory problems (such as shock) or breathing difficulties. These conditions may cause inadequate oxygen supply to tissues, which could increase your risk of lactic acidosis (see section “Warnings and precautions” below).

If you are in any of the above conditions, consult your doctor before starting this medicine.

Make sure you ask your doctor for advice if:

• you are due to undergo examinations such as X-rays or diagnostic tests requiring injection into the bloodstream of iodinated contrast agents;
• you are due to undergo surgery.

You must stop taking Metformina Hexal AG for a certain period of time before and after the examination or surgery. Your doctor will decide whether you need alternative treatment during this time. It is important that you follow your doctor’s instructions precisely.

Warnings and precautions

Risk of lactic acidosis

Metformina Hexal AG 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, or any other medical condition characterised by reduced oxygen supply to part of the body (such as severe heart disease).

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

Temporarily stop taking Metformina Hexal AG 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 normal. Consult your doctor for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking Metformina Hexal AG and seek immediate medical advice from your doctor or the nearest hospital, because lactic acidosis may 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 heart rate.

Lactic acidosis is a medical emergency and must be treated in hospital.

Metformina Hexal AG alone does not cause hypoglycaemia (low blood glucose levels). However, if you take Metformina Hexal AG together with other diabetes medicines 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, blurred vision or difficulty concentrating, it is usually helpful to eat or drink something containing sugar.

If you are undergoing major surgery, you must stop taking Metformina Hexal AG during the operation and for a certain period afterwards. Your doctor will decide when you should stop and when you should restart treatment with Metformina Hexal AG.

During treatment with Metformina Hexal AG, your doctor will monitor your kidney function at least once a year, or more frequently if you are elderly and/or have impaired kidney function.

Other medicines and Metformina Hexal AG

If you are due to receive an injection of an iodinated contrast agent into the bloodstream, for example for an X-ray, you must stop taking Metformina Hexal AG before or during the injection. Your doctor will decide when you should stop and when you should restart treatment with Metformina Hexal AG.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. 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 AG. It is particularly important to mention the following:

• corticosteroids (used to treat a range of conditions, such as severe skin inflammation or asthma);
• 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);
• medicines that may alter the blood levels of Metformina Hexal AG, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib);
• medicines used to lower blood sugar levels, such as insulin or oral antidiabetic agents. Taking these medicines together with Metformina Hexal AG may cause excessive lowering of blood sugar levels. See also section “Warnings and precautions”.

Metformina Hexal AG and alcohol

Avoid excessive alcohol consumption during treatment with Metformina Hexal AG, 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, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

• Pregnancy If you are pregnant or planning to become pregnant, you must not take Metformina Hexal AG. If this applies to you, inform your doctor, as treatment with metformin must be stopped and replaced with insulin therapy.
• Breastfeeding You must not take Metformina Hexal AG without first consulting your doctor if you are breastfeeding.

Driving and using machines

Metformina Hexal AG 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 Hexal AG together with other diabetes medicines 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 begin to experience these symptoms.

3. How to take Metformina Hexal AG

Metformina Hexal AG 500 mg film-coated tablets
Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. If you have reduced kidney function, your doctor may prescribe a
lower dose.
Metformina Hexal AG cannot replace the benefits of a healthy lifestyle. Continue to follow all dietary advice
given by your doctor and exercise regularly.

Adults

• The recommended starting dose is 1 tablet of Metformina Hexal AG 2–3 times a day.
• About 2 weeks after starting Metformina Hexal AG, your doctor may measure your blood sugar levels to adjust the dosage.
• Maximum dose: 6 tablets* of Metformina Hexal AG per day, divided into 3 doses.

Children aged 10 years and above

• Usual starting dose: 1 tablet of Metformina Hexal AG or 850 mg* of metformin hydrochloride once daily.
• About 2 weeks after the child starts taking Metformina Hexal AG, the doctor may measure blood sugar levels and adjust the dose accordingly.
• Maximum dose: 4 tablets* of Metformina Hexal AG per day, divided into 2 or 3 doses.

*For individual dose adjustments, film-coated tablets containing
850 mg and 1000 mg of the active substance metformin hydrochloride are also available.

Patients aged 65 years and over
Your doctor will determine the dose of Metformina Hexal AG based on kidney function, as the frequency of kidney impairment is high in this age group. See also section 2, "Warnings and precautions."

Metformina Hexal AG 850 mg film-coated tablets
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist. If you have reduced kidney function, your doctor may prescribe a lower dose.

Adults

• Usual dose: 1 tablet of Metformina Hexal AG 2–3 times a day.
• About 2 weeks after starting Metformina Hexal AG, your doctor may measure your blood sugar levels and adjust the dose.
• Maximum dose: 3000 mg* of metformin hydrochloride per day, divided into 3 doses.

Children aged 10 years and above

• Usual starting dose: 500 mg* of metformin hydrochloride or 1 tablet of Metformina Hexal AG once daily.
• About 2 weeks after the child starts taking Metformina Hexal AG, the doctor may measure blood sugar levels and adjust the dose accordingly.
• Maximum dose: 2000 mg* of metformin hydrochloride per day, divided into 2 or 3 doses.

*For individual dose adjustments, film-coated tablets containing
500 mg and 1000 mg of the active substance metformin hydrochloride are also available.

Patients aged 65 years and over
Your doctor will determine the dose of Metformina Hexal AG based on kidney function, as the frequency of kidney impairment is high in this age group. See also section 2, "Warnings and precautions."

Method of administration
Swallow the tablets whole with a glass of water, during or after meals.

Monitoring

• Your doctor will perform regular blood glucose tests and adjust the dose of Metformina Hexal AG 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. More frequent monitoring may be needed if you are elderly or if your kidneys do not function normally.

Duration of treatment
The duration of treatment will be determined by your doctor.

If you take more Metformina Hexal AG than you should
If you have taken more tablets than prescribed, contact your doctor immediately or go to the nearest hospital.
An overdose of Metformina Hexal AG does not cause excessively low blood sugar levels. However, it increases the risk of blood hyperacidity due to lactic acid (lactic acidosis). Symptoms of hyperacidity are described at the end of the section “Do not take Metformina Hexal AG”.
Muscle pain accompanied by cramps, deep and rapid breathing, loss of consciousness, and coma may develop within a few hours. These symptoms require immediate emergency treatment in hospital.

If you forget to take Metformina Hexal AG
If you forget to take a dose of Metformina Hexal AG, skip the missed dose and take the next dose at the scheduled time.
Do not take a double dose to make up for the missed dose.

If you stop taking Metformina Hexal AG
Stopping treatment with Metformina Hexal AG without your doctor's approval may lead to uncontrolled increases in blood sugar levels. This may increase the risk of long-term complications, such as damage to the eyes, kidneys, and blood vessels.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Metformina Hexal AG 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 Hexal AG and contact your doctor or go to the nearest hospital immediately, because lactic acidosis can lead to coma.

Other possible side effects

Very common, may affect more than 1 in 10 people:

• nausea
• vomiting
• diarrhoea
• abdominal pain
• loss of appetite

These effects occur mainly at the beginning of treatment and in most cases disappear spontaneously. To help prevent these effects, take Metformina Hexal AG during or after meals, in 2 or 3 separate daily doses.

Common, may affect up to 1 in 10 people:

• altered taste

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

• decreased intestinal absorption of vitamin B_{12} (during long-term treatment with Metformina Hexal AG)
• skin redness
• itching
• itchy rash
• changes in liver function tests or liver inflammation; this may cause:
  • fatigue
  • loss of appetite
  • weight loss
  • yellowing of the skin or whites of the eyes

If this occurs, stop treatment with Metformina Hexal AG and inform your doctor immediately.

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 Hexal AG

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 pack, blister, or bottle 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 Hexal AG contains

• The active substance is metformin hydrochloride.
  Metformina Hexal AG 500 mg: Each film-coated tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin base.
  Metformina Hexal AG 850 mg: Each film-coated tablet contains 850 mg of metformin hydrochloride, equivalent to 662.9 mg of metformin base.
• The other components are: povidone K90, magnesium stearate, hypromellose, macrogol 4000, titanium dioxide (E171).

Description of the appearance of Metformina Hexal AG and contents of the pack
Metformina Hexal AG 500 mg
White, round, film-coated tablets with a double-layer coating, marked “M 500” on one side and flat on the reverse.
The tablets are packaged in PVC/AL blisters and placed in a carton or packaged in an HDPE bottle with LDPE cap.
Pack sizes:

• HDPE bottles: 30, 60, 90, 100, 250, 400 film-coated tablets;
• Blister packs: 30, 50, 60, 84, 90, 100, 250 film-coated tablets.

Metformina Hexal AG 850 mg
White, oval, film-coated tablets with a score line on one side and marked “M 850” on the other side.
The tablets are packaged in PVC/AL blisters and placed in a carton or packaged in an HDPE bottle with LDPE cap.
Pack sizes:

• HDPE bottles: 30, 100, 200, 250 film-coated tablets;
• Blister packs: 30, 40, 56, 60, 90, 100, 250 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Hexal AG – Industriestrasse, 25 – Holzkirchen (Germany)
Representative in Italy: Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA)
Marketing Authorization Holder in Italy: Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Manufacturers
Salutas Pharma GmbH – Otto von Guericke Allee 1 – 39179 Barleben (Germany)
Salutas Pharma GmbH – Dieselstrasse, 5 – 70839 Gerlingen (Germany)
LEK S.A. - Ul. Domaniewska 50 C, 02-672 Warszawa (Poland)
Lek Pharmaceuticals d.d - Verovskova 57 - 1526 Ljubljana (Slovenia)
LEK S.A. - Ul. Podlipie 16 - 95010 Strykow (Poland)

This medicinal product has been authorized in the Member States of the European Economic Area under the following names:
Ireland: METOPHAGE 500 MG Film-Coated Tablets
METOPHAGE 850 MG Film-Coated Tablets
Italy: METFORMINA HEXAL AG
Netherlands: METFORMINE HCL SANDOZ TABLET 500 mg, filmomhulde tabletten
METFORMINE HCL SANDOZ TABLET 850 mg, filmomhulde tabletten