Zenofor

Package Leaflet: Information for the User

Zenofor, 500 mg, film-coated tablets

Zenofor, 850 mg, film-coated tablets

Zenofor, 1000 mg, film-coated tablets

Metformin hydrochloride

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What Zenofor is and what it is used for

Zenofor contains metformin, a medicine used to treat diabetes. It belongs to a group of medicines called biguanides.
Insulin, a hormone produced by the pancreas, allows the body to use glucose (sugar) from the blood for energy or to store it for future use.
In diabetic patients, the pancreas does not produce enough insulin or the body is unable to use the insulin produced. This leads to high blood sugar levels. Zenofor helps lower blood sugar levels to as close to normal as possible.
In adults with overweight, long-term use of Zenofor also reduces the risk of complications associated with diabetes. Taking Zenofor is associated with either weight loss or no change in body weight.
Zenofor is used to treat patients with type 2 diabetes mellitus (also called non-insulin-dependent diabetes mellitus), where diet and exercise alone are not enough to control blood sugar levels. It is especially used in patients with overweight.
Adults can take Zenofor alone or in combination with other oral anti-diabetic medicines or with insulin.
Children from 10 years of age and adolescents can take Zenofor alone or in combination with insulin.

2. What you need to know before you take Zenofor

Do not take Zenofor:

• if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6).

(see section 6).

• if you have liver problems.
• if you have severe kidney problems.
• if you have uncontrolled diabetes, such as severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below) 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 abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odor from the mouth.
• in case of severe dehydration (loss of water from the body), for example due to prolonged or severe diarrhea or repeated vomiting. Dehydration can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions").
• in case of severe infection, such as pneumonia, bronchitis or pyelonephritis. Severe infections can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions").
• in case of acute heart failure or recent myocardial infarction, severe circulatory problems (such as shock) or breathing difficulties. This can cause tissue hypoxia, which can increase the risk of lactic acidosis (see "Warnings and precautions").
• in case of alcohol abuse.

If any of the above conditions apply to you, you should consult your doctor before taking this medicine.
It is essential to consult your doctor if it is necessary to:

• perform a radiological examination or an examination that requires the injection of a contrast agent containing iodine into the bloodstream.
• perform major surgery.

Zenofor must be discontinued for a certain period before and after the examination or surgery. Your doctor will decide whether you need other treatment during this time. It is essential to follow your doctor's instructions.

Warnings and precautions

Risk of lactic acidosis

Zenofor may cause a very rare but very serious side effect called lactic acidosis, especially if you have kidney problems. The risk of lactic acidosis increases in case of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see below), liver problems, and any condition that may cause tissue hypoxia (such as acute heart failure).
If any of the above conditions apply to you, you should consult your doctor for more detailed instructions.

Temporarily discontinue Zenofor if you have a condition that may lead to dehydration

(significant loss of water from the body), such as severe vomiting, diarrhea, fever, or exposure to high temperatures, or if you drink less fluid than usual. You should consult your doctor for more detailed instructions.

Stop taking Zenofor and contact your doctor immediately or go to the nearest hospital if you experience any symptoms of lactic acidosis

as it can lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell, accompanied by severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a medical emergency that requires immediate hospital treatment.
If you are going to have major surgery, you should not take Zenofor during and for some time after the surgery. Your doctor will decide when you should stop and restart taking Zenofor.
Zenofor does not cause hypoglycemia (low blood sugar). However, if Zenofor is taken with other anti-diabetic medicines that 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, blurred vision, or difficulty concentrating, eating or drinking a sugary snack usually helps.
During treatment with Zenofor, your doctor will check your kidney function at least once a year or more often if you are elderly and/or have impaired kidney function.

Zenofor with other medicines

If you are going to have a contrast agent containing iodine injected into your bloodstream, for example for an X-ray examination or computed tomography, you must stop taking Zenofor before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart taking Zenofor.
Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood sugar checks and kidney function tests or a dose adjustment of Zenofor by your doctor.
It is particularly important to inform your doctor if you are taking:

• 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 adrenergic receptor agonists, such as salbutamol or terbutaline (used to treat asthma),
• corticosteroids (used to treat various diseases, such as severe skin inflammation or asthma),
• medicines that may change the level of Zenofor in the blood, especially if you have kidney problems (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other anti-diabetic medicines.

Zenofor with alcohol

Avoid excessive alcohol consumption while taking Zenofor, as it may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, you should consult your doctor, as changes in treatment or blood sugar monitoring may be necessary.
This medicine is not recommended for breastfeeding women or women planning to breastfeed.

Driving and using machines

Zenofor does not cause hypoglycemia (low blood sugar). This means it does not affect your ability to drive or use machines.
However, you should be careful if you are taking Zenofor with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, rapid heartbeat, blurred vision, or difficulty concentrating. If you experience such symptoms, do not drive or use machines.
Zenofor contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, which means it is essentially "sodium-free".

3. How to take Zenofor

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Zenofor does not replace the benefits of a healthy lifestyle.
Continue to follow your doctor's advice on diet and regular physical activity.

Recommended dose

Children from 10 years of age and adolescents: usually start with a dose of 500 mg or 850 mg of Zenofor once a day. The maximum daily dose is 2000 mg and is taken in 2 or 3 divided doses. Treatment of children from 10 to 12 years of age is only used if specifically recommended by a doctor, as experience with Zenofor in this age group is limited.
Adults: usually start with a dose of 500 mg or 850 mg of Zenofor, 2 or 3 times a day. The maximum daily dose is 3000 mg and is taken in 3 divided doses.
If you have kidney problems, your doctor may prescribe a lower dose.
If you are also taking insulin, your doctor will tell you how to start taking Zenofor.

Monitoring of treatment

• Your doctor will prescribe regular blood sugar tests and adjust the dose of Zenofor based on blood sugar levels. You should regularly visit your doctor for check-ups. This is especially important for children and adolescents and for people over 65 years of age.
• Your doctor will check your kidney function at least once a year. More frequent checks may be necessary for people over 65 years of age or if your kidneys are not working properly.

How to take Zenofor

Zenofor should be taken with a meal or just after a meal to avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablet with a glass of water.

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

evening (dinner).
If after some time you feel that the effect of Zenofor is too strong or too weak, you should consult your doctor or pharmacist.

Taking a higher dose of Zenofor than recommended

If you take a higher dose of Zenofor than recommended, you may experience lactic acidosis. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (abdominal cramps), general feeling of being unwell, accompanied by severe fatigue, and breathing difficulties. Other symptoms include decreased body temperature and slowed heart rate. If you experience any of these symptoms, you should seek medical attention immediately, as lactic acidosis can lead to coma.
Stop taking Zenofor and contact your doctor or go to the nearest hospital.

Missing a dose of Zenofor

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Zenofor may very rarely cause (may affect up to 1 in 10,000 people) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to you, you should stop taking Zenofor and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

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

• gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain (abdominal cramps), loss of appetite. These side effects usually occur at the beginning of treatment with Zenofor. It may be helpful to divide the daily dose into several smaller doses taken throughout the day and to take Zenofor with a meal or just after a meal. If the symptoms do not disappear, you should stop taking Zenofor and tell your doctor.

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

• taste disorders.
• decreased or low levels of vitamin B12 in the blood (symptoms may include extreme fatigue, pain and redness of the tongue, numbness or pale or yellowish skin). Your doctor may prescribe several tests to find the cause of the symptoms, as some of them may also be caused by diabetes or other health problems unrelated to diabetes.

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

• lactic acidosis. This is a very rare but serious complication, especially if your kidneys are not working properly. Symptoms of lactic acidosis are non-specific (see "Warnings and precautions").
• abnormal liver function test results or symptoms of liver inflammation (accompanied by fatigue, loss of appetite, and weight loss, as well as yellowing or non-yellowing of the skin and whites of the eyes). If such symptoms occur, you should stop taking Zenofor and tell your doctor.
• skin reactions, such as skin redness, itching, or itchy rash.

Children and adolescents

Limited data in children and adolescents suggest that the side effects are similar in nature and severity to those observed in adults.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact details for reporting side effects" section below.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zenofor

Keep this medicine out of the sight and reach of children. If a child is being treated with Zenofor, parents and caregivers are advised to supervise the use of this medicine.
There are no special storage precautions for this medicine.
Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Zenofor contains

The active substance is metformin hydrochloride.
Each film-coated tablet Zenofor 500 mg contains 500 mg of metformin hydrochloride, which corresponds to 390 mg of metformin.
Each film-coated tablet Zenofor 850 mg contains 850 mg of metformin hydrochloride, which corresponds to 662.9 mg of metformin.
Each film-coated tablet Zenofor 1000 mg contains 1000 mg of metformin hydrochloride, which corresponds to 780 mg of metformin.
The other ingredients are:
Core: hypromellose 615, sodium carbonate anhydrous, povidone K 25, magnesium stearate
Coating: hypromellose 606, macrogol 6000, titanium dioxide (E 171)

What Zenofor looks like and contents of the pack

Zenofor 500 mg, film-coated tablets:
White, round, biconvex film-coated tablets. One side of the tablet has a score line in the shape of a V. The diameter of the tablet is approximately 12 mm. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.
Zenofor 850 mg, film-coated tablets:
White, oval, film-coated tablets. Both sides have a score line in the shape of a V. The dimensions of the tablet are approximately 19 x 8.7 mm. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.
Zenofor 1000 mg, film-coated tablets:
White, oval film-coated tablets. The score lines are engraved on both sides of the tablet, in the shape of a V on one side. The dimensions of the tablet are approximately 19 x 10 mm. The tablet can be divided into equal doses.
PVC/Aluminum blisters in a cardboard box
Pack sizes:
Zenofor 500 mg: 20, 28, 30, 50, 56, 60, 84, 90, 100, 120, 180, 300, 400, 500 film-coated tablets
Zenofor 850 mg: 30, 40, 50, 56, 60, 80, 90, 100, 120, 180, 200, 500 film-coated tablets
Zenofor 1000 mg: 28, 30, 50, 56, 60, 80, 90, 100, 120, 180 film-coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
(marketing authorization holder's logo)

Importer

S.C. ZENTIVA S.A.
B-dul Theodor Pallady nr.50, sector 3
032266 Bucharest
Romania

This medicine has been authorized for use in the Member States of the European Economic Area under the following names:

Mulado
Metformin Zentiva
Metformine Zentiva
Metformin Zentiva
Poland, Romania:
Zenofor
Lithuania:
Metformin hydrochloride Zentiva
Slovakia:
Mirovian

For further information on this medicine, please contact the marketing authorization holder in your country:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
Czech Republic:
Denmark, Estonia,
Germany, Latvia,
Norway:
France:
Finland, Sweden:
Date of last revision of the leaflet:March 2023