Zenofor

Leaflet attached to the packaging: information for the user

Zenofor, 500 mg, coated tablets

Zenofor, 850 mg, coated tablets

Zenofor, 1000 mg, coated tablets

Metformin hydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Zenofor and what is it used for

Zenofor 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 allows the body to take up glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for later use.
In diabetic patients, the pancreas does not produce enough insulin or the body is unable to use the insulin produced properly. This leads to an excessive increase in blood glucose levels. Zenofor helps to reduce blood glucose levels to values 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 maintaining body weight or moderate weight loss.
Zenofor is used to treat patients with type 2 diabetes (also called "insulin-independent" diabetes), in whom diet and physical exercise alone cannot achieve sufficient blood glucose control. It is particularly used in patients with overweight.
Adults can take Zenofor as the only medicine or in combination with other anti-diabetic medicines (oral medicines or insulin).
Children from 10 years of age and adolescents can take Zenofor as the only medicine or in combination with insulin.

2. Important information before taking Zenofor

When not to take Zenofor:

(listed in section 6).

If any of the above situations apply to you, you should consult your doctor before taking this medicine.
You must consult your doctor if it is necessary to:

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

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 function disorders. The risk of lactic acidosis increases in case of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver function disorders, and any conditions in which a part of the body is not sufficiently supplied with oxygen (e.g., acute severe heart disease).
If any of the above circumstances apply to you, you should consult your doctor for more detailed instructions.

You should temporarily stop taking Zenofor if you have a condition that

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

You should stop taking Zenofor and contact your doctor or the nearest hospital immediately if you experience any symptoms of

lactic acidosis, as this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general malaise with severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.
If you are to undergo a major surgical procedure, you should not take Zenofor during the procedure and for some time after it. Your doctor will decide when you should stop and resume 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, vision disturbances, or difficulty concentrating, eating or drinking a sugary drink 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 and other medicines

If you are to be injected with a contrast agent containing iodine into the 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 such injection. Your doctor will decide when you should stop and resume taking Zenofor.
You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood glucose checks and kidney function tests or dose adjustments of Zenofor by your doctor.
It is particularly important to inform your doctor if you are taking:

• diuretics (medicines that increase urine production),
• 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 can change the level of Zenofor in the blood, especially if you have impaired kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other medicines used to treat diabetes.

Zenofor and alcohol

You should avoid consuming excessive amounts of alcohol while taking Zenofor, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to have a baby, you should consult your doctor, as changes in treatment or blood glucose 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 that it does not affect your ability to drive or use machines.
However, you should be careful if you take 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, vision disturbances, or difficulty concentrating. If you experience such symptoms, you should not drive or use machines.
Zenofor contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, so it is considered "sodium-free".

3. How to take Zenofor

You should 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.
You should continue to follow your doctor's recommendations regarding diet and regular physical activity.

Recommended dose

Children from 10 years of age and adolescents: usually start treatment 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 in case of special recommendation by the doctor, as experience with Zenofor in this age group is limited.
Adults: usually start treatment with a dose of 500 mg or 850 mg of Zenofor, two or three times a day. The maximum daily dose is 3000 mg and is taken in 3 divided doses.
If you have impaired kidney function, your doctor may prescribe a lower dose.
If you are also taking insulin, your doctor will tell you how to start taking Zenofor.

Treatment monitoring

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

How to take Zenofor

Zenofor should be taken during or immediately after a meal. This will help 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

in the 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 malaise with 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 the nearest hospital.

Missing a dose of Zenofor

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

4. Possible side effects

Like all medicines, Zenofor can cause side effects, although not everybody gets them.
The following side effects may occur:
Zenofor may very rarely cause (may occur in 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 (occurring in 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 take Zenofor with a meal or immediately after a meal. If the symptoms do not disappear, you should stop taking Zenofor and tell your doctor.

Common side effects (occurring in less than 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 non-diabetic health problems.

Very rare side effects (occurring in less than 1 in 10,000 people)

• lactic acidosis. This is a very rare but serious complication, especially when the kidneys are not functioning properly. Symptoms of lactic acidosis are non-specific (see "Warnings and precautions").
• abnormal liver function test results or symptoms of liver inflammation (with accompanying fatigue, loss of appetite, and weight loss, as well as with or without 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 indicate that the side effects that occur have a similar nature and severity to those observed in adults.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
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

The medicine should be stored 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.
Do not use this medicine after the expiry date stated on the carton after "EXP".
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Zenofor contains

The active substance of Zenofor is metformin hydrochloride.
Each Zenofor 500 mg coated tablet contains 500 mg of metformin hydrochloride, which corresponds to 390 mg of metformin.
Each Zenofor 850 mg coated tablet contains 850 mg of metformin hydrochloride, which corresponds to 662.9 mg of metformin.
Each Zenofor 1000 mg coated tablet contains 1000 mg of metformin hydrochloride, which corresponds to 780 mg of metformin.
The other ingredients of the medicine 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, coated tablets:
White, round, biconvex 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, coated tablets:
White, oval, 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, coated tablets:
White, oval, coated tablets. 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 coated tablets
Zenofor 850 mg: 30, 40, 50, 56, 60, 80, 90, 100, 120, 180, 200, 500 coated tablets
Zenofor 1000 mg: 28, 30, 50, 56, 60, 80, 90, 100, 120, 180 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 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 more information about this medicine, please contact the representative of the marketing authorization holder in Poland:

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