ZENOFOR 750 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Zenofor SR, 500 mg, prolonged-release tablets
3. Zenofor SR, 750 mg, prolonged-release tablets
4. Zenofor SR, 1000 mg, prolonged-release tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient
   2. Table of contents of the leaflet
5. What is Zenofor SR and what is it used for
   1. What is Zenofor SR used for
   2. How does Zenofor SR work
6. Important information before taking Zenofor SR
   1. When not to take Zenofor SR:
   2. Warnings and precautions
   3. Zenofor SR and other medicines
   4. Zenofor SR and alcohol
   5. Pregnancy and breastfeeding
   6. This medicine is not recommended for breastfeeding women or women planning to breastfeed.
   7. Driving and using machines
7. How to take Zenofor SR
   1. How and when to take the tablets
   2. Zenofor SR 1000 mg
   3. The dividing line is not intended for breaking the tablet.
   4. Recommended dose
   5. Taking a higher dose of Zenofor SR than recommended
   6. Missing a dose of Zenofor SR
8. Possible side effects
   1. Severe side effects
9. How to store Zenofor SR
10. Contents of the pack and other information
    1. What Zenofor SR contains
    2. What Zenofor SR looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer/Importer
    5. This medicinal product has been authorized in the Member States of the European Economic Area under the following names:
    7. For more information about this medicine, please contact the representative of the marketing authorization holder in Poland:

Leaflet attached to the packaging: information for the user

Zenofor SR, 500 mg, prolonged-release tablets

Zenofor SR, 750 mg, prolonged-release tablets

Zenofor SR, 1000 mg, prolonged-release 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 doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

This medicine is called Zenofor SR 500 mg, 750 mg, 1000 mg prolonged-release tablets, but in this leaflet, it is referred to as Zenofor SR.

Table of contents of the leaflet

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

1. What is Zenofor SR and what is it used for

Zenofor SR prolonged-release tablets contain metformin hydrochloride as the active substance and belong to a group of medicines called biguanides, used to treat type 2 diabetes (non-insulin-dependent diabetes).

What is Zenofor SR used for

Zenofor SR is used to treat type 2 diabetes when diet and exercise alone cannot control blood sugar levels. The medicinal product is intended only for adults.

How does Zenofor SR work

Insulin is a hormone that allows the body to take up glucose and use it for energy or store it for later use. In patients with type 2 diabetes, the pancreas does not produce enough insulin or the body is unable to use the insulin produced. This leads to an excessive increase in blood sugar levels. Zenofor SR helps to lower blood sugar levels to as normal a level as possible. Taking Zenofor SR is associated with maintaining weight or moderate weight loss. Zenofor SR is in the form of prolonged-release tablets, which are specially designed to release the medicine slowly in the body and therefore differ from many other types of metformin tablets.

2. Important information before taking Zenofor SR

When not to take Zenofor SR:

• if the patient is allergic to metformin or any of the other ingredients of the medicine (listed in section 6). An allergic reaction may cause a rash, itching, or difficulty breathing.
• if the patient has liver function disorders.
• if the patient has significantly reduced kidney function.
• if the patient abuses alcohol.
• if the patient has uncontrolled diabetes, such as severe hyperglycemia (high blood sugar levels), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis (symptoms include abdominal pain, rapid and deep breathing, drowsiness, or a fruity odor from the mouth).
• if the patient has any of the following conditions, as they may increase the risk of lactic acidosis (see "Risk of lactic acidosis" below)
• in case of excessive water loss from the body(dehydration). Dehydration may lead to kidney function disorders.
• in case of severe infection, such as pneumonia, bronchitis, or kidney infection. Severe infections may lead to kidney function disorders.
• in case of treatment for acute heart failureor recent myocardial infarction, severe circulatory disorders, or breathing difficulties.

Warnings and precautions

Risk of lactic acidosis(see symptoms in section 4)
Zenofor SR may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney function disorders. The risk of lactic acidosis increases in case of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration, 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 the patient, they should consult their doctor for more detailed instructions.
If the patient is to undergo a major surgical procedure, they must stop taking Zenofor SR before the procedure and for some time after it. The doctor will decide when the patient should stop and resume treatment with Zenofor SR.
During treatment with Zenofor SR, the doctor will monitor the patient's kidney function
at least once a year or more often if the patient is elderly and (or) has deteriorating kidney function.
If the patient is over 75 years old, it is not recommended to start treatment with Zenofor SR to reduce the risk of developing type 2 diabetes.
It may happen that the tablet coating is visible in the stool. Do not be concerned, as this is normal when taking this type of tablet.
Follow the dietary recommendations given by your doctor and eat carbohydrates regularly throughout the day.
Do not stop taking this medicine without consulting your doctor.

Zenofor SR and other medicines

If the patient is to be injected with a radiographic contrast agentcontaining iodine, the patient must stop taking Zenofor SR before or at the latest at the time of such injection. The doctor will decide when the patient should stop and resume treatment with Zenofor SR.
Tell your doctor about all 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 assessments or dose adjustments of Zenofor SR by your doctor.
It is especially important to tell your doctor about taking the following medicines:

• diuretics (e.g., furosemide),
• medicines used to treat pain and inflammation(non-steroidal anti-inflammatory drugs (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),
• steroids, such as prednisolone, mometasone, beclomethasone,
• sympathomimetic medicines, including epinephrine and dopamineused to treat heart attacks and low blood pressure. Epinephrine is also contained in some dental anesthetics,
• medicines that may change the level of Zenofor SR in the blood, especially if the patient has reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Zenofor SR and alcohol

Consuming excessive amounts of alcohol while taking this medicine may increase the risk of lactic acidosis(see symptoms in section 4).
Therefore, do not take Zenofor SR if you are addicted to alcohol.

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 sugar monitoring may be necessary.

This medicine is not recommended for breastfeeding women or women planning to breastfeed.

Driving and using machines

Zenofor SR taken as the only antidiabetic medicinedoes not cause hypoglycemia (symptoms such as fainting, confusion, and excessive sweating), and therefore should not affect the ability to drive or operate machinery.
However, if you take Zenofor SR in combination with other antidiabetic medicinesthat may cause hypoglycemia, you should be careful when driving or operating machinery.

3. How to take Zenofor SR

Your doctor may prescribe Zenofor SR as the only antidiabetic medicine or in combination with other oral antidiabetic medicines or insulin.

How and when to take the tablets

Zenofor SR should always be taken according to your doctor's instructions.
If you have any doubts, consult your doctor or pharmacist.
Treatment usually starts with one tablet once a daytaken with the evening meal.
In some cases, your doctor may recommend taking tablets twice a day, but tablets should always be taken with a meal or some food.
Tablets should be swallowed whole with a glass of water, without chewing.

Zenofor SR 1000 mg

The dividing line is not intended for breaking the tablet.

Recommended dose

Treatment usually starts with one Zenofor SR tablet containing 500 mg of metformin taken once a day (1 x 500 mg tablet). After about 2 weeks, based on blood sugar measurements, your doctor may adjust the dose. The maximum daily dose of Zenofor SR is 2000 mg (e.g., 4 x 500 mg tablets).
If you have kidney function disorders, your doctor may prescribe a lower dose.

Taking a higher dose of Zenofor SR than recommended

If you accidentally take extra tablets, do not worry. If unusual symptoms occur, contact your doctor.
If the overdose is large, it is more likely that lactic acidosis will occur (see symptoms in section 4). You should then stop taking Zenofor SR immediately and contact your doctor or go to the nearest hospital.

Missing a dose of Zenofor SR

Take the missed tablet as soon as you remember. Do not take a double dose to make up for the missed dose.

4. Possible side effects

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

Severe side effects

Stop taking Zenofor SRand contact your doctor or go to the nearest hospital immediately if you experience any of the symptoms of lactic acidosis, as this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain (abdominal pain),
• muscle cramps,
• general poor condition in combination with severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate. Lactic acidosis is a life-threatening condition that requires hospital treatment.

You should temporarily stop taking Zenofor SRif you experience symptoms of 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. Consult your doctor for more detailed instructions.
Zenofor SR may cause abnormal liver function test results and liver inflammation, which can lead to jaundice(may occur in up to 1 in 10,000 patients). If you experience yellowing of the eyes and (or) skin, contact your doctor immediately.
Other possible side effectsare listed according to their frequency of occurrence as follows:
Very common(may affect more than 1 in 10 patients):

• Diarrhea, nausea, vomiting, abdominal pain, or loss of appetite. If such symptoms occur, do not stop taking the tablets, as they usually disappear after about 2 weeks. It may be helpful to take the tablets with a meal or immediately after a meal.

Common(may affect up to 1 in 10 patients)

• 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 order several tests to find the cause of the symptoms, as some of them may also be caused by diabetes or other unrelated health problems.

Very rare(may affect up to 1 in 10,000 patients)

• Skin rash, including redness, itching, and hives.

Reporting side effects
If you experience any side effects, including any side effects 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 or its representative.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Zenofor SR

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the packaging after the abbreviation "EXP". The expiry date refers to the last day of the specified month.
There are no special storage precautions.
If the tablets become discolored or show any other signs of deterioration, consult your pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Zenofor SR contains

The active substance of Zenofor SR is metformin (in the form of metformin hydrochloride).
Zenofor SR, 500 mg: Each prolonged-release tablet contains 500 mg of metformin hydrochloride, which corresponds to 390 mg of metformin.
Zenofor SR, 750 mg: Each prolonged-release tablet contains 750 mg of metformin hydrochloride, which corresponds to 585 mg of metformin.
Zenofor SR, 1000 mg: Each prolonged-release tablet contains 1000 mg of metformin hydrochloride, which corresponds to 780 mg of metformin.
The other ingredients of the medicine are:
Tablet core:stearic acid, shellac, povidone (K30), colloidal silica, and magnesium stearate
Tablet coating:hypromellose (15 cps), hydroxypropyl cellulose, titanium dioxide (E 171), propylene glycol, macrogol 6000, and talc.

What Zenofor SR looks like and contents of the pack

Zenofor SR, 500 mg: White, oval, biconvex, film-coated tablets, smooth on both sides, approximately 15.00 × 8.5 mm in size.
Zenofor SR, 750 mg: White, biconvex, film-coated tablets in the shape of a capsule, smooth on both sides, approximately 19.1 × 9.3 mm in size.
Zenofor SR, 1000 mg: White, oval, biconvex, film-coated tablets with a dividing line on one side and smooth on the other, approximately 20.4 × 9.7 mm in size.
The dividing line is not intended for breaking the tablet.
Zenofor SR, 500 mg, is available in packs of 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 180, or 600 tablets packaged in PVC/PVDC/Aluminum blisters.
Zenofor SR, 750 mg, is available in packs of 14, 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 180, or 600 tablets packaged in PVC/PVDC/Aluminum blisters.
Zenofor SR, 1000 mg, is available in packs of 14, 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 180, or 600 tablets packaged in PVC/PVDC/Aluminum blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer/Importer

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

This medicinal product has been authorized in the Member States of the European Economic Area under the following names:

Czech Republic
Mulado Prolong
Poland
Zenofor SR
Hungary
Zenofor 500, 750, 1000 mg retard tabletta
Slovakia
Mirovian XR 500 mg/750 mg/1000 mg

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
Date of last revision of the leaflet:February 2025