GLIBENESE 10 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Glibenese GITS and what is it used for
3. Important information before taking Glibenese GITS
   1. When not to take Glibenese GITS
   2. Warnings and precautions
   3. Glibenese GITS and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Glibenese GITS contains sodium
4. How to take Glibenese GITS
   1. Overdose of Glibenese GITS
   2. Missed dose of Glibenese GITS
   3. Discontinuation of Glibenese GITS
5. Possible side effects
   1. Reporting side effects
6. How to store Glibenese GITS
7. Contents of the packaging and other information
   1. What Glibenese GITS contains
   2. What Glibenese GITS looks like and contents of the packaging
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Glibenese GITS, 5 mg, prolonged-release tablets
Glibenese GITS, 10 mg, prolonged-release tablets
Glipizide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 as yours.
• 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.

Table of contents of the leaflet

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

1. What is Glibenese GITS and what is it used for

Glibenese GITS is used in the form of oral prolonged-release tablets containing 5 mg or 10 mg of glipizide. Glipizide belongs to a group of sulfonylurea derivatives with a glucose-lowering effect.
Glibenese GITS is indicated for the treatment of non-insulin-dependent diabetes (type 2) when adequate blood glucose levels cannot be achieved through diet alone.

2. Important information before taking Glibenese GITS

When not to take Glibenese GITS

• if the patient is allergic to glipizide or any of the other ingredients of this medicine (listed in section 6),
• in patients with type 1 diabetes (insulin-dependent),
• in patients with acute complications of diabetes (ketoacidosis, diabetic coma),
• in patients with severe liver, kidney, or pancreatic disorders,
• in patients with significant narrowing of the gastrointestinal tract,
• in patients being treated with miconazole at the same time,
• in pregnant or breastfeeding women.

Warnings and precautions

Before starting treatment with Glibenese GITS, discuss it with your doctor or pharmacist.

• Like all sulfonylurea-containing medicines, this medicine may cause hypoglycemia, i.e., excessive lowering of blood glucose levels. You should learn to recognize the early symptoms of hypoglycemia, such as headache, vision disturbances, hearing impairment, tingling sensation, feeling of hunger, muscle weakness, hand tremors,

anxiety, sweating, feeling of palpitations, so that you can report to your doctor in time.
Family members of diabetic patients should pay attention to the following symptoms that may indicate hypoglycemia: weakness, impaired concentration, speech disturbances, aggression, depression, unexplained laughter, confusion, convulsions, paleness, loss of consciousness. In renal or hepatic insufficiency, there is a greater risk of severe hypoglycemia with coma, convulsions, or other neurological symptoms. This is a condition that requires hospital treatment. Malnourished or undernourished patients, as well as those with adrenal or pituitary insufficiency, are particularly at risk of hypoglycemia.
In elderly patients and those taking beta-adrenergic blockers, hypoglycemia may be difficult to recognize. The likelihood of hypoglycemia is higher in case of insufficient calorie intake, after intense or prolonged physical exertion, after alcohol consumption, and when taking more than one glucose-lowering medicine.

• During treatment with Glibenese GITS, stress, fever, injury, infection, or surgery may cause loss of glycemic control. In such cases, the doctor will decide whether it is necessary to discontinue Glibenese GITS and administer insulin temporarily. In many patients, the effectiveness of each oral glucose-lowering medicine, including Glibenese GITS, decreases over time. This may be related to the progression of diabetes or the patient's decreasing responsiveness to the medicine. During treatment, dietary recommendations, medication dosing, regular physical exercise, and regular blood glucose monitoring should be followed.
• In patients with gastrointestinal diseases, due to the shortened tablet retention time, the effectiveness of the medicine may change. There have also been rare reports of obstruction symptoms in patients with gastrointestinal narrowing who took another medicine containing a non-absorbable coating similar to the one in Glibenese GITS. For this reason, the use of Glibenese GITS in these patients is contraindicated.
• In patients with glucose-6-phosphate dehydrogenase deficiency, caution should be exercised when taking Glibenese GITS. Taking Glibenese GITS in patients with glucose-6-phosphate dehydrogenase deficiency may lead to hemolytic anemia.

You should consult your doctor even if the above warnings refer to situations that have occurred in the past.

Glibenese GITS and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Substances that may increase the hypoglycemic effect (i.e., excessive lowering of blood glucose levels) of Glibenese GITS:

• Miconazole Increases the hypoglycemic effect, which may cause hypoglycemia or coma. Concurrent use of glipizide and miconazole is contraindicated.
• Fluconazole There have been reports of hypoglycemia during concurrent use of glipizide and fluconazole, probably due to the prolonged half-life of glipizide.
• Voriconazole Although not studied, voriconazole may increase the plasma concentration of sulfonylurea derivatives (e.g., tolbutamide, glipizide, gliburide) and thus cause hypoglycemia. It is recommended to closely monitor blood glucose levels during concurrent administration of voriconazole and Glibenese GITS.
• Non-steroidal anti-inflammatory drugs (e.g., phenylbutazone) Increase the hypoglycemic effect of sulfonylurea derivatives (displacement of sulfonylurea derivatives from plasma protein binding or decreased excretion).
• Salicylates (acetylsalicylic acid) Acetylsalicylic acid administered in large doses increases the hypoglycemic effect.
• Alcohol Enhances the hypoglycemic effect and may cause coma.
• Beta-adrenergic blockers Mask some symptoms of hypoglycemia, such as palpitations and tachycardia. Most non-cardioselective beta-adrenergic blockers often increase the frequency of hypoglycemia and the severity of its symptoms.
• Angiotensin-converting enzyme inhibitors During concurrent use of sulfonylurea derivatives and angiotensin-converting enzyme inhibitors, hypoglycemia may occur, and it may be necessary to reduce the dose of glipizide.
• H2 receptor antagonists The use of H2 receptor antagonists (e.g., cimetidine) may enhance the hypoglycemic effect of sulfonylurea derivatives, including glipizide.
• The hypoglycemic effect of sulfonylurea derivatives may be enhanced by monoamine oxidase inhibitors, quinolones, and medicines that bind strongly to plasma proteins, such as sulfonamides, chloramphenicol, probenecid, and coumarin derivatives. If these medicines are used or discontinued, patients taking Glibenese GITS should consult their doctor if they experience any disturbing symptoms that may indicate hypoglycemia (or loss of glycemic control).

Substances that may lead to hyperglycemia (excessive blood glucose levels) when used concurrently with Glibenese GITS:

• Phenothiazine derivatives (e.g., chlorpromazine) In large doses (> 100 mg of chlorpromazine per day), they cause an increase in blood glucose levels (due to decreased insulin secretion).
• Corticosteroids Increase blood glucose levels.
• Sympathomimetic medicines (e.g., rytodrine, salbutamol, terbutaline) May cause an increase in blood glucose levels due to stimulation of beta-adrenergic receptors.
• Medicines that may cause hyperglycemia and lead to loss of glycemic control include certain diuretics, including thiazides, medicines used to treat thyroid diseases, estrogens, progestogens, oral contraceptives, phenytoin, nicotinic acid, calcium channel blockers, and isoniazid.

After starting to use the above medicines (or after discontinuing them), patients taking glipizide should consult their doctor if they experience any disturbing symptoms that may indicate hypoglycemia or loss of glycemic control.
Colesevelam
Glibenese GITS should be administered at least 4 hours before the administration of colesevelam to avoid reduced absorption of Glibenese GITS.

Pregnancy and breastfeeding

Pregnancy
If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult her doctor before taking this medicine.
In reproductive studies in rats, Glibenese GITS has been shown to have a slight toxic effect on the fetus. In studies in rats or rabbits, no teratogenic effect of Glibenese GITS has been demonstrated.
Insulin is recommended for pregnant women with diabetes to maintain blood glucose levels as close to normal as possible, as data suggest that abnormal blood glucose levels during pregnancy are associated with a higher frequency of congenital malformations.
There have been reports of prolonged, severe hypoglycemia (lasting from 4 to 10 days) in newborns whose mothers took sulfonylurea derivatives during pregnancy.
Breastfeeding
Consult your doctor before taking the medicine.
It is not known whether glipizide passes into breast milk. It has been proven that some sulfonylurea derivatives pass into breast milk. Due to the risk of hypoglycemia in the child, breastfeeding should be discontinued or the medicine should be discontinued, considering the importance of the medicine for the mother. If Glibenese GITS is discontinued, and the diet used to control blood glucose levels is insufficient, the doctor will consider the need for insulin treatment.

Driving and using machines

The effect of Glibenese GITS on the ability to drive and use machines has not been studied.
Patients should be aware of the risk of hypoglycemia and exercise caution when driving and using machines.

Glibenese GITS contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Glibenese GITS

This medicine should always be taken according to the doctor's or pharmacist's recommendations. If you have any doubts, consult your doctor or pharmacist.
Tablets should be swallowed whole with a sufficient amount of liquid. Tablets should not be chewed, divided, or crushed. In Glibenese GITS, the active substance is inside a non-absorbable coating that allows for slow release of the medicine. After the release of the medicine is complete, the empty coating is excreted from the body (it may be visible in the stool).
Initial dose:
The initial dose of Glibenese GITS is 5 mg per day. The medicine should be taken during breakfast.
Dose adjustment:
The doctor may increase the dose by 5 mg every few days, based on the result of blood glucose measurement. There should be an interval of at least a few days between consecutive dose changes.
Maintenance treatment:
The medicine taken once a day effectively lowers blood glucose levels. The maximum recommended daily dose is 20 mg, as this is when the strongest effect of the medicine is observed.
Glipizide administered in the form of immediate-release tablets in doses of 5 mg to 20 mg per day; the doctor may safely switch to Glibenese GITS taken once a day, in the same dose or lower than previously used.
Patients treated with insulin
Many patients with stable type 2 diabetes taking insulin may be safely switched to Glibenese GITS by their doctor, as well as other glucose-lowering medicines from the sulfonylurea derivative group.
When switching from insulin to Glibenese GITS, the doctor should follow the following rules.

• In patients whose insulin requirement is 20 units per day or less, insulin can be discontinued and Glibenese GITS can be started at the recommended dose of 5 mg. The dose can be increased after a few days.
• In patients whose daily insulin requirement is more than 20 units, the insulin dose should be reduced by 50% and Glibenese GITS should be started at the recommended dose of 5 mg. Further reduction of the insulin dose should be based on the patient's response to treatment. The dose of Glibenese GITS can be increased after a few days. During the period of reducing insulin doses, the patient should self-monitor their blood glucose levels at least three times a day. The patient should immediately contact their doctor if the results of these tests are abnormal. In some cases, especially in patients who receive more than 40 units of insulin per day, the doctor should consider hospitalizing the patient during the switch in treatment.

Patients previously treated with other oral glucose-lowering medicines
When switching from another sulfonylurea derivative (especially one with a prolonged half-life, e.g., chlorpropamide) to Glibenese GITS, the doctor should closely monitor the patient for at least two weeks due to the risk of hypoglycemia (e.g., observation of clinical symptoms or blood glucose monitoring) and exercise caution when changing the dose.
Patients treated concurrently with other oral glucose-lowering medicines
In patients who have not achieved satisfactory glycemic control with Glibenese GITS alone or in whom it is ineffective, the doctor should add another oral glucose-lowering medicine to the treatment.
In the case of concurrent use of Glibenese GITS and colesevelam, Glibenese GITS should be administered at least 4 hours before the administration of colesevelam.

Overdose of Glibenese GITS

Overdose of sulfonylurea derivatives, including glipizide, may cause hypoglycemia.
If any disturbing symptoms occur, consult your doctor.
A patient with symptoms of severe hypoglycemia with coma, loss of consciousness, or other neurological disorders should be hospitalized immediately. Treatment involves replenishing blood glucose levels in any available way, including intravenous administration, and monitoring the patient for at least 24 to 48 hours.

Missed dose of Glibenese GITS

Take the missed dose as soon as possible, unless it is close to the time for the next dose. Do not take two doses at the same time or at short intervals. If you have any doubts, consult your doctor.

Discontinuation of Glibenese GITS

The decision to discontinue treatment is made by the doctor. If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with other sulfonylurea derivatives, the following side effects are possible:
Frequent(may occur in up to 1 in 10 people)

• hypoglycemia‡
• headache*, tremors*
• vision disturbances
• abdominal pain, nausea, constipation, diarrhea, vomiting
• itching
• changes in laboratory test results (increased aspartate aminotransferase activity§, increased alkaline phosphatase activity in blood§, increased creatinine levels in blood§)

Infrequent(may occur in up to 1 in 100 people)

• confusion*
• hives

Frequency not known(cannot be estimated from the available data)

• leukopenia (decreased white blood cell count), agranulocytosis (lack of granulocytes), thrombocytopenia (decreased platelet count), hemolytic anemia, aplastic anemia, and pancytopenia (decreased count of all blood cells);
• hyponatremia
• blurred vision*, decreased visual acuity*
• discomfort in the upper abdomen
• cholestatic jaundice†, toxic hepatitis
• allergic skin reactions, including skin and mucous membrane rashes, and papular-pustular rash
• porphyria
• malaise*
• changes in laboratory test results (increased lactate dehydrogenase activity in blood§, increased urea levels in blood§)

* symptoms are usually transient and do not require discontinuation of treatment; however, they may be a sign of hypoglycemia.
‡ may be severe, prolonged, and may cause coma.
† in case of cholestatic jaundice, treatment should be discontinued.
§ the relationship with Glibenese GITS is not certain.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw,
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the representative of the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Glibenese GITS

Keep the medicine out of the sight and reach of children.
Store in a temperature below 30°C. Protect from moisture.
Do not use this medicine after the expiry date stated on the packaging 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 needed. This will help protect the environment.

6. Contents of the packaging and other information

What Glibenese GITS contains

5 mg tablet

• The active substance of the medicine is glipizide. One tablet contains 5 mg of glipizide.
• Other ingredients are: polyethylene oxide, sodium chloride (see section 2 "Glibenese GITS contains sodium"), hypromellose, iron oxide red, magnesium stearate, cellulose acetate, polyethylene glycol, outer coating: Opadry White, black ink (S-1-17823). 10 mg tablet
• The active substance of the medicine is glipizide. One tablet contains 10 mg of glipizide.
• Other ingredients are: polyethylene oxide, sodium chloride (see section 2 "Glibenese GITS contains sodium"), hypromellose, iron oxide red, magnesium stearate, cellulose acetate, polyethylene glycol, outer coating: Opadry White, black ink (S-1-17823).

What Glibenese GITS looks like and contents of the packaging

Glibenese GITS is available in the form of prolonged-release tablets.
Packaging:
5 mg tablets: the packaging contains 30 prolonged-release tablets.
10 mg tablets: the packaging contains 30 prolonged-release tablets.

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Manufacturer

Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocè-sur-Cisse, France
To obtain more detailed information, please contact the local representative of the marketing authorization holder:
Pfizer Polska Sp. z o.o.
phone: 22 335 61 00

Date of last revision of the leaflet:

Detailed and up-to-date information about this product can be obtained by scanning the QR code on the outer packaging using a mobile device. The same information is also available at the URL: https://pfi.sr/ulotka-glibenesegits and on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
http://www.urpl.gov.pl .