Glipizide Bp

Leaflet attached to the packaging: patient information

GLIPIZIDE BP

5 mg, tablets

Glipizide

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

• Please keep this leaflet, so you can read it again if necessary.
• In case of 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Glipizide BP and what is it used for
• 2. Important information before taking Glipizide BP
• 3. How to take Glipizide BP
• 4. Possible side effects
• 5. How to store Glipizide BP
• 6. Package contents and other information

1. What is Glipizide BP and what is it used for

Glipizide BP contains glipizide, which is a sulfonylurea derivative with a blood glucose-lowering effect.
Indications for use
Glipizide BP is used in type 2 diabetes (non-insulin-dependent) when proper blood glucose levels cannot be achieved with a suitable diet and physical exercise.

2. Important information before taking Glipizide BP

When not to take Glipizide BP

• in patients with insulin-dependent type 1 diabetes, diabetic ketoacidosis, diabetic coma,
• in patients with severe infections accompanied by fever,
• in patients with severe kidney or liver failure, thyroid dysfunction, liver and kidney disease,
• in patients after severe injury or surgery,
• in the treatment of diabetes in children and adolescents under 18 years of age,
• in pregnant or breastfeeding women.

Warnings and precautions

Before starting to take Glipizide BP, you should discuss it with your doctor.
All sulfonylurea derivatives, including glipizide, can cause hypoglycemia, i.e., excessive lowering of blood glucose levels. Hypoglycemia may occur due to delayed meals, insufficient food intake, and non-compliance with dietary recommendations.
To maintain proper blood glucose levels, it is necessary to consume carbohydrates regularly at the right times. Kidney or liver failure may cause an increase in glipizide levels in the blood. In these conditions, increased drug levels in the blood can lead to severe hypoglycemia with coma, convulsions, or neurological symptoms. This is a condition that requires hospital treatment. The likelihood of hypoglycemia is higher in cases of low-calorie diets, after intense and prolonged exercise, after alcohol consumption, and when taking more than one glucose-lowering drug. The most vulnerable to hypoglycemia are elderly patients, malnourished patients, patients with adrenal and pituitary insufficiency.
Hypoglycemia can be difficult to recognize in elderly patients and patients taking beta-adrenergic blockers or other sympatholytic drugs.
In case of loss of glycemic control, the doctor will decide whether it is necessary to discontinue Glipizide BP and administer insulin periodically. Loss of glycemic control may occur when the patient is exposed to factors such as fever, injury, infection, or surgery. In many patients, the effectiveness of each oral glucose-lowering drug, including Glipizide BP, decreases over time.
During treatment, it is necessary to strictly follow the recommendations regarding diet, dosing, and administration of Glipizide BP and regularly monitor blood glucose levels. You should learn to recognize early symptoms of hypoglycemia, such as headache, irritability, sleep disturbances, tremors, sweating, so that you can consult a doctor in time. Usually, immediate consumption of carbohydrates (sugar) allows for the restoration of proper blood glucose levels. Family members of patients should be informed that the patient is at risk of hypoglycemia, about how to proceed in case of symptoms of hypoglycemia, and about conditions that favor their occurrence.
You should consult a doctor, even if the above warnings concern situations that have occurred in the past.

Children

The safety and efficacy of glipizide in children have not been established.
Glipizide is not recommended for use in children.

Glipizide BP and other medicines

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.
The blood glucose-lowering effect of glipizide may be enhanced by the following medicines:
antifungal drugs (miconazole, fluconazole, voriconazole), non-steroidal anti-inflammatory drugs, monoamine oxidase inhibitors, angiotensin-converting enzyme inhibitors (e.g., captopril, enalapril), beta-adrenergic blockers, H2 receptor antagonists, salicylates (acetylsalicylic acid), drugs that bind strongly to proteins: sulfonamides, chloramphenicol, probenecid, and coumarin derivatives (warfarin).
The blood glucose-lowering effect of glipizide may be weakened by the following medicines:
phenothiazine derivatives (e.g., chlorpromazine) in large doses, corticosteroids, sympathomimetic drugs (e.g., rytodrine, salbutamol, terbutaline), thiazides, and other diuretics, drugs used in thyroid diseases, estrogens, progestogens, oral contraceptives, phenytoin, nicotinic acid, calcium channel blockers, and isoniazid.
In case of concomitant use of glipizide with these medicines, blood glucose levels should be monitored.

Glipizide BP with food, drink, and alcohol

The medicine should be taken 30 minutes before a meal.
In patients treated with glipizide, a disulfiram-like reaction may occur after alcohol consumption (alcohol intolerance).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.
In pregnant women, insulin is the drug of choice. Glipizide BP may be used only when the benefits of its use outweigh the risk to the fetus.
Glipizide BP is contraindicated in breastfeeding women.

Driving and using machines

There are no data on the effect of glipizide on the ability to drive and use machines.
Due to the risk of hypoglycemia, caution should be exercised when driving and using machines. This is especially true in situations where blood glucose control has not been achieved, for example, when changing diabetes medications or in cases of irregular medication use.

Use of Glipizide BP in patients with kidney and/or liver impairment

Kidney or liver failure may cause an increase in the drug's levels in the blood. It is recommended that patients with kidney or liver impairment be under close medical supervision during the dose-setting period, which is necessary to evaluate laboratory results and clinical symptoms.

Use of Glipizide BP in elderly patients

Glipizide should be used with caution in elderly patients, especially after intense physical exertion, during irregular food intake, and in cases of kidney and/or liver failure.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Glipizide BP

This medicine should always be taken according to the doctor's recommendations. In case of doubts, you should consult a doctor.
Recommended dose
Short-term administration of the medicine may be sufficient in patients who have temporarily lost glycemic control with a proper diet.
To determine the minimum effective dose of glipizide, as well as to detect resistance to the medicine, the doctor will recommend regular monitoring of fasting blood glucose levels.
Initial dose
The doctor usually recommends starting treatment with a dose of 5 mg of glipizide (1 tablet) per day, taken 30 minutes before breakfast or a meal eaten during the day. In patients with mild diabetes, elderly patients, or patients particularly at risk of hypoglycemia, it is recommended to start treatment with a dose of 2.5 mg (1/2 tablet), due to the possibility of hypoglycemia.
Dose adjustment
The dose is usually increased by 2.5 mg to 5 mg of glipizide, depending on blood glucose levels. Several days should pass between consecutive dose changes.
Maintenance treatment
In some patients, glycemic control is achieved after taking the medicine once a day. Usually, proper blood glucose levels are achieved with doses of 2.5 mg to 20 mg of glipizide per day.
The maximum single dose per day is 15 mg. If the daily dose is more than 15 mg, it should be taken in divided doses before meals (usually 2 times a day).
The maximum recommended daily dose is 20 mg.
Elderly patients and those particularly at risk of hypoglycemia
To avoid hypoglycemia in elderly patients, weakened, malnourished patients who irregularly eat meals and patients with liver and/or kidney impairment, the initial and maintenance doses should be reduced.
Patients treated with insulin
In some cases, glipizide reduces the daily insulin requirement. Like other oral antidiabetic drugs, sulfonylurea derivatives, many patients with type 2 diabetes (non-insulin-dependent) receiving insulin can safely take glipizide.
When switching from insulin to Glipizide BP therapy, the doctor should follow the general principles described below.
With an insulin requirement of up to 20 IU per day, the doctor may discontinue insulin and start treatment with the recommended dose of glipizide. The dose should be modified every few or several days.
With an insulin requirement of more than 20 IU per day, the doctor should reduce the insulin dose by half and start administering glipizide in the recommended dose. Further reduction of insulin dosing depends on the individual patient's response to treatment. The dose should be modified every few or several days.
During the period of insulin discontinuation or dose reduction, blood glucose levels should be self-monitored at least 3 times a day. You should immediately contact your doctor if the results of these tests are abnormal. When taking more than 40 IU of insulin per day, hospitalization is recommended during the treatment change period.
Patients previously treated with other oral glucose-lowering medicines
Dosing is dependent on the patient's clinical condition and previous treatment. The doctor usually recommends starting treatment with small doses of glipizide (5 mg per day), then gradually increasing until proper blood glucose levels are achieved. Patients should be under close medical supervision.
In case of switching from other sulfonylurea derivatives to glipizide, a transition period is not necessary. When switching from another sulfonylurea derivative (especially with a prolonged half-life, e.g., chlorpropamide) to glipizide, the doctor should carefully monitor the patient for a period of up to 2 weeks.
Patients treated with other glucose-lowering medicines
In some patients who have not achieved proper blood glucose levels after taking Glipizide BP, or whose treatment has become ineffective after some time, the doctor may add another glucose-lowering medicine to improve glycemic control.
If you feel that the effect of the medicine is too strong or too weak, you should consult a doctor.
Method of administration
Oral administration.
The medicine should be taken 30 minutes before a meal to achieve maximum reduction of postprandial hyperglycemia.

Taking a higher dose of Glipizide BP than recommended

In case of taking a higher dose of the medicine than recommended, you should immediately consult a doctor.
Overdose of the medicine may cause hypoglycemia, sometimes of significant severity.
A patient with symptoms of severe hypoglycemia (e.g., coma, convulsions, 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 48 hours.

Missing a dose of Glipizide BP

You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are mostly related to the size of the Glipizide BP dose, are temporary, and disappear after dose reduction or discontinuation of the medicine.
Hypoglycemia (excessive lowering of blood glucose levels) may occur with symptoms such as weakness, drowsiness, disorientation, excessive sweating, chills, hunger, irritability, nervousness, dizziness, and vision disturbances, concentration disorders, feeling of cold, and in severe cases, loss of consciousness and hypoglycemic coma.

Similarly, as with the use of other sulfonylurea derivatives, severe hypersensitivity reactions may occur, sometimes fatal. You should immediately consult a doctor if you experience wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching (especially of the whole body).

The frequency of side effects listed below is defined as follows:

• very common (occurring in more than 1 in 10 people),
• common (occurring in 1 to 10 people in 100),
• uncommon (occurring in 1 to 10 people in 1,000),
• rare (occurring in 1 to 10 people in 10,000),
• very rare (occurring in less than 1 in 10,000 people),
• unknown (frequency cannot be estimated from available data).

Common:

• hypoglycemia,
• nausea, diarrhea, abdominal pain, stomach pain.

Uncommon:

• dizziness, drowsiness, tremors,
• blurred vision,
• vomiting,
• cholestatic jaundice,
• rash.

Unknown:

• agranulocytosis (lack of granulocytes), leukopenia (reduced white blood cell count), thrombocytopenia (reduced platelet count), hemolytic anemia, and pancytopenia (reduced count of all blood cells),
• hyponatremia (low sodium levels in the blood),
• confusional states,
• headaches,
• double vision, vision disturbances, impaired vision,
• constipation,
• liver dysfunction, hepatitis,
• allergic skin reactions, including skin and mucous membrane eruptions, and rash, urticaria, itching, photosensitivity,
• chronic porphyria,
• malaise,
• changes in laboratory test results.

After alcohol consumption, symptoms of alcohol intolerance may occur, such as abdominal pain, vomiting, headaches, facial flushing, hypoglycemia.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor or pharmacist. 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
Poland
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 marketing authorization holder.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Glipizide BP

Store in the original packaging.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Glipizide BP contains

• The active substance of the medicine is glipizide. One tablet contains 5 mg of glipizide.
• The other ingredients (excipients) are: calcium carbonate, corn starch, sodium lauryl sulfate, sodium carboxymethylcellulose (type A), talc, magnesium stearate, anhydrous colloidal silica.

What Glipizide BP looks like and what the package contains

Glipizide BP is available in the form of tablets. The tablet is white, round, flat, with a beveled edge and a break line on one side.
Available packaging: 30 tablets.
Blisters of aluminum foil and PVC/PVDC film in a cardboard box.

Marketing authorization holder and manufacturer

Pharmaceutical Cooperative "GALENA"
Dożynkowa 10 Street
52-311 Wrocław
Poland
Phone: +48 71 710 62 01
Date of last update of the leaflet:30.06.2023