1. Name of The Medicinal Product

Glipizide Tablets 5mg USP Taj Pharma

  1. Qualitative and Quantitative Composition

Each tablet contains glipizide USP 5 mg

For the full list of excipients, see section 6.1.

  1. Pharmaceutical Form

Tablet

  1. Clinical Particulars

4.1 Therapeutic indications

Glipizide is indicated in the control of blood glucose levels in addition to the control of diet for patients with non insulin dependent diabetes mellitus (Type II NIDDM), when hyperglycaemia cannot be controlled by diet alone and advice has been given on weight reduction and exercise.

Stable patients with non-insulin dependent diabetes mellitus not controlled by regulation of their diet alone are likely to be controlled by glipizide.

4.2 Posology and method of administration

Posology

As for any hypoglycaemic agent, dosage must be adapted for each individual case.

Short term administration of glipizide may be sufficient during periods of transient loss of control in patients usually controlled well on diet.

Initial dose

The recommended starting dose is 5 mg, given before breakfast or the midday meal. Mild diabetics, elderly or those with liver disease may be started on 2.5 mg.

Titration

Dosage adjustments should ordinarily be in increments of 2.5 mg or 5 mg, as determined by blood glucose response. At least several days should elapse between titration steps. The maximum recommended single dose is 15 mg. If this is not sufficient, splitting the daily dosage may prove effective. Doses above 15 mg should ordinarily be divided.

Maintenance

Some patients may be effectively controlled on a once-a-day regimen. Total daily dosages above 15 mg should ordinarily be divided.

The maximum recommended daily dosage is 20 mg.

Paediatric population

Safety and effectiveness in children have not been established.

Elderly and high-risk patients

In elderly, debilitated and malnourished patients or patients with an impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycaemic reactions (see Initial dose and section 4.4).

Patients receiving other oral hypoglycaemic agents

As with other sulfonylurea class hypoglycaemics, no transition period is necessary when transferring patients to glipizide. Patients should be observed carefully (1-2 weeks) for hypoglycaemia when being transferred from longer half-life sulfonylureas (e.g. chlorpropamide) to glipizide due to potential overlapping of drug effect.

Method of administration

For oral use only.

In general, glipizide should be taken 30 minutes before a meal to achieve the greatest reduction in post-prandial hyperglycaemia.

4.3 Contraindications

Hypersensitivity to the active substance, other sulfonylureas or sulfonamides or to any of the excipients listed in section 6.1.

Patients with severe renal, hepatic or thyroid impairment, including patients with renal or hepatic disease.

During pregnancy and lactation.

Patients with insulin dependent (juvenile onset type I) diabetes, or diabetic ketoacidosis (with or without coma) or a history of ketoacidotic coma.

Patients treated with miconazole (see section 4.5).

4.4 Special warnings and precautions for use

Glucose-6-phosphate dehydrogenase deficiency

Since glipizide belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD-deficiency. Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to haemolytic anaemia and a non-sulfonylurea alternative should be considered.

Hypoglycaemia

All sulfonylurea agents are capable of producing severe hypoglycaemia. Renal or hepatic insufficiency may cause elevated blood levels of glipizide and the latter may also diminish gluconeogenic capacity, both of which increase the risk of serious hypoglycaemic reactions. Elderly, debilitated or malnourished patients and those with adrenal or pituitary insufficiency are particularly susceptible to the hypoglycaemic action of glucose-lowering drugs.

Hypoglycaemia may be difficult to recognise in the elderly, and in people who are taking beta-adrenergic blocking drugs (see section 4.5). Hypoglycaemia is more likely to occur when caloric- intake is deficient, after severe or prolonged exercise, when alcohol is ingested, or when more than one glucose-lowering drug is used.

Loss of control of blood glucose

When a patient stabilised on a diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a loss of control may occur. At such times, it may be necessary to discontinue glipizide and administer insulin. The effectiveness of any oral hypoglycaemic drug, including glipizide, in lowering blood glucose to a desired level decreases in many patients over a period of time, which may be due to progression of the severity of diabetes or due to diminished responsiveness to the drug. This phenomenon is known as secondary failure, to distinguish it from primary failure in which the drug is ineffective in an individual patient when first given. Adequate adjustment of dose and adherence to diet should be assessed before classifying a patient as a secondary failure.

Renal and hepatic disease

The pharmacokinetics and/or pharmacodynamics of glipizide may be affected in patients with impaired renal or hepatic function. If hypoglycaemia should occur in such patients, it may be prolonged and appropriate management should be instituted.

Information for patients

Patients should be informed of the potential risks and advantages of glipizide and of alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of urine and/or blood glucose.

The risks of hypoglycaemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members. Primary and secondary failure should also be explained.

Laboratory Tests

Blood and urine glucose should be monitored periodically. Measurement of glycosylated haemoglobin may be useful.

This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

The following products are likely to increase the hypoglycaemic effect:

– Contraindicated combinations

Miconazole

Increase in hypoglycaemic effect, possibly leading to symptoms of hypoglycaemia or even coma.

– Inadvisable combinations

Nonsteroidal Anti-inflammatory Drugs (e.g. phenylbutazone)

Increase in hypoglycaemic effect of sulfonylureas (displacement of sulfonylurea binding to plasma proteins and/or decrease in sulfonylurea elimination).

Alcohol

Increase in hypoglycaemic reaction, which can lead to hypoglycaemic coma.

– Combinations requiring precaution

Fluconazole

Increase in the half-life of the sulfonylurea, possibly giving rise to symptoms of hypoglycaemia.

Voriconazole

Although not studied, voriconazole may increase the plasma levels of sulfonylureas, (e.g. tolbutamide, glipizide and glyburide) and therefore cause hypoglycaemia. Careful monitoring of blood glucose is recommended during co-administration.

Salicylates (acetylsalicylic acid)

Increase in hypoglycaemic effect by high doses of acetylsalicylic acid (hypoglycaemic action of the acetylsalicylic acid).

Beta-blockers

All beta-blockers mask some of the symptoms of hypoglycaemia (i.e. palpitations and tachycardia). Most non cardio selective beta-blockers increase the incidence and severity of hypoglycaemia.

Angiotensin-converting enzyme inhibitors

The use of angiotensin-converting enzyme inhibitors may lead to an increased hypoglycaemic effect in diabetic patients treated with sulfonylureas.

Cimetidine

The use of cimetidine may be associated with a reduction in post prandial blood glucose in patients treated with glipizide.

The hypoglycaemic action of sulfonylureas, in general may also be potentiated by monoamine oxidase inhibitors, quinolones and drugs that are highly protein bound, such as sulfonamides, chloramphenicol, probenecid, coumarins and fibrates.

When such drugs are administered to (or withdrawn from) a patient receiving glipizide, the patient should be observed closely for hypoglycaemia (or loss of control).

The following products could lead to hyperglycaemia:

– Inadvisable combinations

Danazol

Diabetogenic effect of danazol. If it cannot be avoided, warn the patient and step up self monitoring of blood glucose and urine. Possibly adjust the dosage of antidiabetic agent during treatment with danazol and after its discontinuation.

– Combinations requiring precaution

Phenothiazines (e.g. chlorpromazine) at High Doses (> 100 mg/day of chlorpromazine)

Elevation in blood glucose (reduction in insulin release).

Corticosteroids

Elevation in blood glucose.

Sympathomimetics (e.g. ritodrine, salbutamol, terbutaline)

Elevation in blood glucose due to beta-2-adrenoceptor stimulation.

Progestogens

Diabetogenic effects of high-dose progestogens. Warn the patient and step up self-monitoring of blood glucose and urine. Possibly adjust the dosage of antidiabetic agent during treatment with the neuroleptics, corticoids or progestogen and after discontinuation.

Other drugs that may produce hyperglycaemia and lead to a loss of control include the thiazides and other diuretics, thyroid products, oestrogens, oral contraceptives, phenytoin, nicotinic acid, calcium channel blocking drugs, and isoniazid.

When such drugs are administered to (or withdrawn from) a patient receiving glipizide, the patient should be observed closely for hypoglycaemia.

4.6 Fertility, pregnancy and lactation

Pregnancy

Glipizide is contraindicated in pregnancy.

Glipizide was found to be mildly fetotoxic in rat reproductive studies. No teratogenic effects were found in rat or rabbit studies.

Prolonged severe hypoglycaemia (4-10 days) has been reported in neonates born to mothers who were receiving a sulfonylurea drug at the time of delivery.

Because recent information suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities, many experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible.

Breast-feeding

No data are available on secretion into breast milk. Therefore glipizide is contraindicated in lactation.

4.7 Effects on ability to drive and use machines

The effect of glipizide on the ability to drive or operate machines has not been studied; however, there is no evidence to suggest that glipizide may affect these abilities. Patients should be aware of the symptoms of hypoglycaemia and be careful about driving and the use of machines, especially when optimum stabilisation has not been achieved, for example during the change-over from other medications or during irregular use.

4.8 Undesirable effects

The majority of side effects have been dose related, transient, and have responded to dose reduction or withdrawal of the medication. However, clinical experience thus far has shown that, as with other sulfonylureas, some side effects associated with hypersensitivity may be severe and deaths have been reported in some instances.

The reported adverse reactions, which may possibly be associated with glipizide, are listed below by system organ class and frequency group. Frequencies are defined as very common (≥1/10), common (≥1/100 to 1</10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

Blood and lymphatic system disorders
Not known:Leucopenia, agranulocytosis, thrombocytopenia, haemolytic anaemia, pancytopenia. Aplastic anaemia has been reported with other sulfonylureas.
Metabolism and nutrition disorders
Common:Hypoglycaemia.
Not known:Hyponatraemia, disulfiram-like reactions have been reported with other sulfonylureas.
Psychiatric disorders
Not known:Confusional state#.
Nervous system disorders
Uncommon:Dizziness#, somnolence#, tremor#.
Not known:Headache#.
Eye disorders
Uncommon:Vision blurred#.
Not known:Diplopia#, visual impairment#, visual acuity reduced#.
Gastrointestinal disorders
Common:Nausea$, diarrhoea$, abdominal pain upper$ and abdominal pain.
Uncommon:Vomiting.
Not known:Constipation$.
Hepatobiliary disorders
Uncommon:Jaundice cholestatic%
Not known:Hepatic function abnormal, hepatitis,
Skin and subcutaneous tissue disorders
Uncommon:Eczema&.
Not known:Dermatitis allergic&, erythema&, rash morbilliform&, rash maculopapular&, urticaria&, pruritus&, photosensitivity reaction.
Congenital, familial and genetic disorders
Not known:Porphyria non-acute
General disorders and administration site conditions
Not known:Malaise#
Investigations
Not known:Aspartate aminotransferase increased*, blood lactate dehydrogenase increased*, blood alkaline phosphatase increased*, blood urea increased*, blood creatinine increased*.

# This is usually transient and do not require discontinuance of therapy, however, they may also be symptoms of hypoglycaemia.

$ Appear to be dose related and usually disappear on division or reduction of dosage.

% Discontinue treatment if cholestatic jaundice occurs.

& They frequently disappear with continued therapy. However if they persist, the drug should be discontinued.

* The relationship of these abnormalities to glipizide is uncertain and they have rarely been associated with clinical symptoms.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4.9 Overdose

There is no well documented experience with glipizide overdosage. Overdosage of sulfonylureas including glipizide can produce glycaemia. Mild hypoglycaemic symptoms without loss of consciousness or neurologic findings should be treated actively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycaemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalisation. If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50 %) glucose solution. This should be followed by a continuous infusion of a more dilute (10 %) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dL (5.55 mmol/L).

Patients should be closely monitored for a minimum of 48 hours and depending on the status of the patient at this time the physician should decide whether further monitoring is required. Clearance of glipizide from plasma may be prolonged in people with liver disease. Because of the extensive protein binding of glipizide, dialysis is unlikely to be of benefit.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs excl. insulins, sulfonylureas.

Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The primary mode of action of glipizide is the stimulation of insulin secretion from the beta-cells of pancreatic islet tissue. Stimulation of insulin secretion by glipizide in response to a meal is of major importance. Fasting insulin levels are not elevated even on long-term glipizide administration, but the post-prandial insulin response continues to be enhanced after at least 6 months of treatment. The insulinotropic response to a meal occurs within 30 minutes after oral dose of glipizide in diabetic patients, but elevated insulin levels do not persist beyond the time of the meal challenge. There is also increasing evidence that extrapancreatic effects involving potentiation of insulin action form a significant component of the activity of glipizide.

Blood sugar control persists for up to 24 hours after a single dose of glipizide, even though plasma levels have declined to a small fraction of peak levels by that time (see section 5.2).

5.2 Pharmacokinetic properties

Absorption

Gastrointestinal absorption of glipizide in humans is uniform, rapid and essentially complete. Peak plasma concentrations occur 1 to 3 hours after a single oral dose. The half-life of elimination ranges from 2 to 4 hours in normal subjects, whether given intravenously or orally. The metabolic and excretory patterns are similar with the two routes of administration, indicating that first-pass metabolism is not significant. Glipizide does not accumulate in plasma on repeated oral administration. Total absorption and disposition of an oral dose were unaffected by food in normal volunteers, but absorption was delayed by about 40 minutes. Thus, glipizide was more effective when administered about 30 minutes before, rather than with, a test meal in diabetic patients.

Distribution

Protein binding was studied in serum from volunteers who received either oral or intravenous glipizide and found to be 98 % to 99 % one hour after either route of administration. The apparent volume of distribution of glipizide after intravenous administration was 11 L, indicative of localisation within the extracellular fluid compartment. In mice, no glipizide or metabolites were detectable autoradiographically in the brain or spinal cord of males or females, nor in the foetuses of pregnant females. In another study, however, very small amounts of radioactivity were detected in the foetuses of rats given labelled drug.

Biotransformation

The metabolism of glipizide is extensive and occurs mainly in the liver.

Elimination

The primary metabolites are inactive hydroxylation products and polar conjugates and are excreted mainly in the urine. Less than 10 % unchanged glipizide is found in urine.

5.3 Preclinical safety data

Acute toxicity studies showed no specific susceptibility. The acute oral toxicity of glipizide was extremely low in all species tested (LD50 greater than 4 g/kg). Chronic toxicity tests in rats and dogs at doses up to 8.0 mg/kg did not show any evidence of toxic effects.

A 20-month study in rats and an 18-month study in mice at doses up to 75 times the maximum human dose revealed no evidence of drug-related carcinogenicity. Bacterial and in vivo mutagenicity tests were uniformly negative. Studies in rats of both sexes at doses up to 75 times the maximum human dose showed no effects on fertility.

  1. Pharmaceutical particulars

6.1 List of excipients

Lactose monohydrate, Maize starch, Maize starch, pregelatinized & Stearic acid.

6.2 Incompatibilities

Not Applicable

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Store below 25°C and keep in the original package in order to protect from light.

6.5 Nature and contents of container

Tablets are available in PVC/Aluminium Blister pack of 10, 20, 30, 50, 100, 200 and 250 Tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com

Glipizide Tablets 5mg USP Taj Pharma

Package leaflet: Information for the patient

(Glipizide)

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.

What is in this leaflet:

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

 

  1. What Glipizide is and what it is used for

This medicine contains glipizide which is one of a group of medicines called sulfonylureas.

Glipizide is used to treat diabetes (Type II, non-insulin-dependent diabetes) and helps to lower your blood glucose (sugar) levels, when a change in diet alone is not enough to control the condition.

Diabetics produce too much glucose due to a lack of insulin in the body. This can be controlled by glipizide, which reduces high blood glucose (sugar) levels by increasing insulin production.

You must talk to a doctor if you do not feel better or if you feel worse after taking this medicine.

  1. What you need to know before you take Glipizide

Do not take Glipizide if you:

  • are allergic to glipizide, similar antidiabetic medicines (sulfonylureas or sulfonamides) or any of the other ingredients of this medicine (listed in section 6)
  • have insulin-dependent diabetes (also called juvenile or Type I diabetes) which would have probably started in your childhood
  • have ketone bodies and sugar in your urine (this may mean you have diabetic ketoacidosis)
  • suffer from episodes of unconsciousness (this may mean you have diabetic coma
  • have problems with your kidneys or liver
  • suffer from thyroid problems
  • are pregnant, planning to become pregnant or breast-feeding
  • are currently taking miconazole to treat a fungal infection

Warnings and precautions

Talk to your doctor or pharmacist before taking Glipizide if:

  • you have been told that you have problems with your adrenal or pituitary glands
  • you are about to have major surgery, have had a recent injury (trauma) or develop a fever or severe infection. (See Section 3 “If you are going to have an operation” for further information).
  • you suffer from G6PD deficiency (a disease that causes abnormal destruction of your red blood cells).

You should test your blood and urine glucose regularly, particularly if you are elderly, debilitated or malnourished. If the results of the tests are outside the limits recommended by your doctor you should contact them immediately.

Glipizide can cause hypoglycaemia (low blood sugar levels), which is characterised by confusion, faintness, sweating, dizziness, drowsiness, headache, shakiness (tremor) and visual disturbances. (These symptoms may also be unrelated to hypoglycaemia). Low blood sugar levels can be prevented by taking a regular intake of carbohydrates (e.g. bread, or other products containing starch/sugar). You should eat regular meals, and not exercise heavily or for a long period without eating something first.

Other medicines and Glipizide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Do not take Glipizide with miconazole (used to treat fungal infections) (see ‘Do not take Glipizide’).

Taking the following medicines with Glipizide may reduce your blood sugar levels too much:

  • Fluconazole or voriconazole (used to treat fungal infections).
  • Non-steroidal anti-inflammatory agents (used to treat muscle and joint pain e.g. phenylbutazone).
  • Aspirin or aspirin like medicines known as salicylates (usually used as pain killers).
  • Beta-blockers (used to treat high blood pressure and certain heart conditions e.g. propranolol).
  • Angiotensin converting enzyme (ACE) inhibitors (used to treat high blood pressure e.g. captopril).
  • Cimetidine (used to treat stomach and duodenal ulcers and other digestive disorders).
  • Sulfonamides or chloramphenicol (used to treat bacterial infections).
  • Quinolones (used to treat bacterial infections).
  • Monoamine oxidase inhibitors (used to treat depression).
  • Probenecid (drugs used to treat gout).
  • Coumarin anticoagulants (used to treat blood clots e.g. warfarin).
  • Fibrates (used to treat high cholesterol e.g. clofibrate).
  • Medicines to treat bacterial infections called quinolones (e.g. ciprofloxacin)

Taking the following medicines with Glipizide may increase your blood sugar levels:

  • Danazol (a hormone treatment).
  • Phenothiazines tranquillisers (used to treat psychiatric conditions e.g. chlorpromazine, thioridazine).
  • Corticosteroids (used to treat inflammatory conditions (e.g. prednisolone).
  • Sympathomimetic agents, such as nasal decongestants and bronchodilators used to treat asthma (e.g. salbutamol, ritodrine, terbutaline, isoprenaline).
  • Hormonal agents containing progesterone or oestrogen, including oral contraceptives (the Pill) and hormone replacement therapy (HRT).
  • Thiazides or other diuretics (water tablets e.g. bendroflumethiazide).
  • Thyroid products (used to treat patients with a low production of thyroid hormones).
  • Phenytoin (used to treat epilepsy).
  • Nicotinic acid (used in vitamin supplements and to lower cholesterol and other lipid levels).
  • Calcium channel blocking agents (used to treat angina and high blood pressure e.g. nifedipine or verapamil).
  • Isoniazid (used to treat tuberculosis).

Glipizide with food, drink and alcohol

As food may delay absorption of the drug, each dose should be taken 30 minutes before food.

Try to avoid alcohol. Alcoholic drinks (wine, beer, spirits) can further increase the reduction in blood sugar levels and could cause unconsciousness (hypoglycaemic coma).

Pregnancy and breast-feeding

Glipizide must not be taken during pregnancy or if you are breast-feeding (see section 2, “Do not take Glipizide”). If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Do not drive or operate machinery if you feel dizzy, drowsy, suffer from headaches or have difficulty concentrating after taking this medicine.

Glipizide contains lactose.

If your doctor has told you that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.

  1. How to take Glipizide

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Glipizide should only be taken by mouth. It is important that you take your tablets according to the instructions of your doctor. These will be written on the label of the pack. Do not take more Glipizide than your doctor has recommended.

Your dose will be adapted to your individual requirements. Some patients, whose condition is usually controlled by diet alone, may only require Glipizide for a short time. The recommended dose is:

Adults

The initial dose is usually 5 mg, taken approximately 30 minutes before breakfast or the midday meal, although this may be lower in some patients.

If you are elderly, have mild diabetes or suffer from liver or kidney problems you may be started on 2.5 mg daily

If your doctor feels your dose needs to be altered, they will instruct you to adjust the dose in small increments, usually in 2.5 – 5 mg steps.

The maximum recommended daily dose is 20 mg.

The label on the pack will tell you what dose you should take and how often to take it. If you are still not sure, ask your doctor or pharmacist.

Do not stop taking the tablets or adjust your dosage without seeing your doctor. Stopping the medicine may make your diabetes worse.

The tablet can be divided into equal doses.

Elderly patients, patients with poor diets and patients with kidney or liver disease

Your doctor may start you on the lower dose of half a tablet (2.5 mg) a day before gradually increasing your dose, as you may be more sensitive to the effects of Glipizide.

Use in children

Glipizide is not recommended for use in children.

If you take more Glipizide than you should

  • If you accidentally take too many tablets, seek medical advice immediately.
  • If you suffer faintness, confusion, drowsiness, headache, dizziness, sweating or shakiness and visual disturbances, these may be symptoms of low blood sugar. You should eat or drink something sugary.
  • If you suffer fits or loss of consciousness occur, someone should seek urgent medical assistance for you.

If you forget to take Glipizide

If you miss a dose, it is important that you take your medicine as soon as you remember or feel faint, otherwise your blood sugar will become too high and you may go into a coma (or fall unconscious). Do not take a double dose to make up for a forgotten dose.

If you stop taking Glipizide

Do not stop taking your tablets or alter the dose you are currently taking without seeing your doctor first.

Stopping these tablets may make your diabetes worse.

If you are going to have an operation

If you are going to have major surgery or you have recently suffered a severe illness or infection, diabetic control may be lost. At such times it may be necessary to temporarily stop using Glipizide and take insulin.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience any of the following symptoms after taking this medicine:

  • An allergic reaction such as wheeziness, difficulty breathing or swelling of the eyelids, face or lips, rash or itching (especially affecting the whole body)
  • Reductions in blood cells and blood platelets. This can make the skin pale yellow, cause weakness or breathlessness, or make bruising, bleeding or infections more likely.
  • Liver inflammation which can cause nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, light coloured bowel movements, dark coloured urine and jaundice which causes yellowing of the skin and whites of the eyes.
  • A blood pigment disorder. This can cause blistering or peeling of skin exposed to sunlight, skin darkening or excessive hair growth

In some people, a sudden, severe reaction to alcohol can occur. You may experience a sudden ‘hangover’ feeling with a throbbing headache, flushed skin, increased heart rate, shortness of breath, feeling or being sick, vision problems, confusion and low blood pressure which may make you dizzy especially on standing up from lying or sitting.

Other side effects that may occur include:

Common (may affect up to 1 in 10 people):

  • Low blood sugar (hypoglycaemia – for signs of hypoglycaemia see section 2)
  • Feeling sick, diarrhoea or stomach pains. These side effects usually improve if your doctor divides up your dosage during the day

Uncommon (may affect up to 1 in 100 people):

  • Dizziness, drowsiness/sleepiness
  • Shakiness (tremor), blurred vision, being sick
  • Eczema (inflammation of the skin)

Not known (frequency cannot be estimated from the available data):

  • Headache
  • A reduction in your blood sodium. This can occur if you are dehydrated.
  • Confusion
  • Double vision, changes in vision (you may find it more difficult to focus or see clearly)
  • Constipation
  • General feeling of being unwell
  • Increased sensitivity of the skin to sunlight
  • Skin redness (erythema)
  • Itchy skin
  • Rash (red, bumpy or measle-like)
  • Itching, skin redness or inflammation (dermatitis allergic)
  • Pale red, raised, itch bumps (urticaria)
  • Abnormal liver function
  • Abnormal laboratory results that can be seen with a blood test

The results of some laboratory tests have been affected by this medicine but it is rare for patients to have any symptoms.

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist.

  1. How to store Glipizide

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after “EXP”. The expiry date refers to the last day of that month.

Store below 25°C and keep in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. Contents of the pack and other information

What Glipizide contains

The active substance is glipizide. Each tablet contains 5 mg of glipizide.

The other ingredients are:

Lactose monohydrate, Maize starch, Maize starch, pregelatinized & Stearic acid.

What Glipizide looks like and contents of the pack

Tablets are available in PVC/Aluminium Blister pack of 10, 20, 30, 50, 100, 200 and 250 Tablets.

Not all pack sizes may be marketed.

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com