Patient Information Leaflet

Minodiab 5 mg Tablets

Glipizide

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Minodiab is and what it is used for

2.What you need to know before you start taking Minodiab

3.How to take Minodiab

4.Possible side effects

5Storage of Minodiab

6.Contents of the pack and additional information

Minodiab is an oral antidiabetic medication. It belongs to a family of medications known as sulfonylureas and works by reducing blood sugar levels in adult patients with type 2 diabetes, when diet and physical exercise are not adequate for controlling blood sugar levels.

Do not take Minodiab

• If you are allergic to glipizide or any of the other components of this medication (listed in section 6).
• If you have diabetes type 1.
• If you have diabetes with increased blood acidity due to the accumulation of ketone bodies and their presence in urine (diabetic ketoacidosis).
• If you are experiencing diabetic coma (decreased level of consciousness).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Minodiab.

If you experience symptoms of low blood sugar (hypoglycemia) such as sweating, paleness, intense hunger, palpitations. In this case, and to feel better, you should take sugar or sweetened drinks immediately.

• If you have any liver and kidney impairment (hepatic and renal insufficiency), consult your doctor as it may indicate a change in dosage since these impairments may favor the appearance of severe hypoglycemia.
• If you are elderly, weakened, or do not maintain an adequate diet. These situations may favor the appearance of hypoglycemia.
• If you engage in prolonged or intense physical exercise, the risk of hypoglycemia is higher.
• If you are to undergo surgery, if you have an accident, or if you have an infection with fever, your blood sugar levels (hyperglycemia) may increase. In these cases, consult your doctor who may temporarily suspend treatment and replace it with insulin.
• If you have been taking Minodiab for a period of time, its effectiveness in reducing blood sugar levels may be reduced. In this case, consult your doctor.
• If you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase, as it may produce a type of anemia characterized by the rupture of red blood cells (hemolytic anemia).

To determine your response to treatment, your doctor may require you to undergo various tests.

Minodiab with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Some medications cause a decrease in blood sugar levels, others cause an increase, while others may have both effects. In each case, it may be necessary to adjust the dosage of Minodiab to avoid excessively low or high blood sugar levels.

If you take Minodiab with the following medications, hypoglycemia may appear:

• Medications used to treat fungal infections (antifungals).
• Medications to treat pain (analgesics) or inflammation or fever, such as non-steroidal anti-inflammatory drugs (NSAIDs) like phenylbutazone and salicylates (such as acetylsalicylic acid).
• Medications used to treat certain heart conditions or to treat high blood pressure, such as ACE inhibitors (angiotensin-converting enzyme inhibitors) and beta blockers.
• Medications to treat certain gastrointestinal disorders, such as stomach ulcers or stomach discomfort (H2 antagonists).
• Medications to treat acid reflux (antacids).
• Medications used to treat depression or certain mental and emotional disorders (MAOIs - monoamine oxidase inhibitors).
• Antibiotics (quinolones).

If you take Minodiab with the following medications, hyperglycemia may appear:

• Medications used to treat certain mental and emotional disorders (phenothiazines).
• Medications called corticosteroids (used to treat inflammation, excluding topical administration).
• Medications that enhance the effects of the sympathetic nervous system (sympathomimetics such as ritodrine, salbutamol, terbutaline).
• Medications to eliminate fluids (diuretics).
• Medications to treat thyroid disorders.
• Oral contraceptives or female sex hormones used for birth control or to treat certain hormonal disorders in women (estrogens and progestogens).
• Medications to treat epilepsy (phenytoin).
• Nicotinic acid.
• Medications to treat tuberculosis (isoniazid).
• Medications to treat certain heart conditions or hypertension or fluid retention (calcium channel blockers).

Minodiab with food, drinks, and alcohol

In general, Minodiab should be taken 30 minutes before meals with a sufficient amount of water to ensure maximum control of blood sugar levels after meals (postprandial hyperglycemia). Never take Minodiab with alcohol as it may cause a decrease in blood sugar levels and lead to hypoglycemic coma.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

In general, it is recommended to substitute oral antidiabetic medications, including Minodiab, with insulin during pregnancy. Glipizide will be administered during pregnancy only when your doctor considers it appropriate. Your doctor will inform you of the potential risks of taking Minodiab during pregnancy. If glipizide is administered during pregnancy, treatment should be suspended at least one month before delivery and other treatments should be administered to maintain blood sugar levels as close to normal as possible.

If you are breastfeeding, inform your doctor. It is recommended to suspend breastfeeding or interrupt glipizide treatment during this period. Your doctor will evaluate the most suitable treatment for you.

Driving and operating machinery

Your ability to concentrate and react may be affected due to the symptoms caused by hypoglycemia or hyperglycemia, such as visual difficulties.

This may be hazardous in situations where these skills are essential (e.g., driving or operating machinery). Therefore, consult your doctor if it is recommended to drive or operate machinery.

Minodiab contains lactose

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will set the dose according to your condition based on periodic blood sugar controls and response to treatment.

Generally, Minodiab should be administered 30 minutes before meals with a sufficient amount of water to ensure maximum blood sugar control after meals (postprandial hyperglycemia). Never take Minodiab with alcohol.

The recommended initial dose is 5 mg/day, administered before breakfast or lunch.

Your doctor will adjust the dose gradually based on blood sugar results.

Some patients may be adequately controlled with a single daily dose.

The maximum recommended dose per single intake is 15 mg per day. If this dose is not sufficient, dividing the 15 mg dose into two intakes (one and a half tablets each) may be effective. Doses above 15 mg should be divided into at least 2 intakes before meals.

The maximum recommended dose is 40 mg/day.

Your doctor will set the dose according to your condition based on periodic blood sugar controls and response to treatment.

Substitution or association with other medications for blood sugar control:

Minodiab may be used alone or in association with other oral medications or insulin for better control of blood sugar levels. Do not suspend dietary measures or weight control or exercise guidelines indicated by your doctor when starting treatment with Minodiab.

When an oral antidiabetic medication or insulin is replaced or combined with Minodiab, your doctor will adjust the doses to avoid a higher risk of hypoglycemia, and may ask you to closely monitor your blood sugar levels. Any change, substitution, or combination will be made under strict medical supervision.

Use in elderly patients and high-risk patients

Due to the higher risk of hypoglycemia, dose adjustment may be necessary. Dose adjustment will be made gradually, taking into account blood sugar control, increasing the dose in a range of 2.5 to 5 mg of glipizide. Your doctor will set the most suitable dose.

Use in patients with liver or kidney function impairment

Due to the higher risk of hypoglycemia, dose adjustment may be necessary. It is recommended to adjust initial and maintenance doses, possibly starting treatment with 2.5 mg/day. Your doctor will set the most suitable dose.

Use in children

The safety and efficacy of glipizide have not been established in children.

If you take more Minodiab than you should

Immediately inform your doctor or pharmacist if you take more Minodiab than you should. Overdose may lead to hypoglycemia.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Minodiab

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Minodiab

Do not interrupt treatment with Minodiab unless your doctor tells you to.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can have side effects, although not everyone will experience them.

Frequent side effects (which are likely to occur in at least 1 in 100 patients) include:

• Hypoglycemia.
• Nausea, diarrhea, upper abdominal pain, abdominal pain.

Less frequent side effects (which are likely to occur in more than 1 in 1,000 patients) include:

• Dizziness, drowsiness, tremor.
• Blurred vision.
• Vomiting.
• Yellow discoloration of the skin due to bile duct alterations (cholestatic jaundice).
• Eczema (skin redness).

Side effects of unknown frequency (cannot be estimated with available data) include:

• Decreased levels of a type of white blood cell called neutrophils and total white blood cell count (agranulocytosis and leucopenia), decreased platelet count (thrombocytopenia), decreased red blood cell count in blood due to massive destruction of these cells (hemolytic anemia), decreased levels of blood cells (pancytopenia).
• Decreased sodium levels in blood (hyponatremia).
• Confusion.
• Headache.
• Diplopia (double vision), visual disturbances, decreased visual acuity.
• Constipation.
• Altered liver function, liver inflammation (hepatitis).
• Allergic skin reaction (allergic dermatitis), skin redness (erythema), flat rash with undefined edges (morbilliform rash), flat or elevated skin redness (maculopapular reaction), urticaria, itching, light exposure-induced skin reactions (phototoxicity).
• A condition known as acute porphyria.
• General discomfort.
• Elevations of liver enzymes such as AST and other substances found in blood LDH, alkaline phosphatase, urea, and creatinine.

With other sulfonylureas (medicines in the Minodiab family) cases of bone marrow failure to produce all different types of blood cells (aplastic anemia) and disulfiram-like reactions when consumed together with alcohol have been reported, which include symptoms such as: facial flushing, headache, tachycardia, nausea, and/or breathing difficulties.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the outer packaging after (CAD). The expiration date is the last day of the month indicated.

Do not use this medication if you observe visible signs of deterioration. Do not use any damaged or open packaging.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Minodiab

• The active ingredient is glipizide.
• The other components (excipients) are lactose monohydrate, microcrystalline cellulose, cornstarch, and stearic acid.

Appearance of the product and contents of the packaging

Minodiab 5 mg tabletsare presented in white, round, convex, and scored tablets on both faces. The tablet can be divided into two equal halves.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Pfizer, S.L.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Responsible for manufacturing:

Pfizer Italia S.r.l.

Viadel Comercio, Zona Industriale,

63046Marino de Tronto (Ascoli Piceno)

Italy

Last review date of this leaflet:10/2016

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/