Minodiab 5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Minodiab 5 mg tablets

Glipizide

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

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

Leaflet contents

1. What Minodiab is and what it is used for

2. What you need to know before taking Minodiab

3. How to take Minodiab

4. Possible side effects

5. How to store Minodiab

6. Contents of the pack and other information

1. What Minodiab is and what it is used for

Minodiab is an oral antidiabetic medicine. It belongs to a family of medicines called sulfonylureas and works by lowering blood sugar levels in adult patients with type 2 diabetes when diet and physical exercise are not sufficient to control blood sugar levels.

2. What you need to know before taking Minodiab

Do not take Minodiab

• If you are allergic to glipizide or to any of the other ingredients of this medicine (listed in section 6).
• If you have type 1 diabetes.
• If you have diabetes with increased blood acidity due to accumulation of ketone bodies and presence of ketones in urine (diabetic ketoacidosis).
• If you are suffering from diabetic coma (reduced level of consciousness).

Warnings and precautions

Talk to your doctor or pharmacist before taking Minodiab.

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

• If you have liver or kidney problems (hepatic or renal insufficiency), consult your doctor, as your dose may need to be adjusted, since these conditions may increase the risk of severe hypoglycemia.
• If you are elderly, debilitated, or do not maintain an adequate diet. These conditions may increase the risk of hypoglycemia.
• If you engage in prolonged or intense physical exercise, your risk of hypoglycemia is higher.
• If you are undergoing surgery, have suffered an accident, or have an infection with fever, your blood sugar levels may rise (hyperglycemia). In such cases, consult your doctor, who may temporarily discontinue this treatment and switch you to insulin.
• If you have been on treatment with Minodiab for a prolonged period, its effectiveness in lowering blood sugar levels may decrease. In this case, consult your doctor.
• If you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase, as this may lead to anemia characterized by the breakdown of red blood cells (hemolytic anemia).

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

Taking Minodiab with other medicines

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

Some medicines 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 dose of Minodiab to avoid blood sugar levels that are too low or too high.

If you take Minodiab with the following medicines, hypoglycemia may occur:

• Medicines used to treat fungal infections (antifungals).
• Medicines for pain (analgesics) or inflammation or to reduce fever, such as non-steroidal anti-inflammatory drugs (NSAIDs), for example phenylbutazone and salicylates (such as acetylsalicylic acid).
• Medicines used for certain heart conditions or to treat high blood pressure, such as ACE inhibitors (angiotensin-converting enzyme inhibitors) and beta-blockers.
• Medicines for treating certain gastrointestinal disorders, such as stomach ulcers or stomach discomfort (H2 antagonists).
• Medicines for treating stomach acidity (antacids).
• Medicines used to treat depression or certain mental and emotional disorders (antidepressants of the MAOI type - monoamine oxidase inhibitors).
• Antibiotics (quinolones).

If you take Minodiab with the following medicines, hyperglycemia may occur:

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

Taking Minodiab with food, drinks, and alcohol

Minodiab should generally be taken within 30 minutes before a meal with sufficient water to ensure optimal control of blood sugar after meals (postprandial hyperglycemia). You should never take Minodiab with alcohol, as this may cause a decrease in blood sugar levels and potentially lead to hypoglycemic coma.

Pregnancy, breastfeeding, and fertility

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

Generally, oral antidiabetic agents, including Minodiab, should be replaced by insulin during pregnancy. Glipizide will only be administered during pregnancy if 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 discontinued at least one month before delivery, and alternative treatments will be provided to maintain blood sugar levels as close to normal as possible.

If you are breastfeeding, inform your doctor. It is recommended to discontinue breastfeeding or stop treatment with glipizide during this period. Your doctor will assess the most appropriate treatment for you.

Driving and using machines

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

This may be dangerous in situations where these skills are important (e.g., driving or operating machinery). Therefore, consult your doctor to determine whether it is advisable to drive or operate machinery.

Minodiab contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Minodiab

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

In general, Minodiab should be taken within the 30 minutes before a meal, with a sufficient amount of water, to ensure maximum control of blood sugar after meals (postprandial hyperglycemia). Minodiab must never be taken together with alcohol.

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

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

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

The maximum recommended single dose is 15 mg per day. If this dose is not sufficient, it may be effective to divide the 15 mg dose into two doses (1.5 tablets per dose). Doses higher than 15 mg should be divided into at least two doses taken before meals.

The maximum recommended dose is 40 mg/day.

Your doctor will determine the dose according to your condition, based on periodic blood sugar monitoring and response to treatment.

Substitution or combination with other blood sugar-lowering medicines:

Minodiab may be used alone or in combination with other oral blood sugar-lowering medicines or insulin for better control of blood sugar levels. Do not discontinue the dietary measures or weight control and exercise regimens prescribed by your doctor when starting treatment with Minodiab.

When switching from or combining with another antidiabetic oral medicine or insulin, your doctor will adjust your doses to avoid an increased risk of hypoglycemia, and may ask you to monitor your blood sugar levels more closely. Any change, substitution, or combination must be carried out under strict medical supervision.

Use in elderly and high-risk patients

Due to the increased risk of hypoglycemia, a dose adjustment may be necessary. The dose adjustment should be gradual, taking into account blood sugar control, increasing the dose in the range of 2.5 to 5 mg of glipizide. Your doctor will determine the most appropriate dose.

Use in patients with impaired liver or kidney function

Due to the increased risk of hypoglycemia, a dose adjustment may be necessary. It is recommended to adjust both initial and maintenance doses, possibly starting treatment with 2.5 mg per day. Your doctor will determine the most appropriate dose.

Use in children

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

If you take more Minodiab than you should

If you take more Minodiab than you should, inform your doctor or pharmacist immediately. Overdose may lead to hypoglycemia.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Minodiab

Do not take a double dose to make up for missed doses.

If you stop taking Minodiab

Do not stop treatment with Minodiab unless instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Frequent adverse effects (likely to occur in at least 1 out of every 100 patients) include:

• Hypoglycaemia.
• Nausea, diarrhoea, upper abdominal pain, abdominal pain.

Uncommon adverse effects (likely to occur in more than 1 out of every 1,000 patients) include:

• Dizziness, drowsiness (somnolence), tremor.
• Blurred vision.
• Vomiting.
• Yellowish skin discoloration due to biliary tract disorders (cholestatic jaundice).
• Eczema (skin redness).

Adverse effects with unknown frequency (cannot be estimated from the available data) include:

• Decrease in a type of white blood cells called neutrophils and in total white blood cell count (agranulocytosis and leucopenia), decrease in platelet count (thrombocytopenia), reduction in red blood cells due to massive destruction (haemolytic anaemia), reduction in all blood cell elements (pancytopenia).
• Decreased sodium levels in blood (hyponatraemia).
• Confusion.
• Headache.
• Double vision (diplopia), visual disturbances, decreased visual acuity.
• Constipation.
• Impaired liver function, liver inflammation (hepatitis).
• Skin allergic reaction (allergic dermatitis), skin redness (erythema), flat red rash with ill-defined borders (morbilliform rash), flat or raised red skin lesions (maculopapular reaction), urticaria, itching, skin reactions triggered by light exposure (photosensitivity reaction).
• A condition known as non-acute porphyria.
• General malaise.
• Increased liver enzymes such as AST and other blood substances including LDH, alkaline phosphatase, urea, and creatinine.

With other sulfonylureas (medicines in the Minodiab family), cases of bone marrow failure to produce all types of blood cells (aplastic anaemia) and disulfiram-like reactions when alcohol is consumed concomitantly have been reported. These reactions include symptoms such as facial flushing, headache, tachycardia, nausea and/or difficulty breathing.

Reporting of adverse effects

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

5. Storage of Minodiab

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the outer packaging after (EXP). The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice any visible signs of deterioration. Do not use any pack that is damaged or open.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Minodiab

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

Appearance of the product and contents of the pack

Minodiab 5 mg tablets are presented as white, round, biconvex, and scored on both sides. The tablet can be divided into equal halves.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Pfizer, S.L.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Manufacturer:

Pfizer Italia S.r.l.

Via del Comercio, Zona Industriale,

63046 Marino di Tronto (Ascoli Piceno)

Italy

Date of the most recent review of this leaflet: 10/2016

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/