MINIDIAB 5 mg Коированная Таблетка

Содержание инструкции

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

MINIDIAB 5 mg tablets

Glipizide

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

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Minidiab and what is it used for

Minidiab contains the active ingredient glipizide. Glipizide belongs to a group of medicines called
sulfonylureas and works by lowering blood sugar levels.
Minidiab is used in adultsfor the treatment of diabetesmellitus not controllable with diet alone.

2. What you need to know before you take Minidiab

Do not take Minidiab

• if you are allergicto glipizide or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from insulin-dependent diabetes(diabetes that started in childhood or adolescence and requires insulin treatment);
• if you have diabetic ketoacidosis (ketone bodies and sugar in the urine);
• if you suffer from episodes of loss of consciousness(this condition may indicate a diabetic coma);
• if you suffer from severe kidneyor liverproblems;
• if you suffer from adrenal insufficiency(reduced production of certain hormones by the adrenal glands).

It is advisable that you do not use this medicine if you suffer from latent diabetesor prediabetes
(mild forms of diabetes mellitus characterized only by increased blood sugar levels).

Warnings and precautions
Talk to your doctor or pharmacist before taking Minidiab.
Tell your doctor or pharmacist beforetaking this medicine if you think that any of the following
conditions apply to you:

• you suffer from glucose-6-phosphate dehydrogenase(G6PD) deficiency, a disease that causes anemia due to abnormal destruction of red blood cells;
• you suffer from kidneyor liverdisorders;
• you are elderly, debilitatedand/or malnourished;
• you are taking beta-blocker medicines;
• you have problems with the pituitary gland, a gland located at the base of the brain.

Minidiab can cause hypoglycemia(low blood glucose levels), a condition characterized by headache,
irritability, sleep disturbances, tremor and excessive sweating that may require hospitalization
and develop into coma. If you are elderly, debilitated or malnourished, have problems with the pituitary gland or are taking beta-
blocker medicines, you may be more likely to experience hypoglycemia. It is also more common for hypoglycemia to
occur when there is insufficient calorie intake, after significant and prolonged physical exercise, when
alcohol is ingested or if you are taking other medicines that lower blood sugar levels.
Tell your doctor if you need to undergo surgery, have suffered a trauma, have contracted an
infectionor have a fever. In these cases, blood sugar control may be insufficient and your doctor
may prescribe you to take insulin.

Laboratory tests
During treatment with Minidiab, your doctor will subject you to regular checks to assess your blood
sugar levels and the effects of the medicine.
The effectiveness of this medicine may decrease over time and your doctor may decide to
increase the dose.

Other medicines and Minidiab
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The following medicines can cause excessive decreasein blood sugar levels
(hypoglycemia) if administered together with Minidiab:

• miconazole, fluconazole, voriconazole, medicines used against fungal infections;
• non-steroidal anti-inflammatory drugs (NSAIDs)(e.g. phenylbutazone and acetylsalicylic acid), medicines used against inflammation, pain and fever;
• beta-blockers, medicines used to treat high blood pressure and certain heart conditions;
• ACE inhibitors, medicines used to lower blood pressure;
• H receptor antagonists(e.g. cimetidine), medicines used for the treatment of stomach and esophageal ulcers;
• monoamine oxidase inhibitors, medicines used against depression;
• quinolones,medicines used against bacterial infections;
• sulfonamidesand chloramphenicol, antibiotics;
• probenecid, medicine used against gout;
• dicoumaroland other similar medicines, medicines used to thin the blood;
• cyclophosphamide, medicine against tumors;
• pheniramine, medicine used to relax muscles.

The following medicines can cause excessive increasein blood sugar levels (hyperglycemia)
if administered together with Minidiab:

• phenothiazines(e.g. chlorpromazine), medicines used against mental illnesses;
• corticosteroids, medicines used against inflammation and allergic reactions;
• sympathomimetics(e.g. ritodrine) medicines used to stop premature labor, salbutamoland terbutaline,medicines used against asthma;
• diuretics, medicines used to increase urine production;
• thyroid hormones, used when the thyroid gland is functioning poorly or has been removed with surgery;
• estrogenand progestinhormones, oral contraceptives;
• phenytoin, medicine used against seizures;
• nicotinic acid, used to reduce cholesterol and other fat levels;
• calcium antagonists, medicines used to lower blood pressure;
• isoniazid, medicine against tuberculosis;
• adrenaline, medicine against shock from a severe allergic reaction and in cases of cardiac arrest.

Minidiab with alcohol
Do notdrink alcohol while taking Minidiab. Alcohol can increase the lowering of blood sugar levels
and cause loss of consciousness (hypoglycemic coma).

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor for advice before taking this medicine.
The administration of glipizide is not recommended during pregnancy.
If you are breastfeeding, your doctor will prescribe Minidiab only if strictly necessary.
Minidiab can cause drowsiness, headache, dizziness, confusion and visual disturbances. If you experience
these side effects, do not drive vehicles or use machinery.

Minidiab contains lactose
Minidiab contains lactose. If your doctor has diagnosed you with intolerance to some sugars, contact him
before taking this medicine.

3. How to take Minidiab

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Swallow the tablets with a glass of water. The tablet can be divided into equal parts.
The doctor will decide the most suitable dose for you based on your condition and your blood sugar levels
and urine.
The recommended doses range from half a tablet (2.5 mg) to 4 tablets (20 mg) per day, divided into 2
or more administrations to be taken immediately before main meals.

If you are taking Minidiab for the first time
Start treatment with half a tablet or with 1 tablet per day. The doctor will tell you how
to increase the dosage.

If you are already treated with oral hypoglycemic medicines
The doctor will decide the most suitable dose for you starting with low doses and increasing them gradually and
may allow an appropriate period of time to pass between the end of the previous treatment and
the start of treatment with Minidiab.

If you are being treated with insulin:
In some cases Minidiab allows you to reduce the daily insulin requirement, during the first period of
treatment, however, you need to frequently check your blood glucose levels.

If you take more Minidiab than you should
If you have accidentally taken an excessive dose of Minidiab, inform your doctor immediately.
An overdose may produce moderate symptoms of hypoglycemia, in this case promptly take food or
sugary drinks or reduce the dose of Minidiab.
If you experience convulsions or loss of consciousness, hospitalization is necessary at the nearest
hospital.

If you forget to take Minidiab
If you forget to take a dose, ask your doctor if you can take the medicine as soon as you
remember or if you should wait for the next dose. Do not take a double dose to make up for the
forgotten dose.

If you stop taking Minidiab
If you stop treatment with this medicine, your blood sugar levels may vary
suddenly and your illness may worsen. This could endanger your life.
Do not stop treatment with Minidiab unless your doctor prescribes it.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stoptreatment with this medicine immediately and contact your doctor if you experience:

• cholestatic jaundice
• reactions, redness and skin allergies (eczema, allergic dermatitis, erythema, measles-like or maculopapular reactions
• urticaria, itching, increased skin sensitivity to sunlight

Contact your doctor if you experience the following side effects:

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

• reduction of blood glucose levels (hypoglycemia) (see section 2 “Warnings and precautions”)
• nausea, diarrhea, abdominal pain

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

• dizziness
• drowsiness
• tremor
• blurred vision
• vomiting

Frequency not known(frequency cannot be estimated from available data):

• decrease in the blood of the number of white blood cells, platelets and red blood cells
• decrease in blood sodium levels
• confusion
• headache
• double vision, impaired or reduced vision
• constipation
• decreased liver function, liver inflammation
• acute intermittent porphyria (altered hemoglobin production)
• general malaise
• alteration of some blood laboratory tests that evaluate liver, kidney and muscle function (increased aspartate aminotransferase, increased blood lactate dehydrogenase, increased blood alkaline phosphatase, increased blood urea, increased blood creatinine)

The majority of side effects are related to the dosage, are transient and respond to dosage reduction or discontinuation of treatment.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Minidiab

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 package and on the blister after “Exp.”. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Minidiab contains
The active ingredient is glipizide.
Each tablet contains 5 mg of glipizide.
The other ingredients are: lactose(see section 2 “Minidiab contains lactose”), microcrystalline cellulose,
starch, stearic acid.

Description of the appearance of Minidiab and contents of the pack
Minidiab tablets are available in PVC/aluminium blisters in packs of 30 or 40 divisible tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Italia S.r.l.
via Isonzo, 71
04100 Latina

Manufacturer
Pfizer Italia S.r.l.
Località Marino del Tronto

• 63100 – Ascoli Piceno (AP)