REPAGLINIDE TSENTIVA 0.5 MG Tablets

Зміст інструкції

1. Repaglinide Zentiva 0.5 mg tablets, 1 mg tablets, 2 mg tablets
   1. What is Repaglinide Zentiva and what is it used for
   2. What you need to know before taking Repaglinide Zentiva
   3. How to take Repaglinide Zentiva
   4. Possible side effects
   5. How to store Repaglinide Zentiva
   6. Package contents and other information

Repaglinide Zentiva 0.5 mg tablets, 1 mg tablets, 2 mg tablets

Generic medicine

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

1. What is Repaglinide Zentiva and what is it used for

Repaglinide Zentiva is an oral antidiabetic medicinethat contains repaglinide, which helps the
pancreas to produce more insulin and therefore lower blood sugar (glucose).
Type 2 diabetesis a disease in which the pancreas does not produce a sufficient amount of
insulin to control blood sugar or where the body does not respond
normally to the insulin it produces.
Repaglinide Zentiva is used for the control of type 2 diabetes in adults in addition to
diet and exercise: treatment is started if diet, exercise and weight reduction
alone have not been able to control (or lower) blood sugar.
Repaglinide Zentiva can be given with metformin, another medicine for diabetes.
Repaglinide Zentiva has been shown to reduce blood glucose, helping to prevent the
complications caused by diabetes.

2. What you need to know before taking Repaglinide Zentiva

Do not take Repaglinide Zentiva

• If you are allergicto repaglinide or to any of the other ingredients of this medicine (listed in section 6).
• If you have type 1 diabetes.
• If the level of acid in your blood is high (diabetic ketoacidosis).
• If you have severe liver disease.
• If you are taking gemfibrozil(a medicine used to reduce high levels of fats in the blood).

Warnings and precautions
Talk to your doctor before taking Repaglinide Zentiva:

• If you have liver problems. Repaglinide Zentiva is not recommended in patients with moderate liver disease. Repaglinide Zentiva must not be taken if you have severe liver disease (see “Do not take Repaglinide Zentiva”).
• If you have kidney problems. Repaglinide Zentiva should be used with caution.
• If you are going to undergo major surgeryor if you have been seriously illrecently or have had an infection. In these conditions, you may lose control of your diabetes.
• If you are under 18 years of ageor over 75 years of age. Repaglinide Zentiva is not recommended. It has not been studied in these age groups. Talk to your doctorif any of the above conditions apply to you. Repaglinide Zentiva is not suitable for you. Your doctor will advise you about this. Children and adolescentsDo not take this medicine if you are under 18 years of age. If you have hypoglycemia (low blood sugar)

You may experience a hypoglycemic episode (a short period during which a hypoglycemic reaction occurs) if your blood sugar is very low. This can happen:

• If you take too much Repaglinide Zentiva;
• If you exercise more than usual;
• If you take other medicines or have liver or kidney problems (see other paragraphs of “2. What you need to know before taking Repaglinide Zentiva”). The warning signs of a hypoglycemic episodecan appear suddenly and may include: cold sweats; cold and pale skin; headache; rapid heartbeat; feeling unwell; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty concentrating. If your blood sugar is low or you feel that a hypoglycemic episode is coming on: eat sugar cubes or a snack or a high-sugar drink, and then rest. When the symptoms of hypoglycemia have disappeared or when blood sugar levels have stabilizedcontinue treatment with Repaglinide Zentiva.

Talk to people who are aware that you have diabetes that, if you
experience fainting(with loss of consciousness) due to a hypoglycemic episode,
they must turn you onto your side and immediately seek medical help. They must not
give you food or drink. You could choke.

• If severe hypoglycemiais not treated, it can damage the brain (temporarily or permanently) or even lead to death.
• If you have had a hypoglycemic episodethat caused you to faint, or repeated hypoglycemic episodes, consult your doctor. It may be necessary to adjust the dosage of Repaglinide Zentiva, the amount of food or the amount of exercise.

If your blood sugar is too high
Your blood sugar may be too high (hyperglycemia). This can happen:

• If you take too little Repaglinide Zentiva;
• If you have an infection or fever;
• If you eat more than usual;
• If you exercise less than usual.

The danger signs of very high blood sugar levelsdevelop
gradually. They include: increased urination; feeling thirsty; dry mouth and skin.
Talk to your doctor. It may be necessary to adjust the dosage of
Repaglinide Zentiva, the amount of food or the amount of exercise.

Other medicines and Repaglinide Zentiva
Tell your doctoror pharmacist if you are taking, have recently taken or might
take any other medicines.
You can take Repaglinide Zentiva with metformin, another medicine for diabetes, if
your doctor has prescribed it.
If you are taking gemfibrozil (used to lower high levels of fats in the blood) you must not
take Repaglinide Zentiva.
Your body's response to Repaglinide Zentiva may change if you take other medicines
especially these:

• Monoamine oxidase inhibitors (MAOIs) (used to treat depression);
• Beta-blockers (used to treat high blood pressure or heart conditions);
• ACE inhibitors (used to treat heart conditions);
• Salicylates (e.g. aspirin);
• Octreotide (used to treat cancer);
• Non-steroidal anti-inflammatory drugs (NSAIDs) (a type of painkiller);
• Steroids (anabolic steroids and corticosteroids - used for anemia or to treat inflammation);
• Oral contraceptives (birth control pills);
• Thiazides (diuretics);
• Danazol (used to treat breast cysts and endometriosis);
• Thyroid medicines (used to treat low levels of thyroid hormones);
• Sympathomimetics (used to treat asthma);
• Clarithromycin, trimethoprim, rifampicin (antibiotic medicines);
• Itraconazole, ketoconazole (antifungal medicines);
• Gemfibrozil (used to treat high levels of fats in the blood);
• Cyclosporine (used to suppress the action of the immune system);
• Deferasirox (used to reduce chronically high levels of iron)
• Clopidogrel (prevents blood clot formation)
• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy);
• St. John's Wort (herbal medicine).

Repaglinide Zentiva with alcohol
Alcohol can alter Repaglinide Zentiva’s ability to lower blood sugar.
Be careful of the signs related to hypoglycemic episodes.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor for advice before taking this medicine.
You must not take Repaglinide Zentiva if you are pregnant or planning a pregnancy..
You must not take Repaglinide Zentiva if you are breastfeeding.

Driving and using machines
Your ability to drive or use machines may be impaired if you have high or low blood sugar
levels. Be aware that you could be a danger to yourself and others. Ask your doctor if you can drive if:

• You have frequent hypoglycemic episodes
• You have no or few warning signs of hypoglycemic episodes

3. How to take Repaglinide Zentiva

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your doctor.
The doctor will establish the dose.

• The usual initial doseis 0.5 mg before each main meal. Swallow the tablets with a glass of water immediately before or up to 30 minutes before each main meal.
• The dose may be adjusted by the doctor up to a maximum of 4 mg taken immediately before or up to 30 minutes before each main meal. The maximum recommended daily dose is 16 mg.

Do not take more Repaglinide Zentiva than your doctor has recommended.

If you take more Repaglinide Zentiva than you should
If you take too many tablets, your blood sugar level may become too low
and lead to a hypoglycemic crisis. See “If you have hypoglycemia” to find out what it is and how to
treat it.

If you forget to take Repaglinide Zentiva
If you miss a dose, take the next dose as usual - do not take a double dose.

If you stop taking Repaglinide Zentiva
If you stop treatment with Repaglinide Zentiva you should be aware that you will not
achieve the desired effects. Your diabetes may worsen. If any change in treatment is necessary, consult your doctor first.
If you have any further questions on 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.
Hypoglycemia
The most frequent side effect is hypoglycemia which can affect up to 1 in 10 patients
(see “If you have hypoglycemia”in section 2 ).Hypoglycemic reactions are
generally mild/moderate but can occasionally develop into loss of
consciousness or hypoglycemic coma. If this occurs, immediate medical
assistance is necessary.
Allergy
Allergy is very rare (can affect up to 1 in 10,000 patients). Symptoms such as swelling,
difficulty breathing, rapid heartbeat, dizziness and sweating may be signs
of an anaphylactic reaction. Contact a doctor immediately.
Other side effects

Common(may affect up to 1 in 10 patients)

• Stomach pain;
• Diarrhea.

Rare(may affect up to 1 in 1,000 patients)

• Acute coronary syndrome (but may not be caused by the medicine).

Very rare(may affect up to 1 in 10,000 patients)

• Vomiting;
• Constipation;
• Visual disturbances;
• Serious liver problems, abnormal liver function, such as increased liver enzymes in the blood. Frequency not known
• Hypersensitivity reactions (such as erythema, skin itching, reddened skin, skin swelling);
• Feeling unwell (nausea).

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 to provide more information on the safety of this medicine.

5. How to store Repaglinide Zentiva

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

Repaglinide Zentiva 0.5 mg tablets:
Blister (aluminum/aluminum)
Store in the original package
Blister (PVC/PVDC-aluminum):
Do not store at a temperature above 30 °C
Keep the PVC/PVDC-aluminum blister in the cardboard box.
Bottle (HDPE):
Keep the bottle in the cardboard box.

Repaglinide Zentiva 1 mg and 2 mg tablets:
Store in the original package
Do not use this medicine after the expiry date which is stated on the cardboard box,
on the blister and on the bottle after EXP. The expiry date refers to the last day of that
month.
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. Package contents and other information

What Repaglinide Zentiva contains.
The active ingredient is repaglinide.
Each tablet contains 0.5 mg of repaglinide.
Each tablet contains 1 mg of repaglinide.
Each tablet contains 2 mg of repaglinide.
The other ingredients are:
Microcrystalline cellulose, Anhydrous calcium hydrogen phosphate, Corn starch, Potassium polyacrilin,
Povidone, Glycerol 85%, Magnesium stearate, Meglumine, Poloxamer 407, Titanium dioxide
(E171), Yellow iron oxide (E172) and Red iron oxide (E172).

Description of the appearance of Repaglinide Zentivaand package contents
Repaglinide tablets are white or off-white, round, flat, with beveled edges
and flat on both sides.
Repaglinide tablets are yellow, round, flat, with beveled edges and flat on
both sides.
Repaglinide tablets are pink, round, flat, with beveled edges and flat on
both sides.
Repaglinide Zentiva is available in packs of:
Blisters (aluminum/aluminum or PVC/PVDC/-aluminum): 30, 90, 120, 270 or 360 tablets.
Bottle (HDPE): 1000 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zentiva Italia S.r.l.
Viale L. Bodio, 37/B – 20158 Milano

Manufacturers:
Delorbis Pharmaceuticals LTD
17, Athinon Str. Ergates, Industrial Area
2643 Nicosia (Lefkosia)
Cyprus

Dragenopharm Apotheker Püschl GmbH
Göllstrasse, 1, 84529 Tittmoning
Germany

This medicinal product has been authorised in the Member States of the European
Economic Area under the following denominations:
Italy: Repaglinide Zentiva
France: REPAGLINIDE ZENTIVA 0.5/1/2 mg, tablet

This leaflet was last updated on