PATIENT LEAFLET: INFORMATION FOR THE USER

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

Equivalent medicinal product
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:

What Repaglinide Zentiva is and what it is used for
What you need to know before taking Repaglinide Zentiva
How to take Repaglinide Zentiva
Possible side effects
How to store Repaglinide Zentiva
Contents of the pack and other information

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

Repaglinide Zentiva is an oral antidiabetic medicinal product containing repaglinide, which helps the pancreas produce more insulin and thereby lower blood sugar (glucose).
Type 2 diabetes is a condition in which the pancreas does not produce enough insulin to control blood sugar, or where the body does not respond normally to the insulin it produces.
Repaglinide Zentiva is used to control type 2 diabetes in adults, in addition to diet and physical exercise. Treatment is started when diet, exercise, and weight reduction alone have not been sufficient to control (or lower) blood sugar levels.
Repaglinide Zentiva may be given together with metformin, another antidiabetic medicine.
Repaglinide Zentiva has been shown to reduce blood glucose, helping to prevent diabetes-related complications.

2. What you need to know before taking Repaglinide Zentiva

Do not take Repaglinide Zentiva

If you are allergic to 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 taken with caution.
If you are about to undergo major surgery, or if you have recently been seriously ill or had an infection. In these conditions, you may lose control of your diabetes.
If you are under 18 years or over 75 years of age. Repaglinide Zentiva is not recommended. It has not been studied in these age groups. Talk to your doctor if any of the above conditions apply to you. Repaglinide Zentiva is not suitable for you. Your doctor will advise you accordingly. Children and adolescents Do not take this medicine if you are under 18 years of age.

If you have hypoglycaemia (low blood sugar)

You may experience a hypoglycaemic episode (a short period during which a hypoglycaemic reaction occurs) if your blood sugar is very low. This may 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 sections of "2. What you need to know before taking Repaglinide Zentiva").

Warning signs of a hypoglycaemic episode may appear suddenly and may include: cold sweats; cold, pale skin; headache; rapid heartbeat; feeling unwell; intense hunger; temporary vision changes; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.

If your blood sugar is low or if you feel a hypoglycaemic episode coming on: eat sugar cubes, a snack, or a sugary drink, and then rest. Once hypoglycaemia symptoms have disappeared or your blood sugar levels have stabilized, continue your treatment with Repaglinide Zentiva.

Tell people who know you have diabetes that, if you faint (lose consciousness) due to a hypoglycaemic episode, they should turn you onto your side and immediately seek medical help. They must not give you food or drink. You could choke.

If severe hypoglycaemia is not treated, it may damage the brain (temporarily or permanently) or even lead to death.
If you have had a hypoglycaemic episode that caused you to faint, or repeated hypoglycaemic episodes, consult your doctor. You may need an adjustment in the dosage of Repaglinide Zentiva, food intake, or physical activity.

If your blood sugar is too high
Your blood sugar may become too high (hyperglycaemia). This may occur:

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.

Warning signs of very high blood sugar levels develop gradually and include: increased urination; feeling thirsty; dry mouth and dry skin.
Talk to your doctor. You may need an adjustment in the dosage of Repaglinide Zentiva, food intake, or physical activity.

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

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 anaemia 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 thyroid hormone levels);
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 immune system);
Deferasirox (used to reduce chronically high iron levels);
Clopidogrel (prevents blood clots);
Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy);
St. John's Wort (herbal remedy).

Repaglinide Zentiva and alcohol
Alcohol may alter the ability of Repaglinide Zentiva to lower blood sugar. Be alert for signs of hypoglycaemic episodes.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor 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 operate machinery may be impaired if your blood sugar levels are too high or too low. Remember that this could be dangerous for yourself and others. Ask your doctor whether you may drive if:

You have frequent hypoglycaemic episodes;
You have no or few warning signs of hypoglycaemia.

3. How to take Repaglinide Zentiva

Take this medicine exactly as your doctor has instructed you. If you have
any doubts, consult your doctor.
Your doctor will determine your dose.

The usual starting dose is 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.
Your doctor may adjust the dose 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 prescribed.
If you take more Repaglinide Zentiva than you should
If you take too many tablets, your blood sugar level may become too low,
leading to a hypoglycaemic episode. See “If you have hypoglycaemia” for information on what it is and how
to treat it.
If you forget to take Repaglinide Zentiva
If you miss a dose, take your next dose as usual – do not take a double dose.
If you stop taking Repaglinide Zentiva
If you stop treatment with Repaglinide Zentiva, be aware that you will no
longer obtain the desired effects. Your diabetes may worsen. If any change in treatment is needed, consult your doctor first.
If you have any questions about how to use 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.
Hypoglycaemia
The most common side effect is hypoglycaemia, which may affect up to 1 in 10 patients
(see “If you have hypoglycaemia” in section 2). Hypoglycaemic reactions are generally
mild/moderate but may occasionally progress to loss of consciousness or hypoglycaemic coma.
If this occurs, immediate medical assistance is required.
Allergy
Allergic reaction is very rare (may 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;
Diarrhoea.

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, itching of the skin, skin redness, skin swelling);
Feeling unwell (nausea).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 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 packaging.
Blister (PVC/PVDC-aluminum):
Do not store 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 packaging.
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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Repaglinide Zentiva contains.
The active substance 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 components are:
Microcrystalline cellulose, Anhydrous calcium hydrogen phosphate, Maize starch, Polacrilin potassium,
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 Zentiva and pack sizes
Repaglinide tablets are white or ivory white, round, flat, with bevelled edges and flat on both sides.
Repaglinide tablets are yellow, round, flat, with bevelled edges and flat on both sides.
Repaglinide tablets are pink, round, flat, with bevelled edges and flat on both sides.
Repaglinide Zentiva is available in pack sizes of:
Blister packs (aluminium/aluminium or PVC/PVDC/aluminium): 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 European Economic Area Member States under the following names:
Italy: Repaglinide Zentiva
France: REPAGLINIDE ZENTIVA 0.5/1/2 mg, tablet
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