REPAGLINIDE KERN PHARMA 2 mg TABLETS

2. Before taking Repaglinida Kern Pharma

Do not take Repaglinida Kern Pharma

• If you are hypersensitive(allergic) to repaglinide or any of the other components of the medication.
• If you have type 1 diabetes(insulin-dependent diabetes).
• If your body's acid levels have increased (diabetic ketoacidosis).
• If you have severe liver disease.
• If you are taking gemfibrozil(a medication that lowers blood fat levels).

If any of these cases apply to you, tell your doctorand do not take Repaglinida Kern Pharma.

Be careful with Repaglinida Kern Pharma

• If you have liver problems. Repaglinida Kern Pharma is not recommended for patients with moderate liver disease. Repaglinida Kern Pharma should not be taken if you have severe liver disease (see Do not take Repaglinida Kern Pharma).
• If you have kidney problems. Repaglinida Kern Pharma should be taken with caution.
• If you are going to undergo major surgeryor have recently suffered a serious illnessor infection. In these circumstances, diabetic control may not be achieved.
• If you are under 18or over 75 years old, Repaglinida Kern Pharma is not recommended. It has not been studied in these age groups.

Consult your doctor ifany of these cases apply to you, Repaglinida Kern Pharma may not be suitable for you. Your doctor will advise you.

If you have hypoglycemia

You may experience hypoglycemia (low blood sugar symptoms) if your blood sugar levels are too low. This can happen if:

• You take too much Repaglinida Kern Pharma.
• You engage in more physical exercise than usual.
• You take other medications or have kidney or liver problems (see other sections of 2. Before taking Repaglinida Kern Pharma).

Warning signs of hypoglycemiaappear suddenly and can include: cold sweat, cool pale skin, headache, palpitations, nausea, excessive hunger, temporary visual disturbances, fatigue, unusual weakness, nervousness or tremors, anxiety, confusion, and difficulty concentrating.

If your blood sugar levels are low or if you feel you are going to have hypoglycemia:take glucose tablets or a sugary product or drink, and then rest.

When hypoglycemia symptoms disappear or when blood sugar levels stabilize, continue treatment with Repaglinida Kern Pharma.

Tell others that you are diabetic and that if you lose consciousnessdue to hypoglycemia, they should lay you on your side and seek immediate medical attention. They should not give you anything to eat or drink, as you may choke.

• If severe hypoglycemiais not treated, it can cause brain damage (temporary or permanent) and even death.
• If you experience hypoglycemiathat makes you lose consciousness or if you suffer from repeated hypoglycemia, inform your doctor. You may need to adjust the dose or administration schedule of Repaglinida Kern Pharma, diet, or exercise.

If your blood sugar levels are very high

Your blood sugar levels may be very high (hyperglycemia). This can happen:

• If you take too little Repaglinida Kern Pharma.
• If you have an infection or fever.
• If you eat more than usual.
• If you engage in less exercise than usual.

Warning signsappear gradually. These include: excessive urination, thirst, dry skin, and a dry mouth feeling. Inform your doctor. You may need to adjust the dose of Repaglinida Kern Pharma, diet, or exercise.

Using other medications

If your doctor prescribes it, you can take Repaglinida Kern Pharma in combination with metformin, another diabetes medication. If you take gemfibrozil (used to lower blood fat levels), you should not take Repaglinida Kern Pharma.

Your body's response to Repaglinida Kern Pharma may change if you take other medications, especially:

• Monoamine oxidase inhibitors (MAOIs) (for depression treatment).
• Beta-blockers (for high blood pressure or heart disease treatment).
• Angiotensin-converting enzyme (ACE) inhibitors (for heart disease treatment).
• Salicylates (e.g., aspirin).
• Octreotide (for cancer treatment).
• Non-steroidal anti-inflammatory drugs (NSAIDs) (a type of pain reliever).
• Steroids (anabolic steroids and corticosteroids, for anemia or to treat inflammation).
• Deferasirox (to reduce chronic iron overload).
• Oral contraceptives (to prevent pregnancy).
• Thiazides (diuretics).
• Danazol (for breast cysts and endometriosis treatment).
• Thyroid products (for low thyroid hormone levels treatment).
• Sympathomimetics (for asthma treatment).
• Clarithromycin, trimethoprim, rifampicin (antibiotic medications).
• Itraconazole, ketoconazole (medications for fungal infections).
• Gemfibrozil (to treat high blood fat levels).
• Cyclosporin (to suppress the immune system).
• Phenytoin, carbamazepine, phenobarbital (for epilepsy treatment).
• St. John's Wort (herbal medicinal plant).
• Clopidogrel (to prevent blood clots formation).

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

Using Repaglinida Kern Pharma with food and drinks

Take Repaglinida Kern Pharma before main meals. Alcohol can alter Repaglinida Kern Pharma's ability to lower blood sugar levels. Be aware of hypoglycemia symptoms.

Pregnancy and breastfeeding

Do not take Repaglinida Kern Pharma if you are pregnant or planning to become pregnant. Consult your doctor as soon as possible if you become pregnant or plan to become pregnant during treatment.

Do not take Repaglinida Kern Pharma if you are breastfeeding.

Driving and using machines

Your concentration and reaction abilities may be impaired due to hypoglycemia or hyperglycemia symptoms, such as vision disturbances. This can be dangerous in situations where these skills are important (e.g., driving or using machines). Therefore, consult your doctor if it is advisable to drive or use machines.

3. How to take Repaglinida Kern Pharma

Your doctor will calculate your dose.

• Normally, the initial doseis 0.5 mg taken just before each main meal. The tablets should be taken with a glass of water just before or within 30 minutes before each main meal.
• The dose may be adjusted by your doctor up to 4 mg, which should be taken just before or within 30 minutes before each main meal. The maximum recommended dose is 16 mg per day.

Do not take more Repaglinida Kern Pharma than your doctor has recommended. Always take Repaglinida Kern Pharma exactly as your doctor has told you. Consult your doctor if you are unsure.

If you take more Repaglinida Kern Pharma than you should

If you take too many tablets, your blood sugar levels may become too low and cause hypoglycemia. Please read what hypoglycemia is and how to treat it in the section If you have hypoglycemia.

If you forget to take Repaglinida Kern Pharma

If you forget to take a dose, take the next dose as you normally would, never take a double dose.

If you stop taking Repaglinida Kern Pharma

Note that the desired effect is not achieved if you stop taking Repaglinida Kern Pharma. Your diabetes may worsen. If any changes to your treatment are necessary, consult your doctor first.

If you have any further questions on the use of Repaglinida Kern Pharma, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Repaglinida Kern Pharma can have side effects, although not everybody gets them.

Frequent:affect 1 to 10 in every 100 patients

• Hypoglycemia (see the section If you have hypoglycemia). The risk of hypoglycemia may increase if you take other medications.
• Stomach pain.
• Diarrhea.

Rare:affect 1 to 10 in every 10,000 patients

• Acute coronary syndrome (but may not be due to the medication).

Very rare:affect less than 1 in every 10,000 patients

• Allergic reaction (such as swelling, difficulty breathing, palpitations, symptoms of dizziness, and sweating that can be symptoms of anaphylaxis). Consult your doctor immediately.
• Vomiting.
• Constipation.
• Visual disturbances.
• Severe liver problems, abnormal liver function, and increased liver enzymes in the blood.

Frequency not known:frequency cannot be estimated from available data

• Hypoglycemic coma or loss of consciousness (very severe hypoglycemic reactions, see the section If you have hypoglycemia). Contact your doctor immediately.
• Hypersensitivity (such as rash, itching, redness, and swelling).
• Nausea.

If you experience any serious side effectsor if you notice any side effects not mentioned in this leaflet, inform your doctor.

5. Storing Repaglinida Kern Pharma

Keep out of the reach and sight of children.

Do not use Repaglinida Kern Pharma after the expiration date stated on the carton and blister. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Further information

Composition of Repaglinida Kern Pharma

• The active ingredient is repaglinide. Each Repaglinida Kern Pharma 2 mg tablet contains 2 mg of repaglinide.
• The other ingredients are: microcrystalline cellulose (E460), calcium hydrogen phosphate, cornstarch, amberlite (potassium polacrylate), povidone K30 (polyvidone), glycerol 85%, magnesium stearate, meglumine, poloxamer, and red iron oxide (E172).

Appearance of the product and packaging contents

Repaglinida Kern Pharma 2 mg tablets are peach-colored, round, biconvex, and have a score line on one side. The tablets can be divided into two equal halves.

Repaglinida Kern Pharma is available in four blister pack presentations. Each pack contains 30, 90, 120, or 270 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

PharmaPath S.A.

1, 28 Octovriou str., Ag. Varvara, 12351 Athens

Greece

This leaflet was approved in April 2013.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.