PATIENT INFORMATION LEAFLET

Repaglinide Kern Pharma 2 mg Tablets

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can report it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

1.What Repaglinide Kern Pharma is and what it is used for

2.Before taking Repaglinide Kern Pharma

3.How to take Repaglinide Kern Pharma

4.Possible side effects

5.Storage of Repaglinide Kern Pharma

6.Further information

Repaglinida Kern Pharma is an oral antidiabetic that contains repaglinide, which helps your pancreas to produce more insulin and lower your blood sugar (glucose).

Thetype 2 diabetesis a disease in which the pancreas does not produce enough insulin to control the level of sugar in the blood or in which the body does not respond normally to the insulin it produces (previously known as non-insulin dependent diabetes or maturity-onset diabetes).

Repaglinida Kern Pharma is used to control type 2 diabetes, as a complement to diet and exercise: treatment should be initiated if diet, physical exercise, and weight reduction alone have not been sufficient to control (or decrease) the level of sugar in the blood. Repaglinida Kern Pharma can also be administered with metformin, another diabetes medication.

Do not take Repaglinida Kern Pharma

• If you areallergicto repaglinide or any of the other components of the medication
• If you havetype 1 diabetes(insulin-dependent diabetes)
• If your body has an increased level of acid (diabetic ketoacidosis)
• If you havesevere liver disease
• If you takegemfibrozil(a medication that lowers blood lipid levels).

If any of the above cases occur, inform your doctor and do not take Repaglinida Kern Pharma.

Be especially careful with Repaglinida Kern Pharma

• If you haveliver 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 (seeDo not take Repaglinida Kern Pharma).
• If you havekidney problems. Repaglinida Kern Pharma should be taken with caution.
• If you are about to undergomajor surgeryor have recently had anillnessorinfection. In these circumstances, blood sugar control may not be achieved.
• If you areunder 18orover 75 years old, Repaglinida Kern Pharma is not recommended. It has not been studied in these age groups.

Consult your doctor ifany of the above cases occur, Repaglinida Kern Pharma may not be indicated for you. Your doctor will advise you.

If you have hypoglycemia

You may experience hypoglycemia (symptoms of low blood sugar) if your blood sugar level is too low. This can occur if:

• You take too much Repaglinida Kern Pharma
• You engage in excessive physical exercise
• You take other medications or have kidney or liver problems (see other sections of the2. Before taking Repaglinida Kern Pharmasection).

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

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

When the symptoms of hypoglycemia disappear or when blood sugar levels stabilizecontinue treatment with Repaglinida Kern Pharma.

Inform others that you are diabetic and that if you lose consciousness due to hypoglycemia, they should lay you on your side and seek immediate medical assistance. Do not give you anything to eat or drink, as you may choke.

• Severe hypoglycemiaif not treated can cause brain damage (temporary or permanent) and even death.
• Recurring hypoglycemiacan cause loss of consciousness or repeated episodes. Inform your doctor. Your doctor may need to adjust the amount or schedule of Repaglinida Kern Pharma, diet, or exercise.

If your blood sugar level is very high

Your blood sugar level may be very high (hyperglycemia). This can occur:

• 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 physical activity than usual.

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

Use of other medications

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

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

• Monamine oxidase inhibitors (MAOIs) (for depression treatment).
• Beta-blockers (for hypertension or heart disease treatment).
• Angiotensin-converting enzyme inhibitors (ACE inhibitors) (for heart disease treatment).
• Salicylates (e.g., aspirin).
• Octreotide (for cancer treatment).
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (a type of analgesic).
• Corticosteroids (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 cyst treatment and endometriosis).
• Thyroid products (for low thyroid hormone levels).
• Sympathomimetics (for asthma treatment).
• Clarithromycin, trimethoprim, rifampicin (antibiotics).
• Itraconazole, ketoconazole (antifungal medications).
• Gemfibrozil (to treat high blood lipid levels).
• Cyclosporine (to suppress the immune system).
• Phenytoin, carbamazepine, phenobarbital (for epilepsy treatment).
• St. John's Wort (herbal medicine).
• Clopidogrel (to prevent blood clot formation).

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

Use of Repaglinida Kern Pharma with food and beverages

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

Pregnancy and breastfeeding

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

You should not take Repaglinida Kern Pharma if you are breastfeeding.

Driving and operating machinery

Your ability to concentrate and react may be affected due to symptoms caused by hypoglycemia or hyperglycemia, such as visual disturbances. This can be hazardous in situations where these skills are essential (e.g., driving or operating machinery). Consult your doctor if it is recommended to drive or operate machinery.

Your doctor will calculate your dose.

• Normally theinitial doseis 0.5 mg taken exactly before each main meal. The tablets must be taken with a glass of water just before or within 30 minutes before each main meal.
• Your dose may be adjusted by your doctor up to 4 mg, which must 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 may become too low and cause hypoglycemia. Please read what hypoglycemia is and how to treat it in the sectionIf 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 do, never take a double dose.

If you stop taking Repaglinida Kern Pharma

Be aware that the desired effect will not be achieved if you stop taking Repaglinida Kern Pharma. Your diabetes may worsen. If any change in your treatment is necessary, consult your doctor beforehand.

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

Like all medications, Repaglinida Kern Pharma may have adverse effects, although not all people will experience them.

Frequent:Affect between 1 and 10 of every 100 patients

• Hypoglycemia (see the sectionIf you have hypoglycemia). The risk of experiencing hypoglycemia may increase if you take other medications.
• Abdominal pain.
• Diarrhea.

Rare:Affect between 1 and 10 of every 10,000 patients

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

Very Rare:Affect less than 1 of every 10,000 patients

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

Unknown Frequency:The frequency cannot be estimated from available data

• Coma or loss of consciousness due to hypoglycemia (very severe hypoglycemic reactions, see the sectionIf you have hypoglycemia). Contact your doctor immediately.
• Hypersensitivity (such as hives, itching, redness, and swelling).
• Nausea.

If you consider that anyof the adverse effects you experience is severeor if you notice any adverse effect not mentioned in this prospectus, inform your doctor.

Keep out of the reach and sight of children.

Do not use Repaglinida Kern Pharma after the expiration date that appears on the packaging and in the blister pack. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and unused medicines.By doing so, you will help protect the environment.

Composition of Repaglinida Kern Pharma

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

Appearance of the product and contents of the package

Repaglinida Kern Pharma 2 mg tablets are orange in color, round, biconvex, and have a partition mark on one face. The tablets can be divided into two equal halves.

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa – Barcelona

Spain

Responsible for manufacturing

PharmaPath S.A.

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

Greece

This leaflet was approved in April 2013.

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/.