REPAGLINIDA 1 mg Tablets

Contents of the leaflet

1. Introduction
2. What is Repaglinida Kern Pharma and what is it used for
3. Before taking Repaglinida Kern Pharma
4. How to use Repaglinida Kern Pharma
5. Possible side effects
6. Storage of Repaglinida Kern Pharma
7. Additional information

Introduction

Patient Information Leaflet: INFORMATION FOR THE USER

Repaglinida Kern Pharma 1 mg tablets EFG

Read the entire leaflet carefully before starting to take the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

1. What is Repaglinida Kern Pharma and what is it used for
2. Before taking Repaglinida Kern Pharma
3. How to take Repaglinida Kern Pharma
4. Possible side effects
5. Storage of Repaglinida Kern Pharma
6. Additional information

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

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

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

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

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 medicine
• If you have type 1 diabetes(insulin-dependent diabetes)
• If your body's acid level has increased (diabetic ketoacidosis)
• If you have severe liver disease
• If you are taking gemfibrozil(a medication that lowers blood fat levels).

If any of the above cases apply to you, inform 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 the above cases apply to you, Repaglinida Kern Pharma may not be suitable for you. Your doctor will advise you.

If you have hypoglycemia

You may suffer from hypoglycemia (low blood sugar symptom) if your blood sugar level is too low. This can happen if:

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

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

If your blood sugar level is low or if you feel you are going 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 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 (transient or permanent) and even death.
• If you have 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 level is very high

Your blood sugar level 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 do less exercise than usual.

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

Use of other medications

If your doctor prescribes it, you can take Repaglinida Kern Pharma along 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 the treatment of depression).
• Beta-blockers (for the treatment of high blood pressure or heart disease).
• Angiotensin-converting enzyme (ACE) inhibitors (for the treatment of heart disease).
• Salicylates (e.g., aspirin).
• Octreotide (for the treatment of cancer).
• 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 the treatment of breast cysts and endometriosis).
• Thyroid products (for the treatment of low thyroid hormone levels).
• Sympathomimetics (for the treatment of asthma).
• Clarithromycin, trimethoprim, rifampicin (antibiotic medications).
• Itraconazole, ketoconazole (medication for fungal infections).
• Gemfibrozil (to treat high blood fat levels).
• Cyclosporin (to suppress the immune system).
• Phenytoin, carbamazepine, phenobarbital (for the treatment of epilepsy).
• St. John's Wort (herbal medicinal plant).
• Clopidogrel (to prevent blood clots).

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

Use of Repaglinida Kern Pharma with food and drinks

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

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 ability to concentrate and react may be impaired due to the symptoms of hypoglycemia or hyperglycemia, such as vision problems. 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 use 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 can 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 level 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 change in your treatment is necessary, consult your doctor first.

If you have any other doubts about 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 everyone gets them.

Possible side effects

Frequent:affect between 1 and 10 out of 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 between 1 and 10 out of 10,000 patients

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

Very rare: affect less than 1 in 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.
• Serious liver problems, abnormal liver function, and increased liver enzymes in the blood.

Frequency unknown:the frequency cannot be estimated from the 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 consider that any of the side effects you are suffering from is seriousor if you notice any side effect not mentioned in this leaflet, inform your doctor.

5. Storage of 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 through wastewater or household waste. Deposit the containers and medications you no longer need in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of Repaglinida Kern Pharma

• The active ingredient is repaglinide. Each Repaglinida Kern Pharma 1 mg tablet contains 1 mg of repaglinide.
• The other ingredients are: microcrystalline cellulose (E460), calcium hydrogen phosphate, cornstarch, amberlite (potassium polacrylate), povidone K30 (povidone), glycerol 85%, magnesium stearate, meglumine, poloxamer, and yellow iron oxide (E172).

Appearance of the product and packaging contents

Repaglinida Kern Pharma 1 mg tablets are yellow, 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

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/.