REPAGLINIDE NORMON 0.5 mg TABLETS

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

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

Type 2 diabetes is a disease in which your pancreas does not produce enough insulin to control your blood sugar levels or in which your body does not respond normally to the insulin it produces (previously known as non-insulin-dependent diabetes mellitusor maturity-onset diabetes). Repaglinide Normon is used to control type 2 diabetes, as a supplement to diet and exercise: treatment should be started if diet, physical exercise, and weight reduction alone have not been sufficient to control (or reduce) your blood sugar levels. Repaglinide Normon can also be administered with metformin, another diabetes medication.

2. What you need to know before you take Repaglinide Normon

Do not take Repaglinide Normon

• If you are allergic to repaglinide or any of the other ingredients of this medicine (listed in section 6).
• 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 the above applies to you, inform your doctor and do not take Repaglinide Normon.

Warnings and precautions

Consult your doctor before starting to take Repaglinide Normon

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

Consult your doctor if any of the above applies to you, Repaglinide Normon 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 Repaglinide Normon.
• You do more physical exercise than usual.
• You take other medications or have kidney or liver problems (see other sections of section 2 “What you need to know before you take Repaglinide Normon”).

The warning symptoms of hypoglycemia appear suddenly and can be: cold sweat, cold and pale skin, headache, palpitations, nausea, excessive appetite, temporary visual disturbances, fatigue, unusual tiredness and weakness, nervousness or tremors, anxiety, confusion, and difficulty concentrating.

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

When the symptoms of hypoglycemia disappear or when your blood sugar levels stabilize, continue treatment with Repaglinide Normon.

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 attention. They should not give you anything to eat or drink, as you may choke.

If severe hypoglycemia is not treated, it can cause brain damage (temporary or permanent) and even death.

If you experience severe hypoglycemia or repeated hypoglycemic attacks, inform your doctor. You may need to adjust the dose or administration schedule of Repaglinide Normon, your 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 Repaglinide Normon.
• If you have an infection or fever.
• If you eat more than usual.
• If you do less exercise than usual.

The warning symptoms appear 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 Repaglinide Normon, your diet, or exercise.

Other medications and Repaglinide Normon

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

If your doctor prescribes it, you can take Repaglinide Normon with metformin, another diabetes medication.

If you are taking gemfibrozil (used to lower blood fat levels), you should not take Repaglinide Normon.

Your body's response to Repaglinide Normon 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).
• 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 (medications for fungal infections).
• Gemfibrozil (to treat high blood fat levels).
• Cyclosporin (immunosuppressive treatment).
• Phenytoin, carbamazepine, phenobarbital (for the treatment of epilepsy).
• Deferasirox (to reduce chronic iron overload).
• St. John's Wort (herbal medicinal plant).
• Clopidogrel (to prevent blood clots).

Taking Repaglinide Normon with food and drinks

Take Repaglinide Normon before main meals. Alcohol can alter Repaglinide Normon's ability to lower your blood sugar levels. Be aware of the symptoms of hypoglycemia.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

You should not take Repaglinide Normon if you are pregnant or planning to become pregnant.

You should not take Repaglinide Normon if you are breastfeeding.

Driving and using machines

Your ability to drive or operate machinery may be affected if your blood sugar levels are too low or too high. Be aware that you may put yourself or others at risk. Consult your doctor about the possibility of driving a car if:

• You have frequent hypoglycemic attacks.
• You have few or no symptoms of hypoglycemia or find it difficult to recognize them.

Repaglinide Normon contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

3. How to take Repaglinide Normon

Follow exactly the administration instructions of the medication indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

Your doctor will calculate your dose.

• Normally, the initial dose is 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 Repaglinide Normon than your doctor has recommended. Always take Repaglinide Normon exactly as your doctor has told you. Consult your doctor if you are not sure.

If you take more Repaglinide Normon 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”.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Repaglinide Normon

If you forget to take a dose, take the next dose as you normally would. Do not take a double dose to make up for forgotten doses.

If you stop taking Repaglinide Normon

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects:

Frequent (may affect up to 1 in 10 people)

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

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

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

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

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

Frequency not known

• 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.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Repaglinide Normon

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Repaglinide Normon:

The active substance is repaglinide. Each tablet contains 0.5 mg of repaglinide.

The other ingredients are: cornstarch, microcrystalline cellulose, magnesium carbonate, macrogol 40 stearate, sodium croscarmellose, povidone, and magnesium stearate.

Appearance of the product and pack contents:

Repaglinide Normon 0.5 mg tablets are white or almost white, round, and engraved tablets that come in packs of 90 tablets.

Marketing authorization holder and manufacturer:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Other presentations

Repaglinide Normon 1 mg tablets EFG

Repaglinide Normon 2 mg tablets EFG

Additional information for the patient

As a diabetic patient, it is essential to keep in mind the following tips:

Regular visits to the doctor:

Maintaining health is crucial in controlling your diabetes. With reasonable care, you can lead a normal active life. You should visit your doctor regularly.

Diet:

The diet used in the treatment of diabetes consists of regular, well-balanced meals that help control blood sugar levels. Your doctor and dietitian will establish a meal plan based on your individual needs. Foods high in sugar are limited because they release sugar quickly and require large amounts of insulin to restore balance.

Meal planning should become an essential part of your treatment. You should choose healthy foods, eat the right amount, and at the right times.

Exercise:

Exercise is especially important for diabetic patients.

Skin care:

You should pay special attention to personal hygiene due to the possibility of infections. High blood sugar levels and poor blood circulation can lead to skin problems.

• Shower daily. Use mild soap, warm water, and lotions to keep your skin soft.
• Protect your skin. Wear gloves when working may cause damage or injury to the skin. Use protective creams to prevent sunburn.
• Treat injuries promptly. Wash wounds with water and soap. Cover them with a dry, sterile bandage. Do not use strong antiseptics.
• Consult your doctor if cuts or bruises do not heal or become infected.

Do not smoke:

Both diabetes and nicotine can worsen blood circulation and cause more severe problems.

Dental care:

Dental care is essential for diabetics, as many infections originate in the mouth. Daily cleaning of teeth with toothpaste prevents tooth decay and gum infections. Visit your dentist regularly and inform them that you are diabetic.

Travel:

Time differences between countries may require you to inject insulin and eat at different times than usual. Therefore, you should consult your doctor if you plan to travel abroad.

Date of last revision of this leaflet:January 2016

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/