REPAGLINIDE NORMON 1 mg TABLETS

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

Repaglinida 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 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 mellitusor maturity-onset diabetes). Repaglinida 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 loss alone have not been sufficient to control (or reduce) blood sugar levels. Repaglinida Normon can also be administered with metformin, another diabetes medication.

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

Do not take Repaglinida 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 cases apply to you, inform your doctor and do not take Repaglinida Normon.

Warnings and precautions

Consult your doctor before starting to take Repaglinida Normon

• If you have liver problems. Repaglinida Normon is not recommended for patients with moderate liver disease. Repaglinida Normon should not be taken if you have severe liver disease (see “Do not take Repaglinida Normon”).
• If you have kidney problems. Repaglinida 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, Repaglinida Normon is not recommended. It has not been studied in these age groups.

Consult your doctor if any of the above cases apply to you, Repaglinida 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 Repaglinida 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 Repaglinida Normon”).

The warning symptoms of hypoglycemia appear suddenly and can be: cold sweat, cold and pale skin, headache, palpitations, nausea, excessive hunger, 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 blood sugar levels stabilize, continue treatment with Repaglinida 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 Repaglinida Normon, 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 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 Repaglinida Normon, diet, or exercise.

Other medications and Repaglinida 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 Repaglinida Normon with metformin, another diabetes medication.

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

Your body's response to Repaglinida 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 (medication 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 Repaglinida Normon with food and drinks

Take Repaglinida Normon before main meals. Alcohol can alter the ability of Repaglinida Normon to lower 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 plan to become pregnant, consult your doctor before using this medication.

You should not take Repaglinida Normon if you are pregnant or plan to become pregnant.

You should not take Repaglinida 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 low or high. Be aware that you may be putting 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.

Repaglinida Normon contains sodium

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

3. How to take Repaglinida 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 Repaglinida Normon than your doctor has recommended. Always take Repaglinida Normon exactly as your doctor has told you. Consult your doctor if you are not sure.

If you take more Repaglinida 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Repaglinida 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 Repaglinida Normon

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everybody gets them.

Possible side effects:

Frequent (may affect up to 1 in 10 patients)

• 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 patients)

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

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

• Allergic reaction (such as swelling, difficulty breathing, palpitations, symptoms of dizziness, and sweating that can 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 through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Repaglinida Normon

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

This medication does not require special storage conditions.

Do not use this medication after the expiry date which is stated on the packaging after “EXP”. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medication to a pharmacy. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Repaglinida Normon

The active substance is repaglinide. Each tablet contains 1 mg of repaglinide.

The other ingredients are: cornstarch, microcrystalline cellulose, magnesium carbonate, macrogol 40 stearate, sodium croscarmellose, povidone, magnesium stearate, and yellow iron oxide (E-172).

Appearance of the product and pack contents:

Repaglinida Normon 1 mg tablets are yellow, 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

Repaglinida Normon 0.5 mg tablets EFG

Repaglinida 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 about this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/