Package Leaflet: Information for the User

Repaglinida Normon 1 mg Tablets EFG

repaglinida

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• 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 only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

3.How to take Repaglinida Normon

4.Possible side effects

5.Storage of Repaglinida Normon

6.Contents of the pack and additional information

Repaglinida Normonis an oral antidiabetic that contains repaglinide, which helps your pancreas to 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 asnon-insulin-dependent diabetes mellitusoronset diabetes in maturity). Repaglinida Normon 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 reduce) blood sugar levels. Repaglinida Normon can also be administered with metformin, another diabetes medication.

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

If any of these cases occur, 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 about to undergo a major surgical procedure or have recently had a serious illness or infection. In these circumstances, blood sugar control may not be achieved.
• If you are under 18 or over 75 years, Repaglinida Normon is not recommended. It has not been studied in these age groups.

Consult your doctor if any of the cases mentioned occur, Repaglinida Normon 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 Normon.
• You engage in more physical exercise than usual.
• You take other medicines or have kidney or liver problems (see other sections of section 2 “What you need to know before taking Repaglinida Normon”).

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

If your blood sugar level is low or if you feel that you are about to have a hypoglycemia: 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 assistance. Do not give you anything to eat or drink, as you may choke.

Severe hypoglycemia that is not treated can cause brain damage (temporary or permanent) and even death.

If hypoglycemia causes you to lose consciousness or if you experience repeated hypoglycemia, inform your doctor. You may need to adjust the amount or schedule of Repaglinida Normon, 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 Normon.
• If you have an infection or fever.
• If you eat more than usual.
• If you engage in less physical exercise than usual.

The warning signs appear gradually. These include: frequent urination, thirst, dry skin, and a sensation of dryness in the mouth. Inform your doctor. You may need to adjust the amount of Repaglinida Normon, diet, or exercise.

?Other medicines and Repaglinida Normon

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

If your doctor prescribes it, you can take Repaglinida Normon with metformin, another diabetes medicine.

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

Your body's response to Repaglinida Normon may change if you take other medicines, especially:

• Monamine oxidase inhibitors (MAOIs) (for the treatment of depression).
• Beta-blockers (for the treatment of high blood pressure or heart disease).
• Angiotensin-converting enzyme inhibitors (ACE inhibitors) (for the treatment of heart disease).
• Salicylates (e.g. aspirin).
• Octreotide (for the treatment of cancer).
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (a type of analgesic).
• Corticosteroids (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 (antibiotics).
• Itraconazole, ketoconazole (medicine for fungal infections).
• Gemfibrozil (to treat high blood fat levels).
• Ciclosporin (immunosuppressive treatment).
• Phenobarbital, phenytoin, carbamazepine (for the treatment of epilepsy).
• Deferasirox (to reduce chronic iron overload).
• St. John's Wort (herbal medicine).
• Clopidogrel (to prevent blood clot formation).

?Taking Repaglinida Normon with food and drinks

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

?Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medicine.

Do not take Repaglinida Normon if you are pregnant or planning to become pregnant.

Do not take Repaglinida Normon if you are breastfeeding.

?Driving and operating machinery:

Your ability to drive cars and operate machinery may be affected if your blood sugar level is low or 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 hypoglycemia.
• You have few or no symptoms of hypoglycemia or find it difficult to recognize them.

?Repaglinida Normon contains sodium

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

Follow exactly the medication administration instructions provided by your doctor. If in doubt, ask your doctor or pharmacist.

Your doctor will calculate your dose.

• Normally, the initial dose is 0.5 mg taken exactly before each main meal. The tablets should be taken with a glass of water just before or within 30 minutes before each main meal.
• Your doctor may adjust the dose up to 4 mg, which should be taken just before or within 30 minutes before each main meal. The maximum recommended daily dose is 16 mg.

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 unsure.

?If you take more Repaglinida Normon 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 section“If you have hypoglycemia”.

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

?If you forgot to take Repaglinida Normon

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

?Ifyou interrupt treatment with Repaglinida Normon

Be aware that the desired effect will not be achieved if you stop taking Repaglinida Normon. Your diabetes may worsen. If any changes to your treatment are necessary, consult your doctor beforehand.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Possible Adverse Effects:

Frequent (may affect up to 1 in 10 patients)

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

• 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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaRAM.es . By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging

and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofRepaglinide Normon

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

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

Appearance of the product and contents of the package:

Repaglinide Normon 1mg tablets are yellow, round, and printed tablets that are presented in packages of 90 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Laboratorios Normon, S.A.

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

Other presentations

Repaglinide Normon 0.5 mg tablets EFG

Repaglinide Normon 2 mg tablets EFG

Additional information for the patient

As a diabetic patient, it is important that you take the following advice into account:

Regular visits to the doctor:

Maintenance of health is important 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 meals well balanced that help control the amount of sugar in the blood. Your doctor and dietitian will establish a meal plan based on your individual needs. Foods rich in sugar are limited because they release sugar quickly and require large amounts of insulin to restore balance.

Meal planning should become an important 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.

• Take a bath every day. Use mild soap, warm water, and lotions to keep your skin soft.
• Protect your skin. Use gloves when work may cause damage or skin lesions. Use protective creams to prevent sunburns.
• Treat cuts quickly. Wash wounds with water and soap. Cover them with a sterile dry dressing. 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 serious problems.

Dental care:

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

Travel:

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

Last review date of this prospectus:January 2016

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/