Repaglinide Normon 0.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Repaglinide Normon 0.5 mg tablets EFG

repaglinide

Read this entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Repaglinide Normon is and what it is used for
2. What you need to know before taking Repaglinide Normon
3. How to take Repaglinide Normon
4. Possible adverse effects
5. How to store Repaglinide Normon
6. Contents of the pack and other information

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

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

Type 2 diabetes is a condition 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). Repaglinide Normon is used to manage type 2 diabetes as an adjunct to diet and exercise: treatment should be initiated when diet, physical exercise, and weight reduction alone have not been sufficient to control (or lower) blood sugar levels. Repaglinide Normon may also be given in combination with metformin, another antidiabetic medicine.

2. What you need to know before taking Repaglinide Normon

? Do not take Repaglinide Normon

• If you are allergic to repaglinide or to any of the other components of this medicine (listed in section 6).
• If you have type 1 diabetes (insulin-dependent diabetes).
• If the level of acid in your body has increased (diabetic ketoacidosis).
• If you have severe liver disease.
• If you are taking gemfibrozil (a medicine that lowers fat levels in the blood).

If any of the above apply to you, inform your doctor and do not take Repaglinide Normon.

? Warnings and precautions

Talk to 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 used with caution.
• If you are undergoing major surgery or have recently had a serious illness or infection. In these circumstances, diabetic control may not be achieved.
• If you are under 18 or over 75 years of age, Repaglinide Normon is not recommended. It has not been studied in these age groups.

Talk to your doctor if any of the above apply to you, as Repaglinide Normon may not be suitable for you. Your doctor will advise you.

If you experience hypoglycaemia:

You may experience hypoglycaemia (a symptom of low blood sugar) if your blood sugar level becomes too low. This may happen if:

• You take too much Repaglinide Normon.
• You exercise more than usual.
• You take other medicines or have kidney or liver problems (see other sections in section 2 “What you need to know before taking Repaglinide Normon”).

Warning symptoms of hypoglycaemia appear suddenly and may include: cold sweat, cold and pale skin, headache, palpitations, nausea, excessive hunger, temporary visual disturbances, fatigue, unusual tiredness and weakness, nervousness or trembling, anxiety, confusion, and difficulty concentrating.

If your blood sugar level is low or if you feel a hypoglycaemic episode coming on: take glucose tablets or a sugary drink or food, and then rest.

Once the symptoms of hypoglycaemia have subsided or when your blood sugar levels have stabilized, continue your treatment with Repaglinide Normon.

Inform others that you are diabetic and that if you lose consciousness due to hypoglycaemia, they should lay you on your side and seek immediate medical help. They should not give you anything to eat or drink, as you could choke.

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

If a hypoglycaemic episode causes you to lose consciousness or if you experience repeated hypoglycaemic episodes, inform your doctor. Your doctor may need to adjust your dose or dosing schedule of Repaglinide Normon, your diet, or your physical activity.

If your blood sugar level is very high:

Your blood sugar level may become very high (hyperglycaemia). This may happen:

• If you take too little Repaglinide Normon.
• If you have an infection or fever.
• If you eat more than usual.
• If you exercise less than usual.

Warning symptoms develop gradually and include: frequent urination, thirst, dry skin, and dry mouth. Inform your doctor. Your doctor may need to adjust your dose of Repaglinide Normon, your diet, or your physical activity.

? Other medicines and Repaglinide Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If prescribed by your doctor, you may take Repaglinide Normon together with metformin, another medicine for diabetes.

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 medicines, especially:

• Monoamine oxidase inhibitors (MAOIs) (for treatment of depression).
• Beta-blockers (for treatment of high blood pressure or heart conditions).
• ACE inhibitors (for treatment of heart conditions).
• Salicylates (e.g. aspirin).
• Octreotide (for treatment of cancer).
• Non-steroidal anti-inflammatory drugs (NSAIDs) (a type of painkiller).
• Steroids (anabolic steroids and corticosteroids, for anaemia or to treat inflammation).
• Oral contraceptives (to prevent pregnancy).
• Thiazides (diuretics).
• Danazol (for treatment of breast cysts and endometriosis).
• Thyroid products (for treatment of low thyroid hormone levels).
• Sympathomimetics (for treatment of asthma).
• Clarithromycin, trimethoprim, rifampicin (antibiotic medicines).
• Itraconazole, ketoconazole (medicines for fungal infections).
• Gemfibrozil (to treat high blood fat levels).
• Cyclosporine (immunosuppressive treatment).
• Phenytoin, carbamazepine, phenobarbital (for treatment of epilepsy).
• Deferasirox (to reduce chronic iron overload).
• St. John’s wort (herbal remedy).
• Clopidogrel (to prevent blood clots).

? Taking Repaglinide Normon with food and drinks

Take Repaglinide Normon before main meals. Alcohol may interfere with Repaglinide Normon’s ability to lower blood sugar. Be alert for symptoms of hypoglycaemia.

? Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

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

You must 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 level is too low or too high. Be aware that you could be putting yourself or others at risk. Consult your doctor about whether you can drive if:

• You have frequent hypoglycaemic episodes.
• You have few or no symptoms of hypoglycaemia or find it difficult to recognize them.

?Repaglinide Normon contains sodium

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

3. How to take Repaglinide Normon

Follow exactly the dosing instructions provided by your doctor. If you are unsure, ask your doctor or pharmacist.

Your doctor will determine your dose.

• The usual starting 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 the 30 minutes before each main meal.
• Your doctor may adjust your dose up to 4 mg, which should be taken just before or within the 30 minutes before each main meal. The maximum recommended daily dose is 16 mg.

Do not take more repaglinide than your doctor has prescribed. Always take Repaglinide Normon exactly as your doctor has instructed. Consult your doctor if you are unsure.

?If you take more Repaglinide Normon than you should

If you take too many tablets, your blood sugar may become too low, causing hypoglycemia. Please read about what hypoglycemia is and how to treat it in the section “If you have hypoglycemia”.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

?If you forget to take Repaglinide Normon

If you miss a dose, take the next dose as you normally would. Do not take a double dose to make up for a missed dose.

?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 needed, consult your doctor first.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Possible adverse effects:

Frequent (may affect up to 1 in 10 patients)

• Hypoglycaemia (see section “If you have a hypoglycaemia”). The risk of experiencing hypoglycaemia may increase if you take other medicines.
• Stomach pain.
• Diarrhoea.

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

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

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

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

Frequency not known

• Hypoglycaemic coma or loss of consciousness (very severe hypoglycaemic reactions, see section “If you have a hypoglycaemia”). Contact your doctor immediately.
• Hypersensitivity (such as rash, itching, redness, and swelling).
• Nausea.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse 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 stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This 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 components are: maize starch, microcrystalline cellulose, magnesium carbonate, macrogol 40 stearate, sodium croscarmellose, povidone, and magnesium stearate.

Appearance of the product and contents of the pack:

Repaglinide Normon 0.5 mg tablets are white or almost white, round tablets, film-coated and printed. They are available 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 important that you keep the following advice in mind:

Regular visits to the doctor:

Maintaining good health is essential in managing your diabetes. With proper 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 rapidly release sugar into the bloodstream, requiring 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 amounts, and eat at the right times.

Exercise:

Exercise is especially important for the diabetic patient.

Skin care:

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

• Shower daily. Use mild soap, lukewarm water, and moisturizing lotions to keep your skin soft.
• Protect your skin. Wear gloves when performing tasks that could cause skin damage or injury. Use protective creams to prevent sunburn.
• Treat injuries promptly. Wash wounds with water and soap. Cover them with a dry, sterile 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 impair blood circulation and lead to more serious complications.

Dental care:

Dental care is important for people with diabetes, as many infections originate in the mouth. Daily tooth cleaning with toothpaste helps prevent tooth decay and gum infections. Visit your dentist regularly and inform them that you have diabetes.

Travel:

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

Date of the most recent revision of this leaflet: January 2016

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