Repaglinide Sandoz 1 mg tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Repaglinide Sandoz 0.5 mg Tablets EFG

Repaglinide Sandoz 1 mg Tablets EFG

Repaglinide Sandoz 2 mg Tablets EFG

Read the entire leaflet carefully before starting to take 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Repaglinide Sandoz is an oral antidiabetic medicine that contains 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.

Repaglinide is used to control type 2 diabetes in adults, as an addition to diet and exercise. Treatment should be started when diet, physical exercise, and weight reduction alone have not been sufficient to control (or lower) blood sugar levels.

Repaglinide may also be given together with metformin, another diabetes medicine.

Repaglinide has been shown to reduce blood sugar levels, thereby helping to prevent diabetes-related complications.

2. What you need to know before taking Repaglinide Sandoz

Do not take Repaglinide Sandoz

• if you are allergic to repaglinide or to any of the other ingredients of this medicine (listed in section 6),
• if you have type 1 diabetes,
• if the level of acid in your blood has increased (diabetic ketoacidosis),
• if you have severe liver disease,
• if you are taking gemfibrozil (a medicine that lowers lipid levels in the blood).

Warnings and precautions

Talk to your doctor before starting to take repaglinide.

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

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

Children and adolescents

Do not take this medicine if you are under 18 years of age.

If you experience hypoglycemia (low blood sugar)

You may experience hypoglycemia if your blood sugar level becomes too low. This may happen if:

• you take too much repaglinide,
• you exercise more 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 Repaglinide Sandoz").

Warning symptoms of hypoglycemia 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 is low or if you feel a hypoglycemia coming on: take glucose tablets or a sugary drink or food, and then rest.

Once the symptoms of hypoglycemia have subsided or when your blood sugar levels have stabilized, continue your treatment with repaglinide.

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 help. They should not give you anything to eat or drink. You could choke.

• If severe hypoglycemia is not treated, it may cause brain damage (temporary or permanent) and even death.
• If you lose consciousness due to hypoglycemia or if you experience repeated episodes of hypoglycemia, inform your doctor. You may need to adjust your dose or dosing schedule of repaglinide, your diet, or your physical activity.

If your blood sugar level is very high

Your blood sugar level may become very high (hyperglycemia). This may occur:

• if you take too little repaglinide,
• if you have an infection or fever,
• if you eat more than usual,
• if you exercise less than usual.

Warning symptoms of high blood sugar appear gradually. These include: frequent urination, thirst, dry skin, and dry mouth. Inform your doctor. You may need to adjust your dose of repaglinide, your diet, or your physical activity.

Taking Repaglinide Sandoz with other medicines

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 together with metformin, another medicine for diabetes.

If you are taking gemfibrozil (used to lower lipid levels in the blood), you should not take repaglinide.

Your body's response to repaglinide may change if you take other medicines, especially the following:

• monoamine oxidase inhibitors (MAOIs) (used to treat depression),
• beta-blockers (for the treatment of high blood pressure or heart conditions),
• angiotensin-converting enzyme inhibitors (ACE inhibitors) (for the treatment of heart conditions),
• salicylates (e.g. aspirin),
• octreotide (for cancer treatment),
• non-steroidal anti-inflammatory drugs (NSAIDs) (a type of painkiller),
• 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 (antibiotics),
• itraconazole, ketoconazole (medicines for fungal infections),
• gemfibrozil (to treat high cholesterol and triglyceride levels in the blood),
• cyclosporine (to suppress the immune system),
• deferasirox (to reduce chronic iron overload),
• clopidogrel (to prevent blood clots),
• phenytoin, carbamazepine, phenobarbital (for the treatment of epilepsy),
• St. John's wort (herbal remedy).

Taking Repaglinide Sandoz with alcohol

Alcohol may alter the ability of repaglinide to lower blood sugar. Remain alert for 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 or pharmacist before using this medicine.

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

You should not take repaglinide during breastfeeding.

Driving and using machines

Your ability to drive and use machines may be affected if your blood sugar level is too low or too high. Be aware that you could put yourself and others at risk. Consult your doctor about whether you can drive a car if:

• you have frequent hypoglycemic episodes,
• you have few or no symptoms of hypoglycemia.

3. How to take Repaglinide Sandoz

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Do not take more repaglinide than recommended by your doctor.

If you take more Repaglinide Sandoz than you should

If you take too many tablets, your blood sugar level 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: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Repaglinide Sandoz

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 missed doses.

If you stop taking Repaglinide Sandoz

Please note that the desired effect will not be achieved if you stop taking repaglinide. 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 side effects

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

Hypoglycaemia

The most common side effect is hypoglycaemia, which may affect up to 1 in 10 patients (see “If you have hypoglycaemia” in section 2). Hypoglycaemic reactions are usually mild or moderate, but occasionally they may lead to loss of consciousness or hypoglycaemic coma. If this occurs, immediate medical assistance is required.

Allergy

Cases of allergic reactions are very rare (may affect up to 1 in 10,000 patients). Symptoms such as swelling, difficulty breathing, palpitations, dizziness and sweating may be signs of an anaphylactic reaction. Contact your doctor immediately.

Other side effects

Common (may affect up to 1 in 10 patients):

• 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):

• vomiting,
• constipation,
• visual disturbances,
• serious liver problems, abnormal liver function and increased liver enzymes in blood.

Frequency not known (cannot be estimated from available data):

• hypersensitivity (such as skin rash, itching, redness, skin swelling),
• feeling unwell (nausea).

Reporting of side effects

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Repaglinide Sandoz

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

This medicine does not require any special storage conditions.

Expiry after opening the bottles: 6 months.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Repaglinide Sandoz

Repaglinide Sandoz 0.5 mg

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

The other components are: glycerol 85%, meglumine, maize starch, anhydrous calcium hydrogen phosphate, hydroxypropylcellulose, poloxamer 188, anhydrous colloidal silica, magnesium stearate, potassium polacrilin and microcrystalline cellulose.

Repaglinide Sandoz 1 mg

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

The other components are: glycerol 85%, meglumine, maize starch, anhydrous calcium hydrogen phosphate, hydroxypropylcellulose, poloxamer 188, anhydrous colloidal silica, magnesium stearate, potassium polacrilin, microcrystalline cellulose and yellow iron oxide (E172).

Repaglinide Sandoz 2 mg

The active substance is repaglinide. Each tablet contains 2 mg of repaglinide.

The other components are: glycerol 85%, meglumine, maize starch, anhydrous calcium hydrogen phosphate, hydroxypropylcellulose, poloxamer 188, anhydrous colloidal silica, magnesium stearate, potassium polacrilin, microcrystalline cellulose and red iron oxide (E172).

Appearance of the product and contents of the pack

Repaglinide Sandoz 0.5 mg are white, round tablets.

Repaglinide Sandoz 1 mg are yellowish speckled, round tablets with a score line.

Repaglinide Sandoz 2 mg are pale red, slightly speckled, round tablets with a score line.

Packaged in blisters containing 30, 60, 90, 120 or 270 tablets and in HDPE bottles containing 30, 60, 90 or 250 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

c/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH Otto-von-Guericke-Allee 1, 39179 Barleben Germany

or

Lek Pharmaceuticals d.d. Verovškova 57, 1526 Ljubljana Slovenia

or

LEK S.A. Ul. Domaniewska 50 C, 02-672 Warszawa

Poland

or

Salutas Pharma GmbH

Dieselstrasse 5, 70839 Gerlingen

Germany

or

Sandoz S.R.L.

Str. Livezeni nr. 7A, 540472 Targu-Mures

Romania

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany
Repaglinid Sandoz 0.5 mg Tablets
Repaglinid Sandoz 1 mg Tablets
Repaglinid Sandoz 2 mg Tablets

Austria
Repaglinid Sandoz 0.5 mg – Tablets
Repaglinid Sandoz 1 mg – Tablets
Repaglinid Sandoz 2 mg – Tablets

Belgium
Repaglinide Sandoz 0.5 mg tablets
Repaglinide Sandoz 1 mg tablets
Repaglinide Sandoz 2 mg tablets

France
REPAGLINIDE SANDOZ 0.5 mg, tablet
REPAGLINIDE SANDOZ 1 mg, tablet
REPAGLINIDE SANDOZ 2 mg, tablet

Italy
REPAGLINIDE SANDOZ 0.5 mg tablets
REPAGLINIDE SANDOZ 1 mg tablets
REPAGLINIDE SANDOZ 2 mg tablets

Sweden
Repaglinid Sandoz 0.5 mg tablets
Repaglinid Sandoz 1 mg tablets
Repaglinid Sandoz 2 mg tablets

Date of the most recent review of this leaflet: December 2016

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/