REPAGLINIDE TEVA 0.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Repaglinida Teva 0.5mg tablets EFGRepaglinida Teva 1mg tablets EFGRepaglinida Teva 2mg tablets EFGrepaglinida

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Type 2 diabetesis 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.

Repaglinida Teva is used to control type 2 diabetes in adults, as a supplement 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 Teva may also be administered with metformin, another diabetes medication.

It has been shown that repaglinide reduces blood sugar levels, which helps prevent diabetes complications.

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

Do not take Repaglinida Teva

• If you are allergicto repaglinide or any of the other ingredients of this medicine (listed in section 6).
• If you have type 1 diabetes.
• If your blood acid levels have increased (diabetic ketoacidosis).
• If you have severe liver disease.
• If you are taking gemfibrozil(a medicine that lowers blood fat levels).

Warnings and precautions

Consult your doctor before taking Repaglinida Teva:

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

Consult your doctor ifany of the above cases apply to you, Repaglinida Teva 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 old.

If you have hypoglycaemia (low blood sugar)

You may experience hypoglycaemia if your blood sugar levels are too low. This can happen if:

• You take too much Repaglinida Teva.
• You do 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 you take Repaglinida Teva).

Warning signs of hypoglycaemiaappear suddenly and can be: cold sweat; cool, pale skin; headache; palpitations; nausea; excessive hunger; temporary visual disturbances; fatigue; unusual weakness and tiredness; nervousness or tremors; anxiety; confusion and difficulty concentrating.

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

When hypoglycaemia symptoms disappear or when blood sugar levelsstabilizecontinue treatment with Repaglinida Teva.

Inform others that you are diabeticand if you lose consciousnessdue to hypoglycaemia, 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 hypoglycaemiais not treated, it can cause brain damage (temporary or permanent) and even death.
• If you have hypoglycaemiathat makes you lose consciousness or if you suffer from repeated hypoglycaemias, inform your doctor. You may need to adjust the dose or administration schedule of Repaglinida Teva, your diet, or exercise.

If your blood sugar levels are too high

Your blood sugar levels may be too high (hyperglycaemia). This can happen:

• If you take too little Repaglinida Teva.
• If you have an infection or fever.
• If you eat more than usual.
• If you do less exercise than usual.

Warning signs of high blood sugarappear gradually. These include: excessive urination, thirst, dry skin, and a dry mouth feeling. Inform your doctor. You may need to adjust the dose of Repaglinida, your diet, or exercise.

Other medicines and Repaglinida Teva

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

If your doctor prescribes it, you can take Repaglinida Teva with metformin, another diabetes medication.

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

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

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

Using Repaglinida Teva with alcohol

Alcohol may alter Repaglinida Teva's ability to lower blood sugar levels. Be aware of hypoglycaemia symptoms.

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 medicine.

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

You should not take Repaglinida Teva if you are breastfeeding.

Driving and using machines

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

• you have frequent hypoglycaemias.
• you have few or no symptoms of hypoglycaemia or find it difficult to recognize them.

3. How to take Repaglinida Teva

Follow the administration instructions of this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor again.

Your doctor will calculate your dose.

• Normally, the initial doseis 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 Teva than your doctor has recommended.

If you take more Repaglinida Teva than you should

If you take too many tablets, your blood sugar levels may become too low and cause hypoglycaemia. Please read what hypoglycaemia is and how to treat it in the section If you have hypoglycaemia.

If you forget to take Repaglinida Teva

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 the forgotten doses.

If you stop taking Repaglinida Teva

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

If you have any further questions on 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 can affect up to 1 in 10 patients (see If you have hypoglycaemiain section 2). Hypoglycaemic reactions are normally mild or moderate but can occasionally lead to loss of consciousness or hypoglycaemic coma. If this happens, you need immediate medical attention.

Allergic reactions

Cases of allergy are very rare (may affect up to 1 in 10,000 patients). Symptoms such as swelling, difficulty breathing, palpitations, dizziness symptoms, 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 may not be due to the medicine).

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

• Vomiting
• Constipation
• Visual disturbances
• Severe liver problems, abnormal liver function such as increased liver enzymes in the blood.

Frequency not known

• 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, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Repaglinida Teva

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

Store in the original package to protect from light.

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

6. Package Contents and Additional Information

Composition of Repaglinida Teva

• The active ingredient is repaglinide.

Each Repaglinida Teva 0.5 mg tablet contains 0.5 mg of repaglinide.

Each Repaglinida Teva 1 mg tablet contains 1 mg of repaglinide.

Each Repaglinida Teva 2 mg tablet contains 2 mg of repaglinide.

• The other ingredients are: microcrystalline cellulose (E460), meglumine, poloxamer 188, povidone K-30, calcium hydrogen phosphate, colloidal anhydrous silica dioxide, potassium polacrylate, corn starch, magnesium stearate, aluminum carmine (E132) (only in the 0.5 mg tablets), yellow iron oxide (E172) (only in the 1 mg tablets) and red iron oxide (E172) (only in the 2 mg tablets)

Appearance of the Product and Package Contents

The Repaglinida Teva 0.5 mg tablets are light blue/blue, capsule-shaped, engraved with "93" on one side and "210" on the other side of the tablet.

The Repaglinida Teva 1 mg tablets are yellow/light yellow, capsule-shaped, engraved with "93" on one side and "211" on the other side of the tablet.

The Repaglinida Teva 2 mg tablets are peach, speckled, capsule-shaped, engraved with "93" on one side and "212" on the other side of the tablet.

Repaglinida Teva is available in pack sizes of 30, 90, 120, 270 and 360 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder:

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer:

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13.

Debrecen H-4042

Hungary

Teva Pharmaceuticals Works Private Limited Company

H-2100 Gödöllő,

Táncsics Mihály út 82

Hungary

Teva UK Ltd

Brampton Road

Hampden Park

Eastbourne,

East Sussex

BN22 9AG,

United Kingdom

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

GALIEN LPS

98 rue Bellocier

89100 Sens

France

Merckle GmbH

Ludwig-Merckle-Straße 3,

89143 Blaubeuren-Weiler

Germany

TEVA PHARMA S.L.U

C/ C, n° 4, Polígono Industrial Malpica,

50016 Zaragoza

Spain

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

This leaflet was approved on

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu