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

1. What Repaglinida Teva is and what it is 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 your pancreas does not produce enough insulin to control your blood sugar levels or in which your 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 started if diet, physical exercise, and weight reduction alone have not been sufficient to control (or lower) your blood sugar levels. Repaglinida Teva can also be given with metformin, another medicine for diabetes.

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

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 used to lower blood fat levels).

Warnings and precautions

Consult your doctor before starting to take 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 have a major surgical operationor have recently suffered a serious illness or infection. In these circumstances, you may not achieve diabetic control.
• 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 applies 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 low blood sugar (hypoglycaemia)

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

• If you take too much Repaglinida Teva.
• If you do more physical exercise than usual.
• If 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; fast heartbeat; nausea; excessive hunger; temporary visual disturbances; fatigue; unusual weakness and tiredness; nervousness or tremor; anxiety; confusion and difficulty concentrating.

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

When the symptoms of hypoglycaemia have disappeared or when your blood sugar levels have stabilised, continue treatment with Repaglinida Teva.

Tell others that you are diabeticand if you lose consciousnessdue to hypoglycaemia, they should lay you on your side and seek immediate medical assistance. 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 a hypoglycaemic attackthat makes you lose consciousness or if you have repeated hypoglycaemic attacks, 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 very 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 sugar levelsappear 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 Teva, your diet, or exercise.

Other medicines and Repaglinida Teva

Tell 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 medicine for diabetes.

If you are taking 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 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 anaemia 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 (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 medicinal plant).

Using Repaglinida Teva with alcohol

Alcohol may alter the ability of Repaglinida Teva to lower your blood sugar levels. Be aware of the warning signs of hypoglycaemia.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking 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 breast-feeding.

Driving and using machines

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

• you have frequent hypoglycaemic attacks.
• you have few or no symptoms of hypoglycaemia or find it difficult to recognise them.

3. How to take Repaglinida Teva

Take this medicine exactly as your doctor has told you. If you are not sure, ask 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 you may have a hypoglycaemic attack. Please read what a hypoglycaemic attack is and how to treat it in the section If you have low blood sugar (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 get worse. If any change in your treatment is necessary, consult your doctor first.

If you have any further questions on the use of this product, 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 low blood sugar (hypoglycaemia)in section 2). Hypoglycaemic reactions are usually mild or moderate but can occasionally lead to loss of consciousness or hypoglycaemic coma. If this happens, you need immediate medical assistance.

Allergic reactions

Cases of allergic reactions are very rare (may affect up to 1 in 10,000 patients). Symptoms such as swelling, difficulty breathing, fast heartbeat, dizziness, 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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. Storing 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. These measures 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 0.5 mg tablets), yellow iron oxide (E172) (only in 1 mg tablets), and red iron oxide (E172) (only in 2 mg tablets)

Product Appearance and Package Contents

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.

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.

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 package sizes of 30, 90, 120, 270, and 360 tablets.

Only some package 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

You can request more information about this medicinal product by contacting 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