REPAGLINIDE TEVA

Package leaflet: Information for the user

Repaglinide Teva 0.5 mg tablets, 1 mg tablets, 2 mg tablets

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

• Keep this leaflet. 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Repaglinide Teva is an oral antidiabetic medicine containing repaglinide that helps the pancreas
produce a greater amount of insulin and, thus, reduces the level of sugar (glucose) in the
blood.
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 Teva is used to control type 2 diabetes in adults, in addition to diet and
physical exercise; treatment is usually started when diet, physical activity, and weight reduction alone are not sufficient to control (or reduce) blood glucose levels.
Repaglinide Teva may also be given in combination with metformin, another antidiabetic medicine.
Repaglinide has been shown to reduce blood sugar levels, thereby helping to prevent diabetes complications.

2. What you need to know before taking Repaglinide Teva

Do not take Repaglinide Teva

• 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 your blood acid level is high ( diabetic ketoacidosis )
• if you have severe liver disease
• if you are taking gemfibrozil (a medicine used to lower blood fat levels)

Warnings and precautions
Talk to your doctor before taking Repaglinide Teva:

• If you have liver problems. Repaglinide Teva is not recommended in patients with moderate liver disease. Repaglinide Teva must not be taken if you have severe liver disease (see Do not use Repaglinide Teva).
• If you have kidney problems. Repaglinide Teva should be taken with caution.
• If you are about to undergo major surgery or if you have recently had a serious illness or infection. In these cases, your diabetes may no longer be under control.
• Repaglinide Teva is not recommended if you are under 18 years of age or over 75 years of age. Repaglinide Teva has not been studied in these age groups.

Talk to your doctor if any of the conditions listed above apply to you. Repaglinide 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 of age.
If you have hypoglycaemia (low blood sugar)
If your blood sugar level drops too low, you may experience hypoglycaemia (short for hypoglycaemic episode). This may happen:

• If you have taken too much Repaglinide Teva
• If you do more physical activity than usual
• If you take other medicines or have liver or kidney disorders (see other sections of paragraph 2. What you need to know before taking Repaglinide Teva).

Early warning signs of hypoglycaemia may occur suddenly and may include: cold sweat; cold, pale skin; headache; rapid heartbeat; feeling unwell (nausea); intense hunger; temporary vision disturbances; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.
If your blood sugar is low or if you feel a hypoglycaemic episode coming on: eat sugar lumps, or have a snack or a sugary drink, then rest.
Once hypoglycaemia symptoms have subsided or your blood sugar has stabilised, continue your treatment with Repaglinide Teva.
Explain to people around you that you are diabetic and that, if you faint (lose consciousness) due to hypoglycaemia, they must turn you onto your side and seek immediate medical help. Do not allow them to give you food or drink. These could cause you to choke.

• If severe hypoglycaemia is not treated, it may lead to brain damage (temporary or permanent) and even death.
• If you experience hypoglycaemia that causes you to lose consciousness, or if you have repeated episodes of hypoglycaemia, consult your doctor. Your dose of Repaglinide Teva, your diet, or your physical activity may need to be adjusted.

If your blood sugar becomes too high
The sugar level in your blood may become too high (hyperglycaemia). This may happen:

• If you have not taken enough Repaglinide Teva
• If you have an infection or fever
• If you have eaten more than usual
• If you have done less physical activity than usual

Warning signs of high blood sugar develop gradually. They include: increased urination (urine production); thirst; dry skin and mouth.
Contact your doctor. Your dose of Repaglinide Teva, your diet, or your physical activity may need to be adjusted.
Other medicines and Repaglinide Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You may take Repaglinide Teva together with metformin, another diabetes medicine, if prescribed by your doctor. Do not take Repaglinide Teva if you are taking gemfibrozil (used to lower blood fat levels).
Your body's response to Repaglinide Teva may change if you take other medicines, particularly:

• Monoamine oxidase inhibitors (MAOIs, used to treat depression)
• Beta-blockers (used to treat high blood pressure and heart conditions)
• ACE inhibitors (used to treat heart conditions)
• Salicylates (e.g. aspirin)
• Octreotide (used to treat tumours)
• Non-steroidal anti-inflammatory drugs (NSAIDs, a type of painkiller)
• Steroids (anabolic steroids and corticosteroids – used for anaemia or to treat inflammation)
• Oral contraceptives (used for birth control)
• Thiazides (diuretics or “water pills”)
• Danazol (used to treat breast cysts and endometriosis)
• Thyroid products (used for low thyroid hormone levels)
• Sympathomimetics (used to treat asthma)
• Clarithromycin, trimethoprim, rifampicin (antibiotics)
• Itraconazole, ketoconazole (medicines for fungal infections)
• Gemfibrozil (used to lower blood fat levels)
• Cyclosporine (used to suppress the immune system)
• Deferasirox (used to reduce chronically high iron levels)
• Clopidogrel (prevents blood clots)
• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
• St. John’s wort (herbal medicine).

Repaglinide Teva and alcohol
The ability of Repaglinide Teva to lower blood sugar may be affected by alcohol consumption. Be alert for signs of hypoglycaemia.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
You must not take Repaglinide Teva if you are pregnant or planning a pregnancy.
You must not take Repaglinide Teva if you are breastfeeding.
Driving and using machines
Your ability to drive or operate machinery may be impaired by low or high blood sugar levels. Be aware that you could be putting yourself and others at risk. Ask your doctor whether you may drive if:

• you frequently experience hypoglycaemic episodes
• you do not feel the warning signs of hypoglycaemia, or feel them only weakly.

3. How to take Repaglinide Teva

Use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.
Your doctor will determine the dose for you.

• The usual starting dose is 0.5 mg before each main meal. Swallow the tablets with a glass of water immediately before each main meal or within the 30 minutes preceding the meal.
• Your doctor may adjust the dose up to a maximum of 4 mg to be taken immediately before each main meal or within the 30 minutes preceding the meal. The maximum recommended daily dose is 16 mg.

Do not take higher doses of Repaglinide Teva than those prescribed by your doctor.
If you take more Repaglinide Teva than you should
If you take too many tablets, your blood sugar may become too low, leading to hypoglycaemia. See If you get a hypo for information on what a hypo is and how to treat it.
If you forget to take Repaglinide Teva
If you miss a dose, take the next dose as usual. Do not take a double dose to make up for the missed dose.
If you stop taking Repaglinide Teva
Please note that if you stop treatment with Repaglinide Teva, the desired effect will not be achieved. Your diabetes may worsen. Contact your doctor before making any changes to your treatment.
If you have any 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 a hypo in section 2). Hypoglycaemic reactions are usually mild/moderate, but may occasionally progress to unconsciousness or hypoglycaemic coma. In such cases, immediate medical attention is required.

Allergic reaction
Allergy is very rare (may affect up to 1 in 10,000 patients). Symptoms such as swelling, difficulty breathing, rapid heartbeat, dizziness, and sweating may be signs of an anaphylactic reaction. Contact a doctor immediately.

Other side effects

Common (may affect up to 1 in 10 patients)

• stomach ache
• diarrhoea

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

• acute coronary syndrome (however, this effect may not be related to the medicine)

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

• vomiting
• constipation
• visual disturbances
• severe liver problems, abnormal liver function, as well as increased liver enzymes in the blood

Frequency not known

• hypersensitivity (for example, skin rash, itching, skin redness, skin swelling)
• malaise (nausea)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Repaglinide Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after
Exp. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Repaglinide Teva contains

• The active substance is repaglinide. Each 0.5 mg tablet of Repaglinide Teva contains 0.5 mg of repaglinide. Each 1 mg tablet of Repaglinide Teva contains 1 mg of repaglinide. Each 2 mg tablet of Repaglinide Teva contains 2 mg of repaglinide.
• The other ingredients are: microcrystalline cellulose (E460), meglumine, poloxamer 188, povidone K-30, calcium hydrogen phosphate, anhydrous colloidal silicon dioxide, polacrilin potassium, maize starch, magnesium stearate, indigo carmine aluminium lake (E132) (only in 0.5 mg tablets), yellow iron oxide (E172) (only in 1 mg tablets), red iron oxide (E172) (only in 2 mg tablets).

Description of the appearance of Repaglinide Teva and contents of the pack
The 0.5 mg tablet of Repaglinide Teva is a blue to sky-blue, capsule-shaped tablet, marked with “93” on one side and “210” on the other side.
The 1 mg tablet of Repaglinide Teva is a yellow to pale yellow, capsule-shaped tablet, marked with “93” on one side and “211” on the other side.
The 2 mg tablet of Repaglinide Teva is a mottled peach-coloured, capsule-shaped tablet, marked with “93” on one side and “212” on the other side.
Repaglinide Teva tablets are available in packs of 30, 90, 120, 270 and 360 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13.
Debrecen H-4042
Hungary
Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The 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 medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
Specifar A.B.E.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
Specifar A.B.E.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.