Repaglinide Teva 0.5 mg tablets

Repaglinide Teva is an oral antidiabetic agent containing repaglinide which helps your pancreas produce more insulin and thereby lower your blood sugar (glucose).

Type 2 diabetes is a disease in which your pancreas does not make enough insulin to control the sugar in your blood or where your body does not respond normally to the insulin it produces (formerly known as non-insulin-dependent diabetes mellitus or maturity onset diabetes).

Repaglinide Teva is used to control type 2 diabetes as an add-on to diet and exercise: treatment is usually started if diet, exercise and weight reduction alone have not been able to control (or lower) your blood sugar. Repaglinide Teva can also be given with metformin, another medicine for diabetes.

Do not take Repaglinide Teva

• If you are hypersensitive (allergic) to repaglinide or any of the other components of the medicine.
• If you have type 1 diabetes ( insulin-dependent diabetes).
• If the acid level in your body is raised (diabetic ketoacidosis).
• If you have a severe liver disease.
• If you take gemfibrozil (a medicine used to lower increased fat levels in the blood).

If any of these apply to you, tell your doctor and do not take Repaglinide.

Take special care with Repaglinide Teva

• If you have liver problems. Repaglinide Teva is not recommended in patients with moderate liver disease. Repaglinide Teva should not be taken if you have a severe liver disease (see Do not take Repaglinide Teva).
• If you have kidney problems. Repaglinide Teva should be taken with caution.
• If you are about to have major surgery or you have recently suffered a severe illness or infection. At such times diabetic control may be lost.
• If you are under 18 or over 75 years of age. Repaglinide Teva is not recommended. It has not been studied in these age groups.

Talk to your doctor if any of the above applies to you. Repaglinide Teva may not be suitable for you. Your doctor will advise you

If you get a hypo

You may get a hypo (short for a hypoglycaemic reaction and is symptoms of low blood sugar) if your blood sugar gets too low. This may happen:

• If you take too much Repaglinide Teva.
• If you exercise more than usual.
• If you take other medicines or suffer from liver or kidney problems (see other sections of

2. Before you take Repaglinide Teva).

The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

If your blood sugar is low or you feel a hypo coming on: eat glucose tablets or a high sugar snack or drink, then rest.

When symptoms of hypoglycaemia have disappeared or when blood sugar levels are stabilised continue Repaglinide Teva treatment.

Tell people you have diabetes and thatif you pass out (become unconscious) due to a hypo, they must turn you on your side and get medical help straight away. They must not give you any food or drink.It could choke you.

• If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death.
• If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor. The amount of Repaglinide Teva, food or exercise may need to be adjusted.

If your blood sugar gets too high
Your blood sugar may get too high (hyperglycaemia). This may happen:

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

The warning signs appear gradually. They include: increased urination; feeling thirsty; dry skin and dry mouth. Talk to your doctor. The amount of Repaglinide, food or exercise may need to be adjusted.

Taking other medicines
You can take Repaglinide Teva with metformin, another medicine for diabetes, if your doctor prescribes it. If you take gemfibrozil (used to lower increased fat levels in the blood) you should not take Repaglinide Teva.

Your body?s response to Repaglinide Teva may change if you take other medicines, especially these:

• Monoamine oxidase inhibitors (MAOI) (used to treat depression).
• Beta blockers (used to treat high blood pressure or heart conditions).
• ACE-inhibitors (used to treat heart conditions).
• Salicylates (e.g. aspirin).
• Octreotide (used to treat cancer).
• Nonsteroidal anti-inflammatory drugs (NSAID) (a type of painkillers).
• Steroids (anabolic steroids and corticosteroids ? used for anemia or to treat inflammation).
• Oral contraceptives (birth control pills).
• Thiazides (diuretics or ?water pills?).
• Danazol (used to treat breast cysts and endometriosis).
• Thyroid products (used to treat low levels of thyroid hormones).
• Sympathomimetics (used to treat asthma).
• Clarithromycin, trimethoprim, rifampicin (antibiotic medicines).
• Itraconazole, ketokonazole (antifungal medicines).
• Gemfibrozil (used to treat high blood fats).
• Ciclosporin (used to suppress the immune system).
• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy).
• St. John?s wort (herbal medicine).

Tell your doctor if you have recently taken or are planning to take any of these medicines, or any medicines obtained without a prescription.

Taking Repaglinide Teva with food and drink

Take Repaglinide Teva before main meals. Alcohol can change the ability of Repaglinide Teva to reduce the blood sugar. Watch for signs of a hypoglycaemia.

Pregnancy and breast-feeding

You should not take Repaglinide Teva if you are pregnant or you are planning to become pregnant. See your doctor as soon as possible if you become pregnant or are planning to become pregnant during treatment.

You should not take Repaglinide Teva if you are breast-feeding.

Driving and using machines

Your ability to drive or operate a machine may be affected if your blood sugar is low or high. Bear in mind that you could endanger yourself or others. Please ask your doctor whether you can drive a car if you:

• have frequent hypos,
• have few or no warning signs of hypos.

Your doctor will work out your dose.

• The normal starting dose is 0.5 mg before each main meal. Swallow the tablets with a glass of water immediately before or up to 30 minutes before each main meal.
• The dose may be adjusted by your doctor by up to 4 mg to be taken immediately before or up to 30 minutes before each main meal. The maximum recommended daily dose is 16 mg.

Do not take more Repaglinide Teva than your doctor has recommended. Always take Repaglinide Teva exactly as your doctor has told you. Check with your doctor if you are not sure.

If you take more Repaglinide Teva than you should

If you take too many tablets, your blood sugar may become too low, leading to a hypo. Please see If you get a hypo 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 double the dose.

If you stop taking Repaglinide Teva

Be aware that the desired effect is not achieved if you stop taking Repaglinide Teva. Your diabetes may get worse. If any change of your treatment is necessary contact your doctor first.

If you have any further questions on the use of Repaglinide Teva, ask your doctor or pharmacist.

Like all medicines, Repaglinide Teva can cause side effects, although not everybody gets them.

The following side effects have been reported at the approximate frequencies shown:

Possible side effects

Common: affects 1 to 10 users in 100

• Hypoglycaemia (see If you get a hypo). The risk of getting a hypo may increase if you take other medicines
• Stomach pain
• Diarrhoea.

Rare: affects 1 to 10 users in 10,000

• Acute coronary syndrome (but it may not be due to the medicinal product).

Very rare: affects less than 1 user in 10,000

• Allergy (such as swelling, difficulty in breathing, rapid heart beat, feeling dizzy, sweating which could be signs of anaphylactic reaction). Contact a doctor immediately
• Vomiting
• Constipation
• Visual disturbances
• Severe liver problems, abnormal liver function, increased liver enzymes in your blood.

Not known: frequency cannot be estimated from the available data

• Hypoglycaemic coma or unconsciousness (very severe hypoglycaemic reactions ? see If you get a hypo). Contact a doctor immediately
• Hypersensitivity (such as rash, itchy skin, reddening of the skin, swelling of the skin)
• Feeling sick (nausea).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Keep out of the reach and sight of children.
Do not use Repaglinide Teva after the expiry date which is stated on the outer carton and blister. The expiry date refers to the last day of that month.
Store in the original package in order 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 to protect the environment.

What Repaglinide Teva contains

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

What Repaglinide Teva looks like and contents of the pack

Repaglinide Teva 0.5 mg tablet is a light blue to blue, capsule shaped tablet, debossed with "93" on one side and ?210? on the other side of the tablet.

Repaglinide Teva 1 mg tablet is a yellow to light yellow, capsule shaped tablet, debossed with "93" on one side and ?211? on the other side of the tablet.

Repaglinide Teva 2 mg tablet is a mottled peach, capsule shaped tablet, debossed with "93" on one side and ?212? on the other side of the tablet.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva Pharma B.V.
Computerweg 10
3542 DR Utrecht
The Netherlands

Manufacturer

Teva Pharmaceutical Works Private Limited Company
Pallagi út 13.
Debrecen H-4042
Hungary

Teva Pharmaceuticals Works Private Limited Company

H-2100 Gödöllö,

Táncsics Mihály út 82

Hungary

Teva UK Ltd.

Brampton Road

Hampden ParkEastbourne,East Sussex
BN22 9AG,

United Kingdom

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

TEVA Santé SA

Rue Bellocier

89107 Sens

France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A. TelTél 32 3 820 73 73 LuxembourgLuxemburg Teva Pharma Belgium S.A. Tél 32 3 820 73 73

Te 359 2 489 95 82 Magyarország Teva Magyarország Zrt Tel. 36 1 288 64 00

eská republika Teva Pharmaceuticals CR, s.r.o. Tel 420 251 007 111 Malta Teva .. el 30 210 72 79 099

Danmark Teva Denmark AS Tlf 45 44 98 55 11 Nederland Teva Nederland B.V. Tel 31 0 800 0228400

Deutschland Teva GmbH Tel 49 351 834 0 Norge Teva Sweden AB Tlf 46 42 12 11 00

Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel 43 1 97007 Eesti Teva Eesti esindus UAB Sicor Biotech Eesti filiaal Tel 372 611 2409

Teva .. 30 210 72 79 099 Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel. 48 22 345 93 00

España Teva Pharma, S.L.U Tél 34 91 387 32 80 Portugal Teva Pharma - Produtos Farmacêuticos Lda Tel 351 214 235 910

France Teva Santé Tél 33 1 55 91 7800 România Teva Pharmaceuticals S.R.L Tel 4021 212 08 90

Ireland Teva Pharmaceuticals Ireland Tel 353 042 9395 892 Slovenija Pliva Ljubljana d.o.o. Tel 386 1 58 90 390

Ísland Teva UK Limited Sími 44 1323 501 111. Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel 421 2 5726 7911

Italia Teva Italia S.r.l. Tel 39 0289179805 SuomiFinland Teva Sweden AB PuhTel 46 42 12 11 00

Teva .. 30 210 72 79 099 Sverige Teva Sweden AB Tel 46 42 12 11 00

Latvija UAB Sicor Biotech filile Latvij Tel 371 67 784 980 United Kingdom Teva UK Limited Tel 44 1323 501 111

Lietuva

UAB ?Sicor Biotech?
Tel: +370 5 266 02 03

This leaflet was last approved in