Package leaflet: Information for the user

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

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.

  
  

  What is in this leaflet

  
  

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

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

  3. How to take Repaglinide Teva

  5. Possible side effects

  1. How to store Repaglinide Teva

  2. 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 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.

     
     

     Repaglinide Teva is used to control type 2 diabetes in adults 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.

     
     

     Repaglinide has been shown to lower the blood sugar, which helps to prevent complications from your diabetes.

     
     

  2. What you need to know before you take Repaglinide Teva Do not take Repaglinide Teva

  • If you are allergic to repaglinide or any of the other ingredients in this medicine (listed in section 6).

  • If you have type 1 diabetes.

  • If the acid level in your blood 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).

    
    

    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 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.

    
    

    Children and adolescents

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

    
    

    If you get a hypo (low blood sugar)

    You may get a hypo (short for hypoglycaemia) 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. What you need to know 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 that if 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 of too high blood sugar appear gradually. They include: increased urination; feeling thirsty; dry skin and dry mouth. Talk to your doctor. The amount of Repaglinide Teva, food or exercise 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 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).

  • Deferasirox (used to reduce chronic iron overload).

  • Clopidogrel (prevents blood clots).

  • Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy).

  • St. John’s wort (herbal medicine).

    
    

    Repaglinide Teva with alcohol

    
    

    Alcohol can change the ability of Repaglinide Teva to reduce the blood sugar. Watch for signs of a hypo.

    
    

    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 Repaglinide Teva if you are pregnant or you are planning to become pregnant. You should not take Repaglinide Teva if you are breast-feeding.

    Driving and using machines

    
    

    Your ability to drive or use 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.

    
    

    1. How to take Repaglinide Teva

       
       

       Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

       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.

    
    

    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 take a double dose to make up for a forgotten 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 this medicine, ask your doctor or pharmacist.

    
    

    1. Possible side effects

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

       The most frequent side effect is hypoglycaemia which may affect up to 1 in 10 patients (see If you get

       a hypo in section 2). Hypoglycaemic reactions are generally mild/moderate but may occasionally develop into hypoglycaemic unconsciousness or coma. If this happens, medical assistance is needed immediately.

       
       

       Allergy

       Allergy is very rare (may affect up to 1 in 10,000 patients). Symptoms such as swelling, difficulty in breathing, rapid heartbeat, feeling dizzy and sweating could be signs of anaphylactic reaction. Contact a 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 it 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 your blood.

    
    

    Frequency not known

  • Hypersensitivity (such as rash, itchy skin, reddening of the skin, swelling of the skin)

  • Feeling sick (nausea).

  
  

  Reporting of side effects

  

  If you get 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.

  
  

  1. 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 which is stated on the carton and blister foil after EXP. The expiry date refers to the last day of that month.

     
     

     Store in the original package in order to protect from light.

     
     

     Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

     
     

  2. Contents of the pack and other information What Repaglinide Teva contains

• The active substance is repaglinide.

  Each Repaglinide Teva 0.5 mg tablet contains 0.5 mg of repaglinide. Each Repaglinide Teva 1 mg tablet contains 1 mg of repaglinide. Each Repaglinide 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 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 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373

Lietuva

UAB Teva Baltics Tel: +370 52660203

България

Тева Фарма ЕАД Teл: +359 24899585

Luxembourg/Luxemburg

Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien

Tél/Tel: +32 38207373

Česká republika

Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111

Magyarország

Teva Gyógyszergyár Zrt. Tel: +36 12886400

Danmark

Teva Denmark A/S Tlf: +45 44985511

Malta

Teva Pharmaceuticals Ireland L-Irlanda

Tel: +44 2075407117

Deutschland

TEVA GmbH

Tel: +49 73140208

Nederland

Teva Nederland B.V. Tel: +31 8000228400

Eesti

UAB Teva Baltics Eesti filiaal Tel: +372 6610801

Norge

Teva Norway AS Tlf: +47 66775590

Ελλάδα

Specifar A.B.E.E.

Τηλ: +30 2118805000

Österreich

ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070

España

Teva Pharma, S.L.U. Tel: +34 913873280

Polska

Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300

France

Teva Santé

Tél: +33 155917800

Portugal

Teva Pharma - Produtos Farmacêuticos, Lda. Tel: +351 214767550

Hrvatska

Pliva Hrvatska d.o.o. Tel: +385 13720000

România

Teva Pharmaceuticals S.R.L. Tel: +40 212306524

Ireland

Teva Pharmaceuticals Ireland Tel: +44 2075407117

Slovenija

Pliva Ljubljana d.o.o. Tel: +386 15890390

Ísland

Teva Pharma Iceland ehf. Sími: +354 5503300

Slovenská republika

TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911

Italia

Teva Italia S.r.l. Tel: +39 028917981

Suomi/Finland

Teva Finland Oy

Puh/Tel: +358 201805900

Κύπρος

Specifar A.B.E.E.

Ελλάδα

Τηλ: +30 2118805000

Sverige

Teva Sweden AB Tel: +46 42121100

Latvija

UAB Teva Baltics filiāle Latvijā Tel: +371 67323666

United Kingdom (Northern Ireland)

Teva Pharmaceuticals Ireland Ireland

Tel: +44 2075407117

This leaflet was last approved in