Repaglinide Krka
repaglinide
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 Repaglinide Krka is and what it is used for
What you need to know before you take Repaglinide Krka
How to take Repaglinide Krka
Possible side effects
How to store Repaglinide Krka
Contents of the pack and other information
Repaglinide Krka is an oral antidiabetic medicine containing repaglinide which helps your pancreas produce more insulin and thereby lower your blood sugar (glucose).
Repaglinide Krka 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 Krka can also be given with metformin, another medicine for diabetes.
Repaglinide Krka has been shown to lower the blood sugar, which helps to prevent complications from your diabetes.
if you are allergic to repaglinide or any of the other ingredients of 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).
Talk to your doctor before taking Repaglinide Krka:
if you have liver problems. Repaglinide Krka is not recommended in patients with moderate liver disease. Repaglinide Krka should not be taken if you have a severe liver disease (see Do
not take Repaglinide Krka).
if you have kidney problems. Repaglinide Krka should be taken with caution.
if you are about to have major surgery or you have recently suffered a severe illness or
if you are under 18 or over 75 years of age. Repaglinide Krka is not recommended. It has not been studied in these age groups.
Do not take this medicine if you are under 18 years of age.
You may get a hypo (short for hypoglycaemia) if your blood sugar gets too low. This may happen:
if you take too much Repaglinide Krka
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 Krka).
continue repaglinide treatment.
Repaglinide Krka, food or exercise may need to be adjusted.
Your blood sugar may get too high (hyperglycaemia). This may happen:
if you take too little Repaglinide Krka,
if you have an infection or a fever,
if you eat more than usual,
if you exercise less than usual.
If you take gemfibrozil (used to lower increased fat levels in the blood) you should not take Repaglinide Krka.
Your body’s response to Repaglinide Krka 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 anaemia 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).
Alcohol can change the ability of Repaglinide Krka to reduce the blood sugar. Watch for signs of a hypo.
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 Krka if you are pregnant or you are planning to become pregnant. You should not take Repaglinide Krka if you are breast-feeding.
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.
RepaglinideKrkacontainssodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-
free’.
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 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 Krka than your doctor has recommended.
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 miss a dose, take the next dose as usual.
Do not take a double dose to make up for a forgotten tablet.
Be aware that the desired effect is not achieved if you stop taking Repaglinide Krka. 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.
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 people (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 people). Symptoms such as swelling, difficulty in
breathing, rapid heartbeat, feeling dizzy and sweating could be signs of anaphylactic reaction. Contact a doctor immediately.
Othersideeffects
Stomach pain
Diarrhoea
Acute coronary syndrome (but it may not be due to the medicine)
Vomiting
Constipation
Visual disturbances
Severe liver problems, abnormal liver function, such as increased liver enzymes in your blood.
Hypersensitivity (such as rash, itchy skin, reddening of the skin, swelling of the skin)
Feeling sick (nausea)
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 nationalreportingsystem listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 blister and outer carton. 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.
The active substance is repaglinide. Each tablet contains 0.5 mg, 1 mg or 2 mg repaglinide.
The other ingredients are: microcrystalline cellulose (E460); calcium hydrogen phosphate,
croscarmellose sodium; povidone K25; glycerol; magnesium stearate; meglumine; poloxamer; yellow iron oxide (E172) only in the 1 mg tablets and red iron oxide (E172) only in the 2 mg tablets. See section 2 “Repaglinide Krka contains sodium”.
The 0.5 mg tablets are white, round and biconvex with bevelled edges.
The 1 mg tablets are pale brown-yellow, round, biconvex with bevelled edges and possible darker
spots.
The 2 mg tablets are pink, marbled, round, biconvex with bevelled edges and possible darker spots.
Boxes of 30, 60, 90, 120, 270 or 360 tablets in blister are available. Not all pack sizes may be marketed.
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany KRKA - FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62
UAB KRKA Lietuva
Tel: + 370 5 236 27 40
КРКА България ЕООД Teл.: + 359 (02) 962 34 50
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 (BE)
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)
E.J. Busuttil Ltd.
Tel: + 356 21 445 885
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300
KRKA Farmacéutica, S.L.
Tel: + 34 911 61 03 80
KRKA-POLSKA Sp.z o.o. Tel.: + 48 (0)22 573 7500
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25
KRKA Farmacêutica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 650
KRKA – FARMA d.o.o.
Tel: + 385 1 6312 100
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100
LYFIS ehf.
Sími: + 354 534 3500
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841
KRKA Finland Oy
Puh/Tel: + 358 20 754 5330
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)
KRKA Latvija SIA
Tel: + 371 6 733 86 10
Consilient Health Limited
Tel: + 353 (0)1 2057760