Repaglinide Krka: detailed information

Package leaflet: Information for the patient

Repaglinide Krka 0.5 mg tablets, 1 mg tablets, 2 mg tablets

repaglinide
Please 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 effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
1. What Repaglinide Krka is and what it is used for
2. What you need to know before taking Repaglinide Krka
3. How to take Repaglinide Krka
4. Possible side effects
5. How to store Repaglinide Krka
6. Contents of the pack and other information

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

Repaglinide Krka is an oral antidiabetic medicinal product containing repaglinide, which helps
the pancreas produce a greater amount of insulin and thus reduce blood sugar levels.
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 Krka is used to control type 2 diabetes in adults, in addition to diet and
physical exercise: treatment is usually initiated when diet, physical activity, and weight reduction alone
are not sufficient to control (or reduce) blood sugar levels.
Repaglinide Krka may also be administered in combination with metformin, another antidiabetic medicine.
Repaglinide Krka has been shown to reduce blood sugar levels, thereby helping to prevent
diabetes-related complications.

2. What you need to know before taking Repaglinide Krka

Do not take Repaglinide Krka

if you are allergic to repaglinide or to any of the other ingredients in 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 elevated blood fat levels).

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

If you have liver problems. Repaglinide Krka is not recommended for patients with moderate liver disease. Repaglinide Krka must not be taken if you have 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 undergo major surgery or have recently had a serious illness or infection. In these cases, your diabetes may become difficult to control.
Repaglinide Krka is not recommended if you are under 18 years or over 75 years of age. Repaglinide Krka has not been studied in these age groups. Talk to your doctor if any of the above conditions apply to you, as Repaglinide Krka 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 drops too low, you may experience hypoglycaemia (shortened to "hypo"). This may happen:

if you have taken too much Repaglinide Krka,
if you are more physically active than usual,
if you are taking other medicines or have liver or kidney problems (see other sections of paragraph 2. What you need to know before taking Repaglinide Krka).

Warning signs of hypoglycaemic attack
These may occur suddenly and can 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 hypo coming on:
Eat sugar cubes or a sugary snack or drink a sugary beverage, then rest.
Once symptoms of hypoglycaemia have subsided or your blood sugar has stabilized, continue your treatment with Repaglinide Krka.

Explain to people around you that you are diabetic and that, if you faint (lose consciousness) due to a hypo, they must turn you onto your side and immediately call a doctor. They must not give you food or drink, as this could cause choking.

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 Krka, your diet, or your physical activity may need to be adjusted.

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

if you have not taken enough Repaglinide Krka,
if you have an infection or fever,
if you have eaten more than usual,
if you have been less physically active than usual.

Warning signs of high blood sugar
These develop gradually and include: increased urination, thirst, dry skin and mouth.
Contact your doctor. Your dose of Repaglinide Krka, your diet, or your physical activity may need to be adjusted.

Other medicines and Repaglinide Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
You may take Repaglinide Krka in combination with metformin, another diabetes medicine, if prescribed by your doctor.
Do not take Repaglinide Krka if you are taking gemfibrozil (used to lower blood fat levels).
Your body's response to Repaglinide Krka may change if you take other medicines, especially:

Monoamine oxidase inhibitors (MAOIs) (used to treat depression).
Beta-blockers (used to treat high blood pressure and heart conditions).
ACE inhibitors (Angiotensin-Converting Enzyme 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 (used to promote diuresis, i.e. "urine elimination").
Danazol (used to treat breast cysts and endometriosis).
Thyroid products (used when thyroid hormone levels are low).
Sympathomimetics (used to treat asthma).
Clarithromycin, trimethoprim, rifampicin (antibiotic medicines).
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 Krka and alcohol
The ability of Repaglinide Krka to lower blood sugar may be altered if you drink alcohol. Be alert for signs of hypoglycaemia.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, inform your doctor before taking this medicine.
You must not take Repaglinide Krka if you are pregnant or planning to become pregnant.
You must not take Repaglinide Krka 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. Remember that you could be putting yourself and others at risk. Ask your doctor whether you may drive if:

you experience frequent hypoglycaemic episodes,
you do not notice the warning signs of hypoglycaemia or notice only a few.

Repaglinide Krka contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Repaglinide Krka

Always use this medicine exactly as instructed by your doctor. If you have any doubts,
consult your doctor.
Your doctor will determine the dose suitable 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 more Repaglinide Krka than prescribed by your doctor.
If you take more Repaglinide Krka than you should
If you take too many tablets, your blood sugar may become too low, leading to hypoglycaemia. See If you have a hypo for information on what a hypo is and how to treat it.
If you forget to take Repaglinide Krka
If you miss a dose, take the next dose as usual, but do not double the dose.
If you stop taking Repaglinide Krka
Please note that if you stop treatment with Repaglinide Krka, the desired effect will not be achieved and your diabetes may worsen. Contact your doctor before stopping or changing 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 people (see If you have a hypo in section 2). Hypoglycaemic reactions are generally mild/moderate, but may occasionally progress to unconsciousness or hypoglycaemic coma. In such cases, medical assistance must be sought immediately.
Allergy
Allergic reaction is very rare (may affect up to 1 in 10,000 people). 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 people)

Stomach ache
Diarrhoea

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

Acute coronary syndrome (but this effect may not be related to the medicine)

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

Vomiting
Constipation
Vision disorders
Severe liver problems, abnormal liver function, increased liver enzymes in the blood

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 detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Repaglinide Krka

Keep this medicine out of the reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and on the blister.
The expiry date refers to the last day of the month indicated.
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 Krka contains

The active substance is repaglinide. Each tablet contains 0.5 mg, 1 mg, or 2 mg of repaglinide.
The other ingredients (excipients) are: microcrystalline cellulose (E460), calcium hydrogen phosphate, sodium croscarmellose, povidone K25, glycerol, magnesium stearate, meglumine, poloxamer, yellow iron oxide (E 172) only in the 1 mg tablets, and red iron oxide (E 172) only in the 2 mg tablets. See section 2 “Repaglinide Krka contains sodium”. Description of the appearance of Repaglinide Krka and package contents The 0.5 mg tablets are white, round, biconvex, with bevelled edges. The 1 mg tablets are light yellow-brown, round, biconvex, with bevelled edges and possible darker specks. The 2 mg tablets are marbled pink, round, biconvex, with bevelled edges and possible darker specks. Packaging with blisters containing 30, 60, 90, 120, 270, or 360 tablets is available. Not all pack sizes may be marketed. Marketing Authorisation Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
KRKA Belgium, SA. UAB KRKA Lietuva
Tél/Tel: + 32 (0) 487 50 73 62 Tel: + 370 5 236 27 40
България Luxembourg/Luxemburg
КРКА България ЕООД KRKA Belgium, SA
Teл.: + 359 (02) 962 34 50 Tél/Tel: + 32 (0) 487 50 73 62 (BE)
Česká republika Magyarország
KRKA ČR, s.r.o. KRKA Magyarország Kereskedelmi Kft.
Tel: + 420 (0) 221 115 150 Tel.: + 36 (1) 355 8490
Danmark Malta
KRKA Sverige AB E.J. Busuttil Ltd.
Tlf: + 46 (0)8 643 67 66 (SE) Tel: + 356 21 445 885
Deutschland Nederland
TAD Pharma GmbH KRKA Belgium, SA.
Tel: + 49 (0) 4721 6060 + 32 (0) 487 50 73 62 (BE)
Eesti Norge
KRKA, d.d., Novo mesto Eesti filiaal KRKA Sverige AB
Tel: + 372 (0)6 671 658 Tlf: + 46 (0)8 643 67 66 (SE)
Ελλάδα Österreich
KRKA ΕΛΛΑΣ ΕΠΕ KRKA PharmaGmbH, Wien
Τηλ: +30 2100101613 Tel: + 43 (0)1 66 24 300
España Polska
KRKA Farmacéutica, S.L. KRKA-POLSKA Sp.z o.o.
Tel: + 34 911 61 03 81 Tel.: + 48 (0)22 573 7500
France Portugal
KRKA France Eurl KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tél: + 33 (0)1 57 40 82 25 Tel: + 351 (0)21 46 43 650
Hrvatska România
KRKA – FARMA d.o.o. KRKA Romania S.R.L., Bucharest
Tel: + 385 1 6312 100 Tel: + 4 021 310 66 05
Ireland Slovenija
KRKA Pharma Dublin, Ltd. KRKA, d.d., Novo mesto
Tel: + 353 1 293 91 80 Tel: + 386 (0) 1 47 51 100
Ísland Slovenská republika
LYFIS ehf. KRKA Slovensko, s.r.o.,
Sími: + 354 534 3500 Tel: + 421 (0) 2 571 04 501
Italia Suomi/Finland
KRKA Farmaceutici Milano S.r.l. KRKA Finland Oy
Tel: + 39 02 3300 8841 Puh/Tel: + 358 20 754 5330
Κύπρος Sverige
KI.PA. (PHARMACAL) LIMITED KRKA Sverige AB
Τηλ: + 357 24 651 882 Tel: + 46 (0)8 643 67 66 (SE)
Latvija United Kingdom
KRKA Latvija SIA Consilient Health (UK) Ltd.
Tel: + 371 6 733 86 10 Tel: + 44 (0)203 751 1888
More detailed information on this medicine is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu