REPAGLINIDE 0.5 MG Таблетки

Содержание инструкции

1. Repaglinide Krka 0.5 mg tablets, 1 mg tablets, 2 mg tablets
   1. What is Repaglinide Krka and what is it 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. Package contents and other information

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

repaglinide

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours because it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Repaglinide Krka and what is it used for

Repaglinide Krka is a medicine for oral antidiabetic treatment containing repaglinide which helps
the pancreas to produce a greater quantity of insulin and thus to reduce the level of sugar in
the blood.

Type 2 diabetesis a disease in which the pancreas does not produce enough insulin to control the
level of sugar in the blood or in which the organism does not respond normally to the insulin that
it produces.
Repaglinide Krka is used to control type 2 diabetes in adults in addition to diet and
exercise: treatment usually begins when diet, physical activity and weight reduction are not sufficient, on
their own, to control (or reduce) blood sugar levels.
Repaglinide Krka can also be administered in association with metformin, another
medicine for diabetes.
Repaglinide Krka has shown to reduce blood sugar levels and this contributes to
preventing the complications of diabetes.

2. What you need to know before taking Repaglinide Krka

Do not take Repaglinide Krka

• if you are allergicto repaglinide or any of the other ingredients in this medicine (listed in section 6).
• if you have type 1 diabetes.
• if the level of acid in your blood is high (diabetic ketoacidosis),
• if you have a severe liver disease,
• if you are taking gemfibrozil(medicine used to lower increased levels of fats in the blood).

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

• If you have liver problems. Repaglinide Krka is not recommended in patients who have moderate liver disease. Repaglinide Krka must not be taken in case of 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 surgeryor if you have recently had a serious illness or infection. In these cases, diabetes may no longer be under control.
• Repaglinide Krka is not recommended if you are under 18 years of ageor over 75 years of age. Repaglinide Krka has not been studied in these age groups. Talk to your doctorif any of the above conditions apply to you, Repaglinide Krka may not be suitable for you. Your doctor will inform you. Children and adolescentsDo not take this medicine if you are under 18 years of age. If you have a hypo (low blood sugar)If your blood sugar gets too low, you may experience a hypo (abbreviation for hypoglycemia). This can happen:
• if you have taken too much Repaglinide Krka,
• if you do more physical activity than usual,
• if you have taken other medicines or suffer from liver or kidney problems (see other sections of section 2. What you need to know beforetaking Repaglinide Krka). The warning signs of hypoglycemiacan occur suddenly and may include: cold sweat; cold and pale skin; headache; rapid heartbeat; feeling unwell (nausea); strong sense of hunger; temporary vision disturbances; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating. If your blood sugar is low or if you feel a hypo coming on:eat sugar lumps or a snack or a high-sugar drink, then rest. When the symptoms of hypoglycemia disappear or when your blood sugar has stabilizedcontinue treatment with Repaglinide Krka. Tell people you are diabetic and that, if you were to faint(lose consciousness) due to a hypo, they should turn you on your side and seek immediate medical attention. They should not give you food or drink. This could choke you.
• If severe hypoglycemiais not treated, it can cause brain damage (temporary or permanent) up to death.
• If you have hypoglycemiathat makes you lose consciousness, or have repeated episodes of hypo, consult your doctor. It may be necessary to change the dose of Repaglinide Krka, diet or type of exercise. If your blood sugar becomes too highThe level of sugar in the blood can become too high (hyperglycemia). This can happen:
• if you have taken insufficient amounts of Repaglinide Krka,
• if you have an infection or fever,
• if you have eaten more than usual,
• if you have done less physical activity than usual.

The warning signs of a blood sugar level that is too highappear gradually. They
include: increased urination; thirst; dry skin and mouth.
Consult your doctor. It may be necessary to change the amount of Repaglinide Krka to
take, diet or exercise.

Other medicines and Repaglinide Krka
Tell your doctoror pharmacist if you are taking, have recently taken or might take
any other medicine.
You can take Repaglinide Krka in combination with metformin, another medicine for diabetes, if
your doctor prescribes it.
If you are taking gemfibrozil (used to lower blood fat levels) you should not take
Repaglinide Krka.
The body's response to Repaglinide Krka may vary if you take other medicines, in particular:

• Monoamine oxidase inhibitors (MAOIs) (used to treat depression).
• Beta-blockers (used to treat high blood pressure and heart disease).
• ACE inhibitors, i.e. Angiotensin Converting Enzyme (ACE) inhibitors (used to treat heart disease).
• Salicylates (e.g. aspirin).
• Octreotide (used to treat tumors).
• Non-steroidal anti-inflammatory drugs (NSAIDs) (a type of pain reliever).
• Steroids (anabolic steroids and corticosteroids - used for anemia or to treat inflammation).
• Oral contraceptives (used for birth control).
• Thiazides (used to stimulate diuresis, i.e. “elimination of urine”).
• Danazol (used to treat breast cysts and endometriosis).
• Thyroid products (used in case of low levels of thyroid hormones).
• Sympathomimetics (used to treat asthma).
• Clarithromycin, trimethoprim, rifampicin (antibiotic medicines).
• Itraconazole, ketoconazole (medicine against 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 clot formation)
• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy).
• St. John's Wort (herbal medicine).

Repaglinide Krka with alcohol
The ability of Repaglinide Krka to lower blood sugar may vary if you drink alcohol. Pay attention to
the signs of hypoglycemia.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you are pregnant or are planning a
pregnancy, tell your doctor before taking this medicine.
You should not take Repaglinide Krka if you are pregnant or planning a
pregnancy.
You should not take Repaglinide Krka if you are breastfeeding

Driving and using machines
Your ability to drive or use machines may be affected by low or high blood sugar.
Be aware that you may put yourself and others at risk. Ask your doctor if you can drive
a vehicle if:

• you experience frequent episodes of hypoglycemia,
• you do not recognize the warning signs of hypoglycemia or recognize few of them.

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

Use this medicine following the instructions of your doctor exactly. If you have any doubts,
consult your doctor.
The doctor will determine the dose for you.

• The usual starting doseis 0.5 mg before each main meal. Swallow the tablets with a glass of water immediately before each main meal or within 30 minutes before the meal itself.
• The dose may be adjusted by your doctor up to a maximum of 4 mg to be taken immediately before each main meal or within 30 minutes before the meal itself. The maximum recommended daily dose is 16 mg. Do not take doses of Repaglinide Krka higher than those prescribed by your doctor. If you take more Repaglinide Krka than you shouldIf you take too many tablets, your blood sugar may become too low, leading to hypoglycemia. See If you have a hypoto find out what a hypo is and how to treat it. If you forget to take Repaglinide KrkaIf you miss a dose, take the next one as usual, but without doubling it. If you stop taking Repaglinide KrkaKeep in mind that if you stop treatment with Repaglinide Krka, the desired effect will not be achieved. Diabetes may worsen. Contact your doctor before changing treatment. If you have any further questions on 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.
Hypoglycemia
The most common side effect is hypoglycemia, which can affect up to 1 in 10 people (see

If you have a hypoin section 2). Hypoglycemic reactions are generally mild/ moderate, but
can occasionally develop into a state of unconsciousness or hypoglycemic coma. In this case, it is
necessary to contact medical assistance immediately.
Allergy
Allergy is very rare (can 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 pain
• Diarrhea.

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
• Serious liver problems, abnormal liver function, increased liver enzymes in the blood. Not known
• Hypersensitivity (such as skin rash, itching, skin redness, skin swelling).
• Feeling unwell (nausea). Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 Krka

Keep this medicine out of the reach of children.
Do not use this medicine after the expiry date which is 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 package to keep the medicine protected from light.
Do not dispose of any medicine in 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 excipients are: microcrystalline cellulose (E460), calcium hydrogen phosphate, sodium croscarmellose, povidone K25, glycerol, magnesium stearate, meglumine, poloxamer, yellow iron oxide (E 172) only in 1 mg tablets and red iron oxide (E 172) only in 2 mg tablets. See section 2 “Repaglinide Krka contains sodium”. Description of the appearance of Repaglinide Krka and package contentsThe 0.5 mg tablets are white, round, biconvex and with chamfered edges. The 1 mg tablets are light yellow-brown in colour, round, biconvex with chamfered edges and possible darker spots. The 2 mg tablets are marbled pink in colour, round, biconvex with chamfered edges and possible darker spots. Packs are available in blisters containing 30, 60, 90, 120, 270 or 360 tablets. 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 on this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62

Lietuva
UAB KRKA Lietuva
Tel: +370 5 236 27 40

България
КРКА България ЕООД
Teл.: +359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA
Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: +420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: +36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: +46 (0)8 643 67 66 (SE)

Malta
E.J. Busuttil Ltd.
Tel: + 356 21 445 885

Deutschland
TAD Pharma GmbH
Tel: +49 (0) 4721 6060

Nederland
KRKA Belgium, SA.
+ 32 (0) 487 50 73 62 (BE)

Eesti
KRKA, d.d., Novo mesto Eesti filiaal
Tel: +372 (0)6 671 658

Norge
KRKA Sverige AB
Tlf: +46 (0)8 643 67 66 (SE)

Ελλάδα
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: +30 2100101613

Österreich
KRKA PharmaGmbH, Wien
Tel: +43 (0)1 66 24 300

España
KRKA Farmacéutica, S.L.
Tel: +34 911 61 03 81

Polska
KRKA-POLSKA Sp.z o.o.
Tel.: +48 (0)22 573 7500

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: +351 (0)21 46 43 650

Hrvatska
KRKA – FARMA d.o.o.
Tel: + 385 1 6312 100

România
KRKA Romania S.R.L., Bucharest
Tel: +4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: +353 1 293 91 80

Slovenija
KRKA, d.d., Novo mesto
Tel: +386 (0) 1 47 51 100

Ísland
LYFIS ehf.
Sími: + 354 534 3500

Slovenská republika
KRKA Slovensko, s.r.o.,
Tel: +421 (0) 2 571 04 501

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: + 358 20 754 5330

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: +357 24 651 882

Sverige
KRKA Sverige AB
Tel: +46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: +371 6 733 86 10

United Kingdom
Consilient Health (UK) Ltd.
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