ENYGLID 0.5 MG Tabletki

Treść ulotki

1. Enyglid 0.5 mg tablets, 1 mg tablets, 2 mg tablets
   1. What is Enyglid and what is it used for
   2. What you need to know before taking Enyglid
   3. How to take Enyglid
   4. Possible side effects
   5. How to store Enyglid
   6. Package contents and other information

Enyglid 0.5 mg tablets, 1 mg tablets, 2 mg tablets

repaglinide

Read this leaflet carefully before 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 they have the same symptoms as you, as 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 Enyglid is and what it is used for
• 2. What you need to know before you take Enyglid
• 3. How to take Enyglid
• 4. Possible side effects
• 5. How to store Enyglid
• 6. Contents of the pack and other information

1. What is Enyglid and what is it used for

Enyglid 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
produces.
Enyglid is used to control type 2 diabetes in adults in addition to diet and exercise:
treatment usually begins when diet, physical activity and weight loss are not
sufficient, on their own, to control (or reduce) blood sugar levels.
Enyglid can also be administered in association with metformin, another medicine for
diabetes.
Enyglid has shown to reduce blood sugar levels and this contributes to preventing the
complications of diabetes.

2. What you need to know before taking Enyglid

Do not take Enyglid:

• if you are allergic to repaglinide or any of the other ingredients contained 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 severe liver disease,
• if you are taking gemfibrozil(medicine used to lower blood fat levels).

Warnings and precautions
Talk to your doctor before taking Enyglid:

• If you have liver problems. Enyglid is not recommended in patients who have moderate liver disease. Enyglid must not be taken in case of severe liver disease (see Do not take Enyglid).
• If you have kidney problems. Enyglid 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, your diabetes may no longer be under control.
• Enyglid is not recommended if you are under 18 years of ageor over 75 years of age. Repaglinide has not been studied in these age groups. Talk to your doctorif any of the above conditions apply to you, Enyglid 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 Enyglid,
• 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 before taking Enyglid). The warning signs of hypoglycemiacan occur suddenly and may include: cold sweat; cold and pale skin; headache; rapid heartbeat; feeling unwell (nausea); strong feeling 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 glucose tablets 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 Enyglid. Explain to people that you are diabetic and that, in the event that you 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 cause you to choke.
• If severe hypoglycemiais not treated, it can cause brain damage (temporary or permanent) up to death.
• If you have hypoglycemiathat causes you to lose consciousness, or have repeated episodes of hypo, consult your doctor. It may be necessary to change the dose of Enyglid, your diet or the type of exercise. If your blood sugar becomes too highThe level of sugar in your blood can become too high (hyperglycemia). This can happen:
• if you have taken Enyglid in an insufficient amount,
• 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 Enyglid you take, your diet
or exercise.

Other medicines and Enyglid
Tell your doctoror pharmacist if you are taking, have recently taken or might take
any other medicines.
You can take Enyglid 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 must not take Enyglid.
The body's response to Enyglid may vary if you take other medicines, in particular:

• Monoamine oxidase inhibitors (MAOIs) (used to treat depression).
• Non-selective beta-blockers (used to treat high blood pressure and some heart conditions).
• ACE inhibitors, i.e. Angiotensin Converting Enzyme (ACE) inhibitors (used to treat some heart conditions).
• Salicylates (e.g. aspirin).
• Octreotide (used to treat tumors).
• Non-steroidal anti-inflammatory drugs (NSAIDs) (a type of painkiller).
• 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).

Enyglid with alcohol
Enyglid's ability 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 must not take Enyglid if you are pregnant or planning a pregnancy.
You must not take Enyglid 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 endanger yourself and others. Ask your doctor if you can drive
a vehicle if:

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

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

3. How to take Enyglid

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

• The initial dose is usually 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 modified by the 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 dosages of Enyglid higher than those prescribed by your doctor. If you take more Enyglid than you shouldIf you take too many tablets, your blood sugar may become too low, up to having ’hypoglycemia. See If you have hypoto know what hypo is and how to treat it. If you forget to take EnyglidIf you miss a dose, take the next one as usual, but without doubling it. If you stop treatment with EnyglidKeep in mind that if you stop treatment with Enyglid the desired effect will not be achieved. Diabetes may worsen. Contact your doctor first if you need to change the treatment. If you have any doubts 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.
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 progress to loss of consciousness 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)
• Acute coronary syndrome (but this effect may not be related to the medicine). Very rare(may affect up to 1 in 10,000)
• Vomiting
• Constipation
• Vision disorders
• Severe liver problems, abnormal liver function, increased liver enzymes in the blood. Not known(the frequency cannot be estimated from available data)
• Hypersensitivity (such as skin rash, itching, redness of the skin, 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 Enyglid

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 protect the medicine 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 Enyglid 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 “Enyglid contains sodium”. Description of the appearance of Enyglid and package contentsThe 0.5 mg tablets are white, round, biconvex and with beveled edges. The 1 mg tablets are light yellow-brown in color, round, biconvex with beveled edges and possible darker spots. The 2 mg tablets are marbled pink in color, round, biconvex with beveled edges and possible darker spots. Packages with blisters containing 30, 60, 90, 120, 180, 270 or 360 tablets are available. Not all pack sizes may be marketed. Marketing authorization holderKRKA, 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 Authorization 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.: +361 (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 Pharma GmbH, Wien
Tel: +43 (0)1 66 24 300

España
KRKA Farmacéutica, S.L.
Tel: +34 911610381

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