Enyglid: detailed information

Patient Information Leaflet

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

repaglinide
Please 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Enyglid is and what it is used for
What you need to know before taking Enyglid
How to take Enyglid
Possible side effects
How to store Enyglid
Contents of the pack and other information

1. What Enyglid is and what it is used for

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

2. What you need to know before taking Enyglid

Do not take Enyglid:

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 fat levels in the blood).

Warnings and precautions
Talk to your doctor before taking Enyglid:

If you have liver problems. Enyglid is not recommended for patients with moderate liver disease. Enyglid must not be taken if you have 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 surgery or 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 age or over 75 years of age. Repaglinide has not been studied in these age groups. Talk to your doctor if any of the above conditions apply to you, as Enyglid 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 a hypo (low blood sugar level) If your blood sugar level drops too low, you may experience a hypo (short for hypoglycaemia). This can happen:
if you have taken too much Enyglid,
if you do more physical activity than usual,
if you take other medicines or have liver or kidney problems (see other sections of paragraph 2. What you need to know before taking Enyglid). Warning signs of a hypoglycaemic attack may occur suddenly and may include: cold sweating; 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 lumps or have a snack or a sugary drink, then rest. When hypoglycaemia symptoms disappear or when your blood sugar has stabilized, continue treatment with Enyglid. Inform 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 for medical help. Do not let them give you food or drink. These could cause choking.
If severe hypoglycaemia is not treated, it may lead to brain damage (temporary or permanent) and even death.
If you have hypoglycaemia that causes you to lose consciousness, or if you have repeated episodes of hypos, consult your doctor. Your dose of Enyglid, 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 Enyglid,
if you have an infection or fever,
if you have eaten more than usual,
if you have done less physical activity than usual.

Warning signs of high blood sugar levels appear gradually and include: increased urination, thirst, dryness of the skin and mouth.
Contact your doctor. Your dose of Enyglid, your diet, or your physical activity may need to be adjusted.
Other medicines and Enyglid
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You may take Enyglid in combination with metformin, another diabetes medicine, if prescribed by your doctor.
If you are taking gemfibrozil (used to lower fat levels in the blood), you must not take Enyglid.
Your body's response to Enyglid may be affected by other medicines, particularly:

Monoamine oxidase inhibitors (MAOIs) (used to treat depression).
Non-selective beta-blockers (used to treat high blood pressure and certain heart conditions).
ACE inhibitors (angiotensin-converting enzyme inhibitors) (used to treat certain 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 stimulate diuresis, i.e. “urine elimination”).
Danazol (used to treat breast cysts and endometriosis).
Thyroid products (used in case of low thyroid hormone levels).
Sympathomimetics (used to treat asthma).
Clarithromycin, trimethoprim, rifampicin (antibiotic medicines).
Itraconazole, ketoconazole (medicines for fungal infections).
Gemfibrozil (used to lower fat levels in the blood).
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).

Enyglid and alcohol
The ability of Enyglid 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, think you may be pregnant, or are planning to become pregnant, inform your doctor before taking this medicine.
You must not take Enyglid if you are pregnant or planning to become pregnant.
You must not take Enyglid 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.
Keep in mind that this could put yourself and others at risk. Ask your doctor whether you may drive if:

you experience frequent hypoglycaemic episodes,
you do not feel the warning signs of hypoglycaemia or feel them only slightly.

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 exactly as your doctor has instructed you. If you have any doubts,
consult your doctor.
Your doctor will determine the dose 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 Enyglid in amounts higher than those prescribed by your doctor. If you take more Enyglid than you should If you take too many tablets, your blood sugar may become too low, leading to hypoglycemia. See If you have a hypo to find out what a hypo is and how to treat it. If you forget to take Enyglid If you miss a dose, take the next one as usual, but do not double the dose. If you stop taking Enyglid Please note that if you stop treatment with Enyglid, the desired effect will not be achieved. Your diabetes may worsen. Contact your doctor first if it is necessary to change your treatment. If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 (however, this effect may not be related to the medicine)
Very rare (may affect up to 1 in 10,000 people)
Vomiting
Constipation
Visual disturbances
Severe liver problems, abnormal liver function, increased liver enzymes in the blood
Not known (frequency cannot be estimated from available data)
Hypersensitivity (such as 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 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 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 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, croscarmellose sodium, 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 “Enyglid contains sodium”. Description of the appearance of Enyglid and contents of the pack The 0.5 mg tablets are white, round, biconvex and with bevelled edges. The 1 mg tablets are light yellow-brown, round, biconvex with bevelled edges and may have darker spots. The 2 mg tablets are mottled pink, round, biconvex with bevelled edges and may have darker spots. Packs with blisters containing 30, 60, 90, 120, 180, 270 or 360 tablets are 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 on 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.: + 361 (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 Pharma GmbH, 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 911610381 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