Enyglid 0.5 mg tablets

2. What you need to know before you take Enyglid

Do not take Enyglid

• 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 your blood acid level has increased (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

Consult your doctor before taking Enyglid:

• If you have liver problems. Enyglid is not recommended for patients with moderate liver disease. Enyglid should 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 going to have major surgeryor have recently had a serious illness or infection. In these circumstances, you may not be able to control your diabetes.
• If you are under 18or over 75 years old, Enyglid is not recommended. It has not been studied in these age groups.

Consult your doctorif any of the above applies to you. 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 old.

If you have low blood sugar (hypoglycaemia)

You may have hypoglycaemia if your blood sugar level is too low. This can happen:

• If you take too much Enyglid.
• If you do more exercise than usual.
• If you take other medicines or have kidney or liver problems (see other sections of section 2, What you need to know before you take Enyglid).

Warning signs of hypoglycaemiaappear suddenly and can be: cold sweat, cool pale skin, headache, fast heartbeat, nausea, excessive hunger, temporary visual disturbances, fatigue, unusual weakness, nervousness or tremor, anxiety, confusion, and difficulty concentrating.

If your blood sugar level is low or if you feel that you are going to have hypoglycaemia:take glucose tablets or a sugary product or drink, and then rest.

When the symptoms of hypoglycaemia have disappeared or when your blood sugar levels have stabilised, continue with your treatment with Enyglid.

Tell others that you have diabetesand if you lose consciousnessdue to hypoglycaemia, they should lay you on your side and seek immediate medical assistance. They should not give you anything to eat or drink, as you may choke.

• If severe hypoglycaemiais not treated, it can cause brain damage (temporary or permanent) or even death.
• If you have hypoglycaemiathat makes you lose consciousness or if you have repeated hypoglycaemias, tell your doctor. You may need to adjust the dose or administration schedule of Enyglid, your diet, or exercise.

If your blood sugar level is very high

Your blood sugar level may be very high (hyperglycaemia). This can happen:

• If you take too little Enyglid,
• If you have an infection or fever,
• If you eat more than usual,
• If you do less exercise than usual.

Warning signs of high blood sugarappear gradually. These include: excessive urination, thirst, dry skin, and a dry mouth feeling. Inform your doctor. You may need to adjust the dose of Enyglid, your diet, or exercise.

Using Enyglid with other medicines

Tell your doctoror pharmacist if you are taking, have recently taken, or might take any other medicines.

If your doctor prescribes it, you can take Enyglid with metformin, another diabetes medicine.

If you are taking gemfibrozil (used to lower fat levels in the blood), you should not take Enyglid.

Your body's response to Enyglid may change if you take other medicines, especially:

• Monoamine oxidase inhibitors (MAOIs) (for depression treatment).
• Beta-blockers (for high blood pressure or heart disease treatment).
• ACE inhibitors (for heart disease treatment).
• Salicylates (e.g., aspirin).
• Octreotide (for cancer treatment).
• Non-steroidal anti-inflammatory drugs (NSAIDs) (a type of pain reliever).
• Steroids (anabolic steroids and corticosteroids, for anaemia or to treat inflammation).
• Oral contraceptives (to prevent pregnancy).
• Thiazides (diuretics).
• Danazol (for breast cysts and endometriosis treatment).
• Thyroid products (for low thyroid hormone levels treatment).
• Sympathomimetics (for asthma treatment).
• Clarithromycin, trimethoprim, rifampicin (antibiotic medicines).
• Itraconazole, ketoconazole (medicine for fungal infections).
• Gemfibrozil (to treat high fat levels in the blood).
• Ciclosporin (to suppress the immune system).
• Deferasirox (to reduce chronic iron overload)
• Clopidogrel (to prevent blood clots)
• Phenytoin, carbamazepine, phenobarbital (for epilepsy treatment).
• St John's Wort (a herbal medicinal plant).

Using Enyglid with alcohol

Alcohol may change the effect of Enyglid on lowering your blood sugar level. Be aware of the signs of hypoglycaemia.

Pregnancy and breast-feeding

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.

Do not take Enyglid if you are pregnant or planning to become pregnant.

Do not take Enyglid if you are breast-feeding.

Driving and using machines

Your ability to drive or use machines may be affected if your blood sugar level is too low or too high. Be aware that you may put yourself or others at risk.

Consult your doctor about the possibility of driving a car if:

• You have frequent hypoglycaemias
• You have few or no symptoms of hypoglycaemia

Enyglid contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Enyglid

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor again.

Your doctor will calculate your dose.

• Normally, the initial dose is 0.5 mg taken just before each main meal. The tablets should be taken with a glass of water just before or within 30 minutes before each main meal.
• The dose may be adjusted by your doctor up to 4 mg, which should be taken just before or within 30 minutes before each main meal. The maximum recommended dose is 16 mg per day.

Do not take more Enyglid than your doctor has recommended.

If you take more Enyglid than you should

If you take too many tablets, your blood sugar level may become too low and cause hypoglycaemia. Please read what hypoglycaemia is and how to treat it in the section If you have low blood sugar (hypoglycaemia).

If you forget to take Enyglid

If you miss a dose, take the next dose as you normally would.

Do not take a double dose to make up for forgotten doses.

If you stop taking Enyglid

Be aware that the desired effect will not be achieved if you stop taking Enyglid. Your diabetes may worsen. If any change in your treatment is needed, consult your doctor first.

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.

Hypoglycaemia

The most common side effect is hypoglycaemia, which can affect up to 1 in 10 people (see If you have low blood sugar (hypoglycaemia) in section 2). Hypoglycaemic reactions are usually mild or moderate but can occasionally lead to loss of consciousness or hypoglycaemic coma. If this happens, you need immediate medical assistance.

Allergic reactions

Cases of allergic reactions are very rare (may affect up to 1 in 10,000 people). Symptoms like swelling, difficulty breathing, fast heartbeat, dizziness, and sweating may be signs of an anaphylactic reaction. Contact your doctor immediately.

Other side effects

Common(may affect up to 1 in 10 people)

• Stomach pain
• Diarrhoea

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

• Acute coronary syndrome (but may not be due to the medicine)

Rare(may affect up to 1 in 10,000 people):

• Vomiting
• Constipation
• Visual disturbances
• Severe liver problems, abnormal liver function such as increased liver enzymes in the blood

Frequency not known(cannot be estimated from the available data)

• Hypersensitivity (such as rash, itching, redness, and swelling)
• Feeling unwell (nausea)

Reporting of side effects

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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Enyglid

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 or carton after EXP. The expiry date refers to the last day of that month.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack 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 other ingredients are microcrystalline cellulose (E460), calcium hydrogen phosphate, sodium croscarmellose, 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 “Enyglid contains sodium”.

Appearance of Enyglid and pack contents

The 0.5 mg tablets are white, round, and biconvex with bevelled edges.

The 1 mg tablets are pale yellow-brown, round, and biconvex with bevelled edges and possible dark spots.

The 2 mg tablets are pink, mottled, round, and biconvex with bevelled edges and possible dark spots.

Available in packs of 30, 60, 90, 120, 180, 270, or 360 tablets in blisters. Not all pack sizes may be marketed.

Marketing authorisation holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

ManufacturerKRKA, 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 medicine, please contact the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency (EMA) website http://www.ema.europa.eu/.