REPAGLINIDE AUROBINDO

Package leaflet: Information for the user

Repaglinide Aurobindo 0.5 mg tablets, 1 mg tablets, 2 mg tablets

Equivalent medicinal product
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 or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Repaglinide Aurobindo is and what it is used for
2. What you need to know before taking Repaglinide Aurobindo
3. How to take Repaglinide Aurobindo
4. Possible side effects
5. How to store Repaglinide Aurobindo
6. Contents of the pack and other information

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

Repaglinide Aurobindo is an oral antidiabetic medicine containing repaglinide, which helps your
pancreas produce more insulin, thereby reducing blood sugar (glucose) 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 produced.
Repaglinide Aurobindo is used to control type 2 diabetes in adults, in addition to diet and exercise.
Treatment is usually started when diet, physical activity, and weight reduction have not been sufficient to control (or reduce) blood sugar levels. Repaglinide Aurobindo may also be taken in combination with metformin, another medicine used to treat diabetes.
Repaglinide has been shown to reduce blood sugar, helping to prevent diabetes complications.

2. What you need to know before taking Repaglinide Aurobindo

Do not take Repaglinide Aurobindo:

• If you are allergic to repaglinide or to any of the other ingredients of this medicine (listed in section 6)
• If you have type 1 diabetes
• If your blood acid levels are 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 or pharmacist before taking Repaglinide Aurobindo:

• If you have liver problems. Repaglinide Aurobindo is not recommended in patients with moderate liver disease. Repaglinide Aurobindo must not be taken if you have severe liver disease (see Do not take Repaglinide Aurobindo).
• If you have kidney problems. Repaglinide Aurobindo should be used with caution.
• If you are about to undergo major surgery or have recently had a serious illness or infection. In these cases, control of your diabetes may be lost.
• If you are under 18 years of age or over 75 years of age. Repaglinide Aurobindo is not recommended. It has not been studied in this patient group.

Talk to your doctor if any of the above conditions apply to you, as Repaglinide Aurobindo may not be suitable for you. Your doctor will advise you accordingly.
Children and adolescents
Do not take this medicine if you are under 18 years of age.
If you have a hypoglycaemic attack (low blood sugar levels)
If your blood sugar level drops too low, you may experience a hypoglycaemic attack. This can occur:

• If you are taking too much Repaglinide Aurobindo
• If you are doing more physical exercise than usual
• If you are taking other medicines or have liver or kidney problems (see other sections of 2. What you need to know before taking Repaglinide Aurobindo).

Warning signs of a hypoglycaemic attack may appear suddenly and may include: cold sweats, pale and cold skin, headache, rapid heartbeat, feeling unwell, intense hunger, temporary vision changes, drowsiness, unusual tiredness and weakness, nervousness or trembling, anxiety or confusion, and difficulty concentrating.
If your blood sugar is low or you feel a hypoglycaemic attack coming on : you must take glucose tablets, a snack, or a sugary drink, and then rest.
Once the symptoms of hypoglycaemia have disappeared or your blood sugar levels have stabilized , continue your normal treatment with Repaglinide Aurobindo.
It is important that you inform others that you have diabetes and that in case of fainting (loss of consciousness) due to a hypoglycaemic attack, they must turn you onto your side and seek immediate medical help. Do not allow anyone to give you food or drink, as this could cause choking.

• If severe hypoglycaemia is not treated, it may cause brain damage (temporary or permanent) and even death.
• If you have a hypoglycaemic attack that causes you to faint or if you have frequent hypoglycaemic reactions, talk to your doctor. You may need to adjust your dose of Repaglinide Aurobindo, food intake, or physical activity.

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

• If you are taking too little Repaglinide Aurobindo;
• If you have an infection or fever;
• If you eat more than usual;
• If you do less physical exercise than usual.

Warning signs of high blood sugar levels appear gradually and include: increased urination, thirst, dry skin, and dry mouth.
Talk to your doctor. You may need to adjust your dose of Repaglinide Aurobindo, food intake, or physical activity.
Other medicines and Repaglinide Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You may take Repaglinide Aurobindo with metformin, another diabetes medicine, if prescribed by your doctor. Do not take Repaglinide Aurobindo if you are taking gemfibrozil (used to lower elevated fat levels in the blood).
Your body's response to Repaglinide Aurobindo may change if you take other medicines, especially the following:

• Monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• Beta-blockers (used to treat high blood pressure and certain heart conditions)
• ACE inhibitors (used to treat certain heart conditions)
• Salicylates (e.g. aspirin)
• Octreotide (used to treat cancer)
• Non-steroidal anti-inflammatory drugs (NSAIDs) (a type of painkiller)
• Steroids (anabolic steroids and corticosteroids – used for anaemia or to treat inflammation)
• Oral contraceptives (the pill)
• Thiazides (diuretics)
• Danazol (used to treat breast cysts and endometriosis)
• Thyroid products (used to treat patients with low thyroid hormone levels)
• Sympathomimetics (used to treat asthma)
• Clarithromycin, trimethoprim, and rifampicin (antibiotics)
• Itraconazole, ketoconazole (antifungal medicines)
• Gemfibrozil (used to treat high fat levels in the blood)
• Cyclosporine (used to suppress the immune system)
• Deferasirox (used to reduce chronic iron overload)
• Clopidogrel (prevents blood clots)
• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
• St. John’s wort (herbal remedy).

Repaglinide Aurobindo and alcohol
Alcohol may alter the ability of Repaglinide Aurobindo to lower blood sugar. Be alert for signs of hypoglycaemic reactions.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
You must not take Repaglinide Aurobindo if you are pregnant or planning a pregnancy.
You must not take Repaglinide Aurobindo if you are breastfeeding.
Driving and using machines
Your ability to drive or operate machinery may be affected by low or high blood sugar levels. Always keep in mind that you could be putting yourself and others at risk.
Ask your doctor whether you may drive if:

• you have frequent hypoglycaemic attacks;
• you have few or no warning signs of hypoglycaemia.

3. How to take Repaglinide Aurobindo

Take this medicine exactly as your doctor has told you. If you are unsure,
consult your doctor.
Your doctor will determine your dose.

• The usual starting dose is one 0.5 mg tablet taken before each main meal. Swallow the tablets with a glass of water immediately before, or up to 30 minutes before, each main meal.
• Your doctor may adjust your dose up to a maximum of 4 mg taken immediately before, or up to 30 minutes before, each main meal. The maximum recommended daily dose is 16 mg.

Do not take more Repaglinide Aurobindo than prescribed by your doctor.
If you take more Repaglinide Aurobindo than you should
If you take too many tablets, your blood sugar level may become too low and lead to
a hypoglycaemic episode. Read the section If you have a hypoglycaemic episode to find out what a hypoglycaemic episode is and how it should be treated.
If you forget to take Repaglinide Aurobindo
If you miss a dose, take your next dose as usual. Do not double the dose.
If you stop taking Repaglinide Aurobindo
You should be aware that if you stop treatment with Repaglinide Aurobindo, the desired effect will not be achieved and your diabetes may worsen. If any change in your treatment is needed, contact your doctor first.
If you have any doubts 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 everybody gets them.

Hypoglycaemia
The most common side effect is hypoglycaemia, which may affect up to 1 in 10 patients (see If you have a hypoglycaemic attack in section 2). Hypoglycaemic episodes are usually mild/moderate, but may occasionally progress to loss of consciousness or hypoglycaemic coma. If this occurs, immediate medical assistance is required.

Allergic reactions
Allergy is very rare (may affect up to 1 in 10,000 patients). Symptoms such as swelling, difficulty in breathing, rapid heartbeat, dizziness and sweating could 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

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

• Acute coronary syndrome (although this may not be caused by the medicine)

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

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

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

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

Reporting of side effects
If you experience any side effects, 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 at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Repaglinide Aurobindo

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton, label or blister after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Aurobindo contains

• The active substance is repaglinide. Each tablet contains 0.5 mg/1 mg/2 mg of repaglinide.

The other components are: calcium hydrogen phosphate (anhydrous), povidone, meglumine, poloxamer, glycerol, microcrystalline cellulose (grade 101), microcrystalline cellulose (grade 102), maize starch, potassium polacrilin, magnesium stearate, yellow iron oxide (for the 1 mg tablets), red iron oxide (for the 2 mg tablets).

Description of the appearance of Repaglinide Aurobindo and package contents

Repaglinide Aurobindo 0.5 mg tablets
Uncoated, white to almost white, round, biconvex tablets, marked with ‘H’ on one side and ‘10’ on the other side.

Repaglinide Aurobindo 1 mg tablets
Uncoated, yellow, round, biconvex tablets, marked with ‘H’ on one side and ‘11’ on the other side.

Repaglinide Aurobindo 2 mg tablets
Uncoated, peach-coloured, mottled, round, biconvex tablets, marked with ‘H’ on one side and ‘12’ on the other side.

Repaglinide Aurobindo tablets are available in blister packs and in HDPE bottles with polypropylene caps. Each HDPE bottle contains silica gel desiccant packets.

Pack sizes:
Blister pack: 1, 28, 30, 90, 100, 120, 180 and 270 tablets
Bottle pack: 30 and 1000 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via S. Giuseppe 102
21047 Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000
Malta

Milpharm Limited
Ares Block, Odyssey Business Park, West End Road,
South Ruislip HA4 6QD
United Kingdom

This medicinal product is authorized in the European Economic Area countries under the following names:
France: Repaglinide Arrow Lab 0.5 mg/1 mg/2 mg, comprimé
Germany: Repaglinid Aurobindo 0.5 mg/1 mg/2 mg Tabletten
Italy: Repaglinide Aurobindo
Malta: Repaglinide Aurobindo 0.5 mg/1 mg/2 mg Tablets
Spain: Repaglinida Aurobindo 0.5 mg/1 mg/2 mg comprimidos EFG