REPAGLINIDE 0.5 MG Tabletki

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

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

Generic medicine

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, pharmacist or nurse.
• 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, 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 you take 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 is Repaglinide Aurobindo and what is it used for

Repaglinide Aurobindo is an oral antidiabetic medicine containing repaglinide that helps your
pancreas to produce more insulin, thus reducing blood sugar (glucose) levels.
Type 2 diabetesis a condition in which the pancreas does not produce enough insulin to control
blood sugar levels or in which your 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 alone: treatment is usually started if diet, exercise
and weight loss have not been able to control (or reduce) blood sugar
levels. Repaglinide Aurobindo can also be taken in combination with metformin, another
medicine used for diabetes.
Repaglinide has been shown to reduce blood sugar, helping to prevent
diabetes complications.

2. What you need to know before you take Repaglinide Aurobindo

Do not take Repaglinide Aurobindo:

• 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 you have high levels of acid in your blood (diabetic ketoacidosis)
• If you have severe liver disease
• If you are taking gemfibrozil(a medicine used to decrease levels of fats 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 must be taken with caution.
• If you are about to have major surgery or have recently suffered from a serious illness, or infection. In these cases, your diabetes control may be lost.
• If you are under 18 years of ageor over 75 years of age. Repaglinide Aurobindo is not recommended. It has not been studied in this patient group.

Talk to your doctorif any of the above conditions apply to you, as Repaglinide Aurobindo 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 hypoglycaemia (low blood sugar)
If your blood sugar gets too low, you may have hypoglycaemia. This can
happen:

• If you are taking too much Repaglinide Aurobindo
• If you are doing more 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 you take Repaglinide Aurobindo).

The warning signsof hypoglycaemiacan appear suddenly and may
include: cold sweats, pale and cold skin, headache, rapid heartbeat, feeling unwell, feeling of intense hunger, temporary changes in vision, drowsiness,
tiredness and unusual weakness, nervousness or tremor, feeling anxious or confused and difficulty
concentrating.

If your blood sugar is low or you feel that hypoglycaemia is about to occur: you should take glucose tablets or a snack or a sugary drink, and then rest.

When the symptoms of hypoglycaemia have disappeared or when your blood sugar levels have
stabilized, continue your treatment with Repaglinide Aurobindo as normal.

It is important that you inform others that you have diabetes and that in case of fainting(loss of
consciousness) due to hypoglycaemia, they should turn you onto your side and seek
immediate medical help. They should not give you anything to eat or drink, as it could
cause you to choke.

• Ifsevere hypoglycaemiais not treated it can cause damage to the brain (temporary or permanent) and even death.
• If you have hypoglycaemiathat causes fainting or if you have many hypoglycemic reactions, talk to your doctor. You may need to change the amount of Repaglinide Aurobindo, food or exercise.

If your blood sugar becomes too high
Your blood sugar can become too high (hyperglycemia). This can happen:

• 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 exercise than usual.

The warning signsof blood sugar levels that are too highappear gradually.
These include: increased urination, feeling thirsty, dry skin and dry mouth.
Talk to your doctor. You may need to change the amount of Repaglinide
Aurobindo, food or exercise.

Other medicines and Repaglinide Aurobindo
Tell your doctoror pharmacist if you are taking, have recently taken or might take
any other medicines.
You can take Repaglinide Aurobindo with metformin, another medicine for diabetes, if
your doctor prescribes it for you. If you are taking gemfibrozil (used to lower increased levels of fats
in the blood) you must not take Repaglinide Aurobindo.
The way your body responds to Repaglinide Aurobindo can 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 some heart conditions)
• ACE inhibitors (used to treat some 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 anemia 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 levels of thyroid hormones)
• Sympathomimetics (used to treat asthma)
• Clarithromycin, trimethoprim and rifampicin (antibiotics)
• Itraconazole, ketoconazole (antifungal medicines)
• Gemfibrozil (used to treat high levels of fats 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 medicine).

Repaglinide Aurobindo with alcohol
Alcohol can change the ability of Repaglinide Aurobindo to lower blood sugar. Be
alert for any signs of hypoglycemic reactions.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice 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 use machines may be affected by low or high blood
sugar levels. Always be aware that you could endanger yourself and others.
Ask your doctor if you can drive when:

• you have frequent hypoglycemic episodes;
• you have few or no warning signs of hypoglycemic episodes.

3. How to take Repaglinide Aurobindo

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

• The usual starting doseis one 0.5 mg tablet to be taken before each main meal. Swallow the tablets with a glass of water immediately before or up to 30 minutes before each main meal.
• The dose may be adjusted by your doctor up to 4 mg to be 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 your doctor has prescribed.

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 hypoglycemic crisis. Read the paragraph If you have a hypoglycemic crisisto know what a hypoglycemic
crisis is and how it should be treated.

If you forget to take Repaglinide Aurobindo
If you forget a dose, take the next dose as usual. Do not double the dose.

If you stop taking Repaglinide Aurobindo
You should be informed that if you stop treatment with Repaglinide Aurobindo, you will not
achieve the desired effect and your diabetes may worsen. If any change in your
treatment is necessary, contact your doctor first.
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 frequent side effect is hypoglycemia which can affect up to 1 in 10 patients (see

If you have a hypoglycemic crisisin section 2). Hypoglycemic crises are generally
mild/moderate, but can occasionally progress to loss of consciousness or hypoglycemic coma.
If this happens, immediate medical assistance is necessary.
Allergies
Allergy is very rare (can affect up to 1 in 10,000 patients). Symptoms such as swelling, difficulty
breathing, rapid 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 patients):

• Stomach pain
• Diarrhea.

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

• Acute coronary syndrome (although this may not be due to the medicine).

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

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

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

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through 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 particular storage conditions.
Do not use this medicine after the expiry date which is stated on the package, label or on the
blister after EXP. The expiry date refers to the last day of that month.
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 Aurobindo contains

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

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

Description of the appearance of Repaglinide Aurobindo and package contents
Repaglinide Aurobindo 0.5 mg tablets
Uncoated tablets, white to off-white, round, biconvex, with ‘H’ imprinted on one side and
‘10’ on the other side.
Repaglinide Aurobindo 1 mg tablets
Uncoated tablets, yellow in colour, round, biconvex, with ‘H’ imprinted on one side and ‘11’
on the other side.
Repaglinide Aurobindo 2 mg tablets
Uncoated tablets, peach-coloured, mottled, round, biconvex, with ‘H’ imprinted on one side and
‘12’ on the other side.
Repaglinide Aurobindo tablets are available in blister packs and in HDPE bottles
with a polypropylene closure. Each HDPE bottle contains silica gel sachets (as
a desiccant).
Packs:

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 Authorisation 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 authorised in the Member States of the European Economic Area with the
following denominations:
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