REPAGLINIDE AKKORD 0.5 mg Tablet

Зміст інструкції

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

Repaglinide Accord 0.5 mg tablets, 1 mg tablets, 2 mg tablets

Repaglinide

Read this leaflet carefully before you start to take 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 their symptoms are the same as yours, as it could 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 Repaglinide Accord is and what it is used for
• 2.What you need to know before you take Repaglinide Accord
• 3.How to take Repaglinide Accord
• 4.Possible side effects
• 5.How to store Repaglinide Accord
• 6.Contents of the pack and other information

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

Repaglinide Accord is an oral antidiabetic medicinecontaining repaglinidethat helps the pancreas to
produce a greater amount of insulin and thus to reduce the level of sugar (glucose) 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 body does not respond normally to the insulin that
produces.
Repaglinide Accord 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 glucose levels.
Repaglinide Accord can also be administered in association with metformin, another
medicine for diabetes.
Repaglinide Accord has been shown to reduce blood sugar levels and this contributes to
preventing the complications of diabetes.

2. What you need to know before taking Repaglinide Accord

Do not take Repaglinide Accord:

• 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 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 the level of fats in the blood).

Warnings and precautions
Talk to your doctor before taking Repaglinide Accord:

• If you have liver problems. Repaglinide Accord is not recommended in patients who have moderate liver disease. Repaglinide Accord should not be taken in case of severe liver disease (see Do not take Repaglinide Accord).
• If you have kidney problems. Repaglinide Accord must 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, diabetes may no longer be under control.
• Repaglinide Accord is not recommended if you are under 18 years of ageor over 75 years of age. Repaglinide Accord has not been studied in these age groups.

Talk to your doctorif any of the above conditions apply to you, Repaglinide Accord 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)
If your blood sugar level drops too low, you may experience a hypo
(abbreviation for hypoglycemic). This can happen:

• If you take too much Repaglinide Accord
• If you do more physical activity than usual
• If you take other medicines or suffer from liver or kidney disorders (see other sections of paragraph 2. What you need to know before taking Repaglinide Accord).

The warning signs of hypoglycemiacan occur suddenly and may
include: cold sweat; cold and pale skin; headache; rapid heartbeat; feeling
unwell; strong feeling of hunger; temporary visual disturbances; drowsiness; fatigue and unusual weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating.

If your blood sugar is low or if you feel a hypoglycemic attack coming on:eat sugar cubes 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 Repaglinide Accord.

Explain to people that you are diabetic and that, if you were to faint(lose consciousness) a
cause of a hypo, they must turn you on your side and request immediate medical attention. Do 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 makes you lose consciousness, or have repeated episodes of hypoglycemia, consult your doctor. It may be necessary to change the dose of Repaglinide Accord, diet or type of exercise.

If your blood sugar becomes too high
The level of sugar in your blood can become too high (hyperglycemia). This can
happen:

• If you take Repaglinide Accord in insufficient quantities
• If you have an infection or fever
• If you eat more than usual
• If you do less physical activity than usual.

The warning signs of a blood sugar level that is too highappear gradually. They
include: increased urination; thirst; dryness of the skin and mouth. Consult your doctor.
It may be necessary to change the amount of Repaglinide Accord to be taken, diet or
exercise.

Other medicines and Repaglinide Accord
Tell your doctoror pharmacist if you are taking, have recently taken or might take
any other medicines.
You can take Repaglinide Accord in combination with metformin, another medicine for diabetes,
if your doctor prescribes it.
If you are taking gemfibrozil (used to lower the level of fats in the blood) you should not take
Repaglinide Accord.
The body's response to Repaglinide Accord may vary if you take other drugs, in particular:.

• Monoamine oxidase inhibitors (MAOIs, used to treat depression)
• Beta-blockers (used to treat high blood pressure and heart disease)
• ACE inhibitors (used to treat heart disease)
• 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 for the treatment of inflammation)
• Oral contraceptives (used for birth control)
• Thiazides (diuretics or “water pills”)
• Danazol (used to treat breast cysts and endometriosis)
• Thyroid hormones (used in case of low levels of thyroid hormones)
• Sympathomimetics (used to treat asthma)
• Clarithromycin, trimethoprim, rifampicin (antibiotics)
• Itraconazole, ketoconazole (medicine against fungal infections)
• Gemfibrozil (used to lower the level of fats in the blood)
• 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).

Repaglinide Accord with alcohol
The ability of Repaglinide Accord to lower blood sugar may vary if you drink alcohol. Pay attention
to the signs of hypoglycemia.

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 should not take Repaglinide Accord if you are pregnant or planning a pregnancy.
You should not take Repaglinide Accord if you are breastfeeding.

Driving and operating machinery
The ability to drive or operate machinery 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 hypoglycemic episodes
• You do not feel the warning signs of hypoglycemia or feel few of them.

3. How to take Repaglinide Accord

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

• The initial dose is usually0.5 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 Repaglinide Accord higher than those prescribed by your doctor.

If you take more Repaglinide Accord than you should
If you take too many tablets, your blood sugar may become too low, up to having
hypoglycemia. See If you have hypofor what hypo is and how to treat it.

If you forget to take Repaglinide Accord
If you miss a dose, take the next one as usual, but do not take a double dose to
compensate for the missed dose.

If you stop taking Repaglinide Accord
Keep in mind that if you stop treatment with Repaglinide Accord the desired effect will not be
achieved. Diabetes may worsen. Contact your doctor first if it is necessary to change the
treatment.
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.
Hypoglycemia
The most common side effect is hypoglycemia which can affect up to 1 in 10 patients (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 (may 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 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 people)

• Acute coronary syndrome (but this effect may not be related to the medicine).

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

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

Frequency not known

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

Reporting of side effects
Ifyou get any side effects, talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system reported in Annex V. By
reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Repaglinide Accord

Keep this medicine out of sight and reach of children.
Do not use Repaglinide Accord after the expiry date, which is stated on the package, bottle,
label and blister after Exp./ . The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Accord contains
The active ingredient is repaglinide.
Repaglinide Accord 0.5 mg: each tablet contains 0.5 mg of repaglinide
Repaglinide Accord 1 mg: each tablet contains 1 mg of repaglinide
Repaglinide Accord 2 mg: each tablet contains 2 mg of repaglinide
The other ingredients are microcrystalline cellulose, anhydrous calcium hydrogen phosphate, corn starch,
meglumine, poloxamer 188, povidone, glycerol, magnesium stearate, yellow iron oxide (E172) only
in the 1 mg tablets and red iron oxide (E172) only in the 2 mg tablets.

Description of the appearance of Repaglinide Accord and package contents
Repaglinide Accord 0.5 mg tablets are round, biconvex, with a beveled edge, of color
from white to off-white, with the inscription ‘R’ embossed on one side and smooth on the other side.
Repaglinide Accord 1 mg tablets are round, biconvex, with a beveled edge, of color from
pale yellow to yellow, with the inscription ‘R’ embossed on one side and smooth on the other side; may have an
uneven color.
Repaglinide Accord 2 mg tablets are round, biconvex, with a beveled edge, of color
peach, with the inscription ‘R’ embossed on one side and smooth on the other side; may have an
uneven color.
Repaglinide Accord is available in the following pack sizes:
30, 90, 120, 180 and 270 tablets in blisters.
100 tablets in a HDPE (high-density polyethylene) bottle.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu