Repaglinide 2 mg. 90 tablets

What Repaglinide Accord is and what it is used for
Repaglinide Accord is an oral antidiabetic medicine containing repaglinide that helps your pancreas produce more insulin and thus reduces your blood glucose (glucose).

Type 2 diabetes is a disease in which your pancreas does not produce enough insulin to control your blood sugar or your body does not normally react to the insulin it produces.
Repaglinide Accord is used to control type 2 diabetes in adults as a complement to diet and physical activity: treatment usually begins when diet, exercise and weight loss can not control (or lower) your blood sugar . Repaglinide Accord can also be prescribed in combination with metformin, another antidiabetic medicine.
Repaglinide Accord has been shown to reduce blood sugar levels, which helps prevent complications from your diabetes.

 

2. What you need to know before you take Repaglinide accord
Do not take Repaglinide Accord:

If you are allergic to repaglinide or any of the other ingredients of the medicine (listed in section 6).

If you have type 1 diabetes
If the acidity in your body is elevated (diabetic ketoacidosis).
If you suffer from severe liver disease.
If you are taking gemfibrozil (a medicine used to lower elevated blood lipids).

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

If you have liver problems, Repaglinide Accord is not recommended for patients with moderate hepatic disease. Repaglinide Accord should not be used in severe liver disease.
If you have kidney problems, Repaglinide Accord should be taken with caution.
If you are going to have a major surgery or you have recently had a severe illness or infection. In such cases, diabetes control may be impaired.
If you are under 18 or over 75 years of age, Repaglinide Accord is not recommended. Its use has not been studied in these age groups.
Tell your doctor if any of the above applies to you, it is likely that treatment with Repaglinide Accord is not 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 experience hypoglycaemia (a decrease in your blood sugar level)
You may get hypoglycaemia (symptoms of low blood sugar) if your blood sugar gets too low. This can happen:

If you take too much Repaglinide Accord
At a greater than usual physical load
If you are taking other medicines or have liver or kidney problems
Warning signs of hypoglycaemia may occur suddenly and include: cold sweat; cool pale skin; headache; accelerated heart beating; feeling sick; strong hunger; temporary visual disturbances; drowsiness; unusual fatigue and weakness; nervousness or trembling; a sense of anxiety; confusion; difficult concentration.

If your blood sugar is low or you feel you are getting hypoglycaemia:
take glucose tablets, a sugar-rich breakfast or drink and take a rest.
When symptoms of hypoglycaemia disappear or when blood sugar levels stabilize, continue treatment with Repaglinide Accord.
Tell people around you that you have diabetes and that if you become faint (unconscious) due to hypoglycaemia, they should turn aside and immediately call for medical attention. They should not give you anything to eat or drink. It could choke you.

If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death
If you have unconscious hypoglycaemia or recurrent hypoglycaemia, talk to your doctor. The amount of Repaglinide Accord, food or physical exercise may need to be adjusted.
If your blood sugar gets too high
Your blood sugar may become too high (hyperglycaemia). This can happen:

If you take too little Repaglinide Accord
If you have an infection or fever
If you eat more than usual
Less than the usual physical load.
The warning symptoms of excessively high blood sugar appear gradually. These include: frequent urination; thirst; dry skin; dry mouth.
Consult your doctor. The amount of Repaglinide Accord, food or physical exercise may need to be adjusted.

Other medicines and Repaglinide Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You may take Repaglinide Accord in combination with metformin, another antidiabetic medicine. If you are taking gemfibrozil (used to lower elevated levels of blood lipids), you should not take Repaglinide Accord.
Your body's response to Repaglinide Accord
Thyroid hormones (used to treat low levels of thyroid hormones)

- Sympathomimetics (used to treat asthma)

- Clarithromycin, trimethoprim, rifampicin (antibiotic medicines)

- Itraconazole, ketoconazole (antifungal medicines)

- Gemfibrozil (used to treat high levels of lipids in the blood)

- Ciclosporin (used to suppress the immune system)

- Deferasirox (used to reduce chronic iron accumulation in the body)

- Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)

- St John's wort (herbal medicinal product)

 

Taking Repaglinide Accord with food, drink and alcohol
Alcohol may change the ability of Repaglinide Accord to reduce blood sugar. Watch out for signs of hypoglycaemia.

Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor before taking this medicine.
Repaglinide Accord should not be taken if you are pregnant or planning to become pregnant.
You should not take Repaglinide Accord if you are breast-feeding.

Driving and using machines
Your ability to drive or use machines may be impaired if your blood sugar is low or high. Keep in mind that you can expose yourself or others to danger. Please ask your doctor if you can drive if:

You get frequent hypoglycemia
You get little or no warning signs of hypoglycaemia.

3. How to take Repaglinide accord
Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist. Your doctor will determine your dose.

The usual starting dose is 0.5 mg taken prior to each main meal. Swallow the tablets with a glass of water just before or within 30 minutes before each main meal.
The dose can be adjusted by your doctor with up to 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 Repaglinide Accord any longer than your doctor has told you.
Consult your doctor if you are not sure.

If you take more Repaglinide Accord than you should
If you take too many tablets, your blood sugar may fall too low resulting in hypoglycaemia. Please see If you experience hypoglycaemia about hypoglycaemia and how to treat it.

If you forget to take Repaglinide Accord
If you miss a dose, take the next dose as usual - do not double the dose.

If you stop taking Repaglinide Accord
Keep in mind that if you stop taking Repaglinide Accord, the desired effect will not be achieved. Your diabetes may get worse. If you need to make any changes to your treatment, contact 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 everyone gets them.
Hypoglycemia
The most common side effect is hypoglycaemia, which may affect up to 1 in 10 patients (see If you get hypoglycaemia in section 2). Hypoglycaemic reactions are usually mild / moderate but may in some cases develop to hypoglycaemic loss of consciousness or coma. If this happens, seek medical attention immediately.

Alergy
Allergy is very rare (it can affect up to 1 in 10,000 patients). The Signs of
the anaphylactic reaction may be swelling, difficulty breathing, fasting
heartburn, feeling dizzy and sweating. Contact a doctor immediately.

Other Adverse Reactions
Common (may affect up to 1 in 10 patients)
- Stomachache
- Diarrhea

Rare (may affect up to 1 in 1,000 patients)
- Acute coronary syndrome (but may not be due to the medicine).

Very rare (may affect up to 1 in 10,000 patients)
- Vomiting
- Constipation
- Visual disturbances
- Severe hepatic impairment, impaired hepatic function, increased liver enzymes in the blood.

Not known
- Hypersensitivity (such as rash, itching, redness, swelling of the skin)
- Lift (nausea).
If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not listed in this leaflet

 

5. How to store Repaglinide Accord
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the label of the carton on the bottle and the 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 medicines in the sewers or in the household waste container.
Ask your pharmacist how to dispose of medicines you no longer use.
These measures will
6. Packaging content and additional 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 hydrogenphosphate, maize starch, meglumine, poloxamer 188, povidone, glierin, yellow iron oxide (E172) only in the 1 mg tablets and red iron oxide (E172) only in the 2 mg tablets.

 

What Repaglinide Accord looks like and contents of the pack

Repaglinide Accord 0.5 mg tablets are white to off-white, round, biconvex, bevelled, uncoated, with "R" on one side and no inscription on the other.

Repaglinide Accord 1 mg tablets are light yellow to yellow, round, biconvex, bevelled, uncoated, with the inscription "R" on one side and no inscription on the other, may have spots.

Repaglinide Accord 2 mg tablets are peach-colored, round, biconvex, with a bevelled edge, uncoated, with "R" on one side and no inscription on the other, may have spots.

 

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