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What is Indorin and what it is used for
Indorin 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 blood sugar or your body does not normally respond to the insulin it produces (formerly known as non-insulin dependent diabetes mellitus or diabetes in adults). Indorin is used to control type 2 diabetes as an adjunct to diet and physical activity: treatment usually begins when you can not control (or lower) your blood sugar by diet, physical activity and weight loss. Indorin may also be prescribed in combination with metformin, another antidiabetic medicinal product.
2. What you need to know before taking Indorin
Do not take Indorin
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 (insulin-dependent diabetes mellitus)
If the acid level in your body is increased (diabetic ketoacidosis)
If you suffer from severe liver disease
If you are taking gemfibrozil (a medicine to lower your blood lipid levels).
If any of the above applies to you, tell your doctor and do not take Indorin.
Warnings and precautions
Talk to your doctor or pharmacist before taking Indorin:
If you have liver problems. Indorin is not recommended in patients with moderate hepatic disease. Indorin should not be used in severe liver disease (see Do not take Indorin).
If you have kidney problems. Indorin 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. Indorin is not recommended. Its use has not been studied in these age groups.
If you get a hypoglycaemia
You may get a hypoglycaemia (symptoms of low blood sugar) if your blood sugar gets too low. This can happen:
If you take too much Indorin
At a greater than usual physical load
If you are taking other medicines or have liver or kidney problems (see the other sections of section 2. What you need to know before taking Indorin)
The 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 Indorin.
Tell people around you that you have diabetes and that if you become faint (unconscious) due to a hypoglycaemia, they should turn aside and immediately get 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 Indorine, the food or the physical load may require correction.
If your blood sugar gets too high
Your blood sugar may become too high (hyperglycaemia). This can happen:
If you take too little Indorin.
If you have an infection or fever.
If you eat more than usual.
Less than the usual physical load.
The warning symptoms appear gradually, These include: frequent urination; thirst; dry skin; dry mouth. Consult your doctor. The amount of Indorin, food or physical exercise may need to be adjusted.
Other medications and Indorin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You may take Indorin in combination with metformin, another anti-diabetes medicine if prescribed by your doctor. If you are taking gemfibrozil (used to lower elevated blood lipids), you should not take Indorin.
Your body's response to Indorin may change if you are taking other medicines, especially those:
Monoamine oxidase inhibitors (MAOIs) (used to treat depression).
Beta-blockers (used to treat high blood pressure or heart disease).
ACE inhibitors (used to treat heart disease).
Salicylates (eg aspirin).
Octreotide (used to treat cancer).
Non-steroidal anti-inflammatory drugs (NSAIDs) (an analgesic).
Steroids (anabolic steroids and corticosteroids - used to treat anemia or inflammation).
Oral contraceptives (contraceptives).
Thiazides (diuretics or dewatering agents).
Danazol (used to treat chest cysts and endometriosis).
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 in the chronic accumulation of iron in the body).
Clopidogrel (to prevent blood clots).
Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy).
St John's wort (herbal medicine).
Indorin with food, drink and alcohol
Take Indorin before the main meals. Alcohol may change the ability of Indorin to reduce blood sugar. Watch for signs of hypoglycaemia.
Pregnancy, breastfeeding and fertility
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Indorin if you are pregnant or plan to become pregnant. Visit your doctor as soon as possible if you become pregnant or plan to become pregnant during treatment.
You should not take Indorin if you are breast-feeding.
Driving and using machines
Your ability to drive or operate machinery 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 Indorin
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 recommended 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.
Indorin 4 mg tablets can be divided into two equal doses.
Do not take Indorin any longer than your doctor has recommended.
If you take more Indorin than you should
If you take too many tablets, your blood sugar may fall too much, leading to hypoglycaemia. Please see If you get hypoglycaemia about what is hypoglycaemia and how to treat it.
If you forget to take Indorin
If you miss a dose, take the next dose as usual - do not double the dose.
Do not take a double dose to make up for the missed dose
If you stop taking Indorin
Keep in mind that if you stop taking Indorin, 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, Indorin can cause side effects, although not everyone gets them.
Possible side effects
Common (may affect up to 1 in 10 patients)
Hypoglycaemia (see If you get hypoglycaemia in section 2 of the leaflet). The risk of getting hypoglycaemia may increase if you take other medicines
Rare: (may affect up to 1 in 1,000 patients)
Acute coronary syndrome (but may not be due to the medicinal product). Very rare (may affect up to 1 in 10,000 patients)
Allergy (such as developing edema, difficulty breathing, accelerated heart beating, dizziness, sweating that
How to store Indorin
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions. Do not use Indorin after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What contains Indorin
The active substance is repaglinide. Indorin 0.5 mg, 1 mg, 2 mg, 4 mg. 1 tablet contains 0.5 mg, 1 mg, 2 mg or 4 mg repaglinide, respectively.
The other ingredients are: Microcrystalline cellulose, poloxamer 188, croscarmellose sodium, magnesium stearate.
What Appidorin looks like and what the package contains
Indorin 0.5 mg tablets
White, round, 3.4 mm thick and biconvex.
Indorin 1 mg tablets
White, round, 3.4 mm thick and biconvex, labeled "1".
Indorin 2 mg tablets
White, round with a thickness of 4.2 mm and biconvex, with the inscription "2".
Indorin 4 mg tablets
White, round with a thickness of 4.0 mm with a dividing line on both sides.
Indorin 4 mg tablets can be divided into two equal halves.
Pack sizes of 15, 30, 90, 120, 180 or 270 tablets, respectively. Not all pack sizes may be marketed.
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