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Aroba 100 mg. 30 tablets

Product Code: Aroba 100 mg. 30 tablets
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What is Aroba and what is it used for?

Aroba belongs to a group of medicinal products for the treatment of diabetes (alpha-glucoidase inhibitor).

The medicinal substance of Aroba is acarbose and is of biological origin.
Acarbose exerts its action mainly in the small intestine. The active substance is almost not absorbed in the body. Aroba slows down the breakdown of carbohydrates, which slows down the release of glucose from them and its passage into the blood. In this way, Aroba slows down and reduces the rise in blood sugar after a meal. As a result of the balancing effect of glucose intake from the intestine, diurnal changes in blood sugar levels are reduced and average blood sugar values ​​are lowered.

When administered alone, Aroba does not cause hypoglycemia.

Aroba is used for:

Adjunctive treatment along with diet in patients with diabetes mellitus (diabetes melUtus).
Prevention of type 2 diabetes in patients with proven impaired glucose tolerance*, in combination with diet and exercise.
*defined as second-hour post-glucose (2HPG) plasma concentration between 7.8 and 11.1 mmol/L (140-200 mg/Dl) and fasting levels between 5.6 and 7.0 mmol/L (100-125 mg/dL)

2. What you need to know before you take Aroba

Do not take Aroba

if you are allergic to acarbose or any of the other ingredients of this medicine (listed in section 6).
in patients with severe liver damage (liver cirrhosis);
in patients with severe renal impairment (creatinine clearance < 25 ml/m in);
if you have inflammatory bowel disease, an intestinal ulcer, partial bowel obstruction or a predisposition to bowel obstruction;

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Aroba.

Take special care when using Aroba

During the first 6-12 months of treatment In rare cases during therapy with Aroba, liver enzymes may increase, which may be a sign of liver damage. There have been isolated reports of rapidly developing hepatitis (fulminant hepatitis). Therefore, liver enzymes should be monitored during the first 6 to 12 months of treatment. If liver enzymes are elevated, dose reduction or discontinuation of therapy may be required. In the studied cases, these changes were reversible after discontinuation of Aroba treatment (see also "Possible side effects").
In rare cases, if Aroba is prescribed in addition to other blood sugar-lowering medicines (eg sulphonylureas, metformin or insulin), hypoglycaemic symptoms (such as rapid heart rate, sweating, tremors) may develop. In this case, you should take glucose, not refined sugar (cane sugar), to relieve the problem (see also "Using other medicines").
Even if you take Aroba, it is extremely important that you strictly follow your prescribed diet.

Children and adolescents
The safety and efficacy of Aroba in patients under 18 years of age have not been established.

Other medicines and Aroba
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Aroba lowers blood sugar levels, but taking it alone does not lead to very low blood sugar levels (hypoglycemia).
If Aroba is prescribed as adjunctive therapy to drugs containing sulphonylurea, metformin or insulin, lowering of blood glucose values ​​to hypoglycemia may necessitate an appropriate reduction in the doses of these drugs.
In individual cases, serious complaints related to low blood sugar values ​​(hypoglycemic shock) may occur.
In acute hypoglycaemia, it should be borne in mind that sucrose (cane sugar) is broken down and absorbed more slowly during treatment with Aroba, which is why it is not suitable for rapid hypoglycaemia and glucose should be used.

In some cases, acarbose may affect the level of digoxin (an active substance used mainly to treat heart failure), necessitating an adjustment of the digoxin dose.

Do not take the following medicines while you are being treated with Aroba, as they may weaken its effect:

cholestyramine (a medicine to lower high blood cholesterol levels)
activated carbon and other intestinal absorbents
substances that aid digestion (digestive enzymes).
If you take oral acarbose and neomycin at the same time, it may lower your blood glucose level after eating and may cause more serious abdominal discomfort, if symptoms are severe, tell your doctor. He can reduce the dose of acarbose.

Food and drink cart
Refined sugar (cane sugar) and foods containing it can easily cause severe abdominal discomfort and diarrhea during treatment with Aroba (see "Possible side effects").

Pregnancy, lactation and fertility
If you are pregnant or breastfeeding, think you may be pregnant or planning to become pregnant, advise
Driving and using machines

Aroba monotherapy does not cause hypoglycemia and therefore does not affect the ability to drive and operate machinery.
Combined treatment with other blood sugar-lowering medicinal products (metformin, sulphonylurea, insulin) may negatively affect your ability to drive or operate machinery, as they may potentially cause hypoglycaemia.

3. How to take Aroba

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Dosage should be determined by a physician for each individual patient, as efficacy and tolerability vary among individuals.

The recommended dose is:
Additional treatment in connection with diet in patients with diabetes mellitus:
Unless otherwise prescribed, the recommended dosage is as follows:

Initial dose: 3 x 1 tab. of 50 mg Aroba daily (equivalent to 150 mg acarbose daily)

In some patients, a gradual increase in the dose helps to reduce gastrointestinal side effects, and the initial dose is: 1 to 2 times 1 tab. Aeroba 50 mg daily (equivalent to 50 to 100 mg acarbose daily).

Your doctor may gradually increase the dose depending on your blood sugar level and also as a continuation of treatment if it is not effective enough, up to 3 x 1 tablet of Aroba 100 mg daily (equivalent to 300 mg acarbose daily).

In rare cases, if necessary, the dose can be further increased to 3 x 2 tablets of Aroba 100 mg daily (equivalent to 600 mg acarbose daily).

You should start with a low dose that is slowly increased over time to reduce possible intestinal side effects.

If serious complaints occur despite a strictly observed diet (see "Possible side effects"), the dose should not be increased further, and if necessary, should be reduced to a certain extent.

For the prevention of type 2 diabetes in patients with impaired glucose tolerance, the recommended dose is:

Your doctor will gradually increase the dose depending on your blood sugar level and also as a continuation of the treatment if it is not effective enough, up to: 3 x 1 tablet Aroba 100 mg daily (equivalent to 300 mg acarbose daily).

Use in children and adolescents
The safety and efficacy of Aroba in children and adolescents below 18 years of age have not been established.

When and how should you take Aroba?
Aroba tablets should be chewed with the first bites of food. If you prefer, you can swallow the tablets whole with a small amount of liquid, immediately before a meal.

If your doctor has prescribed you other antidiabetic medicines in addition to Aroba, you should also take these medicines.

How long should you take Aroba?
Your doctor will assess the duration of your treatment with Aroba. It depends on the severity and development of your disease.

If you have taken more than the required dose of Aroba
If you have exceeded the prescribed dose or in the event of an overdose, you may experience diarrhea and other intestinal symptoms such as gas formation (flatulence) and abdominal pain.

In case of overdose, it is recommended to avoid liquids or foods containing carbohydrates for the next 4-6 hours.

If you forget to take Aroba
If you have forgotten to take one or more doses of Aroba, do not take the tablets between meals, but wait for the time for your next dose and continue according to your schedule.
Do not take a double dose to make up for a missed tablet.

If you stop taking Aroba
If you have any further questions related to the use of this medicine, please ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this can cause side effects, although not everybody gets them.

The following side effects have been reported:

Very common side effects
(affects more than 1 in 10 patients)

gas formation (flatulence)
Common side effects
(affects less than 1 in 10 but more than 1 in 100 patients)

gastrointestinal and abdominal pain
These symptoms usually disappear with continued therapy and adherence to your prescribed diet.

Uncommon side effects
(affects less than 1 in 100 but more than 1 in 1,000 patients)

digestive disorders (dyspepsia)
transient elevation of liver enzymes
Rare side effects
(affects less than 1 in 1,000 but more than 1 in 10,000 patients)

swelling (fluid retention, mainly in the legs)
jaundice (yellowing of the skin)
Adverse reactions of unknown frequency

decrease in the number of platelets (thrombocytopenia)
allergic reactions (redness, rash and irritated skin)
If the symptoms last more than 2-3 days, or are severe, you should consult your doctor, especially in cases of diarrhea.

These side effects may increase if you do not follow your prescribed diabetes diet. If you experience sharp pain despite its strict compliance, immediately seek your doctor
5. How to store Aroba

Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton. The expiration date corresponds to the last day of the specified month.

To be stored at a temperature below 30°C. Store in the original package to protect from light and moisture.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

Expiry date
2 years

6. Contents of the package and additional information

What does Aeroba contain?

The active substance is: acarbose.
Each tablet of Aroba 100 mg contains 100 mg of acarbose.

The other ingredients are: microcrystalline cellulose, pregelatinized starch, colloidal anhydrous, silicon dioxide and magnesium stearate.

What does Aroba look like and what is in the package?
Aroba 100 mg are white or yellowish, round, smooth tablets, scored on one side.

The dividing line serves only to facilitate breaking for ease of ingestion, it is not a measure of dividing equal doses.

Aroba is available in transparent PVC/PE/PVDC blisters covered with aluminum foil.

Aroba 100 mg tablets are available in packs containing 30 tablets.

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