50 mg, 100 mg tablets, acarbose
1. WHAT GLUCOBAY IS AND WHAT IT IS USED FOR
Appearance of the drug:
Agents for diabetes (blood sugar lowering). Glucobay acts in the gut by delaying the uptake of glucose into the bloodstream. Glucobay is used in non-insulin-requiring diabetes mellitus (so-called age-related diabetes or type 2 diabetes ) where diet alone does not give satisfactory results.
2. WHAT YOU NEED TO KNOW BEFORE USING GLUCOBAY
Do not use Glucobay
- if you are allergic to acarbose or any of the other ingredients of this medicine (listed in section 6),
- if you have a chronic intestinal disease, intestinal ulcer, inflammatory bowel disease or intestinal obstruction or risk of intestinal obstruction
- if you have impaired liver function
- if you have kidney failure
- if you are in a condition that can be aggravated by increased gas formation in the intestine.
Warnings and cautions
Glucobay has a hypoglycaemic effect but does not cause hypoglycaemia (abnormally low blood sugar). However, concomitant treatment with Glucobay and insulin or blood glucose-lowering tablets (eg sulphonylureas, metformin ) may cause hypoglycaemia (abnormally low blood sugar). In such cases, take pure glucose (glucose tablets) and no sugar. In rare cases, hypoglycaemic coma may occur.
Other drugs and Glucobay
The treatment effect can be affected if Glucobay and digestive enzyme or cholestyramine (anti-high blood fats) are taken at the same time. Acarbose can affect the effect of digoxin (a heart medicine) with concomitant treatment. Therefore, consult a physician before concomitantly using other medications.
Glucobay with food and drink
It is important to continue with the recommended dietary advice when treating with Glucobay tablets. Treatment with Glucobay should not be stopped without consulting a doctor as it may lead to an increase in blood sugar.
Pregnancy and breastfeeding
Limited use experience. Glucobay should not be used during pregnancy. Talk to your doctor about other treatments during pregnancy.
Glucobay should not be used during breastfeeding. Therefore consult a doctor before use during breastfeeding.
Driving and using machines
There is no evidence that Glucobay affects the ability to drive or use machines.
3. HOW TO USE GLUCOBAY
The dose should be determined by a doctor, who will tailor it individually for you. You should wait for the effect of dietary treatment before starting Glucobay. Glucobay tablets are swallowed whole with liquid just before meals or chewed with food at the beginning of a meal.
You should start with a low dose which is then slowly increased to reduce any bowel side effects.
The usual dosing schedule for adults can be:
|Week 1-3||–||–||50 mg|
|Week 4-6||50 mg||–||50 mg|
|Week 7-9||50 mg||50 mg||50 mg|
Continue treatment with 50 mg x 3 for a total of 4-6 weeks. Depending on the blood glucose response, the dose may then be increased according to the following dosing schedule.
|Week 1-3||50 mg||50 mg||100 mg|
|Week 4-6||100 mg||50 mg||100 mg|
|Week 7-9||100 mg||100 mg||100 mg|
The usual maintenance dose is 100 mg 3 times daily.
The safety and efficacy of Glucobay in children and adolescents below 18 years of age have not yet been established.
If you use more Glucobay than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you take more dose you should avoid carbohydrate-containing food and drink for about 4-6 hours after taking the tablet, to avoid risk of flatulence, bloating and diarrhea.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: (affects more than 1 patient in 10)
Common: (less than 1 in 10 patients but more than 1 in 100 users)
diarrhea, stomach / abdominal pain.
Uncommon: (less than 1 in 100 patients but more than 1 in 1000 patients)
nausea, vomiting, acid regurgitation.
Rare: (less than 1 in 1,000 patients but more than 1 in 10,000)
swelling, edema , jaundice.
No known frequency: (can not be calculated from the available data)
decreased platelet count ( platelets ), allergic reactions with symptoms such as skin rash and hives, pneumatosis cystoides intestinalis (an intestinal disease with gas-filled blisters in the intestinal mucosa), acute generalized exanthematous pustulosis (skin reaction with widespread redness and blisters)
In patients receiving the usual dose (50-100 mg 3 times daily), abnormal liver function values have been observed in rare cases. Values may return to normal levels during ongoing Glucobay treatment. In isolated cases, more severe liver effects with or without jaundice have occurred. In these cases, Glucobay treatment should be stopped immediately. Your doctor may prescribe blood tests regularly during the first year of treatment. This is done in order to be able to rule out liver effects at an early stage.
Following the launch, cases of liver disease, abnormal liver function and liver damage have been reported. Isolated cases of liver disease fulminant hepatitis with fatal outcome have also been reported, mainly from Japan.
If you do not follow a strict diabetic diet, intestinal symptoms may worsen. This is especially true when consuming sugar or sugary foods due to the increase in carbohydrate fermentation in the intestine. In isolated, extremely rare cases, bowel movements may occur.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects ar
If you get any side effects , talk to your doctor, pharmacist or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects , you can help increase drug safety information.
The Medical Products Agency
751 03 Uppsala
5. HOW TO STORE GLUCOBAY
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION
- The active substance is acarbose.
- The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, corn starch.
What the medicine looks like and contents of the pack
Tablet 50 mg: White to off-white, round tablet with notch, Ø 7 mm, marked with Bavarian cross and G50.
The breaker is not for dividing the tablet into two equal parts, but only for easier swallowing.
Tablets in blisters: 30 pcs, 120 pcs.
Tablet 100 mg: White to off-white, oblong tablet with a notch, 13 mm in length, marked G100.
The tablet can be divided into two equal parts.
Tablets in blisters: 120 pcs.
Marketing Authorisation Holder
SE-169 26 Solna