GLUCOBAY 50MG TABLETS
Active substance: ACARBOSE
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Package leaflet - information for the user
0 Glucobay
Acarbose
Other medicines and Glucobay
Tell your doctor about any other medicines that you are taking, or took recently. This includes any products you bought without a prescription.
2012
April
50mg tablets
REVISED
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again. If you have more questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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.
Some medicines affect the way Glucobay works in the body. Other medicines are affected by Glucobay. Tell your doctor if you are taking: Medicines called intestinal absorbants, such as charcoal. Medicines containing digestive enzymes that help digestion, such as amylase and lipase. Neomycin, an antibiotic. Colestyramine, to treat high cholesterol. Digoxin, to treat heart problems. Other blood glucose lowering drugs (e.g sulpho yl reas, metformin, or insulin). n u
In this leaflet
1 2 3 4 5 6
What Glucobay is and what it is used for Before you take Glucobay How you take Glucobay Possible side effects How to store Glucobay Further information
Pregnancy and breastfeeding
Do not take Glucobay if you are pregnant or breastfeeding. If you think you might be pregnant or are planning a family, tell your doctor before taking Glucobay.
Driving and using machines
Glucobay is unlikely to affect your ability to drive or use machines.
1 What Glucobay is and
what it is used for
The active ingredient in this medicine is acarbose. This belongs to a group of medicines called glucosidase inhibitors. Glucobay is used to treat non-insulin dependent diabetes. It helps to control your blood sugar levels. It works by slowing down the digestion of carbohydrates (complex sugars) which reduces the abnormally high blood sugar levels in your body after each meal. Glucobay can be used to treat diabetes when a restricted diet alone or a restricted diet plus other sugar-lowering drugs do not work well enough.
3 How you take Glucobay
Always take Glucobay exactly as your doctor has told you. Adults including over 65s: the usual dose is 1 or 2 tablets, three times a day Children and under 18s: Glucobay is not recommended. The treatment is for long-term use. Take the tablets for as long as your doctor has told you to. To start treatment your doctor may recommend taking the tablets only once or twice a day. He or she will then increase your dose to three times a day. The maximum dose is 200mg three times a day.
2 Before you take Glucobay
Take special care with Glucobay:
Food and drink with Glucobay
Take Glucobay with your meal. Chew the tablets with your first mouthful of food. If you prefer not to chew, swallow the tablets whole with a little liquid immediately before your meal. Keep to the diet prescribed by your doctor. If distressing complaints develop in spite of strict adherence to your diet (see Possible side effects), contact your doctor as your dose of Glucobay may need to be reduced. Household sugar (cane sugar) and foods containing it can lead to severe abdominal discomfort and diarrhoea during treatment with Glucobay (see "Possible side effects")."
If you are allergic to the active ingredient (acarbose), or to any of the other ingredients. The ingredients are listed in section 6. If you are pregnant or breastfeeding. If you have inflammation or ulceration of the bowel, for example ulcerative colitis or Crohns disease. If you have an obstruction in your intestines, or are likely to get this. If you have a severe liver disorder. If you have an intestine disease where you do not digest or absorb food properly. If you have a large hernia, or any other condition where increased gas in your intestine may make it worse. Do not take Glucobay if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist.
Hypos and Glucobay
You may be used to taking ordinary sugar to treat a hypo. Do not take ordinary sugar (sucrose) if you take Glucobay. Take glucose (or dextrose) to treat a hypo. Glucose tablets, syrup or sweets are available from your pharmacist (chemist).
Take special care with Glucobay:
If you take too many tablets
Get medical help immediately. Do not take food or drinks containing carbohydrates. If possible take your tablets or the box with you to show the doctor.
If you have a kidney disorder tell your doctor before you take Glucobay. Glucobay may affect the enzyme levels in your blood. Your doctor may want to do regular tests to check this.
80719094
PMR 80719094 (93/02/MU-0201201983) Pantone: Schwarz, Orange 021
If you forget to take the tablets
If you forget a dose, wait until the next mealtime and take your next dose. Do not take the missed dose. Do not take the tablets between meals.
If you get side effects
Tell your doctor if any side effect gets severe, or if you get any effects not listed in this leaflet.
4 Possible side effects
Like all medicines, Glucobay can cause side effects, although not everybody gets them. The following side effects have been observed during treatment with Glucobay.
5 How to store Glucobay
Keep this medicine out of the reach and sight of children. Do not store above 25C and keep in a dry place. Store in the original carton. Do not use after the expiry date which is marked on both the outer container and on each blister strip of tablets. Do not dispose of medicines in waste water or household rubbish. Any unused Glucobay tablets should be returned to a pharmacist (chemist) who will dispose of them properly. This helps the environment.
Effects occuring in first 2 or 3 days
increased wind (flatulence) rumbling in your stomach a feeling of fullness or abdominal cramps. Contact your doctor if these effects continue for more than 2 or 3 days, if they are severe, or particularly if you have diarrhoea. Do not take indigestion preparations (antacids) as they are unlikely to help
6 Further information
What Glucobay 50mg tablets contain
Glucobay tablets contain the active ingredient, acarbose. Glucobay tablets also contain starch, cellulose, magnesium stearate and silicon dioxide.
Very common side effects
(These may affect more than 1 in 10 people) wind (flatulence)
Common side effects
(These may affect up to 1 in 10 people) diarrhoea stomach or abdominal pain
Whats in the pack
Each tablet contains 50 mg acarbose. Each pack contains 90 tablets. Marketing authorisation holder: Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA Manufacturer: Bayer Pharma AG, Leverkusen, Germany This leaflet was last revised: April 2012 Product licence number: PL 00010/0171
Uncommon side effects
(These may affect up to 1 in 100 people) feeling sick (nausea) being sick (vomiting) indigestion increase in liver enzymes (transaminases) in the blood
Rare side effects
(These may affect up to 1 in 1,000 people) swelling yellowing of the whites of the eyes or skin (jaundice)
Other side effects
(Frequency unknown) a decrease in the number of blood cells necessary for clotting allergic reaction, such as rash, redness of the skin, skin eruptions, itching a decrease in bowel activity inflammation of the liver (hepatitis) Gas pockets in the bowel (Pneumatosis cystoides intestinalis) In addition, side effects like liver disorder, abnormal liver function and liver injury have been reported, particularly from Japan. Individual cases of severe liver infection have also been reported in Japan, but it is not clear whether these are a result of taking Glucobay.
U
80719094
PMR 80719094 (93/02/MU-0201201983) Pantone: Schwarz, Orange 021
0 Glucobay
Acarbose
Other medicines and Glucobay
Tell your doctor about any other medicines that you are taking, or took recently. This includes any products you bought without a prescription.
2012
April
50mg tablets
REVISED
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again. If you have more questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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.
Some medicines affect the way Glucobay works in the body. Other medicines are affected by Glucobay. Tell your doctor if you are taking: Medicines called intestinal absorbants, such as charcoal. Medicines containing digestive enzymes that help digestion, such as amylase and lipase. Neomycin, an antibiotic. Colestyramine, to treat high cholesterol. Digoxin, to treat heart problems. Other blood glucose lowering drugs (e.g sulpho yl reas, metformin, or insulin). n u
In this leaflet
1 2 3 4 5 6
What Glucobay is and what it is used for Before you take Glucobay How you take Glucobay Possible side effects How to store Glucobay Further information
Pregnancy and breastfeeding
Do not take Glucobay if you are pregnant or breastfeeding. If you think you might be pregnant or are planning a family, tell your doctor before taking Glucobay.
Driving and using machines
Glucobay is unlikely to affect your ability to drive or use machines.
1 What Glucobay is and
what it is used for
The active ingredient in this medicine is acarbose. This belongs to a group of medicines called glucosidase inhibitors. Glucobay is used to treat non-insulin dependent diabetes. It helps to control your blood sugar levels. It works by slowing down the digestion of carbohydrates (complex sugars) which reduces the abnormally high blood sugar levels in your body after each meal. Glucobay can be used to treat diabetes when a restricted diet alone or a restricted diet plus other sugar-lowering drugs do not work well enough.
3 How you take Glucobay
Always take Glucobay exactly as your doctor has told you. Adults including over 65s: the usual dose is 1 or 2 tablets, three times a day Children and under 18s: Glucobay is not recommended. The treatment is for long-term use. Take the tablets for as long as your doctor has told you to. To start treatment your doctor may recommend taking the tablets only once or twice a day. He or she will then increase your dose to three times a day. The maximum dose is 200mg three times a day.
2 Before you take Glucobay
Take special care with Glucobay:
Food and drink with Glucobay
Take Glucobay with your meal. Chew the tablets with your first mouthful of food. If you prefer not to chew, swallow the tablets whole with a little liquid immediately before your meal. Keep to the diet prescribed by your doctor. If distressing complaints develop in spite of strict adherence to your diet (see Possible side effects), contact your doctor as your dose of Glucobay may need to be reduced. Household sugar (cane sugar) and foods containing it can lead to severe abdominal discomfort and diarrhoea during treatment with Glucobay (see "Possible side effects")."
If you are allergic to the active ingredient (acarbose), or to any of the other ingredients. The ingredients are listed in section 6. If you are pregnant or breastfeeding. If you have inflammation or ulceration of the bowel, for example ulcerative colitis or Crohns disease. If you have an obstruction in your intestines, or are likely to get this. If you have a severe liver disorder. If you have an intestine disease where you do not digest or absorb food properly. If you have a large hernia, or any other condition where increased gas in your intestine may make it worse. Do not take Glucobay if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist.
Hypos and Glucobay
You may be used to taking ordinary sugar to treat a hypo. Do not take ordinary sugar (sucrose) if you take Glucobay. Take glucose (or dextrose) to treat a hypo. Glucose tablets, syrup or sweets are available from your pharmacist (chemist).
Take special care with Glucobay:
If you take too many tablets
Get medical help immediately. Do not take food or drinks containing carbohydrates. If possible take your tablets or the box with you to show the doctor.
If you have a kidney disorder tell your doctor before you take Glucobay. Glucobay may affect the enzyme levels in your blood. Your doctor may want to do regular tests to check this.
80719094
PMR 80719094 (93/02/MU-0201201983) Pantone: Schwarz, Orange 021
If you forget to take the tablets
If you forget a dose, wait until the next mealtime and take your next dose. Do not take the missed dose. Do not take the tablets between meals.
If you get side effects
Tell your doctor if any side effect gets severe, or if you get any effects not listed in this leaflet.
4 Possible side effects
Like all medicines, Glucobay can cause side effects, although not everybody gets them. The following side effects have been observed during treatment with Glucobay.
5 How to store Glucobay
Keep this medicine out of the reach and sight of children. Do not store above 25C and keep in a dry place. Store in the original carton. Do not use after the expiry date which is marked on both the outer container and on each blister strip of tablets. Do not dispose of medicines in waste water or household rubbish. Any unused Glucobay tablets should be returned to a pharmacist (chemist) who will dispose of them properly. This helps the environment.
Effects occuring in first 2 or 3 days
increased wind (flatulence) rumbling in your stomach a feeling of fullness or abdominal cramps. Contact your doctor if these effects continue for more than 2 or 3 days, if they are severe, or particularly if you have diarrhoea. Do not take indigestion preparations (antacids) as they are unlikely to help
6 Further information
What Glucobay 50mg tablets contain
Glucobay tablets contain the active ingredient, acarbose. Glucobay tablets also contain starch, cellulose, magnesium stearate and silicon dioxide.
Very common side effects
(These may affect more than 1 in 10 people) wind (flatulence)
Common side effects
(These may affect up to 1 in 10 people) diarrhoea stomach or abdominal pain
Whats in the pack
Each tablet contains 50 mg acarbose. Each pack contains 90 tablets. Marketing authorisation holder: Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA Manufacturer: Bayer Pharma AG, Leverkusen, Germany This leaflet was last revised: April 2012 Product licence number: PL 00010/0171
Uncommon side effects
(These may affect up to 1 in 100 people) feeling sick (nausea) being sick (vomiting) indigestion increase in liver enzymes (transaminases) in the blood
Rare side effects
(These may affect up to 1 in 1,000 people) swelling yellowing of the whites of the eyes or skin (jaundice)
Other side effects
(Frequency unknown) a decrease in the number of blood cells necessary for clotting allergic reaction, such as rash, redness of the skin, skin eruptions, itching a decrease in bowel activity inflammation of the liver (hepatitis) Gas pockets in the bowel (Pneumatosis cystoides intestinalis) In addition, side effects like liver disorder, abnormal liver function and liver injury have been reported, particularly from Japan. Individual cases of severe liver infection have also been reported in Japan, but it is not clear whether these are a result of taking Glucobay.
U
80719094
PMR 80719094 (93/02/MU-0201201983) Pantone: Schwarz, Orange 021
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
