Tuesday, October 11, 2016

Glucobay 100mg tablets




Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.


If you have any doubts or queries about your medication, please contact your doctor or pharmacist.





Glucobay 100 mg tablets



Acarbose



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.



In this leaflet



1 What Glucobay is and what it is used for

2 Before you take Glucobay

3 How you take Glucobay

4 Possible side effects

5 How to store Glucobay

6 Further information




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.




Before you take Glucobay



Take special care with Glucobay:



  • 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 Crohn's disease.


  • If you have an obstruction in your intestines, or are likely to get this.


  • If you have a 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.


Take special care with Glucobay:



  • 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.



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.


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.



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.





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.



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”).




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).




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 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.





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.




Effects occurring 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.



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




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.




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.




How to store Glucobay



Keep this medicine out of the reach and sight of children.


Do not store above 25°C 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.




Further information



What Glucobay 100 mg tablets contain


Glucobay tablets contain the active ingredient, acarbose.


Glucobay tablets also contain starch, cellulose, magnesium stearate and silicon dioxide.




What’s in the pack


Each tablet contains 100mg acarbose.


Each pack contains 90 tablets.




Marketing authorisation holder:



Bayer plc

Bayer Schering Pharma

Bayer House

Strawberry Hill

Newbury

Berkshire
RG14 1JA




Manufacturer:



Bayer Schering Pharma AG

Leverkusen

Germany





This leaflet was last revised: May 2010



Product licence number: PL 00010/0172





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