Package leaflet: Information for the user

0 Glucobay® 100mg tablets

Acarbose

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1	What Glucobay is and what it is used for
2	What you need to know before you take Glucobay
3	How to take Glucobay
4	Possible side effects
5	How to store Glucobay
6	Contents of the pack and other information

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.

2 What you need to know before you take Glucobay

Do not take Glucobay:

•    If you are allergic to acarbose or any of the other ingredients of this medicine (listed in section 6).

•    If you are pregnant or breast-feeding.

•    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 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.

Warnings and precautions

Talk to your doctor before taking 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 if you are taking, have recently taken or might take any other medicines.

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 sulphonylureas, metformin, or insulin)

Pregnancy and breast-feeding

Do not take Glucobay if you are pregnant or breast-feeding. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Glucobay is unlikely to affect your ability to drive or use machines.

3 How to take Glucobay

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

_•    Adults including old people: the usual dose is 1 or 2 tablets, three times a day

•    Children and adolescents: 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 200 mg 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 section 4), 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 section 4).

€

82162178

PMR 82162178 (69/03/MU-0201503085) Pantone: Schwarz, Orange 021

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 more Glucobay than you should

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 Glucobay

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 have any further questions on the use of this medicine, ask your doctor.

In addition, side effects like liver disorder, abnormal liver function and liver injury have been reported. Individual cases of a rapidly progressive and fatal form of liver injury have also been reported, particularly from Japan.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/ adrportal

5    How to store Glucobay

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

Do not store above 25°C and keep in a dry place. Store in the original package.

Do not use this medicine after the expiry date which is stated on both the outer carton and on each blister strip of tablets after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6    Contents of the pack and other information

What Glucobay contains

Glucobay tablets contain the active ingredient, acarbose.

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

What Glucobay looks like and contents of the pack

Each tablet contains 100 mg acarbose.

Each pack contains 90 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder:

Bayer plc,

Bayer House, Strawberry Hill, Newbury Berkshire RG14 1JA

Manufacturer:

Bayer Pharma AG,

Leverkusen, Germany

This leaflet was last revised in May 2015.

Product licence number: PL 00010/0172

Bayer

PMR 82162178 (69/03/MU-0201503085) Pantone: Schwarz, Orange 021

148x315-07508