iMedi.co.uk

Acarbose 50mg Tablets

Document: leaflet MAH BRAND_PLPI 15184-1648 change

Ref: 1648/080716/1/F

Glucobay 50mg Tablets

(Acarbose)

Patient Information Leaflet

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.

Your medicine is called Glucobay 50mg Tablets but will be referred to as Glucobay throughout the leaflet.

What is in this leaflet:

What Glucobay is and what it is used for What you need to know before you take Glucobay How to take Glucobay Possible side effects ^ How to store Glucobay

Contents of the pack and other information

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.


^ 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.

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).

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).


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.

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

(Acarbose)

Patient Information Leaflet (continued)

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.

[4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been observed during treatment with Glucobay.

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

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 not known: frequency cannot be estimated from the available data)

*    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)

*    rash with pus filled pimples/blisters (acute generalised exanthematous pustulosis)

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 via Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

[m How to store Glucobay

Keep out of the sight and reach of children.

Do not store above 25°C.

Store in the original package in a dry place.

Do not take Glucobay after the expiry date which is stated on the blister label and carton. The expiry date refers to the last day of the month.

If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine if your doctor tells you to.

If the tablet becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

Contents of the pack and other information

What Glucobay contains:

Each tablet contains 50mg of acarbose.

Other ingredients are microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate, maize starch

What Glucobay look like and contents of the pack

A white to yellow-tinged round, convex tablets marked with ‘G50' on one side and the BAYER-cross on the other side.

Each pack contains 90 Tablets.

Manufacturer and Licence Holder

Manufactured by Bayer Pharma AG D - 51368, Leverkusen, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

POM PL 15184/1648    Glucobay 50mg Tablets

Glucobay is a registered trademark of Bayer Intellectual Property GmbH Revision date: 08/07/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Patient Information Leaflet

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.

Your medicine is called Acarbose 50mg Tablets but will be referred to as Acarbose throughout the leaflet.

What is in this leaflet:

What Acarbose is and what it is used for What you need to know before you take Acarbose How to take Acarbose Possible side effects ^ How to store Acarbose

Contents of the pack and other information

Other medicines and Acarbose

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

Some medicines affect the way Acarbose works in the body. Other medicines are affected by Acarbose.

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 Acarbose 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:

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


^ What Acarbose 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.

Acarbose 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.

Acarbose 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.

^ What you need to know before you take Acarbose

Do not take Acarbose:

*    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 Acarbose if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist.

How to take Acarbose

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: Acarbose 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 Acarbose

Take Acarbose 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 Acarbose may need to be reduced.

Household sugar (cane sugar) and foods containing it can lead to severe abdominal discomfort and diarrhoea during treatment with Acarbose (see section 4).

Hypos and Acarbose

You may be used to taking ordinary sugar to treat a hypo. Do not take ordinary sugar (sucrose) if you take Acarbose. Take glucose (or dextrose) to treat a hypo. Glucose tablets, syrup or sweets are available from your pharmacist (chemist).


Warnings and precautions

Talk to your doctor before taking Acarbose

*    If you have a kidney disorder tell your doctor before you take Acarbose.

*    Acarbose may affect the enzyme levels in your blood. Your doctor may want to do regular tests to check this.

If you take more Acarbose 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

[m How to store Acarbose

Keep out of the sight and reach of children.

Do not store above 25°C.

Store in the original package in a dry place.

Do not take Acarbose after the expiry date which is stated on the blister label and carton. The expiry date refers to the last day of the month.

If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine if your doctor tells you to.

If the tablet becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.


Contents of the pack and other information

What Acarbose contains:

Each tablet contains 50mg of acarbose.

Other ingredients are microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate, maize starch

What Acarbose look like and contents of the pack

A white to yellow-tinged round, convex tablets marked with ‘G50' on one side and the BAYER-cross on the other side.

Each pack contains 90 Tablets.

Manufacturer and Licence Holder

Manufactured by Bayer Pharma AG D - 51368, Leverkusen, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.


Patient Information Leaflet (continued)

If you forget to take Acarbose

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.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been observed during treatment with Acarbose.

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

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 not known: frequency cannot be estimated from the available data)

*    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)

*    rash with pus filled pimples/blisters (acute generalised exanthematous pustulosis)

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 via Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

POM PL 15184/1648    Acarbose 50mg Tablets

Revision date: 08/07/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.