Acarbose 100mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Acarbose 50 & 100 mg Tablets
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 any further 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What acarbose is and what it is used for
2. Before you take Acarbose Tablets
3. How to take Acarbose Tablets
4. Possible side effects
5. How to store Acarbose Tablets
6. Further information
1. What acarbose is and what it is used for
Acarbose belongs to a group of medicines called ‘alpha glucosidase inhibitors’ which are used to treat non-insulin dependent diabetes.
Acarbose works by controlling your blood sugar levels. This is achieved by slowing down the digestion of carbohydrates (complex sugars) in your food into simpler sugars and therefore reduces the high blood sugar levels which can occur after each meal.
Acarbose can be used to treat diabetes when a restricted diet alone or in combination with other sugar-lowering medicines does not work well enough.
2. Before you take Acarbose Tablets Do not take Acarbose Tablets:
• if you are allergic (hypersensitive) to acarbose
• if you are allergic to any of the other ingredients in the tablets (see section 6 - Further information)
• you are pregnant, likely to become pregnant or are breast-feeding
• you are suffering from inflammation or ulceration of the bowel e.g. ulcerative colitis or Crohn’s disease
• you have or are susceptible to an obstruction in your intestines (gut)
• you have trouble digesting or absorbing food properly due to a problem with your gut
• you have a large hernia or any other condition where increased gas in your gut may make your condition worse
• you have severe liver disease
• you have severe kidney disease.
Take special care with Acarbose Tablets
As a diabetic you may also be receiving other treatments for your diabetes. If you are taking insulin or certain medicines (e.g. glibenclamide or chlorpropamide) to control your blood sugar, you will probably be used to avoiding hypoglycaemic episodes (‘hypos’) by taking sugar when you feel that your blood sugar level is too low.
When taking acarbose, do not treat a hypoglycaemic episode with ordinary sugar (sucrose). You must instead take some glucose (also known as dextrose) in the form of tablets, syrup, or sweets which should be available from your local pharmacist.
Acarbose Tablets may also affect the levels of certain proteins called enzymes in your blood. Your doctor may wish to see you more often to monitor the levels of these enzymes particularly in the first year of your treatment.
Taking other medicines
Tell your doctor if you are already taking any of the following as they may interact with your medicine. Your doctor may therefore need to adjust the dose of acarbose or the other medicine:
• medicines known as ‘intestinal adsorbents’ such as charcoal, as these can reduce the effect of acarbose
• medicines to aid digestion containing digestive enzymes (e.g. amylase), as these can reduce the effect of acarbose
• neomycin (an antibiotic), as this can increase the side-effects acarbose can cause
• cholestyramine (used for the treatment of high cholesterol), as this can increase the effect of acarbose
• digoxin (used for the treatment of heart failure), as acarbose can alter its effect.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Acarbose Tablets with food and drink
As you will be on a restricted diet, do not take food or drinks containing carbohydrates (including ordinary sugar (sucrose)) at the same time as your tablets as this can lead to diarrhoea, wind and stomach pain.
You should always follow your doctor’s advice on your diet.
Pregnancy and breast-feeding
Do not take Acarbose Tablets if you are pregnant, think you may be pregnant or are breastfeeding. If you think you may have become pregnant whilst taking these tablets, you should contact your doctor as soon as possible.
Ask your doctor or pharmacist for advice before taking any medicine.
3. How to take Acarbose Tablets
Always take Acarbose Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
It is important that you take your tablets at the start of a meal and not at any other time. They should preferably be chewed with the first mouthful of food. If you prefer not to chew your tablets they should be swallowed whole with a little liquid immediately before your meal.
Dosage:
The usual starting dose is one 50 mg tablet taken three times a day with meals. However at the start of the treatment your doctor may recommend that you take your tablets once or twice a day before increasing the dose to three times a day.
Six to eight weeks after the start of your treatment your doctor may decide to increase your dose depending on how the tablets are working. You should be aware that acarbose is intended for long-term treatment.
To gain the maximum benefit from your Acarbose Tablets you should adhere to the diet prescribed by your doctor. This should also help in reducing any side effects you may experience. If any distressing side effects develop in spite of strict adherence to your diet, contact your doctor as your dose of acarbose may need to be reduced.
Use in children:
Acarbose Tablets are not recommended for children and adolescents under the age of 18 years.
If you take more Acarbose Tablets than you should, you may suffer from flatulence (wind), stomach pain and diarrhoea especially if you take the tablets with food and drink containing carbohydrates. If you take too many tablets, you should contact your doctor immediately or go to the nearest casualty department. Remember to take the pack and any remaining tablets with you.
If you forget to take your Acarbose Tablets, simply take your next dose on time. Do not take the missed dose or a double dose to make up for the one you missed. Do not take the tablets between meals.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Acarbose Tablets can cause side effects, although not everybody gets them.
If you get any of the following side effects you should stop taking your tablets and tell your doctor immediately:
• swelling of the lips, face and tongue, difficulty in breathing, feeling faint, rash or itching (affecting the whole body)
• unusual bruising, nosebleeds or bleeding gums
• your skin or eyes start turning yellow or you have severe stomach ache
The following side effects have been reported:
Very common side effects (probably affecting more than 1 in 10 people):
• flatulence (wind)*
Common side effects (probably affecting fewer than 1 in 10 people):
• diarrhoea* • stomach pain*
Uncommon side effects (probably affecting fewer than 1 in 100 people):
• nausea and vomiting • indigestion* • increase in liver
(feeling and being sick)* enzymes
Rare side effects (probably affecting fewer than 1 in 1,000 people): • swelling • jaundice (yellowing of
the skin and eyes)
Other side effects (frequency unknown):
gas pockets in the bowel a decrease in bowel activity
• a decrease in the • inflammation of the liver
number of blood cells (hepatitis)
needed for clotting • allergic reactions
(thrombocytopenia) • skin rash with disease or
fever
* Do not take indigestion (antacid) preparations for the treatment of these symptoms as they have been shown to have no effect. If your symptoms persist for more than 2-3 days or if they are severe, please consult your doctor, especially in the case of diarrhoea.
In addition, side effects including liver disorder, abnormal liver function and liver injury have been reported. Individual cases of severe liver infection have also been reported, but it is not clear whether these are as a result of taking acarbose.
Blood tests have sometimes shown an increase in liver enzymes in patients taking acarbose. If you are having a test on your liver you should inform the doctor that you are taking acarbose.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Acarbose Tablets
Keep out of the reach and sight of children.
Do not use Acarbose Tablets after the expiry date which is stated on the blister and carton after EXP:. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light.
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. Further information What Acarbose Tablets contain:
- The active substance is acarbose (each tablet contains 50 or 100mg of acarbose)
- The other ingredients are microcrystalline cellulose, maize starch, croscarmellose sodium, colloidal silica anhydrous and magnesium stearate.
What Acarbose Tablets look like and contents of the pack
Your medicine is in the form of round, convex tablets.
• The 50 mg tablets are off-white with ‘AR’ over ‘50’ on one side and ‘>’ on the other side.
• The 100 mg tablets are off-white with ‘AR’ over ‘100’ on one side and ‘>’ on the other side.
Acarbose Tablets are available in blister packs of 10, 21, 30, 42, 84, 90, 100, 105, 420 & 500 tablets (not all pack sizes may be marketed).
Marketing Authorisation Holder
Actavis Group PTC ehf. Reykjavlkurvegi 76-78, 220 Hafnarfjordur, Iceland.
Manufacturer:
Selamine Ltd T/A Arrow Generics Limited, Unit 4/5 Willsborough Cluster, Clonshaugh Industrial Estate, Clonshaugh, Dublin 17, Republic of Ireland
or
Juta Pharma GmbH, Gutenbergstrasse 13, 24941 Flensburg, Germany or
Arrow Pharm (Malta) Limited, 62 Hal Far Industrial Estate, Birzebbugia, BBG3000, Malta This leaflet was last revised in December 2014