Acarbose 100mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACARBOSE 50 mg AND 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 Tablets are and what they are 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 TABLETS ARE AND WHAT THEY ARE USED FOR
Your medicine belongs to a class of medicines called “Alpha glucosidase inhibitors” and is used in the management of Type II diabetes (diabetes that does not require treatment with insulin injections). It can be used alone or in combination with a sulphonylurea and / or metformin.
If you have Type II diabetes then levels of sugar (glucose) in your blood are too high. Your medicine works by slowing down digestion and absorption of sugars from your diet. This stops levels of blood sugar from rising too high.
During treatment you should also ensure that you follow the diet recommended by your doctor.
2. BEFORE YOU TAKE ACARBOSE TABLETS Do NOT take Acarbose Tablets:
• if you are allergic (hypersensitive) to acarbose (the active ingredient in your medicine) or to any of the other ingredients
• if you have inflammatory bowel disease
• if you suffer from ulcers in your colon - e.g. Crohn’s Disease or Ulcerative colitis. Ask your doctor if unsure
• if you have or have previously suffered from an obstruction in your intestines (gut)
• if you suffer from any digestive disorders caused by ongoing problems with your intestines (gut). Ask your doctor if unsure
• if you have any condition which may be made worse by the formation of gas in your intestine. For example, if you have a large hernia. Ask your doctor if unsure.
• if you have liver problems
• if you have severe kidney problems.
Take special care with Acarbose Tablets
You may experience low blood sugar levels if you take other anti-diabetic agents at the same time as acarbose, such as sulphonylureas or insulin. Tell your doctor if you are already taking medicines for the treatment of your diabetes. Low blood sugar levels can cause some of the following symptoms:
• double vision
• confusion
• slurred speech
• faintness
• trembling
• palpitations (abnormal awareness of your own heartbeat).
Low blood sugar is a potentially serious condition. If you experience any of the above symptons then take some glucose to increase your levels of blood sugar back to normal. You will be able to buy glucose tablets, syrup or sweets at your local pharmacy. It is a good idea to carry some glucose with you at all times in case you need to use it. Other sugars such as sucrose (table sugar) will not work because Acarbose Tablets prevents them from being absorbed.
If you have experienced the above symptoms then you should make an appointment to see your doctor for your medication to be reviewed.
Your doctor may decide to conduct blood tests to monitor your liver during treatment with Acarbose Tablets, particularly during the first 6 to 12 months of treatment.
Taking other medicines
Talk to your doctor if you are taking any of the following:
• charcoal (used for treatment of poisoning or drug overdose)
• digestive enzyme preparations (e.g. pancreatin and amylase)
• neomycin (antibiotic used before bowel surgery)
• colestyramine (used for treating itchiness resulting from liver problems, high cholesterol or diarrhoea)
• digoxin (used for treatment of heart failure or heart rhythm problems).
• thiazides or calcium channel blockers (used in the treatment of high blood pressure)
• corticosteroids (used to treat inflammation)
• phenytoin (used to treat epileptic fits)
• phenothiazine (used to treat mental health)
• thyroid medicines
• female sex hormone (oestrogens), oral contraceptives
• nicotinic acid (used to lower blood cholesterol)
• medicines called “sympathomimetics” such as epinephrine and norepinephrine: these may be used in the treatment of cardiac arrest, severe drop in blood pressure or premature labour
• isoniazid (used to treat tuberculosis)
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 Tabletswith food and drink
Your tablets should be swallowed whole immediately before a meal or chewed with the first mouthful of food. Your tablets should not be taken between meals.
Sucrose (cane sugar) and foods containing sucrose can cause abdominal discomfort or even diarrhoea due to carbohydrate-fermentation in the colon during treatment with Acarbose Tablets.
Pregnancy and breast-feeding
Acarbose Tablets_are not recommended for use during pregnancy or breast-feeding as the effects on your baby are not known. If you are planning to become pregnant, or are already pregnant or breastfeeding, you should speak to your doctor before taking Acarbose Tablets.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Acarbose Tablets do not affect your ability to drive or operate machinery if taken on their own. However, you may experience low blood sugar levels if you take other anti-diabetic agents at the same time, such as sulphonylureas or metformin. This may affect your ability to drive or operate machinery safely.
3. HOW TO TAKE ACARBOSE TABLETS
Always take Acarbose Tablets exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.
Adults and elderly patients
The usual dose is 50mg three times a day before meals. However, your doctor may start you on a lower dose (e.g. 50mg once or twice a day) and increase your dose slowly to reduce the risk of side effects occurring.
If you require a larger dose your doctor may decide to increase your dose further to 100mg three times a day. Occasionally it may be necessary to increase the dose to 200mg three times a day
Acarbose Tablets_should be swallowed whole immediately before meals or chewed with the first mouthful of food.
Children and adolescents under 18 years
Use of Acarbose Tablets_is not recommended.
If you take more Acarbose Tablets_than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. You should also not consume any carbohydrate containing food or drink. An overdose is likely to cause a swollen abdomen (resulting from the presence of excessive amounts of gas), flatulence (wind) and diarrhoea. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Acarbose Tablets
If you forgot to take a dose of your medicine then do not take the missed dose between meals. Wait until your next scheduled dose and meal and continue taking your tablets as per normal. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Acarbose Tablets
It is important to keep taking Acarbose Tablets_according to your doctor’s instructions to ensure that levels of blood sugars do not rise too high. Do not stop taking Acarbose Tablets_without discussing it with your doctor first.
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.
Some of the side effects are serious. The frequencies of the following side effects are unknown. However, if you suffer from any of these reactions you should seek urgent medical attention:
• Bleeding or bruising more easily than normal (caused by a reduction in blood platelets)
• Allergic reaction (rash, redness of the skin, skin eruptions, nettle rash)
• Partial or complete obstruction of the intestine leading to pain and vomiting
• Inflammation of the liver (may cause abdominal discomfort, jaundice, loss of appetite)
The following side effects have also been reported:
Very common (affects more than 1 user in 10):
• Flatulence (wind).
Common (affects 1 to 10 users in 100):
• Diarrhoea
• Pain in the stomach or abdomen.
Uncommon (affects 1 to 10 users in 1,000):
• Nausea
• Vomiting
• Indigestion
• Increase in liver enzymes, which may cause a change in blood test results that report on how the liver is working
Rare (affects 1 to 10 users in 10,000):
• Fluid retention causing swelling of arms and legs
• Jaundice (yellowing of the skin and whites of the eyes).
Other possible side effects (frequency cannot be estimated from the available data):
• Gas pockets in the bowel
During treatment it is important to follow the diet that your doctor has recommended carefully. If you do not follow this diet some of the side effects described above such as flatulence (wind), diarrhoea and abdominal pain may be made worse.
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 store above 25 oC. Store in the original packaging in order to protect from moisture.
Do not use Acarbose Tablets_after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.
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.
What Acarbose Tablets_contain:
• The active ingredient is acarbose.
• Each Acarbose 50 mg Tablet contains 50 mg acarbose. Each Acarbose 100 mg Tablet contains 100 mg acarbose.
• The other ingredients are microcrystalline cellulose, pregelatinized maize starch, anhydrous colloidal silica and magnesium stearate.
What Acarbose Tablets_look like and contents of the pack:
• Acarbose 50mg Tablets are round, biconvex, white to off-white tablets with “ACA 50” on one side.
• Acarbose 100mg Tablets are round, biconvex, white to off-white tablets, with a score-line on one side and “ACA 100” on the other side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
• Acarbose Tablets_are available in pack sizes of 20, 21, 30, 40, 50, 60, 90, 100, 105, 120 and 270 tablets.
Marketing Authorisation Holder:
GeneVida GmbH,
Heinrich Strater Str. 49a 44229 DORTMUND,
Germany
Manufacturer:
FAMAR ITALIA SPA Via Zambeletti 25 20021 Baranzate (MI)
Italy
Or
Corden Pharma GmbH Otto Hahn Strasse D-68723 Plankstadt
This leaflet was last revised 04/2014
PL 43059/0001 PL 43059/0002