Avandamet
rosiglitazone, metformin
Medicinal product no longer authorised
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.
In this leaflet:
Avandamet tablets are a combination of two different medicines called rosiglitazone and
metformin. These two medicines are used to treat type 2 diabetes.
People with type 2 diabetes either don’t make enough insulin (a hormone that controls blood sugar levels), or don’t respond normally to the insulin their body makes. Rosiglitazone and metformin work together so your body makes better use of the insulin it produces, and this helps reduce your blood sugar to a normal level. Avandamet can be used alone or with a sulphonylurea, another medicine for diabetes.
To help manage your diabetes, it is important that you follow any diet and lifestyle advice from your doctor as well as taking Avandamet.
if you are allergic (hypersensitive) to rosiglitazone or metformin or any of the other ingredients of Avandamet (listed in Section 6)
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-+ Check with your doctor, as Avandamet may not be suitable for you.
Avandamet and other medicines for diabetes can make some existing conditions worse, or cause serious side effects. You must look out for certain symptoms while you are taking Avandamet, to reduce the risk of any problems. See ‘Conditions you need to look out for’ in Section 4.
Women who are infertile due to a condition affecting their ovaries (such as Polycystic Ovarian Syndrome), may start ovulating again when they start taking Avandamet. If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy (see ‘Pregnancy and breast-feeding’ later in Section 2).
Your kidneys should be checked at least once a year – more often if you are over 65, or if your kidney function is close to abnormal.
if you become dehydrated – for example, after severe vomiting, diarrhoea or fever. These can lead to severe loss of water (dehydration). Speak to your doctor, as you may need to stop taking Avandamet for a short while.
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Tell your doctor or pharmacist if you are taking any other medicines, if you’ve taken any recently, or if you start taking new ones. This includes herbal medicines and other medicines you bought without a prescription.
Certain medicines are especially likely to affect the amount of sugar in your blood:
steroids (used to treat inflammation) such as prednisolone or dexamethasone
beta-2-agonists (used to treat asthma), such as salbutamol or salmeterol
diuretics (used to get rid of water), such as furosemide or indapamide
ACE inhibitors (used to treat high blood pressure), such as enalapril or captopril
gemfibrozil (used to lower cholesterol)
rifampicin (used to treat tuberculosis and other infections)
cimetidine (used to reduce stomach acid).
-+ Tell a doctor or pharmacist if you are taking any of these. Your blood sugar will be checked, and your dose of Avandamet may need to be changed.
This medicine should not affect your ability to drive or use machines.
Avandamet tablets contain a small amount of lactose. Patients who are intolerant to lactose or have a rare hereditary problem of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Always take Avandamet tablets exactly as your doctor has told you. Do not take more than the recommended dose. Check with your doctor or pharmacist if you are not sure.
After about 8 weeks your doctor may need to increase your dose. The maximum dose is 4 mg rosiglitazone and 1000 mg metformin, taken twice a day. (You can also take this dose as two 2 mg/500 mg tablets, twice a day.)
Take your tablets around the same time every day and follow any dietary advice that your doctor has given you.
Medicinal product no longer authorised
If you accidentally take too many tablets, contact your doctor or pharmacist for advice.
Don’t take extra tablets to make up for a missed dose. Just take your next dose at the usual time.
Take Avandamet for as long as your doctor recommends. If you stop taking Avandamet, your blood sugar will not be controlled, and you may become unwell. Talk to your doctor if you want to stop.
Like all medicines, Avandamet can cause side effects, but not everybody gets them.
raised and itchy rash (hives)
swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
collapse.
Lactic acidosis: An increase in the amount of lactic acid in the blood (lactic acidosis) is a very rare side effect of metformin. This most often affects people who have severe kidney disease. Symptoms of lactic acidosis include:
rapid breathing
feeling cold
stomach pain, nausea and vomiting.
Fluid retention and heart failure: Avandamet can cause you to retain water (fluid retention) which leads to swelling and weight gain. Extra body fluid can make some existing heart problems worse or lead to heart failure. This is more likely if you are also taking other medicines for your diabetes (like insulin), if you have kidney problems, or if you are over 65. Check your weight regularly; if it goes up rapidly, tell your doctor. Symptoms of heart failure include:
shortness of breath, waking up short of breath at night
getting tired easily after light physical activity such as walking
rapid increase in your weight
swollen ankles or feet.
-+ Tell your doctor as soon as possible if you get any of these symptoms - either for the first time or if they get worse.
Low blood sugar (hypoglycaemia): If you are taking Avandamet with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level. Early symptoms of low blood sugar are:
shaking, sweating, faintness
nervousness, palpitations
hunger.
The severity can increase, leading to confusion and loss of consciousness.
-+ Tell your doctor as soon as possible if you get any of these symptoms. The dose of your medicines may need to be reduced.
nausea and vomiting
stomach (abdominal) pain
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loss of appetite
dark-coloured urine.
-+ Tell your doctor as soon as possible if you get these symptoms.
Eye problems: Swelling of the retina at the back of the eye which can cause blurred vision (macular oedema) can be a problem for people with diabetes. New or worse cases of macular oedema have occurred on rare occasions in people taking Avandamet and similar medicines.
-+ Discuss with your doctor any concerns about your eyesight.
These may affect more than 1 in 10 people:
stomach pain, feeling sick (nausea), vomiting, diarrhoea or loss of appetite.
These may affect up to 1 in 10 people:
chest pain (angina)
broken bones
reduction in blood count (anaemia)
small increases in blood cholesterol, increased amount of fats in the blood
increased weight, increased appetite
dizziness
constipation
lower blood sugar than normal (hypoglycaemia)
swelling (oedema) due to water retention
metallic taste in the mouth.
These may affect up to 1 in 1,000 people:
fluid in the lungs (pulmonary oedema) causing breathlessness
heart failure
swelling of the retina at the back of the eye (macular oedema)
liver doesn’t function as well as it should (increase in liver enzymes).
These may affect up to 1 in 10,000 people:
allergic reactions
inflammation of the liver (hepatitis)
decrease in amount of vitamin B12 in the blood
rapid and excessive weight gain caused by fluid retention
increase of lactic acid in the blood.
-+ Tell your doctor or pharmacist if any of the side effects listed gets severe or troublesome, or if you notice any side effects not listed in this leaflet.
Keep out of the reach and sight of children.
Do not use Avandamet after the expiry date shown on the pack.
Medicinal product no longer authorised
This medicine does not require any special storage conditions.
If you have any unwanted tablets, don’t put them in waste water or household rubbish. Ask your pharmacist how to dispose of tablets you don’t need. This will help to protect the environment.
The active substances are rosiglitazone and metformin. Avandamet tablets come in different strengths. Each tablet contains either: 1 mg rosiglitazone and 500 mg metformin; 2 mg rosiglitazone and 500 mg metformin; 2 mg rosiglitazone and 1000 mg metformin or 4 mg rosiglitazone and 1000 mg metformin.
The other ingredients are: sodium starch glycollate, hypromellose (E464), microcrystalline cellulose (E460), lactose monohydrate, povidone (E1201), magnesium stearate, titanium dioxide (E171), macrogol, iron oxide yellow or red (E172).
Not all pack sizes or tablet strengths may be available in your country.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
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Tél/Tel: + 32 (0)2 656 21 11
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
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