Avandia
rosiglitazone
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.
Avandia can be used alone or in combination with other medicines to treat diabetes (such as metformin or a sulphonylurea).
To help manage your diabetes, it is important that you follow any diet and lifestyle advice from your doctor as well as taking Avandia.
if you are allergic (hypersensitive) to rosiglitazone or any of the other ingredients of Avandia (listed in Section 6)
Medicinal product no longer authorised
-+ Check with your doctor, as Avandia may not be suitable for you.
Avandia 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 Avandia, 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 Avandia. 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).
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:
gemfibrozil (used to lower cholesterol)
rifampicin (used to treat tuberculosis and other infections)
-+ Tell a doctor or pharmacist if you are taking any of these. Your blood sugar will be checked, and your dose of Avandia may need to be changed.
This medicine should not affect your ability to drive or use machines.
Avandia 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 Avandia 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 8 mg of Avandia a day.
Medicinal product no longer authorised
Take your tablets around the same time every day and follow any dietary advice that your doctor has given you.
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 Avandia for as long as your doctor recommends. If you stop taking Avandia, your blood sugar will not be controlled, and you may become unwell. Talk to your doctor if you want to stop.
Like all medicines, Avandia 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.
Fluid retention and heart failure: Avandia 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 Avandia 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
loss of appetite
dark-coloured urine.
-+ Tell your doctor as soon as possible if you get these symptoms.
Medicinal product no longer authorised
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 Avandia and similar medicines.
-+ Discuss with your doctor any concerns about your eyesight.
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
constipation
swelling (oedema) due to water retention.
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
rapid and excessive weight gain caused by fluid retention.
-+ 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 Avandia after the expiry date shown on the pack. 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.
Medicinal product no longer authorised
The active substance is rosiglitazone. Avandia tablets come in different strengths. Each tablet contains either: 2 mg, 4 mg or 8 mg rosiglitazone.
The other ingredients are: sodium starch glycollate (Type A), hypromellose, hypromellose 6cP, microcrystalline cellulose, lactose monohydrate, magnesium stearate, titanium dioxide (E171), macrogol 3000, glycerol triacetate and iron oxide red (E172). The 4 mg tablet also contains purified talc and iron oxide yellow (E172).
a unit dose pack.
Not all pack sizes or tablet strengths may be available in your country.
Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain.
Medicinal product no longer authorised
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Tél/Tel: + 32 (0)2 656 21 11
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701
GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900
GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0
GlaxoSmithKline A.E.B.E.
Τηλ: + 30 210 68 82 100
GSK Commercial Sp. z o.o. Tel.: + 48 (0)22 576 9000
GlaxoSmithKline – Produtos Farmacêuticos, Lda Tel: + 351 21 412 95 00
Laboratoire GlaxoSmithKline Tél.: + 33 (0)1 39 17 84 44
GlaxoSmithKline (GSK) S.R.L. Tel: + 4021 3028 208
GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000
Medicinal product no longer authorised
GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
GlaxoSmithKline Cyprus Ltd
Τηλ: + 357 22 39 70 00
GlaxoSmithKline Latvia SIA Tel: + 371 67312687
GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00