Avaglim
rosiglitazone, glimepiride
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:
Avaglim tablets are a combination of two different medicines called rosiglitazone and glimepiride.
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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 glimepiride work together so your body makes better use of the insulin it produces, and this helps reduce your blood sugar to a normal level.
To help manage your diabetes, it is important that you follow any diet and lifestyle advice from your doctor as well as taking Avaglim.
if you are allergic (hypersensitive) to rosiglitazone, glimepiride, or any of the other ingredients of Avaglim (listed in Section 6), or to other medicines called sulphonylureas (like glibenclamide) or sulphonamides
-+ Check with your doctor, as Avaglim may not be suitable for you.
Haemolytic anaemia: If you have an inherited condition where your red blood cells don’t produce enough of the enzyme G6PD, Avaglim may cause your red blood cells to be destroyed too quickly (haemolytic anaemia).
-+ Tell your doctor if you have this condition, as Avaglim may not be suitable for you.
Avaglim 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 Avaglim, 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 Avaglim. 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).
Avaglim can cause reductions in some types of blood cells. Your doctor should regularly test your blood while you are taking Avaglim.
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If you have kidney disease, or are over 65, your kidney function should be checked while you are taking Avaglim.
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.
Many medicines (or alcohol) can affect the way Avaglim controls the amount of sugar in your blood. Your blood sugar levels may become too high or too low (see ‘Low blood sugar’ in Section 4). Some of the medicines most likely to do this are:
gemfibrozil (used to lower cholesterol)
rifampicin (used to treat tuberculosis and other infections)
fluconazole (used to treat fungal infections).
-+ Tell a doctor or pharmacist if you think that Avaglim is not working as it should, particularly if you are taking any other medicines. You may need to have the dose adjusted or change the other medicines you are taking.
Some medicines used to treat high blood pressure (such as beta-blockers, clonidine, guanethidine or reserpine) may make you less aware of the warning signs of low blood sugar (sweating; fast irregular heartbeats).
Avaglim can also strengthen or weaken the effects of medicines to prevent blood clots
(anticoagulants such as warfarin).
Avaglim can make you dizzy or cause your blood sugar to become lower than normal (see ‘Low blood sugar’ in Section 4).
-+ Don’t drive or operate machinery unless you’re feeling well.
Avaglim 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 Avaglim 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.
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After about 8 weeks your doctor may need to increase your dose. The maximum dose is one combined tablet of 8 mg rosiglitazone and 4 mg glimepiride, taken once a day.
given you.
If you accidentally take too many tablets, contact your doctor or pharmacist for advice. You may be at risk of having low blood sugar and need hospital treatment.
Don’t take extra tablets to make up for a missed dose. Just take your next dose at the usual time.
Take Avaglim for as long as your doctor recommends. If you stop taking Avaglim, your blood sugar will not be controlled, and you may become unwell. Talk to your doctor if you want to stop.
Like all medicines, Avaglim 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: Avaglim 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): Certain conditions can make you more likely to suffer from low blood sugar while you are taking Avaglim. These include:
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taking other medicines to treat diabetes
kidney disease
low body weight or poor diet
stress situations (such as trauma, surgery or infections) 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.
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 Avaglim and similar medicines.
-+ Discuss with your doctor any concerns about your eyesight.
These may affect more than 1 in 10 people:
lower blood sugar than normal (hypoglycaemia)
swelling (oedema) due to water retention.
These may affect up to 1 in 10 people:
chest pain (angina)
heart failure
broken bones
increased weight, increased appetite
dizziness
constipation
reduction in blood count (anaemia) low numbers of white blood cells (leucopaenia) and blood cells needed for blood clotting (thrombocytopaenia)
small increases in blood cholesterol, increased amount of fats in the blood
These may affect up to 1 in 1,000 people:
fluid in the lungs (pulmonary oedema) causing breathlessness
swelling of the retina at the back of the eye (macular oedema)
reduction in the number of red blood cells, or a type of white blood cell (granulocytopaenia) which can be severe (agranulocytosis), reduction in the number of all types of blood cells (pancytopaenia)
liver doesn’t function as well as it should (increase in liver enzymes).
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These may affect up to 1 in 10,000 people:
allergic reactions, inflammation of blood vessels (allergic vasculitis)
increased sensitivity to the sun causing skin rash
inflammation of the liver (hepatitis), yellowing of the skin (jaundice)
rapid and excessive weight gain caused by fluid retention
stomach pain, bloating, feeling sick (nausea), vomiting or diarrhoea
decrease in the amount of sodium in your 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 Avaglim 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.
The active substances are rosiglitazone and glimepiride. Avaglim tablets come in different strengths. Each tablet contains either: 4 mg or 8 mg rosiglitazone and 4 mg glimepiride.
The other ingredients are: sodium starch glycollate (Type A), hypromellose (E464), microcrystalline cellulose (E460), lactose monohydrate, magnesium stearate, titanium dioxide (E171), macrogol 400, iron oxide black and/or red (E172).
The tablets are supplied in blister packs containing 14, 28, 56, 84 or 112 film-coated tablets. Not all pack sizes or tablet strengths may be available in your country.
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For any information about this medicine, 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
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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
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
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