Avandia® (rosiglitazone maleate)

AVANDIA®

The name of your medicine is AVANDIA. It is also known as rosiglitazone.
AVANDIA belongs to a group of medicines called glitazones.

AVANDIA is used to treat patients with type 2 diabetes mellitus. This is also called non-insulin dependent diabetes (NIDDM) or maturity onset diabetes.

Type 2 diabetes mellitus is a condition in which your body does not make enough insulin or where the insulin that your body produces does not work as well as it should. Insulin is a natural body chemical that helps the body’s cells use the sugar from the blood and so stops your blood sugar levels from rising too high. High blood sugar levels can cause damage to the body’s cells.

AVANDIA acts by making your body more sensitive to insulin. It therefore helps your body make better use of the insulin it produces and thus helps to restore your blood sugar towards a normal level.

Your doctor may have prescribed AVANDIA for another reason.

AVANDIA can be used alone (when diet and exercise is not enough to treat your diabetes) or together with other anti-diabetic medicines.

There is no evidence that AVANDIA is addictive.

Do not take AVANDIA if:

• you have heart failure or have had heart failure in the past.
  
  
• you are being treated for angina or having a heart attack.
  
  
• you have ever had an allergic reaction to AVANDIA or any of the ingredients listed in the Ingredients section of this leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
  
  
• the expiry date (EXP) printed on the pack has passed.
  
  
• the packaging is torn or shows signs of tampering.

Tell your doctor if:

You must tell your doctor if:

• you are breastfeeding, pregnant or trying to become pregnant. Your doctor will decide if this medicine is suitable for you.
  
  
• you have heart failure or have had heart failure in the past.
  
  
• you have breathing difficulties.
  
  
• you have a history of swelling or pain of legs and feet.
  
  
• you have a problem with your liver. The medicine may remain in your body longer than usual.
  
  
• you have visual disorders.
  
  
• you are taking insulin.
  
  
• you are taking nitrates for existing heart disease because heart problems such as angina and heart attack have been reported.
  
  
• you are taking other anti-diabetic medications. The dose of these other medications may need to be decreased to reduce any risk of hypoglycaemia (low sugar levels in the blood).
  
  
• you have polycystic ovary syndrome. Due to the way your medicine works there may be an increased risk of pregnancy.
  
  
• you are allergic to foods, dyes, preservatives or any other medicines.
  
  
• you are taking any other medicines, including medicines you buy without a prescription.

Broken bones, usually in the hand, upper arm or foot, have been seen with rosiglitazone use in women. Talk to your doctor for advice on how to keep your bones healthy.

AVANDIA only works in the presence of the body’s own insulin therefore it should not be used in patients with type 1 (or insulin dependent) diabetes mellitus.

Things you must do:

Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.

Otherwise, your doctor may think that it was not working as it should and change your treatment unnecessarily.

Check with your doctor, pharmacist or dentist before taking any other medicines. This includes medicines that you buy without a prescription as well as prescribed medicines.

Things you must not do:

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Do not use AVANDIA to treat any other complaints unless your doctor says to.

Things to be careful of:

Be careful driving or operating machinery until you know how AVANDIA affects you.

Check with your doctor as soon as possible if you think you are experiencing any side effects or allergic reactions due to taking AVANDIA, even if the problem is not listed below.

Like other medicines, AVANDIA can cause some side-effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.

AVANDIA may increase the risk of heart attack or heart failure in some patients. You must tell your doctor immediately if you develop any of the following:

• rapid increase in weight
  
• shortness of breath
  
• swelling of legs and feet
  
• chest pain

A few patients have experienced the following side-effects whilst taking AVANDIA:

• heart failure or fluid in the lungs (pulmonary oedema)
  
• heart problems such as angina or heart attack
  
• localised swelling (oedema)
  
• a small increase in weight
  
• low sugar levels in the blood (hypoglycaemia). This occurs more often when AVANDIA is taken with sulfonylureas.
  
• a small reduction in red blood cell count (anaemia) and white blood cell count
  
• broken bones, usually in the hand, upper arm or foot.

AVANDIA may increase your total cholesterol level slightly. Total cholesterol is made up of ‘good cholesterol’ (HDLc) and ‘bad cholesterol’ (LDLc) and it is the balance of these that is more important than the total level. AVANDIA does not affect the balance of good and bad cholesterol. If you have any concerns about your cholesterol levels you should speak to your doctor.

Tell your doctor immediately if you notice any of the following:

• Wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash (hives) or fainting. These could be symptoms of an allergic reaction.
  
• chest pain
  
• itching, rash
  
• dark urine or pale stools
  
• yellowing of the skin or eyes (jaundice)
  
• severe stomach cramps
  
• nausea or vomiting
  
• loss of weight
  
• tiredness
  
• shortness of breath
  
• swelling or pain of legs and feet
  
• rapid increase in weight
  
• visual disorders

This is not a complete list of all possible side-effects. Others may occur in some people and there may be some side-effects not yet known.

Tell your doctor or pharmacist if you notice any side effects from your medicine which are not mentioned here.

Do not be alarmed by this list of possible side-effects. You may not experience any of them.