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Avandia - rosiglitazone
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   Avandia - Information for Patients

Avandia™ Tablets

Rosiglitazone 4mg and 8mg tablets

 

What Avandia is used for

Avandia tablets contain the active ingredient rosiglitazone.

This medicine belongs to a group of drugs that lower high blood sugar levels (anti-diabetic) called thiazolidinediones.

It is used in the treatment of Type 2 diabetes (non-insulin dependent diabetes mellitus) .

It may be used in patients inadequately controlled by diet and exercise and in combination with sulphonylureas and metformin (other blood glucose lowering agents) to improve blood glucose levels.

Diabetes is a condition in which the body does not produce enough insulin or else the body tissues are not able to use the insulin present. This leads to hyperglycaemia (too much sugar in the blood). Symptoms include excessive thirst, the passing of a greatly increased amount of urine, increase in appetite with a loss of weight, feeling tired, drowsy, weak, depressed, irritable and generally unwell.

Before you take your Avandia tablet

When you must not take Avandia

  • Do not take Avandia tablets if you have ever had an allergic reaction to rosiglitazone or any of the ingredients listed at the end of this leaflet.
  • Do not take Avandia tablets if you have severe liver problems.
  • Do not take Avandia tablets if you are pregnant, trying to become pregnant or breastfeeding, unless your doctor says you should.

Your doctor will discuss the risks and benefits of using Avandia tablets if you are pregnant or breastfeeding.

  • Do not take Avandia tablets after the expiry date (EXP) printed on the pack.

If you use the tablets after the expiry date has passed, they may not work as well.

  • Do not take Avandia tablets if the packaging is torn or shows signs of tampering.

If you're not sure whether you should be taking Avandia tablets, talk to your doctor.

What you must do

You must tell your doctor if:

  • you have liver disease
  • you have been treated for a condition called polycystic ovary syndrome because as a consequence of improving your diabetic symptoms, it may also also resume ovulation in premenopausal women and put patients at risk of pregnancy.
  • you have had heart failure, as thiazolidinediones can cause fluid retention, which can exacerbate congestive heart failure.
  • Have had any menstrual irregularity
  • you are taking any other medicines, including those you buy from a supermarket, pharmacy or health food shop.
  • Are using only insulin (a Type 1 diabetic)

Some medicines may affect the way others work. Your doctor or pharmacist will be able to tell you what to do when using Avandia tablets while taking other medicines.

Use in children

There is no information on the use of Avandia tablets in children who are under 18 years of age and therefore use in this age group is not recommended.

How to take Avandia tablets

Take your medicine as your doctor has told you. The label on the pack will tell you how many tablets to take and how often you should take them. If you do not understand what you should do, ask your doctor or pharmacist.

Avandia tablets can be taken with or without food.

How much to take

Treatment of diabetes mellitus

Adults

The dosage of Avandia is different for each patient.

The recommended starting dose for Avandia is 4mg/day. If you require a higher dose, after 6 to 8 weeks of therapy the dose can be increased to 8mg/day. Avandia can be given once or twice a day.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (0800 POISON) or 0800 764 766) for advice, if you think you or anyone else may have taken too many Avandia tablets, even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep telephone numbers for these places handy.

If you are not sure what to do, contact your doctor or pharmacist.

While you are taking Avandia tablets

Things you must do

Tell your doctor or pharmacist that you are taking Avandia if you are about to be started on any new medicines.

Tell your doctor if you become pregnant or are trying to become pregnant.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think it was not effective and change your treatment unnecessarily.

Things you must not do

Do not change the dose of your Avandia tablets without first checking with your doctor.

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

Things to be careful of

Avandia tablets generally do not cause any problems with your ability to drive a car or operate machinery. Avandia does not cause drowsiness or sedation.

Side-Effects

Check with your doctor as soon as possible if you have any problems while taking Avandia tablets, even if you do not think the problems are connected with the medicine or are not listed.

Like other medicines, Avandia tablets 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.

  • Fluid retention
  • cough, chest infection
  • weight gain
  • low blood sugar
  • headache

If you think you are having an allergic reaction to Avandia tablets, tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital. Symptoms of an allergic reaction usually include some or all of the following:

  • wheezing.
  • swelling of the lips/mouth.
  • difficulty in breathing.
  • hay fever.
  • lumpy rash ("hives").
  • fainting.

This is not the 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 if you notice anything else that is making you feel unwell, even if it is not on this list.

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

After taking Avandia tablets

Storage

Keep this medicine where young children cannot reach it.

A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines.

Keep Avandia tablets in the pack in a cool, dry place where it stays below 30°C and out of direct light.

Do not store them, or any other medicine, in a bathroom or near a sink.

Do not leave them in the car or on window sills.

Heat, light and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking Avandia tablets or the medicine has passed the expiry date, ask your pharmacist what to do with any medicine left over.

Product description

What Avandia tablets look like

Avandia tablets are pentagonal shaped. The tablets are 4.0mg (orange) and 8mg (red-brown)

Ingredients

Each Avandia tablet contains the active ingredients rosiglitazone 4mg or 8mg.

Avandia tablets also contain inactive ingredients: Sodium starch glycollate, hydroxypropyl methylcellulose, microcrystalline cellulose, lactose monohydrate magnesium stearate.

Avandia tablets are film coated. The film coat contains: hydroxypropyl methylcellulose 6cP, titanium, iron oxide yellow E172, iron oxide red E172, purified talc.

 




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