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AVANDIA Ū 4-8 mg. film-coated tablets rosiglitazone
AVANDIA 4-8 mg. film-coated tablets
rosiglitazone
The active substance is rosiglitazone. Each tablet contains rosiglitazone maleate corresponding to 4 mg. rosiglitazone.
The other ingredients are:
Tablet core:
Sodium starch glycollate (Type A), hypromellose, microcrystalline cellulose, lactose monohydrate, magnesium stearate.
Film coating:
Opadry orange OY-L-23028 (hypromellose 6cP, titanium dioxide E171, macrogol 3000, lactose monohydrate, glycerol triacetate, iron oxide red E172, iron oxide yellow E172, purified talc).
WHAT IS AVANDIA
AVANDIA is an anti-diabetic medicine taken by mouth to treat Type 2 (non-insulin dependent) diabetes mellitus.
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 you control your blood sugar levels. By helping your body make better use of the insulin it produces AVANDIA helps to reduce your blood sugar towards a normal level.
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AVANDIA should be used alone or in combination with metformin or a sulphonylurea which are also oral anti-diabetic medicines.
BEFORE TAKING AVANDIA
Do not take AVANDIA:
- If you are hypersensitive (allergic) to rosiglitazone or any other ingredients of AVANDIA.
- If you have or have had heart failure.
- If you have a liver disease.
- If you already take insulin.
Take special care with AVANDIA:
Tell your doctor before you start to take this medicine:
- If you are planning to become pregnant.
- If you are breast-feeding.
- If you have polycystic ovary syndrome. Due to the way this medicine works there may be an increased likelihood of your becoming pregnant.
- If you have a problem with your liver, heart or kidneys.
- If you are already taking sulphonylurea and metformin, because the triple combination therapy is not recommended.
- There is no information available on the use of AVANDIA in people under 18 years of age, therefore its use in these patients is not recommended.
Taking AVANDIA with food and drink:
Your tablets may be taken with or after a meal or on an empty stomach.
Swallow the tablets with a glass of water.
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Pregnancy
Tell your doctor if you are, you think you might be or are planning to become pregnant. Your doctor will advise you to discontinue this medicine.
Breast-feeding
Tell your doctor if you are breast-feeding or if you are planning to breast-feed your baby. Your doctor will discontinue this medicine.
Driving and using machines:
This medicine will not affect your ability to drive or operate machinery.
Important information about some of the ingredients of AVANDIA:
Patients who are intolerant to lactose should note that each AVANDIA tablet contains a small amount of lactose (about 105 mg.). Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Taking other medicine:
You can usually continue treatment with other medications while you take AVANDIA. However always tell your doctor or pharmacist which medicines you are taking including those you have bought yourself without a prescription.
HOW TO TAKE AVANDIA
Follow your doctor's instructions about how and when to take your tablets otherwise you will not fully benefit from your medicine.
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The amount of AVANDIA people take can be different, and this depends on your condition. Your doctor will prescribe the best dose for you.
The usual starting dose of AVANDIA is 4 mg. (1 of these tablets) per day. This should be taken as a single dose.
If necessary, your doctor may increase this dose up to 8 mg. (2 of these tablets) per day, taken as a single dose or as two doses to be taken during the day (e.g. 1 of these tablets in the morning and 1 of these tablets in the evening).
Your tablets should be swallowed with a glass of water. They may be taken with or after a meal or on an empty stomach. It is best to take the tablets at the same time every day.
If you feel the effect of your medicine is too weak or too strong do not change the dose yourself, but ask your doctor.
Do not take more tablets than your doctor has recommended.
Your doctor will prescribe AVANDIA alone or in combination with other oral anti-diabetic medicines.
It is recommended that you have blood tests every two months for the first twelve months, and periodically thereafter to check that your liver is working normally, following initiation of therapy with AVANDIA.
If you are following a diabetic weight control diet, you should continue with this while you are taking AVANDIA.
Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
If you take more AVANDIA than you should:
If you take more AVANDIA than you should or if someone else has taken your medicine, tell a doctor or pharmacist immediately. Show them the package.
If you forget to take AVANDIA:
Take your tablet as soon as you remember. Take your next dose at the usual time. Do not take a double dose to make up for forgotten doses.
POSSIBLE SIDE EFFECTS
Like all medicine, AVANDIA can have side effects.
Some patients have experienced the following side effects whilst taking AVANDIA:
- Localised swelling (oedema).
- Weight gain.
- Headache.
- Abnormal sensation such as "pins and needles".
- Flatulence, nausea, gastritis, dyspepsia.
- Change in appetite, vomiting, constipation.
- Breathlessness.
- Rash, including hives.
- Allergic swelling (angioedema), sometimes of the face or mouth which may cause difficulty in breathing or swallowing.
- In rare cases hair loss.
- Fatigue.
- Changes in blood sugar (hypoglycaemia, diabetes mellitus aggravated).
- Increased levels of fats in the blood.
- Slight decrease in the number of red cells in the blood (including anaemia).
- In rare cases your liver function may be impaired.
- Sugar (glucose) in the urine.
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Rare cases of heart failure and pulmonary oedema (fluid accumulation in the lungs) have been reported. The major symptom is breathlessness. Some patients also have experienced rapid and excessive weight gain due to fluid accumulation. If this happens you should tell your doctor as soon as possible.
AVANDIA may increase your total cholesterol level slightly. If you have any concerns about your cholesterol levels, you should speak to your doctor.
If you develop any unusual discomfort, tell your doctor as soon as possible.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
STORAGE OF AVANDIA
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
If your doctor stops your medicine, do not keep any leftover tablets unless your doctor tells you to. Return any unused tablets to your pharmacist who will discard them safely.
Do not use after the expiry date stated on the pack.
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