General Information
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before taking AVAPRO. This leaflet answers some common questions about AVAPRO. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. Do not throw this leaflet away. You may need to refer to it again later.
Always follow the instructions that your doctor and pharmacist give you about AVAPRO. If you have any concerns about taking AVAPRO, ask your doctor or pharmacist.
What is AVAPRO
AVAPRO is a trade name (manufacturer's name) for the medicine, irbesartan. This medicine is in the tablets your doctor has prescribed for you.
What AVAPRO is used for AVAPRO lowers high blood pressure, which doctors call hypertension Your doctor measured your blood pressure and found it to be too high. Everyone has blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) which means your blood pressure stays high, even when you are calm and relaxed. There are usually no symptoms of high blood pressure. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. High blood pressure, if not treated, can damage blood vessels in several organs such as the heart, the kidneys, the brain and the eyes. This may lead to heart attacks, heart or kidney failure, strokes, or blindness. There are usually no symptoms of high blood pressure before damage occurs, so your doctor needs to measure your blood pressure to see if it is too high. High blood pressure can be treated and controlled with medicines such as AVAPRO. Your doctor may also have recommended that you adjust your lifestyle to help to lower your high blood pressure (losing weight, avoiding smoking, reducing alcohol consumption and restricting the amount of salt in the diet). Your doctor may also have encouraged the practice of regular, mild (not strenuous) exercise such as walking, swimming, etc. AVAPRO is also used in the treatment of kidney disease in patients with high blood pressure and type 2 diabetes. What AVAPRO does and how it works AVAPRO belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin II is a substance produced in the body which causes blood vessels to tighten. AVAPRO blocks angiotensin-II and therefore relaxes your blood vessels. This helps to lower your blood pressure. AVAPRO slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. Your doctor may have prescribed AVAPRO for another use. If you want more information, ask your doctor. When you must not take AVAPRO Do not take AVAPRO if:
you are pregnant (or think you may be pregnant) or are planning to become pregnant
Your baby may absorb this medicine in the womb and there is a possibility of harm to the baby.
you are breast-feeding
It is not known if AVAPRO passes into breast milk, therefore it is not recommended to be taken while you are breast-feeding.
you are allergic to irbesartan or to any of the ingredients listed under Product Description at the end of this leaflet.
the packaging is torn or shows signs of tampering
the expiry date on the pack has passed
If you take this medicine after the expiry date has passed, it may not work.
If you are not sure if you should start taking AVAPRO, talk to your doctor. AVAPRO should not be given to children. Before you start to take AVAPRO Tell your doctor if:
you are or intend to become pregnant or plan to breast-feed
AVAPRO should not be used during pregnancy or while breast-feeding
you have recently had excessive vomiting or diarrhoea
you suffer from any medical conditions especially -
kidney or heart problems
liver problems, or have had liver problems in the past
you are strictly restricting your salt intake
you are lactose intolerant or have had any allergies to any other medicine or any other substances, such as foods, preservatives or dyes.
Be sure you tell your doctor about any of these things before you take any AVAPRO. Taking AVAPRO with other medicines
Tell your doctor if you are taking or intend to take any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.
It is especially important that you tell your doctor if you are taking, or plan to take any of the following:
other tablets for high blood pressure
fluid tablets or diuretics
lithium or lithium containing medicines (for example Lithicarb)
potassium tablets (for example Span-K, Slow-K, Mag-K)
potassium containing salt substitutes (for example Pressor-K)
anti-inflammatory medicines (these are used to relieve pain, swelling and other symptoms of inflammation, including arthritis) and include nonsteroidal anti-inflammatory agents - NSAIDs (for example Voltaren, Indocid) and COX-2 inhibitors (for example Celebrex).
Taking a combination of Avapro with a thiazide diuretic (fluid tablet) and an anti-inflamatory medicine may damage your kidneys.
Your doctor will decide whether your treatment needs to be altered or whether you should have check ups or blood tests more frequently How to take AVAPRO The tablets should be taken regularly as directed by your doctor. The tablets should be swallowed with a glass of water. How much to take
Your doctor will tell you how many tablets to take each day.
Usually patients start with one 150 mg tablet once a day, however some patients may need a lower starting dose. Your doctor will tell you if this is necessary. The full blood pressure lowering effect of AVAPRO should be reached about 4-6 weeks after starting treatment. Depending on how your blood pressure responds, your daily dose of AVAPRO may need to be increased. Most patients take either 150mg or 300mg each day. In patients with high blood pressure and type 2 diabetes, 300mg once daily is the preferred maintenance dose for the treatment of associated kidney disease. Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet. If you do not understand the instructions on the box, ask your doctor or pharmacist for help. When to take it
You should try to take your daily dose of AVAPRO at about the same time each day. Taking your AVAPRO tablets at the same time each day will have the best effect.
To help you remember to take your tablets each day, AVAPRO tablets are supplied in a Calendar pack with the foil backing marked with the days of the week. This is just a way to help you to remember to take your tablets. All of the tablets in the pack are the same. When you start a new strip of tablets, take the tablet marked "START". On the next day, take the tablet marked with the relevant day of the week. Continue taking your tablets each day until all of the tablets are taken. Commence the next strip at "START" and continue as before. It does not matter whether you take AVAPRO tablets before or after food. How long to take it
AVAPRO helps to control your high blood pressure, but it does not cure it. Therefore AVAPRO must be taken every day. Continue taking AVAPRO until your doctor tells you to stop.
If you miss a dose
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and go back to taking your tablets as you would normally.
If you are not sure whether to skip the dose, talk to your doctor or pharmacist. Do not take a double dose to make up for the missed dose. If you have trouble remembering to take your tablets, ask your pharmacist for some hints. If you take too much AVAPRO (overdose) Immediately telephone your doctor or Poisons Information Centre (telephone : 131126) or go to the Accident and Emergency Department at your nearest hospital, if you or anyone else may have taken too much AVAPRO. Do this even if there are no signs of discomfort or poisoning. If you take too many AVAPRO tablets you will probably feel lightheaded or dizzy. While you are using Avapro Things you must do
If you become pregnant while taking AVAPRO tell your doctor immediately.
Have your blood pressure checked when your doctor tells you to, to make sure AVAPRO is working.
If you are about to start on any new medicine, tell your doctor and pharmacist that you are taking AVAPRO.
Get up slowly when getting out of bed or standing up.
You may feel light-headed or dizzy while taking AVAPRO, especially if you are also taking a diuretic (fluid tablet). This may become worse if you stand up quickly as your blood pressure may fall. Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. This problem is not common. If it occurs talk to your doctor.
If you plan to have surgery (even at the dentist) that needs a general anaesthetic, tell your doctor or dentist that you are taking AVAPRO.
Make sure you drink enough water during exercise and hot weather when you are taking AVAPRO, especially if you sweat a lot.
If you do not drink enough water while taking AVAPRO, you may faint or feel light-headed or sick. This is because your body does not have enough fluid and your blood pressure is low. If you continue to feel unwell, tell your doctor.
If you have excessive vomiting and/or diarrhoea while taking AVAPRO, tell your doctor.
This can also mean that you are losing too much water and your blood pressure may become too low. Things you must not do
Do not give AVAPRO tablets to anyone else, even if they have the same condition as you.
Things to be careful of
Be careful driving or operating machinery until you know how AVAPRO affects you.
As with many other medicines used to treat high blood pressure, AVAPRO may cause dizziness or light-headedness in some people. Make sure you know how you react to AVAPRO before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy or light-headed.
If you drink alcohol, dizziness or light-headedness may be worse.
Side effects AVAPRO helps most people with high blood pressure, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking AVAPRO. Tell your doctor if you notice any of the following and they worry you -
headache
dizziness or light-headedness
unusual tiredness or weakness, fatigue
nausea/vomiting
These are common side effects. They are generally mild and do not normally require treatment to be interrupted.
Tell your doctor immediately if you notice any of the following -
skin rash or itchiness
aching muscles or aching joints, not caused by exercise
muscle pain
buzzing, ringing or other persistent noise in the ears
yellowing of the skin and/or eyes, also called jaundice
symptoms that may indicate kidney disease, such as passing little or no urine, drowsiness, nausea, vomiting, breathlessness, loss of appetite and weakness
symptoms that may indicate high potassium levels in the blood such as nausea, diarrhoea, muscle weakness and change in heart rhythm
These are serious side effects. Skin rash and itchiness may be symptoms of an allergic reaction. You may need medical attention.
These side effects are not common. If any of the following happen, stop taking AVAPRO and tell your doctor immediately or go to Accident and Emergency Department at your nearest hospital -
swelling to the face, lips, tongue or throat which may cause difficulty in swallowing or breathing
severe and sudden onset of pinkish, itchy swellings on the skin, also called hives or nettlerash.
These are serious side effects. If you have them you have had a serious allergic reaction to AVAPRO. You may need urgent medical attention or hospitalisation. These side effects are very rare. Other side effects not listed above may occur in some patients. If you notice any other unwanted effects, you should tell your doctor or pharmacist and ask for their advice. After using AVAPRO Storage
Keep your AVAPRO tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep well.
Keep AVAPRO tablets in a cool dry place where the temperature stays below 25 °C. Do not store AVAPRO or any other medicine in the bathroom or near a sink. Do not leave them near a radiator, in a car on hot days or on a window sill. Heat and dampness can destroy some medicines. Keep all medicines out of the reach of children. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines. Disposal
If your doctor tells you to stop taking AVAPRO or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.
Product description What it looks like
Starting from January 2006 the manufacturer will be supplying a new formulation of Avapro tablets with some different inactive ingredients. Therefore, until all stocks of the original formulation have been used up, your pharmacist may give you either the original formulation or the new one. There is only a slight difference between the appearance of the original and the new tablets (see below).
There is no difference between the two formulations in the active ingredient or how well Avapro tablets work. Original formulation: AVAPRO 75 mg tablets - white to off-white, oval tablet with a heart shape on one side and "2771" on the other. Pack size : 30 tablets. AUST R 61267 AVAPRO 150 mg tablets - white to off-white, oval tablet with a heart shape on one side and "2772" on the other. Pack size : 30 tablets. AUST R 61269 AVAPRO 300 mg tablets - white to off-white, oval tablet with a heart shape on one side and "2773" on the other. Pack size : 30 tablets. AUST R 61271 New formulation: AVAPRO 75 mg tablets - white to off-white, oval, film-coated tablet with a heart shape on one side and "2871" on the other. Pack size : 30 tablets. AUST R 101730 AVAPRO 150 mg tablets - white to off-white, oval, film-coated tablet with a heart shape on one side and "2872" on the other. Pack size : 30 tablets. AUST R 101734 AVAPRO 300 mg tablets - white to off-white, oval, film-coated tablet with a heart shape on one side and "2873" on the other. Pack size : 30 tablets. AUST R 101736 Active ingredients
AVAPRO 75 mg tablets - 75 mg irbesartan per tablet.
AVAPRO 150 mg tablets - 150 mg irbesartan per tablet. AVAPRO 300 mg tablets - 300 mg irbesartan per tablet. Other Ingredients
Original formulation:
AVAPRO tablets also contain, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, silicon dioxide, pregelatinised maize starch, and poloxamer 188
New formulation:
AVAPRO tablets also contain carnauba wax, croscarmellose sodium, hypromellose, lactose, macrogol 3000, magnesium stearate, microcrystalline cellulose, silicon dioxide, and titanium dioxide.
How current is this information and where can I find out more? This leaflet was produced based on information known by Bristol-Myers Squibb Australia Pty Ltd in January 2006 and updated in October 2006. You need to consult your doctor regularly as your doctor has access to information on any changes which may affect you. Who makes AVAPRO? AVAPRO is made available by:
Bristol-Myers Squibb Australia Pty Ltd
A.B.N. 33 004 333 322
556 Princes Highway
Noble Park VIC 3174
Australia
This information in no way replaces the advice of your doctor or pharmacist.
AVAPRO is a registered Sanofi-Synthelabo Trademark.