Irbesartan plus hydrochlorothiazide
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Irbesartan HCTZ AN.
It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking Irbesartan HCTZ AN against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
What Irbesartan HCTZ AN is used for
Irbesartan HCTZ AN lowers high blood pressure, which doctors call hypertension.
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 often 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.
If high blood pressure is not treated it can lead to serious health problems, such as stroke, heart disease and kidney failure.
How Irbesartan HCTZ AN works
Irbesartan HCTZ AN contains irbesartan and hydrochlorothiazide. Both medicines reduce blood pressure in different ways. Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that causes blood vessels to narrow. Irbesartan blocks angiotensin-II and therefore widens your blood vessels, making it easier for your heart to pump blood throughout your body. This helps to lower your blood pressure.
Hydrochlorothiazide belongs to the class of medicines known as diuretics. Diuretics cause an increase in the volume of urine. They also help with lowering blood pressure particularly when combined with other blood pressure reducing medicines.
Your doctor may have prescribed Irbesartan AN HCTZ for another reason. Ask your doctor if you have any questions about why Irbesartan HCTZ AN has been prescribed for you.
This medicine is only available with a doctors prescription.
There is no evidence that this medicine is addictive.
Before you take Irbesartan HCTZ AN
When you must not take it
Do not take Irbesartan HCTZ AN if:
- You are pregnant (or think you may be pregnant) or are planning to become pregnant.
Irbesartan HCTZ AN may affect your developing baby if you take it during pregnancy. - You are breast-feeding or are planning to breast-feed.
- You are allergic to irbesartan or hydrochlorothiazide or to sulfonamide derived medicines (commonly known as sulphur drugs), or to any of the ingredients listed under at the end of this leaflet. You are allergic to medicines containing irbesartan or any of the ingredients listed at the end of this leaflet.
- You are not producing urine.
- 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 Irbesartan HCTZ AN, talk to your doctor.
Irbesartan HCTZ AN should not be given to children.
Before you start to take it
Tell your doctor if have any allergies to:
- any of the ingredients listed at the end of this leaflet including lactose
- any other medicines, including sulfonamide derived medicines (commonly known as sulphur drugs)
- any other substances, such as foods, preservatives or dyes
Tell your doctor if you are breast-feeding or wish to breast-feed.
Tell your doctor if you are pregnant or plan to become pregnant.
Tell your doctor if you have, or have had, any medical conditions, especially the following:
- recent excessive vomiting or diarrhoea or think you are dehydrated
- kidney problems, or have had a kidney transplant or dialysis
- heart problems
- liver problems, or have had liver problems in the past
- diabetes
- gout or have had gout in the past
- lupus erythematosus
- high or low levels of potassium or sodium or other electrolytes in your blood
- primary aldosteronism
- you are strictly restricting your salt intake
- you have had a sympathectomy
- you have been taking diuretics
- you have a history of allergy or asthma
Tell your doctor if you plan to have surgery (even at the dentist) that needs a general anaesthetic.
If you have not told your doctor about any of the above, tell them before you start taking Irbesartan HCTZ AN.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a 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 medicines for high blood pressure
- other 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 non-steroidal anti-inflammatory agents – NSAIDs (for example Voltaren, Indocid) and COX- 2 inhibitors (for example Celebrex). Taking a combination of Irbesartan HCTZ AN and an anti-inflammatory medicine may damage your kidneys.
- alcoholic drinks
- sleeping tablets
- strong pain killing medicines such as codeine or morphine
- medicines for diabetes (oral tablets or capsules or insulins)
- calcium supplements or medicines containing calcium
- Vitamin D
- medicines for gout
- powder or granules used to help reduce cholesterol (Questran Lite or Colestid Granules)
- heart medicines such as digoxin or antiarrhythmic medicines (for example Sotacor)
- corticosteroid medicines such as prednisone, cortisone or ACTH
- medicines used to treat cancer (cytotoxic medicines)
- amantadine (Symmetrel), a medicine used to treat Parkinson’s disease or to prevent influenza
- anticholinergic medicines, these can be used to treat Parkinson’s disease, to relieve stomach cramps or spasms or used to prevent travel sickness
- medicines used during surgery
- medicines used in an emergency situation such as adrenaline
Your doctor will decide whether your treatment needs to be altered or whether you should have check-ups more frequently.
Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking Irbesartan HCTZ AN.
How to take Irbesartan HCTZ AN
How much to take
Irbesartan HCTZ AN will usually be prescribed by your doctor if previous treatment does not produce a sufficient drop in your blood pressure. Your doctor will tell you how to switch from your previous treatment to Irbesartan HCTZ AN.
The usual dose of Irbesartan HCTZ AN is one tablet a day. The full blood pressure lowering effect should be reached 6-8 weeks after beginning treatment.
If your blood pressure is not satisfactorily reduced with Irbesartan HCTZ AN, your doctor may prescribe another medicine to be taken with Irbesartan HCTZ AN.
How to take it
Swallow the tablets whole with a glass of water.
It does not matter whether you take Irbesartan HCTZ AN tablets before or after food.
When to take it
Take Irbesartan HCTZ AN at about the same time each day. Taking your tablets at the same time each day will have the best effect. It will also help you remember when to take the tablets.
How long to take it
Continue taking Irbesartan HCTZ AN until your doctor tells you to stop.
Irbesartan HCTZ AN helps to control your high blood pressure, but it does not cure it. Therefore Irbesartan HCTZ AN must be taken every day.
To help you remember to take your tablets each day, Irbesartan HCTZ AN 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” at the end of the blister strip. 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.
If you forget to take it
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 the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.
Do not take a double dose to make up for the dose you missed. This may increase the chance of you getting any unwanted side effects.
If you have trouble remembering to take your tablets, ask your pharmacist for some hints.
If you take too much Irbesartan HCTZ AN (overdose)
Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Irbesartan HCTZ AN. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you take too much Irbesartan HCTZ AN you may feel dizzy or light-headed.
While you are taking Irbesartan HCTZ AN
Things you must do
Tell any other doctors, dentists and pharmacists who are treating you that you are taking Irbesartan HCTZ AN.
If you become pregnant while taking Irbesartan HCTZ AN tell your doctor immediately.
Have your blood pressure checked regularly to make sure Irbesartan HCTZ AN is working.
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Irbesartan HCTZ AN.
If you plan to have surgery, including dental surgery, that needs a general anaesthetic, tell your doctor or dentist that you are taking Irbesartan HCTZ AN. Your blood pressure may drop suddenly.
Make sure you drink enough water during exercise and hot weather when you are taking Irbesartan HCTZ AN, especially if you sweat a lot. If you do not drink enough water while taking Irbesartan HCTZ AN, 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 Irbesartan HCTZ AN, tell your doctor. You may lose too much water and salt and your blood pressure may drop too much.
If you feel light-headed or dizzy after taking your first dose of Irbesartan HCTZ AN, or when your dose is increased, tell your doctor immediately.
Things you must not do
Do not use Irbesartan HCTZ AN to treat any other conditions unless your doctor tells you to.
Do not give Irbesartan HCTZ AN to anyone else, even if they have the same condition as you.
Do not stop taking Irbesartan HCTZ AN or lower the dose without checking with your doctor.
Things to be careful of
Be careful getting up from a sitting or lying position. Dizziness, lightheadedness or fainting may occur, especially when you get up quickly. Getting up slowly may help. This problem can be more common if you are also taking a diuretic (fluid tablets). 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.
Be careful driving or operating machinery until you know how Irbesartan HCTZ AN affects you. Irbesartan HCTZ AN may cause drowsiness, dizziness or lightheadedness in some people. If any of these occur, do not drive, operate machinery or do anything else that could be dangerous.
If you drink alcohol, dizziness or lightheadedness may be worse.
The hydrochlorothiazide contained in this medicine could produce a positive analytical result in an antidoping test.
Things that would be helpful for lowering your blood pressure:
Some self-help measures suggested below may help your condition. Talk to your doctor of pharmacist about these measures and for more information.
Your doctor may advise you to limit your alcohol intake.
If you are overweight, your doctor may suggest losing some weight to help lower your blood pressure and help lessen the amount of work your heart has to do. Some people may need a dieticians help to lose weight.
Your doctor may advise you to eat a healthy low-fat diet which includes plenty of fresh vegetables, fruit, bread, cereals and fish.
Your doctor may advise you to watch the amount of salt in your diet. To reduce your salt intake you should avoid using salt in cooking or at the table.
Regular exercise helps to reduce blood pressure and helps get the heart fitter, but it is important not to overdo it. Walking is good exercise, but try to find a route that is reasonably flat. Before starting any exercise, ask your doctor about the best kind of programme for you.
Your doctor may advise you to stop smoking or at least cut down.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Irbesartan HCTZ AN.
Like all other medicines, Irbesartan HCTZ AN may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
- headache
- dizziness or lightheadedness (vertigo)
- unusual tiredness or weakness, fatigue
- nausea/vomiting
- sexual problems.
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 or weakness
- buzzing, ringing or other persistent noise in the ears
- changes in heart rhythm
- you are not urinating (passing water) as much as normal
- numbness or tingling in fingers or toes
- painful, swollen joints that may be symptoms of gout
- fainting
- yellowing of the skin and/or eyes, also called jaundice
- symptoms that may occur if you have developed diabetes, such as excessive thirst, passing greatly increased amounts of urine, increased appetite with weight loss, feeling tired, drowsy, weak, depressed, irritable and generally unwell
- 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 changes in heart rhythm
- symptoms that may indicate liver disease such as nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes and dark coloured urine.
These are uncommon but serious side effects. Skin rash and itchiness may be symptoms of an allergic reaction. You may need medical attention.
If any of the following happen, stop taking Irbesartan HCTZ AN and tell your doctor immediately, or go to Accident and Emergency at the 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 very rare but serious side effects. If you have them you have had a serious allergic reaction to Irbesartan HCTZ AN. You may need urgent medical attention or hospitalisation.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.
After using Irbesartan HCTZ AN
Storage
Keep your Irbesartan HCTZ AN 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 Irbesartan HCTZ AN where 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 your tablets in a cool dry place where the temperature stays below 25°C.
Do not store Irbesartan HCTZ AN or any other medicine in the bathroom or near a sink. Do not leave in the car or on window sills. Heat and dampness can destroy some medicines.
Disposal
If your doctor tells you to stop taking Irbesartan HCTZ AN, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
Product description
What it looks like
Irbesartan HCTZ AN is presented in PVC/PVDC/Al blisters pack of 30 tablets.
- Irbesartan HCTZ AN 150/12.5 irbesartan and hydrochlorothiazide tablets (AUST R 192837) – Peach, oval biconvex coated tablet, debossed with L183 on one side and plain on the other side
- Irbesartan HCTZ AN 300/12.5 irbesartan and hydrochlorothiazide tablets (AUST R 192834) – Peach coloured, oval shaped, biconvex, film coated tablet, debossed with “L184” on one side and plain on the other
- Irbesartan HCTZ AN 300/25 irbesartan and hydrochlorithiazide mg tablets (AUST R 192829) – Pinkish brown, oval shaped, biconvex, film coated tablet, debossed with “L185” on one side and plain on the other side
Ingredients
Active ingredient
Irbesartan and hydrochlorothiazide
- each Irbesartan HCTZ AN 150/12.5 tablet contains 150 mg Irbesartan and 12.5 mg hydrochlorothiazide
- each Irbesartan HCTZ AN 300/12.5 tablet contains 300 mg Irbesartan and 12.5 mg hydrochlorothiazide
- each Irbesartan HCTZ AN 300/25 tablet contains 300 mg Irbesartan and 25 mg hydrochlorothiazide
The tablets also contain:
- lactose
- croscarmellose sodium
- povidone
- magnesium stearate
- Pigment blend PB-24899 PINK
- OPADRY II complete film coating system 30F84418 PINK (150/12.5 and 300/12.5 tablets only)
- OPADRY ll Complete film coating system 30F86974 BROWN (300/25 tablets only)
Sponsor
Amneal Pharma Australia Pty Ltd
12 River St
South Yarra
Vic – 3141
Australia.
Date of preparation: June 2014
Published by MIMS November 2014
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