KSART HCT 150/12.5 Tablets

KSART HCT 150/12.5 Tablets is a brand of medicine containing the active ingredients irbesartan - hydrochlorothiazide.

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

Ksart® HCT 150/12.5
Ksart® HCT 300/12.5
Ksart® HCT 300/25

irbesartan & hydrochlorothiazide tablets


Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Ksart HCT.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

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WHAT KSART HCT IS USED FOR

This medicine is used to lower 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) when your blood pressure stays higher than is needed, even when you are calm and relaxed.

There are often no symptoms of high blood pressure. The only way of knowing that you have high blood pressure 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.

This medicine contains the active ingredients 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.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is only available with a doctor's prescription.

There is no evidence that this medicine is addictive.

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BEFORE YOU TAKE KSART HCT

When you must not take it

Do not take this medicine if you have an allergy to:

  • Irbesartan or hydrochlorothiazide, the active ingredients, or to sulfonamide derived medicines (commonly known as sulphur drugs) or to any of the other ingredients listed at the end of this leaflet under PRODUCT DESCRIPTION.
  • any other similar medicines.

Do not take this medicine if you are pregnant or are planning to become pregnant. It may affect your developing baby if you take it during pregnancy.

Do not breastfeed if you are taking this medicine. It is not known if the active ingredient in Ksart HCT passes into breast milk, therefore it is recommended that you do not take it while you are breastfeeding.

Do not give this medicine to children. Safety and effectiveness in children have not been established.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • heart problems
  • kidney problems, or have had a kidney transplant or dialysis
  • liver problems, or have had liver problems in the past
  • recent excessive vomiting or diarrhoea or think you are dehydrated
  • 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 him/her before you start taking Ksart HCT.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Ksart HCT may interfere with each other. These include:

  • other medicines for high blood pressure
  • diuretics (fluid tablets)
  • potassium supplements (e.g. Span-K, Slow-K, Mag-k) or potassium-containing salt substitutes (e.g. Pressor-K)
  • lithium or lithium containing medicines (e.g. Lithicarb)
  • anti-inflammatory medicines (these are used to relieve pain, swelling and other symptoms of inflammation, including arthritis) and include non-steroidal antinflammatory agents - NSAIDs (for example Voltaren, Indocid) and COX-2 inhibitors (for example Celebrex). Taking a combination of Ksart HCT 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 have more information on medicines to be careful with or avoid while taking this medicine.

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HOW TO TAKE KSART HCT

How much to take

Ksart HCT 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 Ksart HCT.

The usual dose of Ksart HCT 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 Ksart HCT, your doctor may prescribe another medicine to be taken with Ksart HCT.

Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take.

Follow the instructions they give you.

How to take it

Swallow the tablets whole with a full glass of water.

It does not matter whether you take the tablets before or after food.

When to take it

Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

How long to take it

Continue taking your medicine until your doctor tells you to stop. This medicine helps to control your high blood pressure, but it does not cure it. Therefore Ksart HCT must be taken every day.

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 your dose as soon as you remember, and continue to take it as you would normally.

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

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

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Ksart HCT. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of an overdose may include light-headedness or dizziness.

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WHILE YOU ARE TAKING KSART HCT

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Ksart HCT.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you become pregnant while taking this medicine, tell your doctor immediately.

Have your blood pressure checked when your doctor tells you to, to make sure Ksart HCT is working.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine. Your blood pressure may drop suddenly.

Make sure you drink enough water during exercise and hot weather when you are taking this medicine, especially if you sweat a lot. If you do not drink enough water while taking this medicine, 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 this medicine, 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 this medicine, or when your dose is increased, tell your doctor immediately.

Things you must not do

Do not stop taking your medicine or lower the dosage without checking with your doctor.

Do not take Ksart HCT to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Things to be careful of

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. 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. If this problem continues or gets worse, talk to your doctor.

Be careful driving or operating machinery until you know how Ksart HCT affects you. As with many other medicines used to treat high blood pressure, Ksart HCT may cause dizziness or light-headedness in some people. If this occurs do not drive. Make sure you know how you react to Ksart HCT before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy or light-headed.

Be careful when drinking alcohol while you are taking this medicine. If you drink alcohol, dizziness or light-headedness may be worse.

The hydrochlorothiazide contained in this medicine could produce a positive analytical result in an antidoping test.

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SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Ksart HCT. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • headache
  • dizziness or light-headedness (vertigo)
  • unusual tiredness or weakness, fatigue
  • pain in the stomach or gut 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 (symptoms of an allergic reaction)
  • aching muscles or sore joints (not caused by exercise), muscle pain or weakness
  • buzzing, ringing or other persistent noise in the ear
  • change 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 known as 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 liver disease such as nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes and dark coloured urine
  • symptoms that may indicate high potassium levels in the blood, such as nausea, diarrhoea, muscle weakness, change in heart rhythm.

The above list includes serious side effects that may require medical attention. Serious side effects are not common.

If any of the following happen, stop taking this medicine and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • swelling of 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 nettle rash.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.

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AFTER TAKING KSART HCT

Storage

Keep your medicine 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 your medicine in a cool dry place where the temperature stays below 25°C.

Do not store Ksart HCT or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it 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.

Disposal

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

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PRODUCT DESCRIPTION

What it looks like

Ksart HCT comes in three types of tablets:

  • Ksart HCT 150/12.5 tablets contain 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide as white, cylindrical, biconvex tablets embossed 1H1 on one side.
  • Ksart HCT 300/12.5 tablets contain 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide as white, oblong, biconvex tablets embossed 1H12 on one side.
  • Ksart HCT 300/25 tablets contain 300 mg of irbesartan and 25 mg of hydrochlorothiazide as white, oblong, biconvex tablets embossed 1H25 on one side.

Available in packs of 30 tablets.

Ingredients

Active ingredients:

  • Ksart HCT 150/12.5 tablets contain 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide
  • Ksart HCT 300/12.5 tablets contain 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide
  • Ksart HCT 300/25 tablets contain 300 mg of irbesartan and 25 mg of hydrochlorothiazide.

Inactive ingredients:

  • povidone k
  • magnesium stearate
  • microcrystalline cellulose
  • lactose
  • croscarmellose sodium
  • colloidal anhydrous silica
  • hydrogenated castor oil
  • maize starch.

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MANUFACTURER

Distributor

Aspen Pharma Pty Ltd
34-36 Chandos St
St Leonards NSW 2065

This leaflet was prepared in February 2013.

Australian Register Number(s)
150/12.5 mg tablets: AUST R 186257
300/12.5 mg tablets: AUST R 186254
300/25 mg tablets: AUST R 186252

® Registered Trade Mark

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CMI provided by MIMS Australia, November 2014  

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22 Sep 2016 Information on medicines available in Australia containing irbesartan - hydrochlorothiazide, including our latest evidence-based information and resources for health professionals and consumers. The active ingredient is the chemical in a medicine that makes it work. Medicines that contain the same active ingredient can be available under more than one brand name. Brands include both active ingredients and inactive ingredients. You'll find information about brands of medicines that contain irbesartan - hydrochlorothiazide below, including their consumer medicine information (CMI) leaflets.