Mizart

Telmisartan

Consumer Medicine Information

This leaflet answers some common questions about MIZART.

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 MIZART against the benefits they expect it will have for you.

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

This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from your pharmacist, doctor, or from www.medicines.org.au and may contain important information about the medicine and its use of which you should be aware.

Keep this leaflet with the medicine.

You may need to read it again.

MIZART is used to:

treat high blood pressure (also called hypertension)

prevent cardiovascular complications, including death due to cardiovascular causes, in patients older than 55 years of age with coronary artery disease, peripheral vascular disease, previous stroke, previous transient ischaemic attack (TIA) or high risk diabetes with evidence of end organ damage.

Treatment of Hypertension

MIZART is used to lower high blood pressure (hypertension).

Everyone has blood pressure.This pressure helps your blood move 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 normal, even when you are calm or relaxed.

There are usually no signs of hypertension.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, including stroke, heart disease and kidney failure.

MIZART contains telmisartan.Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists.Angiotensin II is a substance in the body which causes blood vessels to narrow, thus increasing blood pressure.

Telmisartan works by blocking the effect of angiotensin II.When the effect of angiotensin II is blocked, your blood vessels relax and your blood pressure goes down.

Telmisartan may be used either alone or in combination with other medicines used to treat high blood pressure.

Prevention of Cardiovascular Complications, including Death due to Cardiovascular Causes

Telmisartan is also used to prevent cardiovascular complications, including death due to cardiovascular causes that may arise in high risk patients older than 55 years of age.Examples include heart attack, stroke, death caused by heart diseases or hospitalisation due to heart failure (a condition which can cause shortness of breath or ankle swelling).

Patients who may be considered at high risk of developing cardiovascular complications or at high risk of death due to cardiovascular causes are those aged 55 years or more who have problems such as coronary artery disease (a heart disease caused by poor blood flow in the blood vessels of the heart), peripheral vascular disease (poor circulation in the hands or feet), previous stroke, previous transient ischaemic attack (TIA) or diabetes with additional high risk factors and evidence of end organ damage (e.g. damage occurring in the kidneys, heart, brain or eyes).

Your doctor can tell you if you are at high risk of developing cardiovascular complications or if you are at high risk of death due to cardiovascular causes.

Your doctor may have prescribed MIZART for another reason.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

This medicine is not addictive.

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

Do not take MIZART if you have an allergy to:

any medicine containing telmisartan (the active ingredient in MIZART)

any other ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue or other parts of the body

rash, itching or hives on the skin

Do not take MIZART if you have a rare hereditary condition of fructose intolerance.

The maximum recommended daily dose of MIZART contains approximately 341 mg of mannitol.

Do not take this medicine if you are pregnant.

It may affect your developing baby if you take it during pregnancy.

Do not breast-feed if you are taking this medicine.

It is not known if telmisartan, the active ingredient in MIZART, passes into breast milk and there is a possibility that your baby may be affected.

Do not give telmisartan to a child under the age of 18 years.

Safety and effectiveness in children and teenagers up to 18 years of age have not been established.

Do not take telmisartan if you suffer from:

severe liver disease

biliary obstructive disorders (problem with the flow of bile from the gall bladder)

diabetes or kidney problems and you are taking aliskiren (a medicine used to treat high blood pressure).

Do not take MIZART 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.

Do not take MIZART if the tablets are discoloured.

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

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:

kidney problems

liver problems

heart problems

diabetes

a condition known as primary hyperaldosteronism (raised aldosterone levels, also known as Conn’s syndrome)

fructose intolerance

recent severe diarrhoea or vomiting.

Sodium and/or volume depletion

Imbalance of salts in the body

Tell your doctor if you are following a very low salt diet.

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.

Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell them before you start taking MIZART.

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 MIZART may interfere with each other. These include:

ramipril or any other medicines used to treat high blood pressure or heart problems

potassium supplements or potassium- containing salt substitutes

medicines or salt substitutes which may increase your potassium levels

diuretics or fluid tablets, medicines used to help the kidneys get rid of salt and water by increasing the amount of urine produced

nonsteroidal anti-inflammatory agents such as aspirin or ibuprofen (medicines used to relieve pain, swelling and other symptoms of inflammation including arthritis)

lithium, a medicine used to treat certain mental illnesses

digoxin, a medicine used to treat heart failure.

trimethoprim, a medicine used to treat bacterial infections

warfarin or heparin, a medicine used to thin your blood

corticosteroids, medicines used to treat inflammatory conditions

immunosuppressants, such as ciclosporin or tacrolimus (medicines used to prevent organ rejection after transplantation).

Simvastatin, used to reduce blood cholesterol

Glibenclamide, a medicine used in diabetes.

These medicines may be affected by MIZART or may affect how well it works. Other medicines used to treat high blood pressure or medicines with blood pressure lowering potential may have an additive effect with telmisartan in lowering your blood pressure. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

Your doctor or pharmacist will tell you how many tablets you will need to take each day.This depends on your condition and whether or not you are taking any other medicines.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

For the Treatment of Hypertension

The usual dose of telmisartan for adults is one 40 mg tablet once a day.

If your blood pressure is still too high after 4-8 weeks of starting treatment, your doctor may increase your dose to 80 mg.

For the Prevention of Cardiovascular Complications, including Death due to Cardiovascular Causes

The usual dose of telmisartan is one 80 mg tablet once a day.

Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

It is important to take telmisartan exactly as your doctor or pharmacist has told you.

Swallow the tablet whole with a full glass of water.

Take MIZART at about the same time each day, either morning or evening.

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

It does not matter if you take MIZART before or after food.

Continue taking MIZART for as long as your doctor tells you.

Telmisartan helps to control your high blood pressure, and/or prevents you from developing cardiovascular complications, but does not cure it.It is important to keep taking MIZART every day even if you feel well.

People who have high blood pressure often feel well and do not notice any signs of this problem.

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 dose as soon as you remember, and then go back to taking 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 unwanted side effects.

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

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

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 MIZART.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you take too much telmisartan you may feel dizzy, light-headed or faint.Your heartbeat may be faster or slower than usual. You may experience rapid, shallow breathing or cold, clammy skin, because your blood pressure is too low.

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

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

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.

It may affect other medicines used during surgery.

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

If you are about to have any blood tests, tell your doctor that you are taking this medicine.

Keep all of your doctor’s appointments so that your progress can be checked.

Your doctor may do some tests and checks from time to time to make sure the medicine is working and to prevent unwanted side effects.

If you feel that telmisartan is not helping your condition, tell your doctor or pharmacist.

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

Do not take MIZART 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.

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

If you stop taking it suddenly, your condition may worsen or you may have unwanted side effects. If possible, your doctor will gradually reduce the amount you take each day before stopping the medicine completely.

Be careful driving or operating machinery until you know how MIZART affects you.

Like other medicines used to treat high blood pressure, MIZART may cause dizziness or drowsiness occasionally in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

You may feel dizzy or light-headed when you begin to take MIZART, especially if you are also taking a diuretic (or fluid tablet) or if you are dehydrated.

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.

If you exercise, or if you sweat, or if the weather is hot, you should drink plenty of water.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking MIZART.

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.

Do not be alarmed by the following lists of side effects.

You may not experience any of them.

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:

dizziness or light-headedness when you stand up especially when getting up from a sitting or lying position

dizziness or spinning sensation, fainting

tiredness or weakness

‘flu-like’ symptoms

pain in the chest

diarrhoea

indigestion

stomach pain or discomfort

wind or excessive gas in the stomach or bowel (flatulence)

upper respiratory tract infections

shortness of breath

back pain

aching muscles, not caused by exercise (myalgia)

muscle spasms or leg cramps or leg pain

painful joints (arthralgia)

tendon pain or tendinitis-like symptoms

urinary tract infections (including cystitis)

trouble sleeping (insomnia)

feeling anxious

depression

fast or slow heart beats

visual disturbance

increased sweating

dry mouth

allergic skin reactions including skin rash (eczema); itchiness (pruritus); redness of the skin (erythema)

symptoms that may indicate low blood sugar levels in the blood, such as sweating, weakness, hunger, dizziness, trembling, headache or numbness (especially in diabetic patients)

abnormal liver functions

symptoms that may indicate a worsening of the kidney function, 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

signs of anaemia such as tiredness, being short of breath when exercising, dizziness and looking pale

bleeding or bruising more easily than normal (thrombocytopenia)

symptoms that may indicate an infection of the blood, such as high fever, chills, headache, confusion and rapid breathing

changes in your red or white blood cell levels may occur (such changes are usually detected by a blood test).

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

swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing

severe and sudden onset of itchy or raised skin rash, hives or nettle rash.

These are serious side effects.You may need urgent medical attention or hospitalisation. These side effects are rare.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

Keep your tablets in the pack until it is time to take them.

The blister pack protects the tablets from light and moisture.

Keep your tablets in a cool dry place where the temperature stays below 30°C.

Do not store MIZART 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.

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.

MIZART is the brand name of your medicine.

MIZART tablets are available in two strengths: 40 mg and 80 mg tablets.

40 mg Tablet

White to off-white, biconvex, oval- shaped tablets, one face marked with L203 and plain on the other side.

80 mg Tablet

White to off-white, biconvex, oval- shaped tablets, one face marked with L204 and plain on the other side.

MIZART tablets are available in blister packs of 28.

Each tablet contains (40 mg or 80 mg) of telmisartan as the active ingredient.

It also contains the following inactive ingredients:

Povidone

Mannitol

Meglumine

Magnesium stearate

Sodium hydroxide

Sodium stearylfumarate

This medicine is gluten-free, lactose- free, sucrose-free, tartrazine-free and free of other azo dyes.

MIZART is supplied in Australia by:

Alphapharm Pty Ltd

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

www.mylan.com.au

This leaflet was prepared in September 2020.

MIZART 40 mg:

AUST R 230974

MIZART 80 mg:

AUST R 230975

MIZART cmi\Sep20/01