APO-Telmisartan

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Contains the active ingredient telmisartan
Consumer Medicine Information
 
 

What is in this leaflet

This leaflet answers some common questions about this medicine. 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.

What this medicine is used for

Telmisartan is used to:
treat high blood pressure (also called hypertension)
prevent cardiovascular complications, including death due to cardiovascular causes, in patients aged 55 years of age or older with coronary artery disease, peripheral vascular disease, previous stroke, previous transient ischaemic attack (TIA) or high-risk diabetes with evidence of end organ damage
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.
Prevention of cardiovascular complications, including death due to cardiovascular causes
Patients who may be considered at a high risk of developing cardiovascular complications, or at a high risk of death due to cardiovascular causes, are those aged 55 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 a high risk of developing cardiovascular complications or if you are at a high risk of death due to cardiovascular causes.
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, the 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.
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 available only with a doctor's prescription.
There is no evidence that this medicine is addictive.
There is not enough information to recommend the use of this medicine for children under the age of 18 years.

Before you take this medicine

When you must not take it

Do not take this medicine if you have an allergy to:
any medicine containing telmisartan
any of the 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 this medicine if you have or have had any of the following medical conditions:
severe liver disease (severe hepatic impairment)
biliary obstructive disorders (problems 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 this medicine if you are pregnant or are planning to become pregnant.
Telmisartan may affect your developing baby if you take it during pregnancy.
Do not take this medicine if you are breastfeeding or are planning to breastfeed.
Telmisartan may pass into human breast milk.
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:
kidney problems
liver problems
heart problems
diabetes
a condition known as primary hyperaldosteronism (raised aldosterone levels, also known as Conn's syndrome)
recent severe diarrhoea or vomiting
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
Your doctor can discuss with you the risks and benefits involved.
Tell your doctor if you are following a very low salt diet.

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 may interact with telmisartan. These include:
other medicines used to treat high blood pressure or heart problems, such as ACE inhibitors (e.g. ramipril).
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 (e.g. spironolactone or frusemide)
nonsteroidal anti-inflammatory agents (NSAIDs) – medicines used to relieve pain, swelling and other symptoms of inflammation (including arthritis), such as aspirin or ibuprofen
lithium, used to treat certain mental illnesses
digoxin, used to treat heart failure
trimethoprim, used to treat bacterial infections
heparin, used to thin your blood
corticosteroids, medicines used to treat inflammatory conditions
immunosuppressants, such as ciclosporin or tacrolimus, used to prevent organ rejection after transplantation
These medicines may be affected by telmisartan or may affect how well it works. 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.

How to take this medicine

Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the directions, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
For the treatment of high blood pressure (hypertension):
The usual dose 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 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.

How to take it

Swallow the tablet whole with a full glass of water.

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.
It does not matter if you take it before, with or after food.

How long to take it for

Continue taking your medicine 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 telmisartan every day, even if you feel well.
People who have high blood pressure often feel well and do not notice any symptoms.

If you forget to take it

If it is almost time to take 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 then go back to taking your medicine as you would normally.
Do not take a double dose to make up for missed doses.
This may increase the chance of you experiencing side effects.
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 of this medicine. 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 lower than usual and you may experience rapid, shallow breathing or cold, clammy skin. This is because your blood pressure is too low.

While you are taking this medicine

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.
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 or start to breastfeed 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.
It may interfere with the results of some tests.
Keep all your doctor's appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things you must not do

Do not take this medicine 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.

Things to be careful of

Be careful when driving or operating machinery until you know how this medicine affects you.
Like other medicines used to treat high blood pressure, telmisartan may cause sleepiness, dizziness or light headedness 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 telmisartan, especially if you are also taking a diuretic (or fluid tablet) or if you are dehydrated.
If this medicine makes you feel dizzy or light-headed, be careful when getting up from a sitting or lying position.
Standing up slowly, especially when you get up from a bed or chair, 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, sweat or if the weather is hot, you should drink plenty of water.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking this medicine.
All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Tell your doctor if you notice any of the following and they worry you:
headache
dizziness, spinning sensation or fainting
dizziness or light-headedness when you stand up, especially when getting up from a sitting or lying position
tiredness or weakness
diarrhoea
indigestion
stomach pain or discomfort
wind or excessive gas in the stomach or bowel (flatulence)
Tell your doctor as soon as possible if you notice any of the following:
chest pain
'flu-like' symptoms
upper respiratory tract infections
back pain
aching muscles not caused by exercise (myalgia)
painful joints (arthralgia)
tendon pain or tendinitis-like symptoms
urinary tract infections (including cystitis)
trouble sleeping (insomnia)
feeling anxious
depression
shortness of breath
muscle spasms, leg cramps or leg pain
fast or slow heart beats
visual disturbances
increased sweating
dry mouth
allergic skin reactions including skin rash, itchiness and redness of the skin
signs of anaemia such as tiredness, being short of breath when exercising, dizziness and looking pale
changes in your red or white blood cell levels – usually only detected through blood tests
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
symptoms that may indicate low blood sugar levels, such as sweating, weakness, hunger, dizziness, trembling, headache or numbness (especially in diabetic patients)
abnormal liver function
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
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
symptoms of an allergic reaction including cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin
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 that is making you feel unwell.
Other side effects not listed above may occur in some patients.
Some of these side effects can only be found when your doctor does tests from time to time to check your progress.

Storage and disposal

Storage

Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 30°C. Protect from light and moisture.
Do not store your medicine, 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 this medicine 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.

Product description

What APO-Telmisartan looks like

40 mg Tablet
White to off-white colour, oval shape, biconvex, uncoated tablets debossed with L203 on one side and plain on other side. AUST R 209336.
Blister packs of 28 tablets.
80 mg Tablet
White to off-white colour, oval shape, biconvex, uncoated tablets debossed with L204 on one side and plain on other side. AUST R 209334.
Blister packs of 28 tablets.
*Not all strengths may be available.

Ingredients

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.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park, NSW 2113
Australia
Tel: (02) 8877 8333
Web: www1.apotex.com/au
 
This leaflet was last updated in September 2019.