2. What should I know before I take DILART?
Do not take if you have ever had an allergic reaction to valsartan or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with DILART and affect how it works.
4. How do I take DILART?
For hypertension, the usual dose is one 80 mg tablet once a day. If your blood pressure
is still too high after 4 weeks, your doctor may increase the dose to 160 mg to 320
mg once a day. If your blood pressure is still too high, your doctor may add a different
type of blood pressure lowering medicine.
For heart failure, the usual starting dose is 40 mg twice daily. Your doctor may increase
the dose gradually up to one 160 mg tablet twice daily.
Following a heart attack, treatment is generally started at a dose of 20 mg (half
a 40 mg tablet) twice daily. Your doctor may increase the dose gradually up to 160
mg twice daily
5. What should I know while taking DILART?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using DILART.
If you become pregnant while taking DILART, tell your doctor immediately.
Tell your doctor, if for any reason, you have not taken your medicine exactly as prescribed.]
|
|
Things you should not do
|
Do not take DILART to treat any other complaints unless your doctor says you can.
Do not give DILART to anyone else, even if their condition seems to be similar to
yours
|
|
Driving or using machines
|
DILART can cause tiredness, sleepiness or dizziness in some people. If you have these
symptoms, do not drive or do anything else that could be dangerous.
|
|
Looking after your medicine
|
Keep the tablets in the original packet and foils until it is time to take them.
Store the tablets in a cool, dark and dry place at room temperature.
|
6. Are there any side effects?
Common side effects: headache, dizziness, tiredness, diarrhoea, constipation or wind, muscle or joint
pain or tenderness, abdominal pain, nausea, vomiting, dry cough, sore throat, hoarse
voice, runny or blocked nose, blistering skin, difficulty sleeping, feeling anxious,
tingling or numbness in the hands or feet, problems with sexual function.
Serious side effects: swelling of hands, feet or limbs, feeling of fast or irregular heartbeat, shortness
of breath, tiredness, chest pain, severe dizziness, liver disease with nausea, vomiting,
loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin
and eyes, and dark coloured urine, constant "flu-like" symptoms.
Active ingredient:
valsartan
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking DILART. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking DILART.
Where to find information in this leaflet:
1. Why am I taking DILART?
DILART contains the active ingredient valsartan. DILART belongs to a group of medicines called angiotensin II receptor antagonists
(AIIRAs).
DILART is used to control high blood pressure, which is also called hypertension.
Everyone has blood pressure. This pressure helps get your blood 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 when your blood pressure stays higher
than is needed, even when you are calm and relaxed.
There are usually no symptoms of hypertension. The only way of knowing that you have
it is to have your blood pressure checked regularly.
High blood pressure increases the workload of the heart and blood vessels. If it continues
for a long time, it can damage the blood vessels in the brain, heart and kidneys.
This can lead to stroke, heart failure or kidney failure. High blood pressure increases
the risk of heart attacks.
Lowering your blood pressure reduces the chance of these disorders happening.
DILART is also used to treat heart failure.
DILART helps the heart to function better and relieve some of the symptoms. Heart
failure is where the heart muscle cannot pump blood strongly enough to supply all
the blood needed throughout the body. Heart failure is not the same as heart attack
and does not mean that the heart stops.
DILART is also used to treat people after they have had a heart attack to reduce the
risk of further heart damage and reduce further heart problems.
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 purpose.
2. What should I know before I take DILART?
Warnings
Do not take DILART if:
you are allergic to valsartan, or 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
Always check the ingredients to make sure you can take this medicine.
you are pregnant or intend to become pregnant
you have impaired liver function caused by a blockage in the bile duct or any other
severe liver problems
you are also taking other blood pressure lowering medications containing aliskiren
and have type 2 diabetes
expiry date printed on the pack has passed or if the packaging is torn or shows signs
of tampering.
Check with your doctor if you have any other medical conditions such as:
heart disease or high blood pressure that is being treated with large doses of diuretics
(also called water or fluid tablets), or being treated with beta-blockers, aliskiren
and/or ACE-inhibitors
high blood pressure due to narrowing of the arteries in the kidney
any other kidney problems or you are having dialysis
liver problems
swelling, mainly of the face and throat, while taking other medicines (including an
ACE inhibitor or aliskiren)
you have recently had severe vomiting or diarrhoea
very low sodium levels and/or low blood pressure
primary hyperaldosteronism (Conn's syndrome), a hormone disorder causing accumulation
of fluid in the body
obstructed blood flow through the heart from narrowing of valves (stenosis) or enlarged
septum of the heart (HOCM).
Your doctor may want to take special precautions if you have any of the above conditions.
Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Do not take DILART if you are pregnant or intend to become pregnant.
DILART is not recommended for use in pregnancy. Like other similar medicines, it could
affect your unborn baby.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not recommended to breast feed while taking DILART as it is not known if valsartan,
the active ingredient of DILART, passes into the breast milk.
Use in children
There is not enough information to recommend the use of DILART in children (below
18 years of age).
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with DILART and affect how it works. You may need to
take different amounts of your medicines or you may need to take different medicines.
These medicines include:
beta-blockers, which are medicines used to treat hypertension or other heart conditions
ACE-inhibitors or aliskiren, which are also medicines used to treat hypertension or
other heart conditions
some diuretics (water or fluid pills)
potassium supplements , salt substitute containing potassium, or other drugs that
may increase potassium levels (heparin, trimethoprim)
lithium (a medicine used to treat some types of psychiatric illness)
some antibiotics (rifamycins), anti-rejection drugs (cyclosporin), antiretrovirals
(ritonavir) which may increase the effect of DILART
anti-inflammatory medicines such as celecoxib, diclofenac and indometacin (NSAIDs)
or Selective cyclooxygenase-2 Inhibitors (Cox-2 inhibitors) used to treat arthritis
trimethoprim containing medicines.
Your doctor may also check your kidney function.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect DILART.
Your doctor or pharmacist have a more complete list of medicines to be careful of
while taking DILART.
4. How do I take DILART?
Follow carefully all directions given to you by your doctor and pharmacist. These instructions may differ from the information contained in the leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist
for help.
How much to take
How much DILART to take will depend on what you are taking it for:
For hypertension, the usual dose is one 80 mg tablet once a day. If your blood pressure
is still too high after 4 weeks, your doctor may increase the dose to 160 mg to 320
mg once a day. If your blood pressure is still too high, your doctor may add a different
type of blood pressure lowering medicine.
For heart failure the usual starting dose is 40 mg twice daily. Your doctor may increase
the dose gradually up to one 160 mg tablet twice daily.
Following a heart attack, treatment is generally started at a dose of 20 mg (half
a 40 mg tablet) twice daily. Your doctor may increase the dose gradually up to 160
mg twice daily.
Follow the instructions provided and use DILART until your doctor tells you to stop.
When to take DILART
Following a heart attack, your first dose of DILART will be started as early as 12
hours after your heart attack.
When you take the first tablet from the pack of DILART, take the one marked with the
correct day of the week (e.g. if it is Wednesday, take the tablet marked Wednesday).
DILART comes in a calendar pack with the days of the week marked on it to help you
remember to take your tablet each day.
Take it at the same time each day.
This also helps you remember to take it, especially if you take it as part of your
usual routine (i.e. at breakfast time).
How to take DILART
Swallow the tablet with a full glass of water. Always take it in the same way in relation
to food.
It does not matter if you take it after food or on an empty stomach, as long as you
take it the same way each day.
If your stomach is upset after taking DILART, always take it after a meal (e.g. breakfast).
How long to take DILART for
Take this medicine until your doctor tells you to stop even if you feel quite well.
It will take at least 4 weeks for this medicine to have its full effect. After that,
it will be continued for as long as your doctor thinks is needed
If you forget to take DILART
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 you missed. This may increase the chance of you getting unwanted side effects.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you take too much DILART
If you think that you or anyone else has taken too much DILART, urgent medical attention
may be needed.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Too much DILART may make you feel dizzy, lightheaded or faint. You may experience
rapid, shallow breathing or cold, clammy skin. Your heartbeat may be faster than usual.
This is because your blood pressure is too low.
5. What should I know while taking DILART?
Things you should do
If you become pregnant while taking DILART, tell your doctor immediately. You should
not be taking this medicine while you are pregnant.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise your doctor may think that it was not effective and change your treatment
unnecessarily.
Be sure to keep all your doctor's appointments so that your progress can be checked.
Do this even if you feel well.
It is important to keep track of your progress. Your doctor will want to check your
blood pressure and your kidney and liver function from time to time.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking DILART.
Tell any other doctor, dentist or pharmacist who treats you that you are taking DILART.
Call your doctor straight away if you notice any of the following:
signs of allergy such as rash, itching or hives on the skin; swelling of the face,
lips, tongue or other parts of the body; fever, shortness of breath, wheezing or troubled
breathing.
Things you should not do
Do not use DILART to treat any other complaints unless your doctor says you can.
Do not give this medicine to anyone else, even if their condition seems to be similar
to yours.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DILART
affects you.
DILART may cause tiredness, sleepiness or dizziness in some people. If you have these
symptoms, do not drive or do anything else that could be dangerous.
If this medicine makes you feel dizzy or light-headed, be careful when getting up
from a sitting or lying position.
Dizziness can usually be prevented by getting up slowly and flexing leg muscles and
toes to get the blood flowing. When getting out of bed, dangle your legs over the
side for a minute or two before standing up.
Looking after your medicine
Keep your tablets in the original container until it is time to take them.
Store at room temperature.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines. DILART will keep well if it is cool
and dry.
Keep it where young children cannot reach it.
A locked cupboard at least one-and- a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date or if the packaging is torn or shows
signs of tampering. In that case, return it to your pharmacist for disposal.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
Do not be alarmed by this list of possible side effects. You may not experience any
of them.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people. Some side effects can
only be found when your doctor does tests to check your progress. DILART can affect
certain blood and liver function tests.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What DILART contains
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Active ingredient
(main ingredient)
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valsartan
|
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Other ingredients
(inactive ingredients)
|
microcrystalline cellulose
crospovidone
povidone
croscarmellose sodium
colloidal anhydrous silica
magnesium stearate
The 40 mg tablet contains:
Opadry Complete Film Coating System 08F520002 Yellow (ID: 144620)
The 80 mg tablet contains:
Opadry Complete Film Coating System 08F540003 Pink (ID: 146273)
The 160 mg tablet contains
Opadry Complete Film Coating System 08F520000 Yellow (ID: 146272)
The 320 mg tablet contains:
Opadry Complete Film Coating System 08F565001 Brown (ID: 146276)
|
Do not take this medicine if you are allergic to any of these ingredients.
What DILART looks like
DILART 40 mg tablets are yellow, oval shaped, biconvex, film coated tablets debossed
with "VN" and "1" on either side of the score line on one side and "M" on the other
side (AUST R 167425).
DILART 80 mg tablets are pale red, round, biconvex, bevelled edge, film- coated tablets
having a score line on one side and debossed with "M" over "VN 2" on other side (AUST
R 167427).
DILART 160 mg tablets are beige, oval-shaped, biconvex, bevelled edge, film-coated
tablets debossed with "M" to the left of the score on one side and "VN 3" on the other
side (AUST R 167426).
DILART 320 mg tablets are dark grey, oval shaped, biconvex, film coated tablets debossed
with "VN 4" on one side and "M" on the other side (AUST R 167421).
DILART tablets are supplied in blister packs of 28.
Who distributes DILART
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in October 2024.
DILART® is a Viatris company trade mark
DILART_cmi\Oct24/00