Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Exforge HCT?
Exforge HCT contains the active ingredients Amlodipine Besilate, Valsartan and hydrochlorothiazide.
Exforge HCT is used to control high blood pressure, also called hypertension.
2. What should I know before I use Exforge HCT?
Do not use if you have ever had an allergic reaction to Exforge HCT 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 Exforge HCT and affect how it works.
4. How do I use Exforge HCT?
The usual dose is one tablet a day. Your doctor will tell you how many tablets to
take each day. Depending on how you respond to the treatment, your doctor may suggest
a higher or lower dose.
Take this medicine until your doctor tells you to stop even if you feel quite well.
5. What should I know while using Exforge HCT?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Exforge HCT.
If you become pregnant while taking Exforge HCT, tell your doctor immediately.
Tell your doctor, if for any reason, you have not taken your medicine exactly as prescribed.
If you are going to have surgery, tell your doctor and anaesthetist that you are taking
Exforge HCT. Exforge HCT may affect some medicines you receive during surgery.
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Things you should not do
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Do not stop use Exforge HCT 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.
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Driving or using machines
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This medicine 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.
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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 (30°C).
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6. Are there any side effects?
Common side effects: headache, persistent ringing in the ears, 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 or sad, tingling or numbness in the hands or feet, problems
with sexual function, breast enlargement in men, unusual hair loss or thinning.
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(s):
Amlodipine besilate/Valsartan/hydrochlorothiazide
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Exforge HCT. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Exforge HCT.
Where to find information in this leaflet:
1. Why am I using Exforge HCT?
Exforge HCT contains the active ingredients, amlodipine besilate, valsartan and hydrochlorothiazide. Exforge HCT belongs to a group of medicines called antihypertensives. These medicines
help treat high blood pressure. The ingredients in Exforge HCT reduce blood pressure
in three different ways:
Valsartan blocks the effect of angiotensin II, which is a substance in the body that
tightens blood vessels and makes your blood pressure rise. When the effect of angiotensin
II is blocked, your blood vessels relax and your blood pressure goes down.
Amlodipine besilate blocks the movement of calcium into the cells of the heart and
blood vessels. As a result, they relax blood vessels and increase the supply of blood
and oxygen to the heart while reducing its workload.
Hydrochlorothiazide helps reduce the amount of excess fluid in the body by increasing
the amount of urine produced. This helps lower your blood pressure.
Exforge HCT is used to control high blood pressure, which is also called hypertension.
Exforge HCT is only used to treat high blood pressure in patients who already use
and have success with the combination of valsartan, amlodipine besilate and hydrochlorothiazide
individually. Exforge HCT is used to substitute these three medicines into a single
tablet.
2. What should I know before I use Exforge HCT?
Warnings
Do not use Exforge HCT if:
you are allergic to valsartan, amlodipine besilate or hydrochlorothiazide; allergic
to medicines belonging to a group of chemicals called dihydropyridines, used to treat
blood pressure and other heart problems; allergic to medicines belonging to a group
of chemicals called sulfonamide-derived (such as some antibiotics e.g. Bactrim trimethoprim
and sulfamethoxazole) or any of the ingredients listed at the end of this leaflet.
you are pregnant or intending to become pregnant.
you have severe kidney disease or are having dialysis
you have a liver problem caused by a blockage in the bile duct or any other severe
liver problems.
you have cholestasis, which is reduced or stopped bile flow
you have anuria, which is a condition where you are unable to urinate
you have high uric acid levels in the blood, which may cause gout
you have low level of potassium or sodium, or high level of calcium in your blood
you are also taking other blood pressure lowering medications containing aliskiren
and have type 2 diabetes.
it is after the expiry date printed on the pack or if the packaging is torn or shows
signs of tampering. In that case, return it to your pharmacist for disposal.
Check with your doctor if you have any other medical conditions such as:
kidney problems or received a kidney transplant
liver problems
systemic lupus erythematosus, a disease affecting the skin, joints and kidneys
heart problems, including obstructed blood flow through the heart from narrowing of
valves (stenosis) or an enlarged septum of the heart (HOCM)
primary hyperaldosteronism (Conn's syndrome), a hormone disorder causing build-up
of fluid in the body.
swelling, mainly of the face and throat, while taking other medicines (including an
ACE inhibitor or aliskiren)
suffering from vomiting or diarrhoea
passing less urine than is normal for you or difficulty passing urine
a salt restricted diet
skin cancer
breathing or lung problems (including inflammation or fluid in the lungs) following
the use of hydrochlorothiazide in the past.
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 Exforge HCT if you are pregnant or intend to become pregnant. Exforge
HCT 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. Ask your doctor
about the risks and benefits of taking Exforge HCT. Hydrochlorothiazide and amlodipine
are known to pass into the breast milk. It is not known if valsartan, an active ingredient
of Exforge HCT, passes into the breast milk and could affect your baby.
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 Exforge HCT 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:
medicines used to treat high blood pressure and some other heart conditions including
fluid tablets or diuretic medicines, ACE-inhibitors, aliskiren and beta blockers
simvastatin (a medicine used to help lower cholesterol levels), since the dose may
have to be reduced when taken with Exforge HCT
intravenous dantrolene used to treat malignant hyperthermia
some antibiotics (rifamycins), anti-rejection drugs (Cyclosporin), antiretrovirals
(Ritonavir) which may increase the effect of valsartan
potassium supplements, salt substitutes containing potassium, or other drugs that
may increase potassium levels
anti-inflammatory medicines such as Celebrex, Voltaren and Indocid (NSAIDs) or Selective
Cyclooxygenase-2 Inhibitors (Cox-2 inhibitors)
medicines or supplements containing calcium
vitamin D
medicines used to relax muscles before or during surgery
steroid medicines such as cortisone, prednisone and ACTH
lithium, antidepressants, antipsychotics, medicines used to treat mood swings and
some types of depression
cyclophosphamide or methotrexate
penicillin
amphotericin, a medicine used to treat fungal infections
insulin and tablets used to treat diabetes
medicines used to treat gout
cyclosporine
carbamazepine, an anticonvulsant and mood stabilising drug used primarily in the treatment
of epilepsy and bipolar disorder
digoxin or other digitalis glycosides (medicines used to treat heart problems)
antiarrhythmics (medicines used to treat heart problems)
medicines used for oesophageal ulceration and inflammation
amantadine, and anti-Parkinson therapy also used to treat or prevent certain illnesses
caused by viruses
cytotoxic drugs used in cancer therapy
medicine used to treat gastrointestinal cramps, urinary bladder spasm, asthma, motion
sickness, muscular spasms, Parkinson's disease and as aid to anaesthesia from a class
called anticholinergic agents
cholestyramine, colestipol, and other resins (medicines used mainly to treat high
levels of lipids in the blood)
pressor amines, such as noradrenaline (substances that raise blood pressure)
barbiturates, narcotics (medicines with sleep-inducing properties) and alcohol.
radioactive iodine, used as a medical tracer or diagnosis.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Exforge HCT.
Your doctor or pharmacist have a more complete list of medicines to be careful of
while taking Exforge HCT.
4. How do I use Exforge HCT?
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
Your doctor will tell you how many tablets to take each day. The usual dose is one
tablet a day.
Depending on how you respond to the treatment, your doctor may suggest a higher or
lower dose.
Take this medicine until your doctor tells you to stop even if you feel quite well.
People who have high blood pressure often feel well and do not notice any signs of
this problem.
When to take Exforge HCT
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 Exforge HCT
Swallow the tablet with a full glass of water
Always take Exforge HCT in the same way, with or without food.
You can take it with or without food but it will work best if you always take it in
the same day everyday.
If you forget to take Exforge HCT
Exforge HCT should be used regularly at the same time each day.
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 Exforge HCT (overdose)
If you think that you have used too much Exforge HCT, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), 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.
Taking too much Exforge HCT 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 using Exforge HCT?
Things you should do
If you become pregnant while taking Exforge HCT, 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.
People with high blood pressure often do not notice any signs of this problem. 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 going to have surgery, tell your doctor and anaesthetist that you are taking
Exforge HCT. Exforge HCT may affect some medicines you receive during surgery.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking Exforge HCT.
Things to be careful of
Avoid eating grapefruit or drinking grapefruit juice. Grapefruit juice can affect
the metabolism of some medicines, including amlodipine.
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.
Remind any doctor, dentist or pharmacist you visit that you are using Exforge HCT.
Things you should not do
Do not use Exforge HCT 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 Exforge
HCT affects you.
Exforge HCT 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
Follow the instructions in the carton on how to take care of your medicine properly.
Keep your tablets in the original container until it is time to take them.
Store it in a cool dry place below 30°C (room temperature) 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. Exforge HCT 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 meters above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
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.
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
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Serious side effects
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What to do
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signs of allergy such as rash, itching or hives on the skin; swelling of the face,
lips, tongue or other part of the body; fever, shortness of breath, wheezing or troubled
breathing
feeling of fast or irregular heart beat (pounding, racing, skipping beats)
chest pain
shortness of breath not caused by exercise, with swelling of legs and feet
tiredness or lack of energy, being short of breath when exercising, dizziness and
looking pale
bleeding or bruising more easily
constant "flu-like" symptoms such as chills, fever, sore throat, aching joints, sores
in mouth, swollen glands
severe dizziness or fainting
liver disease with nausea, vomiting, loss of appetite, feeling generally unwell, fever,
itching, yellowing of the skin and eyes, and dark coloured urine
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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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.
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
Exforge HCT is only available with a doctor's prescription.
What Exforge HCT contains
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Active ingredient
(main ingredient)
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Amlodipine besilate, Valsartan, and Hydrochorothiazide
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Other ingredients
(inactive ingredients)
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The tablets contain the following non active ingredients:
cellulose microcrystalline
crospovidone
silica - colloidal anhydrous
magnesium stearate
hypromellose
macrogol 4000
talc - purified
titanium dioxide
iron oxide yellow
iron oxide red
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Potential allergens
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None
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Do not take this medicine if you are allergic to any of these ingredients.
What EXFORGE HCT looks like
EXFORGE HCT 5/160/12.5 (5 mg amlodipine, 160 mg valsartan and 12.5 mg hydrochlorothiazide)
tablets are white, ovaloid, biconvex with bevelled edge and imprinted with NVR on
one side and VCL on the other. Packs of 7's and 28's.
EXFORGE HCT 10/160/12.5 (10 mg amlodipine, 160 mg valsartan and 12.5 mg hydrochlorothiazide)
tablets are pale yellow, ovaloid, biconvex with bevelled edge and imprinted with NVR
on one side and VDL on the other. Packs of 7's and 28's.
EXFORGE HCT 5/160/25 (5 mg amlodipine, 160 mg valsartan and 25 mg hydrochlorothiazide)
tablets are yellow, ovaloid, biconvex with bevelled edge and imprinted with NVR on
one side and VEL on the other. Packs of 7's and 28's.
EXFORGE HCT 10/160/25 (10 mg amlodipine, 160 mg valsartan and 25 mg hydrochlorothiazide)
tablets are brown yellow, ovaloid, biconvex with bevelled edge and imprinted with
NVR on one side and VHL on the other. Packs of 7's and 28's.
EXFORGE HCT 10/320/25 (10 mg amlodipine, 320 mg valsartan and 25 mg hydrochlorothiazide)
tablets are brown yellow, ovaloid, biconvex with bevelled edge and imprinted with
NVR on one side and VFL on the other. Packs of 7's and 28's.
EXFORGE HCT tablets are non-divisible and cannot be divided into equal doses.
Australian Registration Numbers:
EXFORGE HCT 5/160/12.5
(AUST R 157954)
EXFORGE HCT 5/160/25
(AUST R 158162)
EXFORGE HCT 10/160/12.5
(AUST R 158164)
EXFORGE HCT 10/160/25
(AUST R 158166)
EXFORGE HCT 10/320/25
(AUST R 158168)
Who distributes Exforge HCT
EXFORGE HCT is supplied in Australia by:
Novartis Pharmaceuticals Australia Pty Limited
(ABN 18 004 244 160)
54 Waterloo Road
Macquarie Park NSW 2113
Telephone 1 800 671 203
®= Registered Trademark
This leaflet was prepared in September 2024.
(Internal reference only: exh050924c.doc based on PI exh050924i.doc)