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?
EXFORGE contains the active ingredients Valsartan and Amlodipine Besilate. EXFORGE
is used to control high blood pressure, also called hypertension.
2. What should I know before I use EXFORGE?
Do not use if you have ever had an allergic reaction to EXFORGE 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 and affect how it works.
4. How do I use EXFORGE?
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?
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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.
If you become pregnant while taking EXFORGE, 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. EXFORGE 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 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
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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 gas, muscle or joint pain, abdominal pain, nausea, vomiting, dry cough, sore throat,
croaky 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
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using EXFORGE. 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.
Where to find information in this leaflet:
1. Why am I using EXFORGE?
EXFORGE contains the active ingredients Valsartan and amlodipine besilate. EXFORGE belongs to a group of medicines called antihypertensives. These medicines
help treat high blood pressure. The ingredients in EXFORGE reduce blood pressure in
two 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.
EXFORGE is used to control high blood pressure, which is also called hypertension.
EXFORGE is used to treat high blood pressure in patients whose blood pressure is not
controlled enough with either amlodipine or valsartan on its own.
2. What should I know before I use EXFORGE?
Warnings
Do not use EXFORGE if:
you are allergic to Valsartan or amlodipine besilate, allergic to medicines belonging
to a group of chemicals called dihydropyridines, used to treat blood pressure and
other heart problems, or allergic to any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
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
you are pregnant or intending to become pregnant.
you have severe kidney disease or are having dialysis.
you have liver problems 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 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:
severe kidney problems or received a kidney transplant
liver problems
heart problems, including obstructed blood flow through the heart from narrowing of
valves (stenosis) or 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 several episodes of vomiting or diarrhoea or are taking a diuretic
(a drug increasing the amount of urine).
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 if you are pregnant or intend to become pregnant. EXFORGE 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 in this case. It is not known if valsartan
or amlodipine, the active ingredients of EXFORGE, pass 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 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
some antibiotics (rifamycins), anti-rejection drugs (Cyclosporin), antiretrovirals
(Ritonavir) which may increase the effect of EXFORGE
potassium supplements, salt substitutes containing potassium, or other drugs that
may increase potassium levels
anticonvulsant agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin,
primidone), rifampicin, St. John's wort
nitroglycerin and other nitrates, or other substances called "vasodilators"
medicines used for HIV/AIDS (e.g. ritonavir) or for treatment of fungal infections
(e.g. ketoconazole)
anti-inflammatory medicines such as Celebrex, Voltaren and Indocid (NSAIDs) or Selective
Cyclooxygenase-2 Inhibitors (Cox-2 inhibitors)
intravenous dantrolene used to treat malignant hyperthermia
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 EXFORGE.
Your doctor and pharmacist have a more complete list of medicines to be careful of
while taking EXFORGE.
4. How do I use EXFORGE?
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
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
Swallow the tablet with a full glass of water.
Always take EXFORGE 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 way every day.
If you forget to take EXFORGE
EXFORGE 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.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you take too much EXFORGE (overdose)
If you think that you have used too much EXFORGE, 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.
Keep the telephone numbers for these places handy.
Too much EXFORGE 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?
Things you should do
If you become pregnant while taking EXFORGE, 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. EXFORGE 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.
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.
Things you should not do
Do not use EXFORGE 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
affects you.
EXFORGE 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 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
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Less serious side effects
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What to do
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headache
buzzing, whistling, ringing or other persistent noise in the ears
dizziness, spinning sensation, changes in vision, uncoordinated movements
dizziness on standing up, especially when getting up from a sitting or lying position
sleepiness, tiredness, weakness or difficulty sleeping
pain in the back or joints
muscle pain, muscle tenderness or weakness, cramps
runny nose or congested sinuses
dry cough, sore throat or hoarse voice
dry mouth
bleeding, tender or enlarged gums
stomach upset, pain, diarrhoea or constipation
nausea (feeling sick) or vomiting
tingling or numbness in hands or feet
rash, redness, blistering or peeling of skin, itching
excessive sweating
feeling anxious or sad
problems with sexual function
breast enlargement in men
unusual hair loss or thinning
passing more urine than normal or frequent urge to urinate
redness and warm feeling of the face and/or neck
swelling of the ankles, feet, face or hands
upset stomach or indigestion
weight gain
feeling nervous, depressed or moody
change in sense of taste
sensitivity to light
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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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.
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 is only available with a doctor's prescription.
What EXFORGE contains
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Active ingredient
(main ingredient)
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Valsartan and Amlodipine besilate
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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
titanium dioxide
iron oxide yellow
talc - purified
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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 looks like
EXFORGE 5/80 (5 mg of amlodipine and 80 mg valsartan) tablets are dark yellow, round
and imprinted with NVR on one side and NV on the other. Packs of 7 and 28.
EXFORGE 5/160 (5 mg of amlodipine and 160 mg valsartan) tablets are dark yellow, oval
and imprinted with NVR on one side and ECE on the other. Packs of 7 and 28.
EXFORGE 10/160 (10 mg of amlodipine and 160 mg valsartan) tablets are light yellow,
oval and imprinted with NVR on one side and UIC on the other. Packs of 7 and 28.
EXFORGE 5/320 (5 mg of amlodipine and 320 mg valsartan) tablets are very dark yellow,
oval and imprinted with NVR on one side and CSF on the other. Packs of 7 and 28.
EXFORGE 10/320 (10 mg of amlodipine and 320 mg valsartan) tablets are dark yellow,
oval and imprinted with NVR on one side and LUF on the other. Packs of 7 and 28.
Australian Registration Numbers:
EXFORGE 5/80 (5 mg of amlodipine and 80 mg valsartan) tablets
(AUST R 130787)
EXFORGE 5/160 (5 mg of amlodipine and 160 mg valsartan) tablets
(AUST R 130834)
EXFORGE 10/160 (10 mg of amlodipine and 160 mg valsartan) tablets
(AUST R 130841)
EXFORGE 5/320 (5 mg of amlodipine and 320 mg valsartan) tablets
(AUST R 161820)
EXFORGE 10/320 (10 mg of amlodipine and 320 mg valsartan) tablets
(AUST R 161824)
Who distributes EXFORGE
EXFORGE 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 August 2024.
(Internal document code: exf300824c.doc based on PI exf300824i.doc)