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Co-Diovan®
Film Coated Tablet
Valsartan and hydrochlorothiazide
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.
Co-Diovan contains the active ingredients Valsartan and hydrochlorothiazide. Co-Diovan
is used to treat high blood pressure. Symptoms include headache, fatigue, irregular
heartbeat and vision problems.
For more information, see Section 1. Why am I using Co-Diovan? in the full CMI.
For more information, see Section 1. Why am I using Co-Diovan? in the full CMI.
Do not use if you have ever had an allergic reaction to Co-Diovan 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. For more information, see Section 2. What should I know before I use Co-Diovan? in the full 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. For more information, see Section 2. What should I know before I use Co-Diovan? in the full CMI.
Some medicines may interfere with Co-Diovan and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
Your doctor will advise you on the appropriate dose.
Follow the instructions provided and use Co-Diovan until your doctor tells you to
stop.
More instructions can be found in Section 4. How do I use Co-Diovan? in the full CMI.
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Things you should do
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Remind any doctor, dentist, pharmacist or specialist you visit that you are using
Co-Diovan.
Tell your doctor if you become pregnant or intend to become pregnant or if you are
breastfeeding.
Contact your doctor immediately if you develop any signs of allergic reaction.
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Things you should not do
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Do not stop using this medicine suddenly.
Do not give Co-Diovan to anyone else, even if they seem to have the same condition
as you.
Do not use Co-Diovan in children.
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Driving or using machines
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Co-Diovan may cause dizziness in some people. Be careful before driving or using any
machines or tools.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
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Looking after your medicine
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Store below 30°C.
Protect from moisture.
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For more information, see Section 5. What should I know while using Co-Diovan? in the full CMI.
Common side effects include dizziness, headache, muscular weakness, joint pain, blurred
vision , dry mouth, feeling sick, tiredness. For more information, including what
to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
Co-Diovan®
Film Coated Tablet
Active ingredients:
Valsartan and hydrochlorothiazide
Consumer Medicine Information (CMI)
This leaflet provides important information about using Co-Diovan. 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
Co-Diovan
.
Where to find information in this leaflet:
Co-Diovan contains the active ingredients Valsartan and Hydrochlorothiazide.
Co-Diovan is used to treat high blood pressure. Symptoms include headache, fatigue,
irregular heartbeat and vision problems.
Co-Diovan helps to
reduce blood pressure in two ways:
Valsartan helps to lower your blood pressure by blocking the effect of angiotensin
II. This is a substance which makes your blood vessels tighten, which raises your
blood pressure. When Valsartan blocks it, your blood vessels become relaxed, making
it easier for blood to flow and thus helping to lower your blood pressure.
Hydrochlorothiazide is a diuretic (water pill) type of medicine. It helps in reducing
the amount of excess fluid in the body by increasing the amount of urine produced
and thereby helps in lowering your blood pressure.
Do not use Co-Diovan
If you are allergic to Valsartan, Hydrochlorothiazide or other sulfonamide-derived
medicines or 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 allergic reaction
may include shortness of breath, difficulty breathing, swelling of the face, lips,
tongue or other parts of the body, rash, hives.
In pregnancy
In children
If you have severe liver diseases, symptoms such as and tiredness, itchy skin, and
yellowing of the skin and eyes or intense itching, dark urine and light-colored stools.
If you suffer from symptoms such as tiredness, weakness, little to no urine output
or severe kidney problems.
If you have following symptoms:
Muscle weakness and muscle cramps, irregular heartbeat, weakness.
Feeling sick, vomiting, headache, loss of energy
Tiredness, pain in bone, headache
Joint pain and swelling, redness and warmth around affected joints.
If you use a medicine called aliskiren.
Check with your doctor if you:
have any other medical conditions.
take any medicines for any other condition.
are taking any medicines similar to Hydrochlorothiazide (diuretics).
have severe heart failure.
suffer from problems with your kidneys.
have headache, muscle weakness, tiredness.
have an allergy or symptoms such as wheezing, shortness of breath, coughing.
have heart problems
suffer from skin rashes (butterfly-shaped), tiredness, joint and muscle pain.
have eye problems.
suffer from non-melanoma skin cancer.
have any breathing problems.
suffer from mild to moderate liver diseases or any kidney problems.
have high levels of cholesterol, triglycerides in your blood.
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
Check with your doctor if you are pregnant or intend to become pregnant.
Do not use Co-Diovan during pregnancy or if you are planning to become pregnant. It
may affect your unborn baby.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Do not use Co-Diovan during breastfeeding.
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 Co-Diovan and affect how it works.
Tell your doctor if you take any of the following medicines:
Medicines used to relieve pain, swelling e.g. non-steroidal anti-inflammatory drugs
(NSAIDs), salicylic acid derivatives indomethacin including Selective Cyclooxegase-2
Inhibitors (COX-2 Inhibitors)
Medicines used to treat high blood pressure and some other heart problems such as
diuretic medicines, ACE-inhibitors, aliskiren and beta blockers
Potassium supplements, potassium-sparing diuretics, or other drugs that may alter
potassium levels e.g. heparin, trimethoprim containing medicines
Antiretrovirals (ritonavir), antibiotics (rifamycins)
Other antihypertensive drugs e.g. guanethidine, methyldopa, beta-blockers, vasodilators,
calcium channel blockers, methyldopa.
Diazoxide, drug used to treat low blood sugar level.
Non-depolarising muscle relaxants (e.g. curare derivatives).
Insulin and antidiabetic medicines
Medicines used for treatment of heart problems and high blood pressure e.g. kaliuretic
diuretics
Carbenoxolone, medicine used for treatment of various stomach problems.
Penicillin G, antibiotic used in treatment of bacterial infections
Medicines used to treat irregular heart beats e.g. antiarrhythmics and digitalis glycosides
Antidepressants, antipsychotics e.g. Lithium
Antiepileptics e.g. carbamazepine
Anticholinergic agents (e.g. atropine, biperiden, which are used to treat Parkinson's
disease, relieve stomach cramps, spasms
Pressor amines (e.g. noradrenaline)
Medicines used to lower cholesterol e.g. cholestyramine or colestipol resins
Tetracycline, a drug used to treat some infections
Alcohol, anaesthetics and sedatives (sleeping tablets)
Radioactive iodine, used as a medical tracer or diagnosis
Cyclophosphamide, methotrexate, a drug used to treat arthritis and some cancers
Medicines or supplements containing calcium
Vitamin D
Medicines used in organ transplants e.g. cyclosporin
Steroid medicines such as cortisone, prednisone and ACTH
Amphotericin, a drug used to treat fungal infections
Medicines used to treat gout e.g. Allopurinol, probenacid or sulfinpyrazone
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Co-Diovan.
How much to take
Your doctor will advise you on the appropriate dose.
Follow the instructions provided and use Co-Diovan until your doctor tells you to
stop.
The usual dose is one tablet per day as advised by your doctor.
When to take Co-Diovan
Co-Diovan should be taken at the same time each day.
When you take the first dose from the pack of Co-Diovan, take the one marked with
the correct day of the week (e.g. if it is Wednesday, take the dose from the section
of the foil marked Wednesday).
How to take Co-Diovan
Swallow the tablet with a full glass of water.
Take Co-Diovan consistently with or without food
If you feel that your stomach gets upset after taking Co-Diovan, always take it after
a meal.
If you forget to use Co-Diovan
Co-Diovan should be used regularly at the same time each day. If you miss your dose
at the usual time, take the dose as soon as you remember and then go back to taking
it as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you use too much Co-Diovan
If you think that you have used too much Co-Diovan, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
(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.
Things you should do
Check your skin for any new lesions and report any suspicious skin lesions to your
doctor immediately.
There may be a risk of developing non-melanoma skin cancer while on treatment with
Co-Diovan.
Avoid direct exposure to sunlight and UV rays, in case of exposure, use adequate protection
to avoid the risk of skin cancer.
Call your doctor straight away if you:
develop any signs of allergic reaction.
become pregnant or intend to become pregnant or if you are breastfeeding.
are going to have surgery, tell your doctor that you are taking Co-Diovan.
notice symptoms such as increased sensitivity of the skin to sun. Symptoms of sunburn
such as redness, itching, swelling, blistering which may occur more quickly than normal.
have muscle weakness or cramps, tiredness.
Remind any doctor, dentist, pharmacist or specialist you visit that you are using
Co-Diovan.
Things you should not do
Do not stop using this medicine suddenly.
Do not give Co-Diovan to anyone else, even if they seem to have the same condition
as you.
Do not use Co-Diovan to treat any other complaints unless your doctor tells you to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Co-Diovan
affects you.
Co-Diovan may cause dizziness in some people. Precaution should be taken before driving
or using any machines or tools.
Looking after your medicine
Store below 30°C.
Keep in the original package.
Protect from moisture.
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.
Keep it where young children cannot reach it.
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.
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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General problems:
Headache
Dizziness
Back pain
Joint pain
Tiredness
Unusual hair loss or thinning
Anxiety
Unusual weakness
Dry mouth and skin, dark colour urine, tiredness, dizziness
Excessive sweating
Inability to sleep
Muscle spasms
Muscle strain
Muscular weakness
Fever
Sleepiness
Vision blurred
Vision problems
Respiratory problems:
Sore throat, stuffy nose, cough, mild body pain
Sore throat and discomfort when swallowing
Runny or blocked nose, sneezing, facial pressure or pain
Cough
Sore throat, dry cough, fever, muscle pain.
Stomach problems:
Diarrhoea
Pain in stomach
Indigestion
Dry mouth
Feeling sick
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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
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Serious side effects
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What to do
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Respiratory problems:
Shortness of breath, wheezing, feeling of chest tightness or pain, cough
Shortness of breath, fever, fast breathing, extreme tiredness
Abnormal blood tests:
Muscle weakness or cramps, tiredness, muscle spasms may indicate decrease in potassium
level in your blood.
Swelling in your legs or around your eyes, shortness of breath may indicate increase
in creatinine level.
Swelling in your arms, legs, or feet, muscle cramps, tiredness may indicate increased
blood urea nitrogen level in your blood.
Fever, tiredness, sore throat, mouth ulcers may indicate low level of Neutrophils
in your blood.
Feeling sick, vomiting, headache, loss of energy may indicate low level of sodium
in your blood.
Tiredness, pain in bone, headache may indicate high level of calcium in your blood.
Tremors or shaking, muscle spasms, cramps may indicate low level of magnesium your
blood.
Eye problems:
Decreased vision, eye pain, vision distortion, blind spots, and other changes in vision,
Headache, blurred vision, eye pain
Severe eye pain, redness of eye, feeling sick
Other problems:
Decreased urine output, dark colour urine.
Tiredness, vomiting, shortness of breath.
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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.
This medicine is only available with a doctor's prescription.
What Co-Diovan contains
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Active ingredient
(main ingredient)
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Valsartan and hydrochlorothiazide.
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Other ingredients
(inactive ingredients)
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Co-Diovan 80/12.5: silica-colloidal anhydrous; crospovidone; hypromellose; magnesium stearate; cellulose-microcrystalline;
macrogol 8000; talc-purified; titanium dioxide; iron oxide red; iron oxide yellow.
Co-Diovan 160/12.5: silica-colloidal anhydrous; crospovidone; hypromellose; magnesium stearate; cellulose-microcrystalline;
macrogol 8000; talc-purified; titanium dioxide; iron oxide red.
Co-Diovan 160/25: silica-colloidal anhydrous; crospovidone; hypromellose; magnesium stearate; cellulose-microcrystalline;
macrogol 4000; talc-purified; titanium dioxide, iron oxide red, iron oxide yellow,
iron oxide black.
Co-Diovan 320/12.5: silica-colloidal anhydrous; crospovidone; hypromellose; magnesium stearate; cellulose-microcrystalline;
macrogol 4000; talc-purified; titanium dioxide, iron oxide red, iron oxide black.
Co-Diovan 320/25: silica-colloidal anhydrous; crospovidone; hypromellose; magnesium stearate; cellulose-microcrystalline;
macrogol 4000; talc-purified; titanium dioxide, iron oxide yellow.
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Potential allergens
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NA
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Do not take this medicine if you are allergic to any of these ingredients.
What Co-Diovan looks like
Co-Diovan 80/12.5: Ovaloid, non-divisible, film-coated tablets coloured light orange
and imprinted with HGH on one side and CG on the other side. It is available in PA/Al/PVC/Al
blister packs of 7, 14, 28, 30 and 56.
Co-Diovan 160/12.5: Ovaloid, non-divisible, film-coated tablets coloured dark red
and imprinted with HHH on one side and CG on the other side. It is available in PA/Al/PVC/Al
blister packs of 7, 14, 28, 30 and 56.
Co-Diovan 160/25: Ovaloid, non-divisible, film-coated tablets coloured brown-orange
and imprinted with HXH on one side and NVR on the other side. It is available in PA/Al/PVC/Al
blister packs of 7, 14, 28, 30 and 56.
Co-Diovan 320/12.5: Ovaloid, non-divisible, film-coated tablets coloured pink and
imprinted with HIL on one side and NVR on the other side. It is available in PA/Al/PVC/Al
blister packs of 7, 14, 28, 30 and 56.
Co-Diovan 320/25: Ovaloid, non-divisible, film-coated tablets coloured yellow and
imprinted with CTI on one side and NVR on the other side. It is available in PA/Al/PVC/Al
blister packs of 7, 14, 28, 30 and 56.
Not all strengths and pack sizes may be marketed.
Australian Registration Numbers
Co-Diovan 80/12.5 mg tablets AUST R 96740
Co-Diovan 160/12.5 mg tablets AUST R 96741
Co-Diovan 160/25 mg tablets AUST R 96742
Co-Diovan 320/12.5 mg tablets AUST R 135782
Co-Diovan 320/25 mg tablets AUST R 135812
Who distributes Co-Diovan
Co-Diovan is supplied in Australia by:
NOVARTIS Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road North Ryde NSW 2113
Telephone: 1 800 671 203
®= Registered Trademark
This leaflet was prepared in October 2025
Internal code:
cod271022c_V2 based on PI cod271022i
