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VALSARTAN HYDROCHLOROTHIAZIDE 160/25 MG FILM-COATED TABLETS

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

80 mg/12.5 mg
film-coated tablets
160 mg/12.5 mg
film-coated tablets
160 mg/25 mg
film-coated tablets
Valsartan/hydrochlorothiazide

Read all of this leaflet carefully before you
start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your
doctor or pharmacist.
This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,

even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Co-Diovan is and what it is used for
2. Before you take Co-Diovan
3. How to take Co-Diovan
4. Possible side effects
5. How to store Co-Diovan
6. Further information
1. WHAT CO-DIOVAN IS AND WHAT IT IS USED
FOR
Co-Diovan film-coated tablets contain
two active substances called valsartan
and hydrochlorothiazide. Both of these
substances help to control high blood pressure
(hypertension).
Valsartan belongs to a class of medicines
known as angiotensin II receptor
antagonists , which help to control high blood
pressure. Angiotensin II is a substance in
the body that causes vessels to tighten,
thus causing your blood pressure to increase.
Valsartan works by blocking the effect of
angiotensin II. As a result, blood vessels relax
and blood pressure is lowered.
Hydrochlorothiazide belongs to a group

of medicines called thiazide diuretics (also
known as water tablets ). Hydrochlorothiazide
increases urine output, which also lowers blood
pressure.
Co-Diovan is used to treat high blood pressure
which is not adequately controlled by a single
substance alone.
High blood pressure increases the workload
of the heart and arteries. If not treated, it can
damage the blood vessels of the brain, heart,
and kidneys, and may result in a stroke, heart
failure or kidney failure. High blood pressure
increases the risk of heart attacks. Lowering
your blood pressure to normal reduces the risk
of developing these disorders.
2. BEFORE YOU TAKE CO-DIOVAN
Do not take Co-Diovan:
if you are allergic (hypersensitive) to
valsartan, hydrochlorothiazide, sulphonamide
derivatives (substances chemically related
to hydrochlorothiazide) or to any of the other
ingredients of Co-Diovan.
if you are more than 3 months pregnant
(it is also better to avoid Co-Diovan in early
pregnancy see pregnancy section).
if you have severe liver disease, destruction
of the small bile ducts within the liver (biliary
cirrhosis) leading to the build up of bile in the

liver (cholestasis).
if you have severe kidney disease.
if you are unable to produce urine (anuria).
if you are treated with an artificial kidney.
if the level of potassium or sodium in your
blood is lower than normal, or if the level of
calcium in your blood is higher than normal
despite treatment.
if you have gout.
If any of the above apply to you, do not take
this medicine and speak to your doctor.
Take special care with Co-Diovan
if you are taking potassium-sparing
medicines, potassium supplements, salt
substitutes containing potassium or other
medicines that increase the amount of
potassium in your blood such as heparin.
Your doctor may need to check the amount of
potassium in your blood regularly.
if you have low levels of potassium in your
blood.
if you have diarrhoea or severe vomiting.
if you are taking high doses of water tablets
(diuretics).
if you have severe heart disease.
if you are suffering from heart failure or
have experienced a heart attack. Follow your
doctor s instruction for the starting dose
carefully. Your doctor may also check your

kidney function.
if you suffer from a narrowing of the kidney
artery.
if you have recently received a new kidney.
if you suffer from hyperaldosteronism.
This is a disease in which your adrenal glands
make too much of the hormone aldosterone.
If this applies to you, the use of Co-Diovan is
not recommended.
if you have liver or kidney disease.
if you have ever experienced swelling of the
tongue and face caused by an allergic reaction
called angioedema when taking another drug
(including ACE inhibitors), tell your doctor.
If these symptoms occur when you are taking
Co-Diovan, stop taking Co-Diovan immediately
and never take it again. See also section 4,
Possible side effects .
if you have fever, rash and joint pain,
which may be signs of systemic lupus
erythematosus (SLE, a so-called autoimmune
disease).
if you have diabetes, gout, high levels of
cholesterol or triglycerides in your blood.
if you have had allergic reactions with the use
of other blood pressure-lowering agents of this
class (angiotensin II receptor antagonists) or if
you have allergy or asthma.
if you experience a decrease in vision or eye
pain. These could be symptoms of an increase

of pressure in your eye and can happen
within hours to a week of taking Co-Diovan.
This can lead to permanent vision loss, if not
treated. If you earlier have had a penicillin or
sulphonamide allergy you can be at higher risk
of developing this.
it may cause increased sensitivity of the skin
to sun.
If any of these apply to you, talk to your
doctor.
Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without
a prescription.
The effect of the treatment can be influenced if
Co-Diovan is taken together with certain other
medicines. It may be necessary to change the
dose, to take other precautions, or in some
cases to stop taking one of the medicines.
This especially applies to the following medicines:
lithium, a medicine used to treat some types
of psychiatric diseases.
medicines or substances that may increase
the amount of potassium in your blood.
These include potassium supplements or salt
substitutes containing potassium, potassiumsparing medicines and heparin.
medicines that may reduce the amount of

potassium in your blood, such as diuretics
(water tablets), corticosteroids, laxatives,
carbenoxolone, amphotericin or penicillin G.
some antibiotics (rifamycin group), a drug
used to protect against transplant rejection
(ciclosporin) or an antiretroviral drug used
to treat HIV/AIDS infection (ritonavir). These
drugs may increase the effect of Co-Diovan.
medicines that may induce torsades de
pointes (irregular heart beat), such as
antiarrhythmics (medicines used to treat heart
problems) and some antipsychotics.
medicines that may reduce the amount
of sodium in your blood, such as
antidepressants, antipsychotics, antiepileptics.
medicines for the treatment of gout, such as
allopurinol, probenecid, sulfinpyrazone.
therapeutic vitamin D and calcium
supplements.
medicines for the treatment of diabetes
(oral agents such as metformin or insulins).
other medicines to lower your blood pressure
including methyldopa.
medicines to increase blood pressure, such as
noradrenaline or adrenaline.
digoxin or other digitalis glycosides (medicines
used to treat heart problems).
medicines that may increase blood sugar
levels, such as diazoxide or beta blockers.
cytotoxic medicines (used to treat cancer),

such as methotrexate or cyclophosphamide.
pain killers such as non-steroidal
anti-inflammatory agents (NSAIDs), including
selective cyclooxygenase-2 inhibitors
(Cox-2 inhibitors) and acetylsalicylic acid > 3 g.
muscle relaxing medicines, such as
tubocurarine.
anti-cholinergic medicines (medicines
used to treat a variety of disorders such as
gastrointestinal cramps, urinary bladder
spasm, asthma, motion sickness, muscular
spasms, Parkinson s disease and as an aid to
anaesthesia).
amantadine (medicine used to treat
Parkinson s disease and also used to treat or
prevent certain illnesses caused by viruses).
cholestyramine and colestipol (medicines
used mainly to treat high levels of lipids in the
blood).
ciclosporin, a medicine used for organ
transplant to avoid organ rejection.
alcohol, sleeping pills and anaesthetics
(medicines with sleeping or painkilling effect
used for example during surgery).
iodine contrast media (agents used for
imaging examinations).
Taking Co-Diovan with food and drink
You can take Co-Diovan with or without food.
Avoid taking alcohol until you have talked to

your doctor. Alcohol may make your blood
pressure fall more and/or increase the risk of you
becoming dizzy or feeling faint.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.
You must tell your doctor if you think that
you are (or might become) pregnant
Your doctor will normally advise you to stop
taking Co-Diovan before you become pregnant
or as soon as you know you are pregnant, and
will advise you to take another medicine instead
of Co-Diovan. Co-Diovan is not recommended
in early pregnancy, and must not be taken when
more than 3 months pregnant, as it may cause
serious harm to your baby if it is used after the
third month of pregnancy.
Tell your doctor if you are breast-feeding or
about to start breast-feeding
Co-Diovan is not recommended for mothers
who are breast-feeding, and your doctor may
choose another treatment for you if you wish to
breast-feed, especially if your baby is newborn,
or was born prematurely.
Driving and using machines
Before you drive a vehicle, use tools or operate
machines or carry out other activities that
require concentration, make sure you know

how Co-Diovan affects you. Like many other
medicines used to treat high blood pressure,
Co-Diovan may occasionally cause dizziness and
affect the ability to concentrate.
3. HOW TO TAKE CO-DIOVAN
Always take Co-Diovan exactly as your doctor
has told you. This will help you to get the best
results and lower the risk of side effects.
You should check with your doctor or pharmacist
if you are not sure.
People with high blood pressure often do not
notice any signs of this problem. Many may
feel quite normal. This makes it all the more
important for you to keep your appointments with
your doctor even if you are feeling well.
Your doctor will tell you exactly how many
tablets of Co-Diovan to take. Depending on how
you respond to the treatment, your doctor may
suggest a higher or lower dose.
The usual dose of Co-Diovan is one tablet per
day.
Do not change the dose or stop taking the
tablets without consulting your doctor.
The medicine should be taken at the same
time each day, usually in the morning.
You can take Co-Diovan with or without food.
Swallow the tablet with a glass of water.
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If you take more Co-Diovan than you should
If you experience severe dizziness and/or
fainting, lie down and contact your doctor
immediately.
If you have accidentally taken too many tablets,
contact your doctor, pharmacist or hospital.
If you forget to take Co-Diovan
If you forget to take a dose, take it as soon as
you remember. However, if it is almost time for
your next dose, skip the dose you missed.
Do not take a double dose to make up for a
forgotten dose.
If you stop taking Co-Diovan
Stopping your treatment with Co-Diovan may
cause your high blood pressure to get worse.
Do not stop taking your medicine unless your
doctor tells you to.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Co-Diovan can cause side
effects, although not everybody gets them.
These side effects may occur with certain
frequencies, which are defined as follows:
very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100

uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated
from the available data
Some side effects can be serious and need
immediate medical attention:
You should see your doctor immediately if you
experience symptoms of angioedema, such as:
swollen face, tongue or pharynx
difficulty in swallowing
hives and difficulties in breathing
If you get any of these symptoms, stop taking
Co-Diovan and contact your doctor straight
away (see also section 2 Take special care
with Co-Diovan ).
Other side effects include:
Uncommon:
cough
low blood pressure
light-headedness
dehydration (with symptoms of thirst,
dry mouth and tongue, infrequent urination,
dark colored urine, dry skin)
muscle pain
tiredness
tingling or numbness

blurred vision
noises (e.g. hissing, buzzing) in ears
Very rare:
dizziness
diarrhoea
joint pain
Not known:
breathing difficulty
severely decreased urine output
low level of sodium in the blood (which can
trigger tiredness, confusion, muscle twitching
and / or convulsions in severe cases)
low level of potassium in the blood
(sometimes with muscle weakness,
muscle spasms, abnormal heart rhythm)
low level of white cells in the blood (with
symptoms such as fever, skin infections,
sore throat or mouth ulcers due to infections,
weakness)
the level of bilirubin increased in blood
(which can, in severe cases, trigger yellow
skin and eyes)
the level of blood urea nitrogen and creatinine
increased in blood (which can indicate
abnormal kidney function)
the level of uric acid in blood increased
(which can, in severe cases, trigger gout)
syncope (fainting)

The following side effects have been reported
with products containing valsartan or
hydrochlorothiazide alone:
Valsartan
Uncommon:
spinning sensation
abdominal pain
Not known:
skin rash with or without itching together with
some of the following signs or symptoms:
fever, joint pain, muscle pain, swollen lymph
nodes and/or flu-like symptoms
rash, purplished-red spots, fever, itching
(symptoms of inflammation of blood vessels)
low level of blood platelets (sometimes with
unusual bleeding or bruising)
high level of potassium in the blood
(sometimes with muscle spasms, abnormal
heart rhythm)
allergic reactions (with symptoms such as
rash, itching, hives, difficulty breathing or
swallowing, dizziness)
swelling mainly of the face and throat; rash;
itching
elevation of liver function values
the level of haemoglobin decreased and the
percentage of red cells decreased in the blood
(which both can, in severe cases, trigger an
anaemia).

kidney failure
low level of sodium in the blood (which can
trigger tiredness, confusion, muscle twitching
and/or convulsions in severe cases)
Hydrochlorothiazide
Very common:
low level of potassium in the blood
increase of lipids in the blood
Common:
low level of sodium in the blood
low level of magnesium in the blood
high level of uric acid in the blood
itchy rash and other types of rash
reduced appetite
mild nausea and vomiting
dizziness, fainting on standing up
inability to achieve or maintain erection
Rare:
swelling and blistering of the skin
(due to increased sensitivity to sun)
high level of calcium in the blood
high level of sugar in the blood
sugar in the urine
worsening of diabetic metabolic state
constipation, diarrhoea, discomfort of the
stomach or bowels, liver disorders which can
occur together with yellow skin and eyes
irregular heart beat

headache
sleep disturbances
sad mood (depression)
low level of blood platelets (sometimes with
bleeding or bruising underneath the skin)
dizziness
tingling or numbness
vision disorder
Very rare:
inflammation of blood vessels with symptoms
such as rash, purplish-red spots, fever
(vasculitis)
rash, itching, hives, difficulty breathing
or swallowing, dizziness (hypersensitivity
reactions)
severe skin disease that causes rash,
red skin, blistering of the lips, eyes or mouth,
skin peeling, fever (toxic epidermal necrolysis)
facial rash, joint pain, muscle disorder,
fever (lupus erythematosus)
severe upper stomach pain (pancreatitis)
difficulty breathing with fever, coughing,
wheezing, breathlessness (respiratory
distress including pneumonitis and pulmonary
oedema)
fever, sore throat, more frequent infections
(agranulocytosis)
pale skin, tiredness, breathlessness,
dark urine (haemolytic anaemia)

fever, sore throat or mouth ulcers due to
infections (leucopenia)
confusion, tiredness, muscle twitching and
spasm, rapid breathing (hypochloraemic
alkalosis)
Not known:
weakness, bruising and frequent infections
(aplastic anemia)
severely decreased urine output (possible
signs of renal disorder or renal failure)
decrease in vision or pain in your eyes due to
high pressure (possible signs of acute
angle-closure glaucoma)
rash, red skin, blistering of the lips, eyes or
mouth, skin peeling, fever (possible signs of
erythema multiforme)
muscle spasm
fever (pyrexia)
weakness (asthenia)
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CO-DIOVAN
Keep out of the reach and sight of children.
Do not use Co-Diovan after the expiry date
which is stated on the pack. The expiry date
refers to the last day of that month.
Keep your tablets in their original pack at a

temperature below 30 C.
Do not use any Co-Diovan pack that is
damaged or shows signs of tampering.
Medicines should not be disposed of via
wastewater or household waste.
Ask your pharmacist how to dispose of
medicines no longer required.
These measures will help to protect the
environment.
6. FURTHER INFORMATION
What Co-Diovan contains
Co-Diovan 80/12.5 contains 80mg of valsartan
and 12.5mg of hydrochlorothiazide.
Co-Diovan 160/12.5 contains 160mg of
valsartan and 12.5mg of hydrochlorothiazide and
Co-Diovan 160/25 contains 160mg of valsartan
and 25mg of hydrochlorothiazide.
The tablets also contain the following inactive
ingredients: Colloidal anhydrous silica,
crospovidone, hypromellose, magnesium
stearate, microcrystalline cellulose,
Macrogol 8000, talc, red iron oxide (E172) and
titanium dioxide (E171).
In addition, Co-Diovan 80/12.5 Tablets contain
yellow iron oxide (E172), and Co-Diovan 160/25
Tablets contain yellow iron oxide (E172) and
black iron oxide (E172).

What Co-Diovan looks like and contents of
the pack
Co-Diovan 80/12.5 Tablets are light orange and
oval. They are marked HGH on one side and CG
on the other. The tablets come in blister packs
containing 28, 56 or 98 tablets. Some pack sizes
may not be marketed.
Co-Diovan 160/12.5 Tablets are dark red and
oval. They are marked HHH on one side and CG
on the other. The tablets come in blister packs
containing 28, 56 or 98 tablets. Some pack sizes
may not be marketed.
Co-Diovan 160/25 Tablets are brown orange and
oval. They are marked HXH on one side and NVR
on the other. The tablets come in blister packs
containing 28, 56 or 98 tablets. Some pack sizes
may not be marketed.
Marketing Authorisation Holder and
Manufacturer
The product licence holder is:
Novartis Pharmaceuticals UK Ltd
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR.
Co-Diovan is manufactured by:
Novartis Pharmaceuticals UK Ltd.
Wimblehurst Road
Horsham, West Sussex RH12 5AB

If you would like any more information, or would
like this leaflet in a different format, please contact
Medical Information at Novartis pharmaceuticals
UK Ltd, telephone number 01276 698370.
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Denmark, Finland, Iceland,
Diovan Comp
Norway, Sweden
Austria, Bulgaria, Cyprus,
Co-Diovan
Czech Republic, Estonia,
Germany, Greece,
Ireland, Latvia, Lithuania,
Luxembourg, Malta,
Netherlands, Poland,
Portugal, Romania, Slovak
Republic, Slovenia, Spain,
United Kingdom
Austria, Germany,
Co-Diovan forte
Luxembourg, Portugal, Spain
Austria
Co-Diovan
fortissimum
Belgium
Co-Diovane
France, Italy
Co-Tareg
Hungary
Diovan HCT
This leaflet was last revised in November 2012.
Copyright Novartis Pharmaceuticals UK Limited.
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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