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CO-DIOVAN 160/25MG FILM-COATED TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / VALSARTAN

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Package leaflet:
Information for the user

Co-Diovan®
160/25mg film-coated tablets

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.

(valsartan/hydrochlorothiazide)
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
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 only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
The name of your medicine is Co-Diovan 160/25mg
film-coated tablets but will be referred to as
Co-Diovan throughout this leaflet. Please note that this
leaflet also contains information about the other
strengths: Co-Diovan 80/12.5mg and 160/12.5mg filmcoated tablets.
What is in this leaflet:
1. What Co-Diovan is and what it is used for
2. What you need to know before you take
Co-Diovan
3. How to take Co-Diovan
4. Possible side effects
5. How to store Co-Diovan
6. Contents of the pack and other information
1. What Co-Diovan is and what it is used
for
Co-Diovan contains 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.

2. What you need to know 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 this medicine (listed in section 6).
if you are more than 3 months pregnant (it is also
better to avoid Co-Diovan in early pregnancy – see
‘Pregnancy and breast-feeding’ 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 you have diabetes or impaired kidney function
and you are treated with a blood pressure lowering
medicine containing aliskiren.
If any of the above apply to you, tell your doctor
and do not take Co-Diovan.
Warnings and precautions
Talk to your doctor
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 socalled 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.
if you are taking any of the following medicines
used to treat high blood pressure:
o
an ACE inhibitors (for example enalapril,
lisinopril, Ramipril), in particular if you have
diabetes-related kidney problems.
o
aliskiren
Your doctor may check your kidney function, blood
pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.
See also information under the heading ‘Do not take
Co Diovan’
Co Diovan may cause increased sensitivity of the skin
to sun.
The use of Co Diovan in children and adolescents
(below the age of 18 years) is not recommended.
You must tell your doctor if you think you are (or might
become) pregnant. Co Diovan is not recommended in
early pregnancy, and must not be taken if you are more
than 3 months pregnant, as it may cause serious harm
to your baby if used at that stage (see pregnancy
section).
Other medicines and Co Diovan
Tell your doctor or pharmacist if you are taking, have
recently taken any other medicines, or might take any
other medicines.

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, potassium-sparing 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
anti-psychotics.
medicines that may reduce the amount of sodium in
your blood, such as antidepressants, antipsychotics, anti-epileptics.
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, ACE inhibitors (such as
enalapril, lisinopril, etc.) or aliskiren (see also
information under the headings ‘Do not take
Co Diovan’ and ‘Warnings and precautions’).
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 pain killing effect used for example
during surgery).
iodine contrast media (agents used for imaging
examinations).
Taking Co-Diovan with food, drink and alcohol
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
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. 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 recommended 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.
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
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
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
Severe skin disease that causes rash, red skin,
blistering of the lips, eyes or mouth, skin peeling,
fever (toxic epidermal necrolysis)
Decrease in vision or pain in your eyes due to high
pressure (possible signs of acute angle-closure
glaucoma)
Fever, sore throat, more frequent infections
(agranulocytosis)
These side effects are very rare or of frequency not
known.

If you get any of these symptoms, stop taking
Co-Diovan and contact your doctor straight away
(see also section 2 ‘Warnings and precautions’).
Side effects include:
Uncommon (may affect up to 1 in 100 people):
cough
low blood pressure
light-headedness
dehydration (with symptoms of thirst, dry mouth and
tongue, infrequent urination, dark coloured urine,
dry skin)
muscle pain
tiredness
tingling or numbness
blurred vision
noises (e.g. hissing, buzzing) in ears
Very rare (may affect up to 1 in 10,000 people):
dizziness
diarrhoea
joint pain
Not known (frequency cannot be estimated from
the available data):
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 (may affect up to 1 in 100 people):
spinning sensation
abdominal pain
Not known (frequency cannot be estimated from
the available data):
blistering skin (sign of dermatitis bullous)

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 (may affect more than 1 in 10 people):
low level of potassium in the blood
increase of lipids in the blood
Common (may affect up to 1 in 10 people):
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 (may affect up to 1 in 1,000 people):
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 (may affect up to 1 in 10,000 people):
inflammation of blood vessels with symptoms such
as rash, purplish-red spots, fever (vasculitis)
rash, itching, hives, difficulty breathing or
swallowing, dizziness (hypersensitivity reactions)
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)
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 (frequency cannot be estimated from
the available data):
weakness, bruising and frequent infections (aplastic
anaemia)
severely decreased urine output (possible signs of
renal disorder or renal failure)
rash, red skin, blistering of the lips, eyes or mouth,
skin peeling, fever (possible signs of erythema
multiforme)
muscle spasm
fever (pyrexia)
weakness (asthenia)
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more
information on the safety of this medicine.
5. HOW TO STORE CO-DIOVAN
Keep out of the sight and reach of children.
Do not take your tablets after the expiry date which
is stated on the blisters or carton label after ‘Exp’.
The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original pack
in order to protect from moisture.
If the tablets become discoloured or show signs of
any deterioration, seek the advice of your
pharmacist.

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
Each film-coated tablet contains 160mg valsartan and
25mg hydrochlorothiazide.
It also contains the following other ingredients:
microcrystalline cellulose, colloidal anhydrous silica,
crospovidone , magnesium stearate, hypromellose,
macrogol, talc, titanium dioxide (E171), black iron oxide
(E172), yellow iron oxide (E172) and red iron oxide
(E172).
What Co-Diovan looks like and contents of the pack
Co-Diovan is orange-brown coloured capsule-shaped
tablet marked ‘HXH’ on one side and ‘NVR’ on the
reverse.
Co-Diovan is available in calendar blister packs of 28
tablets.
Manufactured by: Novartis Pharma S.p.A., Via
Provinciale Schito 131, 80058 Torre Annunziata,
Naples, Italy.
Produced from within the EU and repackaged by
the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU,
UK.
Co-Diovan® 160/25mg film-coated tablets;
PL 18799/2860
POM
Leaflet date: 10.12.2015

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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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