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CO-DIOVAN 160MG/25MG FILM-COATED TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / VALSARTAN

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Package leaflet:
Information for the user
®

Co-Diovan 160mg/25mg film-coated
tablets
(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
160mg/25mg film-coated tablets, but will be referred
to as Co-Diovan throughout this leaflet. Please note
that this leaflet also contains information about other
strengths such 80/12.5mg tablets160/12.5mg 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 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. 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 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 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.
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, 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 anti-psychotics.
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, 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 antiinflammatory agents (NSAIDs), including
selective cyclooxygenase-2 inhibitors (Cox-2
inhibitors) and acetylsalicylic acid > 3g.
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, 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 this medicine 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 angleclosure 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 CoDiovan 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 more 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 anemia)
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 store above 30°C.
Store in the original package in order to protect
from moisture.
Do not take any Co-Diovan pack if you notice
that the package is damaged or shows signs of
tampering.
Do not take the tablet after the expiry date which
is stated on the carton and blister label after
‘Exp’. The expiry date refers to the last day of
that month.
If the tablets become discoloured or show any
signs of 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. Contents of the pack and other information
What Co-Diovan contains
Each film-coated tablet contains 160mg valsartan
and 25mg hydrochlorothiazide.
The other ingredients are: colloidal anhydrous silica,
crospovidone, hypromellose, magnesium stearate,
microcrystalline cellulose, talc, red iron oxide (E172),
titanium dioxide (E171), yellow iron oxide (E172),
black iron oxide (E172) and macrogol 4000.
What Co-Diovan looks like and contents of the
pack
Each film-coated tablet is brown, ovaloid and
imprinted with ‘HXH’ on one side and ‘NVR’ on the
other.
They come in calendar blister packs of 28 tablets.
Manufactured by: Novartis Farma S.p.A., Via
Provinciale Schito 131, 80058, Torre Annunziata,
Italy.
Procured 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® 160mg/25mg film-coated tablets
PL 18799/2148

POM

Leaflet date: 23.06.2016
Co-Diovan is a registered trademark of 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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