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

Active substance: VALSARTAN

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

CO-DIOVAN®
160/25mg 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.
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 other
strengths such as Co-DIovan 80/12.5mg and
160/12.5mg tablets.
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 you have diabetes or impaired kidney function
and you are treated with a blood pressure lowering
medicine called aliskiren.
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.
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).
if you are taking any of the following medicines
used to treat high blood pressure:
o “ACE inhibitors” such as enalapril, lisinopril,
etc
o Aliskiren
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, 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
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, ACE inhibitors (such as
enalapril, lisinopril, etc.) or aliskiren.
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 > 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 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.

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 CoDiovan and contact your doctor straight away
(see also section 2 “Take special care with CoDiovan”).

If you have accidentally taken too many tablets,
contact your doctor, pharmacist or hospital.

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

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.

Very rare:
 dizziness
 diarrhoea
 joint pain

Do not take a double dose to make up for a
forgotten dose.

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)

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 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

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)
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
Do not use this medicine after the expiry date
printed on the foil/packet.
Leave your tablets in the original packaging to
protect from moisture and only remove them
when it is time to take your medicine.
Do not store your tablets above 30°C.
Keep all medicines out of the sight and reach of
children. Your medicine could harm them.
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 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, talc, red iron oxide (E172)
and titanium dioxide (E171). In addition, Co-Diovan
160/25 Tablets contain 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 orange, oval and imprinted
with „NVR‟ on one side and „HXH‟ 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 No: 18799/2018

POM

Leaflet date: 29.05.2014
CO-DIOVAN is a registered trademark 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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