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CO-DIOVAN 160 MG/25 MG 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)
This medicine is called Co-Diovan 160mg/25mg film-coated tablets but
will be referred to as Co-Diovan throughout this leaflet.
This product is available in multiple strengths.
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.



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:
 an ACE inhibitors (for example enalapril, lisinopril, Ramipril), in
particular if you have diabetes-related kidney problems.
 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

Warnings and precautions

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 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 (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
painkilling effect used for example during surgery).

iodine contrast media (agents used for imaging examinations).

Talk to your doctor

Taking Co-Diovan with food, drink and alcohol

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 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) WHAT YOU NEED TO KNOW BEFORE YOU TAKE CODIOVAN
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.



















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 CoDiovan 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

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 breastfeed, 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 CoDiovan 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.
The translations for the days of the week on the blister strip are:

LUN
MON

MAR
TUE

MER
WED

GIO
THU

VEN
FRI

SAB
SAT

DOM
SUN

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 colored 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 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 or pharmacist. 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 use Co-Diovan after the expiry date which is stated on the
pack. The expiry date refers to the last day of that month.
Do not store above 30°C. Leave your tablets in the original
packaging to protect from moisture and only remove them when it
is time to take your medicine.
If your doctor tells you to stop taking this medicine, return any
unused tablets to your doctor for safe disposal. Only keep the
tablets if your doctor tells you to. If your tablets become discoloured
or show any other signs of deterioration, consult your doctor or
pharmacist who will tell you what to do.
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
Co-Diovan 160mg/25mg Tablets contain 160mg of valsartan and 25mg
of hydrochlorothiazide.
The tablets also contain the following inactive ingredients:
microcrystalline cellulose, colloidal anhydrous silica, crospovidone,
magnesium stearate, hypromellose, macrogol 4000, talc, titanium
dioxide (E171), red iron oxide (E172), yellow iron oxide (E172) and black
iron oxide (E172).

What Co-Diovan looks like and contents of the pack
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 of 28 tablets.

Manufacturer
This product is manufactured by Novartis Pharma Stein AG,
Schaffhauserstrasse, CH-4332 Stein, Switzerland. Procured from within
the EU and repackaged by Mediwin Limited, Product Licence Holder:
Mediport Limited, 13 Martello Enterprise Centre, Courtwick Lane,
Littlehampton, BN17 7PA.

POM

PL: 18980/0537

®’

®’

‘CO-TAREG is known in the UK as ‘CO-DIOVAN . Both marks
are registered trademarks of NOVARTIS AG.
Date of leaflet preparation: 19/07/2016
PIL-0537-MFR-CH-S0016

PACKAGE LEAFLET: INFORMATION FOR THE USER

®

CO-DIOVAN 160mg/25mg
film-coated tablets
(valsartan / hydrochlorothiazide)
This medicine is called Co-Diovan 160mg/25mg film-coated tablets but
will be referred to as Co-Diovan throughout this leaflet.
This product is available in multiple strengths.
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.



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:
 an ACE inhibitors (for example enalapril, lisinopril, Ramipril), in
particular if you have diabetes-related kidney problems.
 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

Warnings and precautions

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 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 (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
painkilling effect used for example during surgery).

iodine contrast media (agents used for imaging examinations).

Talk to your doctor

Taking Co-Diovan with food, drink and alcohol

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 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) WHAT YOU NEED TO KNOW BEFORE YOU TAKE CODIOVAN
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.



















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 CoDiovan 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

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 breastfeed, 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 CoDiovan 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.
The translations for the days of the week on the blister strip are:

LUN
MON

MAR
TUE

MER
WED

GIO
THU

VEN
FRI

SAB
SAT

DOM
SUN

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 colored 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 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 or pharmacist. 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 use Co-Diovan after the expiry date which is stated on the
pack. The expiry date refers to the last day of that month.
Do not store above 30°C. Leave your tablets in the original
packaging to protect from moisture and only remove them when it
is time to take your medicine.
If your doctor tells you to stop taking this medicine, return any
unused tablets to your doctor for safe disposal. Only keep the
tablets if your doctor tells you to. If your tablets become discoloured
or show any other signs of deterioration, consult your doctor or
pharmacist who will tell you what to do.
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
Co-Diovan 160mg/25mg Tablets contain 160mg of valsartan and 25mg
of hydrochlorothiazide.
The tablets also contain the following inactive ingredients:
microcrystalline cellulose, colloidal anhydrous silica, crospovidone,
magnesium stearate, hypromellose, macrogol 4000, talc, titanium
dioxide (E171), red iron oxide (E172), yellow iron oxide (E172) and black
iron oxide (E172).

What Co-Diovan looks like and contents of the pack
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 of 28 tablets.

Manufacturer
This product is manufactured by Novartis Farma S.p.A., Via Provinciale
Schito 131, 80058 Torre Annunziata (NA), Italy. Procured from within the
EU and repackaged by Mediwin Limited, Product Licence Holder:
Mediport Limited, 13 Martello Enterprise Centre, Courtwick Lane,
Littlehampton, BN17 7PA.

POM

PL: 18980/0537

®’

®’

‘CO-TAREG is known in the UK as ‘CO-DIOVAN . Both marks
are registered trademarks of NOVARTIS AG.
Date of leaflet preparation: 19/07/2016
PIL-0537-MFR-IT-S0016

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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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