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CO-DIOVAN 160/12.5MG TABLETS

Active substance: VALSARTAN

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Ref: 0877/150812/1/F

®

Co-Diovan 160/12.5mg Tablets
(valsartan/hydrochlorothiazide)
Patient Information Leaflet
Your medicine is called Co-Diovan 160/12.5mg Tablets but will be referred to
as Co-Diovan throughtout this leaflet.
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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

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 illness
* medicines that affect or can be affected by potassium blood levels, such as

In this leaflet:
1 What Co-Diovan is and what is it used for?

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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 is it 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.
* if you have severe kidney disease.
* if you are unable to urinate.
* 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.

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digoxin, a medicine to control the heart rhythm, some antipsychotic
medicines
medicines that may increase the amount of potassium in your blood, such
as potassium supplements, potassium-containing salt substitutes,
potassium sparing medicines, heparin
medicines that may reduce the amount of potassium in your blood, such as
corticosteroids, some laxatives
diuretics (water tablets), medicines for the treatment of gout, such as
allopurinol, therapeutic vitamin D and calcium supplements, medicines for
the treatment of diabetes (oral agents or insulins)
other medicines to lower your blood pressure, such as beta-blockers or
methyldopa, or medicines that tighten your blood vessels or stimulate your
heart, such as noradrenaline or adrenaline
medicines to increase blood sugar levels, such as diazoxide
medicines to treat cancer, such as methotrexate or cyclophosphamide
pain killers
arthritis medicines
muscle relaxing medicines, such as tubocurarine
anti-cholinergic medicines, such as atropine or biperiden
amantadine (a medicine used to prevent influenza)
cholestyramine and colestipol (medicines used to treat high levels of fats
in the blood)
ciclosporin, a medicine used for organ transplant to avoid organ rejection
some antibiotics (tetracyclines), anaesthetics and sedatives
carbamazepine, a medicine used to treat seizure conditions

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.

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 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 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 fats 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.
* 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).

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.
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.

Ref: 0877/150812/1/B

®

Co-Diovan 160/12.5mg Tablets
(valsartan/hydrochlorothiazide)
Patient Information Leaflet (continued)
If you stop taking Co-Diovan
Stopping your treatment with Co-Diovan may cause your high blood
pressure to get worse. Do not stop taking your medicine unless your doctor
tells you to.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4

Possible side effects

Like all medicines, Co-Diovan can cause side effects, although not everybody gets them.
These side effects may occur with certain frequencies, which are defined as
follows:
* very common: affects more than 1 user in 10
* common: affects 1 to 10 users in 100
* uncommon: affects 1 to 10 users in 1,000
* rare: affects 1 to 10 users in 10,000
* very rare: affects less than 1 user in 10,000
* not known: frequency cannot be estimated from the available data
Some side effects can be serious and need immediate medical
attention:
You should see your doctor immediately if you experience symptoms of
angioedema, such as:
* swollen face, tongue or pharynx
* difficulty in swallowing
* hives and difficulties in breathing
Other side effects include:
Uncommon:
* cough
* low blood pressure
* light-headedness
* dehydration (with symptoms of thirst, dry mouth and tongue, infrequent
urination, dark colored urine, dry skin)
* muscle pain
* tiredness
* tingling or numbness
* blurred vision
* noises (e.g. hissing, buzzing) in ears
Very rare:
* dizziness
* joint pain

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
Common:
* itchy rash and other types of rash
* reduced appetite
* mild nausea and vomiting
* faintness, fainting on standing up
* impotence.

Very rare:
* inflammation of blood vessels with symptoms such as rash, purplish-red
spots, fever
* itching or red skin
* blistering of the lips, eyes or mouth
* skin peeling
* fever
* facial rash associated with joint pain
* muscle disorder
* fever (cutaneous lupus erythematosus)
* severe upper stomach pain; lack or low levels of different blood cells
* severe allergic reactions
* difficulty breathing
* lung infection; breathlessness
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

5

How to store Co-Diovan

Storing your medicine
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
* Do not store above 30°C.
* Store in original package in order to protect from moisture and only
remove them when it is time to take your medicine.
Expiry Date
Do not use this medicine after the expiry date shown on the carton label or
blister strip. If your doctor tells you to stop taking this medicine, return any
unused medicine to your pharmacist (chemist) for safe disposal. Only keep
this medicine if your doctor tells you to. If your medicine becomes discoloured
or shows any other signs of deterioration, consult your pharmacist (chemist)
who will tell you what to do.

6

Further information

What this medicine contains:
Each tablet contains 160mg of valsartan and 12.5mg hydrochlorothiazide as
the active ingredient. Your medicine also contains the following inactive
ingredients: colloidal anhydrous silica, crospovidone, magnesium stearate,
microcrystalline cellulose, hypromellose, macrogol 8000, talc, titanium
dioxide (E171) and red iron oxide (E172).
What this medicine looks like and contents of the pack
Co-Diovan are oval, non-divisible, film-coated, tablets coloured dark red and
imprinted with HHH on one side and CG on the other side. The tablets are
available in blister packs of 14 and come in boxes of 28.
Manufacturer and Licence Holder
^
The tablets are manufactured by Novartis Farma - Productos Farmaceuticos,
S.A. Rua do Centro Empresarial, Edificio 8, Quinta da Beloura, 2710-444
Sintra, Portugal and are procured from within the EU and repackaged by the
product Licence Holder: Lexon (UK) Ltd, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
,

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)

Rare:
swelling and blistering of the skin (due to increased sensitivity to sun)
constipation, discomfort of the stomach or bowels, liver disorders (yellow
skin or eyes)
* irregular heart beat
* headache
* sleep disturbances
* sad mood (depression)
* low level of blood platelets (sometimes with bleeding or bruising
underneath the skin).

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If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0877

Co-Diovan is a registered trademark of Novartis AG.
Revision date: 15/08/2012

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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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