CO-DIOVAN 80MG/12.5MG TABLETS

Active substance: VALSARTAN

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PATIENT INFORMATION LEAFLET

CO-DIOVAN® 80 / 12.5 mg TABLETS
(valsartan and hydrochlorothiazide)

• 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).

The name of your medicine is Co-Diovan® 80 / 12.5 mg tablet but will be
referred to as Co-Diovan throughout this Patient Information Leaflet.
This medicine is also available in the other following strengths:
160mg/12.5mg and 160mg/25mg.

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.

Read all of this leaflet carefully before you start taking this medicine.

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:

• 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.
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 contains two active substances called valsartan and
hydrochlorothiazide. Both of these substances help to control high blood
pressure (hypertension).
• Valsartan belongs to a class of medicines known as “angiotensin II
receptor antagonists”, which help to control high blood pressure.
Angiotensin II is a substance in the body that causes vessels to tighten,
thus causing your blood pressure to increase. Valsartan works by
blocking the effect of angiotensin II. As a result, blood vessels relax and
blood pressure is lowered.
• Hydrochlorothiazide belongs to a group of medicines called thiazide
diuretics (also known as “water tablets”). Hydrochlorothiazide increases
urine output, which also lowers blood pressure.
Co-Diovan is used to treat high blood pressure which is not adequately
controlled by a single substance alone.
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 CoDiovan 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 and 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 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 pressurelowering 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.

• lithium, a medicine used to treat some types of psychiatric illness
• medicines that affect or can be affected by potassium blood levels, such
as 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 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 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.
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
• diarrhoea
• joint pain
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)

• 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.
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).
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
• Keep out of the reach and sight 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.
• Store in the original package.
• Protect from moisture.
• Do not store above 30ºC.
• Do not use any Co-Diovan pack that is damaged or shows signs of
tampering.
• 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 80/12.5 mg Tablets contain 80mg of valsartan and 12.5mg of
hydrochlorothiazide.
The tablets also contain the following inactive ingredients: Colloidal
anhydrous silica, crospovidone, hypromellose, magnesium stearate,
microcrystaline cellulose, macrogol 8000, talc, red iron oxide (E172),
yellow iron oxide (E172) and titanium dioxide (E171).
What Co-Diovan looks like and contents of the pack

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)

Co-Diovan 80mg/12.5mg Tablets are oval, non-divisible, peach filmcoated tablets imprinted ‘HGH’ on one side and ‘CG’ on the reverse.
The tablets come in calendar blister strips in packs containing 14, 28 and
98 film-coated tablets.
Co-Diovan Tablets are manufactured by: Novartis Pharma GmbH, 90327
Nürnberg GERMANY. Procured from within the EU and repackaged in the
UK by the Parallel Import Product Licence holder: CD Pharma Ltd, Unit 3,
Manor Point, Manor Way, Borehamwood, Herts WD6 1EE.
Co-Diovan 80/12.5 mg Tablets

PL 20492/0234

Co-Diovan is a registered trademark of Novartis AG.
Date of preparation: 17 September 2012

POM

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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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