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CO-DIOVAN 80MG/12.5MG TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / VALSARTAN

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Patient Information Leaflet
Co-Diovan® 80mg/12.5mg Tablets
(Valsartan and hydrochlorothiazide)
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or
pharmacist.

This medicine has been prescribed for you only. Do not pass
it on to others. It may harm them, even if their signs of illness
are the same as yours.

If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. See section 4.
The name of your medicine is Co-Diovan 80mg/12.5mg Tablets
but will be referred to as Co-Diovan throughout the remainder of
this leaflet.
Co-Diovan is also available in 160mg/12.5mg and 160mg/25mg
strength.
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 Co-Diovan
Do not take Co-Diovan:

if you are allergic (hypersensitive) to valsartan,
hydrochlorothiazide, sulphonamide derivatives (substances
chemically related to hydrochlorothiazide) or to any of the
other ingredients of this medicine (listed in section 6).

if you are more than 3 months pregnant (it is also better to
avoid Co-Diovan in early pregnancy – see pregnancy
section).

if you have severe liver disease, destruction of the small bile
ducts within the liver (biliary cirrhosis) leading to the build up
of bile in the liver (cholestasis).

if you have severe kidney disease.

if you are unable to produce urine (anuria).




if you are treated with an artificial kidney.
if the level of potassium or sodium in your blood is lower than
normal, or if the level of calcium in your blood is higher than
normal despite treatment.

if you have gout.

if you have diabetes or impaired kidney function and you are
treated with a blood pressure lowering medicine containing
aliskiren.
If any of the above apply to you, tell your doctor and do not
take Co-Diovan.
Warnings and precautions
Talk to your doctor

if you are taking potassium-sparing medicines, potassium
supplements, salt substitutes containing potassium or other
medicines that increase the amount of potassium in your
blood such as heparin. Your doctor may need to check the
amount of potassium in your blood regularly.

if you have low levels of potassium in your blood.

if you have diarrhoea or severe vomiting.

if you are taking high doses of water tablets (diuretics).

if you have severe heart disease.

if you are suffering from heart failure or have experienced a
heart attack. Follow your doctor’s instruction for the starting
dose carefully. Your doctor may also check your kidney
function.

if you suffer from a narrowing of the kidney artery.

if you have recently received a new kidney.

if you suffer from hyperaldosteronism. This is a disease in
which your adrenal glands make too much of the hormone
aldosterone. If this applies to you, the use of Co-Diovan is
not recommended.

if you have liver or kidney disease.

if you have ever experienced swelling of the tongue and face
caused by an allergic reaction called angioedema when
taking another drug (including ACE inhibitors), tell your
doctor. If these symptoms occur when you are taking
Co-Diovan, stop taking Co-Diovan immediately and never
take it again. See also section 4, “Possible side effects”.

if you have fever, rash and joint pain, which may be signs of
systemic lupus erythematosus (SLE, a so-called autoimmune
disease).

if you have diabetes, gout, high levels of cholesterol or
triglycerides in your blood.

if you have had allergic reactions with the use of other blood
pressure-lowering agents of this class (angiotensin II receptor
antagonists) or if you have allergy or asthma.

if you experience a decrease in vision or eye pain. These
could be symptoms of an increase of pressure in your eye
and can happen within hours to a week of taking Co-Diovan.
This can lead to permanent vision loss, if not treated. If you
earlier have had a penicillin or sulphonamide allergy you can
be at higher risk of developing this.

if you are taking any of the following medicines used to treat
high blood pressure:
o an ACE inhibitors (for example enalapril, lisinopril,
Ramipril), in particular if you have diabetes-related
kidney problems.
o aliskiren
Your doctor may check your kidney function, blood pressure, and
the amount of electrolytes (e.g. potassium) in your blood at
regular intervals.
See also information under the heading “Do not take Co-Diovan”
Co-Diovan may cause increased sensitivity of the skin to sun.
The use of Co-Diovan in children and adolescents (below the age
of 18 years) is not recommended.
You must tell your doctor if you think you are (or might become)
pregnant. Co-Diovan is not recommended in early pregnancy,
and must not be taken if you are more than 3 months pregnant,
as it may cause serious harm to your baby if used at that stage
(see pregnancy section).

Other medicines and Co-Diovan
Tell your doctor or pharmacist if you are taking, have recently
taken 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).
Taking Co-Diovan with food, drink and alcohol
Avoid taking alcohol until you have talked to your doctor. Alcohol
may make your blood pressure fall more and/or increase the risk
of you becoming dizzy or feeling faint.

Pregnancy and breast-feeding

You must tell your doctor if you think that you are (or
might become) pregnant
Your doctor will normally advise you to stop taking Co-Diovan
before you become pregnant or as soon as you know you are
pregnant, and will advise you to take another medicine instead of
Co-Diovan. Co-Diovan is not recommended in early pregnancy,
and must not be taken when more than 3 months pregnant, as it
may cause serious harm to your baby if it is used after the third
month of pregnancy.

Tell your doctor if you are breast-feeding or about to
start breast-feeding
Co-Diovan is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if
you wish to breast-feed, especially if your baby is newborn, or
was born prematurely.
Driving and using machines
Before you drive a vehicle, use tools or operate machines or carry
out other activities that require concentration, make sure you
know how Co-Diovan affects you. Like many other medicines
used to treat high blood pressure, Co-Diovan may occasionally
cause dizziness and affect the ability to concentrate.
3. How to take Co-Diovan
Always take this medicine exactly as your doctor has told you.
This will help you to get the best results and lower the risk of side
effects. Check with your doctor or pharmacist if you are not sure.
People with high blood pressure often do not notice any signs of
this problem. Many may feel quite normal. This makes it all the
more important for you to keep your appointments with your
doctor even if you are feeling well.
Your doctor will tell you exactly how many tablets of Co-Diovan to
take. Depending on how you respond to the treatment, your
doctor may suggest a higher or lower dose.

The recommended dose of Co-Diovan is one tablet per day.

Do not change the dose or stop taking the tablets without
consulting your doctor.

The medicine should be taken at the same time each day,
usually in the morning.

You can take Co-Diovan with or without food.

Swallow the tablet with a glass of water.
The tablets come in calendar blister strips. A translation of the
days of the weeks is as follows:
LUN MAR MER GIO
VEN SAB DOM
Mon Tues
Weds Thurs Fri
Sat
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 coloured urine, dry skin)

muscle pain

tiredness

tingling or numbness

blurred vision

noises (e.g. hissing, buzzing) in ears
Very rare (may affect up to 1 in 10,000 people):

dizziness

diarrhoea

joint pain
Not known (frequency cannot be estimated from the available
data):

breathing difficulty

severely decreased urine output

low level of sodium in the blood (which can trigger tiredness,
confusion, muscle twitching and / or convulsions in severe
cases)

low level of potassium in the blood (sometimes with muscle
weakness, muscle spasms, abnormal heart rhythm)

low level of white cells in the blood (with symptoms such as
fever, skin infections, sore throat or mouth ulcers due to
infections, weakness)

the level of bilirubin increased in blood (which can, in severe
cases, trigger yellow skin and eyes)

the level of blood urea nitrogen and creatinine increased in
blood (which can indicate abnormal kidney function)

the level of uric acid in blood increased (which can, in severe
cases, trigger gout)

syncope (fainting)
The following side effects have been reported with products
containing valsartan or hydrochlorothiazide alone:
Valsartan
Uncommon (may affect up to 1 in 100 people):

spinning sensation

abdominal pain

Not known (frequency cannot be estimated from the available
data):

blistering skin (sign of dermatitis bullous)

skin rash with or without itching together with some of the
following signs or symptoms: fever, joint pain, muscle pain,
swollen lymph nodes and/or flu-like symptoms

rash, purplish-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

5. How to store Co-Diovan
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
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. If the
tablets show any signs of discolouration or deterioration consult
your pharmacist for advice.
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.

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.

6. Contents of the pack and other information
Co-Diovan tablets contain the active ingredients valsartan and
hydrochlorothiazide
Each oblong, film coated tablet is light orange and imprinted with
HGH on one side and CG on the other side and contains 80mg of
the active ingredient valsartan and 12.5mg of hydrochlorothiazide.
The tablets also contain the following inactive ingredients:
microcrystalline cellulose, crospovidone, magnesium stearate,
colloidal anhydrous silica, hypromellose, macrogol 8000, talc,
titanium dioxide (E171) red iron oxide (E172) and yellow iron
oxide (E172).
The tablets come in calendar blister packs containing 28 Tablets.
This medicine is manufactured by Novartis Farma S.p.A, Via
Provinciale Schito 131, 80058 Torre Annunziata (NA), Italy.
Procured from within the EU. Product Licence Holder: Quadrant
Pharmaceuticals Ltd., Lynstock House, Lynstock Way, Lostock,
Bolton, BL6 4SA. Repackaged by Maxearn Ltd, Bolton, BL6 4SA.
PL 20774/0707

Co-Diovan 80mg/12.5mg Tablets

Date of preparation: 11th August 2016
Co-Diovan is a registered trademark of Novartis AG.

PP8/0707/V4

 
 
 

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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