CO-DIOVAN 160/12.5MG TABLETS

Active substance: VALSARTAN

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S709 LEAFLET Co-Diovan 20140513

S709 LEAFLET Co-Diovan 20140513

Very rare:

What Co-Diovan looks like and contents of the pack



inflammation of blood vessels with symptoms such as rash,
purplish-red spots, fever (vasculitis)

Co-Diovan tablets are oval, coloured dark red and imprinted with
‘HHH’ on one side and ‘CG’ on the other side.



rash, itching, hives, difficulty breathing or swallowing, dizziness
(hypersensitivity reactions)

Co-Diovan is available as calendar blister packs of 28 tablets.
Product Licence holder



severe skin disease that causes rash, red skin, blistering of the
lips, eyes or mouth, skin peeling, fever (toxic epidermal
necrolysis)

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

facial rash, joint pain, muscle disorder, fever (lupus
erythematosus)

Manufacturer



severe upper stomach pain (pancreatitis)



difficulty breathing with fever, coughing, wheezing,
breathlessness (respiratory distress including pneumonitis and
pulmonary oedema)



Leaflet revision date: 13 May 2014

fever, sore throat, more frequent infections (agranulocytosis)



Co-Diovan is a registered trade mark of Novartis AG, Switzerland.

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)

POM

PL No: 19488/0709

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.



Please note that information regarding other strengths
80mg/12.5mg and 160mg/25mg of Co-Diovan Tablets is also
present in the below leaflet.

if the level of potassium or sodium in your blood is lower than
normal, or if the level of calcium in your blood is higher than
normal despite treatment.



if you have gout.



If you have diabetes or impaired kidney function and you are
treated with a blood pressure lowering medicine called aliskiren.

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



This product is manufactured by Novartis Farma S.p.A., Via
Provinciale Schito 131, 80058 Torre Annunziata NA, Italy.



If any of the above apply to you, do not take this medicine and
speak to your doctor.

PACKAGE LEAFLET: INFORMATION FOR THE USER

CO-DIOVAN 160/12.5mg TABLETS
(valsartan / hydrochlorothiazide)
Your medicine is known as Co-Diovan 160/12.5mg Tablets but will
be referred to as Co-Diovan throughout the following patient
information leaflet.

By kariri at 10:55 am, Jul 17, 2014



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



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



S709 LEAFLET Co-Diovan 20140513

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.



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).

In this leaflet:



if you have severe heart disease.

1. What Co-Diovan is and what it is used for



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

Not known:


weakness, bruising and frequent infections (aplastic anemia)



severely decreased urine output (possible signs of renal
disorder or renal failure)



decrease in vision or pain in your eyes due to high pressure
(possible signs of acute angle-closure glaucoma)



rash, red skin, blistering of the lips, eyes or mouth, skin peeling,
fever (possible signs of erythema multiforme)



muscle spasm



fever (pyrexia)



Assessed against UK PIL dated January 2014
Final draft mock up

2. Before you take Co-Diovan
3. How to take Co-Diovan
4. Possible side effects
5. How to store Co-Diovan

if you suffer from a narrowing of the kidney artery.

6. Further information



if you have recently received a new kidney.



if you suffer from hyperaldosteronism.

1.
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.



5. How to store Co-Diovan
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

6. Further information
What Co-Diovan contains




Each film coated tablet contains 160mg of the active ingredient
valsartan
and
12.5mg
of
the
active
ingredient
hydrochlorothiazide.
Co-Diovan also contains the following inactive ingredients:
colloidal anhydrous silica, crospovidone, hypromellose,
magnesium stearate, microcrystalline cellulose, talc, macrogol
8000, red iron oxide (E172) and titanium dioxide (E171).

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”.

Hydrochlorothiazide belongs to a group of medicines called
thiazide diuretics (also known as “water tablets”).
Hydrochlorothiazide increases urine output, which also lowers
blood pressure.

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



if you have diabetes, gout, high levels of cholesterol or
triglycerides in your blood.
if you have had allergic reactions with the use of other blood
pressure-lowering agents of this class (angiotensin II receptor
antagonists) or if you have allergy or asthma.
if you experience a decrease in vision or eye pain. These could
be symptoms of an increase of pressure in your eye and can
happen within hours to a week of taking Co-Diovan. This can
lead to permanent vision loss, if not treated. If you earlier have
had a penicillin or sulphonamide allergy you can be at higher
risk of developing this.



it may cause increased sensitivity of the skin to sun.









Store in the original package to protect from moisture.



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.





Do not store above 30°C.



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.

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).

By reporting side effects, you can help provide more information on
the safety of this medicine.



Your doctor may also check your kidney function.


weakness (asthenia)

Reporting of side effects

Take special care with Co-Diovan

the use of Co-Diovan in children and adolescents below the age
of 18 years is not recommended.



you must tell your doctor if you think you are (or might become)
pregnant. Co-Diovan is not recommended in early pregnancy,
and must not be taken if you are more than 3 months pregnant,
as it may cause serious harm to your baby if used at that stage
(see pregnancy section).



if you are taking any of the following medicines used to treat
high blood pressure:

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).

o

“ACE inhibitors” such as enalapril, lisinopril, etc

o Aliskiren
If any of these apply to you, talk to your doctor.

S709 LEAFLET Co-Diovan 20140513

Taking other medicines

Pregnancy and breast-feeding

4.

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.

Ask your doctor or pharmacist for advice before taking any
medicine.

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:

Uncommon:





spinning sensation

very common: affects more than 1 user in 10





abdominal pain

common: affects 1 to 10 users in 100



uncommon: affects 1 to 10 users in 1,000



Not known:

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

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)

Some side effects can be serious and need immediate medical
attention:



low level of blood platelets (sometimes with unusual bleeding or
bruising)

You should see your doctor immediately if you experience
symptoms of angioedema, such as:



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



swollen face, tongue or pharynx





difficulty in swallowing

allergic reactions (with symptoms such as rash, itching, hives,
difficulty breathing or swallowing, dizziness)

 hives and difficulties in breathing
If you get any of these symptoms, stop taking Co-Diovan and
contact your doctor straight away (see also section 2 “Take
special care with Co-Diovan”).



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).

Other side effects include:



kidney failure

Uncommon:



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

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.

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



therapeutic vitamin D and calcium supplements.

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.



medicines for the treatment of diabetes (oral agents such as
metformin or insulins).

You should check with your doctor or pharmacist if you are not
sure.



other medicines to lower your blood pressure including
methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or
aliskiren.

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.



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.




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.

Possible side effects



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



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





cytotoxic medicines (used to treat cancer), such as
methotrexate or cyclophosphamide.

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



Very rare:

pain killers such as non-steroidal anti-inflammatory agents
(NSAIDs), including selective cyclooxygenase-2 inhibitors (Cox2 inhibitors) and acetylsalicylic acid > 3 g.

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.



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).



dizziness



diarrhoea



joint pain

muscle relaxing medicines, such as tubocurarine.








amantadine (medicine used to treat Parkinson’s disease and
also used to treat or prevent certain illnesses caused by
viruses).
cholestyramine and colestipol (medicines used mainly to treat
high levels of lipids in the blood).
ciclosporin, a medicine used for organ transplant to avoid organ
rejection.



alcohol, sleeping pills and anaesthetics (medicines with
sleeping or painkilling effect used for example during surgery).



iodine contrast media (agents used for imaging examinations).

Taking Co-Diovan with food and drink
You can take Co-Diovan with or without food. Avoid taking alcohol
until you have talked to your doctor. Alcohol may make your blood
pressure fall more and/or increase the risk of you becoming dizzy or
feeling faint.

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.

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)

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.

Valsartan

cough



The following side effects have been reported with products
containing valsartan or hydrochlorothiazide alone:

Hydrochlorothiazide
Very common:


low level of potassium in the blood



increase of lipids in the blood

Common:


low level of sodium in the blood



low level of magnesium in the blood



high level of uric acid in the blood



itchy rash and other types of rash



reduced appetite



mild nausea and vomiting



dizziness, fainting on standing up



inability to achieve or maintain erection

Rare:


swelling and blistering of the skin (due to increased sensitivity
to sun)



high level of calcium in the blood



high level of sugar in the blood



sugar in the urine



worsening of diabetic metabolic state



constipation, diarrhoea, discomfort of the stomach or bowels,
liver disorders which can occur together with yellow skin and
eyes



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





irregular heart beat

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



headache

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



sleep disturbances



sad mood (depression)



low level of blood platelets (sometimes with bleeding or bruising
underneath the skin)



dizziness



tingling or numbness



vision disorder




syncope (fainting)

S709 LEAFLET Co-Diovan 20140513

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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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