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COTAREG 160/12.5MG TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / VALSARTAN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-DIOVAN® 160/12.5MG TABLETS /
COTAREG® 160/12.5MG TABLETS
(valsartan and hydrochlorothiazide)
This product will be referred to as Co-Diovan throughout this leaflet.
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.
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 pressurelowering 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:
◦ 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
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).
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 breastfeeding
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.
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.
Below is a translation of the days of the week on the blister strip:
LUN

MAR

MER

GIO

VEN

SAB

DOM

MON

TUES

WED

THUR

FRI

SAT

SUN

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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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