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VALSARTAN HYDROCHLOROTHIAZIDE 160 MG/25 MG FILM-COATED TABLETS

Active substance: VALSARTAN

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VALSARTAN/HYDROCHLOROTHIAZIDE
80 mg/12.5 mg FILM-COATED TABLETS
VALSARTAN/HYDROCHLOROTHIAZIDE
160 mg/25 mg FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER

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 Valsartan/Hydrochlorothiazide is and
what it is used for
2. What you need to know before you take
Valsartan/Hydrochlorothiazide
3. How to take Valsartan/Hydrochlorothiazide
4. Possible side effects
5. How to store Valsartan/Hydrochlorothiazide
6. Contents of the pack and other information

1

What Valsartan/Hydrochlorothiazide is
and what it is used for

Valsartan/Hydrochlorothiazide 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.
Valsartan/Hydrochlorothiazide 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 Valsartan/Hydrochlorothiazide

DO NOT take Valsartan/Hydrochlorothiazide 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)
• you are more than 3 months pregnant (it is
also better to avoid Valsartan/
Hydrochlorothiazide in early pregnancy - see
Pregnancy section)
• 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)
• you have severe kidney disease
• you are unable to produce urine anuria
• you are treated with an artificial kidney
• 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
• you have gout
• you have diabetes or impaired kidney function
and you are treated with a blood pressure
lowering medicine called aliskiren.
If any of the above apply to you, do not take this
medicine and speak to your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Valsartan/Hydrochlorothiazide.
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
• have low levels of potassium in your blood
• have diarrhoea or severe vomiting
• are taking high doses of water tablets
(diuretics)
• have severe heart disease
• 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.
• suffer from a narrowing of the kidney artery
• have recently received a new kidney
• 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 Valsartan/
Hydrochlorothiazide is not recommended
• have liver or kidney disease
• 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
Valsartan/Hydrochlorothiazide, stop taking
Valsartan/Hydrochlorothiazide immediately
and never take it again. See also section 4,
“Possible side effects”
.
• have fever, rash and joint pain, which may be
signs of systemic lupus erythematosus (SLE, a
so-called autoimmune disease)
• have diabetes, gout, high levels of cholesterol
or triglycerides in your blood
• 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
• 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 Valsartan/
Hydrochlorothiazide. 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.
One of the ingredients (hydrochlorothiazide)
in these tablets may cause increased
sensitivity of the skin to sunlight.
• If you are taking any of the following
medicines used to treat high, blood pressure:
• “ACE inhibitors” such as enalapril,
lisinopril, etc.
• aliskiren.
If any of these apply to you, talk to your doctor.

You must tell your doctor if you think that you
are (or might become) pregnant. Valsartan/
Hydrochlorothiazide 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).
Children and adolescents
The use of Valsartan/Hydrochlorothiazide in
children and adolescents (below the age of
18 years) is not recommended.
Other medicines and Valsartan/
Hydrochlorothiazide
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including medicines obtained without
a prescription.
The effect of the treatment can be influenced if
Valsartan/Hydrochlorothiazide 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 Valsartan/
Hydrochlorothiazide
• 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
• 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 (a 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)
• alcohol, sleeping pills and anaesthetics
(medicines with sleeping or painkilling effect
used for example during surgery)
• iodine contrast media (agents used for
imaging examinations).
Valsartan/Hydrochlorothiazide with food, drink
and alcohol
You can take Valsartan/Hydrochlorothiazide 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
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
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 Valsartan/Hydrochlorothiazide before you
become pregnant or as soon as you know you
are pregnant, and will advise you to take another
medicine instead of Valsartan/
Hydrochlorothiazide. Valsartan/
Hydrochlorothiazide 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.
Valsartan/Hydrochlorothiazide 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
Valsartan/Hydrochlorothiazide affects you. Like
many other medicines used to treat high blood
pressure, Valsartan/Hydrochlorothiazide may
occasionally cause dizziness and affect the ability
to concentrate.
Important information about some of the
ingredients of Valsartan/Hydrochlorothiazide
Valsartan/Hydrochlorothiazide 80 mg/12.5 mg
Tablets contains sunset yellow FCF (E110) and
may cause allergic reactions.

3

How to take Valsartan/
Hydrochlorothiazide

Always take Valsartan/Hydrochlorothiazide
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 Valsartan/Hydrochlorothiazide to take.
Depending on how you respond to the treatment,
your doctor may suggest a higher or lower dose.
• The recommended dose of Valsartan/
Hydrochlorothiazide 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 Valsartan/ Hydrochlorothiazide
with or without food.
• Swallow the tablet with a glass of water.
If you take more Valsartan/Hydrochlorothiazide
than you should
If you experience severe dizziness and/or
fainting, lay 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 Valsartan/
Hydrochlorothiazide
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 Valsartan/Hydrochlorothiazide
Stopping your treatment with Valsartan/
Hydrochlorothiazide 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.

Very rare
• inflammation of blood vessels with symptoms
such as rash, purplish-red spots, fever
(vasculitis)
• rash, itching hives, difficulty breathing or
swallowing, dizziness (hypersensitivity
reactions)
• severe skin disease that causes rash, red skin,
blistering of the lips, eyes or mouth, skin
peeling, fever (toxic epidermal necrolysis)
• 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)
• fever, sore throat, more frequent infections
(agranulocytosis)
• 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
• weakness, bruising and frequent infections
(aplastic anaemia)
4 Possible side effects
• severely decreased urine output (possible
Like all medicines, this medicine can cause side
signs of renal disorder or renal failure)
effects, although not everybody gets them.
• decrease in vision or pain in your eyes due to
These side effects may occur with certain
high pressure (possible signs of acute
frequencies, which are defined as follows:
angle-closure glaucoma)
• very common: affects more than 1 user in 10
• rash, red skin, blistering of the lips, eyes or
• common: affects 1 to 10 users in 100
mouth, skin peeling, fever (possible signs of
• uncommon: affects 1 to 10 users in 1,000
erythema multiforme)
• rare: affects 1 to 10 users in 10,000
• muscle spasm
• very rare: affects less than 1 user in 10,000
• fever (pyrexia)
• not known: frequency cannot be estimated
• weakness (asthenia).
from the available data.
Reporting of side effects
Some side effects can be serious and need
If you get any side effects talk to your doctor or
immediate medical attention:
pharmacist. This includes any possible effects
You should see your doctor immediately if you
not listed in this leaflet.
experience symptoms of angioedema, such as: You can also report side effects directly via the
• swollen face, tongue or throat
Yellow Card Scheme at:
• difficulty in swallowing
www.mhra.gov.uk/yellowcard. By reporting side
• hives and difficulties in breathing.
effects you can help provide more information
If you get any of these symptoms, stop taking
on the safety of this medicine.
Valsartan/Hydrochlorothiazide and contact your
doctor straight away (see also section 2
5 How to store Valsartan/
“Warnings and Precautions”).
Hydrochlorothiazide
Other side effects include:
• Keep this medicine out of the sight and reach
Uncommon
of children.
• cough
• Do not use any Valsartan/ Hydrochlorothiazide
• low blood pressure
pack that is damaged or shows signs of
• light-headedness
tampering.
• dehydration (with symptoms of thirst, dry
• Do not use this medicines after the expiry date
mouth and tongue, infrequent urination, dark
which is stated on the pack. The expiry date
coloured urine, dry skin)
refers to the last day of that month.
• muscle pain
• Do not store above 30°C.
• tiredness
• Do not throw away any medicines via
• tingling or numbness
wastewater or household waste. Ask your
• blurred vision
pharmacist how to throw away medicines you
• noises (e.g. hissing, buzzing) in ears.
no longer use. These measures will help to
Very rare
protect the environment.
• dizziness
• diarrhoea
Contents of
6 information the pack and other
• joint pain.
Not known
• blistering skin (sign of dermatitis bullous)
What Valsartan/Hydrochlorothiazide contains
• breathing difficulty
• The active substances are valsartan and
• severely decreased urine output
hydrochlorothiazide. Each tablet contains 80 or
• low level of sodium in the blood (which can
160 mg valsartan and 12.5 or 25 mg
trigger tiredness, confusion, muscle twitching
hydrochlorothiazide.
and/or convulsions in severe cases)
• The other ingredients are colloidal anhydrous
• low level of potassium in the blood
silica, sodium starch glycolate (type A),
(sometimes with muscle weakness, muscle
crospovidone, microcrystalline cellulose,
spasms, abnormal heart rhythm)
maize starch, and magnesium stearate.
• low level of white cells in the blood (with
The coating contains
symptoms such as fever, skin infections, sore
80 mg/12.5 mg: Opadry 03F24039 (hypromellose,
throat or mouth ulcers due to infections,
macrogol 8000, talc, titanium dioxide (E171),
weakness)
sunset yellow FCF (E110), iron oxide red (E172)).
• the level of bilirubin increased in blood (which
160 mg/25 mg: Opadry 03F26816 (hypromellose,
can, in severe cases, trigger yellow skin and
macrogol 8000, talc, titanium dioxide (E171), iron
eyes)
oxide red (E172), iron oxide black (E172), iron
• the level of blood urea nitrogen and creatinine
oxide yellow (E172)).
increased in blood (which can indicate
What Valsartan/Hydrochlorothiazide looks like
abnormal kidney function)
• the level of uric acid in blood increased (which and contents of the pack
80 mg/12.5 mg: Pink, film-coated round tablets,
can, in severe cases, trigger gout)
debossed with "93" on one side and with "7428"
• syncope (fainting).
on the other side of the tablet.
The following side effects have been reported
160 mg/25 mg: Brown, film-coated round tablets,
with products containing valsartan or
debossed with "93" on one side and with "7430"
hydrochlorothiazide alone:
on the other side of the tablet.
Valsartan
The product is available in transparent
Uncommon
PVC/PE/PVdC – Aluminium blisters.
• spinning sensation
Pack sizes of 1, 10, 14, 15, 20, 28, 30, 50, 56, 60,
• abdominal pain.
90, 98, 100 and 280 tablets. Hospital packs: 30, 50,
Not known
56 x 1, 98 x 1 and 280 x 1 tablets.
• skin rash with or without itching together with
Not all pack sizes may be marketed.
some of the following signs or symptoms:
Marketing Authorisation Holder and
fever, joint pain, muscle pain, swollen lymph
Manufacturer
nodes and/or flu-like symptoms
Marketing Authorisation Holder
• rash, purplish-red spots, fever, itching
TEVA UK Limited, Eastbourne, BN22 9AG.
(symptoms of inflammation of blood vessels)
• low level of blood platelets (sometimes with
Manufacturer
unusual bleeding or bruising)
Teva Pharmaceutical Works Private Limited
• high level of potassium in the blood
Company, Pallagi ut 13, 4042 Debrecen.
(sometimes with muscle spasms, abnormal
This leaflet was last revised in March 2014
heart rhythm)
PL 00289/1233-34
• 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
• 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
• 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.
88100-C

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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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