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VALSARTAN/HYDROCHLOROTHIAZIDE 160 MG/12.5 MG FILM-COATED TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / VALSARTAN

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VALSARTAN/HYDROCHLOROTHIAZIDE
160 mg/12.5 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 of the 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

Version:

4

26 March 2015

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.

TEVA UK Ref:

231-30-88280-C LEA VALSARTAN/HCTZ 160MG/12.5MG TAB TUK
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

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, 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
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 (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).

DO NOT take Valsartan/Hydrochlorothiazide if:
• you are allergic (hypersensitive) to valsartan,
hydrochlorothiazide sulphonamide derivatives
(substances chemically related to
hydrochlorothiazide) or 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
Valsartan/Hydrochlorothiazide with food, drink
• you have diabetes or impaired kidney function
and alcohol
and you are treated with a blood pressure
You can take Valsartan/Hydrochlorothiazide with
lowering medicine called aliskiren.
or without food.
If any of the above apply to you, do not take this Avoid taking alcohol until you have talked to your
medicine and speak to your doctor.
doctor. Alcohol may make your blood pressure
fall more and/or increase the risk of you
Warnings and precautions
becoming dizzy or feeling faint.
Talk to your doctor or pharmacist before taking
Valsartan/Hydrochlorothiazide if you:
Pregnancy and breast-feeding
• are taking potassium-sparing medicines,
If you are pregnant or breast-feeding, think you
potassium supplements, salt substitutes
may be pregnant or are planning to have a baby,
containing potassium or other medicines that ask your doctor or pharmacist for advice before
increase the amount of potassium in your
taking this medicine.
blood such as heparin. Your doctor may need to • You must tell your doctor if you think that you
check the amount of potassium in your blood
are (or might become) pregnant.
regularly
Your doctor will normally advise you to stop
• have low levels of potassium in your blood
taking Valsartan/Hydrochlorothiazide before you
• have diarrhoea or severe vomiting
become pregnant or as soon as you know you are
• are taking high doses of water tablets
pregnant, and will advise you to take another
(diuretics)
medicine instead of Valsartan/ Hydrochlorothiazide.
• have severe heart disease
Valsartan/ Hydrochlorothiazide is not
• are suffering from heart failure or have
recommended in early pregnancy, and must not be
experienced a heart attack. Follow your
taken when more than 3 months pregnant, as it
doctor’s instruction for the starting dose
may cause serious harm to your baby if it is used
carefully. Your doctor may also check your
after the third month of pregnancy.
kidney function.
• Tell your doctor if you are breast-feeding or
• suffer from a narrowing of the kidney artery
about to start breast-feeding.
• have recently received a new kidney
Valsartan/Hydrochlorothiazide is not
• suffer from hyperaldosteronism. This is a
disease in which your adrenal glands make too recommended for mothers who are breast-feeding,
and your doctor may choose another treatment
much of the hormone aldosterone. If this
for you if you wish to breast-feed, especially if
applies to you, the use of Valsartan/
your baby is newborn, or was born prematurely.
Hydrochlorothiazide is not recommended
• have liver or kidney disease
Driving and using machines
• have ever experienced swelling of the tongue Before you drive a vehicle, use tools or operate
and face caused by an allergic reaction called
machines or carry out other activities that require
angioedema when taking another drug
concentration, make sure you know how Valsartan/
(including ACE inhibitors), tell your doctor. If
Hydrochlorothiazide affects you. Like many other
these symptoms occur when you are taking
medicines used to treat high blood pressure,
Valsartan/Hydrochlorothiazide, stop taking
Valsartan/Hydrochlorothiazide may occasionally
Valsartan/Hydrochlorothiazide immediately
cause dizziness and affect the ability to
and never take it again. See also section 4,
concentrate.
“Possible side effects”.
• have fever, rash and joint pain, which may be
How to take Valsartan/
signs of systemic lupus erythematosus (SLE, a 3 Hydrochlorothiazide
so-called autoimmune disease)
• have diabetes, gout, high levels of cholesterol Always take Valsartan/Hydrochlorothiazide
exactly as your doctor has told you. This will help
or fats in your blood
you to get the best results and lower the risk of
• have had allergic reactions with the use of
side effects. Check with your doctor or
other blood pressure-lowering agents of this
class (angiotensin II receptor antagonists) or if pharmacist if you are not sure.
People with high blood pressure often do not
you have allergy or asthma
notice any signs of this problem. Many may feel
• experience a decrease in vision or eye pain.
quite normal. This makes it all the more
These could be symptoms of an increase of
important for you to keep your appointments
pressure in your eye and can happen within
with your doctor even if you are feeling well.
hours to a week of taking Valsartan/
Your doctor will tell you exactly how many
Hydrochlorothiazide. This can lead to
tablets of Valsartan/Hydrochlorothiazide to take.
permanent vision loss, if not treated. If you
Depending on how you respond to the
earlier have had a penicillin or sulphonamide
allergy you can have a higher risk of developing treatment, your doctor may suggest a higher or
lower dose.
this
• are taking any of the following medicines used • The recommended dose of Valsartan/
to treat high blood pressure:
Hydrochlorothiazide is one tablet per day.
• “ACE inhibitors” such as enalapril,
• Do not change the dose or stop taking the
lisinopril, etc.
tablets without consulting your doctor.
• aliskiren.
• The medicine should be taken at the same time
each day, usually in the morning.
One of the ingredients (hydrochlorothiazide) in
these tablets may cause increased sensitivity of • You can take Valsartan/Hydrochlorothiazide
with or without food.
the skin to sunlight.

Swallow
the tablet with a glass of water.
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.

TEVA UK Ref:

231-30-88280-C LEA VALSARTAN/HCTZ 160MG/12.5MG TAB TUK
Version:

4

26 March 2015

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.

• 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
If you forget to take Valsartan/
including pneumonitis and pulmonary
Hydrochlorothiazide
oedema)
If you forget to take a dose, take it as soon as

fever, sore throat, more frequent infections
you remember. However, if it is almost time for
(agranulocytosis)
your next dose, skip the dose you missed. Do not

pale skin, tiredness, breathlessness, dark
take a double dose to make up for a forgotten
urine (haemolytic anaemia)
dose.
• fever, sore throat or mouth ulcers due to
If you stop taking Valsartan/ Hydrochlorothiazide
infections (leucopenia)
Stopping your treatment with Valsartan/
• confusion, tiredness, muscle twitching and
Hydrochlorothiazide may cause your high blood
spasm, rapid breathing (hypochloraemic
pressure to get worse. Do not stop taking your
alkalosis).
medicine unless your doctor tells you to.
Not known
• weakness, bruising and frequent infections
If you have any further questions on the use of
(aplastic anaemia)
this medicine, ask your doctor or pharmacist.
• severely decreased urine output (possible
signs of renal disorder or renal failure)
4 Possible side effects
• decrease in vision or pain in your eyes due
to high pressure (possible signs of acute
Like all medicines, this medicine can cause side
angle-closure glaucoma)
effects, although not everybody gets them.
• rash, red skin, blistering of the lips, eyes or
These side effects may occur with certain
mouth, skin peeling, fever (possible signs
frequencies, which are defined as follows:
of erythema multiforme)
• very common: affects more than 1 user in 10
• muscle spasm
• common: affects 1 to 10 users in 100
• fever (pyrexia)
• uncommon: affects 1 to 10 users in 1,000
• weakness (asthenia).
• rare: affects 1 to 10 users in 10,000
• very rare: affects less than 1 user in 10,000
Reporting of side effects
• not known: frequency cannot be estimated
If you get any side effects talk to your doctor or
from the available data
pharmacist. This includes any possible side
effects not listed in this leaflet.
Some side effects can be serious and need
You can also report side effects directly via
immediate medical attention:
Yellow Card Scheme at:
You should see your doctor immediately if you
www.mhra.gov.uk/yellowcard. By reporting side
experience symptoms of angioedema, such as:
effects you can help provide more information
• swollen face, tongue or throat
on the safety of this medicine.
• difficulty in swallowing
• hives and difficulties in breathing.
If you get any of these symptoms, stop taking
Valsartan/Hydrochlorothiazide and contact your
doctor straight away (see also section 2
“Warnings and Precautions”).
Other side effects include:
Uncommon
• 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
• 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).
The following side effects have been reported
with products containing valsartan or
hydrochlorothiazide alone:
Valsartan
Uncommon
• spinning sensation
• abdominal pain.
Not known
• 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
• 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.
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)

5

How to store Valsartan/
Hydrochlorothiazide

• Keep this medicine out of the sight and reach
of children.
• Do not use this medicine after the expiry date
which is stated on pack. The expiry date refers
to the last day of that month.
• Do not store above 30°C.
Do not use any Valsartan/Hydrochlorothiazide
pack that is damaged or shows signs of
tampering.
• Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help to
protect the environment.

6

Contents of the pack and other
information

What Valsartan/Hydrochlorothiazide contains
• The active substances are valsartan and
hydrochlorothiazide. Each tablet contains 160 mg
valsartan and 12.5 mg hydrochlorothiazide.
• The other ingredients are colloidal anhydrous
silica, sodium starch glycolate (type A),
crospovidone, microcrystalline cellulose,
maize starch, magnesium stearate and Opadry
03F25380 red (hypromellose, macrogol 8000,
talc, titanium dioxide (E171), iron oxide red
(E172), iron oxide yellow (E172)).
What Valsartan/Hydrochlorothiazide looks like
and contents of the pack
• Valsartan/Hydrochlorothiazide
160 mg/12.5 mg Film-Coated Tablets are red,
film-coated, standard convex round tablets,
debossed with "VH" on one side.
• They are available in pack sizes of 1, 14, 15, 28,
30, 56, 60, 84, 90, 98 and 100 film-coated
tablets. Hospital pack: 50 (50 x 1) film-coated
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG.
Manufacturer
Teva Pharmaceutical Works Private Limited
Company, Pallagi ut 13, 4042 Debrecen.
This leaflet was last revised in March 2014.
PL 00289/1215

88280-C

Expand view ⇕

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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