VALSARTAN/HYDROCHLOROTHIAZIDE 80 MG/12.5 MG FILM-COATED TABLETS

Active substance: VALSARTAN

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET:
INFORMATION FOR THE USER

Valsartan/hydrochlorothiazide
80 mg/12.5 mg film-coated tablets
Valsartan/hydrochlorothiazide
160 mg/12.5 mg film-coated tablets
Valsartan/hydrochlorothiazide
160 mg/25 mg film-coated tablets
Valsartan/hydrochlorothiazide
Read all of this leaflet carefully before you start
taking this medicine.
• 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. 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.
IN THIS LEAFLET:
1. What Valsartan/hydrochlorothiazide is and what it is
used for
2. Before you take Valsartan/hydrochlorothiazide
3. How to take Valsartan/hydrochlorothiazide
4. Possible side effects
5. How to store Valsartan/hydrochlorothiazide
6. Further 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. 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 Valsartan/
hydrochlorothiazide,
• if you are more than 3 months pregnant. (It is also better
to avoid Valsartan/hydrochlorothiazide in early pregnancy
– see pregnancy section.),
• if you have severe liver disease,
• if you have severe kidney disease,
• if you are unable to urinate,
• 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 then normal despite treatment,
• if you have gout.
If any of the above apply to you, do not take this
medicine and speak to your doctor.
Take special care with
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.
• 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 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
Valsartan/hydrochlorothiazide is not recommended.
• if you have liver or kidney disease.
• 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
fats 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.
• it may cause increased sensitivity of the skin to sun.



The use of Valsartan/hydrochlorothiazide in children
and adolescents (below the age of 18 years) is not
recommended.
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).
Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken 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 illness,
• medicines that affect or can be affected by potassium
blood levels, such as digoxin, a medicine to control the
heart rhythm, some antipsychotic medicines,
• medicines that may increase the amount of potassium in
your blood, such as potassium supplements, potassiumcontaining salt substitutes, potassium sparing medicines,
heparin,
• medicines that may reduce the amount of potassium in
your blood, such as corticosteroids, some laxatives,
• diuretics (water tablets), medicines for the treatment of
gout, such as allopurinol, therapeutic vitamin D and
calcium supplements, medicines for the treatment of
diabetes (oral agents or insulins),
• other medicines to lower your blood pressure, such as
beta-blockers or methyldopa, or medicines that tighten
your blood vessels or stimulate your heart, such as
noradrenaline or adrenaline,
• medicines to increase blood sugar levels, such as
diazoxide,
• medicines to treat cancer, such as methotrexate or
cyclophosphamide,
• pain killers,
• arthritis medicines,
• muscle relaxing medicines, such as tubocurarine,
• anti-cholinergic medicines, such as atropine or biperiden,

amantadine (a medicine used to prevent influenza),
cholestyramine and colestipol (medicines used to
treat high levels of fats in the blood),
• ciclosporine, a medicine used for organ transplant to
avoid organ rejection,
• some antibiotics (tetracyclines), anaesthetics and
sedatives,
• carbamazepine, a medicine used to treat seizure
conditions.



Taking Valsartan/hydrochlorothiazide with food
and drink
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
Ask your doctor or pharmacist for advice before taking
any medicine.
Pregnancy
You must tell your doctor if you think 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 used after the third month of pregnancy.

Breastfeeding
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 contains lactose. If you have
been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this
medicinal product.

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. You should 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 usual 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, 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 Valsartan/hydrochlorothiazide
If you forget to take a dose, take one 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
product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Valsartan/hydrochlorothiazide can
cause side effects, although not everybody gets them.
These side effects may occur with certain frequencies,
which are defined as follows:
• very common: affects more than 1 user in 10
• common: affects 1 to 10 users in 100
• uncommon: affects 1 to 10 users in 1,000
• 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.
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
Other side effects include:
Uncommon
• cough
• low blood pressure
• light-headedness
• dehydration (with symptoms of thirst, dry mouth and
tongue, infrequent urination, dark colored urine, dry skin)

• muscle

pain

• tiredness

Valsartan

or numbness
vision
• noises (e.g. hissing, buzzing) in ears

Uncommon
• spinning sensation
• abdominal pain.

Very rare
• dizziness
• diarrhea
• joint pain.

Not known
• 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)
• 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.

• tingling
• blurred

Not known
• breathing difficulty
• severely decreased urine output
• low level of sodium in the blood (sometimes with
nausea, tiredness, confusion, malaise, convulsions)
• 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).
Side effects reported with valsartan or
hydrochlorothiazide alone, but not observed with
Valsartan/hydrochlorothiazide:

Hydrochlorothiazide
Common
• itchy rash and other types of rash
• reduced appetite
• mild nausea and vomiting
• faintness, fainting on standing up
• impotence.

Rare
• swelling and blistering of the skin (due to increased
sensitivity to sun)
• constipation, discomfort of the stomach or bowels, liver
disorders (yellow skin or eyes)
• irregular heart beat
• headache
• sleep disturbances
• sad mood (depression)
• low level of blood platelets (sometimes with bleeding
or bruising underneath the skin).
Very rare
• inflammation of blood vessels with symptoms such
as rash, purplish-red spots, fever
• itching or red skin
• blistering of the lips, eyes or mouth
• skin peeling
• fever
• facial rash associated with joint pain
• muscle disorder
• fever (cutaneous lupus erythematosus)
• severe upper stomach pain; lack or low levels of different
blood cells
• severe allergic reactions
• difficulty breathing
• lung infection; breathlessness.
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.

5. HOW TO STORE VALSARTAN/
HYDROCHLOROTHIAZIDE
Keep out of the reach and sight of children.
Do not store above 30°C.
Store in the original package in order to protect from light
and moisture.
Do not use Valsartan hydrochlorothiazide after the expiry
date which is stated on the packaging after EXP. The expiry
date refers to the last day of that month.
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.

6. FURTHER INFORMATION
What Valsartan/hydrochlorothiazide contains
• The active substances are valsartan and
hydrochlorothiazide.
Each Valsartan/hydrochlorothiazide 80 mg/12.5 mg
film-coated tablet contains 80 mg valsartan and
12.5 mg hydrochlorothiazide.
Each Valsartan/hydrochlorothiazide 160 mg/12.5 mg
film-coated tablet contains 160 mg valsartan and
12.5 mg hydrochlorothiazide.
Each Valsartan/hydrochlorothiazide 160 mg/25 mg
film-coated tablet contains 160 mg valsartan and
25 mg hydrochlorothiazide.
• The other ingredients are microcrystalline cellulose,
lactose monohydrate, magnesium stearate,







croscarmellose sodium, povidone K-25, colloidal
anhydrous silica in the tablet core and hypromellose,
titanium dioxide (E171), macrogol, iron oxide red (E172),
iron oxideyellow (E172) – only in 80 mg/12.5 mg and
160 mg/25 mg tablets – in the film coating.

What Valsartan/hydrochlorothiazide looks like and
contents of the pack
Film-coated tablets of 80 mg/12.5 mg are pink, oval,
biconvex.
Film-coated tablets of 160 mg/12.5 mg mg are red brown,
oval, biconvex.
Film-coated tablets of 160 mg/25 mg are light brown, oval,
biconvex.
They are available in boxes of 14, 28, 30, 56, 60, 84, 90,
98, 280, 56 x 1, 98 x 1, 280 x 1 film-coated tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo
mesto, Slovenia
Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo
mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472
Cuxhaven, Germany.
Distributed by: Consilient Health (UK) Ltd, 500 Chiswick
High Road, London. W4 5RG

This leaflet was last approved in October 2011
P0140

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.

Hide
(web5)