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

Active substance: VALSARTAN

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USER PACKAGE LEAFLET: INFORMATION FOR THE
USER
Valsartan and Hydrochlorothiazide 80 mg/12.5 mg
Film-Coated Tablets
Valsartan and Hydrochlorothiazide 160 mg/12.5 mg
Film-Coated Tablets
Valsartan and Hydrochlorothiazide 160 mg/25 mg
Film-Coated Tablets
Valsartan and Hydrochlorothiazide 320 mg/12.5 mg
Film-Coated Tablets
Valsartan and Hydrochlorothiazide 320 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
and
Hydrochlorothiazide
Film-Coated Tablets are and what they are used for
2. Before you take Valsartan and Hydrochlorothiazide
Film-Coated Tablets
3. How to take Valsartan and Hydrochlorothiazide
Film-Coated Tablets
4. Possible side effects
5. How to store Valsartan and Hydrochlorothiazide
Film-Coated Tablets
6. Further information
1.WHAT VALSARTAN AND HYDROCHLOROTHIAZIDE
FILM-COATED TABLETS ARE AND WHAT THEY ARE
USED FOR
Valsartan and 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 and Hydrochlorothiazide Film-Coated Tablets
are used to treat high blood pressure which is not
adequately controlled either by valsartan or
hydrochlorothiazide 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 AND
HYDROCHLOROTHIAZIDE FILM-COATED TABLETS
Do not take Valsartan and Hydrochlorothiazide
Film-Coated Tablets:
if you are allergic (hypersensitive) to valsartan,
hydrochlorothiazide, sulphonamide derivatives
(substances
chemically
related
to
hydrochlorothiazide) or to any of the other
ingredients of Valsartan and Hydrochlorothiazide
Film-Coated Tablets.
if you are more than 3 months pregnant (it is also
better to avoid Valsartan and Hydrochlorothiazide
Film-Coated Tablets 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 than 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
and
Hydrochlorothiazide Film-Coated Tablets
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 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 Valsartan and Hydrochlorothiazide
Film-Coated Tablets 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 and Hydrochlorothiazide
Film-Coated Tablets 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. Valsartan and Hydrochlorothiazide
Film-Coated Tablets are 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).
The hydrochlorothiazide contained in this medicine
could produce a positive result in an anti-doping test.
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 and Hydrochlorothiazide Film-Coated Tablets
are 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,
potassium-containing
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 that may 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)
ciclosporin, 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 and Hydrochlorothiazide Film-Coated
Tablets with food and drink
You can take Valsartan and Hydrochlorothiazide
Film-Coated Tablets with or without food.
Avoid taking alcohol. 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.
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 and Hydrochlorothiazide Film-Coated
Tablets before you become pregnant or as soon as
you know you are pregnant, and will advise you to
take another medicine instead of Valsartan and
Hydrochlorothiazide Film-Coated Tablets. Valsartan
and Hydrochlorothiazide Film-Coated Tablets are 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.
Tell your doctor if you are breast-feeding or about
to start breast-feeding
Valsartan and Hydrochlorothiazide Film-Coated Tablets
are 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, operate machines
or carry out other activities that require concentration,
make sure you know how Valsartan and
Hydrochlorothiazide Film-Coated Tablets affect you.
Like many other medicines used to treat high blood
pressure,
Valsartan
and
Hydrochlorothiazide
Film-Coated Tablets may occasionally cause dizziness
and affect the ability to concentrate.
Important information about some of the ingredients
of Valsartan and Hydrochlorothiazide Film-Coated
Tablets
Valsartan and Hydrochlorothiazide Film-Coated Tablets
contain lactose. If you have been told by your doctor
that you have an intolerance to some sugars, contact
your doctor before taking this medicine.
3.
HOW TO TAKE VALSARTAN AND
HYDROCHLOROTHIAZIDE FILM-COATED TABLETS
Always take Valsartan and Hydrochlorothiazide
Film-Coated Tablets 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 and Hydrochlorothiazide Film-Coated Tablets
to take. Depending on how you respond to the
treatment, your doctor may suggest a higher or lower
dose.
The
usual
dose
of
Valsartan
and
Hydrochlorothiazide Film-Coated Tablets 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 and Hydrochlorothiazide
Film-Coated Tablets with or without food.
Swallow the tablet with a glass of water.
If you take more Valsartan and Hydrochlorothiazide
Film-Coated Tablets 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
and
Hydrochlorothiazide Film-Coated Tablets
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 and Hydrochlorothiazide
Film-Coated Tablets
Stopping your treatment with Valsartan and
Hydrochlorothiazide Film-Coated Tablets 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 and Hydrochlorothiazide
Film-Coated Tablets 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
- tingling or numbness
- blurred vision
- noises (e.g. hissing, buzzing) in ears
Very rare
- dizziness
- diarrhea
- joint pain
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 and Hydrochlorothiazide Film-Coated
Tablets:
Valsartan
Uncommon
- spinning sensation
- abdominal 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
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

Do not use any Valsartan and Hydrochlorothiazide
Film-Coated Tablets pack that is damaged or shows
signs of tampering.
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
and
Hydrochlorothiazide
Film-Coated Tablets contain
The active substances are: valsartan and
hydrochlorothiazide.
One film-coated tablet contains 80 mg of valsartan and
12.5 mg of hydrochlorothiazide.
One film-coated tablet contains 160 mg of valsartan
and 12.5 mg of hydrochlorothiazide.
One film-coated tablet contains 160 mg of valsartan
and 25 mg of hydrochlorothiazide.
One film-coated tablet contains 320 mg of valsartan
and 12.5 mg of hydrochlorothiazide.
One film-coated tablet contains 320 mg of valsartan
and 25 mg of hydrochlorothiazide.
The other ingredients are:
Core: lactose monohydrate, croscarmellose sodium,
povidone, magnesium stearate, talc.
Film-coat:
Valsartan and Hydrochlorothiazide 80 mg/12.5 mg
Film-Coated Tablets:
Hypromellose, titanium dioxide, macrogol 400
Valsartan and Hydrochlorothiazide 160 mg/12.5 mg
Film-Coated Tablets:
Hypromellose, titanium dioxide (E 171), macrogrol
400, ferric oxide red (E 172)
Valsartan and Hydrochlorothiazide 160 mg/25 mg
Film-Coated Tablets:
Hypromellose, titanium dioxide (E 171), macrogol 400,
ferric oxide yellow (E 172)
Valsartan and Hydrochlorothiazide 320 mg/12.5 mg
Film-Coated Tablets:
Hypromellose, titanium dioxide (E 171), macrogrol
400, ferric oxide red (E 172)
Valsartan and Hydrochlorothiazide 320 mg/25 mg
Film-Coated Tablets:
Hypromellose, titanium dioxide (E 171), macrogrol 400
What Valsartan and Hydrochlorothiazide Film-Coated
Tablets look like and contents of the pack
Valsartan and Hydrochlorothiazide 80 mg/12.5 mg
Film-Coated Tablets are white to off white, oval shaped,
bevelled edge, biconvex film coated tablets debossed
with “1071” on one side and plain on the other side.
Valsartan and Hydrochlorothiazide 80 mg/12.5 mg
Film-Coated Tablets are available in PVC/PE/PVdC-Alu
blister packs with 28 tablets.
Valsartan and Hydrochlorothiazide 160 mg/12.5 mg
Film-Coated Tablets are pink coloured, oval shaped,
bevelled edge, biconvex film coated tablets debossed
with “1072” on one side and plain on the other side.
Valsartan and Hydrochlorothiazide 160 mg/12.5 mg
Film-Coated Tablets are available in PVC/PE/PVdC-Alu
blister packs with 28 tablets.
Valsartan and Hydrochlorothiazide 160 mg/25 mg
Film-Coated Tablets are yellow coloured, oval shaped,
bevelled edge, biconvex film coated tablets with a
score line on both sides. The tablet can be divided into
equal halves.
Valsartan and Hydrochlorothiazide 160 mg/25 mg
Film-Coated Tablets are available in PVC/PE/PVdC-Alu
blister packs with 28 tablets.
Valsartan and Hydrochlorothiazide 320 mg/12.5 mg
Film-Coated Tablets are pink coloured, oval shaped,
bevelled edge biconvex film coated tablets debossed
with “1074” on one side and plain on the other side.
Valsartan and Hydrochlorothiazide 320 mg/12.5 mg
Film-Coated Tablets are available in PVC/PE/PVdC-Alu
blister packs with 28 tablets.
Valsartan and Hydrochlorothiazide 320 mg/25 mg
Film-Coated Tablets are white to off white, oval shaped,
bevelled edge, biconvex film coated tablets with a
score line on one side and plain on the other side. The
tablet can be divided into equal halves.
Valsartan and Hydrochlorothiazide 320 mg/25 mg
Film-Coated Tablets are available in PVC/PE/PVdC-Alu
blister packs with 28 tablets.
Marketing Authorisation Holder
Torrent Pharma GmbH
Suedwestpark 50
90449 Nuremberg
Germany
Manufacturer
Heumann Pharma GmbH & Co. Generica KG
Suedwestpark 50
90449 Nuremberg
Germany
This medicinal product is authorised in the Member
States of the EEA under the following names:
United Kingdom Valsartan and Hydrochlorothiazide
80 mg/12.5 mg / 160 mg/12.5 mg /
160 mg/25 mg / 320 mg/12.5 mg /
320 mg/25 mg Film-Coated Tablets
Germany
Valsartan comp. Heumann 80 mg/
12,5 mg / 160 mg/12,5 mg
/ 160 mg/25 mg / 320 mg/12,5 mg /
320 mg/25 mg Filmtabletten
Italy
Valsartan e Idroclorotiazide Torrent,
80 mg/12,5 mg / 160 mg/12.5 mg /
160 mg/25 mg / 320 mg/12.5 mg /
320 mg/25 mg, compresse
revestite con film
Lithuania
Co-Valsartan Torrent 80 mg/
12,5 mg / 160 mg/12.5 mg /
160 mg/25 mg / 320 mg/12.5 mg /
320 mg/25 mg plėvele dengtos
tabletės
Romania
Valsartan Hidroclorotizida Torrent
80 mg/12,5 mg / 160 mg/12,5 mg /
160 mg/25 mg / 320 mg/12,5 mg /
320 mg/25 mg comprimate filmate"
This leaflet was last approved in 02/2012.

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 AND
HYDROCHLOROTHIAZIDE FILM-COATED TABLETS
Do not store above 30 °C.
Keep out of the reach and sight of children.
Do not use Valsartan and Hydrochlorothiazide
Film-Coated Tablets after the expiry date which is
stated on the pack. The expiry date refers to the last
day of that month.

8029957-7803

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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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