Skip to Content

VALSARTAN AND HYDROCHLOROTHIAZIDE 320MG/12.5MG FILM-COATED TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / VALSARTAN

PDF options:  View Fullscreen   Download PDF

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

VALSARTAN AND HYDROCHLOROTHIAZIDE
320mg/12.5mg; 320mg/25mg
FILM-COATED TABLETS
Valsartan and Hydrochlorothiazide
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Ÿ

Keep this leaflet.You may need to read it again.

Ÿ

If you have any further questions, ask your doctor or pharmacist.

Ÿ

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.

Ÿ

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 and Hydrochlorothiazide Tablets are and what
they are used for
2. What you need to know before you take Valsartan and
Hydrochlorothiazide Tablets

Ÿ

3. How to take Valsartan and Hydrochlorothiazide Tablets
4. Possible side effects
5. How to store Valsartan and Hydrochlorothiazide Tablets
6. Contents of the pack and other information

1. What Valsartan and Hydrochlorothiazide
Tablets are and what they are used for
The full name of your medicine is Valsartan and
Hydrochlorothiazide 320mg / 12.5mg film-coated tablets or
Valsartan and Hydrochlorothiazide 320mg / 25mg film-coated
tablets but within the leaflet it will be referred to as Valsartan and
Hydrochlorothiazide Tablets.
Valsartan and Hydrochlorothiazide Tablets contain two active
substances called valsartan and hydrochlorothiazide. Both of
these substances help to control high blood pressure
(hypertension).
Ÿ

Ÿ

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 Tablets are 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 and Hydrochlorothiazide Tablets

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 Valsartan
and Hydrochlorothiazide Tablets”
If any of these apply to you, talk to your doctor.
Children and adolescents
The use of Valsartan and Hydrochlorothiazide Tablets in children
and adolescents (below the age of 18 years) is not
recommended.
Other medicines and Valsartan and Hydrochlorothiazide
Tablets
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Your doctor may need to change your dose and/or to take other
precautions. The effect of the treatment can be influenced if
Valsartan and Hydrochlorothiazide 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:
Ÿ
Ÿ

Ÿ

Ÿ

Ÿ

Do not take Valsartan and Hydrochlorothiazide Tablets:
Ÿ

Ÿ

Ÿ

Ÿ
Ÿ
Ÿ
Ÿ

Ÿ
Ÿ

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).
if you are more than 3 months pregnant (it is also better to
avoid Valsartan and Hydrochlorothiazide Tablets 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, DO NOT take this medicine and
speak to your doctor.

Ÿ
Ÿ
Ÿ
Ÿ
Ÿ

Ÿ
Ÿ
Ÿ
Ÿ
Ÿ

1

Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan and
Hydrochlorothiazide Tablets.
Ÿ

AW.CRC.45.05.V04

Code

Customer

Size

210x570 mm

Ÿ
Ÿ
Ÿ
Ÿ

Colours

Black
Keyline

Description

NO GOOD FOR COLOR PROOF

Notes

VALSARTAN AND HYDROCHLOROTHIAZIDE 320mg/12.5mg; 320mg/25mg
FILM-COATED TABLETS
(Package Leaflet EN)

Grasshopper Sistemas de Informação
geral@gsiportugal.com
www.gsiportugal.com

Ÿ

Ÿ
Ÿ
Ÿ

Ÿ
Ÿ

Ÿ

Ÿ
Ÿ

Ÿ

2016-03-21

Date

Ÿ
Ÿ

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 Valsartan and
Hydrochlorothiazide tablets 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 Valsartan and
Hydrochlorothiazide Film-coated Tablets, STOP taking
Valsartan and Hydrochlorothiazide 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
pressure - lowering 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 Valsartan and
Hydrochlorothiazide Tablets. 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.
it may cause increased sensitivity of the skin to sun.
you must tell your doctor if you think you are (or might

become) pregnant. Valsartan and Hydrochlorothiazide 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).
if you are taking any of the following medicines used to treat
high blood pressure:
Ÿ an ACE inhibitor (for example enalapril, lisinopril, ramipril),
in particular if you have diabetes-related kidney problems.
Ÿ aliskiren.

Ÿ
Ÿ

Ÿ

Ÿ
Ÿ
Ÿ
Ÿ

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 and Hydrochlorothiazide
Tablets.
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 Valsartan and Hydrochlorothiazide Tablets” 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).

Valsartan and Hydrochlorothiazide Tablets with food and
drink
You can take Valsartan and Hydrochlorothiazide Tablets 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 this medicine.
Ÿ

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 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
Tablets. Valsartan and Hydrochlorothiazide 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 if they are used after the third month of pregnancy.
Ÿ

Tell your doctor if you are breast-feeding or about to start
breast-feeding.

Valsartan and Hydrochlorothiazide Tablets are not recommended
for mothers who are breast-feeding, and your doctor may choose
another treatment for you if you wish to breastfeed, 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 and Hydrochlorothiazide tablets affect you.
Like many other medicines used to treat high blood pressure,
Valsartan and Hydrochlorothiazide Tablets may occasionally
cause dizziness and affect the ability to concentrate.

3. How to take Valsartan and Hydrochlorothiazide
Tablets
Always take this medicine exactly as your doctor or pharmacist
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 and
Hydrochlorothiazide Tablets to take.
Depending on how you respond to the treatment, your doctor may
suggest a higher or lower dose.

Ÿ
Ÿ
Ÿ

Ÿ
Ÿ

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 (may affect more than 1 in 10 people):
Ÿ low level of potassium in the blood
Ÿ increase of lipids in the blood
Common (may affect up to 1 in 10 people):
Ÿ
Ÿ
Ÿ

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

Ÿ

The usual dose is one tablet per day.

Ÿ

Ÿ

DO NOT change the dose or stop taking the tablets without
consulting your doctor.

Ÿ

The medicine should be taken at the same time each day,
usually in the morning.

Ÿ

Ÿ

You can take Valsartan and Hydrochlorothiazide Tablets with
or without food.

Rare (may affect up to 1 in 1,000 people):

Ÿ

Swallow the tablet with a glass of water.

Ÿ

Valsartan and Hydrochlorothiazide 320mg/25mg Film-coated
Tablets has a break line on one side. This means that the tablet
can be divided into equal doses.
If you take more Valsartan and Hydrochlorothiazide Tablets
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 and Hydrochlorothiazide
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 Tablets
Stopping your treatment with Valsartan and Hydrochlorothiazide
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 medicine, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
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:
Ÿ
Ÿ
Ÿ
Ÿ

Ÿ
Ÿ

swollen face, tongue or pharynx
difficulty in swallowing
hives and difficulties in breathing
Severe skin disease that causes rash, red skin, blistering of
the lips, eyes or mouth, skin peeling fever (toxic epidermal
necrolysis)
Decrease in vision or pain in your eyes due to high pressure
(possible signs of acute angle-closure glaucoma)
Fever, sore throat, more frequent infections (agranulocytosis)

If you get any of these symptoms, stop taking Valsartan and
Hydrochlorothiazide Tablets and contact your doctor
STRAIGHT AWAY (see also section 2 “Warnings and
Precautions”).

Ÿ
Ÿ

swelling and blistering of the skin (due to increased sensitivity
to sun)
Ÿ high level of calcium in the blood
Ÿ high level of sugar in the blood
Ÿ sugar in the urine
Ÿ worsening of diabetic metabolic state
Ÿ constipation, diarrhoea, discomfort of the stomach or bowels,
liver disorders which can occur together with yellow skin and
eyes
Ÿ irregular heart beat
Ÿ headache
Ÿ sleep disturbances
Ÿ sad mood (depression)
Ÿ low level of blood platelets (sometimes with bleeding or
bruising underneath the skin)
Ÿ dizziness
Ÿ tingling or numbness
Ÿ vision disorder
Very rare (may affect up to 1 in 10,000 people):
Ÿ inflammation of blood vessels with symptoms such as rash,
purplish-red spots, fever (vasculitis)
Ÿ rash, itching, hives, difficulty breathing or swallowing,
dizziness (hypersensitivity reactions)
Ÿ facial rash, joint pain, muscle disorder, fever (lupus
erythematosus)
Ÿ severe upper stomach pain (pancreatitis)
Ÿ difficulty breathing with fever, coughing, wheezing,
breathlessness (respiratory distress including pneumonitis
and pulmonary oedema)
Ÿ pale skin, tiredness, breathlessness, dark urine (haemolytic
anaemia)
Ÿ fever, sore throat or mouth ulcers due to infections
(leucopenia)
Ÿ confusion, tiredness, muscle twitching and spasm, rapid
breathing (hypochloraemic alkalosis)
Ÿ

Not known (frequency cannot be estimated from the available
data):
Ÿ
Ÿ
Ÿ
Ÿ
Ÿ
Ÿ

weakness, bruising and frequent infections (aplastic anemia)
severely decreased urine output (possible signs of renal
disorder or renal failure)
rash, red skin, blistering of the lips, eyes or mouth, skin
peeling, fever (possible signs of erythema multiforme)
muscle spasm
fever (pyrexia)
weakness (asthenia)

Other side effects include:

Reporting of side effects

Uncommon (may affect up to 1 in 100 people):

If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety of this
medicine.

Ÿ
Ÿ
Ÿ
Ÿ
Ÿ
Ÿ
Ÿ
Ÿ
Ÿ

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 (may affect up to 1 in 10,000 people):
Ÿ
Ÿ
Ÿ

dizziness
diarrhoea
joint pain

2

Not known (frequency cannot be estimated from the available
data):
Ÿ
Ÿ

AW.CRC.45.05.V04

Code

Customer

Size

210x570 mm

Ÿ

Ÿ
Ÿ

Description

NO GOOD FOR COLOR PROOF

Notes

VALSARTAN AND HYDROCHLOROTHIAZIDE 320mg/12.5mg; 320mg/25mg
FILM-COATED TABLETS
(Package Leaflet EN)

Grasshopper Sistemas de Informação
geral@gsiportugal.com
www.gsiportugal.com

Black
Keyline

Colours

Ÿ
Ÿ
Ÿ
Ÿ

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 (may affect up to 1 in 100 people):
Ÿ
Ÿ

spinning sensation
abdominal pain

Not known (frequency cannot be estimated from the available
data):
Ÿ
Ÿ

Ÿ
Ÿ
Ÿ
Ÿ

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)

5. How to store Valsartan and
Hydrochlorothiazide Tablets
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN.
DO NOT use this medicine after the expiry date which is stated
on the carton after EXP. The expiry date refers to the last day of
that month.
DO NOT store above 30ºC.
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 protect the environment.

6. Contents of the pack and other information
What Valsartan and Hydrochlorothiazide tablets contain
Ÿ

The active substances are Valsartan and Hydrochlorothiazide.

Valsartan and Hydrochlorothiazide 320mg/12.5mg Tablets contain
320mg valsartan and 12.5mg hydrochlorothiazide.
Valsartan and Hydrochlorothiazide 320mg/25mg Tablets contain
320mg valsartan and 25mg hydrochlorothiazide.
Ÿ

The other ingredients are:

Core: microcrystalline cellulose, crospovidone, sodium starch
glycolate, magnesium stearate, silica, colloidal anhydrous.
Coating:
Valsartan and Hydrochlorothiazide 320mg/12.5mg Tablets:
polyvinyl alcohol – part. hydrolysed, titanium dioxide (E171), talc
(E553b), macrogol 3350, lecithin (soya) (E322), iron oxide red
(E172), iron oxide black (E172), iron oxide yellow (E172).
Valsartan and Hydrochlorothiazide 320mg/25mg Tablets: Polyvinyl
alcohol – part. hydrolysed, talc (E553b), iron oxide yellow (E172),
titanium dioxide (E171), macrogol 3350, lecithin (soya) (E322),
iron oxide red (E172).
What Valsartan and Hydrochlorothiazide Tablets look like and
contents of the pack
Valsartan and Hydrochlorothiazide 320mg/12.5mg Tablets are
pink, biconvex, oval shaped film-coated tablets.
Valsartan and Hydrochlorothiazide 320mg/25mg Tablets are
yellow, biconvex, oval shaped film coated tablets, with a break
line on one side.
Valsartan and Hydrochlorothiazide Tablets are available in
PVC/PE/PVDC-Aluminium blister packs containing 28 tablets.
Marketing Authorisation Holder and Manufacturer
Crescent Pharma Limited,
Units 3 & 4, Quidhampton Business Units,
Polhampton Lane, Overton,
Hants RG25 3ED
United Kingdom
This leaflet was last revised in 03/2016.

2016-03-21

Date

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide