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VALSOL PLUS 160MG /25MG FILM-COATED TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / VALSARTAN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Valsol plus 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 Valsol plus is and what it is used for
2.
Before you take Valsol plus
3.
How to take Valsol plus
4.
Possible side effects
5.
How to store Valsol plus
6.
Further information
1.

WHAT VALSOL PLUS IS AND WHAT IT IS USED FOR

Valsol plus 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.
Valsol plus 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 VALSOL PLUS

Do not take Valsol plus:

if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulphonamide
derivatives (substances chemically related to hydrochlorothiazide) or to any of the other
ingredients of Valsol plus.
if you are more than 3 months pregnant (it is also better to avoid Valsol plus 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 Valsol plus
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 Valsol plus 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
thisclass (angiotensin II receptor antagonists) or if you have allergy or asthma.
it may cause increased sensitivity of the skin to sun.
The use of Valsol plus 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. Valsol plus 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 Valsol plus 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, 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 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)
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 Valsol plus with food and drink
You can take Valsol plus 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.
You must tell your doctor if you think that you are (or might become) pregnant
Your doctor will normally advise you to stop taking Valsol plus before you become pregnant or as
soon as you know you are pregnant, and will advise you to take another medicine instead of Valsol
plus. Valsol plus 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
Valsol plus 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 Valsol plus affects you. Like many other medicines used
to treat high blood pressure, Valsol plus may occasionally cause dizziness and affect the ability to
concentrate.
Important information about some of the ingredients of Valsol plus
Valsol plus contains lactose and sorbitol. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, i.e.
essentially ‘sodium-free’.
3.

HOW TO TAKE VALSOL PLUS

Always take Valsol plus 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 Valsol plus to take. Depending on how you
respond to the treatment, your doctor may suggest a higher or lower dose.
The usual dose of Valsol plus 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 Valsol plus with or without food.
Swallow the tablet with a glass of water.
If you take more Valsol plus 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 Valsol plus
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 Valsol plus
Stopping your treatment with Valsol plus 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, Valsol plus 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
diarrhoea
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
Valsol plus:
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 painlack 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 VALSOL PLUS
Keep out of the reach and sight of children.
Do not use Valsol plus after the expiry date which is stated on the carton and blister after
EXP. The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original package in order to protect from moisture.
Do not use any Valsol plus 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 Valsol plus contains
The active substances are valsartan and hydrochlorothiazide.
Each Valsol plus 160 mg/25 mg film-coated tablet contains 160 mg valsartan and 25 mg
hydrochlorothiazide.
Other excipients are:
Tablet Core: cellulose, microcrystalline, silica, colloidal anhydrous, sorbitol, magnesium
carbonate, pregelatinised maize starch, povidone K-30, sodium stearyl fumarate, sodium
laurylsulphate, crospovidone Type A.
Coating: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E 171), iron
oxide brown (E 172) (only the 160 mg/25 mg strengths), iron oxide yellow (E 172) (only the
160 mg/25 mg strength)
What Valsol plus looks like and contents of the pack
Film-coated tablet.
Valsol plus 160 mg/25 mg film-coated tablets: cylindrical, biconvex, coated brown tablet.
The tablets are supplied in blister packs of 14, 28, 30, 56, 98 or 280 tablets.
Not all pack sizes or tablet strengths may be marketed.
Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
LABORATORIOS LICONSA, S.A.
Gran Vía Carlos III, 98, 7th
08028 Barcelona
Spain
Manufacturer:
Place of manufacture:

Laboratorios CINFA, S.A.
Olaz-Chipi, 10 - Polígono Areta
31620 Huarte (Pamplona)
SPAIN
Laboratorios CINFA, S.A.
Avda Roncesvalles, S/N
31699 Olloqui (Navarra)
SPAIN
Laboratorios LICONSA, S.A.
Avda. Miralcampo, nº 7 – Polígono Miralcampo
19200 Azuqueca de Henares (Guadalajara)
SPAIN
ZENTIVA k.s.
U. Kabelovny 130, 102 37, Praha 10
Czech Republic

This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria:
Valsol plus HCT 160/25 mg Filmtabletten
Belgium:
Valsartan Liconsa 160/25 mg comprimé pelliculé
Bulgaria:
Valsol plus 160/25 mg филмирани таблетки
Estonia:
Valsartan hydrochlorothiazide Liconsa 160/25 mg
France:
Valsartan hydrochlorothiazide Liconsa 160/25 mg comprimé pelliculé
Germany:
Valsol Plus 160/25 mg Filmtabletten
Greece:
AVALSAN PLUS 160/25 mg δισκίο επικαλυμμένο με λεπτό υμένιο
Hungary:
Valsol plus 160/25 mg bevont tabletta
Ireland:
Valsol plus 160/25 mg film-coated tablets
Italy:
Valsol plus 160/25 mg compressa rivestita con film
Latvia:
Valsol plus 160/25 mg apvalkotās tabletes
The Netherlands Valsartan/hydrochlorothiazide Liconsa 160/25 mg filmomhulde tablet
Poland:
Valsartan Hydrochlorothiazide Liconsa
Portugal:
Valsol plus
Slovenia:
Valsartan/hidroklorotiazid Liconsa 160/25 mg filmsko obložene tablete
Slovak Republic: Valsartan/Hydrochlorotiazid Liconsa 160/25 mg
Spain:
Valsartan Hidroclorotiazida Cantabria 160/25 mg comprimidos recubiertos con
película
United Kingdom: Valsol plus 160/25 mg film-coated tablets

This leaflet was last approved in:
02.2010

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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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