Skip to Content

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valsartan/Hydrochlorothiazide 80mg/12.5mg Film-coated Tablets
Valsartan/Hydrochlorothiazide 160mg/12.5mg Film-coated Tablets
Valsartan/Hydrochlorothiazide 160mg/25mg 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 get 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 Tablets are and what they are used for
2. Before you take Valsartan/Hydrochlorothiazide Tablets
3. How to take Valsartan/Hydrochlorothiazide Tablets
4. Possible side effects
5. How to store Valsartan/Hydrochlorothiazide Tablets
6. Further information
1. WHAT VALSARTAN/HYDROCHLOROTHIAZIDE TABLETS ARE AND WHAT
THEY ARE USED FOR
Your tablets contain two active substances called valsartan and hydrochlorothiazide.
Both of these substances help to control high blood pressure (hypertension).
Valsartan belongs to a group 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, 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 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. BEFORE YOU TAKE VALSARTAN/HYDROCHLOROTHIAZIDE TABLETS
Do not take Valsartan/Hydrochlorothiazide Tablets:
•if you are allergic (hypersensitive) to
•if you have severe liver disease.
valsartan, hydrochlorothiazide,
•if you have severe kidney disease.
sulphonamide derivatives (substances
•if you are unable to urinate.
chemically related to
•if you are treated with an artificial
hydrochlorothiazide) or to any of the
kidney.
other ingredients of these tablets.
•if the level of potassium or sodium in
•if you are more than 3 months pregnant
your blood is lower than normal, or if the
(it is also better to avoid
level of calcium in your blood is higher
Valsartan/Hydrochlorothiazide Tablets in
than normal despite treatment.
early pregnancy - see pregnancy
•if you have gout.
section).
If any of the above apply to you, do not take this medicine and speak to your doctor.
Take special care with Valsartan/Hydrochlorothiazide Tablets:
Tell your doctor before you take Valsartan/Hydrochlorothiazide 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.
•have low levels of potassium in your blood.
•have diarrhoea or severe vomiting.
•are taking high doses of water tablets (diuretics).
•have severe heart disease.
•suffer from a narrowing of the kidney artery.
•have recently had a kidney transplant.
•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 Tablets is not recommended.
•have liver or kidney disease.
•have a fever, rash and joint pain, which may be signs of systemic lupus
erythematosus (SLE, a so-called autoimmune disease).
•have diabetes, gout, high levels of cholesterol or fats in your blood.
•have had allergic reactions with the use of other blood pressure-lowering agents of
this class (angiotensin II receptor antagonists) or if you have any allergies or asthma.
This medicine may increase the sensitivity of your skin to sunlight. Speak to your doctor
before sunbathing or using UV tanning lamps.
Valsartan/Hydrochlorothiazide Tablets are not recommended in children and
adolescents (below the age of 18 years).
You must tell your doctor if you think you are (or might become) pregnant.
Valsartan/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).

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 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) and 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, or heparin
•medicines that may reduce the amount of potassium in your blood, such as
corticosteroids and 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 medicines 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 Valsartan/Hydrochlorothiazide Tablets with food and drink
You can take Valsartan/Hydrochlorothiazide Tablets with or without food.
Avoid taking alcohol until you have talked to your doctor. Alcohol may make your blood
pressure fall too much 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 these 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/Hydrochlorothiazide Tablets.
Valsartan/Hydrochlorothiazide Tablets are not recommended in early pregnancy, and
must not be taken when more than 3 months pregnant, as they may cause serious
harm to your baby if they are used after the third month of pregnancy.
Tell your doctor if you are breast-feeding or about to start breast-feeding
Valsartan/Hydrochlorothiazide 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, use tools or operate machines, or carry out other activities that
require concentration, make sure you know how this medicine affects you. Like many
other medicines used to treat high blood pressure Valsartan/Hydrochlorothiazide Tablets
may in rare cases cause dizziness and affect the ability to concentrate.
3. HOW TO TAKE VALSARTAN/HYDROCHLOROTHIAZIDE TABLETS
Always take Valsartan/Hydrochlorothiazide Tablets exactly as your doctor has told you
in order to get the best results and reduce the risk of side effects. You should check
with your doctor or pharmacist if you are not sure. There are other strengths available.
People with high blood pressure often do not notice any signs of their condition.
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 to take. Depending on how you
respond to the treatment, your doctor may suggest a higher or lower dose.
•The usual dose 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 your tablets with or without food.
•Swallow the tablet with a glass of water.

If you take more Valsartan/Hydrochlorothiazide 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/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/Hydrochlorothiazide Tablets
Stopping your treatment with Valsartan/Hydrochlorothiazide Tablets may cause your
disease 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 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
•hives and difficulties in breathing.
•difficulty in swallowing

Very rare:
•dizziness

•muscle pain
•tiredness
•tingling or numbness
•blurred vision
•noises (e.g. hissing, buzzing) in ears.

•joint pain.
•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 valsartan or
hydrochlorothiazide when taken alone, but have not been observed with
Valsartan/Hydrochlorothiazide 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, 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,

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

•headache
•sleep disturbances
•sad mood (depression)
•low level of blood platelets (sometimes
with bleeding or bruising underneath the
skin).
•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 get 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 TABLETS
Keep out of the reach and sight of children.
Do not use Valsartan/Hydrochlorothiazide Tablets after the expiry date which is stated
on the pack. The expiry date refers to the last day of that month.
Store below 25ºC. Store in the original package in order to protect from moisture.

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 Tablets contain

•diarrhoea

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)

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

•faintness, fainting on standing up
•impotence.

Do not use any Valsartan/Hydrochlorothiazide Tablets if the pack is damaged or shows
signs of tampering.

Other side effects which may occur:
Uncommon:
•cough
•low blood pressure
•light-headedness
•dehydration (with symptoms of thirst, dry
mouth and tongue, infrequent urination,
dark colored urine, dry skin)

Hydrochlorothiazide
Common:
•itchy rash and other types of rash
•reduced appetite
•mild nausea and vomiting

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 anaemia).
•kidney failure.

The active substances are valsartan and hydrochlorothiazide.
Each film-coated tablet contains 80mg/12.5mg or 160mg/12.5mg or 160mg/25mg
of valsartan/hydrochlorothiazide.
The other ingredients in the tablet core are Microcrystalline cellulose, Croscarmellose
sodium, Sodium lauril sulphate, Hydroxypropycellulose, Silica, colloidal anhydrous, Low
substituted hydroxypropylcellulose, Magnesium stearate
The other ingredients in the tablet film-coat for different strengths are:
Valsartan/hydrochlorothiazide 80mg/12.5mg Tablets
Colourant Opadry II 85F64732 Pink which contains Polyvinyl alcohol, Titanium dioxide
(E171), Macrogol 3350, Talc (E553b), Yellow Iron oxide (E172), Allura Red (E129), Black
Iron oxide (E172).
Valsartan/hydrochlorothiazide 160mg/12.5mg Tablets
Colourant Opadry II 85F66815 Brown which contains Polyvinyl alcohol, Macrogol 3350,
Titanium dioxide (E171), Talc (E553b), Iron Oxide Red (E172), Allura Red (E129), Iron
Oxide Yellow (E172), Iron Oxide Black (E172).
Valsartan/hydrochlorothiazide 160mg/25mg Tablets
Colourant Opadry II 85F66775 Brown which contains Polyvinyl alcohol, Titanium dioxide
(E171), Macrogol 3350, Talc (E553b), Iron Oxide Black (E172), Iron Oxide Red (E172), Iron
Oxide Yellow (E172).
What Valsartan/Hydrochlorothiazide Tablets look like and contents of the pack
Valsartan/Hydrochlorothiazide 80 mg/12.5 mg Film-coated Tablets
Light orange oval coated tablets with "VH 1" on one side and ">" logo on the other side
Valsartan/Hydrochlorothiazide 160 mg/12.5 mg Film-coated Tablets
Dark red oval coated tablets with "VH 2" on one side and ">" logo on the other side
Valsartan/Hydrochlorothiazide 160 mg/25 mg Film-coated Tablets
Brown oval coated tablets with "VH 3" on one side and ">" logo on the other side
The tablets are packed in aluminium foil blisters.
Pack sizes: 14, 28, 30, 56, 90, 98.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Arrow Generics Limited, Unit 2, Eastman Way, Stevenage SG1 4SZ, U.K.
Manufacturer
Arrow Pharm (Malta) Limited, 62 Hal Far Industrial Estate, Birzebbugia, BBG3000,
Malta.
For any information about this medicine, please contact the Marketing Authorisation
Holder.
This leaflet was last approved in 05/2011.

Expand Transcript

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