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VALSARTAN AND HYDROCHLOROTHIAZIDE 160/25MG FILM-COATED TABLETS

Active substance: VALSARTAN

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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 and Hydrochlorothiazide)
Read a ll o f t his l eaflet carefully b efore y ou s tart t aking t his m edicine because i t contains
important information for you.
• 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 only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• 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.
2.
3.
4.
5.
6.

What Valsartan/Hydrochlorothiazide is and what it is used for
What you need to know before you take Valsartan/Hydrochlorothiazide
How to take Valsartan/Hydrochlorothiazide
Possible side effects
How to store Valsartan/Hydrochlorothiazide
Contents of the pack and other information

1. What Valsartan/ Hydrochlorothiazide is and what it is used for
Valsartan/Hydrochlorothiazide tablets 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.

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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. What you need to know before you take Valsartan/Hydrochlorothiazide
Do not take Valsartan/Hydrochlorothiazide 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/Hydrochlorothiazide tablets (listed in section 6)
• if you are more than 3 months pregnant (it is also better to avoid
Valsartan/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 buoild up of bile in the liver (cholestasis)
• if you have severe kidney disease
• if you are unable to urinate (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 are treated with an artificial kidney
• if you have diabetes or impaired kidney function and you are treated with a blood
pressure lowering medicine called aliskiren.
If any of the above apply to you, do not take this medicine and speak to your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking 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

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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/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/Hydrochlorothiazide
tablets, stop taking Valsartan/Hydrochlorothiazide tablets 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 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
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/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
the use of Valsartan/Hydrochlorothiazide 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. Co-Diovan 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).
if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have
diabetes-releated kidney problems
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- aliskiren
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/Hydrochlorothiazide tablets”.
Other medicines and Valsartan/Hydrochlorothiazide tablets
Tell your doctor of pharmacist if you are taking, have recently taken or might take any other
medicines.
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 diseases



Medicines or substances that may increase the amount of potassium in your blood. These
include potassium supplements or salt substitutes containing potassium, potassiumsparing 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/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/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.
















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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 to treat or prevent
certain illnesses caused by viruses)
Cholestyramine and colestipol (medicines used mainly to treat high levels of fats 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/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 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 t ell you r d octor i f you t hink t hat you ar e (or might b ecome) pregnant
Your doctor will normally advise you to stop taking Valsartan/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/Hydrochlorothiazide tablets.
Valsartan/Hydrochlorothiazide tablets 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.
Valsartan/Hydrochlorothiazide tablets is not recommended for mothers who are breastfeeding, 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

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concentration, make sure you know how Valsartan/Hydrochlorothiazide tablets affects you. Like
many other medicines used to treat high blood pressure, Valsartan/Hydrochlorothiazide tablets
may occasionally cause dizziness and affect the ability to concentrate.
3. How to take Valsartan/Hydrochlorothiazide
Always take this medicine exactly as your doctor or pharmacist has told you. 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 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 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.

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4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
These side effects may occur with certain frequencies, which are defined as follows:

very common: may affect more than 1 in 10 people

common: may affect up to 1 in 10 people

uncommon: may affect up to 1 in 100 people

rare: may affect up to 1 in 1,000 people

very rare: may affect up to 1 in 10,000 people

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
If you ge t an y of t hese s ymptoms, s top t aking V alsartan/Hydrochlorothiazide t ablets an d
contact your doctor straight away (see also section 2 “Warnings and Precautions”).
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
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Not known:

breathing difficulty

severely decreased urine output

low level of sodium in the blood (sometimes with nausea, tiredness, confusion, muscle
twitching and/ or convulsions in severr 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:

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).
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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:



low level of potassium in the blood
increase of fats in the blood

Common:

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 (feeling sick) and vomiting (being sick)

dizziness, fainting on standing up

inability to achieve or maintain erection
Rare:















swelling and blistering of the skin (due to increased sensitivity to sun)
high level of calcium in the blood
high level of sugar in the blood
sugar in the urine
worsening or diabetic metabolic state
constipation, diarrhea, discomfort of the stomach or bowels, liver disorders which can
occur together with yellow skin and eyes
irregular heart beat
headache
sleep disturbances
sad mood (depression)
low level of blood platelets (sometimes with bleeding or bruising underneath the skin)
dizziness
tingling or numbness
vision disorder

Very rare:

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inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever
(vasculitis)
rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity
reactions)
severe skin disease that causes rash, red skin, blistering of the lips, eyes or mouth, skin
peeling, fever (toxic epidermal necrolysis)
facial rash, joint pain, muscle disorder, fever (lupus erythematosus)
severe upper stomach pain (pancreatitis)
difficulty breathing with fever, coughing, wheezing, breathlessness (respiratory distress
including pneumonitis and pulmonary oedema)
fever, sore throat, more frequent infections (agranulocytosis)
pale skin, tiredness, breathlessness, dark urine (haemolytic anaemia)
fever, sore throat or mouth ulcers due to infections (leucopenia)
confusion, tiredness, muscle twitching and spasm, rapid breathing (hypochloraemic
alkalosis)

Not known:








weakness, bruising and frequent infections (aplastic anemia)
severely decreased urine output (possible signs of renal disorder or renal failure)
decrease in vision or pain in your eyes due to high pressure (possible signs of acute
angle-closure glaucoma)
rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (possible signs of
erythema multiforme)
muscle spasm
fever (pyrexia)
weakness (asthenia)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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

5. How to store Valsartan/Hydrochlorothiazide
Keep this medicine out of the sight and reach of children.
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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.
This medicinedoes not require any special temperature storage conditions. Store in the original
package to protect from moisture.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Valsartan/Hydrochlorothiazide tablets contains
Valsartan/Hydrochlorothiazide tablets contains two active ingredients: Valsartan and
Hydrochlorothiazide.
Valsartan/Hydrochlorothiazide tablets are available in three strengths: 80 mg/12.5 mg, 160
mg/12.5 mg and 160 mg/25 mg Film-coated Tablets.
Each Valsartan/Hydrochlorothiazide 80 mg/12.5 mg Film-coated Tablets contains 80 mg
valsartan and 12.5 mg hydrochlorothiazide.
Each Valsartan/Hydrochlorothiazide 160 mg/12.5 mg Film-coated Tablets contains 160 mg
valsartan and 12.5 mg hydrochlorothiazide.
Each Valsartan/Hydrochlorothiazide 160 mg/25 mg, Film-coated Tablets contains 160 mg
valsartan and 25 mg hydrochlorothiazide.
The other ingredients are:
Tablet Core: Microcrystalline cellulose, Crospovidone, Silica Colloidal Anhydrous, Talc,
Magnesium stearate, Starch Pregelatinsed
Tablet Coating: Hydroxypropyl cellulose, Hypromellose, Titanium dioxide (E171).
Besides this Valsartan/Hydrochlorothiazide 160 mg/12.5 mg Film-coated Tablets also contain
yellow iron oxide (E172) and red iron oxide (E172).
What Valsartan/Hydrochlorothiazide tablets look like and contents of the pack
Valsartan/Hydrochlorothiazide 80 mg/12.5 mg tablets are white to off white, film coated, oval
shaped tablets debossed with “VH 1” on one side and plain on the other side. They are supplied
in the blister packs containing 10, 14, 20, 28, 30, 56, 90, 98, 100 and 280 tablets.
Valsartan/Hydrochlorothiazide 160 mg/12.5 mg tablets are peach coloured, film coated, oval
shaped tablets debossed with “VH 2” on one side and plain on the other side. They are supplied
in the blister packs containing 10, 14, 20, 28, 30, 56, 90, 98, 100 and 280 tablets.
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Valsartan/Hydrochlorothiazide 160 mg/25 mg tablets are white to off white, film coated, oval
shaped tablets debossed with “VH 3” on one side and plain on the other side. They are supplied
in the blister packs containing 10, 14, 20, 28, 30, 56, 90, 98, 100 and 280 tablets
Not all pack sizes are marketed.
Marketing Authorisation Holder:
Ranbaxy (UK) Limited
Building 4, Chiswick Park,
566 Chiswick High Road,
London W4 5YE,
United Kingdom
Manufacturers:
Ranbaxy Ireland Limited
Spafield, Cork Road,
Cashel, Co.Tipperary,
Ireland
Basics GmbH
Hemmelrather Weg 201,
D- 51377 Leverkusen,
Germany
Terapia SA
124 Fabricii Street,
400632 Cluj-Napoca,
Romania
This leaflet was revised on September 2014

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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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