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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Valsartan/hydrochlorothiazide 320 mg/12.5 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/hydrochlorothiazide is and what it is used for
2. Before you take Valsartan/hydrochlorothiazide
3. How to take Valsartan/hydrochlorothiazide
4. Possible side effects
5. How to store Valsartan/hydrochlorothiazide
6. Further information
1. WHAT Valsartan/hydrochlorothiazide IS AND WHAT IT IS USED FOR
Valsartan/hydrochlorothiazide film-coated tablets contain medicines called (i) valsartan and (ii) hydrochlorothiazide. Both of these medicines
reduce blood pressure.
(i) Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists”Valsartan helps blood vessels relax and so lowers
.
blood pressure.
(ii) Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as “water tablets”). Hydrochlorothiazide inhibits
the ability of the kidneys to retain fluid and this leads to a reduction in blood pressure.
Valsartan/hydrochlorothiazide is used to treat high blood pressure not adequately controlled by either (i) valsartan or (ii) hydrochlorothiazide
when taken on their own.
People with high blood pressure often do not notice any signs of this problem. Many may feel quite normal. High blood pressure increases the
workload of the heart and may damage arteries. High blood pressure increases the risk of heart attacks, stroke and kidney failure. Lowering your
blood pressure reduces the risk of developing these disorders.
2. Before you take Valsartan/hydrochlorothiazide
Do not take Valsartan/hydrochlorothiazide if you:
• are allergic (hypersensitive) to valsartan, hydrochlorothiazide or chemically-related substances or to any of the other ingredients of Valsartan/
hydrochlorothiazide.
• are more than 3 months pregnant (it is also better to avoid Valsartan/hydrochlorothiazide in early pregnancy - see pregnancy section).
• have severe liver disease.
• have severe kidney disease.
• are unable to pass urine.
• are receiving kidney dialysis
• if, despite treatment, blood tests show that you have either a low sodium, low potassium or high calcium
• have gout.
If any of the above applies to you, do not take this medicine and speak to your doctor.
Take special care with Valsartan/hydrochlorothiazide if you:
• have diarrhoea or severe vomiting.
• are taking high doses of water tablets (diuretics).
• have severe heart disease.
• are known to have a narrowing of the kidney artery.
• have recently received a kidney transplant
• if you have “primary hyperaldosteronism” a hormone imbalance. If this applies to you, the use of Valsartan/hydrochlorothiazide is not
,
recommended.
• have liver or kidney disease.
• have fever, rash and joint pain: these may be signs of systemic lupus erythematosus (SLE, a so-called autoimmune disease).
• have diabetes, gout or high cholesterol.
• have had allergic reactions with the use of similar blood pressure-lowering medicines
• have allergy or asthma.
In addition:
• Your doctor may need to do regular blood checks if
(i) you are taking supplements or medicines that may increase your blood potassium or if
(ii) you are known to have low potassium
• Valsartan/hydrochlorothiazide may cause increased sensitivity of the skin to sun.
• The use of Valsartan/hydrochlorothiazide in children and adolescents (below the age of 18 years) is not recommended.
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 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 mental health
• medicines that may be affected by potassium blood levels e.g. medicines used in mental health e.g. chlorpromazine, haloperidol and
medicines used to control the heart e.g. digoxin, quinidine, amiodarone
• medicines that may affect potassium blood levels e.g. potassium supplements, heparin, steroids used for inflammation, diuretics (water
tablets), some laxatives
• medicines for the treatment of gout e.g. allopurinol
• vitamin D and calcium supplements
• any medicines for the treatment of diabetes (taken by mouth or injection)
• any other medicines to lower your blood pressure
• noradrenaline or adrenaline, medicines used in medical emergencies
• medicines to increase blood sugar levels e.g. diazoxide
• medicines to treat cancer e.g. methotrexate or cyclophosphamide
• pain killers and arthritis medicines known as “NSAIDS”
• medicines used at the time of an operation e.g. anaesthetics, tubocurarine or atropine
• amantadine or biperiden, used in Parkinson’s disease
• cholestyramine and colestipol (medicines used to treat high cholesterol)
• ciclosporin, a medicine used to prevent rejection of an organ transplant
• some antibiotics e.g. tetracyclines
• any sedative, including alcohol (see below)
• carbamazepine, a medicine used to treat epileptic seizures
If you are going to have special x-rays that make use of iodine contrast media then please inform your doctor that you are taking Valsartan/
hydrochlorothiazide.
Taking Valsartan/hydrochlorothiazide with food and drink
You can take Valsartan/hydrochlorothiazide 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 Valsartan/hydrochlorothiazide 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. Valsartan/hydrochlorothiazide is not
recommended in early pregnancy and must not be taken when more than 3 months pregnant because it may cause serious harm to your
baby if taken after the third month of pregnancy.
• Tell your doctor if you are breast-feeding or about to start breast-feeding.
Valsartan/hydrochlorothiazide is not recommended for mothers who are breast-feeding: 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/hydrochlorothiazide affects you. Like many other medicines used to treat high blood pressure, Valsartan/hydrochlorothiazide may
occasionally cause dizziness and affect the ability to concentrate.

Important information about some of the ingredients of Valsartan/hydrochlorothiazide
Valsartan/hydrochlorothiazide contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicinal product.
3. How to take Valsartan/hydrochlorothiazide
Always take Valsartan/hydrochlorothiazide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not
sure.
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 with or without food.
• Swallow the tablet with a glass of water.
If you take more Valsartan/hydrochlorothiazide 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/hydrochlorothiazide
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
Stopping your treatment with Valsartan/hydrochlorothiazide may cause your high blood pressure to rise. 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 can cause side effects, although not everybody gets them. Side effects may occur with
frequencies as shown:
The following side effects (reported with either (i) valsartan or (ii) hydrochlorothiazide alone) are important and will require immediate action if
you experience them. You should stop taking Valsartan/hydrochlorothiazide and see your doctor immediately if the following symptoms occur:
Very rare: affects less than 1 user in 10,000
• swelling of the face, tongue and windpipe which can cause great difficulty in breathing
Not known: frequency cannot be estimated from the available data
• severe, extensive, blistering skin rash
The following side effects have been reported with Valsartan/hydrochlorothiazide:
Uncommon: affects 1 to 10 users in 1,000
• cough
• low blood pressure
• light-headedness
• dehydration (causing thirst and dark-coloured urine)
• muscle pains
• tiredness
• tingling or numbness
• blurred vision
• tinnitus (noises in ears)
Very rare: affects less than 1 user in 10,000
• dizziness
• diarrhoea
• joint pains
Not known: frequency cannot be estimated from the available data
• breathing difficulties
• fever, increased frequency of infections
• jaundice
• kidney problems
• changes in blood test results of salt balance (disturbed salt balance may be associated with nausea, tiredness, muscle weakness, muscle
spasms, confusion, convulsions)
• fainting
The following side effects have been reported with either (i) valsartan or (ii) hydrochlorothiazide alone but have not been observed with
Valsartan/hydrochlorothiazide:
Common: affects 1 to 10 users in 100
• skin rash, hives, itch
• reduced appetite
• nausea, vomiting
• reduced sexual performance
• faintness on standing
Uncommon: affects 1 to 10 users in 1,000
• spinning sensation
• abdominal discomfort
Rare: affects 1 to 10 users in 10,000
• skin sensitive to sunlight causing discomfort and rash
• constipation
• irregular heart beat
• headache
• sleep disturbances
• depressed mood
• unexpected bleeding or bruising
• liver problems
Very rare: affects less than 1 user in 10,000
• Anaemia (may cause pale complexion, breathlessness)
• Allergy reactions
• Inflammation of the pancreas causing pain and vomiting
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/hydrochlorothiazide
Keep out of the reach and sight of children.
Do not store above 30°C.
Store in the original package in order to protect from light and moisture.
Do not use Valsartan/hydrochlorothiazide after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of
that month.
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 contains
• The active substances are valsartan and hydrochlorothiazide.
Each Valsartan/hydrochlorothiazide 320 mg/12.5 mg film-coated tablet contains 320 mg valsartan and 12.5 mg hydrochlorothiazide.
• The other ingredients are cellulose, microcrystalline, lactose monohydrate, magnesium stearate, croscarmellose sodium, povidone and silica,
colloidal anhydrous in the tablet core and hypromellose, titanium dioxide (E171), macrogol, iron oxide red (E172) in the film coating.
What Valsartan/hydrochlorothiazide looks like and contents of the pack
Valsartan/hydrochlorothiazide 320 mg/12.5 mg film-coated tablets are pink, oval, biconvex.
Valsartan/hydrochlorothiazide 320 mg/12.5 mg film-coated tablets are available in boxes of 10, 14, 28, 30, 56, 60, 84, 90, 98, 100, 280, 56 x 1,
98 x 1 and 280 x 1 film-coated tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder: Krka d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturers: Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany.
Distributed by: Consilient Health (UK) Ltd, 500 Chiswick High Road, London, W4 5RG.
This leaflet was last revised in November 2010
P00XX

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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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