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 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:
What /Product/ is and what it is used for
Before you take /Product/
How to take /Product/
Possible side effects
How to store /Product/
Further information

1. WHAT /PRODUCT/ IS AND WHAT IT IS USED FOR
/Product/ 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.
/Product/ 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 /PRODUCT/
Do not take /Product/ if you:
• are allergic (hypersensitive) to valsartan, hydrochlorothiazide or chemicallyrelated substances or to any of the other ingredients of /Product/.
• are more than 3 months pregnant (it is also better to avoid /Product/ 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 apply to you, do not take this medicine and speak to your doctor.
Take special care with /Product/ 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 /Product/ 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
• /Product/ may cause increased sensitivity of the skin to sun.
• The use of /Product/ 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 /Product/ 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. anaeshetics, 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 /Product/
Taking /Product/ with food and drink
You can take /Product/ 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 /Product/ before you become
pregnant or as soon as you know you are pregnant and will advise you to take
another medicine instead of /Product/. /Product/ 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.
/Product/ 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 /Product/ affects you. Like many other
medicines used to treat high blood pressure, /Product/ may occasionally cause dizziness
and affect the ability to concentrate.
Important information about some of the ingredients of /Product/
[To be completed nationally]

3. HOW TO TAKE /PRODUCT/
Always take /Product/ 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 /Product/ to take. Depending on
how you respond to the treatment, your doctor may suggest a higher or lower dose.






The usual dose of /Product/ 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 /Product/ with or without food.
Swallow the tablet with a glass of water.

If you take more /Product/ 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 /Product/
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 /Product/
Stopping your treatment with /Product/ 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, /Product/ 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 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 /Product/:
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 /Product/:
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 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.
• This medicinal product does not require any special temperature storage conditions.
• Store in the original package to protect from moisture.
• Do not use any Valsartan/Hydrochlorothiazide tablets 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 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.
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
following names:>
<{Name of the Member State}> < {Name of the medicinal product}>
<{Name of the Member State}> < {Name of the medicinal product}>
This leaflet was revised on 18th November, 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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