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VALSARTAN HYDROCHLOROTHIAZIDE 160/12.5MG FILM-COATED TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / VALSARTAN

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Package leaflet: Information for the patient

Valsartan/Hydrochlorothiazide 80mg/12.5mg,
160mg/12.5mg and 160mg/25mg
Film-coated Tablets
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
• The full name of this medicine is Valsartan/Hydrochlorothiazide
80mg/12.5mg, 160mg/12.5mg and 160mg/25mg Film-coated Tablets
but within the leaflet it will be referred to as Valsartan HCT tablets.

What is in this leaflet:
1 What Valsartan HCT tablets are and what they are
used for
2 What you need to know before you take
3 How to take Valsartan HCT tablets
4 Possible side effects
5 How to store Valsartan HCT tablets
6 Contents of the pack and other information

1 What Valsartan HCT tablets are and what they are used for

Valsartan HCT 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.
Valsartan HCT 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
Do not take Valsartan HCT tablets:

• if you are allergic to valsartan, hydrochlorothiazide, sulphonamide derivatives
(substances chemically related to hydrochlorothiazide) soya oil, peanut oil or to
any of the other ingredients of this medicine (listed in section 6)
• if you are more than 3 months pregnant (it is also better to avoid Valsartan HCT
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 build up of bile in the liver (cholestasis)
• 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 you have diabetes or impaired kidney function and you are treated with a
blood pressure lowering medicine containing 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, pharmacist or nurse before taking Valsartan HCT tablets,
especially:
• 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 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 HCT 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 HCT tablets, stop taking Valsartan HCT tablets immediately and never
take it again. See also section 4
• 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 pressurelowering 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 HCT tablets. This can lead to permanent vision loss, if not treated.

If you earlier have a penicillin or sulphonamide allergy you can be at higher risk
of developing this
• it may cause increased sensitivity of the skin to sun
• 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-related kidney problems
- 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 HCT tablets”.

Children and adolescents
The use of Valsartan HCT tablets in children and adolescents (below the age of 18
years) is not recommended.

Other medicines and Valsartan HCT tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The effect of the treatment can be influenced if Valsartan HCT 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 or substances that may increase the amount of potassium in your
blood. These include potassium supplements or salt substitutes containing
potassium, potassium sparing medicines and heparin
• medicines that may reduce the amount of potassium in your blood, such
as diuretics (water tablets), corticosteroids, some 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 HCT 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 HCT tablets ” and “Warnings and
precautions”)
• medicines to increase blood pressure, such as noradrenaline or adrenaline
• digoxin or other digitalis glycosides (medcines 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
• pain killers and arthritis medicines, such as non-steroidal anti-inflammatory
agents (NSAIDs), including selective cyclooxygenase-2-inhibitors (Cox-2inhibitors) and acetylsalicylic acid >3g
• 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), such as
atropine or biperiden
• amantadine (a medicine used to prevent influenza and treat Parkinson‘s disease)
• colestyramine and colestipol (medicines used 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)
• carbamazepine, a medicine used to treat seizure conditions
• iodine contrast media (agents used for imaging examinations).

Valsartan HCT tablets with food and alcohol
You can take Valsartan HCT 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
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking this 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 HCT 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 HCT tablets. Valsartan HCT
tablets are 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 HCT tablets is not recommended for mothers who are breast-feeding,
and your doctor may choose another treatment for you if you wish to breastfeed, 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 Valsartan HCT tablets
affect you. Like many other medicines used to treat high blood pressure, Valsartan
HCT tablets may occasionally cause dizziness and affect the ability to concentrate.

Continued top of next column
AAAH0614

Continued over page

Valsartan HCT 80mg/12.5mg, 160mg/12.5mg & 160mg/25mg PIL - UK
item no: AAAH0614

dimensions: 190 x 380

print proof no: 8

pharmacode:

origination date: 16.07.14

min pt size: 7

1. Black
2.
3.
4.
5.
6.

originated by: R.Paul
approved for print/date

colours/plates:

revision date: 12.12.14

Technical Approval

revised by: R.Paul

date sent: 16.07.14

supplier: Actavis Bulgaria Dupnitsa

technically app. date: 17.07.14

Non Printing Colours
1.
2.
3.

Valsartan HCT tablets Contains lactose

Hydrochlorothiazide

If you have been told by your doctor that you have intolerance to some sugars,
contact your doctor before taking this medicinal product.

Valsartan HCT tablets contain soya oil
If you are allergic to peanut or soya, do not take this medicinal product.

Valsartan HCT 160/12.5mg tablets contain Sunset yellow FCF (E110)
This may cause allergic reactions.

3 How to take Valsartan HCT

Always take this medicine exactly as your doctor or pharmacist has told you. This
will help you to get the best results and lower the risk of side effects. 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 HCT tablets to take.
Depending on how you respond to the treatment, your doctor may suggest a
higher or lower dose.
• T he recommended dose of Valsartan HCT tablets 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 HCT tablets with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartan HCT 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 HCT 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 HCT tablets
Stopping your treatment with Valsartan HCT 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, pharmacist or nurse.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody
gets them.

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 get any of these symptoms, stop taking Valsartan HCT and contact your
doctor straight away (see also section 2).

Other side effects include:

Uncommon: (may affect up to 1 in 100 people)
• cough
• low blood pressure
• light-headedness
• dehydration (with symptoms of thirst, dry mouth and tongue, infrequent
urination, dark coloured urine, dry skin)
• muscle pain
• tiredness
• tingling or numbness
• blurred vision
• noises (e.g. hissing, buzzing) in ears.

Very common (may affect more than 1 in 10 people)
• low level of potassium in the blood
• Increase of lipids in the blood.
Common (may affect up to 1 in 10 people)
• 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 and vomiting
• faintness, fainting on standing up
• impotence.
Rare (may affect up to 1 in 1,000 people)
• 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 of diabetic metabolic state
• constipation, diarrhoea, 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)
• dizziness
• tingling or numbness
• vision disorder
Very rare (may affect up to 1 in 10,000 people)
• 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 associated with joint pain, muscle disorder, fever (cutaneous lupus
erythematosus)
• severe upper stomach pain (pancreatitis); lack or low levels of different blood cells
• difficulty breathing with fever, coughing, wheezing, lung infection, 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 (frequency connot be estimated from the available data)
• 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, pharmacist or nurse. 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 HCT tablets

Keep this medicine out of the sight and reach of children.
Blister packs: Do not store above 30°C.
Do not use this medicine after the expiry date which is stated on the carton, blister
as EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.

Very rare: (may affect up to 1 in 10,000 people)
• dizziness
• diarrhoea
• joint pain.
Not known: (frequency cannot be estimated from the available data)
• 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).

6 C
 ontents of the pack and other information
What Valsartan HCT tablets contain

The following side effects have been reported with products
containing valsartan or hydrochlorothiazide alone:

T he active substances are valsartan and hydrochlorothiazide.
Each film-coated tablet contains either
- 80mg valsartan and 12.5mg hydrochlorothiazide
- 160mg valsartan and 12.5mg hydrochlorothiazide
- 160mg valsartan and 25mg hydrochlorothiazide
The other ingredients are: tablet core: Microcrystalline Cellulose, Lactose
Monohydrate, Croscarmellose Sodium, Povidone K29-K32, Talc, Magnesium
Stearate, Colloidal Anhydrous Silica; film-coat:
- 80/12.5mg tablets; Polyvinyl Alcohol, Talc, Titanium Dioxide (E171), Macrogol
3350, Lecithin (contains soya oil) (E322), Iron Oxide Red (E172), Iron Oxide
Yellow (E172), Iron Oxide Black (E172).
- 160/12.5mg tablets; Polyvinyl Alcohol, Talc , Macrogol 3350, Titanium Dioxide
(E171), Iron Oxide Red (E172), Sunset Yellow FCF Aluminium Lake (E110),
Lecithin (contains soya oil) (E322).
- 160/25mg tablets; Polyvinyl Alcohol, Talc , Titanium Dioxide (E171), Macrogol
3350, Iron Oxide Yellow (E172), Lecithin (contains soya oil) (E322), Iron Oxide
Red (E172), Iron Oxide Black (E172).

Valsartan

What Valsartan HCT tablets look like and contents of the pack

Uncommon: ( may affect up to 1 in 100 people)
• spinning sensation
• abdominal pain.
Not known: (frequency cannot be estimated from the available data)
• 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, 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
• low level of sodium in the blood (which can trigger tiredness, confusion, muscle
twitching and/or convulsions in severe cases).








Valsartan HCT 80mg/12.5mg Film-coated Tablets: Pink, oval, biconvex film-coated
tablets, 11 x 5.8 mm, marked ‘V’ on one side and ‘H’ on the other.
Valsartan HCT 160mg/12.5mg Film-coated Tablets: Red, oval, biconvex film-coated
tablets, 15 x 6 mm, marked ‘V’ on one side and ‘H’ on the other.
Valsartan HCT 160mg/25mg Film-coated Tablets: Orange, oval, biconvex filmcoated tablets, 15 x 6 mm, marked ‘V’ on one side and ‘H’ on the other.

Contents of the pack:
28 tablets

Marketing Authorisation Holder
Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland
Manufacturer
Balkanpharma Dupnitsa AD, 3, Samokovsko Shosse Str., 2600 Dupnitsa, Bulgaria
This leaflet was last revised in December 2014.

If you would like a leaflet with larger text,
please contact 01271 385257.

Actavis, Barnstaple, EX32 8NS, UK

Continued top of next column
AAAH0614

Valsartan HCT 80mg/12.5mg, 160mg/12.5mg & 160mg/25mg PIL - UK
item no: AAAH0614

dimensions: 190 x 380

print proof no: 8

pharmacode:

origination date: 16.07.14

min pt size: 7

1. Black
2.
3.
4.
5.
6.

originated by: R.Paul
approved for print/date

colours/plates:

revision date: 12.12.14

Technical Approval

revised by: R.Paul

date sent: 16.07.14

supplier: Actavis Bulgaria Dupnitsa

technically app. date: 17.07.14

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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