Valsartan and HCT 35 mg TajP harma : Uses, Side E ffects, I nteractions, Pict ures, War nings, Valsartan and

HCT Dosage & Rx I nfo | Valsartan and HCT U ses, Side E ffe cts - A ntihypertensive, Valsartan and HCT : I ndicati ons, Side E ffects, Warnings, Valsartan and HCT - Drug Infor mation – Taj P harma, Valsa rtan and HCT dose Taj pharma ceuti cals Valsartan and H CT interactions, Taj Phar maceutical Valsartan and HCT contraindi cations, Valsartan and H CT price, Valsartan and HCT Taj P harma Antihy pertensive Tablet s PIL - TajPhar ma Stay connecte d to all updated on Valsartan a nd HCT Taj Pharma ceuti cals Taj pharma ceuti cals Mumbai. Patie nt Information Lea flets, PI L.

Valsartan and Valsartan and HCT contain two active

substances called valsartan and
Hydrochlorthiazide Tablets hydrochlorothiazide. Both of these substances
USP 80mg/12.5mg, help to control high blood pressure
(hypertension).
160mg/12.5mg, 320mg/12.5mg
Taj Pharma  Valsartan belongs to a class of medicines
known as “angiotensin II receptor
(Valsartan and Hydrochlorthiazide) antagonists”, which help to control high
Package leaflet: Information for the user blood pressure. Angiotensin II is a substance
in the body that causes vessels to tighten,
Read all of this leaflet carefully before you thus causing your blood pressure to increase.
start taking this medicine because it contains Valsartan works by blocking the effect of
important information for you. angiotensin II. As a result, blood vessels
relax and blood pressure is lowered.
 Hydrochlorothiazide belongs to a group of
 Keep this leaflet. You may need to read it
again. medicines called thiazide diuretics (also
 If you have any further questions, ask your known as “water tablets”).
doctor, pharmacist or nurse. Hydrochlorothiazide increases urine output,
 This medicine has been prescribed for you which also lowers blood pressure.
only. Do not pass it on to others. It may
harm them, even if their signs of illness are Valsartan and HCT are used to treat high blood
the same as yours. pressure which is not adequately controlled by a
 If you get any side effects, talk to your single substance alone.
doctor, pharmacist or nurse. This includes High blood pressure increases the workload of
any possible side effects not listed in this the heart and arteries. If not treated, it can
leaflet. See section 4. damage the blood vessels of the brain, heart, and
 The full name of this medicine is kidneys, and may result in a stroke, heart failure
Valsartan/Hydrochlorothiazide or kidney failure. High blood pressure increases
80mg/12.5mg, 160mg/12.5mg and the risk of heart attacks. Lowering your blood
160mg/25mg Film-coated Tablets but within pressure to normal reduces the risk of
the leaflet it will be referred to as Valsartan developing these disorders.
and HCT.
2. What you need to know
What is in this leaflet:
before you take
1. What Valsartan and HCT are and what they
are used for Do not take Valsartan and HCT tablets:
2. What you need to know before you take
3. How to take Valsartan and HCT  if you are allergic to valsartan,
4. Possible side effects hydrochlorothiazide, sulphonamide
5. How to store Valsartan and HCT derivatives (substances chemically related to
6. Contents of the pack and other information hydrochlorothiazide) soya oil, peanut oil or
to any of the other ingredients of this
1. What Valsartan and medicine (listed in section 6)
 if you are more than 3 months pregnant (it
HCTare and what they are is also better to avoid Valsartan and HCT in
used for early pregnancy - see pregnancy section)
 Valsartan and HCT 35 mg TajP harma : Uses, Side E ffects, I nteractions, Pict ures, War nings, Valsartan and HCT Dosage & Rx I nfo | Valsartan and HCT U ses, Side E ffe cts - A ntihypertensive, Valsartan and HCT : I ndicati ons, Side E ffects, Warnings, Valsartan and HCT - Drug Infor mation – Taj P harma, Valsa rtan and HCT dose Taj pharma ceuti cals Valsartan and H CT interactions, Taj Phar maceutical Valsartan and HCT contraindi cations, Valsartan and H CT price, Valsartan and HCT Taj P harma Antihy pertensive Tablet s PIL - TajPhar ma Stay connecte d to all updated on Valsartan a nd HCT Taj Pharma ceuti cals Taj pharma ceuti cals Mumbai. Patie nt Information Lea flets, PI L.

 if you have severe liver disease, destruction much of the hormone aldosterone. If this
of the small bile ducts within the liver applies to you, the use of Valsartan and
(biliary cirrhosis) leading to the build up of HCT is not recommended
bile in the liver (cholestasis)  if you have liver or kidney disease
 if you have severe kidney disease  if you have ever experienced swelling of the
 if you are unable to urinate tongue and face caused by an allergic
 if you are treated with an artificial kidney reaction called angioedema when taking
 if the level of potassium or sodium in your another drug (including ACE inhibitors), tell
blood is lower than normal, or if the level your doctor. If these symptoms occur when
of calcium in your blood is higher than you are taking Valsartan and HCT, stop
normal despite treatment taking Valsartan and HCT immediately and
 if you have gout. never take it again. See also section 4
 if you have diabetes or impaired kidney  if you have fever, rash and joint pain, which
function and you are treated with a blood may be signs of systemic lupus
pressure lowering medicine erythematosus (SLE, a so-called
containing aliskiren. autoimmune disease)
 if you have diabetes, gout, high levels of
If any of the above apply to you, do not take cholesterol or fats in your blood
this medicine and speak to your doctor.  if you have had allergic reactions with the
use of other blood pressure-lowering
Warnings and precautions agents of this class (angiotensin II receptor
Talk to your doctor, pharmacist or nurse antagonists) or if you have allergy or
before taking Valsartan and HCT, especially: asthma
 if you experience a decrease in
 if you are taking potassium-sparing vision or eye pain. These could be
medicines, potassium supplements, salt symptoms of an increase of pressure in your
substitutes containing potassium or other eye and can happen within hours to a week
medicines that increase the amount of of taking Valsartan and HCT. This can lead
potassium in your blood such as heparin. to permanent vision loss, if not treated. If
Your doctor may need to check the amount you earlier have had a penicillin or
of potassium in your blood regularly sulphonamide allergy you can be at higher
 if you have low levels of potassium in your risk of developing this
 it may cause increased sensitivity of the
blood
 if you have diarrhoea or severe vomiting skin to sun
 if you are taking any of the
 if you are taking high doses of water
tablets (diuretics) following medicines used to treat high
 if you have severe heart disease blood pressure:
o an ACE-inhibitor (for example
 if you are suffering from heart failure or
have experienced a heart attack. Follow enalapril, lisinopril, ramipril), in
your doctor„s instruction for the starting particular if you have diabetes-
dose carefully. Your doctor may also check related kidney problems
o aliskiren
your kidney function
 if you suffer from a narrowing of the
kidney artery Your doctor may check your kidney function,
 if you have recently received a new kidney blood pressure, and the amount of electrolytes
 if you suffer (e.g. potassium) in your blood at regular
from hyperaldosteronism. This is a disease intervals.
in which your adrenal glands make too
 Valsartan and HCT 35 mg TajP harma : Uses, Side E ffects, I nteractions, Pict ures, War nings, Valsartan and HCT Dosage & Rx I nfo | Valsartan and HCT U ses, Side E ffe cts - A ntihypertensive, Valsartan and HCT : I ndicati ons, Side E ffects, Warnings, Valsartan and HCT - Drug Infor mation – Taj P harma, Valsa rtan and HCT dose Taj pharma ceuti cals Valsartan and H CT interactions, Taj Phar maceutical Valsartan and HCT contraindi cations, Valsartan and H CT price, Valsartan and HCT Taj P harma Antihy pertensive Tablet s PIL - TajPhar ma Stay connecte d to all updated on Valsartan a nd HCT Taj Pharma ceuti cals Taj pharma ceuti cals Mumbai. Patie nt Information Lea flets, PI L.

See also information under the heading “Do not  medicines that may reduce the amount of
take Valsartan and HCT” sodium in your blood, such as
antidepressants, antipsychotics,
Children and adolescents antiepileptics
The use of Valsartan and HCT in children and  medicines for the treatment of gout, such as
adolescents (below the age of 18 years) is not allopurinol, probenecid, sulfinpyrazone
recommended.  therapeutic vitamin D and calcium
supplements
Other medicines and Valsartan and HCT  medicines for the treatment of diabetes (oral
Tell your doctor or pharmacist if you are agents such as metformin or insulins)
taking, have recently taken or might take any  other medicines to lower your blood
other medicines. pressure including methyldopa, ACE
inhibitors (such as enalapril, lisinopril, etc.)
The effect of the treatment can be influenced if or aliskiren (see also information under the
Valsartan and HCT are taken together with headings “Do not take Valsartan and HCT ”
certain other medicines. It may be necessary to and “Warnings and precautions”) medicines
change the dose, to take other precautions, or in to increase blood pressure, such as
some cases to stop taking one of the medicines. noradrenaline or adrenaline
This especially applies to the following  digoxin or other digitalis glycosides
medicines: (medcines used to treat heart problems).
 medicines that may increase blood sugar
 lithium, a medicine used to treat some types levels, such as diazoxide or beta blockers
of psychiatric illness  cytotoxic medicines (used to treat cancer),
 medicines or substances that may increase such as methotrexate or cyclophosphamide
the amount of potassium in your blood.  pain killers and arthritis medicines, such as
These include potassium supplements or salt non-steroidal anti-inflammatory agents
substitutes containing potassium, potassium (NSAIDs), including selective
sparing medicines and heparin cyclooxygenase-2-inhibitors (Cox-2-
 medicines that may reduce the amount of inhibitors) and acetylsalicylic acid >3g
potassium in your blood (hypokalaemia),  muscle relaxing medicines, such as
such as diuretics (water tablets), tubocurarine
corticosteroids (e.g prednisone), some  anti-cholinergic medicines (medicines used
laxatives (e.g castor oil), ACTH (a to treat a variety of disorders such as
hormone), carbenoxolone (used to treat gastrointestinal cramps, urinary bladder
mouth ulcers), amphotericin (an antifungal spasm, asthma, motion sickness, muscular
medicine), penicillin G (an antibiotic), spasms, Parkinson's disease and as an aid to
salicylic acid and derivatives. anaesthesia), such as atropine or biperiden
 Some antibiotics (rifamycin group), a drug  amantadine (a medicine used to prevent
used to protect against transplant rejection influenza and treat Parkinson„s disease)
(ciclosporin) or an antiretroviral drug used  colestyramine and colestipol (medicines
to treat HIV/AIDS infection (ritonavir). used to treat high levels of fats in the blood)
These drugs may increase the effect of  ciclosporin, a medicine used for organ
Valsartan and HCT transplant to avoid organ rejection
 medicines that may induce “torsades de  alcohol, sleeping pills and anaesthetics
pointes” (irregular heart beat), such as (medicines with sleeping or painkilling
antiarrhythmics (medicines used to treat effect used for example during surgery)
heart problems) and some antipsychotics.  iodine contrast media (agents used for
imaging examinations).
 Valsartan and HCT 35 mg TajP harma : Uses, Side E ffects, I nteractions, Pict ures, War nings, Valsartan and HCT Dosage & Rx I nfo | Valsartan and HCT U ses, Side E ffe cts - A ntihypertensive, Valsartan and HCT : I ndicati ons, Side E ffects, Warnings, Valsartan and HCT - Drug Infor mation – Taj P harma, Valsa rtan and HCT dose Taj pharma ceuti cals Valsartan and H CT interactions, Taj Phar maceutical Valsartan and HCT contraindi cations, Valsartan and H CT price, Valsartan and HCT Taj P harma Antihy pertensive Tablet s PIL - TajPhar ma Stay connecte d to all updated on Valsartan a nd HCT Taj Pharma ceuti cals Taj pharma ceuti cals Mumbai. Patie nt Information Lea flets, PI L.

Valsartan and HCTwith food and alcohol If you have been told by your doctor that you
have intolerance to some sugars, contact your
You can take Valsartan and HCTwith or without doctor before taking this medicinal product.
food.
Valsartan and HCTcontain soya oil.
Avoid taking alcohol until you have talked to
your doctor. Alcohol may make your blood If you are allergic to peanut or soya, do not take
pressure fall more and/or increase the risk of you this medicinal product.
becoming dizzy or feeling faint.
Valsartan and HCT 160/12.5mg tablets
Pregnancy and breast-feeding contain Sunset yellow FCF
If you are pregnant or breast-feeding, think you This may cause allergic reactions.
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before 3. How to take Valsartan and
taking this medicine.
HCT
 You must tell your doctor if you think Always take this medicine exactly as your
that you are (or might become) pregnant doctor or pharmacist has told you. This will help
you to get the best results and lower the risk of
Your doctor will normally advise you to stop side effects. Check with your doctor or
taking Valsartan and HCTbefore you become pharmacist if you are not sure.
pregnant or as soon as you know you are People with high blood pressure often do not
pregnant, and will advise you to take another notice any signs of this problem. Many may feel
medicine instead of Valsartan and HCT tablets.
quite normal. This makes it all the more
Valsartan and HCTare not recommended in
important for you to keep your appointments
early pregnancy, and must not be taken when with your doctor even if you are feeling well.
more than 3 months pregnant, as it may cause
serious harm to your baby if it is used after the Your doctor will tell you exactly how many
third month of pregnancy. tablets of Valsartan and HCTto take. Depending
on how you respond to the treatment, your
 Tell your doctor if you are breast-feeding doctor may suggest a higher or lower dose.
or about to start breast-feeding
 The recommended dose of Valsartan
Valsartan and HCTis not recommended for and HCTis one tablet per day
mothers who are breast-feeding, and your doctor  Do not change the dose or stop taking
may choose another treatment for you if you the tablets without consulting your
wish to breast-feed, especially if your baby is doctor
newborn, or was born prematurely.  The medicine should be taken at the
same time each day, usually in the
Driving and using machines morning
Before you drive a vehicle, use tools or operate  You can take Valsartan and HCTwith or
machines or carry out other activities that without food.
require concentration, make sure you know how  Swallow the tablet with a glass of water.
Valsartan and HCTaffect you. Like many other
medicines used to treat high blood pressure, If you take more Valsartan and HCT than
Valsartan and HCTmay occasionally cause you should
dizziness and affect the ability to concentrate.
Valsartan and HCTContains lactose
 Valsartan and HCT 35 mg TajP harma : Uses, Side E ffects, I nteractions, Pict ures, War nings, Valsartan and HCT Dosage & Rx I nfo | Valsartan and HCT U ses, Side E ffe cts - A ntihypertensive, Valsartan and HCT : I ndicati ons, Side E ffects, Warnings, Valsartan and HCT - Drug Infor mation – Taj P harma, Valsa rtan and HCT dose Taj pharma ceuti cals Valsartan and H CT interactions, Taj Phar maceutical Valsartan and HCT contraindi cations, Valsartan and H CT price, Valsartan and HCT Taj P harma Antihy pertensive Tablet s PIL - TajPhar ma Stay connecte d to all updated on Valsartan a nd HCT Taj Pharma ceuti cals Taj pharma ceuti cals Mumbai. Patie nt Information Lea flets, PI L.

If you experience severe dizziness and/or  light-headedness

fainting, lay down and contact your doctor  dehydration (with symptoms of thirst, dry
immediately. mouth and tongue, infrequent urination, dark
coloured urine, dry skin)
If you have accidentally taken too many tablets,  muscle pain
contact your doctor, pharmacist or hospital.
 tiredness
If you forget to take Valsartan and HCT  tingling or numbness
tablets  blurred vision
 noises (e.g. hissing, buzzing) in ears.
If you forget to take a dose, take it as soon as
you remember. However, if it is almost time for Very rare (may affect up to 1 in 10,000 people)
your next dose, skip the dose you missed.
Do not take a double dose to make up for a  dizziness
forgotten dose.  diarrhoea
 joint pain.
If you stop taking Valsartan and HCT tablets
Stopping your treatment with Valsartan and Not known (frequency cannot be estimated
HCTmay cause your high blood pressure to get from the available data)
worse. Do not stop taking your medicine unless
your doctor tells you to.  breathing difficulty
 severely decreased urine output
If you have any further questions on the use  low level of sodium in the blood (sometimes
of this medicine, ask your doctor, pharmacist with nausea, tiredness, confusion, malaise,
or nurse. convulsions)
 low level of potassium in the blood
4. Possible side effects (sometimes with muscle weakness, muscle
Like all medicines, this medicine can cause side spasms, abnormal heart rhythm)
effects, although not everybody gets them.  low level of white cells in the blood (with
symptoms such as fever, skin infections,
Some side effects can be serious and need sore throat or mouth-ulcers due to
immediate medical attention: infections, weakness)
 the level of bilirubin increased in blood
You should see your doctor immediately if you
experience symptoms of angioedema, such as: (which can, in severe cases, trigger yellow
skin and eyes)
 the level of blood urea nitrogen and
 swollen face, tongue or pharynx
creatinine increased in blood (which can
 difficulty in swallowing
indicate abnormal kidney function)
 hives and difficulties in breathing.
 the level of uric acid in blood increased
(which can, in severe cases, trigger gout)
If you get any of these symptoms, stop taking  syncope (fainting).
Valsartan and HCTand contact your doctor
straight away (see also section 2).
The following side effects have been reported
Other side effects include: with products containing valsartan or
hydrochlorothiazide alone:
Uncommon (may affect up to 1 in 100 people)
Valsartan
 cough Uncommon (may affect up to 1 in 100 people)
 low blood pressure
 Valsartan and HCT 35 mg TajP harma : Uses, Side E ffects, I nteractions, Pict ures, War nings, Valsartan and HCT Dosage & Rx I nfo | Valsartan and HCT U ses, Side E ffe cts - A ntihypertensive, Valsartan and HCT : I ndicati ons, Side E ffects, Warnings, Valsartan and HCT - Drug Infor mation – Taj P harma, Valsa rtan and HCT dose Taj pharma ceuti cals Valsartan and H CT interactions, Taj Phar maceutical Valsartan and HCT contraindi cations, Valsartan and H CT price, Valsartan and HCT Taj P harma Antihy pertensive Tablet s PIL - TajPhar ma Stay connecte d to all updated on Valsartan a nd HCT Taj Pharma ceuti cals Taj pharma ceuti cals Mumbai. Patie nt Information Lea flets, PI L.

 spinning sensation  itchy rash and other types of rash

 abdominal pain.  reduced appetite
 mild nausea and vomiting
Not known (frequency cannot be estimated  faintness, fainting on standing up
from the available data)  impotence.

 skin rash with or without itching together Rare (may affect up to 1 in 1,000 people)
with some of the following signs or
symptoms: fever, joint pain, muscle pain,  swelling and blistering of the skin (due to
swollen lymph nodes and/or flu-like increased sensitivity to sun)
symptoms  high level of calcium in the blood
 rash, purplish-red spots, fever, itching  high level of sugar in the blood
(symptoms of inflammation of blood  sugar in the urine
vessels)  worsening of diabetic metabolic state
 low level of blood platelets (sometimes with  constipation, diarrhoea, discomfort of the
unusual bleeding or bruising) stomach or bowels, liver disorders (yellow
 high level of potassium in the blood skin or eyes)
(sometimes with muscle spasms, abnormal  irregular heart beat
heart rhythm)  headache
 allergic reactions (with symptoms such as  sleep disturbances
rash, itching, hives, difficulty breathing or  sad mood (depression)
swallowing, dizziness)  low level of blood platelets (sometimes with
 swelling mainly of the face and throat; rash; bleeding or bruising underneath the skin)
itching  dizziness
 elevation of liver function values  tingling or numbness
 the level of haemoglobin decreased and the  vision disorder
percentage of red cells decreased in the
blood (which both can, in severe cases, Very rare (may affect up to 1 in 10,000 people)
trigger an anaemia).
 kidney failure  inflammation of blood vessels with
 low level of sodium in the blood (which can symptoms such as rash, purplish-red spots,
trigger tiredness, confusion, muscle fever (vasculitis)
twitching and/or convulsions in severe  rash, itching, hives, difficulty breathing or
cases). swallowing , dizziness (hypersensitivity
reactions)
Hydrochlorothiazide  severe skin disease that causes rash, red
skin, blistering of the lips, eyes or mouth
Very common (may affect more than 1 in 10
skin peeling fever (toxic epidermal
people)
necrolysis)
 facial rash associated with joint pain muscle
 low level of potassium in the blood disorder fever (cutaneous lupus
 Increase of lipids in the blood. erythematosus)
 severe upper stomach pain (pancreatitis);
Common (may affect up to 1 in 10 people) lack or low levels of different blood cells
 difficulty breathing with fever, coughing,
 low level of sodium in the blood wheezing, lung infection, breathlessness
 low level of magnesium in the blood (respiratory distress including pneumonitis
 high level of uric acid in the blood and pulmonary oedema)
 Valsartan and HCT 35 mg TajP harma : Uses, Side E ffects, I nteractions, Pict ures, War nings, Valsartan and HCT Dosage & Rx I nfo | Valsartan and HCT U ses, Side E ffe cts - A ntihypertensive, Valsartan and HCT : I ndicati ons, Side E ffects, Warnings, Valsartan and HCT - Drug Infor mation – Taj P harma, Valsa rtan and HCT dose Taj pharma ceuti cals Valsartan and H CT interactions, Taj Phar maceutical Valsartan and HCT contraindi cations, Valsartan and H CT price, Valsartan and HCT Taj P harma Antihy pertensive Tablet s PIL - TajPhar ma Stay connecte d to all updated on Valsartan a nd HCT Taj Pharma ceuti cals Taj pharma ceuti cals Mumbai. Patie nt Information Lea flets, PI L.

 fever, sore throat, more frequent infections pharmacist how to throw away medicines you no
(agranulocytosis) longer use. These measures will help protect the
 pale skin, tiredness, breathlessness, dark environment.
urine (haemolyticanaemia)
 fever, sore throat or mouth ulcers due to 6. Contents of the pack and other information
infections (leucopenia) What Valsartan HCT TajPharma80mg/12.5
 confusion, tiredness, muscle twitching and mg tablets contain
spasm, rapid breathing (hypochloraemic
alkalosis)  The active substances are valsartan and
hydrochlorothiazide.
Not known (frequency connot be estimated Each film-coated tablet contains either
from the available data) o 80mg valsartan and 12.5mg
hydrochlorothiazide
 weakness, bruising and frequent infections
(aplastic anemia) Nature and contents of container
 severely decreased urine output (possible PVC/aluminium blister packs containing 7,28,
signs of renal disorder or renal failure) 30, 50, 100 and 500 tablets per pack.
 decrease in vision or pain in your eyes due
to high pressure (possible signs of acute Not all pack sizes may be marketed.
angle-closure glaucoma) 7. Manufactured In India By:
 rash, red skin, blistering of the lips, eyes or
TAJ PHARMACEUTICALS LTD.
mouth, skin peeling, fever (possible signs of
erythema multiforme) Mumbai, India
 muscle spasm Unit No. 214.Old Bake House,
 fever (pyrexia) Maharashtra chambers of Commerce Lane,
 weakness (asthenia) Fort, Mumbai - 400001
at:Gujarat, INDIA.
Reporting of side effects Customer Service and Product Inquiries:
If you get any side effects, talk to your doctor, 1-800-TRY-FIRST (1-800-222-434 & 1-800-
pharmacist or nurse. This includes any possible 222-825)
side effects not listed in this leaflet. By reporting Monday through Saturday 9:00 a.m. to 7:00 p.m.
side effects you can help provide more EST
information on the safety of this medicine. E-mail: tajgroup@tajpharma.com
5. How to store Valsartan and
HCT
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