Valsartan Tablets SMPC Taj Pharmaceuticals

Valsartan 40mg, 80 mg, 160 mg, 32 0mg Ta blets TajPhar ma : Us es, Side E ffe cts, Intera ctions, Picture
s, Warni ngs, Valsartan Dosage & Rx Info | Valsartan Use s, Side Effe cts - Antihypertensive, Valsartan : Indications, Side E ffe cts, War nings, Valsartan - Dr ug Information - Taj Pharma , Valsartan dose Taj phar mace uticals Valsartan interacti ons, Taj P harma ceuti cal Valsartan contraindications, Valsart an pri ce, Valsartan TajPhar ma Antihyperten sive Tablets SmPC - TajPhar ma Stay connecte d to all update d on Valsartan Taj P harma ceutical s Taj phar mace uticals M umbai. Patient Infor mation Leaflets, S mP C.
Valsartan Tablets USP Hypertension (40 mg only)
40mg/80mg/160mg/320mg Treatment of hypertension in children and

adolescents 6 to 18 years of age.
1. Name of the medicinal Hypertension (80 mg, 160 mg and 320 mg only)
product Treatment of essential hypertension in adults,
Valsartan Tablets USP 40mg Taj Pharma and hypertension in children and adolescents 6
Valsartan Tablets USP 80mg Taj Pharma to 18 years of age.
Valsartan Tablets USP 160mg Taj Pharma Recent myocardial infarction (40 mg, 80 mg and
Valsartan Tablets USP 320mg Taj Pharma 160 mg only)
2. Qualitative and quantitative Treatment of clinically stable adult patients with
symptomatic heart failure or asymptomatic left
composition ventricular systolic dysfunction after a recent
a) Each film coated tablet contains: (12 hours-10 days) myocardial infarction (see
Valsartan USP 40mg sections 4.4 and 5.1).
Excipients q.s. Heart failure (40 mg, 80 mg and 160 mg only)
Colour: Yellow Oxide Of Iron & Titanium
Dioxide USP Treatment of adult patients with symptomatic
heart failure when ACE-inhibitors are not
b) Each film coated tablet contains: tolerated or in beta-blocker intolerant patients as
Valsartan USP 80mg add-on therapy to ACE-inhibitors when
Excipients q.s. mineralocorticoid receptor antagonists cannot be
Colour: Yellow Oxide Of Iron & Titanium used (see sections 4.2, 4. 4, 4.5 and 5.1).
Dioxide USP
4.2 Posology and method of administration
c) Each film coated tablet contains: Posology
Valsartan USP 160mg
Excipients q.s. Hypertension (only 80 mg, 160 mg and 320 mg)
Colour: Yellow Oxide Of Iron & Titanium
The recommended starting dose of Valsartan is
Dioxide USP
80 mg once daily. The antihypertensive effect is
d) Each film coated tablet contains: substantially present within 2 weeks, and
Valsartan USP 320mg maximal effects are attained within 4 weeks. In
Excipients q.s. some patients whose blood pressure is not
Colour: Yellow Oxide Of Iron & Titanium adequately controlled, the dose can be increased
Dioxide USP to 160 mg and to a maximum of 320 mg.
For the full list of excipients, see section 6.1. Valsartan may also be administered with other
antihypertensive agents (see sections 4.3, 4.4,
3. Pharmaceutical form 4.5 and 5.1). The addition of a diuretic such as
hydrochlorothiazide will decrease blood
Film-coated tablet pressure even further in these patients.
Yellow, oval-shaped, biconvex, film-coated Recent myocardial infarction (only 40 mg, 80
tablets. mg and 160 mg)
4. Clinical particulars In clinically stable patients, therapy may be
initiated as early as 12 hours after a myocardial
4.1 Therapeutic indications infarction.
Valsartan 40mg, 80 mg, 160 mg, 32 0mg Ta blets TajPhar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warni ngs, Valsartan Dosage & Rx Info | Valsartan Use s, Side Effe cts - Antihypertensive, Valsartan : Indications, Side E ffe cts, War nings, Valsartan - Dr ug Information - Taj Pharma , Valsartan dose Taj phar mace uticals Valsartan interacti ons, Taj P harma ceuti cal Valsartan contraindications, Valsart an pri ce, Valsartan TajPhar ma Antihyperten sive Tablets SmPC - TajPhar ma Stay connecte d to all update d on Valsartan Taj P harma ceutical s Taj phar mace uticals M umbai. Patient Infor mation Leaflets, S mP C.
After an initial dose of 20 mg twice daily, Renal impairment

Valsartan should be titrated to 40 mg, 80 mg,
and 160 mg twice daily over the next few weeks. No dose adjustment is required for adult patients
The starting dose is provided by the 40 mg with a creatinine clearance >10 ml/min (see
divisible tablet. sections 4.4 and 5.2). Concomitant use of
Valsartan with aliskiren is contraindicated in
The target maximum dose is 160 mg twice daily. patients with renal impairment (GFR < 60
In general, it is recommended that patients mL/min/1.73 m2) (see section 4.3).
achieve a dose level of 80 mg twice daily by two
weeks after treatment initiation and that the Diabetes Mellitus
target maximum dose, 160 mg twice daily, be Concomitant use of Valsartan with aliskiren is
achieved by three months, based on the patient's contraindicated in patients with diabetes mellitus
tolerability. If symptomatic hypotension or renal (see section 4.3).
dysfunction occur, consideration should be
given to a dosage reduction. Hepatic impairment
Valsartan may be used in patients treated with Valsartan is contraindicated in patients with
other post-myocardial infarction therapies, e.g. severe hepatic impairment, biliary cirrhosis and
thrombolytics, acetylsalicylic acid, beta in patients with cholestasis (see sections 4.3, 4.4
blockers, statins, and diuretics. The combination and 5.2). In patients with mild to moderate
with ACE inhibitors is not recommended (see hepatic impairment without cholestasis, the dose
sections 4.4 and 5.1). of Valsartan should not exceed 80 mg.
Evaluation of post-myocardial infarction Paediatric population

patients should always include assessment of Paediatric hypertension
renal function.
Children and adolescents 6 to 18 years of age
Heart failure (only 40 mg, 80 mg and 160 mg)
The initial dose is 40 mg once daily for children
The recommended starting dose of Valsartan is weighing below 35 kg and 80 mg once daily for
40 mg twice daily. Uptitration to 80 mg and 160 those weighing 35 kg or more. The dose should
mg twice daily should be done at intervals of at be adjusted based on blood pressure response.
least two weeks to the highest dose, as tolerated For maximum doses studied in clinical trials
by the patient. Consideration should be given to please refer to the table below.
reducing the dose of concomitant diuretics. The
maximum daily dose administered in clinical Doses higher than those listed have not been
trials is 320 mg in divided doses. studied and are therefore not recommended.
Valsartan may be administered with other heart Weight Maximum dose studied in clinical
failure therapies. However, the triple trials
combination of an ACE-inhibitor, Valsartan and ≥18 kg to <35 80 mg
a beta-blocker or a potassium-sparing diuretic is kg
not recommended (see sections 4.4 and 5.1). ≥35 kg to <80 160 mg
Evaluation of patients with heart failure should kg
always include assessment of renal function. ≥80 kg to 320 mg
≤160 kg
Additional information on special populations
Children less than 6 years of age
Elderly
Available data are described in sections 4.8, 5.1
No dose adjustment is required in elderly and 5.2. However safety and efficacy of
patients.
Valsartan in children aged 1 to 6 years have not - The concomitant use of Valsartan with
been established. aliskiren-containing products is contraindicated
in patients with diabetes mellitus or renal
Use in paediatric patients aged 6 to 18 years impairment (GFR < 60 ml/min/1.73 m2) (see
with renal impairment sections 4.5 and 5.1).
Use in paediatric patients with a creatinine
4.4 Special warnings and precautions for use
clearance <30 ml/min and paediatric patients Hyperkalaemia
undergoing dialysis has not been studied,
therefore Valsartan is not recommended in these Concomitant use with potassium supplements,
patients. No dose adjustment is required for potassium-sparing diuretics, salt substitutes
paediatric patients with a creatinine clearance containing potassium, or other agents that may
>30 ml/min. Renal function and serum increase potassium levels (heparin, etc.) is not
potassium should be closely monitored (see recommended.
sections 4.4 and 5.2).
Monitoring of potassium should be undertaken
Use in paediatric patients aged 6 to 18 years as appropriate.
with hepatic impairment
Impaired renal function
As in adults, Valsartan is contraindicated in
paediatric patients with severe hepatic There is currently no experience on the safe use
impairment, biliary cirrhosis and in patients with in patients with a creatinine clearance <10
cholestasis (see sections 4.3, 4.4 and 5.2). There ml/min and patients undergoing dialysis,
therefore Valsartan should be used with caution
is limited clinical experience with Valsartan in
paediatric patients with mild to moderate hepatic in these patients. No dose adjustment is required
impairment. The dose of Valsartan should not for adult patients with a creatinine clearance >10
ml/min (see sections 4.2 and 5.2).
exceed 80 mg in these patients.
Paediatric heart failure and recent myocardial The concomitant use of ARBs – including
infarction Valsartan – or of ACEIs with aliskiren is
contraindicated in patients with renal
Valsartan is not recommended for the treatment impairment (GFR < 60 mL/min/1.73 m2) (see
of heart failure or recent myocardial infarction in sections 4.3 and 4.5).
children and adolescents below the age of 18
Hepatic impairment
years due to the lack of data on safety and
efficacy. In patients with mild to moderate hepatic
Method of administration impairment without cholestasis, Valsartan
should be used with caution (see sections 4.2
Valsartan may be taken independently of a meal and 5.2).
and should be administered with water.
Sodium- and/or volume-depleted patients
4.3 Contraindications
In severely sodium-depleted and/or volume-
- Hypersensitivity to the active substance or to
any of the excipients listed in section 6.1. depleted patients, such as those receiving high
doses of diuretics, symptomatic hypotension
- Severe hepatic impairment, biliary cirrhosis may occur in rare cases after initiation of
and cholestasis. therapy with Valsartan . Sodium and/or volume
depletion should be corrected before starting
- Second and third trimester of pregnancy (see treatment with Valsartan , for example by
sections 4.4 and 4.6). reducing the diuretic dose.
Renal artery stenosis
In patients with bilateral renal artery stenosis or The combination of captopril and Valsartan has
stenosis to a solitary kidney, the safe use of shown no additional clinical benefit, instead the
Valsartan has not been established. risk for adverse events increased compared to
treatment with the respective therapies (see
Short-term administration of Valsartan to sections 4.2 and 5.1). Therefore, the
twelve patients with renovascular hypertension combination of Valsartan with an ACE inhibitor
secondary to unilateral renal artery stenosis did is not recommended.
not induce any significant changes in renal
haemodynamics, serum creatinine, or blood urea Caution should be observed when initiating
nitrogen (BUN). However, other agents that therapy in post-myocardial infarction patients.
affect the renin-angiotensin system may increase Evaluation of post-myocardial infarction
blood urea and serum creatinine in patients with patients should always include assessment of
unilateral renal artery stenosis, therefore renal function (see section 4.2).
monitoring of renal function is recommended
when patients are treated with Valsartan . Use of Valsartan in post-myocardial infarction
patients commonly results in some reduction in
Kidney transplantation blood pressure, but discontinuation of therapy
because of continuing symptomatic hypotension
There is currently no experience on the safe use is not usually necessary provided dosing
of Valsartan in patients who have recently instructions are followed (see section 4.2).
undergone kidney transplantation.
Heart Failure (only 40 mg, 80 mg and 160 mg)
Primary hyperaldosteronism
The risk of adverse reactions, especially
Patients with primary hyperaldosteronism hypotension, hyperkalaemia and decreased renal
should not be treated with Valsartan as their function (including acute renal failure), may
renin-angiotensin system is not activated.
increase when Valsartan is used in combination
Aortic and mitral valve stenosis, obstructive with an ACE-inhibitor. In patients with heart
hypertrophic cardiomyopathy failure, the triple combination of an ACE
inhibitor, a beta-blocker and Valsartan has not
As with all other vasodilators, special caution is shown any clinical benefit (see section 5.1). This
indicated in patients suffering from aortic or combination apparently increases the risk for
mitral stenosis, or hypertrophic obstructive adverse events and is therefore not
cardiomyopathy (HOCM). recommended. Triple combination of an ACE-
Pregnancy inhibitor, a mineralocorticoid receptor antagonist
and Valsartan is also not recommended. Use of
Angiotensin II Receptor Antagonists (AIIRAs) these combinations should be under specialist
should not be initiated during pregnancy. Unless supervision and subject to frequent close
continued AIIRAs therapy is considered monitoring of renal function, electrolytes and
essential, patients planning pregnancy should be blood pressure.
changed to alternative anti-hypertensive
treatments which have an established safety Caution should be observed when initiating
profile for use in pregnancy. When pregnancy is therapy in patients with heart failure. Evaluation
diagnosed, treatment with AIIRAs should be of patients with heart failure should always
stopped immediately, and, if appropriate, include assessment of renal function (see section
alternative therapy should be started (see 4.2).
sections 4.3 and 4.6). Use of Valsartan in patients with heart failure
Recent myocardial infarction (only 40 mg, 80 commonly results in some reduction in blood
mg and 160 mg) pressure, but discontinuation of therapy because
of continuing symptomatic hypotension is not
usually necessary provided dosing instructions or aliskiren increases the risk of hypotension,
are followed (see section 4.2). hyperkalaemia and decreased renal function
(including acute renal failure). Dual blockade of
In patients whose renal function may depend on RAAS through the combined use of ACE-
the activity of the renin-angiotensin-aldosterone- inhibitors, angiotensin II receptor blockers or
system (e.g patients with severe congestive heart aliskiren is therefore not recommended (see
failure), treatment with ACE-inhibitors has been sections 4.5 and 5.1).
associated with oliguria and/or progressive
azotaemia and in rare cases with acute renal If dual blockade therapy is considered absolutely
failure and/or death. As Valsartan is an necessary, this should only occur under
angiotensin II receptor blocker, it cannot be specialist supervision and subject to frequent
excluded that the use of Valsartan may be close monitoring of renal function, electrolytes
associated with impairment of the renal function. and blood pressure.
ACE-inhibitors and angiotensin II receptor ACE-inhibitors and angiotensin II receptor
blockers should not be used concomitantly in blockers should not be used concomitantly in
patients with diabetic nephropathy. patients with diabetic nephropathy.
Other conditions with stimulation of the renin- Paediatric population
angiotensin system
Renal function
In patients whose renal function may depend on
the activity of the renin-angiotensin system (e.g. Use in paediatric patients with a creatinine
clearance <30 ml/min and paediatric patients
patients with severe congestive heart failure),
treatment with angiotensin converting enzyme undergoing dialysis has not been studied,
inhibitors has been associated with oliguria therefore Valsartan is not recommended in these
and/or progressive azotaemia and in rare cases patients. No dose adjustment is required for
paediatric patients with a creatinine clearance
with acute renal failure and/or death. As
>30 ml/min (see sections 4.2 and 5.2). Renal
Valsartan is an angiotensin II antagonist, it
function and serum potassium should be closely
cannot be excluded that the use of Valsartan
may be associated with impairment of the renal monitored during treatment with Valsartan . This
function. applies particularly when Valsartan is given in
the presence of other conditions (fever,
History of angioedema dehydration) likely to impair renal function. The
concomitant use of ARBs – including Valsartan
Angioedema, including swelling of the larynx – or of ACEIs with aliskiren is contraindicated
and glottis, causing airway obstruction and/or in patients with renal impairment (GFR < 60
swelling of the face, lips pharynx, and/or tongue mL/min/1.73 m2. ) (see sections 4.3 and 4.5).
has been reported in patients treated with
Valsartan ; some of these patients previously Hepatic function
experienced angioedema with other drugs
including ACE inhibitors. As in adults, Valsartan is contraindicated in
paediatric patients with severe hepatic
Valsartan should be immediately discontinued impairment, biliary cirrhosis and in patients with
in patients who develop angioedema, and cholestasis (see sections 4.3 and 5.2). There is
Valsartan should not be re-administered. limited clinical experience with Valsartan in
paediatric patients with mild to moderate hepatic
Dual Blockade of the Renin-Angiotensin- impairment. The dose of Valsartan should not
Aldosterone System (RAAS) exceed 80 mg in these patients.
There is evidence that the concomitant use of Valsartan Film-coated Tablets contain sodium
ACE-inhibitors, angiotensin II receptor blockers
This medicine contains less than 1 mmol sodium Non-steroidal anti-inflammatory medicines
(23 mg) per dosage unit, that is to say essentially (NSAIDs), including selective COX-2 inhibitors,
'sodium-free'. acetylsalicylic acid >3 g/day), and non-selective
NSAIDs
4.5 Interaction with other medicinal products
and other forms of interaction When angiotensin II antagonists are
Clinical trial data has shown that dual blockade administered simultaneously with NSAIDs,
of the renin-angiotensin-aldosterone-system attenuation of the antihypertensive effect may
(RAAS) through the combined use of ACE- occur. Furthermore, concomitant use of
inhibitors, angiotensin II receptor blockers or angiotensin II antagonists and NSAIDs may lead
aliskiren is associated with a higher frequency of to an increased risk of worsening of renal
adverse events such as hypotension, function and an increase in serum potassium.
hyperkalaemia and decreased renal function Therefore, monitoring of renal function at the
(including acute renal failure) compared to the beginning of the treatment is recommended, as
use of a single RAAS-acting agent (see sections well as adequate hydration of the patient.
4.3, 4.4 and 5.1).
Transporters
Dual blockade of the Renin-Angiotensin –
System (RAS) with ARBs, ACEIs, or aliskiren: In vitro data indicates that Valsartan is a
substrate of the hepatic uptake transporter
Concomitant use of angiotensin receptor OATP1B1/OATP1B3 and the hepatic efflux
antagonists (ARBs) – including Valsartan – or transporter MRP2. The clinical relevance of this
of angiotensin- converting-enzyme inhibitors finding is unknown. Co-administration of
(ACEIs) with aliskiren in patients with diabetes inhibitors of the uptake transporter (e.g.
mellitus or renal impairment (GFR< 60 Rifampicin, ciclosporin) or efflux transporter
mL/min/1.73 m2) is contraindicated (see sections (e.g. ritonavir) may increase the systemic
4.3 and 4.4). exposure to Valsartan . Exercise appropriate care
when initiating or ending concomitant treatment
Concomitant use not recommended
with such drugs.
Lithium Others
Reversible increases in serum lithium In drug interaction studies with Valsartan , no
concentrations and toxicity have been reported interactions of clinical significance have been
during concurrent use of ACE inhibitors. Due to found with Valsartan or any of the following
the lack of experience with concomitant use of substances: cimetidine, warfarin, furosemide,
Valsartan and lithium, this combination is not digoxin, atenolol, indometacin,
recommended. If the combination proves hydrochlorothiazide, amlodipine, glibenclamide.
necessary, careful monitoring of serum lithium
levels is recommended. Paediatric population
Potassium-sparing diuretics, potassium In hypertension in children and adolescents,
supplements, salt substitutes containing where underlying renal abnormalities are
potassium and other substances that may common, caution is recommended with the
increase potassium levels concomitant use of Valsartan and other
substances that inhibit the renin angiotensin
If a medicinal product that affects potassium
aldosterone system which may increase serum
levels is considered necessary in combination potassium. Renal function and serum potassium
with Valsartan , monitoring of potassium plasma should be closely monitored.
levels is advised.
4.6 Fertility, pregnancy and lactation
Caution required with concomitant use
Pregnancy
The use of Angiotensin II Receptor Antagonists Valsartan had no adverse effects on the
(AIIRAs) is not recommended during the first reproductive performance of male or female rats
trimester of pregnancy (see section 4.4). The use at oral doses up to 200 mg/kg/day. This dose is 6
of AIIRAs is contra-indicated during the second times the maximum recommended human dose
and third trimester of pregnancy (see sections on a mg/m2 basis (calculations assume an oral
4.3 and 4.4). dose of 320 mg/day and a 60-kg patient).
Epidemiological evidence regarding the risk of 4.7 Effects on ability to drive and use
teratogenicity following exposure to ACE machines
inhibitors during the first trimester of pregnancy No studies on the effects on the ability to drive
has not been conclusive; however, a small have been performed. When driving vehicles or
increase in risk cannot be excluded. Whilst there operating machines it should be taken into
is no controlled epidemiological data on the risk account that occasionally dizziness or weariness
with AIIRAs, similar risks may exist for this may occur when taking Valsartan .
class of drugs. Unless continued AIIRA therapy
is considered essential, patients planning 4.8 Undesirable effects
pregnancy should be changed to alternative anti- In controlled clinical studies in adult patients
hypertensive treatments which have an with hypertension, the overall incidence of
established safety profile for use in pregnancy. adverse reactions (ADRs) was comparable with
When pregnancy is diagnosed, treatment with placebo and is consistent with the pharmacology
AIIRAs should be stopped immediately, and, if of Valsartan . The incidence of ADRs did not
appropriate, alternative therapy should be appear to be related to dose or treatment
started. duration and also showed no association with
gender, age or race.
AIIRAs therapy exposure during the second and
third trimesters is known to induce human The ADRs reported from clinical studies, post-
foetotoxicity (decreased renal function, marketing experience and laboratory findings
oligohydramnios, skull ossification retardation) are listed below according to system organ class.
and neonatal toxicity (renal failure, hypotension, Adverse reactions are ranked by frequency, the
hyperkalaemia); see also section 5.3 'Preclinical most frequent first, using the following
safety data'. convention:
Should exposure to AIIRAs have occurred from Very common (≥ 1/10);
the second trimester of pregnancy, ultrasound
check of renal function and skull is Common (≥ 1/100 to < 1/10);
recommended.
Uncommon (≥ 1/1,000 to < 1/100);
Infants whose mothers have taken AIIRAs
Rare (≥ 1/10,000 to < 1/1,000) very rare (<
should be closely observed for hypotension (see
1/10,000), including isolated reports.
also sections 4.3 and 4.4).
Within each frequency grouping, adverse
Breast-feeding
reactions are ranked in order of decreasing
Because no information is available regarding seriousness.
the use of Valsartan during breastfeeding,
For all the ADRs reported from post-marketing
Valsartan is not recommended and alternative
experience and laboratory findings, it is not
treatments with better established safety profiles
possible to apply any ADR frequency and
during breast-feeding are preferable, especially
therefore they are mentioned with a 'not known'
while nursing a newborn or preterm infant.
frequency.
Fertility
- Hypertension
Blood and lymphatic system disorders clinical studies (each followed by an extension
period or study) and one open-label study. These
Not known Decrease in haemoglobin,
studies include 771 paediatric patients from 6 to
Decrease in haematocrit,
less than 18 years of age with and without
Neutropenia,
chronic kidney disease (CKD), of which 560
Thrombocytopenia
patients received Valsartan . With the exception
Immune system disorders of isolated gastrointestinal disorders (such as
Not known Hypersensitivity including abdominal pain, nausea, vomiting) and
serum sickness dizziness, no relevant differences in terms of
Metabolism and nutrition disorders type, frequency and severity of adverse reactions
were identified between the safety profile for
Not known Increase of serum potassium, paediatric patients aged 6 to less than 18 years
hyponatraemia and that previously reported for adult patients.
Ear and labyrinth system disorders
A pooled analysis of 560 paediatric hypertensive
Uncommon Vertigo patients (aged 6-17 years) receiving either
Vascular disorders Valsartan monotherapy [n=483] or combination
Not known Vasculitis antihypertensive therapy including Valsartan
[n=77] was conducted. Of the 560 patients, 85
Respiratory, thoracic and mediastinal (15.2%) had CKD (baseline GFR <90
disorders mL/min/1.73m2). Overall, 45 (8.0%) patients
Uncommon Cough discontinued a study due to adverse events.
Gastrointestinal disorders Overall 111 (19.8%) patients experienced an
adverse drug reaction (ADR), with headache
Uncommon Abdominal pain
(5.4%), dizziness (2.3%) and hyperkalaemia
Hepato-biliary disorders (2.3%) being the most frequent. In patients with
Not known Elevation of liver function CKD, the most frequent ADRs were
values including increase of hyperkalaemia (12.9%), headache (7.1%), blood
serum bilirubin creatinine increased (5.9%) and hypotension
Skin and subcutaneous tissue disorders (4.7%). In patients without CKD, the most
frequent ADRs were headache (5.1%) and
Not known Angioedema, Rash, Pruritus dizziness (2.7%). ADRs were observed more
Musculoskeletal and connective tissue frequently in patients receiving Valsartan in
disorders combination with other antihypertensive
Not known Myalgia medications than Valsartan alone.
Renal and urinary disorders Neurocognitive and developmental assessment
Not known Renal failure and of paediatric patients aged 6 to 16 years of age
impairment, Elevation of revealed no overall clinically relevant adverse
serum creatinine impact after treatment with Valsartan for up to
one year.
General disorders and administration site
conditions In a double-blind randomized study in 90
Uncommon Fatigue children aged 1 to 6 years, which was followed
by a one-year open-label extension, two deaths
Paediatric population
and isolated cases of marked liver transaminases
Hypertension elevations were observed. These cases occurred
in a population who had significant
The antihypertensive effect of Valsartan has comorbidities. A causal relationship to Valsartan
been evaluated in two randomised, double-blind
has not been established. In a second study in Respiratory, thoracic and mediastinal
which 75 children aged 1 to 6 years were disorders
randomised, no significant liver transaminase
Uncommon Cough
elevations or death occurred with Valsartan
treatment. Gastrointestinal disorders
Uncommon Nausea, Diarrhoea
Hyperkalaemia was more frequently observed in
children and adolescents aged 6 to 18 years with Hepato-biliary disorders
underlying chronic kidney disease. Not known Elevation of liver
function values
The safety profile seen in controlled-clinical
studies in adult patients with post-myocardial Skin and subcutaneous tissue disorders
infarction and/or heart failure varies from the Uncommon Angioedema
overall safety profile seen in hypertensive Not known Rash, Pruritus
patients. This may relate to the patients
underlying disease. ADRs that occurred in adult Musculoskeletal and connective tissue
patients with post-myocardial infarction and/or disorders
heart failure patients are listed below. Not known Myalgia
- Post-myocardial infarction and/or heart failure Renal and urinary disorders
(studied in adult patients only) Common Renal failure and
impairment
Blood and lymphatic system disorders
Uncommon Acute renal failure,
Not known Thrombocytopenia Elevation of serum
Immune system disorders creatinine
Not known Hypersensitivity Not known Increase in Blood Urea
including serum Nitrogen
sickness General disorders and administration site
Metabolism and nutrition disorders conditions
Uncommon Hyperkalaemia Uncommon Asthenia, Fatigue
Not known Increase of serum Reporting of suspected adverse reactions
potassium,
Reporting suspected adverse reactions after
hyponatraemia
authorisation of the medicinal product is
Nervous system disorders important. It allows continued monitoring of the
Common Dizziness, Postural benefit/risk balance of the medicinal product.
dizziness 4.9 Overdose
Uncommon Syncope, Headache Symptoms
Ear and labyrinth system disorders Overdose with Valsartan may result in marked
Uncommon Vertigo hypotension, which could lead to depressed level
Cardiac disorders of consciousness, circulatory collapse and/or
shock.
Uncommon Cardiac failure
Vascular disorders Treatment
Common Hypotension, The therapeutic measures depend on the time of
Orthostatic hypotension ingestion and the type and severity of the
Not known Vasculitis
symptoms; stabilisation of the circulatory thiazide diuretic experienced cough compared to

condition is of prime importance. 68.5% of those treated with an ACE inhibitor
(P<0.05).
If hypotension occurs, the patient should be
placed in a supine position and blood volume Clinical efficacy and safety
correction should be undertaken. Valsartan is
unlikely to be removed by haemodialysis. Recent myocardial infarction (only 40 mg, 80
mg and 160 mg)
5. Pharmacological properties The Valsartan In Acute myocardial iNfarcTion
trial (VALIANT) was a randomised, controlled,
5.1 Pharmacodynamic properties
multinational, double-blind study in 14,703
Pharmacotherapeutic group: Angiotensin II
patients with acute myocardial infarction and
Antagonists, plain.
signs, symptoms or radiological evidence of
Mechanism of action congestive heart failure and/or evidence of left
ventricular systolic dysfunction (manifested as
Valsartan is an orally active, potent, and an ejection fraction ≤40% by radionuclide
specific angiotensin II (Ang II) receptor ventriculography or ≤35% by echocardiography
antagonist. It acts selectively on the or ventricular contrast angiography). Patients
AT1 receptor subtype, which is responsible for were randomised within 12 hours to 10 days
the known actions of angiotensin II. after the onset of myocardial infarction
The increased plasma levels of Ang II following symptoms to Valsartan , captopril, or the
AT1 receptor blockade with Valsartan may combination of both. The mean treatment
stimulate the unblocked AT2 receptor, which duration was two years. The primary endpoint
appears to counterbalance the effect of the was time to all-cause mortality.
AT1 receptor. Valsartan was as effective as captopril in
Valsartan does not exhibit any partial agonist reducing all-cause mortality after myocardial
activity at the AT1 receptor and has much (about infarction. All cause mortality was similar in the
20,000 fold) greater affinity for the AT1 receptor Valsartan (19.9%), captopril (19.5%), and
than for the AT2 receptor. Valsartan is not Valsartan + captopril (19.3%) groups.
known to bind to or block other hormone Combining Valsartan with captopril did not add
receptors or ion channels known to be important further benefit over captopril alone. There was
in cardiovascular regulation. no difference between Valsartan and captopril
in all-cause mortality based on age, gender, race,
Valsartan does not inhibit ACE (also known as baseline therapies or underlying disease.
kininase II) which converts Ang I to Ang II and Valsartan was also effective in prolonging the
degrades bradykinin. Since there is no effect on time to and reducing cardiovascular mortality,
ACE and no potentiation of bradykinin or hospitalisation for heart failure, recurrent
substance P, angiotensin II antagonists are myocardial infarction, resuscitated cardiac
unlikely to be associated with coughing. In arrest, and non-fatal stroke (secondary
clinical trials where Valsartan was compared composite endpoint).
with an ACE inhibitor, the incidence of dry
cough was significantly (P<0.05) less in patients The safety profile of Valsartan was consistent
treated with Valsartan than in those treated with with the clinical course of patients treated in the
an ACE inhibitor (2.6% versus 7.9% postmyocardial infarction setting. Regarding
respectively). In a clinical trial of patients with a renal function, doubling of serum creatinine was
history of dry cough during ACE inhibitor observed in 4.2% of Valsartan -treated patients,
therapy, 19.5% of trial subjects receiving 4.8% of Valsartan + captopril-treated patients,
Valsartan and 19.0% of those receiving a and 3.4% of captopril-treated patients.
Discontinuations due to various types of renal combination of an ACE inhibitor, a beta blocker
dysfunction occurred in 1.1% of Valsartan - and Valsartan .
treated patients, 1.3% in Valsartan + captopril
patients, and 0.8% of captopril patients. An In a subgroup of patients not receiving an ACE
assessment of renal function should be included inhibitor (n=366), the morbidity benefits were
in the evaluation of patients' post-myocardial greatest. In this subgroup all-cause mortality was
infarction. significantly reduced with Valsartan compared
to placebo by 33% (95% CI: 6% to 58%) (17.3%
There was no difference in all-cause mortality, Valsartan vs. 27.1% placebo) and the composite
cardiovascular mortality or morbidity when beta mortality and morbidity risk was significantly
blockers were administered together with the reduced by 44% (24.9% Valsartan vs. 42.5%
combination of Valsartan + captopril, Valsartan placebo).
alone, or captopril alone. Irrespective of
treatment, mortality was lower in the group of In patients receiving an ACE inhibitor without a
patients treated with a beta blocker, suggesting beta-blocker, all cause mortality was similar
that the known beta blocker benefit in this (p=NS) in the Valsartan (21.8%) and placebo
population was maintained in this trial. (22.5%) groups. Composite mortality and
morbidity risk was significantly reduced by
Heart failure (only 40 mg, 80 mg and 160 mg) 18.3% (95% CI: 8% to 28%) with Valsartan
compared with placebo (31.0% vs. 36.3%).
Val-HeFT was a randomised, controlled,
multinational clinical trial of Valsartan In the overall Val-HeFT population, Valsartan
compared with placebo on morbidity and treated patients showed significant improvement
mortality in 5,010 NYHA class II (62%), III in NYHA class, and heart failure signs and
(36%) and IV (2%) heart failure patients symptoms, including dyspnoea, fatigue, oedema
receiving usual therapy with LVEF <40% and and rales compared to placebo. Patients treated
left ventricular internal diastolic diameter with Valsartan had a better quality of life as
(LVIDD) >2.9 cm/m2. Baseline therapy demonstrated by change in the Minnesota Living
included ACE inhibitors (93%), diuretics (86%), with Heart Failure Quality of Life score from
digoxin (67%) and beta blockers (36%). The baseline at endpoint than placebo. Ejection
mean duration of follow-up was nearly two fraction in Valsartan treated patients was
years. The mean daily dose of Valsartan in Val- significantly increased and LVIDD significantly
HeFT was 254 mg. The study had two primary reduced from baseline at endpoint compared to
endpoints: all cause mortality (time to death) and placebo.
composite mortality and heart failure morbidity
(time to first morbid event) defined as death, Hypertension (only 80 mg, 160 mg and 320 mg)
sudden death with resuscitation, hospitalisation Administration of Valsartan to patients with
for heart failure, or administration of intravenous hypertension results in reduction of blood
inotropic or vasodilator agents for four hours or pressure without affecting pulse rate.
more without hospitalisation.
In most patients, after administration of a single
All cause mortality was similar (p=NS) in the oral dose, onset of antihypertensive activity
Valsartan (19.7%) and placebo (19.4%) groups. occurs within 2 hours, and the peak reduction of
The primary benefit was a 27.5% (95% CI: 17 to blood pressure is achieved within 4-6 hours. The
37%) reduction in risk for time to first heart antihypertensive effect persists over 24 hours
failure hospitalisation (13.9% vs. 18.5%). after dosing. During repeated dosing, the
Results appearing to favour placebo (composite antihypertensive effect is substantially present
mortality and morbidity was 21.9% in placebo within 2 weeks, and maximal effects are attained
vs. 25.4% in Valsartan group) were observed within 4 weeks and persist during long-term
for those patients receiving the triple therapy. Combined with hydrochlorothiazide, a
significant additional reduction in blood pressure Trial) and VA NEPHRON-D (The Veterans
is achieved. Affairs Nephropathy in Diabetes)) have
examined the use of the combination of an ACE-
Abrupt withdrawal of Valsartan has not been inhibitor with an angiotensin II receptor blocker.
associated with rebound hypertension or other
adverse clinical events. ONTARGET was a study conducted in patients
with a history of cardiovascular or
In hypertensive patients with type 2 diabetes and cerebrovascular disease, or type 2 diabetes
microalbuminuria, Valsartan has been shown to mellitus accompanied by evidence of end-organ
reduce the urinary excretion of albumin. The damage. VA NEPHRON-D was a study in
MARVAL (Micro Albuminuria Reduction with patients with type 2 diabetes mellitus and
Valsartan ) study assessed the reduction in diabetic nephropathy.
urinary albumin excretion (UAE) with Valsartan
(80-160 mg/od) versus amlodipine (5-10 These studies have shown no significant
mg/od), in 332 type 2 diabetic patients (mean beneficial effect on renal and/or cardiovascular
age: 58 years; 265 men) with microalbuminuria outcomes and mortality, while an increased risk
(Valsartan : 58 µg/min; amlodipine: 55.4 of hyperkalaemia, acute kidney injury and/or
µg/min), normal or high blood pressure and with hypotension as compared to monotherapy was
preserved renal function (blood creatinine<120 observed. Given their similar pharmacodynamic
µmol/l). At 24 weeks, UAE was reduced properties, these results are also relevant for
(p<0.001) by 42% (–24.2 µg/min; 95% CI: – other ACE-inhibitors and angiotensin II receptor
40.4 to –19.1) with Valsartan and blockers.
approximately 3% (–1.7 µg/min; 95% CI: –5.6
to 14.9) with amlodipine despite similar rates of ACE-inhibitors and angiotensin II receptor
blood pressure reduction in both groups. blockers should therefore not be used
concomitantly in patients with diabetic
The Diovan Reduction of Proteinuria (DROP) nephropathy.
study further examined the efficacy of Valsartan
in reducing UAE in 391 hypertensive patients ALTITUDE (Aliskiren Trial in Type 2 Diabetes
(BP=150/88 mmHg) with type 2 diabetes, Using Cardiovascular and Renal Disease
albuminuria mean=102 µg/min; 20-700 µg/min) Endpoints) was a study designed to test the
benefit of adding aliskiren to a standard therapy
and preserved renal function (mean serum
of an ACE-inhibitor or an angiotensin II receptor
creatinine = 80 μmol/l). Patients were
randomized to one of 3 doses of Valsartan (160, blocker in patients with type 2 diabetes mellitus
320 and 640 mg/od) and treated for 30 weeks. and chronic kidney disease, cardiovascular
The purpose of the study was to determine the disease, or both. The study was terminated early
optimal dose of Valsartan for reducing UAE in because of an increased risk of adverse
hypertensive patients with type 2 diabetes. At 30 outcomes. Cardiovascular death and stroke were
weeks, the percentage change in UAE was both numerically more frequent in the aliskiren
significantly reduced by 36% from baseline with group than in the placebo group and adverse
Valsartan 160 mg (95%CI: 22 to 47%), and by events and serious adverse events of interest
44% with Valsartan 320 mg (95%CI: 31 to (hyperkalaemia, hypotension and renal
54%). It was concluded that 160-320 mg of dysfunction) were more frequently reported in
the aliskiren group than in the placebo group.
Valsartan produced clinically relevant
reductions in UAE in hypertensive patients with Paediatric population
type 2 diabetes.
Hypertension
Two large randomised, controlled trials
(ONTARGET (ONgoingTelmisartan Alone and The antihypertensive effect of Valsartan have
in combination with Ramipril Global Endpoint been evaluated in four randomized, double-blind
clinical studies in 561 paediatric patients from 6 inferiority p-value <0.0001). Consistent results
to 18 years of age and 165 paediatric patients 1 were observed for diastolic blood pressure with
to 6 years of age. Renal and urinary disorders, reductions of 9.1 mmHg and 8.5 mmHg with
and obesity were the most common underlying Valsartan and enalapril, respectively.
medical conditions potentially contributing to
hypertension in the children enrolled in these In a third, open label clinical study, involving
studies. 150 paediatric hypertensive patients 6 to 17
years of age, eligible patients (systolic BP ≥95th
Clinical experience in children at or above 6 percentile for age, gender and height) received
years of age Valsartan for 18 months to evaluate safety and
tolerability. Out of the 150 patients participating
In a clinical study involving 261 hypertensive in this study, 41 patients also received
paediatric patients 6 to 16 years of age, patients
concomitant antihypertensive medication.
who weighed <35 kg received 10, 40 or 80 mg Patients were dosed based on their weight
of Valsartan tablets daily (low, medium and categories for starting and maintenance doses.
high doses), and patients who weighed 35 kg Patients weighing >18 to < 35 kg, ≥35 to < 80
received 20, 80, and 160 mg of Valsartan tablets kg and ≥ 80 to < 160 kg received 40 mg, 80 mg
daily (low, medium and high doses). At the end and 160 mg and the doses were titrated to 80
of 2 weeks, Valsartan reduced both systolic and
mg, 160 mg and 320 mg respectively after one
diastolic blood pressure in a dose-dependent week. One half of the patients enrolled (50.0%,
manner. Overall, the three dose levels of n=75) had CKD with 29.3% (44) of patients
Valsartan (low, medium and high) significantly having CKD Stage 2 (GFR 60 – 89
reduced systolic blood pressure by 8, 10, 12 mm mL/min/1.73m2) or Stage 3 (GFR 30-59
Hg from the baseline, respectively. Patients were mL/min/1.73m2). Mean reductions in systolic
re-randomized to either continue receiving the
blood pressure were 14.9 mmHg in all patients
same dose of Valsartan or were switched to
(baseline 133.5 mmHg), 18.4 mmHg in patients
placebo. In patients who continued to receive the with CKD (baseline 131.9 mmHg) and 11.5
medium and high doses of Valsartan , systolic mmHg in patients without CKD (baseline 135.1
blood pressure at trough was -4 and -7 mm Hg
mmHg). The percentage of patients who
lower than patients who received the placebo achieved overall BP control (both systolic and
treatment. In patients receiving the low dose of diastolic BP <95th percentile) was slightly
Valsartan , systolic blood pressure at trough was higher in the CKD group (79.5%) compared to
similar to that of patients who received the the non-CKD group (72.2%).
placebo treatment. Overall, the dose-dependent
antihypertensive effect of Valsartan was Clinical experience in children less than 6 years
consistent across all the demographic subgroups. of age
In another clinical study involving 300 Two clinical studies were conducted in patients
hypertensive paediatric patients 6 to 18 years of aged 1 to 6 years with 90 and 75 patients,
age, eligible patients were randomized to receive respectively. No children below the age of 1
Valsartan or enalapril tablets for 12 weeks. year were enrolled in these studies. In the first
Children weighing between 18 kg and <35 kg study, the efficacy of Valsartan was confirmed
received Valsartan 80 mg or enalapril 10 mg; compared to placebo but a dose-response could
those between _35 kg and <80 kg received not be demonstrated. In the second study, higher
Valsartan 160 mg or enalapril 20 mg; those _80 doses of Valsartan were associated with greater
kg received Valsartan 320 mg or enalapril 40 BP reductions, but the dose response trend did
mg. Reductions in systolic blood pressure were not achieve statistical significance and the
comparable in patients receiving Valsartan (15 treatment difference compared to placebo was
mmHg) and enalapril (14 mm Hg) (non- not significant. Because of these inconsistencies,
Valsartan is not recommended in this age group Following intravenous administration, plasma
(see section 4.8). clearance of Valsartan is about 2 l/h and its
renal clearance is 0.62 l/h (about 30% of total
The European Medicines Agency has waived the clearance). The half-life of Valsartan is 6 hours.
obligation to submit the results of studies with
Valsartan in all subsets of the paediatric In Heart failure patients (only 40 mg, 80 mg and
population in heart failure and heart failure after 160 mg):
recent myocardial infarction. See section 4.2 for
information on paediatric use. The average time to peak concentration and
elimination half-life of Valsartan in heart failure
5.2 Pharmacokinetic properties patients are similar to that observed in healthy
Absorption: volunteers. AUC and Cmax values of Valsartan
are almost proportional with increasing dose
Following oral administration of Valsartan
over the clinical dosing range (40 to 160 mg
alone, peak plasma concentrations of Valsartan twice a day). The average accumulation factor is
are reached in 2–4 hours. Mean absolute
about 1.7. The apparent clearance of Valsartan
bioavailability is 23%. Food decreases exposure following oral administration is approximately
(as measured by AUC) to Valsartan by about 4.5 l/h. Age does not affect the apparent
40% and peak plasma concentration (Cmax) by clearance in heart failure patients.
about 50%, although from about 8 h post dosing
plasma Valsartan concentrations are similar for Special populations
the fed and fasted groups. This reduction in
Elderly
AUC is not, however, accompanied by a
clinically significant reduction in the therapeutic A somewhat higher systemic exposure to
effect, and Valsartan can therefore be given Valsartan was observed in some elderly subjects
either with or without food. than in young subjects; however, this has not
been shown to have any clinical significance.
Distribution:
Impaired renal function
The steady-state volume of distribution of
Valsartan after intravenous administration is As expected for a compound where renal
about 17 litres, indicating that Valsartan does clearance accounts for only 30% of total plasma
not distribute into tissues extensively. Valsartan clearance, no correlation was seen between renal
is highly bound to serum proteins (94–97%), function and systemic exposure to Valsartan .
mainly serum albumin. Dose adjustment is therefore not required in
Biotransformation: patients with renal impairment (creatinine
clearance >10 ml/min). There is currently no
Valsartan is not biotransformed to a high extent experience on the safe use in patients with a
as only about 20% of dose is recovered as creatinine clearance <10 ml/min and patients
metabolites. A hydroxy metabolite has been undergoing dialysis, therefore Valsartan should
identified in plasma at low concentrations (less be used with caution in these patients (see
than 10% of the Valsartan AUC). This sections 4.2 and 4.4).
metabolite is pharmacologically inactive.
Valsartan is highly bound to plasma protein and
Excretion: is unlikely to be removed by dialysis.
Valsartan shows multiexponential decay Hepatic impairment
kinetics (t½α <1 h and t½ß about 9 h). Valsartan
Approximately 70% of the dose absorbed is
is primarily eliminated by biliary excretion in
faeces (about 83% of dose) and renally in urine eliminated in the bile, essentially in the
(about 13% of dose), mainly as unchanged drug. unchanged form. Valsartan does not undergo
any noteworthy biotransformation. A doubling
of exposure (AUC) was observed in patients haematocrit) and evidence of changes in renal
with mild to moderate hepatic impairment haemodynamics (slightly raised plasma urea,
compared to healthy subjects. However, no and renal tubular hyperplasia and basophilia in
correlation was observed between plasma males). These doses in rats (200 and 600
Valsartan concentration versus degree of hepatic mg/kg/day) are approximately 6 and 18 times
dysfunction. Valsartan has not been studied in the maximum recommended human dose on a
patients with severe hepatic dysfunction (see mg/m2 basis (calculations assume an oral dose of
sections 4.2, 4.3 and 4.4). 320 mg/day and a 60-kg patient).
Paediatric population In marmosets at similar doses, the changes were
similar though more severe, particularly in the
In a study of 26 paediatric hypertensive patients kidney where the changes developed to a
(aged 1 to 16 years) given a single dose of a
nephropathy which included raised urea and
suspension of Valsartan (mean: 0.9 to 2 mg/kg, creatinine.
with a maximum dose of 80 mg), the clearance
(litres/h/kg) of Valsartan was comparable across Hypertrophy of the renal juxtaglomerular cells
the age range of 1 to 16 years and similar to that was also seen in both species. All changes were
of adults receiving the same formulation. considered to be caused by the pharmacological
action of Valsartan which produces prolonged
Renal function
hypotension, particularly in marmosets. For
Use in paediatric patients with a creatinine therapeutic doses of Valsartan in humans, the
clearance <30 ml/min and paediatric patients hypertrophy of the renal juxtaglomerular cells
undergoing dialysis has not been studied, does not seem to have any relevance.
therefore Valsartan is not recommended in these Paediatric population
patients. No dose adjustment is required for
paediatric patients with a creatinine clearance Daily oral dosing of neonatal/juvenile rats (from
>30 ml/min. Renal function and serum a postnatal day 7 to postnatal day 70) with
potassium should be closely monitored (see Valsartan at doses as low as 1 mg/kg/day (about
sections 4.2 and 4.4). 10-35% of the maximum recommended
paediatric dose of 4 mg/kg/day on systemic
5.3 Preclinical safety data exposure basis) produced persistent, irreversible
Non-clinical data reveal no special hazard for kidney damage. These effects above mentioned
humans based on conventional studies of safety
represent an expected exaggerated
pharmacology, repeated dose toxicity, pharmacological effect of angiotensin
genotoxicity, carcinogenic potential.
converting enzyme inhibitors and angiotensin II
In rats, maternally toxic doses (600 mg/kg/day) type 1 blockers; such effects are observed if rats
during the last days of gestation and lactation led are treated during the first 13 days of life. This
to lower survival, lower weight gain and delayed period coincides with 36 weeks of gestation in
development (pinna detachment and ear-canal humans, which could occasionally extend up to
opening) in the offspring (see section 4.6). These 44 weeks after conception in humans. The rats in
doses in rats (600 mg/kg/day) are approximately the juvenile Valsartan study were dosed up to
18 times the maximum recommended human day 70, and effects on renal maturation
dose on a mg/m2 basis (calculations assume an (postnatal 4-6 weeks) cannot be excluded.
oral dose of 320 mg/day and a 60-kg patient). Functional renal maturation is an ongoing
process within the first year of life in humans.
In non-clinical safety studies, high doses of Consequently, a clinical relevance in children <1
Valsartan (200 to 600 mg/kg body weight) year of age cannot be excluded, while preclinical
caused in rats a reduction of red blood cell data do not indicate a safety concern for children
parameters (erythrocytes, haemoglobin, older than 1 year.
6. Pharmaceutical particulars
6.1 List of excipients
Tablet core: Microcrystalline cellulose,
Crospovidone, Povidone, Croscarmellose
Sodium, Silica, colloidal anhydrous, Magnesium
stearate.
Tablet coating: Hypromellose , Titanium
dioxide,Macrogol, Iron oxide yellow.
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
This medicinal product does not require any
special storage conditions.
6.5 Nature and contents of container
PVC/PE/Aluminium blister pack.
Pack Size: 7, 14, 28, 30, 50, 100 and 500 tablets.
Not all packs may be marketed.
6.6 Special precautions for disposal and other
handling
No special requirements for disposal.
7. Manufactured In India By:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai - 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-
222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m.
EST
E-mail: tajgroup@tajpharma.com

Valsartan Tablets SMPC Taj Pharmaceuticals

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Valsartan Tablets SMPC Taj Pharmaceuticals

Uploaded by

Copyright:

Available Formats

Valsartan 40mg, 80 mg, 160 mg, 32 0mg Ta blets TajPhar ma : Us es, Side E ffe cts, Intera ctions, Picture

Valsartan Tablets USP Hypertension (40 mg only)

40mg/80mg/160mg/320mg Treatment of hypertension in children and

After an initial dose of 20 mg twice daily, Renal impairment

Evaluation of post-myocardial infarction Paediatric population

symptoms; stabilisation of the circulatory thiazide diuretic experienced cough compared to

You might also like