Flutamide Tablets USP Taj Pharma SmPC

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Flutamide Tablets USP 250mg
Taj Pharma
1. NAME OF THE MEDICINAL
PRODUCT
Flutamide Tablets USP 250mg Taj Pharma
2. QUALITATIVE AND
QUANTITATIVE COMPOSITION
Each uncoated Tablet contains:
Flutamide Tablet USP 250mg
Excipients: Q.S.
Excipient of known effect:
Each tablet contains 221.7mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film coated Tablets.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Flutamide Taj Pharma is indicated for the
treatment of advanced prostatic carcinoma
in which suppression of testosterone effects
is indicated. Flutamide Taj Pharma may be
used in combination with an LHRH agonist,
both on commencement of treatment or as
an adjunctive therapy in patients already
receiving an LHRH agonist. Flutamide Taj
Pharma may also be used in surgically
castrated patients.
4.2 Posology and method of
administration
Posology
Adults and older people: One tablet three
times daily at 8 hour intervals. When
Flutamide Taj Pharma is used as initial
treatment with an LHRH agonist, a
reduction in severity of the flare reaction
may be achieved if treatment with Flutamide
Taj Pharma is initiated before the LHRH
agonist. Consequently, it is recommended
that treatment with Flutamide Taj Pharma
should commence simultaneously or at least
24 or more hours before the LHRH agonist.
The administration of Flutamide Taj Pharma
should begin 8 weeks prior to radiotherapy
and continue for its duration, or for 12
weeks pre-prostatectomy.
In patients with impaired liver function,
long-term treatment with Flutamide Taj
Pharma should only be initiated after careful
assessment of the individual benefits and
risks.
Flutamide Taj Pharma should be
administered with caution in patients with
impaired renal function.
Method of administration
For oral use.
The tablets are to be taken preferably after
food.
4.3 Contraindications
Hypersensitivity to the active substance or to
any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for
use
Hepatic injury
Flutamide Taj Pharma may be hepatotoxic
and should be used with caution in patients
with pre-existing hepatic dysfunction only
after considering the benefits and potential
risks.

There have been reports of elevated serum
transaminase levels, cholestatic jaundice,
hepatic necrosis and hepatic encephalopathy
associated with Flutamide Taj Pharma
treatment. The hepatic effects were usually
reversible following discontinuation of
Flutamide Taj Pharma, although cases have
been reported of death after severe liver
damage linked to the use of Flutamide Taj
Pharma. Hepatotoxicity, which may be fatal,
may occur after several weeks or months of
therapy. Hepatic function should be
monitored regularly before, during and after
initiation of Flutamide Taj Pharma therapy.
Treatment with Flutamide Taj Pharma
should not be initiated in patients with
serum transaminase levels exceeding 2-3
times the upper limit of normal.
Periodic liver function tests must be
performed before initiation and during
treatment, especially in patients receiving
long term treatment with Flutamide Taj
Pharma. Appropriate laboratory liver
function tests should also be performed for
every patient once a month for the first 4
months and then periodically or when the
first sign or symptom of hepatic dysfunction
occur (e.g. pruritus, dark urine, persistent
anorexia, jaundice, right upper quadrant
tenderness or unexplained “flu-like”
symptoms).
Patients should be advised to discontinue
Flutamide Taj Pharma therapy and seek
medical advice immediately if any
symptoms or signs suggestive of
hepatotoxicity occur. If the patient presents
liver function test results indicative of liver
damage, clinical jaundice in the absence of
hepatic metastasis confirmed by biopsy, or
serum transaminase levels of 2 to 3 times
above the normal limits in patients that do
not present pathological signs, treatment
with Flutamide Taj Pharma must be
suspended.
Impaired renal function
Flutamide Taj Pharma should be
administered with caution in patients with
impaired renal function.
Cardiovascular
Periodic sperm counts should be considered
in patients receiving chronic treatment with
Flutamide Taj Pharma who have not
received medical or surgical castration.
Flutamide Taj Pharma administration may
lead to elevated plasma testosterone and
oestradiol levels in such patients, resulting
in fluid retention. In severe cases this can
lead to an increased risk of angina and heart
failure. Therefore caution should be
exercised in the use of Flutamide Taj
Pharma if cardiac disease is present. It can
exacerbate oedema or ankle swelling in
patients prone to these conditions.
An increase in oestradiol levels may
predispose to thromboembolic events.
It has been reported in the literature that
increased cardiovascular risk (myocardial
infarction, cardiac insufficiency, sudden
cardiac death) and the adverse effects on
independent cardiovascular risk factors
(serum lipoproteins, insulin sensitivity and
obesity) may be linked to androgen
deprivation with LHRH analogues in
patients with prostate cancer. It must be
evaluated whether the benefits of the
combined androgen blockade compensate
the potential cardiovascular risk in patients
with risk factors. Patients treated whose
signs or symptoms suggest the development
of a cardiovascular disease must be
monitored.

Effect on the QT/QTc interval
The potential QT/QTc prolongation with
Flutamide Taj Pharma has not been studied.
Androgen deprivation therapy may prolong
the QT interval.
In patients with a history of or risk factors
for QT prolongation and in patients
receiving concomitant medicinal products
that might prolong the QT interval (see
section 4.5) physicians should assess the
benefit risk ratio including the potential for
Torsade de pointes prior to initiating
Flutamide Taj Pharma.
Endocrinology and metabolism
A decreased tolerance to glucose has been
observed in males in treatment with
combined androgen blockade. This may
manifest as diabetes or a loss of glycaemic
control in patients with pre-existing
diabetes. Monitoring of the blood glucose
and/or glycosylated haemoglobin (HbA1c)
levels must be considered in patients who
are in treatment with Flutamide Taj Pharma
in combination with LHRH agonists.
Musculoskeletal/changes in bone density
Androgen depletion therapy is known to
reduce bone mineral density and increase the
risk of osteoporotic fractures. In recent
studies this has been seen in patients treated
with LHRH analogues plus Flutamide Taj
Pharma. The risk of bone fractures increases
with the duration of combined androgen
blockade. These complications may be
potentiated when patients are already
osteoporotic due to their advanced age at
diagnosis of prostate cancer.
Bone mineral density (BMD) should be
measured regularly to identify patients at
higher risk for fractures. BMD should be
measured at baseline, and then a year later
as a minimum. Further measurements can be
considered at yearly intervals in men with
BMD approaching osteoporosis or those
with decreased bone mineral density in
whom life expectancy warrants it.
In patients with significant risk factors for
decreased bone mineral content and/or bone
mass such as chronic consumers of alcohol
and/or tobacco, a presumed or marked
family history of osteoporosis or chronic use
of medicinal products that can reduce bone
mass such as anticonvulsants or
corticosteroids, the combined androgen
blockade can represent an additional risk. In
these patients the risk and benefit must be
weighed up carefully before starting the
treatment.
There have been cases of interstitial
pneumonitis reported in patients undergoing
treatment with Flutamide Taj Pharma.
Patients should be monitored for the
development of respiratory symptoms such
as dyspnoea during the first few weeks of
therapy.
Flutamide Taj Pharma is indicated only for
use in male patients.
Contraceptive measures must be taken
during treatment.
Patients with rare hereditary problems of
galactose intolerance, the Lapp lactase
deficiency or glucose-galactose
malabsorption should not take this medicine.
4.5 Interaction with other medicinal
products and other forms of
interaction
There have been no interactions between
Flutamide Taj Pharma and leuprorelin;
nevertheless, in the combined treatment with

Flutamide Taj Pharma and an LHRH
agonist, the possible side effects of each
medicinal product must be considered.
Increases in prothrombin time have been
reported in patients receiving chronic
treatment with oral anticoagulants (e.g.
warfarin) following initiation of Flutamide
Taj Pharma monotherapy. Therefore careful
monitoring of prothrombin time is
recommended and it may be necessary to
adjust the dose of anticoagulant if Flutamide
Taj Pharma is administered concomitantly
with oral anticoagulants.
Concomitant administration of other
potentially hepatotoxic drugs should be
undertaken only after careful assessment of
the benefit and risks. Given the known
potential liver and renal toxicities of the
product, it is important to avoid excessive
consumption of alcohol.
Cases of increased theophylline plasma
concentrations have been reported in
patients receiving concomitant theophylline
and Flutamide Taj Pharma treatment.
Theophylline is primarily metabolised by
CYP 1A2 which is the primary enzyme
responsible for the conversion of Flutamide
Taj Pharma to its active agent 2-
hydroFlutamide Taj Pharma.
Since androgen deprivation treatment may
prolong the QT interval, the concomitant use
of Flutamide Taj Pharma with medicinal
products known to prolong the QT interval
or medicinal products able to induce
Torsade de pointes such as class IA
(e.g. quinidine, disopyramide) or class III
(e.g. amiodarone, sotalol, dofetilide,
ibutilide) antiarrhythmic medicinal products,
methadone, moxifloxacin, antipsychotics,
etc. should be carefully evaluated (see
section 4.4).
4.6 Fertility, pregnancy and lactation
Flutamide Taj Pharma is intended only for
use in male patients. Contraceptive measures
should be taken during treatment.
Flutamide Taj Pharma may cause foetal
harm when administered to a pregnant
woman. In animal studies, the reproductive
toxicity of Flutamide Taj Pharma was
associated with the anti-androgenic activity
of this agent. There was decreased 24-hour
survival in the offspring of rats treated with
Flutamide Taj Pharma at doses of 30, 100,
or 200mg/kg/day (approximately 3, 9, and
19 times the human dose) during pregnancy.
A slight increase in minor variations in the
development of the sternebra and vertebra
was seen in foetuses of rats at the two higher
doses. Feminisation of the males also
occurred at the two higher dose levels. There
was a decreased survival rate in the
offspring of rabbits receiving the highest
dose (15mg/kg/day; equal to 1.4 times the
human dose).
No studies have been conducted in pregnant
or lactating women. Therefore, the
possibility that Flutamide Taj Pharma may
cause foetal harm if administered to a
pregnant woman, or may be present in the
breast milk of lactating women, must be
considered.
4.7 Effects on ability to drive and use
machines
No studies on effects on the ability to drive
and use machines have been performed with
Flutamide Taj Pharma. Possible undesirable
effects such as fatigue, dizziness and
confusion have been reported and may
interfere with the ability to drive and use
machines.
4.8 Undesirable effects

Monotherapy
The undesirable effects of Flutamide Taj
Pharma most frequently reported are
gynaecomastia and/or breast tenderness,
sometimes accompanied by periods of
galactorrhoea. These reactions often
disappear with the suspension of the
treatment or reduction of the dose.
It has been proven that Flutamide Taj
Pharma has a low cardiovascular risk
potential, significantly less than that of
diethylstilboestrol.
Combined treatment
The undesirable effects most frequently
reported during combined treatment of
Flutamide Taj Pharma with an LHRH
agonist were hot flushes, reduced libido,
erectile dysfunction, diarrhoea, nausea and
vomiting. With the exception of diarrhoea,
these are known undesirable effects of
LHRH agonists alone, with a similar
frequency.
The high rate of occurrence of
gynaecomastia observed with monotherapy
with Flutamide Taj Pharma decreased
greatly in combined treatment. In clinical
trials, no significant difference was observed
in the rate of occurrence of gynaecomastia
between the placebo group and the group
treated with Flutamide Taj Pharma and
LHRH agonists.
The following convention has been utilised
for the frequency classification:
Very common - (≥1 in 10)
Common - (≥1 in 100 to <1 in 10)
Uncommon - (≥1 in 1,000 to <1 in 100)
Rare – (≥1 in 10,000 to <1 in 1,000)
Very rare - (<1 in 10,000)
Not known – (cannot be estimated from the
available data)
SOC Monotherap
y
Combination
therapy with
LHRH analog
Infections and infestations
Rare Herpes zoster
Neoplasms benign, malignant and
unspecified (incl cysts and polyps)
Very rare Neoplasm of
the male
breast*
Blood and lymphatic system disorders
Rare Anaemia,
leucopenia,
thrombocytopenia
Very rare Haemolytic
anaemia,
megalocytic
anaemia,
methaemoglobinae
mia,
sulfhaemoglobinae
mia, macrocytic
anaemia
Immune system disorders
Rare Lupus-like
syndrome
Metabolism and nutrition disorders
Common Increased

appetite
Rare Anorexia Anorexia
Very rare Hyperglycaemia,
aggravation of
diabetes mellitus
Psychiatric disorders
Common Insomnia
Rare Anxiety,
depression
Depression, anxiety
Nervous system disorders
Rare Dizziness,
headache
Numbness,
confusion,
nervousness,
drowsiness
Eye disorders
Rare Blurred
vision
Cardiac disorders
Rare Cardiovascul
ar disorders
Not
known
QT
prolongation
(see sections
4.4 and 4.5)
Vascular disorders
Very
common
Hot flushes
Rare Hot flushes,
hypertension,
Hypertension
lymphoedem
a
Not
known
Thromboembolism
Respiratory, thoracic and mediastinal
disorders
Rare Interstitial
pneumonitis,
dyspnoea
Very rare Cough Pulmonary
symptoms
(e.g. dyspnoea),
interstitial lung
disease
Gastrointestinal disorders
Very
common
Diarrhoea, nausea,
vomiting
Common Nausea,
vomiting,
diarrhoea
Rare Non-specific
abdominal
disorders,
constipation,
ulcer-like
pain,
dyspepsia,
colitis, upset
stomach,
heartburn
Non-specific
abdominal
disorders,
abdominal pain
Hepatobiliary disorders
Common Hepatitis

Uncomm
on
Hepatitis
Rare Liver
function test
abnormalities
(see section
4.4)
Hepatic
dysfunction,
jaundice
Very rare Cholestatic
jaundice, hepatic
encephalopathy,
liver cell necrosis,
hepatotoxicity with
fatal outcome
Skin and subcutaneous tissue disorders
Rare Urticaria,
pruritus,
ecchymosis,
alteration of
the hair
growth
pattern and
loss of hair
(head)
Rash
Very rare Photosensitiv
ity reactions
Photosensitivity
reactions,
erythema, ulcers,
bullous eruptions,
epidermal
necrolysis
Musculoskeletal and connective tissue
disorders
Rare Muscle
cramps
Neuromuscular
symptoms, reduced
bone mineral
density,
osteoporotic
disorders,
arthralgia, myalgia
Renal and urinary disorders
Rare Genitourinary tract
symptoms, dysuria,
changes in urinary
frequency, change
in urine colour to
amber or yellow-
green
Reproductive system and breast disorders
Very
common
Gynaecomast
ia and/or
breast pain,
breast
tenderness,
galactorrhoea
Decreased libido,
impotence
Uncomm
on
Gynaecomastia
Rare Reversible
increase of
serum
testosterone
levels,
reduced
sperm
counts,
decreased
libido
General disorders and administration site
conditions
Common Somnolence,
tiredness
Rare Oedema,
asthenia,
malaise,
Oedema, injection
site irritation

thirst, chest
pain, hot
flushes,
weakness
Investigations
Common Transient
abnormal
liver function
Changes in liver
function
Rare Elevated blood
urea nitrogen
(BUN) values,
elevated serum
creatinine values
*
There have been a few cases reported of
malignant breast neoplasms in male patients
treated with Flutamide Taj Pharma. One of
them consisted of the aggravation of a lump
that had been detected previously, three or
four months prior to commencing
monotherapy with Flutamide Taj Pharma in
a patient with benign prostatic hypertrophy.
After the excision, a diagnosis was made of
slightly differentiated ductal carcinoma. The
other case consisted of gynaecomastia and a
lump, observed, respectively, two to six
months after the start of monotherapy with
Flutamide Taj Pharma to treat an advanced
prostate carcinoma. Nine months after the
treatment began, the lump was removed and
a moderately differentiated invasive ductal
tumour was diagnosed in T4N0M0, G3
state.
The high incidence of gynaecomastia seen
with Flutamide Taj Pharma monotherapy is
generally reduced with combination therapy.
Micronodular alterations of the body of
breast can uncommonly occur.
An increase in serum testosterone is initially
possible during monotherapy with Flutamide
Taj Pharma. In addition, hot flushes and
changes in hair character can occur.
Following the marketing of Flutamide Taj
Pharma, cases of acute renal failure,
interstitial nephritis, and myocardial
ischemia have been reported with frequency
unknown.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after
authorisation of the medicinal product is
important. It allows continued monitoring of
the benefit/risk balance of the medicinal
product.
4.9 Overdose
Symptoms
In animal studies with Flutamide Taj
Pharma alone, signs of overdose included
hypoactivity, piloerection, slow respiration,
ataxia and/or lacrimation, anorexia,
tranquilisation, emesis and
methaemoglobinaemia.
Clinical trials have been carried out with
Flutamide Taj Pharma at doses of up to
1500mg per day for periods of up to 36
weeks without reports of severe undesirable
effects. The undesirable effects reported
were gynaecomastia, breast sensitivity and
some increases in SGOT.
The acute toxic dose of Flutamide Taj
Pharma in man has not been established.
One patient survived after ingesting more
than 5 g as a single dose, with no apparent
adverse effects. Since Flutamide Taj Pharma
is an anilide compound, it has the theoretic
potential of producing
methaemoglobinaemia. Accordingly, a

patient with acute intoxication may be
cyanotic.
Management
If vomiting does not occur spontaneously it
should be induced, provided that the patient
is alert. Gastric lavage may be considered.
As in the management of overdosage with
any drug, it should be borne in mind that
multiple agents may have been taken.
General supportive measures are
appropriate, including frequent monitoring
of vital signs and close observation of the
patient. Since Flutamide Taj Pharma is
highly protein bound, dialysis may not be of
any use as treatment for overdose.
5. PHARMACOLOGICAL
PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Hormone
anatagonists and related agents, Anti-
androgens, ATC Mechanism of action
Flutamide Taj Pharma is a non-steroidal,
highly specific, orally active anti-androgenic
agent. It has been demonstrated to reduce
prostate and seminal vesicle weights in
intact immature rats and to prevent
androgen-stimulated hypertrophy of these
organs in castrated immature rats. Prostate
weights in dogs and baboons were also
reduced by Flutamide Taj Pharma treatment.
The biological activity of oral Flutamide Taj
Pharma is attributable to its
pharmacologically active metabolite,
hydroxyFlutamide Taj Pharma, which is
believed to exert an anti-androgenic effect
directly on the target tissues, either by
inhibiting androgen uptake or by blocking
cytoplasmic and nuclear binding of
androgen.
Clinical efficacy and safety
In the clinical trial performed with
Flutamide Taj Pharma linked to LHRH
agonists as neoadjuvant therapy for locally
confined prostate carcinomas, pre-radical
surgery or radiotherapy, an increase in the
survival rate has not been proven, although a
decrease in the size of the tumour, a
reduction in morbidity and surgical
consequences and a delays in the disease
progression have been witnessed.
5.2 Pharmacokinetic properties
Absorption
Flutamide Taj Pharma is rapidly and
extensively absorbed and almost completely
metabolised following oral administration.
Distribution
A high proportion of Flutamide Taj Pharma
binds to plasma proteins (94-96%) as does
its active metabolite (92-94%). The peak
plasma concentration of hydroxyFlutamide
Taj Pharma at steady state at the
recommended therapeutic dose (250mg
t.i.d.) is approximately 1700 µg/L.
Biotransformation
The major metabolite is hydroxyFlutamide
Taj Pharma, which has been demonstrated to
possess potent anti-androgenic activity.
Radiolabelled Flutamide Taj Pharma studies
reveal a rapid and extensive conversion to
its metabolites; at least 6 have been
identified in the plasma up to 8 hours after
administration.
Elimination
Approximately 45% of the administered
dose is excreted in the urine and 2% in
faeces during the first two days. The
excretion and metabolism is essentially
complete within two days. The elimination

half-life in plasma is 5 to 6 hours in adults
for Flutamide Taj Pharma and its main
metabolite hydroxyFlutamide Taj Pharma
and 8 hours in older people. The elimination
half-life at steady-state is approximately 10
hours.
5.3 Preclinical safety data
The effects observed in oral repeat dose
toxicology studies in the rat, dog and
monkey were as expected for a potent anti-
androgenic agent.
Studies have been performed in animals to
determine the tolerance after repeated oral
administration for a period of up to 6, 52 and
78 weeks in monkeys, rats and dogs,
respectively. The oral doses administered
daily reached 90mg/kg in monkeys,
40mg/kg in dogs and 180mg/kg in rats,
which corresponded to 1.5 to 18 times the
dose used in humans. In addition to weight
loss and anorexia, which occurred in all of
the animal species, vomiting was observed
in dogs and monkeys. The rest of the clinical
observations did not reveal any anomalies.
Reductions in prostate gland and seminal
vesicle weights were observed in all species
and reduced testicular weights were
observed in the rat and monkey. Histological
changes characteristic of anti-androgenic
activity were observed in all species and
there was evidence of suppression of
spermatogenesis.
In addition, an increase in the weight of the
liver in rats and dogs and elevated
transaminase levels in dogs without the
corresponding morphological changes were
observed. In rats only, the emergence of
adenomas of the interstitial testicular cells
linked to the medicinal product were
observed (although they were not dose-
dependent). This effect is related to the
mechanism of action of Flutamide Taj
Pharma and is species-specific. In a long-
term study in rats, increases were found in
the rate of occurrence of adenomas or
carcinomas of the mammary gland related to
the dose.
Mutagenicity
No mutagenic potential was observed with
Flutamide Taj Pharma in a variety of
screening tests.
Reproductive toxicity
The influence of Flutamide Taj Pharma on
fertility and the development of the progeny
has been studied in rats. Additional
teratogenicity studies have been performed
in rabbits. The effects were related to the
anti-androgenic actions of Flutamide Taj
Pharma. These effects are not relevant to the
clinical use of Flutamide Taj Pharma in the
treatment of prostate cancer.
6. PHARMACEUTICAL
PARTICULARS
6.1 List of excipients
Cellulose, microcrystalline, Lactose
monohydrate, Maize starch, pregelatinised,
Sodium laurilsulfate, Silica, colloidal
anhydrous, Magnesium stearate
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
4 years.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container

Flutamide Taj Pharma tablets are packaged
either in PVC/aluminium blister packs or in
polypropylene pots with polyethylene caps
(with optional polyethylene ullage filler),
containing 20, 21, 30 50, 60, 84, 100, 105,
250 or 10*21 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and
other handling
No special requirements.
Manufactured in India By:
TAJ PHARMACEUTICALS LIMITED
At SURVEY NO.188/1 TO 189/1,190/1 TO
4, ATHIYAWAD, DABHEL, DAMAN-
396210 (INDIA)
Flutamide Tablets USP 250mg
Taj Pharma
PACKAGE LEAFLET: INFORMATION
FOR THE USER
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 or pharmacist.
• 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 or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Flutamide Taj Pharma is and what
it is used for
2. What you need to know before you take
Flutamide Taj Pharma
3. How to take Flutamide Taj Pharma
4. Possible side effects
5. How to store Flutamide Taj Pharma
6. Contents of the pack and other
information
1. WHAT FLUTAMIDE TAJ PHARMA
IS AND WHAT IT IS USED FOR
Flutamide Taj Pharma belongs to a group of
medicines called anti-androgens. It blocks
the effect of testosterone (male sex
hormone) in the body. Flutamide Taj
Pharma is used to treat prostate cancer. It
may be taken with another medicine (called
a LHRH agonist) that decreases the levels of
testosterone. Flutamide Taj Pharma can also
be used after surgical castration.
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE FLUTAMIDE
TAJ PHARMA
Do not take Flutamide Taj Pharma:
• if you are allergic to Flutamide Taj
Pharma or any of the other ingredients of
this medicine (listed in section 6).
Flutamide Taj Pharma treats a condition
found only in men. It must not be given to
women or children.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Flutamide Taj Pharma if you:
• Have liver problems. Your doctor will
check your liver function before and
during treatment.

• Have kidney problems.
• Have heart disease.
• are at risk of osteoporosis such as if you
are a long term smoker or drinker, have
a family history of osteoporosis or are
taking medicines to stop epileptic fits
(antiepileptics) or medicines to relieve
inflammation (corticosteroids) or have
osteoporosis (brittle bones) as Flutamide
Taj Pharma can increase the risk of bone
fractures. Your doctor will measure your
bone mineral density (BMD) to check
you are not at risk; at the beginning of
your treatment and then at least on a
yearly basis.
• Suffer from chest problems such as
breathlessness.
• Are diabetic.
• Have any heart or blood vessel
conditions, including heart rhythm
problems (arrhythmia), or are being
treated with medicines for these
conditions. The risk of heart rhythm
problems may be increased when using
If you are taking Flutamide Taj Pharma
long-term you may also have your sperm
count checked if it is appropriate.
While taking this medicine you should use
an effective barrier method of contraception
i.e. condom when engaging in sexual
activity.
Other medicines and Flutamide Taj
Pharma
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines, including medicines
obtained without a prescription, especially
any of the following:
• medicines that thin the blood such as
warfarin
• theophylline, for breathing problems
• medicines that may cause damage to the
liver
• medicines that affect the electrical
activity of your heart
• leuprorelin, a medicine used to treat
some cancers
Flutamide Taj Pharma might interfere with
some medicines used to treat heart rhythm
problems (e.g. quinidine, procainamide,
amiodarone and sotalol) or might increase
the risk of heart rhythm problems when used
with some other drugs (e.g. methadone (used
for pain relief and part of drug addiction
detoxification), moxifloxacin (an antibiotic),
antipsychotics used for serious mental
illnesses).
Flutamide Taj Pharma with alcohol
You should not drink large quantities of
alcohol while being treated with this
medicine.
Pregnancy and breast-feeding
Flutamide Taj Pharma must not be
prescribed to women and therefore must not
be given to pregnant or breast-feeding
mothers.
Driving and using machines
Flutamide Taj Pharma may cause tiredness,
dizziness or confusion. Do not drive or
operate machinery if it happens to you.
Flutamide Taj Pharma tablets contain
lactose
If you have been told by your doctor that
you have an intolerance to some sugars,
such as lactose, contact your doctor before
taking this medicine.

3. HOW TO TAKE FLUTAMIDE TAJ
PHARMA
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not
sure.
• Take the tablets with a glass of water
preferably after food every 8 hours.
• Do not chew the tablets. If you do, there
is a danger you could overdose because
this medicine will be absorbed into your
body too quickly.
• The score line is only there to help you
break the tablet if you have difficulty
swallowing it whole. It is not for
dividing tablets into equal doses.
Adults (including older people)
The recommended dose is one tablet three
times daily, every 8 hours.
You may also be given another medicine
with your Flutamide Taj Pharma called a
LHRH agonist. LHRH agonists (e.g.
goserelin, buserelin) are given by injection.
In that case, it is very important that the two
medicines are taken as directed. You will
start your Flutamide Taj Pharma treatment
either at the same time as or at least a day
before taking the LHRH agonist.
If you have had your testicles removed
(castrated) you will not be given a LHRH
agonist.
Use in children
Flutamide Taj Pharma must not be given to
children.
Patients with liver problems
If you have liver problems your doctor will
arrange for you to have regular blood tests.
If you take more Flutamide Taj Pharma than
you should
You may suffer from methaemoglobinaemia
(where your blood cannot deliver as much
oxygen to your body as normal). Symptoms
can include cyanosis (bluish colouring of the
skin), blood that is darker than usual,
headache, weakness, confusion, chest pain
or vomiting.
If you take more medicine than you should,
tell your doctor immediately or go to your
nearest hospital emergency department.
If you forget to take Flutamide Taj
Pharma
Take it as soon as you remember unless it is
almost time for your next tablet. If this
happens, skip the missed tablet and take the
next tablet on time. Do not take a double
dose to make up for a forgotten tablet.
If you stop taking Flutamide Taj Pharma
Do not stop taking this medicine, even if
you are feeling well, unless your doctor tells
you to.
If you have any further questions on the use
of this medicine, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Possible side effects if you take Flutamide
Taj Pharma by itself:
Tell your doctor straight away or go to your
nearest hospital emergency department right
away if you have any of the following side
effects:

Common (may affect up to 1 in 10 people)
liver disease (hepatitis) which may cause
nausea, vomiting, itching, dark coloured
urine, pale stools, loss of appetite, yellowing
of the skin or whites of the eyes or
abdominal pain
Rare (may affect up to 1 in 1,000 people)
• Reactions similar to lupus, which can
cause joint or muscle pain or swelling,
fatigue, general feeling of being unwell,
hair loss or a butterfly shaped rash
normally across the nose and cheeks
• Difficulty breathing, shortness of breath,
wheezing or coughing
• Diarrhoea containing blood or mucus
which may be signs of inflammation of
the colon (colitis)
Very rare (may affect up to 1 in 10,000
people)
• lumps in your breast tissue
Not known (cannot be estimated from the
available data)
• Allergic reactions such as swelling of the
lips, tongue, face or throat causing
difficulty breathing or swallowing, a
rash or swollen itchy skin.
• changes in the electrical activity of the
heart (which may show up in tests which
show how the heart is working known as
“ECG” tests).
Other side effects include:
Very common (may affect more than 1 in
10 people)
• Enlarged, painful or tender breast tissue
• Production of milk from the breasts
Common (may affect up to 1 in 10 people)
• increased appetite
• difficulty sleeping
• sleepiness
• tiredness
• diarrhoea
• feeling sick (nausea)
• being sick (vomiting)
• blood tests show abnormal liver function
• Painful, itchy fluid filled lumpy skin
rash commonly known as chicken pox or
shingles. This is a sign of nerve or skin
infection caused by the herpes virus
• Swelling, especially in the arms, legs,
chest or genitals (also known as fluid
retention)
• bruising
• Loss of appetite (anorexia)
• Anxiety
• Depression
• Dizziness
• blurred vision
• Other problems with the heart or
circulation
• High blood pressure
• Constipation
• Thirst
• Indigestion or stomach pain
• Upset stomach
• Heartburn
• hives
• changes in hair growth pattern
• Hair loss
• Muscle cramps
• Reversible increases in blood
testosterone levels as seen in a blood test
• reduced sperm counts as seen in a
fertility test
• decreased sex drive

• Unusual weakness (asthenia)
• Headache
• Chest pain
• General feeling of being unwell
• Hot flushes
people)
• Cough
• Rash or blisters resulting from skin
sensitive to strong or long periods of
sunlight
Possible side effects if you take Flutamide
Taj Pharma with LHRH agonists
The following side effects have been seen in
patients taking Flutamide Taj Pharma
together with LHRH agonist treatment. They
could be additional side effects or the same
as above but seen more commonly:
Tell your doctor straight away or go to your
nearest hospital emergency department right
away if you have any of the following side
effects:
• Lack of white blood cells which may
cause more frequent infections such as
fever, sore throat or mouth ulcers
people)
• serious skin reactions such as painful red
areas, fluid filled blisters or peeling of
layers of skin
• pale, yellow or bluish colouring of the
skin especially around the lips, blood
that is darker than normal, loss of
appetite, headache, vomiting, weakness,
chest pain, cold or numb hands or feet
which are signs that your blood cannot
deliver as much oxygen to the body as
normal
• mood or personality changes,
disorientation, forgetfulness, mental
fogginess. These are signs of a disease of
the brain caused by liver problems
• Not known (cannot be estimated from
the available data)
• severe pain or swelling in one of your
legs, sudden severe chest pain that might
spread to your left arm, sudden
breathlessness, sudden cough without an
obvious cause, problems speaking,
irregular muscle movements, sudden
severe stomach pain, weakness, strange
feeling or numbness in any part of the
body. This may suggest you have a
blood clot.
Other side effects include:
Very common (may affect more than 1 in
10 people)
• hot flushes
• decreased sex drive
• problems getting or maintaining an
erection
• feeling sick (nausea)
• being sick (vomiting)
• diarrhoea
• Bleeding or bruising more easily or for a
longer time. These may be signs of a
lack of platelets
• (blood clotting cells) in the blood
• Numbness or lack of sense of touch
• Confusion
• Nervousness
• Nerve or muscle problems
• Joint or muscle pain
• Reduced bone mineral density or
osteoporotic disorders (these can mean

you are more likely to suffer broken
bones)
• Painful urination
• Changes in how often you urinate
• Change in urine colour to amber or
yellow-green
• Skin irritation where the LHRH agonist
was injected
• Raised levels of blood urea and
creatinine seen in a blood test
• Very rare (may affect up to 1 in 10,000
people)
• Raised blood sugar levels
• Worsening of existing diabetes
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
By reporting side effects you can help
provide more information on the safety of
this medicine.
5. HOW TO STORE YOUR
MEDICINE
Keep this medicine out of the sight and
reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry
date which is stated on the packaging after
“EXP”. The expiry date refers to the last day
of the 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.
6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Flutamide Taj Pharma contains
The active substance is Flutamide Taj
Pharma. Each tablet contains 250mg
The other ingredients are microcrystalline
cellulose, lactose monohydrate (see section
2 ‘Flutamide Taj Pharma contains lactose'),
pregelatinised maize starch, sodium
laurilsulfate, colloidal anhydrous silica,
magnesium stearate.
What Flutamide Taj Pharma tablets look
like and contents of the pack
Flutamide Taj Pharma tablets are available
in blister packs or plastic pots containing 20,
21, 30, 50, 60, 84, 100, 105, 250 or 10 x 21
tablets.
Not all pack sizes may be marketed.
Manufactured in India By:
TAJ PHARMACEUTICALS LIMITED
At SURVEY NO.188/1 TO 189/1,190/1 TO
4, ATHIYAWAD, DABHEL, DAMAN-
396210 (INDIA)

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