post-title portfolio-title Flutamide Tablets IP 250mg Taj Pharma 2020-02-18 07:06:32 no no

Flutamide Tablets IP 250mg Taj Pharma

Flutamide Tablets IP 250mg Taj Pharma

Overview

INTRODUCTION

Flutamide 250mg Tablet is used in the treatment of cancer of the prostate gland. It may be also used to treat other conditions, as determined by the doctor. It works by blocking the effects of male hormones such as testosterone.

Flutamide 250mg Tablet should be taken with or without food, preferably at a fixed time every day. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to.

Breast enlargement in males, sleepiness, nausea, and vomiting are some very common side effects of this medicine. Other than this, yellowing of skin, loss of appetite, shortness of breath, abdominal pain, dark urine, and skin rashes are some side effects that require immediate action. Regular blood tests are required to check your blood cells along with liver function during treatment with this medicine. It makes your skin more sensitive towards sunlight, hence take extra caution while going out.

Before taking it, tell your doctor if have diabetes, liver, or kidney problems or are taking any medicines to treat infections. Many other medicines can affect, or be affected by, this medicine so let your doctor know all medications you are using. This medicine is not recommended during pregnancy or while breastfeeding. It may harm your baby. The use of effective contraception by both males and females during treatment is important to avoid pregnancy.? You may be asked for regular monitoring of blood glucose level while on treatment.

USES OF FLUTAMIDE TABLET

  • Prostate cancer

SIDE EFFECTS OF FLUTAMIDE TABLET

Common

  • Breast enlargement in male
  • Sleepiness
  • Nausea
  • Vomiting
  • Abdominal pain
  • Anemia (low number of red blood cells)
  • Breast tenderness
  • Constipation
  • Decreased appetite
  • Decreased libido
  • Depression
  • Dizziness
  • Indigestion
  • Flatulence
  • Hot flashes
  • Increased liver enzymes
  • Rash
  • Weakness
  • Weight gain

HOW TO USE FLUTAMIDE TABLET

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Flutamide 250mg Tablet may be taken with or without food, but it is better to take it at a fixed time.

HOW FLUTAMIDE TABLET WORKS

Flutamide 250mg Tablet blocks the effect of the natural male hormones on the growth of prostate cells. Flutamide 250mg Tablet also blocks the undesired effects of androgens in females such as excessive hair growth and acne.

SAFETY ADVICE

warningsAlcohol

UNSAFE

It is unsafe to consume alcohol with Flutamide 250mg Tablet.

warningsPregnancy

CONSULT YOUR DOCTOR

Flutamide 250mg Tablet is unsafe to use during pregnancy as there is definite evidence of risk to the developing baby. However, the doctor may rarely prescribe it in some life-threatening situations if the benefits are more than the potential risks. Please consult your doctor.

warningsBreastfeeding

CONSULT YOUR DOCTOR

Information regarding the use of Flutamide 250mg Tablet during breastfeeding is not available. Please consult your doctor.

warningsDriving

CONSULT YOUR DOCTOR

It is not known whether Flutamide 250mg Tablet alters the ability to drive. Do not drive if you experience any symptoms that affect your ability to concentrate and react.

warningsKidney

SAFE IF PRESCRIBED

Flutamide 250mg Tablet is probably safe to use in patients with kidney disease. Limited data available suggests that dose adjustment of Flutamide 250mg Tablet may not be needed in these patients. Please consult your doctor.

warningsLiver

UNSAFE

Flutamide 250mg Tablet is probably unsafe to use in patients with liver disease and should be avoided. Please consult your doctor.
“You should not take FLUTAMIDE tablets if you have liver problems or if you are allergic to it. Women should not take FLUTAMIDE tablets.

Flutamide Tablets IP 250mg Taj Pharma

1. NAME OF THE MEDICINAL PRODUCT

Flutamide Tablets IP 250mg Taj Pharma

2.QUALITATIVE AND QUANTITATIVE COMPOSITION??????????????????????????????

Each tablet contains:
Flutamide IP???????????? ????????250mg
Lactose monohydrate????? 221.7mg
Excipients????? q.s.

For the full list of excipients, see section 6.1.

3.PHARMACEUTICAL FORM????

Tablets.

Yellow biconvex tablets.

4.CLINICAL PARTICULARS

4.1 Therapeutic indications

Flutamide is indicated for the treatment of advanced prostatic carcinoma in which suppression of testosterone effects is indicated. Flutamide 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 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 is used as initial treatment with an LHRH agonist, a reduction in severity of the flare reaction may be achieved if treatment with Flutamide is initiated before the LHRH agonist. Consequently, it is recommended that treatment with Flutamide should commence simultaneously or at least 24 or more hours before the LHRH agonist.

The administration of Flutamide 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 should only be initiated after careful assessment of the individual benefits and risks.

Flutamide 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 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 treatment. The hepatic effects were usually reversible following discontinuation of flutamide, although cases have been reported of death after severe liver damage linked to the use of flutamide. 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 therapy. Treatment with Flutamide 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. 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 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 must be suspended.

Impaired renal function

Flutamide 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 who have not received medical or surgical castration. Flutamide 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 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 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.

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 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. 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. Patients should be monitored for the development of respiratory symptoms such as dyspnoea during the first few weeks of therapy.

Flutamide 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 and leuprorelin; nevertheless, in the combined treatment with flutamide 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 monotherapy. Therefore careful monitoring of prothrombin time is recommended and it may be necessary to adjust the dose of anticoagulant if Flutamide 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 treatment. Theophylline is primarily metabolised by CYP 1A2 which is the primary enzyme responsible for the conversion of Flutamide to its active agent 2-hydroflutamide.

Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Flutamide 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 is intended only for use in male patients. Contraceptive measures should be taken during treatment.

Flutamide may cause foetal harm when administered to a pregnant woman. In animal studies, the reproductive toxicity of flutamide was associated with the anti-androgenic activity of this agent. There was decreased 24-hour survival in the offspring of rats treated with flutamide at doses of 30, 100, or 200 mg/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 (15 mg/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 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. 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 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 famotidine has a low cardiovascular risk potential, significantly less than that of diethylstilboestrol.

Combined treatment

The undesirable effects most frequently reported during combined treatment of famotidine 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 Famotidine 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 famotidine 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)

SOCMonotherapyCombination therapy with LHRH analog
Infections and infestations
RareHerpes zoster
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Very rareNeoplasm of the male breast*
Blood and lymphatic system disorders
RareAnaemia, leucopenia, thrombocytopenia
Very rareHaemolytic anaemia, megalocytic anaemia, methaemoglobinaemia, sulfhaemoglobinaemia, macrocytic anaemia
Immune system disorders
RareLupus-like syndrome
Metabolism and nutrition disorders
CommonIncreased appetite
RareAnorexiaAnorexia
Very rareHyperglycaemia, aggravation of diabetes mellitus
Psychiatric disorders
CommonInsomnia
RareAnxiety, depressionDepression, anxiety
Nervous system disorders
RareDizziness, headacheNumbness, confusion, nervousness, drowsiness
Eye disorders
RareBlurred vision
Cardiac disorders
RareCardiovascular disorders
Not knownQT prolongation (see sections 4.4 and 4.5)
Vascular disorders
Very commonHot flushes
RareHot flushes, hypertension, lymphoedemaHypertension
Not knownThromboembolism
Respiratory, thoracic and mediastinal disorders
RareInterstitial pneumonitis, dyspnoea
Very rareCoughPulmonary symptoms (e.g.?dyspnoea), interstitial lung disease
Gastrointestinal disorders
Very commonDiarrhoea, nausea, vomiting
CommonNausea, vomiting, diarrhoea
RareNon-specific abdominal disorders, constipation, ulcer-like pain, dyspepsia, colitis, upset stomach, heartburnNon-specific abdominal disorders, abdominal pain
Hepatobiliary disorders
CommonHepatitis
UncommonHepatitis
RareLiver function test abnormalities (see section 4.4)Hepatic dysfunction, jaundice
Very rareCholestatic jaundice, hepatic encephalopathy, liver cell necrosis, hepatotoxicity with fatal outcome
Skin and subcutaneous tissue disorders
RareUrticaria, pruritus, ecchymosis, alteration of the hair growth pattern and loss of hair (head)Rash
Very rarePhotosensitivity reactionsPhotosensitivity reactions, erythema, ulcers, bullous eruptions, epidermal necrolysis
Musculoskeletal and connective tissue disorders
RareMuscle crampsNeuromuscular symptoms, reduced bone mineral density, osteoporotic disorders, arthralgia, myalgia
Renal and urinary disorders
RareGenitourinary tract symptoms, dysuria, changes in urinary frequency, change in urine colour to amber or yellow-green
Reproductive system and breast disorders
Very commonGynaecomastia and/or breast pain, breast tenderness, galactorrhoeaDecreased libido, impotence
UncommonGynaecomastia
RareReversible increase of serum testosterone levels, reduced sperm counts, decreased libido
General disorders and administration site conditions
CommonSomnolence, tiredness
RareOedema, asthenia, malaise, thirst, chest pain, hot flushes, weaknessOedema, injection site irritation
Investigations
CommonTransient abnormal liver functionChanges in liver function
RareElevated 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 famotidine. 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 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 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 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. In addition, hot flushes and changes in hair character can occur.

Following the marketing of flutamide, 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 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 famotidine at doses of up to 1500 mg 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 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 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 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,

Mechanism of action

Flutamide 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 treatment. The biological activity of oral flutamide is attributable to its pharmacologically active metabolite, hydroxyflutamide, 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 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 is rapidly and extensively absorbed and almost completely metabolised following oral administration.

Distribution

A high proportion of flutamide binds to plasma proteins (94-96%) as does its active metabolite (92-94%). The peak plasma concentration of hydroxyflutamide at steady state at the recommended therapeutic dose (250 mg t.i.d.) is approximately 1700 ?g/L.

Biotransformation

The major metabolite is hydroxyflutamide, which has been demonstrated to possess potent anti-androgenic activity. Radiolabelled flutamide 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 and its main metabolite hydroxyflutamide and 8 hours in older people. The elimination half-life at steady-state is approximately 10 hours.

5.3 Preclinical safety data

Administration of lamivudine in animal toxicity studies at high doses was not associated with any major organ toxicity. At the highest dosage levels, minor effects on indicators of liver and kidney function were seen together with occasional reduction in liver weights. Reduction of erythrocytes and neutrophil counts were identified as the effects most likely to be of clinical relevance. These events were seen infrequently in clinical studies.

Lamivudine was not mutagenic in bacterial tests but, like many nucleoside analogues showed activity in an?in vitro?cytogenetic assay and the mouse lymphoma assay. Lamivudine was not genotoxic?in vivo?at doses that gave plasma concentrations around 60-70 times higher than the anticipated clinical plasma levels. As the?in vitro?mutagenic activity of lamivudine could not be confirmed by?in vivo?tests, it is concluded that lamivudine should not represent a genotoxic hazard to patients undergoing treatment.

Reproductive studies in animals have not shown evidence of teratogenicity and showed no effect on male or female fertility. Lamivudine induces early embryolethality when administered to pregnant rabbits at exposure levels comparable to those achieved in man, but not in the rat even at very high systemic exposures.

The results of long term carcinogenicity studies with lamivudine in rats and mice did not show any carcinogenic potential.

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 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.

7. Manufactured in India By:
TAJ PHARMACEUTICALS LIMITED
Mumbai, India
Survey No.188/1 to 189/1,190/1 to 4,
Athiyawad, Dabhel,
Daman- 396210 (INDIA)

Flutamide Tablets IP 250mg Taj Pharma
Package leaflet: Information for the patient

Flutamide

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 itagain.
  • If you have any further questions, ask your doctor orpharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harmthem, even if their signs of illness are the same asyours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section4.

What is in this leaflet:

  1. What Flutamide is and what it is usedfor
  2. What you need to know before you take Flutamide
  3. How to take Flutamide
  4. Possible sideeffects
  5. How to store Flutamide
  6. Contents of the pack and otherinformation
1 WHAT FLUTAMIDE IS AND WHAT IT IS USED FOR

Flutamide belongs to a group of medicines called anti-androgens. It blocks the effect of testosterone (male sex hormone) in the body. Flutamide is used to treat prostate cancer. It may be taken with another medicine (called a LHRH agonist) that decreases the levels of testosterone. Flutamide can also be used after surgical castration.

2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUTAMIDE

Do not take Flutamide:
? if you are allergic to flutamide or any of the other ingredients of this medicine (listed in section 6).
Flutamide 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 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 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 Flutamide.
If you are taking Flutamide 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
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 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 with alcohol
You should not drink large quantities of alcohol while being treated with this medicine.

Pregnancy and breast-feeding
Flutamide must not be prescribed to women and therefore must not be given to pregnant or breast-feeding mothers.

Driving and using machines
Flutamide may cause tiredness, dizziness or confusion. Do not drive or operate machinery if it happens to you.

Flutamide 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

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 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 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 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 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
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
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 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
? diarrhea
? feeling sick (nausea)
? being sick (vomiting)
? blood tests show abnormal liver function

Rare (may affect up to 1 in 1,000 people)
? 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

Very rare (may affect up to 1 in 10,000 people)
? cough
? rash or blisters resulting from skin sensitive to strong or long periods of sunlight

Possible side effects if you take flutamide with LHRH agonists
The following side effects have been seen in patients taking Flutamide 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:

Rare (may affect up to 1 in 1,000 people)
? lack of white blood cells which may cause more frequent infections such as fever, sore throat or mouth ulcers

Very rare (may affect up to 1 in 10,000 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? 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

Rare (may affect up to 1 in 1,000 people)
? 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 STOREFLUTAMIDE

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 contains

The active substance is flutamide.

Each tablet contains:
Flutamide IP???????????????????? 250mg
Lactose monohydrate????? 221.7mg
Excipients????? q.s.

The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2 ?Flutamide contains lactose’), pregelatinised maize starch, sodium laurilsulfate, colloidal anhydrous silica, magnesium stearate.

Contents of the pack

The tablets are yellow, curved on both sides.
Flutamide 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

7. Manufactured in India By:
TAJ PHARMACEUTICALS LIMITED
Mumbai, India
at SURVEY NO. 188/1, 190/1TO 4,
ATHIYAWAD , DABHEL,
DAMAN- 396210 (INDIA)

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