Flutamide for Tablets USP 250mg 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.

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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.

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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

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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 2hydroFlutamide 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

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Monotherapy

Very rare - (<1 in 10,000)

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.

Not known – (cannot be estimated from the available data) SOC

Monotherap Combination y therapy with LHRH analog

Infections and infestations It has been proven that Flutamide Taj Pharma has a low cardiovascular risk potential, significantly less than that of diethylstilboestrol.

Combined treatment

Rare

Herpes zoster

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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.

Very rare Neoplasm of the male breast*

Rare

Anaemia, leucopenia, thrombocytopenia

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.

Very rare

Haemolytic anaemia, megalocytic anaemia, methaemoglobinae mia, sulfhaemoglobinae mia, macrocytic anaemia

The following convention has been utilised for the frequency classification:

Immune system disorders

Very common - (≥1 in 10)

Rare

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)

Blood and lymphatic system disorders

Lupus-like syndrome

Metabolism and nutrition disorders Common Increased

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appetite Rare

Anorexia

Very rare

lymphoedem a Anorexia Hyperglycaemia, aggravation of diabetes mellitus

Not known

Thromboembolism

Respiratory, thoracic and mediastinal disorders

Psychiatric disorders Rare Common Insomnia Rare

Anxiety, depression

Interstitial pneumonitis, dyspnoea

Depression, anxiety Very rare Cough

Nervous system disorders Rare

Dizziness, headache

Numbness, confusion, nervousness, drowsiness

Rare

Gastrointestinal disorders Very common

Eye disorders Blurred vision

Pulmonary symptoms (e.g. dyspnoea), interstitial lung disease

Diarrhoea, nausea, vomiting

Common Nausea, vomiting, diarrhoea

Cardiac disorders Rare Rare

Cardiovascul ar disorders

Not known

QT prolongation (see sections 4.4 and 4.5)

Vascular disorders Very common

Hot flushes

Non-specific abdominal disorders, constipation, ulcer-like pain, dyspepsia, colitis, upset stomach, heartburn

Hepatobiliary disorders Common Hepatitis

Rare

Hot flushes, Hypertension hypertension,

Non-specific abdominal disorders, abdominal pain

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Uncomm on

Hepatitis

arthralgia, myalgia Renal and urinary disorders

Rare

Liver Hepatic function test dysfunction, abnormalities jaundice (see section 4.4)

Very rare

Cholestatic jaundice, hepatic encephalopathy, liver cell necrosis, hepatotoxicity with fatal outcome

Skin and subcutaneous tissue disorders Rare

Urticaria, Rash pruritus, ecchymosis, alteration of the hair growth pattern and loss of hair (head)

Rare

Genitourinary tract symptoms, dysuria, changes in urinary frequency, change in urine colour to amber or yellowgreen

Reproductive system and breast disorders Very Gynaecomast Decreased libido, common ia and/or impotence breast pain, breast tenderness, galactorrhoea Uncomm on Rare

Very rare Photosensitiv Photosensitivity ity reactions reactions, erythema, ulcers, bullous eruptions, epidermal necrolysis

Gynaecomastia

Reversible increase of serum testosterone levels, reduced sperm counts, decreased libido

Musculoskeletal and connective tissue disorders

General disorders and administration site conditions

Rare

Common Somnolence, tiredness

Muscle cramps

Neuromuscular symptoms, reduced bone mineral density, osteoporotic disorders,

Rare

Oedema, asthenia, malaise,

Oedema, injection site irritation

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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.

thirst, chest pain, hot flushes, weakness Investigations Common Transient Changes in liver abnormal function 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.

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

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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, Antiandrogens, 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 Âľg/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

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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.

mechanism of action of Flutamide Taj Pharma and is species-specific. In a longterm study in rats, increases were found in the rate of occurrence of adenomas or carcinomas of the mammary gland related to the dose.

5.3 Preclinical safety data

Mutagenicity

The effects observed in oral repeat dose toxicology studies in the rat, dog and monkey were as expected for a potent antiandrogenic agent.

No mutagenic potential was observed with Flutamide Taj Pharma in a variety of screening tests.

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 dosedependent). This effect is related to the

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 Phar ma Tablets USP 250 mg Taj Phar ma : U ses -Anti-Ca ncer, Side Effects , Interactions, Pi ctures, Warnings, Fluta mide Taj P harma D osage & Rx Info | Flutamide Taj Phar ma Uses , Side Effects - Na usea and Vomiting , Fluta mide Taj P harma : I ndicati ons To treat pr ostatic car cinoma, Side E ffe cts - Naus ea, diarrhea, vomiting, diz zines s, Warni ngs, Flutami de Taj Phar ma - Dr ug Information - Taj P harma, Fluta mide Taj P harma dose Taj pharma ceuti cals Flutami de Taj Phar ma interactions, Taj P harma ceutical Fluta mide Taj P harma contraindications, Fluta mide Taj Phar ma pri ce, Flutami de Taj Phar ma T aj Pharma Fluta mide Taj Phar ma 25 0mg, SMP C- Taj Pharma Stay conne cted to all updated on Flutami de Taj Phar ma Taj Phar ma ceuticals Taj phar mace uticals. Patient I nformation Lea flets, SMPC.

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, DAMAN396210 (INDIA)

Flutamide Tablets USP 250mg Taj Pharma

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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

2.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Do not take Flutamide Taj Pharma:

•

•

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•

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 YOU NEED TO KNOW BEFORE YOU 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.

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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 Flutamide Taj Pharma.

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.

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3. HOW TO TAKE FLUTAMIDE TAJ PHARMA

If you take more Flutamide Taj Pharma than you should

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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.

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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 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:

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Common (may affect up to 1 in 10 people)

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

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

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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) •

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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

increased appetite difficulty sleeping sleepiness tiredness diarrhoea feeling sick (nausea) being sick (vomiting) blood tests show abnormal liver function

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

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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

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• • • • •

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

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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: 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

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

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

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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

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• • • • • • • •

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 Flutamide Taj Pharma.

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, DAMAN396210 (INDIA)