Bicalutamide Teva 50 mg Film-coated Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Bicalutamide
Available from:
Teva Pharma B.V.
ATC code:
L02BB; L02BB03
INN (International Name):
Bicalutamide
Dosage:
50 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Anti-androgens; bicalutamide
Authorization status:
Marketed
Authorization number:
PA0749/032/001
Authorization date:
2007-05-18

BICALUTAMIDE TEVA 50 mg

FILM-COATED TABLETS

Bicalutamide

PATIENT 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 Bicalutamide Teva is and what it is

used for

2. What you need to know before you take

Bicalutamide Teva

3. How to take Bicalutamide Teva

4. Possible side effects

5. How to store Bicalutamide Teva

6. Contents of the pack and other

information

What Bicalutamide Teva is and

what it is used for

Bicalutamide contains a medicine called

bicalutamide. This belongs to a group of

medicines called ‘anti-androgens’.

Bicalutamide Teva is used to treat

prostrate cancer.

It works by blocking the effects of male

hormones such as testosterone.

What you need to know before

you take Bicalutamide Teva

Do not take Bicalutamide Teva

if you are allergic to bicalutamide or any

of the other ingredients of this medicine

(listed in section 6)

if you are already taking a medicine

called cisapride or certain anti-histamine

medicines (terfenadine or astemizole).

if you are a woman.

Do not take Bicalutamide if any of the above

apply to you. If you are not sure, talk to

your doctor or pharmacist before taking

Bicalutamide.

Bicalutamide must not be given to children.

Warnings and precautions

Talk to your doctor or pharmacist before

taking Bicalutamide Teva:

if you have any of the following: 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

Bicalutamide Teva.

if you are taking blood thinners or

medicines to prevent blood clots.

if you have problems with your liver.

if you have diabetes and are already

taking an ‘LHRH analogue’. These include

goserelin, buserelin, leuprorelin and

triptorelin.

if you go into hospital, tell the medical staff

that you are taking Bicalutamide Teva.

if you are taking Bicalutamide Teva, you

and/or your partner should use birth

control while you are taking Bicalutamide

Teva and for 130 days after stopping

Bicalutamide Teva.

Talk to your doctor if you have questions

about birth control.

Other medicines and Bicalutamide Teva

Tell your doctor or pharmacist if you are

taking, have recently taken or might take any

other medicines. This includes medicines

obtained without a prescription and herbal

medicines. This is because Bicalutamide

Teva can affect the way other medicines

work. Also some other medicines can affect

the way Bicalutamide Teva works.

Do not take Bicalutamide Teva if you are

already taking any of the following

medicines:

Cisapride (used for some types of

indigestion)

Certain anti-histamine medicines

(terfenadine or astemizole).

Bicalutamide Teva 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 illness.

Also, tell your doctor or pharmacist if you

are taking any of the following medicines:

Medicines taken by mouth to prevent

blood clots (oral anti-coagulants) e.g.

warfarin. Blood thinners or medicines to

prevent blood clots.

Ciclosporin (to suppress your immune

system).

Calcium channel blockers (to treat high

blood pressure or some heart conditions).

Cimetidine (for stomach problems).

Ketoconazole (to treat infections caused by

a fungus).

Pregnancy, breast-feeding and fertility

Bicalutamide must not be taken by women,

including pregnant women or mothers who

are breast-feeding their babies.

Bicalutamide may have an effect on male

fertility which could be reversible.

Driving and using machines

Bicalutamide Teva is not likely to affect

you being able to drive or use any tools or

machines. However, if you feel sleepy take

care with these activities.

Bicalutamide Teva contains lactose

If you have been told by your doctor that you

have an intolerance to some sugars, contact

your doctor before taking this medicinal

product.

Bicalutamide contains Sodium

This medicine contains less than 1 mmol

sodium (23 mg) per tablet, that is to say

essentially ‘sodium-free’.

How to take Bicalutamide Teva

Always take this medicine exactly as your

doctor has told you. Check with your doctor

or pharmacist if you are not sure.

The recommended dose for an adult is one

tablet each day.

Swallow the tablet whole with a drink of

water.

Try to take your tablet at the same time

each day.

Do not stop taking this medicine even if

you feel well, unless your doctor tells you

If you take more Bicalutamide Teva than you

should

If you take more Bicalutamide than

prescribed by your doctor, talk to a doctor or

go to a hospital straight away.

If you forget to take Bicalutamide Teva

If you forget to take a dose, skip the missed

dose and take the next dose as usual.

Do not take a double dose (two doses at

the same time) to make up for a forgotten

dose.

If you stop taking Bicalutamide Teva

Do not stop taking the medicine even if you

feel absolutely healthy, unless your doctor

tells you to.

If you have any further questions on the

use of this medicine, ask your doctor or

pharmacist.

Possible side effects

Like all medicines, this medicine can cause

side effects, although not everybody gets

them.

Contact your doctor or seek medical help

immediately if you experience any of the

following:

Allergic reactions

Uncommon: may affect up to 1 in 100 people

The symptoms can include sudden onset of:

Rash, itching or hives on the skin.

Swelling of the face, lips, tongue, throat or

other parts of the body.

Shortness of breath, wheezing or trouble

breathing. If this happens to you, see a

doctor straight away.

11.06.2019

18.06.2019

160x360 mm

Teva Hungary

9 pt

11.06.2019

1. Pharmacode

position

1. Black

2. PMS Green

AAAL4257 - Bicalutamide 50 mg -, PIL, Teva Ireland

Also tell your doctor straight away if you

notice any of the following:

Very common: may affect more than 1 in

10 people

Pain in your abdomen.

Blood in your urine.

Common: may affect up to 1 in 10 people

Yellowing of the skin or whites of your

eyes (jaundice). These may be signs of

liver problems or in rare cases (may affect

up to 1 in 1,000 people) liver failure.

Uncommon: may affect up to 1 in 100 people

Serious shortness of breath or shortness

of breath which suddenly gets worse.

This may be with a cough or high

temperature (fever). These may be signs

of an inflammation of the lungs called

‘interstitial lung disease’.

Not known: frequency cannot be estimated

from the available data

Changes in ECG (QT prolongation).

Other possible side effects:

Very common: may affect more than 1 in

10 people

Dizziness.

Constipation.

Feeling sick (nausea).

Swelling and tenderness of your breasts.

Hot flushes.

Feeling weak.

Swelling.

Low levels of red blood cells (anaemia).

This may make you feel tired or look pale.

Common: may affect up to 1 in 10 people

Loss of appetite.

Reduced sex drive.

Depression.

Feeling sleepy.

Indigestion.

Wind (flatulence).

Hair loss.

Hair re-growth or growth of extra hair.

Dry skin.

Itching.

Skin rash.

Being unable to get an erection

(impotence).

Weight gain.

Chest pain.

Reduced heart function.

Heart attack.

Rare: may affect up to 1 in 1,000 people

Increased skin sensitivity to sunlight.

Your doctor may do blood tests to check for

any changes to your blood.

Do not be concerned by this list of possible

side effects. You may not get any of them.

Reporting of side effects

If you get any side effects, talk to your

doctor, pharmacist or nurse. This includes

any possible side effects not listed in this

leaflet. You can also report side effects

directly via HPRA Pharmacovigilance,

Earlsfort Terrace, IRL - Dublin 2; Tel:

+353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie;

E-mail: medsafety@hpra.ie. By reporting

side effects you can help provide more

information on the safety of this medicine.

How to store Bicalutamide Teva

Keep this medicine out of the sight and reach

of children.

Store in the original package.

Do not use this medicine after the expiry

date which is stated on the blister and outer

packaging. The expiry date refers to the last

day of that 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.

Contents of the pack and other

information

What Bicalutamide Teva contains

- The active substance is bicalutamide.

Each film-coated tablet contains 50 mg

bicalutamide.

- The other ingredients are:

Core: Microcrystalline cellulose, povidone,

croscarmellose sodium, sodium

laurilsulfate, lactose monohydrate,

anhydrous colloidal silica, magnesium

stearate,

Coating: Hypromellose, polydextrose,

titanium dioxide, macrogol 4000.

What Bicalutamide Teva looks like and

contents of the pack

Bicalutamide Teva 50 mg Film-coated

Tablets are white to off-white biconvex film-

coated tablets, debossed with “93” on one

side and “220” on the other.

Package sizes: 20, 28, 30, 40, 50, 56, 60, 84,

90 and 100 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and

Manufacturer

Teva Pharma B.V.,

Swensweg 5

2031GA Haarlem

The Netherlands

Manufacturers

Teva UK Ltd.,

Brampton Road,

Hampden Park,

Eastbourne,

East Sussex,

BN22 9AG

England

Pharmachemie B.V.,

Swensweg 5,

PO Box 552,

2003 RN Haarlem,

The Netherlands

Galien LPS,

Rue Bellocier,

89107 Sens,

France

Teva Pharmaceutical Works Private Limited

Company,

Pallagi ut 13,

Debrecen,

Hungary

This medicinal product is authorised in

the Member States of the EEA under the

following names:

Austria

Bicalutamid Teva 50 mg

Filmtabletten

Belgium

Bicalutamide Teva 50 mg

filmomhulde tabletten

Czech Republic

Bicaluplex 50 mg

Denmark

Bicalutamide Teva

Estonia

Bicalutamide-Teva

France

BICALUTAMIDE TEVA 50 mg,

comprimé pelliculé

Germany

Bicalutamid Teva 50 mg

Filmtabletten

Greece

Bicalutamide Teva 50 mg

Ireland

Bicalutamide Teva 50 mg

Film-coated Tablets

Italy

Bicalutamide Teva 50 mg,

compresse rivestite con film

Latvia

BICALUTAMIDE-TEVA 50 mg

apvalkotās tabletes

Lithuania

Bicalutamide-Teva 50 mg

plėvele dengtos tabletės

Luxembourg

Bicalutamide Teva 50 mg

comprimés pelliculés

Netherlands

Bicalutamide 50 PCH,

filmomhulde tabletten 50 mg

Norway

Bicalutamide Teva 50 mg

filmdrasjert tablet

Poland

Bicalutamide Teva, 50 mg,

tabletki powlekane

Portugal

Bicalutamida Teva 50mg

comprimido revestido por

película

Slovakia

Bicalutamid-Teva 50 mg

Slovenia

Bikalutamid Teva 50 mg

filmsko obložene tablete

Sweden

Bicalutamide Teva 50 mg

filmdragerade tabletter

United Kingdom Bicalutamide 50 mg film

coated tablets

This leaflet was last revised in June 2019.

AAAL4257

11.06.2019

18.06.2019

160x360 mm

Teva Hungary

9 pt

11.06.2019

1. Pharmacode

position

1. Black

2. PMS Green

AAAL4257 - Bicalutamide 50 mg -, PIL, Teva Ireland

Health Products Regulatory Authority

01 October 2019

CRN008QJH

Page 1 of 6

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Bicalutamide Teva 50 mg Film-coated Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 50 mg bicalutamide.

Excipient with known effect:

Each tablet contains 33.25 mg lactose.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated Tablet

White to off-white biconvex film-coated tablets, debossed with "93" on one side and "220" on the other.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Treatment of advanced prostate cancer in combination with luteinising hormone-releasing hormone (LHRH) analogue therapy

or surgical castration.

4.2 Posology and method of administration

Posology

Adult males including the elderly:

One tablet (50 mg) once daily a day.

Treatment with Bicalutamide should be started at least 3 days before commencing treatment with an LHRH analogue, or at the

same time as surgical castration.

Renal impairment

No dosage adjustment is necessary for patients with renal impairment.

Hepatic impairment

No dosage adjustment is necessary for patients with mild hepatic impairment. Increased accumulation may occur in patients

with moderate to severe hepatic impairment (see section 4.4).

Paediatric population

Bicalutamide is contraindicated for use in children (see section 4.3).

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Bicalutamide is contraindicated in females and children (see section 4.6).

Co-administration of terfenadine, astemizole or cisapride with Bicalutamide is contraindicated (see section 4.5).

4.4 Special warnings and precautions for use

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Initiation of treatment should be under the direct supervision of a specialist.

Bicalutamide is extensively metabolised in the liver. Data suggest that its elimination may be slower in subjects with severe

hepatic impairment, and this could lead to increased accumulation of bicalutamide. Therefore, Bicalutamide should be used

with caution in patients with moderate to severe hepatic impairment.

Periodic liver function testing should be considered due to the possibility of hepatic changes. The majority of changes are

expected to occur within the first 6 months of bicalutamide therapy.

Severe hepatic changes and hepatic failure have been observed rarely with bicalutamide and fatal outcomes have been

reported (see section 4.8) Bicalutamide therapy should be discontinued if changes are severe.

A reduction in glucose tolerance has been observed in males receiving LHRH agonists. This may manifest as diabetes or loss of

glycaemic control in those with pre-existing diabetes. Consideration should therefore be given to monitoring blood glucose in

patients receiving bicalutamide in combination with LHRH agonists.

Bicalutamide has been shown to inhibit cytochrome P450 (CYP 3A4), as such caution should be exercised when

co-administered with drugs metabolised predominantly by CYP 3A4 (see sections 4.3 and 4.5).

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 Bicalutamide.

Antiandrogen therapy may cause morphological changes in spermatozoa. Although the effect of bicalutamide on sperm

morphology has not been evaluated and no such changes have been reported for patients who received bicalutamide, patients

and/or their partners should follow adequate contraception during and for 130 days after bicalutamide therapy.

Potentiation of coumarin anticoagulant effects have been reported in patients receiving concomitant bicalutamide therapy,

which may result in increased Prothrombin Time (PT) and International Normalised Ratio (INR). Some cases have been

associated with risk of bleeding. Close monitoring of PT/INR is advised and anticoagulant dose adjustment should be

considered (see sections 4.5 and 4.8).

Excipients

Lactose

This medicinal product contains lactose.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption

should not take this medicinal product.

Sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

4.5 Interaction with other medicinal products and other forms of interactions

There is no evidence of any pharmacodynamic or pharmacokinetic interactions between bicalutamide and LHRH analogues.

In vitro studies have shown that R-bicalutamide is an inhibitor of CYP 3A4, with lesser inhibitory effects on CYP 2C9, 2C19, and

2D6 activity.

Although clinical studies using antipyrine as a marker of cytochrome P450 (CYP) activity showed no evidence of a drug

interaction potential with bicalutamide, mean midazolam exposure (AUC) was increased by up to 80%, after co-administration

of bicalutamide for 28 days. For drugs with a narrow therapeutic index, such an increase could be of relevance. As such,

concomitant use of terfenadine, astemizole and cisapride is contraindicated (see section 4.3) and caution should be exercised

with the co-administration of Bicalutamide with compounds such as ciclosporin and calcium channel blockers. Dosage

reduction may be required for these products, particularly if there is evidence of enhanced or adverse effect. For ciclosporin, it

is recommended that plasma concentrations and clinical condition are closely monitored following initiation or cessation of

bicalutamide therapy.

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Caution should be exercised when prescribing Bicalutamide with other drugs which may inhibit drug oxidation e.g. cimetidine

and ketoconazole. In theory, this could result in increased plasma concentrations of bicalutamide which theoretically could lead

to an increase in side effects.

In vitro studies have shown that bicalutamide can displace the coumarin anticoagulant warfarin from its protein binding sites.

There have been reports of increased effect of warfarin and other coumarin anticoagulants when co-administered with

bicalutamide it is therefore recommended that if bicalutamide is administered in patients who are concomitantly receiving

coumarin anticoagulants, PT/INR should be closely monitored and adjustments of anticoagulant dose considered (see sections

4.4 and 4.8).

Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Bicalutamide 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).

Paediatric population

Interaction studies have only been performed in adults.

4.6 Fertility, pregnancy and lactation

Pregnancy

Bicalutamide is contraindicated in females and must not be given to pregnant women.

Breast-feeding

Bicalutamide is contraindicated during breast-feeding.

Fertility

Reversible impairment of male fertility has been observed in animal studies (see section 5.3). A period of subfertility or

infertility should be assumed in man.

4.7 Effects on ability to drive and use machines

Bicalutamide is unlikely to impair the ability of patients to drive or operate machinery. However, it should be noted that

occasionally somnolence may occur. Any affected patients should exercise caution.

4.8 Undesirable effects

In this section, undesirable effects are defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon

(≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000), not known (cannot be estimated from the available

data).

Table 1 Frequency of Adverse Reactions

System Organ Class

Frequency

Event

Blood and lymphatic system disorders

Very common

Anaemia

Immune system disorders

Uncommon

Hypersensitivity, angioedema and urticaria

Metabolism and nutrition disorders

Common

Decreased appetite

Psychiatric disorders

Common

Decreased libido

depression

Nervous system disorders

Very common

Dizziness

Common

Somnolence

Cardiac disorders

Common

Myocardial infarction (fatal outcomes have been

reported)

, cardiac failure

Not known

QT prolongation (see sections 4.4 and 4.5)

Vascular disorders

Very common

Hot flush

Respiratory, thoracic and mediastinal disorders

Uncommon

Interstitial lung disease

(fatal outcomes have been

reported)

Gastrointestinal disorders

Very common

Abdominal pain

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constipation

nausea

Common

Dyspepsia

flatulence

Hepatobiliary disorders

Common

Hepatotoxicity, jaundice, hypertransaminasaemia

Rare

Hepatic failure

(fatal outcomes have been reported)

Skin and subcutaneous tissue disorders

Common

Alopecia

hirsutism/hair re-growth

dry skin

pruritus

rash

Rare

Photosensitivity reaction

Renal and urinary disorders

Very common

Haematuria

Reproductive system and breast disorders

Very common

Gynaecomastia and breast tenderness

Common

Erectile dysfunction

General disorders and administration site conditions

Very common

Asthenia

oedema

Common

Chest pain

Investigations

Common

Weight increased

Hepatic changes are rarely severe and were frequently transient, resolving or improving with continued therapy or following

cessation of therapy.

Listed as an adverse drug reaction following review of post-marketed data. Frequency has been determined from the

incidence of reported adverse events of hepatic failure in patients receiving treatment in the open-label bicalutamide arm of

the 150 mg EPC studies.

May be reduced by concomitant castration.

Observed in a pharmaco-epidemiology study of LHRH agonists and anti-androgens used in the treatment of prostate cancer.

The risk appeared to be increased when bicalutamide 50 mg was used in combination with LHRH agonists, but no increase in

risk was evident when bicalutamide 150 mg was used as a monotherapy to treat prostate cancer.

Listed as an adverse drug reaction following review of post-marketed data. Frequency has been determined from the

incidence of reported adverse events of interstitial pneumonia in the randomised treatment period of the 150 mg EPC studies.

Increased PT/INR: Accounts of coumarin anticoagulants interacting with bicalutamide have been reported in post-marketing

surveillance (see sections 4.4. and 4.5).

Reporting of suspected adverse reactions

Reporting

suspected

adverse

reactions

after

authorisation

medicinal

product

important.

allows

continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected

adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail:medsafety@hpra.ie.

4.9 Overdose

There is no human experience of overdosage. There is no specific antidote; treatment should be symptomatic.

Dialysis may not be helpful, since bicalutamide is highly protein bound and is not recovered unchanged in the urine.

General supportive care, including frequent monitoring of vital signs, is indicated.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Anti-androgens, ATC code: L02BB03

Mechanism of action

Bicalutamide is a non-steroidal antiandrogen, devoid of other endocrine activity. It binds to androgen receptors without

activating gene expression, and thus inhibits the androgen stimulus. Regression of prostatic tumours results from this

inhibition. Clinically, discontinuation of bicalutamide can result in antiandrogen withdrawal syndrome in a subset of patients.

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Bicalutamide is a racemate with its antiandrogenic activity being almost exclusively in the (R)-enantiomer.

5.2 Pharmacokinetic properties

Absorption

Bicalutamide is well absorbed following oral administration. There is no evidence of any clinically relevant effect of food on

bioavailability.

Distribution

Bicalutamide is highly protein bound (racemate 96% (R)-enantiomer >99%) and extensively metabolised (via oxidation and

glucuronidation): Its metabolites are eliminated via the kidneys and bile in approximately equal proportions.

Biotransformation

The (S)-enantiomer is rapidly cleared relative to the (R)-enantiomer, the latter having a plasma elimination half-life of about 1

week.

On daily administration of bicalutamide, the (R)-enantiomer accumulates about 10 fold in plasma as a consequence of its long

half-life.

Steady state plasma concentrations of the (R)-enantiomer of approximately 9 microgram/ml are observed during daily

administration of 50 mg doses of bicalutamide. At steady state the predominantly active (R)-enantiomer accounts for 99% of

the total circulating enantiomers.

Elimination

In a clinical study the mean concentration of R-bicalutamide in semen of men receiving bicalutamide 150 mg was 4.9

microgram/ml. The amount of bicalutamide potentially delivered to a female partner during intercourse is low and by

extrapolation possibly equates to approximately 0.3 microgram/kg. This is below that required to induce changes in offspring

of laboratory animals.

Special Populations

The pharmacokinetics of the (R)-enantiomer are unaffected by age, renal impairment or mild to moderate hepatic impairment.

There is evidence that for subjects with severe hepatic impairment, the (R)-enantiomer is more slowly eliminated from plasma.

5.3 Preclinical safety data

Bicalutamide is a potent antiandrogen and a mixed function oxidase enzyme inducer in animals. Target organ changes,

including tumour induction, in animals, are related to these activities. Atrophy of seminiferous tubules of the testes is a

predicted class effect with antiandrogens and has been observed for all species examined. Reversal of testicular atrophy

occurred 4 months after the completion of dosing in a 6-month rat study (at doses of approximately 1.5 times human

therapeutic concentrations at the recommended dose of 50 mg). No recovery was observed at 24 weeks after the completion

of dosing in a 12-month rat study (at doses of approximately 2 times human concentrations at the recommended human dose

of 50 mg). Following 12-months of repeated dosing in dogs (at doses of approximately 7 times human therapeutic

concentrations at the recommended human dose of 50 mg), the incidence of testicular atrophy was the same in dosed and

control dogs after a 6 month recovery period. In a fertility study (at doses of approximately 1.5 times human therapeutic

concentrations at the recommended human dose of 50 mg), male rats had an increased time to successful mating immediately

after 11 weeks of dosing; reversal was observed after 7 weeks off-dose.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core:

Microcrystalline cellulose

Povidone

Croscarmellose sodium

Sodium laurilsulfate

Lactose monohydrate

Anhydrous colloidal silica

Magnesium stearate

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Coating:

Hypromellose

Polydextrose

Titanium dioxide

Macrogol 4000

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years

6.4 Special precautions for storage

Store in the original package

6.5 Nature and contents of container

Transparent PVC/PVdC/Al blister, cardboard carton.

20, 28, 30, 40, 50, 56, 60, 84, 90 and 100 film coated tablets

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Teva Pharma B.V.

Swansweg 5

2031GA Haarlem

Netherlands

8 MARKETING AUTHORISATION NUMBER

PA0749/032/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 18

May 2007

Date of last renewal: 27

October 2008

10 DATE OF REVISION OF THE TEXT

October 2019

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