Bicadex 50 mg film-coated tablets – bicalutamide for the treatment of advanced prostate cancer

Bicadex is a medicine containing bicalutamide, a non-steroidal antiandrogen. It blocks the action of male sex hormones such as testosterone at androgen receptors and thus prevents them from stimulating the growth of prostate tumours.

This page refers to Bicadex 50 mg film-coated tablets (28 tablets), marketing authorisation holder PharmaSwiss. The medicine is used only in men, to treat advanced prostate cancer in combination with an LHRH analogue or surgical castration, and is available on prescription.

What is Bicadex (bicalutamide) used for and how should it be taken correctly?

Key facts about the medicine

What is Bicadex used for?

According to the summary of product characteristics, Bicadex 50 mg is used to treat advanced prostate cancer in combination with LHRH analogue therapy (e.g. goserelin, buserelin, leuprorelin, triptorelin) or surgical castration. The medicine is used only in men.

How is it used and dosed?

• Usual dose for adult men, including the elderly: one 50 mg film-coated tablet a day.
• According to the SmPC, bicalutamide treatment should be started at least 3 days before starting an LHRH analogue or at the same time as surgical castration.
• Swallow the tablet whole with a little water, preferably at the same time each day.
• Do not stop taking the medicine even if you feel better, unless your doctor tells you to.

This is the general dosing from the leaflet – your doctor will decide on your treatment.

Special patient groups

• Elderly men: the dose does not change.
• Kidney impairment: no dose adjustment is needed.
• Liver impairment: no dose change in mild impairment; in moderate to severe impairment the medicine may accumulate – your doctor may request blood tests before and during treatment.
• Children: the medicine must not be prescribed for children.
• Women: must not take the medicine, including pregnant and breast-feeding women.

Contraindications – when the medicine must not be used

• allergy to bicalutamide or any of the excipients;
• concomitant use of cisapride (a medicine for digestive disorders) or the antihistamines terfenadine or astemizole;
• females;
• children.

Warnings and precautions

• Heart or blood vessel problems, including heart rhythm disorders, or medicines to treat them – the risk of rhythm problems may be increased.
• Blood-thinning or anti-clotting medicines – tell your doctor.
• Liver problems – blood tests may be needed before and during treatment.
• Diabetes with an LHRH analogue – blood sugar must be carefully monitored.
• If you go into hospital, tell the medical staff that you are taking bicalutamide.
• Effective contraception (patient and/or partner) during treatment and for 130 days after it ends.
• The medicine contains lactose; it is essentially sodium-free.

Interactions with other medicines

• Must not be taken together: cisapride, terfenadine, astemizole.
• Medicines for heart rhythm disorders (quinidine, procainamide, amiodarone, sotalol) and medicines that can affect the rhythm (methadone, moxifloxacin, antipsychotics) – heart rhythm problems are possible.
• Also tell your doctor if you take: oral anticoagulants (e.g. warfarin), ciclosporin, calcium channel blockers, cimetidine or ketoconazole.

Pregnancy, breast-feeding and fertility

Women must not take Bicadex, including pregnant and breast-feeding women. The medicine may affect male fertility; this effect may be reversible.

Driving and using machines

Bicadex is unlikely to affect your ability to drive and use machines, but if you feel sleepy, be careful.

Possible side effects

• Allergic reactions (uncommon): redness, itching, rash, swelling of the face, lips, tongue or throat, shortness of breath – contact your doctor immediately.
• Very common – consult your doctor immediately: stomach pain, blood in the urine.
• Common – consult your doctor immediately: jaundice (a sign of liver problems; rarely liver failure).
• Uncommon – consult your doctor immediately: difficulty breathing that suddenly gets worse, with cough or fever (possible interstitial lung disease).
• Frequency not known: ECG changes (QT prolongation).
• Other very common effects: dizziness, constipation, nausea, breast swelling and tenderness, hot flushes, weakness, swelling (oedema), anaemia.
• Other common effects: loss of appetite, reduced sex drive, depression, sleepiness, indigestion, flatulence, hair loss or increased hair growth, dry skin, itching, rash, erection problems, weight gain, chest pain, reduced heart function, heart attack.
• Rare: increased sensitivity of the skin to sunlight.

Your doctor will check your blood count. Report any suspected side effect to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: contact a doctor or the nearest healthcare facility immediately.
• Missed dose: take the next dose at the usual time and continue as scheduled; never take a double dose.
• Stopping: do not stop treatment without consulting your doctor.

Related information

No commercial category link is given for this medicine: it is a cancer treatment managed by a specialist. For questions about treatment and supportive care, please ask your oncologist, urologist or pharmacist.

Composition, pack and manufacturer

• Active substance: bicalutamide 50 mg per film-coated tablet.
• Tablet core: lactose monohydrate; povidone K-30; sodium starch glycolate (type A); magnesium stearate.
• Film coating: Opadry Y-1-7000 (hypromellose; titanium dioxide E171; macrogol 400).
• Pack: PVC/PVDC/Alu or PVC/Alu blister of 14 tablets; carton with 2 blisters (28 film-coated tablets).
• Marketing authorisation holder and manufacturer: PharmaSwiss d.o.o. Beograd, Batajnički drum 5A, Belgrade.

Storage

• No special storage conditions.
• Shelf life: 5 years.
• Keep out of the sight and reach of children.

Frequently asked questions

Why is Bicadex taken together with an LHRH analogue?

According to the SmPC, bicalutamide 50 mg is approved for advanced prostate cancer in combination with an LHRH analogue or surgical castration; bicalutamide should be started at least 3 days before the LHRH analogue.

Does Bicadex cause breast enlargement in men?

Breast swelling and tenderness are listed as very common side effects. Discuss these complaints with your doctor.

How long is contraception needed?

The leaflet states that the patient and/or partner should use effective contraception during treatment and for 130 days after the end of bicalutamide treatment.

What tests are needed during treatment?

Your doctor may request liver function tests before and during treatment and check your blood count; in diabetes with an LHRH analogue, blood sugar is also monitored.

Sources

• ALIMS – Summary of Product Characteristics, Bicadex®, 50 mg, film-coated tablets (Serbian)
• ALIMS – Package leaflet, Bicadex® (August 2024, Serbian)

Date sources were checked: 24.10.2026.