50 mg film-coated tablets 
Bicalutamide

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Bicalustad is and what it is used for 
2. What you need to know before using Bicalustad 
3. How to use Bicalustad 
4. Possible side effects 
5. How to store Bicalustad 
6. Contents of the packaging and other information 

1. What Bicalustad is and what it is used for

Bicalustad (50 mg daily dose) is used to treat advanced prostate cancer. It is taken together with a so-called LHRH analogue (a hormone that releases luteinizing hormone ) – an additional hormone treatment – or in combination with surgical removal of the testicles.

For patients with locally advanced prostate cancer who are at high risk for progressive disease, Bicalustad (daily dose 150 mg) is used either alone or as adjunctive therapy ( adjuvant treatment) after surgical removal of the entire prostate (radical prostatectomy ) or radiation therapy.

Bicalustad belongs to a group of medicines called non-steroidal antiandrogens. The active substance bicalutamide blocks the unwanted effect of male sex hormones ( androgens ) and thus inhibits the growth of cells in the prostate.

Bicalutamide contained in Bicalustad may also be approved for the treatment of other diseases not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Bicalustad

Do not use Bicalustad

  • if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6).
  • if you have previously had liver problems after taking Bicalustad.
  • if you are taking terfenadine (for hay fever or allergy ), astemizole (for hay fever or allergy ), or cisapride (for stomach upset).

Bicalustad should not be taken by women or given to children or adolescents.

Talk to your doctor if you are unsure.

Warnings and cautions

Talk to your doctor or pharmacist before taking Bicalustad again

  • your liver function is moderately or severely impaired. The medicine should only be taken after your doctor has carefully considered any benefits and risks. If this is the case, your doctor will regularly check your liver function ( bilirubin, transaminases, alkaline phosphatases). If severe hepatic impairment develops, treatment with Bicalustad should be discontinued
  • your kidney function is severely impaired. The medicine should only be taken after your doctor has carefully considered any benefits and risks
  • you have cardiovascular disease including cardiac arrhythmias ( arrhythmia ), or if you are taking medication for this. The risk of suffering from heart rhythm disorders may be increased when taking Bicalustad. If so, your doctor should check your heart function regularly
  • if you have diabetes and are already taking an “LHRH analog”

Other medicines and Bicalustad

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Bicalustad must not be used with any of the following medicines:

  • terfenadine or astemizole (for hay fever or allergy )
  • cisapride (for stomach upset).

If you take Bicalustad with any of the following medicines, the effect of both bicalutamide and the other medicine may be affected. Talk to your doctor before taking any of these medicines with Bicalustad:

  • warfarin or any other similar medicine to prevent blood clots
  • cyclosporine (used to inhibit the immune system to prevent rejection of transplanted organ or bone marrow transplant )
  • cimetidine (for the treatment of stomach ulcers )
  • ketoconazole (used to treat fungal infections of the skin and nails)
  • calcium channel blockers (for the treatment of high blood pressure )
  • midazolam (used as a sedative before surgery).

Bicalustad may affect certain other medicines used to treat heart rhythm disorders (eg quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm disorders when used with other medicines (eg methadone (used for pain and in case of treatment of drug addiction), moxifloxacin (an antibiotic ), antipsychotics (used for severe mental illness).

Bicalustad with food and drink

The tablets should be swallowed whole with a glass of water, with or without food

Pregnancy, breastfeeding, and fertility

Bicalutamide is contraindicated in women and should not be given to pregnant women or nursing mothers.

Driving and using machines

There is a possibility that these tablets make you dizzy or drowsy. If you are affected in this way, do not drive or use machines. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Bicalustad contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.

3. How to use Bicalustad

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is 1 tablet per day (equivalent to 50 mg bicalutamide) or 3 tablets per day (equivalent to 150 mg bicalutamide). The tablets should be swallowed whole with a glass of water.

Try to take the medicine at about the same time each day so that you do not forget it.

If you forget to use Bicalustad

If you forget to take your daily dose, skip it when you remember and wait until it is time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop using Bicalustad

Do not stop taking the tablets without talking to your doctor first, unless you get a side effect – see section 4 below.

Do not stop taking this medicine even if you feel healthy unless your doctor has recommended it.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

Contact a doctor immediately if you notice any of the following serious side effects.

Common (may affect up to 1 in 10 people)

  • yellowing of the skin or whites of the eyes caused by liver problems (including liver failure, liver enlargement).

Uncommon (may affect up to 1 in 100 people):

  • severe allergic reaction that causes swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing or breathing or severe skin itching with increased rash
  • severe shortness of breath, or sudden worsening of shortness of breath, possibly accompanied by cough or fever. Some patients taking Bicalustad to develop a type of pneumonia called interstitial pneumonia.

Other side effects:

Tell your doctor if you experience any of the following side effects :

Very common (may affect more than 1 user in 10):

  • sore or enlarged breast tissue
  • feeling weak
  • impaired sexual drive, erection problems, impotence
  • hot flashes
  • decreased number of red blood cells which can make the skin pale and cause weakness or shortness of breath
  • dizziness
  • constipation
  • abdominal pain
  • nausea
  • blood in the urine
  • edema (face, hands, feet, arms, legs, torso).

Common (may affect up to 1 in 10 people):

  • diarrhea
  • gas formation
  • indigestion
  • somnolence
  • Depression
  • skin rash, rash with lumps and dots, itching, sweating, increased body hair
  • hair loss
  • dry skin
  • weight gain
  • diabetes mellitus
  • reduced appetite
  • general pain, pelvic pain, chest pain
  • frostbite
  • blood tests that show changes in liver function
  • myocardial infarction
  • heart failure (which can cause shortness of breath, especially with exertion, an increased heart rate, swelling of the arms and legs, and mottled skin).

Uncommon (may affect up to 1 in 100 people):

  • weight loss
  • high blood sugar
  • difficulty sleeping
  • shortness of breath
  • dry mouth, gastrointestinal diseases
  • need to urinate during the night
  • headache, back pain, neck pain.

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

  • vomiting
  • the skin becomes more sensitive to sunlight.

Very rare (may affect up to 1 in 10,000 people):

  • irregular heartbeat, abnormal ECG curve
  • decreased platelet count, which increases the risk of bleeding or bruising.

Has been reported (occurs in an unknown number of users):

  • changes ( QT prolongation) in ECG ( electrocardiogram ).

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Bicalustad

Keep this medicine out of the sight and reach of children.

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is bicalutamide. One film-coated tablet contains 50 mg of bicalutamide.

Other ingredients are:

Core: Lactose monohydrate, sodium starch glycolate (type A), povidone K30, magnesium stearate.

Film coating : titanium dioxide (E171), hypromellose and macrogol 400.

What the medicine looks like and the contents of the pack

Film-coated tablet.

Bicalustad 50 mg tablets are white, round, and biconvex. The tablets are packaged in blisters consisting of plastic and aluminum foil.

Bicalustad 50 mg film-coated tablets are available:

in pack sizes of 7, 10, 14, 15, 28, 30, 50, 56, 60, 84, 90 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

STADA Arzneimittel AG

Stadastr. 2-18

61118 Bad Vilbel

Germany

Other manufacturers

CENTRAFARM Services BV

New Donk 9

4879 AC Etten Leur

Netherlands

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel, Co. Tipperary

Ireland

or

PharmaCoDane ApS

Marielundvej 46 A

2730 Herlev

Denmark

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

or

NV Eurogenerics SA

Heizel Esplanade b 221020 Brussels

Belgium

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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