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 information, 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: 
1. What Bicalutamide Sandoz is and what it is used for 
2. What you need to know before taking Bicalutamide Sandoz 
3. How to take Bicalutamide Sandoz 
4. Possible side effects 
5. How to store Bicalutamide Sandoz 
6. Contents of the packaging and other information 

1. What Bicalutamide Sandoz is and what it is used for

Bicalutamide Sandoz belongs to a group of medicines called antiandrogens. It affects the way male sex hormones work.

Bicalutamide Sandoz is used in treating prostate cancer. Bicalutamide Sandoz is used either as

  • monotherapy in tumor stages called “locally advanced” or as
  • combination therapy for tumor stages called “advanced” along with other treatments such as surgical castration or drugs that reduce the levels of androgenic your body.

Bicalutamide contained in Bicalutamide Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have further questions and always follow their instructions.

What you need to know before you take Bicalutamide Sandoz

Do not take Bicalutamide Sandoz

  • if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6).
  • if you are a woman, child, or youth
  • if you are taking medicines containing terfenadine, astemizole, or cisapride (see “Other medicines and Bicalutamide Sandoz” below).

Warnings and cautions

Talk to your doctor or pharmacist before taking Bicalutamide Sandoz :

  • if you have any liver problems. The levels of bicalutamide in your blood could increase. It is possible that your liver function will be tested at regular intervals.
  • if you have diabetes.
  • if 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 Bicalutamide Sandoz.
  • If you are taking Bicalutamide Sandoz, you and/or your partner should use contraception while taking Bicalutamide Sandoz and for 130 days after stopping Bicalutamide Sandoz. Talk to your doctor if you have any questions about contraception.

Other medicines and Bicalutamide Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. It is especially important to mention if you are taking any of the following:

  • terfenadine or astemizole (for hay fever or allergies ) or cisapride (for stomach problems). See “Do not take Bicalutamide Sandoz”
  • ciclosporin (used to suppress the immune system, to prevent and treat the rejection of a transplanted organ or bone marrow )
  • calcium channel blockers (for the treatment of high blood pressure or certain heart problems)
  • cimetidine (for the treatment of stomach ulcers )
  • ketoconazole (used to treat fungal infections of the skin and nails)
  • medicines to prevent blood clots and blood-thinning medicines such as warfarin. Your doctor may take blood samples before and during your treatment with Bicalutamide Sandoz.

Bicalutamide Sandoz may affect some 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 the treatment of drug addiction), moxifloxacin (an antibiotic ), antipsychotics (used for severe mental illness).

Pregnancy, breastfeeding, and fertility

Bicalutamide Sandoz should not be used by women.

Bicalutamide Sandoz can lead to decreased fertility or infertility in men during menopause.

Driving and using machines

These tablets can 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.

Bicalutamide Sandoz contains lactose

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

Bicalutamide Sandoz contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose unit, ie essentially ‘sodium-free’.

3. How to take Bicalutamide Sandoz

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

Depending on your condition, the usual dose is one 50 mg tablet daily ( combination therapy ), or three 50 mg tablets once daily ( monotherapy ).

  • Swallow the tablets whole with a glass of water.
  • You can take these tablets with or without food.
  • Try to take the tablets at the same time each day.

If you forget to take Bicalutamide Sandoz

If you forget to take your medicine, take the tablet as soon as you remember and then take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Bicalutamide Sandoz

Do not stop taking your medicine even if you feel well unless your doctor has told you to stop taking 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:

You should contact a doctor immediately if you notice any of the following serious side effects.

Common serious side effects are (may affect up to 1 in 10):

  • yellowing of the skin or whites of the eyes due to liver problems or, in rare cases (may affect up to 1 in 1,000 patients), liver failure.

The common serious side effect is (may affect up to 1 in 100):

  • the severe allergic reaction that causes swelling of the face or throat, or severe itching of the skin with hives.
  • severe shortness of breath or sudden worsening of shortness of breath, possibly with cough or fever. Some patients taking Bicalutamide Sandoz develop an inflammation of the lungs called interstitial lung disease.

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

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

Other side effects:

The frequency of some side effects depends on whether Bicalutamide Sandoz is used in monotherapy or combination therapy.

Very common side effect is (can occur in more than 1 in 10):

  • tender or enlarged breasts
  • weakness
  • skin rash – very common in monotherapy but common (may occur in up to 1 patient in 10) in combination therapy.
  • decreased number of red blood cells which can make the skin pale and cause weakness or shortness of breath.

Very common in combination therapy but common in monotherapy are:

  • hot flashes
  • dizziness
  • abdominal pain, constipation, nausea
  • edema (fluid swelling)
  • blood in the urine.

Common side effects are (may affect up to 1 in 10):

  • loss of appetite
  • decreased sex drive
  • difficulty getting an erection ( erectile dysfunction )
  • Depression
  • drowsiness
  • somnolence
  • digestive problems, gases
  • hair loss, heavy hair growth on the body
  • dry skin, itching
  • weight gain
  • blood tests that show changes in liver function
  • heart attack, heart failure
  • chest pain.

Rare  side effects are  (may affect up to 1 in 1000 people):

  • increased sensitivity of the skin to sunlight.

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 Bicalutamide Sandoz

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

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

Do not store above 25 ° C.

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. Each film-coated tablet contains 50 mg of bicalutamide.
  • The other ingredients are:  
    Tablet core: Lactose monohydrate, sodium starch glycolate type A, povidone K 30 (E1201), corn starch, and magnesium stearate (E572). 
    Film coating: Methylcellulose, titanium dioxide (E171) and triacetin (E1518).

What the medicine looks like and the contents of the pack

Round and white film-coated tablet, with a diameter of about 7 mm.

Packs of PVC / Aclar // Al blister cards may contain 20, 28, 30, 50, 56, 60, 84, 90, 98 or 100 film-coated tablets.

The packages with one-piece perforated PVC / Aclar // Al blister cards can contain 50 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Lek Pharmaceuticals dd, Verovśkova 57, 1526 Ljubljana, Slovenia

or

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

Muhammad Nadeem

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