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 Bluefish 50 mg is and what it is used for 
2. What you need to know before you take Bicalutamide Bluefish 50 mg 
3. How to take Bicalutamide Bluefish 50 mg 
4. Possible side effects 
5. How to take it Bicalutamide Bluefish 50 mg should be stored 
6. Contents of the pack and other information 

What Bicalutamide Bluefish 50 mg is and what it is used for

Bicalutamide Bluefish contains a medicine called bicalutamide. It belongs to a group of medicines called “antiandrogens”.

  • This medicine is used to treat prostate cancer.
  • It works by blocking the effects of male hormones such as testosterone.

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

What you need to know before you take Bicalutamide Bluefish 50 mg

Do not take Bicalutamide Bluefish 50 mg

  • 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 antihistamines(terfenadine or astemizole).
  • if you are a woman.

Do not take this medicine 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 cautions

Talk to your doctor or pharmacist before taking Bicalutamide Bluefish:

  • if you have any of the following: cardiovascular disease, including heart rhythm problems ( arrhythmias ), or you are taking medication for this. The risk of heart rhythm disorders may be increased when you use bicalutamide.
  • if you are taking blood thinners or medicines to prevent blood clots.
  • if you have liver problems.
  • if you have diabetes and are already taking an LHRH agonist. These include goserelin, buserelin, leuprorelin, and triptorelin.
  • If you go to the hospital, tell the hospital staff that you are taking bicalutamide.
  • if you are taking bicalutamide, you and / or your partner should use contraception while taking this medicine and for 130 days after stopping this medicine. Talk to your doctor if you have any questions about contraception.

Other medicines and Bicalutamide Bluefish 50 mg

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines as well as (traditional) herbal medicines and herbal medicines, as bicalutamide can affect the effectiveness of certain other medicines. Other medicines may also affect the way this medicine works.

Do not take bicalutamide if you are already taking any of the following medicines:

  • some antihistamines (terfenadine or astemizole)
  • cisapride (used for certain types of indigestion)

Bicalutamide 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 certain other medicines, such as methadone (used for pain and in the treatment of drug addiction), moxifloxacin (an antibiotic ), antipsychotics (used for severe mental illness).

Also, tell your doctor or pharmacist if you are taking any of the following medicines:

  • oral medicines to prevent blood clots (oral anticoagulants ), e.g. warfarin. Blood thinners or medicines to prevent blood clots.
  • ciclosporin (to inhibit the immune system)
  • calcium channel blocker (for high blood pressure or some heart problems)
  • cimetidine (for stomach upset)
  • ketoconazole (against infection caused by a fungus)

Pregnancy, breastfeeding, and fertility

Bicalutamide should not be taken by women, including pregnant or breastfeeding mothers.

Bicalutamide may affect male fertility, an effect that may be transient.

Driving and using machines

Bicalutamide is unlikely to affect your ability to drive or use any tools or machines.

But if you get sleepy, be careful with these activities.

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 Bluefish 50 mg contains lactose.

This medicine contains lactose monohydrate, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Bicalutamide Bluefish 50 mg contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 50 mg tablet, ie essentially ‘sodium-free’.

How to take Bicalutamide Bluefish 50 mg

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

  • The recommended dose for adults is one tablet once a day.
  • Swallow the tablet whole with water.
  • Try to take the medicine at the same time each day.
  • Do not stop taking this medicine even if you feel well unless your doctor tells you to stop.

If you forget to take Bicalutamide Bluefish 50 mg

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 compensate for a missed dose.

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

4. Possible side effects

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

Allergic reactions

These are less common  (may affect up to 1 in 100 people) 

Symptoms may include sudden onset of:

  • Rash, itching, or hives on the skin
  • Swelling of the face, lips, tongue, throat, or other parts of the body.
  • Difficulty breathing, wheezing, or difficulty breathing.

If this happens to you, consult a doctor immediately.

Also, tell your doctor immediately if you have any of the following side effects:

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

  • Stomach pain
  • Blood in the urine

Common (may affect up to 1 in 10 people) 

  • Yellow skin or whites of the eyes (jaundice). This may be a sign 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) 

  • Severe breathing difficulties or sudden worsening of shortness of breath, possibly with cough or fever. This may be a sign of pneumonia called “interstitial lung disease”.

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

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

The following side effects may also occur:

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

  • Dizziness
  • Constipation
  • Nausea
  • Swelling and tenderness in the breasts
  • Impotence
  • Swelling
  • Hot flashes
  • Anemia. This makes you tired or pale.

Common (may affect up to 1 in 10 people)

  • Reduced appetite
  • Decreased sexual desire
  • Depression
  • Somnolence
  • Indigestion
  • Gas formation
  • Hair loss
  • Increased hair growth on the body
  • Dry skin
  • Itching
  • Rash
  • Inability to get an erection ( impotence )
  • Weight gain
  • Pain in the chest
  • Impaired heart function
  • Myocardial infarction

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

  • Photosensitivity reactions in the skin

Your doctor may need to take blood samples to check for changes in your blood.

Do not worry about 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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Bicalutamide Bluefish 50 mg

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 blister and carton 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. Each film-coated tablet contains 50 mg of bicalutamide.

Tablet core:

The other ingredients are Lactose monohydrate, povidone K-25, sodium starch glycolate (type A), magnesium stearate.

Coating (tablet case)

Opadry OY-S-9622 containing hypromellose 5cp (E464), titanium dioxide (E171), and propylene glycol.

What the medicine looks like and the contents of the pack

Bicalutamide Bluefish 50 mg are white, round, biconvex film-coated tablets.

The tablets are packaged in blisters containing 14, 28, 30, 90, 98, 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

Genepharm SA

18th KLM Marathonos Avenue

153 51 Pallini-Attikis

Greece

This medicinal product is authorized under the European Economic Area under the names:
Denmark Bicalutamide Bluefish 50mg Film-coated tablets
Finland Bicalutamide Bluefish 50 mg Kalvopäällysteistä tablet
Italy Medium 50 mg Compressed rivestite with film
Norway Bicalutamide Bluefish 50 mg Film-coated tablets
Spain Bicalutamida Bluefish 50 mg Comprimidos recubiertos conpelícula EFG
UK Bicalutamide 50 mg film-coated tablets
Germany Bicalutamide Bluefish 50 mg Film Tablet
Austria Bicalutamide Bluefish 50 mg Film Tablet

Muhammad Nadeem

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