50 mg film-coated tablets 
bicalutamide

Read all of this leaflet carefully before you start using 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 you will find information about: 
1. For further information about this medicine, contact your local representative: Orion Pharma AB, Danderyd, medinfo@orionpharma.comBicalutamide Orion is and what it is used for 
2. What you need to know before you take Bicalutamide Orion 
3. How to take Bicalutamide Orion 
4. Possible side effects 
5. How To obtain further information about this medicine, contact your local representative: Orion Pharma AB, Danderyd, medinfo@orionpharma.comBicalutamide Orion should be stored 
6. Contents of the pack and other information 

  1. For further information about this medicine, contact your local representative: Orion Pharma AB, Danderyd, medinfo@orionpharma.comBicalutamide Orion is and what it is used for

Bicalutamide belongs to a group of medicines called antiandrogens. The active substance bicalutamide blocks the unwanted effects of male sex hormones ( androgens ) in the body and thus inhibits cell growth in the prostate.

Bicalutamide Orion 50 mg film-coated tablets used in adult men for the treatment of prostate cancer with concomitant drugs called LHRH analogue s ( luteinizing hormone-releasing- hormone ), e.g. gonadorelin, or have undergone or will soon undergo surgical castration.

Bicalutamide contained in Bicalutamide Orion may also be approved for the treatment of other conditions not mentioned in this leaflet. If you have any further questions, ask your doctor, pharmacist, or other healthcare professional and always follow their instructions.

2. What you need to know before you take Bicalutamide Orion

Do not take Bicalutamide Orion

  • if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6).
  • if you are a woman
  • if you are a child or adolescent.
  • if you are taking terfenadine or astemizole used to treat allergies, or cisapride, which is used to treat heartburn and acid reflux.

Warnings and cautions

Talk to your doctor before taking Bicalutamide Orion:

  • if you have liver disease. Your doctor may decide to take blood samples to check that your liver is working properly while you are taking this medicine.
  • if you have diabetes. Treatment with bicalutamide in combination with LHRH analogues may alter your blood sugar level. Your dose of insulin and/or oral antidiabetic medicines may need to be adjusted.
  • if you have heart disease, including heart rhythm problems ( arrhythmias ), or treated with drugs for these conditions. The risk of heart rhythm disorders may increase with the use of Bicalutamide Orion.
  • if you are taking blood-thinning drugs or medicines to prevent blood clots.
  • If you are taking Bicalutamide Orion, you and/or your partner should use contraception while taking Bicalutamide Orion and 130 days after stopping Bicalutamide Orion, as antiandrogen therapy may cause morphological changes in sperm. Talk to your doctor if you have any questions about contraception. See also section “Pregnancy, breast-feeding and fertility”.

Sunlight or ultraviolet (UV) light

Avoid direct exposure to excessive sunlight or UV light when taking Bicalutamide Orion. In rare cases, photosensitivity reactions have been reported in patients taking bicalutamide. Seek medical attention if you experience a photosensitivity reaction that is persistent and/or severe.

Children and young people

This medicine must not be given to children or adolescents.

Other medicines and Bicalutamide Orion 50 mg film-coated tablets

If you take bicalutamide with any of the following medicines, the effect of bicalutamide, as well as the other medicines, may be affected.

Before taking bicalutamide, tell your doctor if you are taking or have recently taken any of the following medicines:

  • ciclosporin (used to suppress the immune system to prevent and treat rejection of transplanted organs or bone marrow ). This is because bicalutamide can increase the concentration of a substance called creatinine in the plasma and your doctor may take blood samples to check this.
  • midazolam (a medicine used to relieve anxiety before surgery or certain procedures, or used for anesthesia before and during surgery). You must tell your doctor or dentist that you are taking bicalutamide if you need surgery or if you are very worried when you are hospitalized.
  • terfenadine or astemizole used to treat allergies or cisapride used to treat heartburn and acid reflux (see section 2, “Do not take Bicalutamide Orion”).
  • a type of drug called calcium channel blocker, e.g. diltiazem or verapamil. These are used to treat heart problems, angina and high blood pressure.
  • drugs used to thin the blood, e.g. warfarin.
  • cimetidine for acid reflux or stomach ulcers,
  • ketoconazole, a medicine used to treat fungal infections.

Bicalutamide Orion may affect certain 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 (eg methadone (used to treat pain and in the treatment of drug dependence), moxifloxacin (an antibiotic ), antipsychotics used for serious mental illness).

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the medicines listed above or other medicines, including medicines obtained without a prescription.

Bicalutamide Orion with food and drink

The tablets do not need to be taken with food but must be swallowed whole with a glass of water.

Pregnancy and breastfeeding

Women are not allowed to take this medicine.

Bicalutamide Orion may cause a period of decreased fertility or infertility in men.

See also section “Warnings and precautions”.

Driving and using machines

There is a possibility that these tablets may make you dizzy or drowsy. Do not drive or use machines if you are affected in this way.

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.

For further information on this medicine, please contact your local representative: Orion Pharma AB, Danderyd, medinfo@orionpharma.comBicalutamide Orion contains excipients

This medicine 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.

3. How to take Bicalutamide Orion

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

The usual dose is one tablet once a day. The tablet must be swallowed whole with a glass of water and can be taken with or without food. Try to take a dose at about the same time each day.

You should start taking these tablets at least 3 days before starting treatment with LHRH analogues , e.g. gonadorelin, or while undergoing surgical castration.

Children and adolescents:

This medicine is not recommended for patients under 18 years of age.

Use for children and adolescents

This medicine must not be used in patients under 18 years of age.

If you forget to take Bicalutamide Orion

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

If you stop taking Bicalutamide Orion

Do not stop taking this medicine even if you feel well unless your doctor has advised you to do so.

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.

If you get any of the following symptoms, tell your doctor immediately or go to the emergency room at the nearest hospital. These are very serious side effects.

  • Severe allergic reactions that cause swelling of the face or neck, lips, tongue, or throat, which may cause difficulty breathing or swallowing or severe itching of the skin with blistering
  • Severe respiratory problems or sudden worsening of breathing problems with or without cough and fever. Some patients who have taken Bicalutamide Orion have pneumonia.
  • Yellowing of the skin or eyes (caused by liver problems).

Other possible side effects of the drug are:

Very common: (affects more than 1 user in 10):

  • Sore breasts
  • Breast development in men
  • Hemorrhoids
  • Dizziness
  • Pain in the abdomen or chest
  • Constipation
  • Nausea
  • Blood in the urine ( hematuria )
  • Feeling weak
  • Swelling of hands, feet, arms, and legs ( edema )
  • Low red blood cell count ( anemia ).

Common: (affects more than 1 user in 100):

  • Reduced sexual drive
  • Depression
  • Somnolence
  • On stomach
  • Gases
  • Changes in liver function including elevated levels of liver enzymes, blockage of bile flow (bile stasis), or yellowing of the skin and whites of the eyes (jaundice)
  • Hair loss
  • Excessive hairiness
  • Dry skin
  • Rash
  • Skin itching
  • Difficulty getting an erection
  • Weight gain
  • Loss of appetite
  • Chest pain
  • Myocardial infarction
  • Heart failure.

Uncommon: (affects less than 1 user in 100):

  • Allergic reactions ( hypersensitivity reactions ). Symptoms of these may include: skin rash, itching, hives, scaling, blistering or crusting of the skin, swelling of the face or neck, lips, tongue, or throat, which may make it difficult to breathe or swallow.
  • Inflammation of the lungs called interstitial lung disease. Symptoms of this disease may include severe shortness of breath with cough or fever

Rare: (affects less than 1 user in 1,000):

  • Liver failure
  • Increased sensitivity of the skin to sunlight.

None known (can not be calculated from available data)

  • Changes in ECG ( QT prolongation).

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

5. How For further information about this medicine, please contact your local representative: Orion Pharma AB, Danderyd, medinfo@orionpharma.comBicalutamide Orion should be stored

Keep out of sight and reach of children.

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

No special storage instructions.

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 tablet contains 50 mg of bicalutamide.

The other ingredients in the tablet core are lactose monohydrate, magnesium stearate, crospovidone (type A), povidone K-29/32, sodium lauryl sulfate. The film coating contains lactose monohydrate, hypromellose, macrogol 4000, and titanium dioxide (E171).

What the medicine looks like and the contents of the pack

White, round, biconvex, film-coated tablet, marked with BCM 50 on one side.

5, 7, 10, 14, 20, 28, 30, 40, 50, 56, 80, 84, 90, 98, 100, 140, 200 or 280 tablets in blister cards.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Orion Corporation

Orionintie 1

FI- 02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI- 02200 Espoo

Finland

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd, medinfo@orionpharma.com

Muhammad Nadeem

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