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

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

Bicalutamide Teva contains bicalutamide. It belongs to a group of medicines called antiandrogens.

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

Bicalutamide contained in Bicalutamide Teva 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 Teva

Do not take Bicalutamide Teva

  • if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6)
  • if you are taking a medicine containing cisapride or certain antihistamines(terfenadine or astemizole)
  • if you are a woman.

Do not take Bicalutamide Teva if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Bicalutamide Teva.

Bicalutamide Teva must not be given to children.

Warnings and cautions

Talk to your doctor or pharmacist before taking Bicalutamide Teva:

  • 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 using Bicalutamide Teva.
  • if you are taking blood-thinning drugs or medicines to prevent blood clots.
  • if you have liver problems.
  • if you have diabetes and are already taking an LHRH analogue. These include goserelin, buserelin, leuprorelin, and triptorelin.
  • if you are hospitalized. Tell your healthcare provider that you are taking Bicalutamide Teva.
  • If you are taking Bicalutamide Teva, you and/or your partner should use contraception while taking Bicalutamide Teva and 130 days after stopping Bicalutamide Teva. Talk to your doctor if you have any questions about contraception.

Other medicines and Bicalutamide Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, (traditional) herbal or herbal medicines. This is because bicalutamide may affect the way other medicines work. Some other medicines may also affect the way bicalutamide works.

Do not take Bicalutamide Teva if you are taking any of the following medicines:

  • Cisapride (used for certain digestive problems).
  • Some antihistamines are (terfenadine or astemizole).

Bicalutamide Teva 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 [e.g. 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 ), such as warfarin. Blood thinners or medicines that prevent blood clots.
  • Ciclosporin (to inhibit the immune system).
  • Calcium antagonists (to treat high blood pressure or certain heart problems).
  • Cimetidine (for stomach upset).
  • Ketoconazole (to treat fungal infections).

Pregnancy, breastfeeding, and fertility

Bicalutamide Teva must not be taken by women, including pregnant women or mothers who are breast-feeding.

Bicalutamide Teva may affect male fertility, which may be transient.

Driving and using machines

Bicalutamide Teva is unlikely to affect your ability to drive or use machines. Some people may occasionally feel drowsy or dizzy when taking the medicine. If you suffer from this, be careful when performing should you feel sleepy, be careful with such tasks.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect this 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 Teva contains lactose and sodium

Bicalutamide Teva contains lactose

Bicalutamide tablets contain 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 Teva contains sodium

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

How to take Bicalutamide Teva

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

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

If you forget to take Bicalutamide Teva

  • If you forget to take a dose, skip the one 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 stop taking Bicalutamide Teva

Do not stop taking this medicine even if you feel completely healthy unless your doctor tells you to.

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.

Contact a doctor immediately or seek medical help if you experience any of the following:

Allergic reactions

Uncommon: may affect up to 1 in 100 people

Symptoms may include sudden onset of:

  • Rash, itching, or hives
  • Swelling of the face, lips, tongue, neck, or other parts of the body.
  • Shortness of breath, wheezing, difficulty breathing. If this happens to you, contact a doctor immediately.

Also, contact a doctor immediately if you notice any of the following:

Very common: may affect more than 1 user in 10

  • Stomach pain
  • Blood in the urine

Common: may affect up to 1 in 10 users

  • Yellowing of the 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 shortness of breath or sudden worsening of shortness of breath. This may be associated with a cough or fever. These can be signs of a type of pneumonia called interstitial pneumonia.

Has been reported: occurs in an unknown number of users

  • ECG changes ( QT prolongation). 

Other possible side effects are :

Very common: may affect more than 1 user in 10

  • Dizziness
  • Constipation
  • Nausea
  • Sore or swollen breasts
  • Hot flashes
  • Weakness
  • Swelling
  • Reduced number of red blood cells ( anemia ). This can make you feel tired and make you look pale.

Common: may affect up to 1 in 10 users

  • Poor appetite
  • Decreased sexual desire
  • Depression
  • Drowsiness
  • Digestive problems
  • Gas problems
  • Hair loss
  • Hair regrowth or increased hair growth
  • Dry skin
  • Itching
  • Rash
  • Erection problems ( impotence )
  • Weight gain
  • Chest pain
  • Decreased heart function
  • Myocardial infarction

Rare: may affect up to 1 in 1,000 users

  • Increased sensitivity of the skin to sunlight

Your doctor may 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 Teva

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

Store in the original package.

Used before the expiration date specified after Expiration Date / 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.
  • The other ingredients are: 
    Core: Microcrystalline cellulose, povidone, croscarmellose sodium, sodium lauryl sulfate, lactose monohydrate, anhydrous colloidal silica, magnesium stearate. 
    Coating: Hypromellose, polydextrose, titanium dioxide, macrogol 4000.

What the medicine looks like and the contents of the pack

Bicalutamide Teva 50 mg film-coated tablets are white to off-white biconvex film-coated tablets, debossed with 93 on one side and 220 on the other.

Pack sizes: 20, 28, 30, 40, 50, 56, 60, 84, 90 and 100 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Muhammad Nadeem

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