Leaflet: information for the user

Bicalutamide Stada 50 mg film-coated tablets EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Bicalutamida belongs to a group of medications called antiandrogens, which means it interferes with some of the actions of androgens (male sex hormones) in the body.

This medication is used in the treatment of advanced prostate cancer in combination with a medication called a luteinizing hormone-releasing hormone (LHRH) analogue – an additional hormonal treatment – or concurrently with surgical removal of the testicles.

Do not take Bicalutamida Stada:

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• If you are taking medications to treat allergies such as terfenadine or astemizol, or cisaprida, a medication to treat gastroesophageal reflux.

Bicalutamida should not be taken by women, nor should it be administered to children or adolescents under 18 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication

• If you have any liver disorder or disease that affects your liver. The medication should only be taken after your doctor has carefully considered the possible benefits and risks. If this is the case, your doctor should perform regular liver function tests. Cases of death (severe liver changes and liver failure) have been reported.

• If you have a lung inflammation called interstitial lung disease. Symptoms of this condition may include severe difficulty breathing with cough or fever. Fatalities have been reported.

• If you have diabetes. The combined treatment of bicalutamida with LHRH analogs may alter your blood sugar levels. Your doctor should adjust your insulin and/or antidiabetic medication dosage.
• If you have severe kidney problems. Caution is necessary, as there is no experience with the use of bicalutamida in these cases.
• If you are taking a daily dose of 150 mg of bicalutamida and have a heart disease. Your doctor may choose to check your cardiac function periodically.
• Inform your doctor if you have any heart or blood vessel conditions or are being treated for them, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when bicalutamida is used.

If any of the above situations apply to you, inform your doctor, who will take it into account during your treatment with bicalutamida.

In case of hospital admission, inform the healthcare staff that you are taking this medication.

If you are taking bicalutamida, you and/or your partner should use a contraceptive method while you are on treatment with bicalutamida and for 130 days after the end of treatment.

Other medications and Bicalutamida Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take bicalutamida with the following medications:

• Terfenadine or astemizol (for hay fever or allergy)
• Cisaprida (for stomach disturbances)

If you take bicalutamida with any of the following medications, the effect of this and other medications may be affected. Consult your doctor before taking any of the following medications with bicalutamida:

• Warfarin or any medication similar to prevent blood coagulation.
• Ciclosporina (used to reduce the immune system to prevent and treat organ or bone marrow transplant rejection).
• Midazolam (medication used to alleviate anxiety before surgery or certain procedures or as an anesthetic before and during surgery).
• Calcium channel blockers (e.g., diltiazem or verapamil. These medications are used to treat high blood pressure or certain heart diseases).
• Cimetidine (to treat stomach ulcers).
• Ketoconazole (used to treat fungal infections of the skin and nails).

Bicalutamida may interfere with some medications used to treat heart rhythm problems (e.g., quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used with other medications (e.g., methadone (used for pain relief and detoxification of other medications), moxifloxacino (an antibiotic), antipsychotics used to treat severe mental illnesses).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication

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

Male fertility may be temporarily reduced due to bicalutamida treatment, including temporary infertility.

Driving and operating machinery

Bicalutamida may make you feel drowsy, so you should be careful when driving or operating machinery.

Bicalutamida Stada contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.Your doctor will inform you of the duration of your treatment.

The recommended dose for adults is 1 tablet per day (equivalent to 50 mg of bicalutamida).

Swallow the tablet whole with water.

Try to take the tablet at the same time every day.

If you take more Bicalutamida Stada than you should

If you ingest a dose higher than the normal, contact your doctor or the nearest hospital.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Bicalutamida Stada

Do not take a double dose to compensate for the missed doses. Simply continue with your regular treatment.

If you interrupt treatment with Bicalutamida Stada

Do not stop taking this medication even if you feel well, unless your doctor tells you otherwise.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Contact your doctor or pharmacist immediately if you experience any of the following severe side effects:

• Skin rash, severe skin itching (with blisters), hives, skin peeling, or the formation of blisters or scabs.

• Swelling of the face, neck, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing.
• Difficulty breathing or sudden worsening of breathing difficulty, possibly with cough or fever. These may be signs of interstitial lung disease.
• Blood in the urine
• Abdominal pain
• Yellow discoloration of the skin and eyes (jaundice). These may be symptoms of liver damage.

Other possible side effects of this medicine are:

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

• Anemia
• Dizziness
• Abdominal pain, constipation, nausea (urge to vomit)
• Confusion
• Blood in the urine
• Skin rash
• Weakness, swelling
• Breast enlargement and breast tenderness. Breast enlargement may not resolve spontaneously after treatment is stopped, particularly after prolonged treatment

Common (may affect up to 1 in 10 people)

• Weight gain
• Drowsiness
• Myocardial infarction (fatalities have been reported), heart failure
• Stomach pain, flatulence (gas)
• Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching
• Decreased appetite
• Chest pain
• Liver toxicity, elevated liver enzymes, jaundice (yellow discoloration of skin and eyes)
• Erectile dysfunction
• Decreased libido, depression
• Diarrhea

Uncommon (may affect up to 1 in 100 people)

• Interstitial lung disease (a lung inflammation). Fatalities have been reported.
• Allergic reactions (hypersensitivity), skin swelling, urticaria

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

• Liver failure. Fatalities have been reported
• Vomiting
• Increased skin sensitivity to sunlight

Frequency not known (cannot be estimated from available data)

• Changes in the electrocardiogram ECG (prolongation of the QT interval).

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special conditions for conservation.

Store in the original packaging.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Bicalutamida Stada

• The active ingredient is bicalutamide. Each tablet contains 50 mg of bicalutamide.
• The other components are:

Core: lactose monohydrate, povidone K-30, sodium carboxymethylcellulose (type A) (from potato), magnesium stearate,

Coating: hypromellose, titanium dioxide (E171), macrogol.

Appearance of the product and contents of the packaging

This medication is presented in the form of coated tablets with a white film coating, round, biconvex. Each package contains 30 coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Tecnimede

Quinta da Cerca, Caixaria

2565-187 Dois Portos (Portugal)

Last review date of this leaflet:November 2017

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/