Leaflet: information for the user

Bicalutamide Almus50 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, and you should 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.

Contents of the pack and additional information

Bicalutamida Almusbelongs to a group of medications called anti-androgens, 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 (daily dose of 50 mg) in combination with a medication called a luteinizing hormone-releasing hormone (LHRH) analog – an additional hormonal treatment – or concurrently with surgical removal of the testicles.

It is also used in the treatment of prostate cancer without metastasis, in cases where there is a high risk of progression (daily dose of 150 mg). It can be used alone or in combination with other therapeutic methods such as surgical removal of the prostate gland or radiation therapy.

Do not take Bicalutamida Almus:

• If you are allergic to bicalutamida or any of the other components of this medication (listed in section 6).
• If you are a woman.
• If you are taking terfenadina or astemizol, which is used to treat allergies, or cisaprida, which is used to treat heartburn and acid reflux.

Bicalutamida should not be administered to children and adolescents under 18 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bicalutamida Almus:

• If you have any liver disorder or disease that may affect 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 regularly perform liver function tests. Fatal cases (severe liver changes and liver failure) have been reported.

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

• If you are taking any medication, including those obtained without a prescription. In particular, if you are taking medications that thin the blood or medications to prevent blood clotting.
• If you have diabetes. The combined treatment of bicalutamida with luteinizing hormone-releasing hormone (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 using Bicalutamida.

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

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

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

Consult your doctor if you have any questions about contraceptive methods.

Children and adolescents

This medication should not be administered to children and adolescents under 18 years old.

Taking Bicalutamida Almus with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication, including those obtained without a prescription and herbal remedies.

Do not take bicalutamida with the following medications:

- Terfenadina or astemizol (for hay fever or allergies).

- Cisaprida (for stomach disturbances).

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

• Particularly, inform your doctor if you are taking blood-thinning medications such as warfarin.
• 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).
• Cimetidina (used to treat stomach ulcers).
• Ketoconazol (used to treat fungal infections of the skin and nails).

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

Please note that these warnings may also apply to medications you have used in the past.

Pregnancy, breastfeeding, and fertility

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

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

Bicalutamida may have an effect on male fertility that may be reversible.

Driving and operating machinery

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

Bicalutamida Almus contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose for adults is 1 tablet per day (equivalent to 50 mg of bicalutamida) or 3 tablets per day (equivalent to 150 mg of bicalutamida).

• Swallow the tablet(s) whole with the help of water.

• Try to take the tablet(s) at the same time every day.

If you take more Bicalutamida Almus than you should

If you ingest a dose higher than the normal dose, 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 ingested).

If you forget to take Bicalutamida Almus

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

If you interrupt treatment with Bicalutamida Almus

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.

If you notice any of the following symptoms, inform your doctor immediately or visit the nearest hospital emergency department. These side effects are very serious.

• Skin rash, severe skin itching (with blisters), hives, skin peeling or formation of blisters or scabs.
• Swelling of the face or 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 10patients):

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

Common(may affect up to 1 in 10patients):

• Weight gain.
• Drowsiness.
• Myocardial infarction (fatalities have been reported), heart failure.
• Indigestion, 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.

Uncommon(may affect up to 1 in 100patients):

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

Rare(may affect up to 1 in 1,000patients):

• Liver failure. Fatalities have been reported.
• 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 adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is an adverse reaction that does not appear in this prospectus.You can also report them directly through theSSpanish System for Pharmacovigilance of Medicines for Human Use. Website:www.notificaram.es.

By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above30 °C

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

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.This will help protect the environment.

Composition of Bicalutamida Almus

The active ingredient is bicalutamide. Each tablet contains 50 mg of bicalutamide.

The other components (excipients) are:

Core:lactose monohydrate, crospovidone, povidone, magnesium stearate.Covering:Opadry II 85F28751 (polyvinyl alcohol, macrogol 3000, titanium dioxide, and talc)

Appearance ofBicalutamida Almusand contents of the packaging

White-coated, oblong, and biconvex tablets.

Each package contains 30 tablets in PVC/PVdC/Aluminum blisters.

Holder of the authorization:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80Email:[email protected]

Responsible for manufacturing

Tecnimede - Sociedade Técnico Medicinal, S.A.

Quinta da Cerca, Caixaria. 2565-187 Dois Portos (Portugal)

Date of the last review of this leaflet:June 2021

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