Bicalutamide Almus 50 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Bicalutamide Almus 50 mg film-coated tablets EFG

Read the entire 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 personally. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Bicalutamide Almus is and what it is used for
2. What you need to know before taking Bicalutamide Almus
3. How to take Bicalutamide Almus
4. Possible adverse effects
5. How to store Bicalutamide Almus

Pack contents and other information

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

Bicalutamide Almus belongs to a group of medicines known as anti-androgens, which means that it interferes with certain actions of androgens (male sex hormones) in the body.

This medicine is used in the treatment of advanced prostate cancer (50 mg daily dose) in combination with a drug called a luteinizing hormone-releasing hormone (LHRH) analogue – an additional hormonal treatment – or together with surgical removal of the testicles.

It is also used in the treatment of non-metastatic prostate cancer in cases where there is a high risk of disease progression (150 mg daily dose). It may be used alone or in combination with other therapeutic methods such as surgical removal of the prostate gland or radiotherapy.

2. What you need to know before taking Bicalutamida Almus

Do not take Bicalutamida Almus:

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

Bicalutamida must not be administered to children and adolescents under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before starting Bicalutamida Almus:

• If you have any liver disorder or liver disease. This medicine should only be taken after your doctor has carefully considered the potential benefits and risks. In such cases, your doctor should regularly perform liver function tests. Deaths have been reported (due to severe liver changes and liver failure).

• If you have a lung inflammation known as interstitial lung disease. Symptoms may include severe shortness of breath with cough or fever. Deaths have been reported.

• If you are taking any medicines, including those obtained without a prescription. In particular, if you are taking blood-thinning medicines or medicines to prevent blood clots.

• If you have diabetes. Combined treatment with bicalutamide and luteinizing hormone-releasing hormone (LHRH) analogues may alter your blood sugar levels. Your doctor must adjust your insulin dose and/or antidiabetic medicines accordingly.

• If you have severe kidney problems. Caution is necessary, as there is no experience with the use of bicalutamide in such cases.

• If you are taking a daily dose of 150 mg of bicalutamide and have heart disease.

Your doctor may decide to periodically monitor your heart function.

Inform your doctor if you have any heart or blood vessel condition or are being treated for such conditions, 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 them into account during your treatment with Bicalutamida.

If you are admitted to hospital, inform healthcare staff that you are taking bicalutamide.

If you are taking bicalutamide, you and/or your partner must use an effective method of contraception during treatment and for 130 days after the end of treatment.

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

Children and adolescents

This medicine must not be administered to children and adolescents under 18 years of age.

Taking Bicalutamida Almus with other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription and herbal products.

Do not take bicalutamide together with the following medicines:

• Terfenadine or astemizole (for hay fever or allergies).
• Cisapride (for stomach disorders).

If you take bicalutamide together with any of the following medicines, the effect of these and other medicines may be affected. Consult your doctor before taking any of the following medicines together with bicalutamide:

• In particular, inform your doctor if you are taking blood-thinning medicines such as warfarin.
• Cyclosporine (used to suppress the immune system to prevent and treat rejection of organ or bone marrow transplants).
• Midazolam (a medicine used to relieve anxiety before surgery or certain procedures, or as an anaesthetic before and during surgery).
• Calcium channel blockers (e.g., diltiazem or verapamil. These medicines are used to treat high blood pressure or certain heart conditions).
• Cimetidine (to treat stomach ulcers).
• Ketoconazole (used to treat fungal infections of the skin and nails).

Bicalutamide may interfere with some medicines 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 medicines (e.g., methadone (used for pain relief and detoxification from other drugs), moxifloxacin (an antibiotic), antipsychotics used to treat serious mental illnesses).

Please note that these warnings may also apply to medicines you have taken some time ago.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine must not be taken by women, including pregnant women or breastfeeding mothers.

Bicalutamide may have an effect on male fertility, which may be reversible.

Driving and using machines

This medicine may make you feel drowsy, so you should be cautious when driving or using machines.

Bicalutamida Almus contains lactose.

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Bicalutamida Almus

Follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor or pharmacist again.

• In adults, the recommended dose is 1 tablet daily (equivalent to 50 mg of bicalutamide) or 3 tablets daily (equivalent to 150 mg of bicalutamide).
• Swallow the tablet(s) whole with water.
• Try to take the tablet(s) at the same time each day.

If you take more Bicalutamida Almus than you should

If you ingest more than the prescribed dose, contact your doctor or nearest hospital.

In case of overdose or accidental ingestion, contact the Toxicology Information Service (telephone 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 make up for missed doses; simply continue with your regular treatment schedule.

If you stop taking Bicalutamida Almus

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• Skin rash, severe skin itching (with lumps), hives, skin peeling, or blistering or crusting.
• 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 problems, possibly with cough or fever. These may be signs of interstitial lung disease.
• Blood in the urine.
• Abdominal pain.
• Yellowing of the skin and eyes (jaundice). These may be symptoms of liver damage.

Other possible adverse effects of this medicine are:

Very common (may affect more than 1 in 10 patients):

• Anaemia.
• Dizziness.
• Abdominal pain, constipation, nausea (feeling of wanting to vomit).
• Hot flush.
• Blood in the urine.
• Skin rash.
• Weakness, swelling.
• Breast enlargement and breast tenderness. Breast enlargement may not resolve spontaneously after stopping therapy, particularly after prolonged treatment.

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

• Weight gain.
• Drowsiness.
• Heart attack (fatal cases have been reported), heart failure.
• Indigestion, flatulence (gas).
• Hair loss (alopecia), excessive hair growth/regrowth of hair, dry skin, itching.
• Decreased appetite.
• Chest pain.
• Liver toxicity, elevated transaminase levels (liver enzymes), jaundice (yellowing of skin and eyes).
• Erectile dysfunction.
• Decreased sexual desire.
• Depression.

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

• Interstitial lung disease (an inflammation of the lungs). Fatal cases have been reported.
• Allergic reactions (hypersensitivity), skin swelling, urticaria.

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

• Liver failure. Fatal cases have been reported.
• Increased sensitivity of the skin to sunlight.

Frequency not known (cannot be estimated from available data):

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products. Website: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bicalutamide Almus

Keep this medicine out of sight and reach of children.

Do not store above 30 °C.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bicalutamide Almus

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

The other components (excipients) are:

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

Appearance of Bicalutamide Almus and contents of the pack

White, film-coated, oblong, biconvex tablets.

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

Marketing Authorisation Holder:

Almus Farmacéutica, S.A.U.
Marie Curie, 54
08840 Viladecans (Barcelona), Spain
Telephone: 93 739 71 80
Email: [email protected]

Manufacturer responsible for manufacturing:

Tecnimede - Sociedade Técnico Medicinal, S.A.
Quinta da Cerca, Caixaria
2565-187 Dois Portos (Portugal)

Date of the most recent review of this leaflet: June 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/