Bicalutamide Stada 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bicalutamida Stada 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Bicalutamida Stada is and what it is used for
2. What you need to know before taking Bicalutamida Stada
3. How to take Bicalutamida Stada
4. Possible adverse effects
5. How to store Bicalutamida Stada
6. Contents of the pack and other information

1. What Bicalutamida Stada is and what it is used for

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

This medicine is used in the treatment of advanced prostate cancer 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.

2. What you need to know before taking Bicalutamide Stada

Do not take Bicalutamide Stada:

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines for allergy such as terfenadine or astemizole, or cisapride, a medicine used to treat gastroesophageal reflux.

Bicalutamide must not be taken by women, nor should it be administered to children or adolescents under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine

• If you have any disorder or disease affecting your liver. 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. Cases of death (severe liver changes and liver failure) have been reported.

• If you have inflammation of the lungs called interstitial lung disease. Symptoms may include severe shortness of breath with cough or fever. Fatal cases have been reported.

• If you have diabetes. Combined treatment with bicalutamide and LHRH analogues may alter your blood sugar levels. Your doctor should adjust your insulin dose and/or antidiabetic medications accordingly.

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

• If you are taking a daily dose of 150 mg bicalutamide and have heart disease. Your doctor may choose to monitor your cardiac function periodically.

• 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 bicalutamide is used.

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

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

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

Other medicines and Bicalutamide Stada

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

Do not take bicalutamide together with the following medicines:

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

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

• Warfarin or any similar medicine used to prevent blood clotting.
• Cyclosporine (used to suppress the immune system to prevent and treat rejection of transplanted organs or bone marrow).
• 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 (used 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 disorders (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 medication detoxification), moxifloxacin (an antibiotic), antipsychotics used to treat serious mental illnesses).

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 medicine.

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

Male fertility may be temporarily reduced due to treatment with bicalutamide, including transient infertility.

Driving and using machines

Bicalutamide may cause drowsiness; therefore, you should be cautious when driving or operating machinery.

Bicalutamide Stada contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Bicalutamida Stada

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, check with your doctor or pharmacist again. Your doctor will advise you on how long to take the treatment.

The recommended dose for adults is 1 tablet daily (equivalent to 50 mg of bicalutamide).

Swallow the tablet whole with water.

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

If you take more Bicalutamida Stada than you should

If you take 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, stating the medication and amount taken. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Bicalutamida Stada

Do not take a double dose to make up for missed doses. Simply continue with your regular treatment schedule.

If you stop taking Bicalutamida Stada

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 may cause adverse effects, although not everyone experiences them.

Contact your doctor or pharmacist immediately if you experience any of the following very serious adverse effects:

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

• Anaemia
• Dizziness
• Abdominal pain, constipation, nausea (feeling sick)
• 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 people)

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

Uncommon (may affect up to 1 in 100 people)

• Interstitial lung disease (an inflammation of the lungs). 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 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 adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bicalutamide Stada

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

This medicine does not require any special storage conditions.

Store in the original packaging.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point in your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the package and other information

Composition of Bicalutamide Stada

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

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

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

Appearance of the medicinal product and contents of the package

This medicinal product is presented as white, round, biconvex film-coated tablets. Each pack contains 30 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

C/ Frederic Mompou 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Tecnimede

Quinta da Cerca, Caixaria

2565-187 Dois Portos (Portugal)

Date of the most recent revision of this leaflet: November 2017

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/