Eftoran 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eftoran 50 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 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.

Leaflet contents:

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

1. What Eftoran is and what it is used for

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

Eftoran 50 mg is indicated for 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 Eftoran

Do not take Eftoran:

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 heartburn and acid reflux.

Eftoran must not be used in children and adolescents under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Eftoran:

• If you have any liver disorder or 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 an inflammation of the lungs called interstitial lung disease. Symptoms may include severe shortness of breath with cough or fever. Deaths have been reported.
• If you have diabetes. Treatment with bicalutamide combined with luteinizing hormone-releasing hormone (LHRH) analogues may alter your blood sugar levels. Your doctor must adjust your insulin dose and/or antidiabetic medications.
• If you have severe kidney problems. Caution is necessary, as there is no experience with the use of bicalutamide in these cases.
• 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 taking Eftoran.

If you are admitted to hospital, inform healthcare staff that you are taking Eftoran 50 mg.

Children and adolescents

Eftoran must not be given to children or adolescents under 18 years of age.

Taking Eftoran with other medicines

Tell 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 allergies).
• Cisapride (for stomach disorders).

If you take Eftoran together with any of the following medicines, the effect of bicalutamide and/or the other medicines may be affected.

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 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 (to treat high blood pressure or certain heart conditions), for example, diltiazem or verapamil.
• Cimetidine (to treat stomach ulcers).
• Ketoconazole (used to treat fungal infections of the skin and nails).

Eftoran 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), or antipsychotics used to treat serious mental illnesses).

Pregnancy and breastfeeding

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

Male fertility may be temporarily reduced due to treatment with bicalutamide, even resulting in transient infertility.

Driving and using machines

Eftoran may make you feel drowsy. Therefore, take care when driving or operating machinery.

Eftoran contains lactose

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

3. How to take Eftoran

Follow exactly the instructions given by your doctor for administering this medicine. If in doubt, consult your doctor or pharmacist again.

• The usual dose in adults is one tablet (50 mg) daily.
• Swallow the tablet whole with water.
• Try to take the tablet at the same time each day.

If you take more Eftoran than you should

If you ingest a dose higher than normal, contact your doctor or nearest hospital. In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to take Eftoran

Do not take a double dose to make up for missed doses; simply continue with your usual treatment.

If you stop taking Eftoran

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, Eftoran may 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 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 patients

• 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 patients

• Weight gain.
• Drowsiness.
• Heart attack (fatal cases have been reported), heart failure.
• Stomach pain, flatulence (gas).
• Chest pain.
• Hair loss (alopecia), excessive hair growth/regrowth of hair, dry skin, itching.
• Loss of appetite.
• 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 (a lung inflammation). 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.

Frequency not known:

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 Eftoran

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

Do not store above 30 °C.

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 must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eftoran

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 (E171) and talc).

Appearance of the product and contents of the pack

Eftoran is presented as film-coated tablets.

The tablets are round and white.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.
Avda. de Bruselas, 13, 3º D. Edificio América.
Polígono Arroyo de la Vega,
28108 Alcobendas (Madrid) SPAIN

Manufacturer:

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

Date of the most recent revision of this leaflet: December 2014

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/