PROBIC 50 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Probic 50 mg film-coated tablets

Bicalutamide

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

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

1. What is Probic and what is it used for

Probic contains bicalutamide, which belongs to a group of medicines called anti-androgens. This means that it interferes with some of the actions of male sex hormones (androgens) in the body. It also reduces the amount of male hormones produced in the body.

This medicine is used for certain prostate conditions, in combination with other treatments, such as medicines that reduce the levels of androgens in the body.

2. What you need to know before you take Probic

Do not take Probic

• If you are allergic to bicalutamide or any of the other ingredients of this medicine.

(listed in section 6).

• If you are taking terfenadine or astemizol, used to treat allergies, or cisapride, used to treat heartburn and acid reflux.
• Bicalutamide should not be given to women, children, or adolescents.

Warnings and precautions

• If you have any liver problems. This medicine should only be taken after your doctor has carefully considered the potential benefits and risks. If this is the case, your doctor will need to perform regular liver function tests.
• If you have any heart problems. Your doctor will need to monitor your heart function.
• If you have severe kidney problems. Caution is necessary, as there is no experience with the use of bicalutamide in these cases.

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

Only stop taking the tablets if your doctor tells you to.

Tell your doctor if you have any heart or blood vessel problems, or if you are being treated for them, including medicines to control your heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using Probic.

Using Probic with other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Bicalutamide should not be used with the following medicines:

• terfenadine or astemizol (for hay fever or allergy)
• cisapride (for stomach problems)

If you take Bicalutamide with some of the following medicines, the effect of bicalutamide or the other medicine may be affected. Consult your doctor before taking Probic with the following medicines:

• warfarin or any medicine to prevent blood clots
• ciclosporin (used to suppress the immune system to prevent and treat transplant rejection or bone marrow transplant)
• midazolam (a medicine used to relieve anxiety before surgery or certain procedures or as an anesthetic before and during surgery)
• cimetidine (to treat stomach ulcers)
• ketoconazole (used to treat fungal infections of the skin and nails)
• calcium channel blockers (e.g., diltiazem or verapamil, used to treat high blood pressure or certain heart conditions)

Probic 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), moxifloxacin (an antibiotic), antipsychotics used to treat severe mental illnesses).

Taking Probic with food and drinks

Taking food does not affect the efficacy of the medicine.

Pregnancy, breast-feeding, and fertility:

Bicalutamide should not be taken by women, including pregnant or breast-feeding women.

The fertility of male patients may be temporarily reduced due to treatment with bicalutamide, even with temporary infertility.

Driving and using machines:

It is unlikely that Probic will affect your ability to drive or use machines. However, you should be cautious if you experience drowsiness.

Probic contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Probic

Follow exactly the instructions of your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose in adults is one tablet per day.

Swallow the tablet whole with water.

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

If you take more Probic than you should

If you ingest more than the normal dose, contact your doctor or the nearest hospital. In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 5620420.

If you forget to take Probic

Do not take a double dose to make up for forgotten doses. If you forget a dose, do not take an extra tablet, simply continue with your usual treatment.

4. Possible side effects

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

• Severe breathing difficulties, or sudden worsening of breathing difficulties, possibly with cough or fever. Some patients taking bicalutamide develop inflammation of the lungs called pulmonary disease. This side effect is uncommon (less than 1 in 100 but more than 1 in 1,000 patients).
• Severe skin itching (with lumps) or swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing. These allergic reactions are uncommon (less than 1 in 100 patients).

Other possible side effects of this medicine are:

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

Breast tenderness or enlargement, Hot flushes.

Common side effects (may affect up to 1 in 100 patients):

Nausea, Diarrhea, Itching, Weakness, Yellowing of the skin and eyes (jaundice).

Uncommon side effects (may affect up to 1 in 1,000 patients):

Vomiting, Dry skin.

Rare side effects (frequency cannot be estimated from the available data):

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

Occasionally, the use of this medicine may be associated with changes in your blood that may require your doctor to perform certain blood tests.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Probic

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

This medicine does not require any special storage conditions.

Store in the original package.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Probic

• The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide.
• The other ingredients are: Core: lactose monohydrate, povidone K-30, sodium starch glycolate (from potato), magnesium stearate. Coating: Opadry white Y-7-100.

Appearance and packaging of the product

Probic 50 mg film-coated tablets are white, round, and biconvex.

Each pack contains 30 film-coated tablets in PVC/PVDC/Aluminum blisters.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorios Q Pharma, S.L.

C/ Moratín 15 Entlo, Oficinas 6-7

03008 Alicante

SPAIN

Responsible for release:

TECNIMEDE SOCIEDADE TECNICO-MEDICINAL, S.A.

Rua Prof. Henrique de Barros, edificio Sagres 3ª

A Prior Velho P-2685-338 Portugal

)

This leaflet was approved in:

November 2013

“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”