Patient Information Leaflet

Probic 50 mg Film-Coated Tablets

Bicalutamide

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you think you have experienced a side effect, you can report it using the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

1. What isProbicand what it is used for

2. What you need to know before you start takingProbic

3. How to takeProbic

4. Possible side effects

5. Storage ofProbic

6. Contents of the pack and additional information

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

This medication is indicated for certain prostate pathologies in conjunction with other treatments, such as medications that reduce androgen levels in the body.

Do not take Probic

• If you are allergic to bicalutamide or any of the other components of the medication.

(listed in section 6).

• If you are taking terfenadine or astemizol, which are used to treat allergies, or cisaprida, which is used to treat heartburn and acid reflux

• Bicalutamide should not be administered to women, nor to children or adolescents.

Warnings and precautions

• If you have any liver disorder or disease that affects 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.

• If you have any heart problem. Your doctor should 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.

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

Only stop taking the tablets if your doctor instructs you to do so.

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

Use of Probic with other medications:

Inform your doctor or pharmacist if you are using, have recently taken, or may need to take another medication. Bicalutamide should not be used with the following medications:

• terfenadine or astemizol (for hay fever or allergy)
• cisaprida (for stomach disturbances)

If you take Bicalutamide with any of the following medications, both the effect of bicalutamide and the other medication may be affected. Consult with your doctor before taking Probic with the following medications:

• warfarina or any medication to prevent blood clot formation
• 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).
• cimetidina (to treat stomach ulcers).
• ketoconazol (used to treat fungal infections of the skin and nails).
• calcium channel blockers (for example, diltiazem or verapamilo. These medications are used to treat high blood pressure or certain heart diseases).

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

Taking Probic with food and drinks

The taking of food does not affect the efficacy of the medication.

Pregnancy, breastfeeding, and fertility:

Bicalutamide should not be taken by women, including pregnant women or those breastfeeding.

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

Driving and operating machinery:

It is unlikely that Probic will adversely affect your ability to drive vehicles or operate machinery. However, you should exercise caution if you experience drowsiness.

Probic contains lactose

If your doctor has indicated that you have intolerance to certain sugars, consult with him before taking this medication.

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

The recommended dose in adults is 1 tablet per day.

Swallow the tablet whole with water.

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

If you take more Probic 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 5620420.

If you forget to take Probic

Do not take a double dose to make up for the missed doses. If you forget a dose, do not take an additional tablet; simply continue with your regular treatment.

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

• Severe difficulty breathing, or sudden worsening of breathing difficulty, possibly with cough or fever. Some patients taking bicalutamide develop a lung inflammation condition called pulmonary disease. This adverse effect is rare (less than 1 in 100 but more than 1 in 1,000 patients).

• Severe skin itching (with blisters) or swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing. These medication reactions are rare (less than 1 in 100 patients).

Other possible adverse effects of this medication are:

Adverse effects that are very common (may affect more than 1 in 10 patients):

Increased sensitivity or breast enlargement, Hot flashes.

Adverse effects that are common (may affect up to 1 in 100 patients):

Nausea, Diarrhea, Itching, Weakness, Yellow skin and eyes (jaundice).

Adverse effects that are rare (may affect up to 1 in 1,000 patients):

Vomiting, Dry skin

Adverse effects of unknown frequency (cannot be estimated from available data):

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system. By4

reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

This medication does not require special storage conditions.

Store in the original packaging.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Probic

- The active principle is bicalutamide. Each tablet contains 50 mg of bicalutamide

- The other components are: Core: lactose monohydrate, povidone K-30, sodium glycolate starch (from potato), magnesium stearate. Coating: Opadry white Y-7-100

Appearance of the product and contents of the packaging

Probic 50 mg tablets are presented in the form of coated tablets with a white film coating, round, and biconvex.

Each package contains 30 coated tablets conditioned in PVC/PVDC/Aluminum blisters.

Holder of the marketing authorization and manufacturer

Holder of the marketing authorization

Laboratorios Q Pharma, S.L.

C/ Moratín 15 Entlo, Offices 6-7

03008 Alicante

SPAIN

Responsible for release:

TECNIMEDE SOCIEDADE TECNICO-MEDICINAL, S.A.

Rua Prof. Henrique de Barros, Sagres 3rd building

A Prior Velho P-2685-338 Portugal

)

This leaflet was approved in:

November 2013

“Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es ”