SAVEPROST 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Saveprost 50 mg film-coated tablets EFG

Bicalutamide

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

• Keep this package 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 package leaflet. See section 4.

Contents of the package leaflet

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

1. What is Saveprost and what is it used for

Saveprost is used in the treatment of advanced prostate cancer. It is taken together with a medicine called luteinizing hormone-releasing hormone (LHRH) analogue, additional hormonal treatment, or accompanied by surgical removal of the testicles.

Saveprost belongs to a group of medicines known as non-steroidal anti-androgens. The active substance bicalutamide blocks the undesirable effects of male sex hormones (androgens) and thus inhibits cell growth in the prostate.

2. What you need to know before you take Saveprost

Do not take Saveprost

• If you are allergic (hypersensitive) to bicalutamide or any of the other ingredients of Saveprost.
• If you are taking terfenadine (for hay fever or allergy), astemizole (for hay fever or allergy), or cisapride (for stomach disorders).

Saveprost should not be administered to women, children, or adolescents.

Warnings and precautions

• If your liver function is severely or moderately impaired. In this case, this medicine should only be taken after your doctor has carefully considered the possible benefits and risks. If that is the case, your doctor will regularly perform liver function tests (bilirubin, transaminases, alkaline phosphatase). If severe liver function disorders develop, treatment with bicalutamide should be discontinued.
• If your kidney function is severely impaired. In this case, this medicine should be taken after your doctor has carefully considered the possible benefits and risks.
• If you suffer from any heart disease. Inform your doctor if you have any heart or blood vessel condition or are being treated for it, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using Saveprost. In this case, your doctor should regularly monitor your heart function.

Other medicines and Saveprost

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

Saveprost should not be taken with any of the following medicines:

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

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

• Warfarin or similar medicines to prevent blood clots.
• Ciclosporin (used as an immunosuppressant to prevent and treat rejection reactions of a transplanted organ or bone marrow).
• Cimetidine (for the treatment of stomach ulcers).
• Ketoconazole (used for the treatment of fungal infections of the skin and nails).
• Calcium channel blockers (for the treatment of hypertension).

Saveprost 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 for treating severe mental illnesses).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

Women should not take Saveprost. Bicalutamide is not indicated in women.

Driving and using machines

These tablets may cause dizziness or drowsiness. If you notice these effects, you should not drive or use machines.

Saveprost contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them 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 Saveprost

Follow exactly the administration instructions of Saveprost indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate the appropriate dose for you. The normal dose is one tablet once a day. Read the instructions on the packaging.

The tablets should be swallowed whole with some liquid. Try to take the medicine at approximately the same time each day.

If you take more Saveprost than you should

If you take too many tablets, contact your doctor or the nearest hospital as soon as possible. Bring the remaining tablets or the packaging with you so the doctor can identify what you were taking.

If you forget to take Saveprost

If you forget to take your daily dose and remember later, do not take it and wait until it is time for your next dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Saveprost

Even if you feel better, do not stop treatment without consulting your doctor.

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

4. Possible side effects

Like all medicines, Saveprost can cause side effects, although not everybody gets them.

Serious side effects:

Contact your doctor immediately if you notice any of the following serious side effects.

Serious side effects, uncommon(affect less than 1 in 100 people):

• Severe allergic reaction that causes swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing or breathing or significant itching of the skin with the appearance of lumps.
• Severe shortness of breath or sudden worsening of shortness of breath, possibly accompanied by cough or fever. Some patients treated with bicalutamide develop a lung inflammation called interstitial lung disease.

Serious side effects, rare(affect less than 1 in 1,000 people):

• Yellowing of the skin or the whites of the eyes caused by liver problems (including liver failure).

Other side effects

Tell your doctor if you suffer from any of the following side effects:

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

• Breast tenderness or enlargement
• Decreased sexual desire, erection problems, impotence
• Hot flashes

Common side effects(affect less than 1 in 10 people):

• Nausea
• Diarrhea or constipation
• Dizziness
• Sleeping difficulties
• Redness of the skin, itching, sweating, excessive body hair
• Weakness
• Weight gain
• Diabetes mellitus
• Edema
• Generalized pain, pelvic pain
• Chills
• Blood tests showing changes in liver function
• Decrease in red blood cells in the blood that can cause paleness, weakness, or shortness of breath

Uncommon side effects(affect less than 1 in 100 people):

• Loss of appetite, weight loss
• Depression
• High blood sugar
• Drowsiness
• Shortness of breath
• Dry mouth, indigestion, flatulence (gas)
• Hair loss
• Need to urinate during the night, blood in urine
• Abdominal pain, chest pain, headache, back pain, neck pain

Rare side effects(affect less than 1 in 1,000 people):

• Vomiting
• Dry skin

Very rare side effects(affect less than 1 in 10,000 people):

• Chest pain and heart failure (which is usually associated with shortness of breath, especially with exertion, rapid heart rate, swelling of the limbs, and skin spots), irregular heartbeats, changes in the electrocardiogram (ECG) (prolongation of the QT interval)
• Reduction of platelets in the blood, which increases the risk of bleeding or the appearance of bruises on the skin

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 package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use http://www.notificaRAM.es.

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

5. Storage of Saveprost

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

Do not use Saveprost after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Do not use Saveprost if you notice any visible signs of deterioration in the appearance of the tablets.

Medicines should not be disposed of via wastewater or household waste. 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 Saveprost

• The active substance is bicalutamide. One tablet contains 50 mg of bicalutamide.

• The other ingredients (excipients) are lactose monohydrate, povidone K-29/32, crospovidone, sodium lauryl sulfate, and magnesium stearate. The coating contains lactose monohydrate, hypromellose, titanium dioxide (coloring agent E171), and macrogol 4000.

Appearance of the product and pack contents

White, round, biconvex film-coated tablet, marked with BCM 50 on one side.

30 tablets packaged in blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Salvat, S.A.

C/ Gall, 30-36 – 08950

Esplugues de Llobregat

Barcelona - Spain

Manufacturer

SYNTHON BV

Microweg, 22

NL-6545 CM, Nijmegen

Netherlands

Synthon Hispania

Castello, 1

Polígono Las Salinas

08830 Sant Boi de Llobregat, Barcelona

Spain

Laboratorios Salvat, S.A.

C/ Gall, 30-36 – 08950

Esplugues de Llobregat

Barcelona - Spain

Date of the last revision of this package leaflet: July 2020