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, 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 give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

1. What Saveprost is and what it is used for

2. What you need to know before you start taking Saveprost

3. How to take Saveprost

4. Possible side effects

5. Storage of Saveprost

6. Contents of the pack and additional information.

Saveprost is used in the treatment of advanced prostate cancer. It is taken along with a medication called a luteinizing hormone-releasing hormone (LHRH) analog, an additional hormonal treatment or in conjunction with surgical removal of the testicles.

Saveprost belongs to a group of medications known as nonsteroidal antiandrogens. The active substance Bicalutamida blocks the undesirable effects of male sex hormones (androgens) and thereby inhibits cell growth in the prostate.

Do not take Saveprost

• If you are allergic (hypersensitive) to bicalutamide or to any of the other components of Saveprost.
• If you are taking terfenadine (for hay fever or allergy), astemizol (for hay fever or allergy) or cisaprida (for stomach disturbances).

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 medication 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 impairments develop, you should discontinue treatment with bicalutamide.

- If your renal function is severely impaired.In this case, this medication should be taken after your doctor has carefully considered the possible benefits and risks.

- If you have any heart disease. Inform your doctor if you have any heart or blood vessel conditions or are being treated for them, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when Saveprost is used. In this case, your doctor should regularly monitor your cardiac function.

Other medications and Saveprost

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

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

- Terfenadine or astemizol (for hay fever or allergy).

- Cisaprida (for stomach disturbances).

If you take Saveprost with any of the following medications, the effect of bicalutamide, as well as other medications, may be influenced. Consult your doctor before taking any of these medications with Saveprost:

- Warfarin or any medication similar to prevent blood clots.

- Ciclosporina (used as an immunosuppressant to prevent and treat organ transplant or bone marrow rejection reactions).

- Cimetidina (for stomach ulcer treatment).

-Ketoconazol (used for fungal infections in the skin and nails).

- Calcium channel blockers (for hypertension treatment).

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medication.

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

Driving and operating machinery

These tablets may cause dizziness or drowsiness. If you experience these effects, you should not drive or operate machinery.

Saveprost contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1mmol) per tablet; it is essentially "sodium-free".

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

Your doctor will tell you the appropriate dose for you. The usual dose is one tablet once a day. Read the instructions that appear on the packaging.

The tablets should be swallowed whole with some liquid. Try to take the medication approximately at the same time every 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 with you the remaining tablets or the box so that 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 administration. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Saveprost

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

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

Like all medications, Saveprost may cause side effects, although not everyone will experience them.

Severe side effects:

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

Less common severe side effects(affect fewer than 1 in 100 people):

• Severe allergic reaction that causes swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing or breathing or significant itching on 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.

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

• Yellowing of the skin or the white part of the eye caused by liver problems (including liver insufficiency).

Other side effects

Inform your doctor if you experience any of the following side effects:

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

• Increased sensitivity or enlargement of the breasts
• Decreased libido, erectile dysfunction, impotence
• Hot flashes

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

• Nausea
• Diarrhea or constipation
• Dizziness
• Difficulty sleeping
• 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
• Decreased red blood cells in the blood that may cause paleness, weakness, or shortness of breath

Less common side effects(affect fewer than 1 in 100 people):

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

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

• Vomiting
• Dry skin

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

• Chest pain and heart failure (usually associated with shortness of breath, especially with exertion, rapid heartbeats, inflammation of the extremities, 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usehttp://www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

This medication does not require special storage conditions.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Saveprost

• The active ingredient is bicalutamide. A tablet contains 50 mg of bicalutamide.

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

Appearance of the product and contents of the packaging

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

30 tablets packaged in blisters.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Salvat, S.A.

C/ Gall, 30-36 – 08950

Esplugues de Llobregat

Barcelona - Spain

Responsible for manufacturing

SYNTHON BV

Microweg, 22

NL-6545 CM, Nijmeden

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

Last review date of this leaflet: July 2020