Saveprost 50 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Saveprost 50 mg film-coated tablets EFG
Bicalutamide
Read all of 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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.
Contents of the leaflet
- What Saveprost is and what it is used for
- What you need to know before taking Saveprost
- How to take Saveprost
- Possible side effects
- How to store Saveprost
- Contents of the pack and other information
1. What Saveprost is and what it is used for
Saveprost is used in the treatment of advanced prostate carcinoma. It is taken together with a medicine called luteinizing hormone-releasing hormone (LHRH) analogue, additional hormonal treatment, or in combination with surgical removal of the testicles.
Saveprost belongs to a group of medicines known as non-steroidal antiandrogens. The active substance, Bicalutamide, blocks the undesirable effects of male sex hormones (androgens) and thereby inhibits cell growth in the prostate.
2. What you need to know before taking Saveprost
Do not take Saveprost
- If you are allergic (hypersensitive) to bicalutamide or to any of the other ingredients of Saveprost.
- If you are taking terfenadine (for hay fever or allergies), astemizole (for hay fever or allergies), or cisapride (for stomach disorders).
Saveprost must not be administered to women, children, or adolescents.
Warnings and precautions
- If you have severely or moderately impaired liver function. In this case, this medicine should only be taken after your doctor has carefully considered the potential benefits and risks. If this applies to you, your doctor will regularly perform tests to monitor your liver function (bilirubin, transaminases, alkaline phosphatase). If severe liver function abnormalities develop, treatment with bicalutamide should be discontinued.
- If you have severely impaired kidney function. In this case, this medicine should be taken only after your doctor has carefully considered the potential benefits and risks.
- If you have any heart disease. Inform your doctor if you have any condition affecting the heart or blood vessels, or if you are being treated for such conditions, 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 cardiac function.
Other medicines and Saveprost
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
Saveprost must not be taken together with any of the following medicines:
- Terfenadine or astemizole (for hay fever or allergies).
- Cisapride (for stomach disorders).
If you take Saveprost together with any of the following medicines, the effect of bicalutamide and/or the other medicines may be altered. Consult your doctor before taking any of these medicines together with Saveprost:
- Warfarin or a similar medicine used to prevent blood clots.
- Cyclosporine (used as an immune system suppressant to prevent and treat rejection reactions following organ or bone marrow transplantation).
- Cimetidine (used to treat stomach ulcers).
- Ketoconazole (used to treat fungal infections of the skin and nails).
- Calcium channel blockers (used to treat high blood pressure).
Saveprost may interfere with certain medicines used to treat heart rhythm disorders (e.g., quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used together with other medicines (e.g., methadone (used for pain relief and medication detoxification), moxifloxacin (an antibiotic), antipsychotics used to treat serious mental illnesses).
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Women must not take Saveprost. Bicalutamide is not indicated for use in 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 medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially “sodium-free”.
3. How to take Saveprost
Follow exactly the administration instructions for Saveprost given by your doctor. Consult your doctor or pharmacist if you have any questions.
Your doctor will determine the appropriate dose for you. The usual dose is one tablet once daily. Read the instructions provided 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 along any remaining tablets or the packaging so the doctor can identify what you have taken.
If you forget to take Saveprost
If you forget to take your daily dose and remember later, do not take it; wait and take your next dose at the usual time. Do not take a double dose to make up for a missed dose.
If you stop taking Saveprost
Even if you feel better, do not stop treatment without consulting your doctor.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Saveprost may cause adverse effects, although not everyone experiences them.
Serious adverse effects:
Contact your doctor immediately if you notice any of the following serious adverse effects.
Uncommon serious adverse effects (affect fewer than 1 in 100 people):
- Severe allergic reaction causing swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing or breathing, or intense itching of the skin with appearance of lumps.
- Severe shortness of breath or sudden worsening of breathing difficulties, possibly accompanied by cough or fever. Some patients treated with bicalutamide develop lung inflammation known as interstitial lung disease.
Rare serious adverse effects (affect fewer than 1 in 1,000 people):
- Yellowing of the skin or whites of the eyes caused by liver problems (including liver failure).
Other adverse effects
Inform your doctor if you experience any of the following adverse effects:
Very common adverse effects (affect more than 1 in 10 people):
- Breast tenderness or increased breast size
- Decreased sex drive, erection problems, impotence
- Hot flushes
Common adverse effects (affect fewer than 1 in 10 people):
- Nausea
- Diarrhea or constipation
- Dizziness
- Difficulty sleeping
- Skin redness, 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 blood, which may cause paleness, weakness, or shortness of breath
Uncommon adverse effects (affect fewer than 1 in 100 people):
- Loss of appetite, weight loss
- Depression
- High blood sugar
- Somnolence
- 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 adverse effects (affect fewer than 1 in 1,000 people):
- Vomiting
- Dry skin
Very rare adverse effects (affect fewer than 1 in 10,000 people):
- Chest pain and heart failure (which is usually associated with shortness of breath, especially during exertion, rapid heartbeat, swelling of the limbs, and skin spots), irregular heartbeat, changes in electrocardiogram (ECG) (prolongation of the QT interval)
- Reduction in platelets in blood, increasing the risk of bleeding or appearance of bruises on the skin
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaRAM.es.
By reporting adverse 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Do not use Saveprost if you notice any visible signs of deterioration in the appearance of the tablets.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Saveprost
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The active substance is bicalutamide. One tablet contains 50 mg of bicalutamide.
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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 (colouring agent E171) and macrogol 4000.
Appearance of the medicinal product and contents of the pack
White, round, biconvex film-coated tablet, marked with "BCM 50" on one side.
30 tablets packed in blisters.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorios Salvat, S.A.
C/ Gall, 30-36 – 08950
Esplugues de Llobregat
Barcelona - Spain
Manufacturer
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
Date of the most recent revision of this leaflet: July 2020