TOSADEX 50MG FILM COATED TABLETS

Država: Cipar

Jezik: grčki

Izvor: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Aktivni sastojci:

BICALUTAMIDE

Dostupno od:

DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629

ATC koda:

L02BB03

INN (International ime):

BICALUTAMIDE

Doziranje:

50MG

Farmaceutski oblik:

FILM COATED TABLETS

Sastav:

BICALUTAMIDE (8000001679) 50MG

Administracija rute:

ORAL USE

Tip recepta:

Εθνική Διαδικασία

Područje terapije:

BICALUTAMIDE

Proizvod sažetak:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) PVC/PCTFE/ALU (300027901) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 TABS IN BLISTER(S) PVC/PCTFE/ALU (300027902) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 40 TABS IN BLISTER(S) PVC/PCTFE/ALU (300027903) 40 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 90 TABS IN BLISTER(S) PVC/PCTFE/ALU (300027904) 90 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 100 TABS IN BLISTER(S) PVC/PCTFE/ALU (300027905) 100 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) ALU/ALU (300027906) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 TABS IN BLISTER(S) ALU/ALU (300027907) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 40 TABS IN BLISTER(S) ALU/ALU (300027908) 40 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 90 TABS IN BLISTER(S) ALU/ALU (300027909) 90 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 100 TABS IN BLISTER(S) ALU/ALU (300027910) 100 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Uputa o lijeku

PATIENT INFORMATION LEAFLET
TOSADEX 50 MG FILM-COATED TABLETS
Bicalutamide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
• 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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist. See section 4.
IN THIS LEAFLET:
1. What Tosadex is and what it is used for
2. Before you take Tosadex
3. How to take Tosadex
4. Possible side effects
5. How to store Tosadex
6. Further information
What
1. WHAT TOSADEX IS AND WHAT IT IS USED FOR
Tosadex contains a medicine called bicalutamide. This belongs to a
group of medicines called
‘anti-androgens’.

Tosadex is used to treat prostate cancer.

It works by blocking effects of male hormones such as testosterone.
2. BEFORE YOU TAKE TOSADEX
DO NOT TAKE TOSADEX IF:

You are allergic (hypersensitive) to bicalutamide or any of the other
ingredients of this
medicine (listed in Section 6: Further information).

You are already taking a medicine called cisapride or certain
anti-histamine medicines
(terfenadine or astemizole).

You are a woman.
Do not take Tosadex if any of the above apply to you. If you are not
sure, talk to your doctor or
pharmacist before taking Tosadex.
Tosadex must not be given to children.
TAKE SPECIAL CARE WITH TOSADEX
Check with your doctor or pharmacist before taking Tosadex if:
1

You have problems with your liver.

You have diabetes and are already taking an ‘LHRH analogue’. These
include goserelin,
buserelin, leuprorelin and triptorelin.
If you go into hospital, tell the medical staff that you are taking
Tosadex.
TAKING OTHER MEDICINES
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines.
This includes medicines that you

Svojstava lijeka

1.
NAME OF THE MEDICINAL PRODUCT
Tosadex 50 mg Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of bicalutamide.
Excipient(s) with known effect: 58.563 mg of lactose monohydrate per
film-coated tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Round, white coated tablet, debossed with "BIC 50" on one side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of advanced prostate cancer in combination with LHRH
analogue therapy or surgical
castration.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adult males including the elderly: one tablet (50 mg) once a day.
Treatment with Tosadex should be started at least 3 days before
commencing treatment with an
LHRH analogue, or at the same time as surgical castration.
Children: Tosadex is contraindicated in children.
Renal impairment: no dosage adjustment is necessary for patients with
renal impairment.
Hepatic impairment: no dosage adjustment is necessary for patients
with mild hepatic
impairment. Increased accumulation may occur in patients with moderate
to severe hepatic
impairment (see section 4.4).
4.3 CONTRAINDICATIONS
Tosadex is contraindicated in females and children (see section 4.6).
1
SUMMARY OF PRODUCT CHARACTERISTICS
Tosadex must not be given to any patient who has shown a
hypersensitivity reaction to the active
substance or to any of the excipients of this product.
Co-administration of terfenadine, astemizole or cisapride with Tosadex
is contraindicated (see
section 4.5).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Initiation of treatment should be under the direct supervision of a
specialist.
Bicalutamide is extensively metabolised in the liver. Data suggests
that its elimination may be
slower in subjects with severe hepatic impairment and this could lead
to increased accumulation
of bicalutamide. Therefore, Tosadex should be used with caution in
patients with moderate to
severe hepatic impairment.
Periodic liver function testing should be conside