TERONRED 250 Tablet

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Dr ReddyÆs Laboratories (Pty) Ltd

Dosage:

Not Indicated

Pharmaceutical form:

Tablet

Composition:

None

Authorization status:

Registered

Patient Information leaflet

APPROVED PATIENT INFORMATION LEAFLET: DR. REDDY’S LABORATORIES (PTY) LTD. TERONRED 250 (FILM-COATED TABLETS) SEQ: 0012
_ _
_ CLINICAL APPROVAL DATE: 11.04.2023 1 OF 13 _
SCHEDULING STATUS:
S4
TERONRED 250, 250 MG, FILM-COATED TABLETS
ABIRATERONE ACETATE
CONTAINS SUGAR (LACTOSE MONOHYDRATE)
Each film-coated tablet contains 198,65 mg of lactose monohydrate and
6,044 mg of sodium.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING TERONRED
250
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.
•
TERONRED 250 has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.
WHAT IS IN THIS LEAFLET:
1. What TERONRED 250 is and what it is used for
2. What you need to know before you take TERONRED 250
3. How to take TERONRED 250
4. Possible side effects
5. How to store TERONRED 250
6. Contents of the pack and other information
APPROVED PATIENT INFORMATION LEAFLET: DR. REDDY’S LABORATORIES (PTY) LTD. TERONRED 250 (FILM-COATED TABLETS) SEQ: 0012
_ _
_ CLINICAL APPROVAL DATE: 11.04.2023 2 OF 13 _
1. WHAT TERONRED 250 IS AND WHAT IT IS USED FOR_ _
TERONRED 250 contains a medicine called abiraterone acetate.
TERONRED 250 belongs to a group of medicines called hormone
inhibitors.
It is used to treat castration resistant prostate cancer in adult men
that has spread to other
parts of the body. It stops your body from making testosterone, which
can then slow down
the growth of prostate cancer.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TERONRED 250
DO NOT TAKE TERONRED 250
-
if you are allergic (hypersensitive) to abiraterone acetate or any of
the other ingredients
of TERONRED 250 (listed in section 6).
-
if you are pregnant or might be pregnant or are trying to get pregnant
(see Pregnancy
and breastfeeding). If you are pregnant or might be pregnant, you
should wear gloves if
you need to touch or handle TERONRED 25

Summary of Product characteristics

DR. REDDY’S LABORATORIES (PTY) LTD.
APPROVED PROFESSIONAL INFORMATION
TERONRED 250 (FILM-COATED TABLETS)
SEQ: 0012
_ CLINICAL APPROVAL DATE: 11.04.2023 PAGE 1 OF 21 _ PROFESSIONAL INFORMATION
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
TERONRED 250 film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg abiraterone acetate. Contains
sugar (lactose
monohydrate).
Excipients with known effect
Each film-coated tablet contains 198,65 mg of lactose monohydrate and
6,044 mg of sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
White to off white, oval shaped, film coated tablets, debossed with
Dr. Reddy’s logo on one side
and “358” on other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TERONRED 250 is indicated with low-dose corticosteroids (prednisone or
prednisolone) in adult
DR. REDDY’S LABORATORIES (PTY) LTD.
APPROVED PROFESSIONAL INFORMATION
TERONRED 250 (FILM-COATED TABLETS)
SEQ: 0012
_ CLINICAL APPROVAL DATE: 11.04.2023 PAGE 2 OF 21 _
males for the treatment of:
•
metastatic castration resistant prostate cancer with bone metastases
who are asymptomatic
or mildly symptomatic after failure of androgen deprivation therapy in
whom chemotherapy is
not yet clinically indicated.
•
metastatic advanced prostate cancer (castration resistant prostate
cancer) who have
received prior chemotherapy containing docetaxel.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of TERONRED 250 is 1 000 mg (four 250 mg tablets)
as a single daily
dose that MUST NOT BE TAKEN WITH FOOD. Taking TERONRED 250 with food
increases systemic
exposure to abiraterone (see sections 4.5 and 5.2).
Patients should be maintained on TERONRED 250 until radiographic
progression and
symptomatic/clinical progression and until PSA progression (confirmed
25 % increase over the
patient’s baseline/nadir).
_Dosage of prednisone or prednisolone _
For metastatic castration-resistant prostate cancer (mCRPC), TERONRED
25