TERIFLUNOMIDE 14 TEVA #N/A

Land: Sør-Afrika

Språk: engelsk

Kilde: South African Health Products Regulatory Authority (SAHPRA)

Tilgjengelig fra:

Teva Pharmaceuticals (Pty) Ltd

Dosering :

Not Indicated

Legemiddelform:

#N/A

Sammensetning:

None

Autorisasjon status:

Registered

Informasjon til brukeren

TEVA PHARMACEUTICALS (PTY) LTD
Product name: Teriflunomide 14 Teva
Dosage form and strength: Film-coated tablets; 14 mg
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1.3.2
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S4
TERIFLUNOMIDE 14 TEVA MAY CAUSE SERIOUS SIDE EFFECTS, INCLUDING:
1. LIVER PROBLEMS:
TERIFLUNOMIDE 14 TEVA MAY CAUSE SERIOUS LIVER PROBLEMS THAT MAY LEAD
TO DEATH. YOUR RISK OF LIVER
PROBLEMS MAY BE HIGHER IF YOU TAKE OTHER MEDICINES THAT ALSO AFFECT
YOUR LIVER. YOUR DOCTOR SHOULD DO
BLOOD TESTS TO CHECK YOUR LIVER FUNCTION:
•
WITHIN 6 MONTHS BEFORE YOU START TAKING TERIFLUNOMIDE 14 TEVA,
•
ONCE A MONTH FOR 6 MONTHS AFTER YOU START TAKING TERIFLUNOMIDE 14
TEVA.
TELL YOUR DOCTOR RIGHT AWAY IF YOU HAVE ANY OF THE FOLLOWING SYMPTOMS
OF LIVER PROBLEMS:
•
NAUSEA,
•
VOMITING,
•
STOMACH PAIN,
•
LOSS OF APPETITE,
•
TIREDNESS,
•
YOUR SKIN OR WHITES OF YOUR EYES TURN YELLOW,
•
DARK URINE.
2. HARM TO YOUR UNBORN BABY:
TERIFLUNOMIDE 14 TEVA MAY CAUSE HARM TO YOUR UNBORN BABY. DO NOT TAKE
TERIFLUNOMIDE 14
TEVA IF YOU ARE PREGNANT. DO NOT TAKE TERIFLUNOMIDE 14 TEVA UNLESS YOU
ARE USING EFFECTIVE BIRTH
CONTROL.
•
IF YOU ARE A FEMALE, YOU SHOULD HAVE A PREGNANCY TEST BEFORE YOU START
TAKING TERIFLUNOMIDE
14 TEVA. USE EFFECTIVE BIRTH CONTROL DURING YOUR TREATMENT WITH
TERIFLUNOMIDE 14 TEVA.
•
AFTER STOPPING TERIFLUNOMIDE 14 TEVA, CONTINUE USING EFFECTIVE BIRTH
CONTROL UNTIL YOU HAVE
BLOOD TESTS TO MAKE SURE YOUR BLOOD LEVELS OF TERIFLUNOMIDE 14 TEVA
ARE LOW ENOUGH. IF YOU
BECOME PREGNANT WHILE TAKING TERIFLUNOMIDE 14 TEVA OR WITHIN 2 YEARS
AFTER YOU STOP TAKING
IT, TELL YOUR DOCTOR RIGHT AWAY.
•
FOR MEN TAKING TERIFLUNOMIDE 14 TEVA:
TEVA PHARMACEUTICALS (PTY) LTD
Product name: Teriflunomide 14 Teva
Dosage form and strength: Film-coated tablets; 14 mg
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1.3.2
IF YOUR FEMALE PARTNER PLANS TO BECOME PREGNANT, YOU SHOULD STOP
TAKING TERIFLUNOMIDE 14
TEVA AND ASK YOUR DOCTOR HOW TO QUICKLY LOWER THE LEVELS OF
TERIFLUNOMIDE 14 TEVA IN YOUR
BLOOD. IF YOUR FEMALE PARTNER DOES NOT PLAN TO BECOME PREGNANT, YOU
AND YOUR F

Preparatomtale

TEVA PHARMACEUTICALS (PTY) LTD
Product name: Teriflunomide 14 Teva
Dosage form and strength: Film-coated tablets; 14 mg
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1.3.1.1 Page
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SCHEDULING STATUS:
S4
1.
NAME OF THE MEDICINE:
TERIFLUNOMIDE 14 TEVA, 14 mg, film-coated tablets
WARNING: HEPATOTOXICITY AND RISK OF TERATOGENICITY
HEPATOTOXICITY:
SEVERE LIVER INJURY INCLUDING FATAL LIVER FAILURE HAS BEEN REPORTED IN
PATIENTS TREATED WITH LEFLUNOMIDE,
WHICH IS INDICATED FOR RHEUMATOID ARTHRITIS. A SIMILAR RISK WOULD BE
EXPECTED FOR TERIFLUNOMIDE 14
TEVA BECAUSE RECOMMENDED DOSES OF TERIFLUNOMIDE 14 TEVA AND
LEFLUNOMIDE RESULT IN A SIMILAR
RANGE OF PLASMA CONCENTRATIONS OF TERIFLUNOMIDE 14 TEVA. OBTAIN
TRANSAMINASE AND BILIRUBIN LEVELS
WITHIN 6 MONTHS BEFORE INITIATION OF TERIFLUNOMIDE 14 TEVA AND MONITOR
ALT LEVELS AT LEAST MONTHLY
FOR SIX MONTHS. IF MEDICINE INDUCED LIVER INJURY IS SUSPECTED,
DISCONTINUE TERIFLUNOMIDE 14 TEVA
AND START ACCELERATED ELIMINATION PROCEDURE.
RISK OF TERATOGENICITY:
BASED ON ANIMAL DATA, TERIFLUNOMIDE 14 TEVA MAY CAUSE MAJOR BIRTH
DEFECTS IF USED DURING
PREGNANCY. TERIFLUNOMIDE 14 TEVA IS CONTRAINDICATED IN PREGNANT WOMEN
OR WOMEN OF
CHILDBEARING POTENTIAL WHO ARE NOT USING RELIABLE CONTRACEPTION.
PREGNANCY MUST BE AVOIDED DURING
TERIFLUNOMIDE 14 TEVA TREATMENT.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION;
TERIFLUNOMIDE 14 TEVA: Each film-coated tablet contains 14 mg of
teriflunomide.
Excipient(s) with known effect: Each film-coated tablet contains 72,25
mg of lactose monohydrate.
For the full list of excipients, see SECTION 6.1.
3.
PHARMACEUTICAL FORM:
Film-coated tablets.
TEVA PHARMACEUTICALS (PTY) LTD
Product name: Teriflunomide 14 Teva
Dosage form and strength: Film-coated tablets; 14 mg
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1.3.1.1 Page
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Blue, round shaped tablet, debossed with "TV" on one side of the
tablet and with "Y12" on the other side of
the tablet.
4.
CLINICAL PARTICULARS:
4.1.
THERAPEUTIC INDICATIONS:
TERIFLUNOMIDE 14 TEVA is indicated for the treatment of adult patients
with relapsing forms of multiple
sclerosis (MS) to reduce the freque