AUSTELL AMLODIPINE 5 mg TABLET

देश: दक्षिण अफ़्रीका

भाषा: अंग्रेज़ी

स्रोत: South African Health Products Regulatory Authority (SAHPRA)

थमां उपलब्ध:

Austell Pharmaceuticals (Pty) Ltd

डोज़:

See ingredients

फार्मास्यूटिकल फॉर्म:

TABLET

रचना:

EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2007-02-03

सूचना पत्रक

PAGE 1 OF 9
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S2
ELLA 30 MG TABLET (UNCOATED)
Ulipristal acetate
Contains sugar (lactose monohydrate 237 mg/tablet).
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
ELLA is available without a doctor’s prescription, for you to use in
situations as described under
section 1. ”What ELLA is and what it is used for”. Nevertheless,
you still need to use ELLA
carefully to get the best results from it.
Keep this leaflet. You may need to read it again.
Do not share ELLA with any other person.
Ask your healthcare provider or pharmacist if you need more
information or advice.
WHAT IS IN THIS LEAFLET
1. What ELLA is and what it is used for
2. What you need to know before you take ELLA
3. How to take ELLA
4. Possible side effects
5. How to store ELLA
6. Contents of the pack and other information
1.
WHAT ELLA IS AND WHAT IT IS USED FOR
ELLA is an emergency contraceptive
ELLA is a contraceptive intended to prevent pregnancy after
unprotected sex or if your
contraceptive method has failed. For example:
if you had sex without protection;
if your or your partner’s condom tore, slipped or came off, or if
you forgot to use one;
if you did not take your contraceptive pill as you should.
You should take the tablet as soon as possible after sex, and within a
maximum of 5 days (120
hours).
This is because it is more effective if you take it as soon as
possible after unprotected sex. PAGE 2 OF 9
This medicine is suitable for any woman of childbearing age, including
adolescents.
You can take the tablet at any time in the menstrual cycle.
ELLA does not work if you are already pregnant
If your menstrual period is late, there is a possibility that you may
be pregnant. When your period
is late or when you have symptoms of pregnancy (heavy breasts, morning
sickness) you should
consult a doctor or other healthcare provider before taking the
tablet.
If you have unprotected sex after taking the tablet, it will not stop
you from becoming pregnant.
Unprotect

उत्पाद विशेषताएं

PAGE 1 OF 15
_ _
SCHEDULING STATUS
S2
1. NAME OF THE MEDICINE
ella
30 mg tablet (uncoated)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg ulipristal acetate.
Excipients with known effect:
Each tablet contains 237 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Tablet
White to marble creamy, round curved tablet engraved with “еllа”
on both sides.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Emergency contraception within 120 hours (5 days) of unprotected
sexual intercourse or contraceptive
failure.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The treatment consists of one tablet to be taken orally as soon as
possible, but no later than 120 hours
(5 days) after unprotected intercourse or contraceptive failure.
The tablet can be taken at any time during the menstrual cycle.
If vomiting occurs within 3 hours of the tablet intake, another tablet
should be taken.
If the patient’s menstrual period is late or in case of symptoms of
pregnancy, PREGNANCY SHOULD BE
EXCLUDED BEFORE THE TABLET IS ADMINISTERED.
PAGE 2 OF 15
_Special populations _
_Renal impairment_
No dose adjustment is necessary.
_Hepatic impairment _
In the absence of specific studies, no alternate dose recommendations
for ELLA can be made.
_Severe hepatic impairment_
In the absence of specific studies, ELLA is not recommended._ _
_Paediatric population _
There is no relevant use of ELLA for children of prepubertal age in
the indication emergency
contraception_. _
Adolescents:
ELLA for emergency contraception is suitable for any woman of child
bearing age, including adolescents.
No differences in safety or efficacy have been shown compared to adult
women aged 18 and older (see
section 5.1).
Method of administration
Oral use.
The tablet can be taken with or without food.
4.3 CONTRAINDICATIONS
Hypersensitivity to ulipristal acetate or to any of the excipients
listed in section 6.1
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
BEFORE ELLA IS TAKEN PREGNANCY SHOUL