Karevonal 5mg Tablets

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

ULIPRISTAL ACETATE

Dostupno od:

Sumar Pharma ehf Haukahlijð 5 102 Reykjavik, Iceland

ATC koda:

G03XB02

INN (International ime):

ULIPRISTAL ACETATE 5 mg

Farmaceutski oblik:

TABLET

Sastav:

ULIPRISTAL ACETATE 5 mg

Tip recepta:

POM

Područje terapije:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Status autorizacije:

Withdrawn

Datum autorizacije:

2019-04-30

Uputa o lijeku

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KAREVONAL 5 MG TABLETS
Ulipristal acetate
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 further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Karevonal 5mg tablets is and what it is used for
2.
What you need to know before you take Karevonal 5mg tablets
3.
How to take Karevonal 5mg tablets
4.
Possible side effects
5.
How to store Karevonal 5mg tablets
6.
Contents of the pack and other information
1.
WHAT KAREVONAL 5MG TABLETSIS AND WHAT IT IS USED FOR
Karevonal 5mg tabletscontains the active substance ulipristal acetate.
It is used to treat moderate to
severe symptoms of uterine fibroids (commonly known as myomas), which
are non-cancerous
tumours of the uterus (womb).
Karevonal 5mg tabletsis used in adult women (over 18 years of age)
before they reach the menopause.
In some women, uterine fibroids may cause heavy menstrual bleeding
(your ‘period’), pelvic pain
(discomfort in the belly) and create pressure on other organs.
This medicine acts by modifying the activity of progesterone, a
naturally occuring hormone in the
body. It is used either before an operation of your fibroids or for
long term treatment of your fibroids
to reduce their size, to stop or reduce bleeding and to increase your
red blood cell count.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KAREVONAL 5MG TABLETS
You should know that most women have no menstrual bleeding (period)
during the treatment and for a
few weeks afterwards.
DO NOT TAKE KAREVONAL 5MG TABLETS:
-
if you are allergic to ulipristal

Svojstava lijeka

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.NAME OF THE MEDICINAL PRODUCT
Karevonal 5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of ulipristal acetate.
Excipient with known effect:
Each tablet contains 118 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White or almost white, round biconvex tablet of 7 mm, engraved with
“149” on one side and “LP” on
the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ulipristal acetate is indicated for one treatment course of
pre-operative treatment of moderate to
severe symptoms of uterine fibroids in adult women of reproductive
age.
Ulipristal acetate is indicated for intermittent treatment of moderate
to severe symptoms of uterine
fibroids in adult women of reproductive age who are not eligible for
surgery
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Karevonal 5 mg tablets treatment is to be initiated and supervised by
physicians experienced in the
diagnosis and treatment of uterine fibroids.
Posology
The treatment consists of one tablet of 5 mg to be taken once daily
for treatment courses of up to
3 months each. Tablets may be taken with or without food.
Treatments should only be initiated when menstruation has occurred:
-
The first treatment course should start during the first week of
menstruation.
-
Re-treatment courses should start at the earliest during the first
week of the second
menstruation following the previous treatment course completion.
The treating physician should explain to the patient the requirement
for treatment free intervals.
Repeated intermittent treatment has been studied up to 4 intermittent
courses.
If a patient misses a dose, the patient should take ulipristal acetate
as soon as possible. If the dose was
missed by more than 12 hours, the patient should not take the missed
dose and simply resume the
usual dosing schedule.
_Special population _
_Renal impairment _
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No dose adjustment is recommended in p