Rigevidon tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Ethinylestradiol; Levonorgestrel

זמין מ:

Gedeon Richter (UK) Ltd

קוד ATC:

G03AA07

INN (שם בינלאומי):

Ethinylestradiol; Levonorgestrel

כמות:

30microgram ; 150microgram

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 07030100; GTIN: 5391512451165

עלון מידע

BLOOD CLOTS IN A VEIN
WHAT CAN HAPPEN IF A BLOOD CLOT FORMS IN A VEIN?
­•­
The­use­of­combined­hormonal­contraceptives­has­been­connected­with­an­increase­in­the­risk­of­blood­clots­in­the­vein­
­
(venous­thrombosis).­However,­these­side­effects­are­rare.­Most­frequently,­they­occur­in­the­first­year­of­use­of­a­combined­
­
hormonal­contraceptive.
­•­
If­a­blood­clot­forms­in­a­vein­in­the­leg­or­foot­it­can­cause­a­deep­vein­thrombosis­(DVT).
­•­
If­a­blood­clot­travels­from­the­leg­and­lodges­in­the­lung­it­can­cause­a­pulmonary­embolism.
­•­
Very­rarely­a­clot­may­form­in­a­vein­in­another­organ­such­as­the­eye­(retinal­vein­thrombosis).
WHEN IS THE RISK OF DEVELOPING A BLOOD CLOT IN A VEIN HIGHEST?
The­risk­of­developing­a­blood­clot­in­a­vein­is­highest­during­the­first­year­of­taking­a­combined­hormonal­contraceptive­for­the­
first­time.­The­risk­may­also­be­higher­if­you­restart­taking­a­combined­hormonal­contraceptive­(the­same­product­or­a­different­
product)­after­a­break­of­4­weeks­or­more.
After­the­first­year,­the­risk­gets­smaller­but­is­always­slightly­higher­than­if­you­were­not­using­a­combined­hormonal­
contraceptive.
When­you­stop­Rigevidon­your­risk­of­a­blood­clot­returns­to­normal­within­a­few­weeks.
WHAT IS THE RISK OF DEVELOPING A BLOOD CLOT?
The­risk­depends­on­your­natural­risk­of­VTE­and­the­type­of­combined­hormonal­contraceptive­you­are­taking.
The­overall­risk­of­a­blood­clot­in­the­leg­or­lung­(DVT­or­PE)­with­Rigevidon­is­small.
•­
Out­of­10,000­women­who­are­not­using­any­combined­hormonal­contraceptive­and­are­not­pregnant,­about­2­will­develop­a­
blood­clot­in­a­year.
•­
Out­of­10,000­women­who­are­using­a­combined­hormonal­contraceptive­that­contains­levonorgestrel­about­5­-­7­will­develo

מאפייני מוצר

OBJECT 1
RIGEVIDON COATED TABLETS
Summary of Product Characteristics Updated 04-Dec-2017 | Consilient
Health Ltd
1. Name of the medicinal product
Rigevidon coated tablets.
2. Qualitative and quantitative composition
Each tablet contains 150 micrograms levonorgestrel and 30 micrograms
ethinylestradiol.
Excipients with known effect: Each tablet contains 33 mg of lactose
monohydrate and 22.46 mg of
sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Coated tablet
White, biconvex, circular tablets
4. Clinical particulars
4.1 Therapeutic indications
Oral contraception.
The decision to prescribe Rigevidon should take into consideration the
individual woman's current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with Rigevidon
compares with other combined hormonal contraceptives (CHCs) (see
sections 4.3 and 4.4).
4.2 Posology and method of administration
Posology
HOW IS RIGEVIDON TAKEN?
Tablets must be taken orally in the order directed on the blister
package at about the same time every day,
with some liquid if necessary.
One tablet is to be taken daily for 21 consecutive days. Every
subsequent blister pack is started after a 7-
day tablet-free interval during which time a withdrawal bleeding
usually occurs. This bleeding will
usually start on the 2nd or 3rd day after the last tablet has been
taken and it may not have stopped, before
the next blister pack is started.
HOW TO START THE USE OF RIGEVIDON
_No preceding hormonal contraceptive use in the past month._
Tablet-taking is started on day 1 of the woman's natural cycle (= the
first day of her menstrual bleeding).
_Changing from another combined hormonal contraceptive (combined oral
contraceptive (COC), vaginal _
_ring or transdermal patch):_
Take the first tablet the day after the dose of the last active tablet
of the previous contraceptive or, at the
latest, the day after the usual period of stopping the tablets.
In case of vaginal ring or transdermal patch, take the first tablet
the day of