Maexeni 150microgram/30microgram tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ethinylestradiol; Levonorgestrel

Available from:

Lupin Healthcare (UK) Ltd

ATC code:

G03AA07

INN (International Name):

Ethinylestradiol; Levonorgestrel

Dosage:

30microgram ; 150microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07030100; GTIN: 8901107025069

Patient Information leaflet

·
If a close relative has or has had breast cancer
PACKAGE LEAFLET: INFORMATION FOR THE USER
BLEEDING BETWEEN PERIODS
During the first few months that you are taking Maexeni, you may have
unexpected bleeding
·
If you have a disease of the liver or the gallbladder
MAEXENI 150/30 MICROGRAM FILM-COATED TABLETS
(bleeding outside the gap week). If this bleeding lasts longer than a
few months, or if it begins after
·
If you have diabetes
levonorgestrel / ethinylestradiol
some months, talk to your doctor who will investigate the cause.
·
If you have depression
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
·
If you have Crohn's disease or ulcerative colitis (inflammatory bowel
disease)
WHAT TO DO IF NO BLEEDING OCCURS IN THE GAP WEEK
IMPORTANT INFORMATION FOR YOU.
·
If you have HUS (haemolytic uraemic syndrome; a blood disease that
causes kidney damage)
If you have taken all the tablets correctly, have not vomited or had
severe diarrhoea, and you have
·
Keep this leaflet. You may need to read it again.
not taken any other medicines, it is highly unlikely that you are
pregnant.
·
If you have epilepsy (see “Other medicines and Maexeni”)
·
If you have any further questions, ask your doctor, pharmacist or
family planning nurse.
If your period (withdrawal bleeding) does not happen twice in a row,
you may be pregnant.
·
If you have SLE (systemic lupus erythematosus; a disease of the immune
system)
·
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
Contact your doctor immediately. Do not start the next strip until you
are sure that you are not
·
If you have a disease that first appeared during pregnancy or earlier
use of sex hormones (for
even if their signs of illness are the same as yours.
pregnant.
example, hearing loss, porphyria (a disease of the blood), gestational
herpes (skin rash with
·
If you get any side effects, talk to your doctor, pharmacist or family
planning nurse. This
vesicles during pregnancy), Sydenh

Summary of Product characteristics

OBJECT 1
MAEXENI 150/30 MICROGRAM FILM COATED TABLETS
Summary of Product Characteristics Updated 08-Jan-2018 | Lupin
Healthcare (UK) Ltd
1. Name of the medicinal product
Maexeni 150/30 microgram film coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 150 micrograms of levonorgestrel and
30 micrograms of ethinylestradiol
Excipient(s) with known effect:
Each tablet contains 58.32 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Yellow, round, biconvex, film-coated tablet, debossed with “LE4”
on one side and plain on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Oral contraception.
4.2 Posology and method of administration
How to use Maexeni tablets
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. Each subsequent
pack is started after a 7-day tablet-free interval, during which time
a withdrawal bleed usually occurs. The
bleeding usually starts within 2 to 3 days after the last tablet and
may not end before the next pack is
started.
How to start the use of Maexeni tablets
• _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).
Starting on days 2–5 is allowed but in that case an additional
barrier method is recommended for the first
7 days of the first cycle
• _Changing from another combined hormonal contraceptive (COC,
vaginal ring, transdermal patch)_
The use of Maexeni tablets is preferably started on the day after the
last active tablet of the previous COC
(or after removal of the ring or patch), but at the latest on the day
following the usual tablet-free (ring-
free, patch-free) break or the last placebo tablet of the previous
hormonal contraceptive.
• _Changing from a progestogen-only method (oralpill, injecti