Lestramyl 30microgram/150microgram tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Desogestrel; Ethinylestradiol

Available from:

Viatris UK Healthcare Ltd

ATC code:

G03AA09

INN (International Name):

Desogestrel; Ethinylestradiol

Dosage:

150microgram ; 30microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07030100; GTIN: 5016695004815

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LESTRAMYL
®
150/30 MICROGRAMS TABLETS
(desogestrel/ethinylestradiol)
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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES
(CHCS):
•
They are one of the most reliable reversible methods of contraception
if used correctly.
•
They slightly increase the risk of having a blood clot in the veins
and arteries, especially in
the first year or when restarting a combined hormonal contraceptive
following a break of
4 or more weeks.
•
Please be alert and see your doctor if you think you may have symptoms
of a blood clot
(see section 2 “Blood clots”).
WHAT IS IN THIS LEAFLET
1.
What Lestramyl
®
150/30 micrograms tablets is and what it is used for
2.
What you need to know before you take Lestramyl
®
150/30 micrograms tablets
3.
How to take Lestramyl
®
150/30 micrograms tablets
4.
Possible side effects
5.
How to store Lestramyl
®
150/30 micrograms tablets
6.
Contents of the pack and other information
1.
WHAT LESTRAMYL
®
150/30 MICROGRAMS TABLET IS AND WHAT IT IS USED FOR
Lestramyl
®
150/30 micrograms tablets is a combined oral contraceptive, also
called ‘the pill’.
Each tablet contains a small amount of two types of female hormones,
namely, a progestogen,
desogestrel and an oestrogen, ethinylestradiol.
These help to stop you from getting pregnant, just as your natural
hormones would stop you
conceiving again when you are already pregnant.
The combined contraceptive pill protects you against getting pregnant
i

Summary of Product characteristics

OBJECT 1
LESTRAMYL 150/30 MICROGRAMS TABLETS
Summary of Product Characteristics Updated 31-May-2018 | Generics UK
T/A Mylan
1. Name of the medicinal product
Lestramyl
®
150/30 micrograms Tablets
2. Qualitative and quantitative composition
Each tablet contains 150 micrograms desogestrel and 30 micrograms
ethinylestradiol.
Excipient with known effect: Each tablet contains 58 mg of lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
Each tablet is round, white to off-white, 5.00 mm, uncoated, biconvex,
debossed with '142' on one side
and other side plain.
4. Clinical particulars
4.1 Therapeutic indications
Oral contraception.
The decision to prescribe Lestramyl
®
150/30 micrograms tablets should take into consideration the
individual woman's current risk factors, particularly those for venous
thromboembolism (VTE), and how
the risk of VTE with Lestramyl
®
150/30 micrograms tablets compares with other CHCs (see sections 4.3
and 4.4).
4.2 Posology and method of administration
Posology
HOW TO TAKE LESTRAMYL
®
150/30 MICROGRAMS TABLETS
The tablets must be taken every day at about the same time, if
necessary with a little liquid, in the order
shown on the blister pack. 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. This
usually starts on day 2-3 after the last tablet and may not have
finished before the next pack is started.
HOW TO START LESTRAMYL
®
150/30 MICROGRAMS TABLETS
• _No preceding hormonal contraceptive use (in the past month)_
Tablet-taking has to start on day 1 of the woman's natural cycle (i.e.
the first day of her menstrual
bleeding). Tablet intake is also allowed to start on day 2-5, but
during the first cycle concurrent use of a
barrier method for the first 7 days of tablet intake is advisable.
• _Changing from a combined hormonal contraceptive (combined oral
contraceptive (COC), vaginal ring _
_or transdermal patch)_
The woman sh