Cerelle 75microgram tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Desogestrel

Available from:

Gedeon Richter (UK) Ltd

ATC code:

G03AC09

INN (International Name):

Desogestrel

Dosage:

75microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07030201; GTIN: 5391512452018

Patient Information leaflet

WHAT IS IN THIS LEAFLET
1. What Cerelle 75 microgram film-coated tablets
(hereafter: Cerelle) is and what it is used for
2. What you need to know before you take Cerelle
3. How to take Cerelle
4. Possible side effects
5. How to store Cerelle
6. Contents of the pack and other information
1. WHAT CERELLE IS AND WHAT IT IS USED FOR
This medicine is for the prevention of pregnancy.
HOW DOES IT WORK?
Cerelle contains a small amount of one type of female sex
hormone, the progestogen, desogestrel. For this reason Cerelle
is called a progestogen-only pill (POP) or mini-pill. Unlike the
combined pill, the POP or mini-pill does not contain an
oestrogen hormone, but only a progestogen. Most POPs or
mini-pills work primarily by preventing the sperm cells from
entering the womb but they do not always prevent the egg cell
from ripening which is the primarily action of combined pills.
Cerelle is distinct from other mini-pills in having a dose that
in most cases is high enough to prevent the egg cell from
ripening. As a result, Cerelle provides high contraceptive
efficacy.
In contrast to the combined pill, Cerelle can be used by women
who do not tolerate oestrogens and by women who are
breast-feeding. A disadvantage is that vaginal bleeding may
occur at irregular intervals during the use of Cerelle. You also
may not have any bleeding at all.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CERELLE
Cerelle will not protect you against HIV infection (AIDS) and
any other sexually transmitted diseases.
DO NOT TAKE CERELLE
Do not use Cerelle if you have any of the conditions listed
below. If any of these apply to you, tell your doctor before
starting to use Cerelle. Your doctor may advise you to use a
non-hormonal method of birth control.
• If you are allergic to desogestrel or any of the other
ingredients of this medicine (listed in section 6.).
• If you have thrombosis. Thrombosis is the formation of a
blood clot in a blood vessel, which may lead to obstruction
of this blood vessel {e.g. of the legs (deep venous
thrombosis), the lungs

Summary of Product characteristics

OBJECT 1
CERELLE 75 MICROGRAMS FILM-COATED TABLETS
Summary of Product Characteristics Updated 15-Mar-2018 | Consilient
Health Ltd
1. Name of the medicinal product
Cerelle 75 microgram film-coated tablets
2. Qualitative and quantitative composition
One film-coated tablet contains 75 microgram desogestrel.
Excipient with known effect: 52.34 mg lactose (as lactose
monohydrate).For the full list of excipients, see
section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White or almost white, round, biconvex film-coated tablets of about
5.5 mm in diameter, with a sign “D”
on one side and “75” on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Contraception
4.2 Posology and method of administration
Posology
To achieve contraceptive effectiveness, Cerelle must be used as
directed (see 'How to take Cerelle and
'How to start Cerelle).
Special populations
_Renal impairment_
No clinical studies have been performed in patients with renal
impairment.
_Hepatic impairment_
No clinical studies have been performed in patients with hepatic
insufficiency. Since the metabolism of
steroid hormones might be impaired in patients with severe hepatic
disease, the use of Cerelle in these
women is not indicated as long as liver function values have not
returned to normal (see section 4.3).
_Paediatric population_
The safety and efficacy of Cerelle in adolescents below 18 years has
not yet been established. No data are
available.
Method of administration
Oral use
HOW TO TAKE CERELLE
Tablets must be taken every day at about the same time so that the
interval between two tablets always is
24 hours. The first tablet should be taken on the first day of
menstrual bleeding. Thereafter one tablet
each day is to be taken continuously, without taking any notice on
possible bleeding. A new blister is
started directly the day after the previous one.
HOW TO START CERELLE
_No preceding hormonal contraceptive use [in the past month]_
Tablet-taking has to start on day 1 of the woman's natural cycle (day
1 is the first day of he