Cerazette 75 microgram film-coated tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Desogestrel
Available from:
Merck Sharp & Dohme Ireland (Human Health) Limited
ATC code:
G03AC; G03AC09
INN (International Name):
Desogestrel
Dosage:
75 microgram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Progestogens; desogestrel
Authorization status:
Not marketed
Authorization number:
PA1286/048/001
Authorization date:
1998-08-14

Package leaflet: Information for the user

Cerazette® 75 microgram film-coated tablets

desogestrel

Read all of this leaflet carefully before you start using 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, please 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 symptoms 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.

What is in this leaflet:

What Cerazette is and what it is used for

What you need to know before you take Cerazette

How to take Cerazette

Possible side effects

How to store Cerazette

Contents of the pack and other information

1.

What Cerazette is and what it is used for

Cerazette is used to prevent pregnancy. Cerazette contains a small amount of one type of female sex

hormone, the progestogen

desogestrel

. For this reason Cerazette is called a progestogen-only-pill

(POP). Contrary to the combined pill, the POP does not contain an oestrogen hormone next to the

progestogen.

Most POPs work primarily by preventing the sperm cells from entering the womb but do not always

prevent the egg cell from ripening, which is the primary action of combined pills. Cerazette is distinct

from most POPs in having a dose that in most cases is high enough to prevent the egg cell from

ripening. As a result, Cerazette provides high contraceptive efficacy.

In contrast to the combined pill, Cerazette 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 Cerazette. You also may not have any bleeding at all.

2.

What you need to know before you take Cerazette

Cerazette, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any

other sexually transmitted disease.

Do not take Cerazette

if you are allergic to desogestrel, or any of the other ingredients of Cerazette (listed in section 6).

if you have a thrombosis. Thrombosis is the formation of a blood clot in a blood vessel [e.g. of the

legs (deep venous thrombosis) or the lungs (pulmonary embolism)].

if you have or have had jaundice (yellowing of the skin) or sev

ere liver disease and your liver

function is still not normal.

if you have or are suspected to have a cancer that is sensitive to sex-steroids, such as certain types

of breast cancer.

if you have any unexplained vaginal bleeding.

Tell your doctor before you start to use Cerazette if any of these conditions apply to you. Your doctor

may advise you to use a non-hormonal method of birth control.

Consult your doctor immediately if any of these conditions appear for the first time while using

Cerazette.

Warnings and precautions

Tell your doctor before you start to use Cerazette, if:

you have ever had breast cancer.

you have liver cancer, since a possible effect of Cerazette cannot be excluded.

you have ever had a thrombosis.

you have diabetes.

you suffer from epilepsy (see section ‘Other medicines and Cerazette’).

you suffer from tuberculosis (see section ‘Other medicines and Cerazette’).

you have high blood pressure.

you have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly

of the face); if so, avoid too much exposure to the sun or ultraviolet radiation.

When Cerazette is used in the presence of any of these conditions, you may need to be kept under

close observation. Your doctor can explain what to do.

Breast cancer

Regularly check your breasts and contact your doctor as soon as possible if you feel any lump in your

breasts.

Breast cancer has been found slightly more often in women who take the Pill than in women of the

same age who do not take the Pill. If women stop taking the Pill, the risk gradually decreases, so that

10 years after stopping the risk is the same as for women who have never taken the Pill. Breast cancer

is rare under 40 years of age but the risk increases as the woman gets older. Therefore, the extra

number of breast cancers diagnosed is higher if the age until which the woman continues to take the

Pill is higher. How long she takes the Pill is less important.

In every 10,000 women who take the Pill for up to 5 years but stop taking it by the age of 20, there

would be less than 1 extra case of breast cancer found up to 10 years after stopping, in addition to the

4 cases normally diagnosed in this age group. Likewise, in 10,000 women who take the Pill for up to

5 years but stop taking it by the age of 30, there would be 5 extra cases in addition to the 44 cases

normally diagnosed. In 10,000 women who take the Pill for up to 5 years but stop taking it by the age

of 40, there would be 20 extra cases in addition to the 160 cases normally diagnosed.

The risk of breast cancer in users of progestogen-only pills like Cerazette is believed to be similar to

that in women who use the Pill, but the evidence is less conclusive.

Breast cancers found in women who take the Pill, seem less likely to have spread than breast cancers

found in women who do not take the Pill. It is not known whether the difference in breast cancer risk

is caused by the Pill. It may be that the women were examined more often, so that the breast cancer is

noticed earlier.

Thrombosis

See your doctor immediately, if you notice possible signs of a thrombosis (see also ‘Regular check-

ups’).

Thrombosis is the formation of a blood clot, which may block a blood vessel. A thrombosis sometimes

occurs in the deep veins of the legs (deep venous thrombosis). If this clot breaks away from the veins

where it is formed, it may reach and block the arteries of the lungs, causing a so-called “pulmonary

embolism”. As a result, fatal situations may occur. Deep venous thrombosis is a rare occurrence. It can

develop whether or not you are taking the Pill. It can also happen if you become pregnant.

The risk is higher in Pill-users than in non-users. The risk with progestogen-only pills like Cerazette is

believed to be lower than in users of Pills that also contain oestrogens (combined Pills).

Psychiatric disorders

Some women using hormonal contraceptives including Cerazette have reported depression or

depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you

experience mood changes and depressive symptoms contact your doctor for further medical advice as

soon as possible.

Children and adolescents

No clinical data on efficacy and safety are available in adolescents below 18 years.

Other medicines and Cerazette

Tell your doctor if you are taking, have recently taken or might take any other medicines or herbal

products. Also tell any other doctor or dentist who prescribes another medicine (or your pharmacist)

that you take Cerazette. They can tell you if you need to take additional contraceptive precautions (for

example condoms) and if so, for how long, or whether the use of another medicine you need must be

changed.

Some medicines:

- can have an influence on the blood levels of Cerazette

- can make it

less effective in preventing pregnancy

- can cause unexpected bleeding.

These include medicines used for the treatment of:

epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate and

phenobarbital),

tuberculosis (e.g. rifampicin, rifabutin),

HIV infection (e.g. ritonavir, nelfinavir, nevirapine, efavirenz),

Hepatitis C virus infection (e.g. boceprevir, telaprevir),

other infectious diseases (e.g. griseofulvin),

high blood pressure in the blood vessels of the lungs (bosentan),

depressive moods (the herbal remedy St. John’s wort),

certain bacterial infections (e.g. clarithromycin, erythromycin),

fungal infections (e.g. ketoconazole, itraconazole, fluconazole),

high blood pressure (hypertension), angina or certain heart rhythm disorders (e.g. diltiazem).

If you are taking medicines or herbal products that might make Cerazette less effective, a barrier

contraceptive method should also be used. Since the effect of another medicine on Cerazette may last

up to 28 days after stopping the medicine, it is necessary to use the additional barrier contraceptive

method for that long. Your doctor can tell you if you need to take additional contraceptive precautions

and if so, for how long.

Cerazette may also interfere with how other medicines work, causing either an increase in effect

(e.g. medicines containing ciclosporine) or a decrease in effect (e.g. lamotrigine).

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy and breast-feeding

Pregnancy

Do not use Cerazette if you are pregnant, or think you may be pregnant.

Breast-feeding

Cerazette may be used while you are breast-feeding. Cerazette does not influence the production or the

quality of breast milk. However, a small amount of the active substance of Cerazette passes over into

the milk.

The health of children breast-fed for 7 months whose mothers were using Cerazette has been studied

up to 2.5 years of age. No effects on the growth and development of the children were observed.

If you are breast feeding and want to use Cerazette, please contact your doctor.

Driving and using machines

There are no indications of any effect of the use of Cerazette on alertness and concentration.

Cerazette contains lactose

Cerazette contains lactose (milk sugar). Please contact your doctor before taking Cerazette if you have

been told by your doctor that you are intolerant to some sugars.

Regular check-ups

When you are using Cerazette, your doctor will tell you to return for regular check-ups. In general, the

frequency and nature of these check-ups will depend on your personal situation.

Contact your doctor as soon as possible if:

you have severe pain or swelling in either of your legs, unexplained pains in the chest,

breathlessness, an unusual cough, especially when you cough up blood (possibly

indicating a

thrombosis

you have a sudden, severe stomach ache or look jaundiced (possibly indicating

liver

problems

you feel a lump in your breast (possibly indicating

breast cancer

you have a sudden or severe pain in the lower abdomen or stomach area (possibly

indicating an

ectopic pregnancy

, this is a pregnancy outside the womb);

you are to be immobilised or are to have surgery (consult your doctor at least four

weeks in advance);

you have unusual, heavy vaginal bleeding;

you suspect that you are

pregnant

3.

How to take Cerazette

When and how to take the tablets?

The Cerazette pack contains 28 tablets. Arrows are printed on the front side of the pack, between the

tablets. If you turn over your pack and look at the back side, you will see the days of the week printed

on the foil. Each day corresponds with one tablet.

Every time you start a new pack of Cerazette, take a tablet from the top row. Don’t start with just any

tablet. For example if you start on a Wednesday, you must take the tablet from the top row marked (at

the back) with WED. Continue to take one tablet a day until the pack is empty, always following the

direction indicated by the arrows. By looking at the back of your pack you can easily check if you

have already taken your tablet on a particular day.

Take your tablet each day at about the same time. Swallow the tablet whole, with water. You may

have some bleeding during the use of Cerazette, but you must continue to take your tablets as normal.

When a pack is empty, you must start with a new pack of Cerazette on the next day - thus without

interruption and without waiting for a bleed.

Starting your first pack of Cerazette

When no hormonal contraceptive has been used in the past month:

Wait for your period to begin. On the first day of your period take the first Cerazette tablet. You

need not take extra contraceptive precautions.

You may also start on days 2-5 of your cycle, but in that case make sure you also use an

additional contraceptive method (barrier method) for the first 7 days of tablet-taking.

When changing from a combined pill, vaginal ring, or transdermal patch:

You can start taking Cerazette on the day after you take the last tablet from the present Pill

pack, or on the day of removal of your vaginal ring or patch (this means no tablet-, ring- or

patch-free break). If your present Pill pack also contains inactive tablets you can start Cerazette

on the day after taking the last active tablet (if you are not sure which this is, ask your doctor or

pharmacist). If you follow these instructions, you need not take extra contraceptive precautions.

You can also start at the latest the day following the tablet-, ring-, patch-free break, or placebo

tablet interval, of your present contraceptive. If you follow these instructions, make sure you use

an additional contraceptive method (barrier method) for the first 7 days of tablet-taking.

When changing from another progestogen-only pill:

You may stop taking it any day and start taking Cerazette right away. You need not take extra

contraceptive precautions.

When changing from an injectable or implant or a progestogen-releasing intrauterine

device (IUD):

Start using Cerazette

when your next injection is due or on the day that your implant or your

IUD is removed. You need not take extra contraceptive precautions.

After having a baby:

You can start Cerazette between 21 to 28 days after the birth of your baby. If you start later,

make sure you use an additional contraceptive method (barrier method) until you have

completed the first 7 days of tablet-taking. However, if intercourse has already occurred,

pregnancy should be excluded before starting Cerazette use. Additional information for breast-

feeding women can be found in ‘Pregnancy and breast-feeding’ in section 2. Your doctor can

also advise you.

After a miscarriage or an abortion:

Your doctor will advise you.

If you forget to take Cerazette

If you are

less than 12 hours

late in taking a tablet, the reliability of Cerazette is maintained.

Take the missed tablet as soon as you remember and take the next tablets at the usual times.

If you are

more than 12 hours

late in taking any tablet, the reliability of Cerazette may be

reduced. The more consecutive tablets you have missed, the higher the risk that the

contraceptive efficacy is decreased. Take the last missed tablet as soon as you remember and

take the next tablets at the usual times. Use an additional contraceptive method (barrier method)

too for the next 7 days of tablet-taking. If you missed one or more tablets in the first week of

starting the tablets and had intercourse in the week before missing the tablets, there is a

possibility of becoming pregnant. Ask your doctor for advice.

If you suffer from gastro-intestinal disturbances (e.g. vomiting, severe diarrhoea)

Follow the advice for missed tablets in the section above. If you vomit within 3–4 hours after taking

your Cerazette tablet or have severe diarrhoea, the active ingredient may not have been completely

absorbed.

If you take more Cerazette than you should

There have been no reports of serious harmful effects from taking too many Cerazette tablets at one

time. Symptoms that may occur are nausea, vomiting and, in young girls, slight vaginal bleeding. For

more information ask your doctor for advice.

If you stop taking Cerazette

You can stop taking Cerazette whenever you want. From the day you stop you are no longer protected

against pregnancy.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, Cerazette can cause side effects, although not everybody gets them.

Serious undesirable effects associated with the use of Cerazette are described in the paragraphs ‘Breast

cancer’ and ‘Thrombosis’ in section 2 ‘What you need to know before you take Cerazette’. Please read

this section for additional information and consult your doctor at once where appropriate.

You should see your doctor immediately if you experience allergic reactions (hypersensitivity),

including swelling of the face, lips, tongue, and/or throat causing difficulty in breathing or swallowing

(angioedema and/or anaphylaxis).

Vaginal bleeding may occur at irregular intervals during the use of Cerazette. This may be just slight

staining which may not even require a pad, or heavier bleeding, which looks rather like a scanty period

and requires sanitary protection. You may also not have any bleeding at all. The irregular bleedings

are not a sign that the contraceptive protection of Cerazette is decreased. In general, you need not take

any action; just continue to take Cerazette. If, however, bleeding is heavy or prolonged you should

consult your doctor.

Users of Cerazette have reported the following side effects:

Common: may affect up to 1 in 10 women

mood altered, depressed mood, decreased sexual drive (libido)

headache

nausea

acne

breast pain; irregular or no menstruation

increased body weight

Uncommon: may affect up to 1 in 100 women

infection of the vagina

difficulties in wearing contact lenses

vomiting

hair loss

painful menstruation, ovarian cyst

tiredness

Rare: may affect up to 1 in 1,000 women

rash, hives, painful blue-red skin lumps (erythema nodosum) (these are skin conditions)

Not known (cannot be estimated from the available data)

allergic reaction

Apart from these side effects, breast secretion may occur.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance,

Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website:

www.hpra.ie; E-mail: medsafety@hpra.ie. By reporting side effects you can help provide more

information on the safety of this medicine.

5.

How to store Cerazette

Keep this medicine out of the sight and reach of children.

Do not use after the expiry date which is stated on the package. The expiry date refers to the last day

of that month.

This medicine does not require any special temperature storage conditions. Store the blister pack in the

original sachet in order to protect from light and moisture. Use within 1 month from the date of the

first opening of the sachet.

The active substance shows an environmental risk to fish.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Cerazette contains

The active substance is: desogestrel (75 microgram)

The other ingredients are: colloidal anhydrous silica; all-

rac

-α-tocopherol; maize starch;

povidone; stearic acid; hypromellose; macrogol 400; talc; titanium dioxide (E 171); lactose

monohydrate (see also ‘Cerazette contains lactose’ in section 2

What Cerazette looks like and contents of the pack

One blister pack of Cerazette contains 28 white round film-coated tablets. The tablets are coded

above 2 on one side and ORGANON* on the reverse side. Each carton contains 1, 3, 6 or 13

blister

packs, each separately packed in a

sachet.

Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Merck Sharp & Dohme Ireland (Human Health) Limited, Red Oak North, South County Business

Park, Leopardstown, Dublin 18, Ireland

Manufacturer:

N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands

This medicinal product is authorised in the Member States of the EEA under the following

names:

Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Luxemburg, Netherlands,

Norway, Portugal, Sweden, United Kingdom: Cerazette.

Spain:

Cerazet.

This leaflet was last revised in January 2020 .

© Merck Sharp & Dohme Ireland (Human Health) Limited 2020. All rights reserved.

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Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Cerazette 75 microgram film-coated tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 75 microgram desogestrel.

Excipient(s) with known effect: Each tablet contains approximately 55mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated tablet

The tablet is white, round, biconvex and 5 mm in diameter. On one side it is coded KV above 2 and on the reverse side

ORGANON*.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Contraception.

4.2 Posology and method of administration

Posology

To achieve contraceptive effectiveness, Cerazette must be used as directed (see ‘How to take ‘Cerazette’ and ‘How to start

Cerazette’).

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 Cerazette 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 Cerazette in adolescents below 18 years has not been established. No data are available.

Method of administration

Oral use.

How to take Cerazette

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 Cerazette

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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 her menstrual bleeding). Starting on

days 2‑5 is allowed, but during the first cycle a barrier method is recommended for the first 7 days of tablet-taking.

Following first-trimester abortion

After first-trimester abortion it is recommended to start immediately. In that case there is no need to use an additional method

of contraception.

Following delivery or second-trimester abortion

The woman should be advised to start any day between day 21 to 28 after delivery or second-trimester abortion. When

starting later, she should be advised to additionally use a barrier method until completion of the first 7 days of tablet-taking.

However, if intercourse has already occurred, pregnancy should be excluded before the actual start of Cerazette use or the

woman has to wait for her first menstrual period.

For additional information for breastfeeding women see section 4.6.

How to start Cerazette when changing from other contraceptive methods

Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch).

The woman should start Cerazette preferably on the day after the last active tablet (the last tablet containing the active

substances) of her previous COC or on the day of removal of her vaginal ring or transdermal patch. In these cases, the use of

an additional contraceptive is not necessary. Not all contraceptive methods may be available in all EU countries.

The woman may also start at the latest on the day following the usual tablet-free, patch-free, ring-free, or placebo tablet

interval of her previous combined hormonal contraceptive, but during the first 7 days of tablet-taking an additional barrier

method is recommended.

Changing from a progestogen-only-method (minipill, injection, implant or from a progestogen-releasing intrauterine system

[IUS]).

The woman may switch any day from the minipill (from an implant or the IUS on the day of its removal, from an injectable

when the next injection would be due).

Management of missed tablets

Contraceptive protection may be reduced if more than 36 hours have elapsed between two tablets. If the user is less than

12 hours late in taking any tablet, the missed tablet should be taken as soon as it is remembered and the next tablet should be

taken at the usual time. If she is more than 12 hours late, she should use an additional method of contraception for the next

7 days. If tablets were missed in the first week after initiation of Cerazette and intercourse took place in the week before the

tablets were missed, the possibility of a pregnancy should be considered.

Advice in case of gastrointestinal disturbances

In case of severe gastro-intestinal disturbance, absorption may not be complete and additional contraceptive measures should

be taken.

If vomiting occurs within 3‑4 hours after tablet-taking, absorption may not be complete. In such an event, the advice

concerning missed tablets, as given in section 4.2 is applicable.

Treatment surveillance

Before prescription, a thorough case history should be taken and a thorough gynaecological examination is recommended to

exclude pregnancy. Bleeding disturbances, such as oligomenorrhoea and amenorrhoea should be investigated before

prescription. The interval between check-ups depends on the circumstances in each individual case. If the prescribed product

may conceivably influence latent or manifest disease (see section 4.4), the control examinations should be timed accordingly.

Despite the fact that Cerazette is taken regularly, bleeding disturbances may occur. If bleeding is very frequent and irregular,

another contraceptive method should be considered. If the symptoms persist, an organic cause should be ruled out.

Management of amenorrhoea during treatment depends on whether or not the tablets have been taken in accordance with

the instructions and may include a pregnancy test.

The treatment should be stopped if a pregnancy occurs.

Women should be advised that Cerazette does not protect against HIV (AIDS) and other sexually transmitted diseases.

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4.3 Contraindications

Active venous thromboembolic disorder.

Presence or history of severe hepatic disease as long as liver function values have not returned to normal.

Known or suspected sex-steroid sensitive malignancies.

Undiagnosed vaginal bleeding.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

If any of the conditions/risk factors mentioned below is present, the benefits of progestogen use should be weighed against

the possible risks for each individual woman and discussed with the woman before she decides to start with Cerazette. In the

event of aggravation, exacerbation, or first appearance of any of these conditions, the woman should contact her physician.

The physician should then decide on whether the use of Cerazette should be discontinued.

The risk for breast cancer increases in general with increasing age. During use of combined oral contraceptives (COCs) the risk

of having breast cancer diagnosed is slightly increased. This increased risk disappears gradually within 10 years after

discontinuation of COC use and is not related to the duration of use, but to the age of the woman when using the COC. The

expected number of cases diagnosed per 10,000 women who use COCs (up to 10 years after stopping) relative to never users

over the same period has been calculated for the respective age groups and is presented in the table below.

age group

expected cases COC-users

expected cases non-users

16-19 years

20-24 years

17.5

25-29 years

48.7

30-34 years

35-39 years

40-44 years

The risk in users of progestogen-only contraceptives (POCs), such as Cerazette, is possibly of similar magnitude as that

associated with COCs. However, for POCs the evidence is less conclusive. Compared to the risk of getting breast cancer ever in

life, the increased risk associated with COCs is low. The cases of breast cancer diagnosed in COC users tend to be less

advanced than in those who have not used COCs. The increased risk in COC users may be due to an earlier diagnosis,

biological effects of the pill or a combination of both.

Since a biological effect of progestogens on liver cancer cannot be excluded an individual benefit/risk assessment should be

made in women with liver cancer.

When acute or chronic disturbances of liver function occur the woman should be referred to a specialist for examination and

advice.

Epidemiological investigations have associated the use of COCs with an increased incidence of venous thromboembolism (VTE,

deep venous thrombosis and pulmonary embolism). Although the clinical relevance of this finding for desogestrel used as a

contraceptive in the absence of an oestrogenic component is unknown, Cerazette should be discontinued in the event of a

thrombosis. Discontinuation of Cerazette should also be considered in case of long-term immobilisation due to surgery or

illness. Women with a history of thrombo-embolic disorders should be made aware of the possibility of a recurrence.

Although progestogens may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a

need to alter the therapeutic regimen in diabetics using progestogen-only pills. However, diabetic patients should be carefully

observed during the first months of use.

If a sustained hypertension develops during the use of Cerazette, or if a significant increase in blood pressure does not

adequately respond to antihypertensive therapy, the discontinuation of Cerazette should be considered.

Treatment with Cerazette leads to decreased estradiol serum levels, to a level corresponding with the early follicular phase. It is

as yet unknown whether the decrease has any clinically relevant effect on bone mineral density.

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The protection with traditional progestogen-only pills against ectopic pregnancies is not as good as with combined oral

contraceptives, which has been associated with the frequent occurrence of ovulations during the use of progestogen-only pills.

Despite the fact that Cerazette consistently inhibits ovulation, ectopic pregnancy should be taken into account in the

differential diagnosis if the woman gets amenorrhoea or abdominal pain.

Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to

chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking Cerazette.

The following conditions have been reported both during pregnancy and during sex steroid use, but an association with the

use of progestogens has not been established: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria;

systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham’s chorea; herpes gestationis; otosclerosis-related

hearing loss; (hereditary) angioedema.

Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use (see section 4.8).

Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide. Women should be advised to

contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment.

The efficacy of Cerazette may be reduced in the event of missed tablets (Section 4.2), gastro-intestinal disturbances (Section

4.2), or concomitant medications that decrease the plasma concentration of etonogestrel, the active metabolite of desogestrel

(Section 4.5).

Cerazette contains lactose and therefore should not be administered to patients with rare hereditary problems of galactose

intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.

Laboratory tests

Data obtained with COCs have shown that contraceptive steroids may influence the results of certain laboratory tests, including

biochemical parameters of liver, thyroid, adrenal and renal function, serum levels of (carrier) proteins, e.g. corticosteroid

binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and

fibrinolysis. The changes generally remain within the normal range. To what extent this also applies to progestogen-only

contraceptives is not known.

4.5 Interaction with other medicinal products and other forms of interactions

Interactions

Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.

Effect of other medicinal products on Cerazette

Interactions can occur with medicinal products that induce microsomal enzymes, which can result in increased clearance of sex

hormones and may lead to breakthrough bleeding and/or contraceptive failure.

Management

Enzyme induction can occur after a few days of treatment. Maximum enzyme induction is generally observed within a few

weeks. After drug therapy is discontinued, enzyme induction can last for about 4 weeks.

Short term treatment

Women on treatment with hepatic enzyme-inducing medicinal or herbal products should be advised that the efficacy of

Cerazette may be reduced. A barrier contraceptive method should be used in addition to Cerazette. The barrier method must

be used during the whole time of concomitant drug therapy and for 28 days after discontinuation of the hepatic

enzyme-inducing medicinal product.

Long term treatment

For women on long-term therapy with enzyme-inducing medicinal products, an alternative method of contraception

unaffected by enzyme-inducing medicinal products should be considered.

Substances increasing the clearance of contraceptive hormones (diminished contraceptive efficacy by enzyme induction) e.g.:

Barbiturates, bosentan, carbamazepine, phenytoin, primidone, rifampicin, efavirenz and possibly also felbamate, griseofulvin,

oxcarbazepine, topiramate, rifabutin and products containing the herbal remedy St. John's Wort (hypericum perforatum).

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Substances with variable effects on the clearance of contraceptive hormones

When co-administered with hormonal contraceptives, many combinations of HIV protease inhibitors (e.g. ritonavir, nelfinavir)

and non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine) and/or combinations with Hepatitis C virus (HCV)

medicinal products (e.g. boceprevir, telaprevir), can increase or decrease plasma concentrations of progestins. The net effect of

these changes may be clinically relevant in some cases.

Therefore, the prescribing information of concomitant HIV/HCV medications should be consulted to identify potential

interactions and any related recommendations. In case of any doubt, an additional barrier contraceptive method should be

used by women on protease inhibitor or non-nucleoside reverse transcriptase inhibitor therapy.

Substances decreasing the clearance of contraceptive hormones(enzyme inhibitors)

Concomitant administration of strong (e.g. ketoconazole, itraconazole, clarithromycin) or moderate (e.g. fluconazole, diltiazem,

erythromycin) CYP3A4 inhibitors may increase the serum concentrations of progestins, including etonogestrel, the active

metabolite of desogestrel.

Effects of Cerazette on other medicinal products

Hormonal contraceptives may interfere with the metabolism of other drugs. Accordingly, plasma and tissue concentrations of

other active substances may either increase (e.g. ciclosporine) or decrease (e.g. lamotrigine).

4.6 Fertility, pregnancy and lactation

Pregnancy

Cerazette is not indicated during pregnancy. If pregnancy occurs during treatment with Cerazette, further intake should be

stopped.

Animal studies have shown that very high doses of progestogenic substances may cause masculinisation of female foetuses.

Extensive epidemiological studies have revealed neither an increased risk of birth defects in children born to women who used

COCs prior to pregnancy, nor a teratogenic effect when COCs were taken inadvertently during early pregnancy.

Pharmacovigilance data collected with various desogestrel-containing COCs also do not indicate an increased risk.

Breastfeeding

Cerazette does not influence the production or the quality (protein, lactose, or fat concentrations) of breast milk. However,

small amounts of etonogestrel are excreted in the breast milk. As a result, 0.01 ‑ 0.05 microgram etonogestrel per kg body

weight per day may be ingested by the child (based on an estimated milk ingestion of 150 ml/kg/day).

Limited long-term follow-up data are available on children, whose mothers started using Cerazette during the 4

to 8

week

post-partum. They were breast-fed for 7 months and followed up to 1.5 years (n=32) or to 2.5 years (n=14) of age. Evaluation

of growth and physical and psychomotor development did not indicate any differences in comparison to nursing infants,

whose mother used a copper-IUD. Based on the available data Cerazette may be used during lactation. The development and

growth of a nursing infant, whose mother uses Cerazette, should, however, be carefully observed.

Fertility

Cerazette is indicated for the prevention of pregnancy. For information on return to fertility (ovulation), see section 5.1.

4.7 Effects on ability to drive and use machines

Cerazette has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

The most commonly reported undesirable effect in the clinical trials is bleeding irregularity. Some kind of bleeding irregularity

has been reported in up to 50% of women using Cerazette. Since Cerazette causes ovulation inhibition close to 100%, in

contrast to other progestogen-only pills, irregular bleeding is more common than with other progestogen-only pills. In 20 ‑

30% of the women, bleeding may become more frequent, whereas in another 20% bleeding may become less frequent or

totally absent. Vaginal bleeding may also be of longer duration. After a couple of months of treatment, bleedings tend to

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become less frequent. Information, counselling, and a bleeding diary can improve the woman's acceptance of the bleeding

pattern.

The most commonly reported other undesirable effects in the clinical trials with Cerazette (>2.5%) were acne, mood changes,

breast pain, nausea and weight increase. The undesirable effects are mentioned in the table below.

All undesirable effects are listed by system organ class and frequency; common (≥1/100), uncommon (1/1,000 to <1/100), rare

(<1/1,000), and not known (cannot be estimated from the available data).

System Organ

Class

(MedDRA)*

Frequency of adverse reactions ​

​ ​

Common

Uncommon

Rare

Not known

Infections and

infestations

Vaginal

infection

Immune system

disorders

Hypersensitivity reactions, including angioedema and

anaphylaxis

Psychiatric

disorders

Mood altered,

Depressed

mood,

Libido

decreased

Nervous system

disorders

Headache

Eye disorders

Contact lens

intolerance

Gastrointestinal

disorders

Nausea

Vomiting

Skin and

subcutaneous

tissue disorders

Acne

Alopecia

Rash,

Urticaria,

Erythema

nodosum

Reproductive

system and

breast disorders

Breast pain,

Menstruation

irregular,

Amenorrhoea

Dysmenorrhoea,

Ovarian cyst

General

disorders and

administration

site condition

Fatigue

Investigations

Weight

increased

* MedDRA version 9.0

Breast discharge may occur during use of Cerazette. On rare occasions, ectopic pregnancies have been reported (see

section 4.4). In addition, aggravation of hereditary angioedema may occur (see section 4.4).

In women using (combined) oral contraceptives a number of (serious) undesirable effects have been reported. These include

venous thromboembolic disorders, arterial thromboembolic disorders, hormone-dependent tumours (e.g. liver tumours, breast

cancer) and chloasma, some of which are discussed in more detail in section 4.4.

Breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers) with

hormonal contraceptives (see section 4.5).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected

adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

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4.9 Overdose

There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in this case are: nausea,

vomiting and, in young girls, slight vaginal bleeding. There are no antidotes and further treatment should be symptomatic.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: hormonal contraceptives for systemic use, ATC code: G03AC09.

Mechanism of action

Cerazette is a progestogen-only pill, which contains the progestogen desogestrel. Like other progestogen-only pills, Cerazette

is best suited for use during breast feeding and for women who may not or do not want to use oestrogens. In contrast to

traditional progestogen-only pills, the contraceptive effect of Cerazette is achieved primarily by inhibition of ovulation. Other

effects include increased viscosity of the cervical mucus.

Clinical efficacy and safety

When studied for 2 cycles, using a definition of ovulation as a progesterone level greater than 16 nmol/L for 5 consecutive

days, the ovulation incidence was found to be 1% (1/103) with a 95% confidence interval of 0.02% ‑ 5.29% in the ITT group

(user and method failures). Ovulation inhibition was achieved from the first cycle of use. In this study, when Cerazette was

discontinued after 2 cycles (56 continuous days), ovulation occurred on average after 17 days (range 7‑30 days).

In a comparative efficacy trial (which allowed a maximum time of 3 hours for missed pills) the overall ITT Pearl-Index found for

Cerazette was 0.4 (95% confidence interval 0.09‑1.20) , compared to 1.6 (95 % confidence interval 0.42‑3.96) for 30 microgram

levonorgestrel.

The Pearl-Index for Cerazette is comparable to the one historically found for COCs in the general COC-using population.

Treatment with Cerazette leads to decreased estradiol levels, to a level corresponding to the early follicular phase. No clinically

relevant effects on carbohydrate metabolism, lipid metabolism, and haemostasis have been observed.

Paediatric population

No clinical data on efficacy and safety are available in adolescents below 18 years.

5.2 Pharmacokinetic properties

Absorption

After oral dosing of Cerazette desogestrel (DSG) is rapidly absorbed and converted into etonogestrel (ENG). Under steady-state

conditions, peak serum levels are reached 1.8 hours after tablet-intake and the absolute bioavailability of ENG is approximately

70%.

Distribution

ENG is 95.5‑99% bound to serum proteins, predominantly to albumin and to a lesser extent to SHBG.

Biotransformation

DSG is metabolised via hydroxylation and dehydrogenation to the active metabolite ENG. ENG is primarily metabolised by the

cytochrome P450 3A (CYP3A) isoenzyme and subsequently conjugated with sulphate and glucuronide.

Elimination

ENG is eliminated with a mean half-life of approximately 30 hours, with no difference between single and multiple dosing.

Steady-state levels in plasma are reached after 4‑5 days. The serum clearance after i.v. administration of ENG is approximately

10 l per hour. Excretion of ENG and its metabolites either as free steroid or as conjugates, is with urine and faeces (ratio 1.5:1).

In lactating women, ENG is excreted in breast milk with a milk/serum ratio of 0.37‑0.55. Based on these data and an estimated

milk intake of 150 ml/kg/day, 0.01‑0.05 microgram etonogestrel maybe ingested by the infant.

Special populations

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Effect of renal impairment

No studies were performed to evaluate the effect of renal disease on the pharmacokinetics of DSG.

Effect of hepatic impairment

No studies were conducted to evaluate the effect of hepatic disease on the pharmacokinetics of DSG. However, steroid

hormones may be poorly metabolized in women with impaired liver function.

Ethnic groups

No studies were performed to assess pharmacokinetics in ethnic groups.

5.3 Preclinical safety data

Toxicological studies did not reveal any effects other than those, which can be explained from the hormonal properties of

desogestrel.

Environmental Risk Assessment (ERA)

The active substance etonogestrel shows an environmental risk to fish.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet Core

Silica, Colloidal anhydrous

All-rac-α-tocopherol

Lactose monhydrate

Maize starch

Povidone

Stearic acid

Film coating

Hypromellose

Macrogol 400

Talc

Titanium dioxide (E 171)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

Shelf-life after first opening the sachet: 1 month.

6.4 Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Store the blister pack in the original

sachet in order to protect from light and moisture. For storage conditions after first opening the sachet, see section 6.3.

6.5 Nature and contents of container

PVC/Aluminium blister.

Each blister contains 28 tablets. Each carton contains 1, 3, 6 or 13 blisters packed separately in an aluminium laminated sachet.

Not all pack sizes may be marketed.

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6.6 Special precautions for disposal

The active substance etonogestrel shows an environmental risk to fish.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Ireland (Human Health) Limited

Red Oak North

South County Business Park

Leopardstown

Dublin 18

Ireland

8 MARKETING AUTHORISATION NUMBER

PA1286/048/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 14

August 1998

Date of last renewal: 12

December 2007

10 DATE OF REVISION OF THE TEXT

January 2020

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