Cerazette

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Desogestrel 0.075 mg;  
Available from:
Merck Sharp & Dohme (New Zealand) Limited
INN (International Name):
Desogestrel 0.075 mg
Dosage:
0.07 mg
Pharmaceutical form:
Film coated tablet
Composition:
Active: Desogestrel 0.075 mg   Excipient: Colloidal silicon dioxide dl-Alpha tocopherol Hypromellose Lactose monohydrate Macrogol 400 Maize starch Povidone Purified talc Stearic acid Titanium dioxide
Units in package:
Calendar pack, 1 strip of 28 tabs, 28 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Aspen Oss B.V
Product summary:
Package - Contents - Shelf Life: Calendar pack, 1 strip of 28 tabs - 28 tablets - 36 months from date of manufacture stored at or below 30°C - Calendar pack, 3 strips of 28 tabs - 84 tablets - 36 months from date of manufacture stored at or below 30°C - Calendar pack, 6 strips of 28 tabs - 168 tablets - 36 months from date of manufacture stored at or below 30°C
Authorization number:
TT50-5968
Authorization date:
1997-05-13

CERAZETTE

®

Tablets for oral use

Consumer Medicine

Information

What is in this leaflet

Keep this leaflet. You may

need to read it again.

This leaflet will provide

information about the benefits

and risks of Cerazette

. It will

also advise you about how to

take Cerazette

properly and

when to tell your doctor about

health-related conditions. If

you have any further

questions, ask your doctor or

your pharmacist.

This medicine has been

prescribed for you. Do not

pass it on to others. It may

harm them, even if their

symptoms are the same as

yours.

If any of the side effects

gets serious, or if you notice

any side effects not listed in

this leaflet, please tell your

doctor or your pharmacist.

What is CERAZETTE

®

and what is it used

for?

How does Cerazette

®

work?

Cerazette

contains a small

amount of one type of female

sex hormone, the progestagen

desogestrel. For this reason

Cerazette

is called a

progestagen-only-pill (POP), or

a mini-pill. Contrary to combined

pills, mini-pills do not contain an

oestrogen hormone next to the

progestagen. Most mini-pills

work primarily by preventing the

sperm cells from entering the

womb but, unlike combined pills,

they do not always prevent an

egg cell from ripening.

Cerazette

is distinct from other

mini-pills because, like

combined pills, in most cases it

does prevent the egg cells 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.

Why is Cerazette

®

used?

To prevent pregnancy.

When Cerazette

is taken

correctly (without missing

tablets), the chance of becoming

pregnant is very low.

Before you start to

take Cerazette

®

Cerazette

, like all hormonal

contraceptives, does not

protect against HIV infection

(AIDS) or any other sexually

transmitted disease.

When should you not take

Cerazette

®

?

Do not use Cerazette

if you

have any of the conditions

listed below. If any of these

apply to you, tell your doctor

before starting to use

Cerazette

. Your doctor may

advise you to use a non-

hormonal method of birth

control.

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 jaundice

(yellowing of the skin) or

severe liver disease.

If you have a cancer that

grows under the influence of

sex steroid hormones.

If you have any unexplained

vaginal bleeding.

If you are pregnant or think

you might be pregnant.

If you are allergic to any of

the ingredients of

Cerazette

If any of these conditions

appear for the first time while

using Cerazette

you should

consult your doctor promptly.

When do you have to take

special care with

Cerazette

®

?

If Cerazette

is used in the

presence of any of the conditions

listed below, you may need to be

kept under close observation.

Your doctor can explain to you

what to do. Therefore, if any of

these apply to you, tell your

doctor before starting to use

Cerazette

You have or have had breast

cancer;

You have liver cancer;

You have ever had a

thrombosis;

You have diabetes;

You suffer from epilepsy;

You suffer from tuberculosis;

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.

Potentially serious

conditions

Decreased Bone Mass

Oestrogens are important to

maintain the strength of your

bones. During the use of

Cerazette

, the concentration

in your blood of the natural

oestrogen estradiol is

comparable to the

concentration seen in the first

half of your natural cycle but is

decreased in comparison with

the second half of the natural

cycle. It is not known whether

this has an effect on the

strength of your bones.

Breast Cancer

Every woman is at risk of breast

cancer whether or not she takes

oral contraceptives (‘the Pill’).

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. When 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 among women who use

the Pill at a higher age. How

long a woman 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.

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

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, but it is not as high as the

risk during pregnancy. The risk

with progestagen-only pills like

Cerazette

is believed to be

lower than in users of Pills that

also contain oestrogens

(combined Pills). If you notice

possible signs of a thrombosis,

you should see your doctor

immediately. (See also section

‘When should you contact

your doctor’?).

Using Other Medicines

Please tell your doctor or

pharmacist if you are taking or

have recently taken any other

medicines or herbal products,

including medicines obtained

without a prescription. Also tell

any other doctor or dentist who

prescribes another medicine (or

your pharmacist) that you use

Cerazette

Some medicines may stop

Cerazette

from working

properly. These include

medicines used for the treatment

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),

stomach upset (medical

charcoal)

depressive moods (the herbal

remedy St. John’s wort)

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 for that

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).

Vaginal Bleeding

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

decreased. In general, you need

not take any action; just continue

to take Cerazette

. If, however,

bleeding is heavy or prolonged

consult your doctor.

Ovarian Cysts

During the use of all low-dose

hormonal contraceptives, small

fluid-filled sacs may develop in

the ovaries. These are called

ovarian cysts. They usually

disappear on their own.

Sometimes they cause mild

abdominal pain. Only rarely,

they may lead to more serious

problems.

Pregnancy

Cerazette

must not be used by

women who are pregnant, or

who think they may be

pregnant.

Breastfeeding

Cerazette

may be used while

you are breastfeeding.

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 breast-fed

children 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 breastfeeding 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.

Important information

about some of the

ingredients of Cerazette

®

If you have been told by your

doctor that you have

intolerance to some sugars,

contact your doctor before

taking Cerazette

When should you contact

your doctor?

How do you 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 to 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.

You can stop taking Cerazette

whenever you want. From the

day you stop you are no longer

protected against pregnancy.

Starting your first pack of

Cerazette

®

If you are not taking the pill

at present.

Wait for your period to

begin. On the first day of

your period take the first

Cerazette

tablet. You

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 notice possible signs of a

thrombosis (e.g. severe pain

or swelling in either of your

legs, unexplained pains in the

chest, breathlessness, an

unusual cough, especially if

you cough up blood);

you have a sudden, severe

stomach ache or look

jaundiced (indicating possible

liver problems);

you feel a lump in your breast;

you have a sudden or severe

pain in the lower part of your

belly or the stomach area

(possibly indicating an ectopic

pregnancy, this is a pregnancy

outside the womb);

you are to be immobilised (for

example being confined to

bed) 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.

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

in the first cycle.

When you change from a

combined pill, vaginal

ring, or transdermal patch.

You can start taking

Cerazette

on the day after

you take the last tablet from

your 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, it is

not necessary to use an

additional contraceptive

method.

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 during the

first cycle an additional

contraceptive method

(barrier method) for the

first 7 days of tablet-taking.

When you change from

another progestagen-only

pill (mini-pill).

You may stop taking it any

day and start taking

Cerazette

right away. You

need not take extra

contraceptive precautions.

When you change from an

injectable or implant or a

progestagen-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.

If you have just had a baby.

You can start Cerazette

between 21 and 28 days

after the birth of your baby.

If you start later, make sure

you use during the first

cycle an additional

contraceptive method

(barrier method) for 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 the paragraph

“Breastfeeding” in the

section “When do you have

to take special care with

Cerazette

”. Your doctor

can also advise you.

After miscarriage or an

abortion.

Your doctor will advise you.

If you forget to take one or

more tablets

If you are

less than 12 hours

late in taking a tablet, the

reliability of Cerazette

maintained. Take the missed

tablet as soon as you

remember and take the next

tablet at the usual time.

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

tablet at the usual time. Use a

condom too for the next 7 days

of tablet-taking. If you missed

one or more tablets in the first

week of tablet-intake 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

gastrointestinal

disturbances (e.g.

vomiting, severe

diarrhoea)

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. Follow the advice for

missed tablets in the section “If

you forget to take one or more

tablets”. If you have severe

diarrhoea, please contact your

doctor.

If too many Cerazette

®

tablets are taken

(overdose)

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 women or girls,

slight vaginal bleeding. For

more information ask your

doctor for advice.

If you want to stop taking

Cerazette

®

You can stop taking Cerazette

at any time you want. If you do

not want to become pregnant,

ask your doctor about other

methods of birth control.

If you stop using Cerazette

because you want to get

pregnant, it is generally

recommended that you wait

until you have had a natural

period before trying to

conceive. This helps you to

work out when the baby will be

due.

Possible Side Effects

Like all medicines, Cerazette

can cause side effects, although

not everybody gets them. Tell

your doctor if you notice any

unwanted effect, especially if

severe or persistent, or if there

is a change in your health that

you think might be caused by

Cerazette

Serious side effects

Serious undesirable effects

associated with the use of

contraceptive Pills are

described in the section “When

do you have to take special

care with Cerazette

”. Please

read this section for additional

information and consult your

doctor at once where

appropriate.

Other possible side effects

Common (occurring in more than

one per 100 users) are:

Mood altered, decreased

sexual drive (libido)

Headache

Nausea

Acne

Breast pain, irregular or no

menstruation

Increased body weight

Uncommon (occurring in more

than one per 1000 users but

not more than one per 100

users) are:

Infection of the vagina

Difficulties in wearing contact

lenses

Vomiting

Hair loss

Painful menstruation, ovarian

cyst

Tiredness

Rare (occurring in less than

one per 1000 users) are:

Rash, hives, painful blue-

red skin lumps (erythema

nodosum) (these are skin

conditions)

Apart from these side effects,

breast secretion may occur.

In addition, allergic reactions

(hypersensitivity), including

swelling of the face, lips,

tongue, and/or throat causing

difficulty in breathing or

swallowing (angioedema

and/or anaphylaxis) have been

reported.

If any of the side effects gets

serious, or if you notice any side

effects not listed in this leaflet,

please tell your doctor.

How to store

CERAZETTE

®

Store between 2°C to 30°C,

protected from light and

moisture. Do not use after the

expiry date stated on the

package.

Keep your tablets out of the

reach and sight of children.

Further information

What Cerazette

®

contains

The active substance is:

desogestrel (75 micrograms).

The other ingredients are:

silica; colloidal anhydrous; all-

rac-

-tocopherol; lactose

monohydrate; maize starch;

povidone; stearic acid;

hypromellose; macrogol 400;

talc and titanium dioxide (E

171).

What Cerazette

®

looks like

and the content of the

package

One blister pack of Cerazette

contains 28 white round tablets.

The tablets are coded KV above

2 on one side and ORGANON*

on the reverse side. Each carton

contains 1 or 3 blister packs,

each separately packed in a

sachet. Not all pack sizes may

be available.

Sponsor

Merck Sharp & Dohme (NZ) Ltd

P O Box 99 851

Newmarket

Auckland 1149

Telephone: 0800 500 673

This leaflet was updated in

February 2019.

S-CCPPI-MK8276-TB-022019

S-CCDS-MK8276-TB-022019

Page 1 of 9

NEW ZEALAND DATA SHEET

1

CERAZETTE 75 microgram Film-coated tablet

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 75 microgram desogestrel.

Excipient with known effect:

- lactose monohydrate

For the full list of excipients, see Section 6.1 List of excipients.

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

Oral contraception.

4.2 Dose and method of administration

How To Take CERAZETTE

Tablets must be taken in the order directed on the package, every day at about the same time,

with some liquid as needed. One tablet is to be taken daily for 28 consecutive days. Each

subsequent pack is started immediately after finishing the previous pack.

How To Start CERAZETTE

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 in addition for the first 7 days of tablet-taking.

Changing from a combined hormonal contraceptive (combined oral contraceptive (COC),

vaginal ring, or transdermal patch)

The woman should start with CERAZETTE preferably on the day after the last active tablet

(the last tablet containing the active substances), or on the day of removal of her vaginal ring

or patch. In these cases, the use of an additional contraceptive is not necessary.

The women 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). An additional contraceptive

method is not necessary.

Following first-trimester abortion

After

first

trimester

abortion

recommended

start

immediately;

additional

contraceptive method is not necessary.

S-CCDS-MK8276-TB-022019

Page 2 of 9

Following delivery or second-trimester abortion

For breastfeeding women see Section 4.6 Fertility, pregnancy and lactation.

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

When starting later, she should be advised to use a barrier method in addition for 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.

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 follow the same advice but also use an additional

method of contraception for the next 7 days. If tablets were missed in the very first week 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 gastrointestinal 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 under Management of missed tablets is applicable.

Paediatric population

No data available.

4.3 Contraindications

Progestogen-only contraceptives should not be used in the presence of any of the conditions

listed below. Should any of the conditions appear for the first time during the use of

CERAZETTE, the product should be stopped immediately.

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

List of excipients

Known or suspected pregnancy

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

4.4 Special warnings and precautions for use

If any of the conditions 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 using 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 the 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 OC 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

S-CCDS-MK8276-TB-022019

Page 3 of 9

combined OCs (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:

Table 1

Age group

Expected cases

combined OC-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 POP users is possibly of similar magnitude as that associated with combined

OCs. However, for POPs 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.

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,

discontinuation with the use of CERAZETTE should be considered.

Epidemiological

investigations have associated

combined OCs

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 thromboembolic 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.

Treatment with CERAZETTE leads to decreased oestradiol 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.

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

S-CCDS-MK8276-TB-022019

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erythematosus; haemolytic uraemic syndrome; Sydenham’s chorea; herpes gestationis;

otosclerosis-related hearing loss; (hereditary) angioedema.

CERAZETTE contains less than 65mg lactose and therefore should not be administered

to patients with rare hereditary problems of galactose intolerance, the Lapp lactase

deficiency, or glucose-galactose malabsorption.

Medical Examination/Consultation

Before prescription, a thorough case history should be taken and a thorough gynaecological

examination

recommended

exclude

pregnancy.

Bleeding

disturbances,

such

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 Special

warnings and precautions for use), 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.

Reduced Efficacy

The efficacy of CERAZETTE may be reduced in the event of missed tablets (see Section 4.2

Dose and method of administration, Management of missed tablets), gastrointestinal

disturbances

(see

Advice

in

case

of

gastrointestinal

disturbances)

concomitant

medications that decrease the plasma concentration of etonogestrel, the active metabolite of

desogestrel (see Section 4.5 Interactions with other medicines and other forms of

interactions).

Changes in Vaginal Bleeding Pattern

During the use of a progestogen-only contraceptive, vaginal bleeding may become more

frequent or of longer duration in some women, whereas in others bleeding may become

incidental or be totally absent. These changes are often a reason for women to reject the

method or to be non-compliant. Acceptance of bleeding pattern can be improved by offering

women who have chosen to use CERAZETTE careful counselling on this point. Evaluation of

vaginal bleeding should be done on an ad hoc basis and may include examination to exclude

malignancy or pregnancy.

Follicular Development

With all low-dose hormonal contraceptives, follicular development occurs and occasionally the

follicle may continue to grow beyond the size it would attain in a normal cycle. Generally, these

enlarged follicles disappear spontaneously. Often, they are asymptomatic; in some cases they

are associated with mild abdominal pain. They rarely require surgical intervention.

4.5 Interactions with other medicines and other forms of interactions

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

potential interactions.

Interactions

between

oral

contraceptives

other

medicinal

products

lead

breakthrough bleeding and/or contraceptive failure. No specific interaction studies have been

performed with CERAZETTE. The following interactions have been reported in the literature

(mainly

with

combined

contraceptives

occasionally

also

with

progestogen-only

contraceptives).

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Hepatic metabolism: Interactions can occur with medicinal or herbal products that induce

microsomal enzymes, specifically cytochrome P450 enzymes (CYP), which can result in

increased clearance reducing plasma concentrations of sex hormones and may decrease the

effectiveness

oral

contraceptives,

including

CERAZETTE.

These

products

include

phenytoin, phenobarbital, primidone, bosentan, carbamazepine, rifampicin; and possibly also

oxcarbazepine, rifabutin, topiramate, felbamate, griseofulvin, some HIV protease inhibitors

(e.g., ritonavir, nelfinavir) and non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz),

and the herbal remedy St John’s wort.

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 28 days.

When co-administered with hormonal contraceptives, many combinations of HIV protease

inhibitors

(e.g.,

nelfinavir)

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,

including etonogestrel, the active metabolite of desogestrel. The net effect of these changes

may be clinically relevant in some cases.

Women receiving any of the above mentioned 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 during administration of the

hepatic enzyme-inducing medicinal product, and for 28 days after discontinuation of the

hepatic enzyme-inducing medicinal product.

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.

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

moderate (e.g., fluconazole, diltiazem, erythromycin) CYP3A4 inhibitors may increase the

serum

concentrations

progestins,

including

etonogestrel,

active

metabolite

desogestrel.

During treatment with medical charcoal, the absorption of the steroid in the tablet may be

reduced and thereby the contraceptive efficacy. In such an event, the advice concerning

missed tablets, as given under Management of missed tablets is applicable.

Hormonal contraceptives may interfere with the metabolism of other medicines. Accordingly,

plasma and tissue concentrations may either increase (e.g. ciclosporine) or decrease (e.g.,

lamotrigine).

Interference with serological testing

Data obtained with combined oral contraceptives 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 relates to progestogen-only contraceptives is not known.

4.6 Fertility, pregnancy and lactation

Pregnancy

Animal studies have shown that very high doses of progestogenic substances may cause

masculinisation of female foetuses.

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Extensive epidemiological studies have revealed neither an increased risk of birth defects in

children born to women who used OCs prior to pregnancy, nor a teratogenic effect when OCs

were taken inadvertently during early pregnancy.

Pharmacovigilance data collected with various desogestrel-containing combined OCs also do

not indicate an increased risk.

Breast-feeding

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 2.5 years 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 be

carefully observed.

Fertility

See Section 5.1 Pharmacodynamic Properties, Mechanism of Action.

4.7 Effects on ability to drive and use machines

On the basis of the pharmacodynamic profile, CERAZETTE is expected to have no or

negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

The most commonly reported undesirable effects in the clinical trials with CERAZETTE

(>2.5%) were bleeding irregularities, acne, mood alterations, breast pain, nausea and weight

increase. The undesirable effects mentioned in the table below have been judged, by the

investigators, as having an established, probable or possible link to the treatment.

Table 2

System Organ

Class

Frequency of adverse reactions

(MedDRA)*

Common

≥ 1/100

Uncommon

< 1/100, ≥ 1/1000

Rare

(< 1/1000)

Infections and

infestations

Vaginal infection

Psychiatric disorders

Mood altered

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

Dysmenorrhoea,

Ovarian cyst

S-CCDS-MK8276-TB-022019

Page 7 of 9

irregular,

Amenorrhoea

General disorders

and administration

site condition

Fatigue

Investigations

Weight increase

*MedDRA version 9.0

Breast discharge and, on rare occasions, ectopic pregnancies have been reported with the

use of CERAZETTE during post-marketing surveillance (see Section 4.4 Special warnings

and precautions for use). In addition, hypersensitivity reactions (including angioedema and

anaphylaxis) have been reported during post-marketing surveillance.

In women using (combined) oral contraceptives a number of (serious) undesirable effects have

been reported, some of which are discussed in more detail under Section 4.4 Special

warnings and precautions for use. These include venous thromboembolic disorders, arterial

thromboembolic disorders, hormone-dependent tumours (e.g. liver tumours, breast cancer)

and chloasma.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It

allows

continued

monitoring

benefit/risk

balance

medicine.

Healthcare

professionals

asked

report

suspected

adverse

reactions

https://nzphvc.otago.ac.nz/reporting/.

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.

For advice on the management of overdose please contact the National Poisons Centre on

0800 POISON (0800 764766).

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).

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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 µg levonorgestrel.

The Pearl-Index for CERAZETTE is comparable to the one historically found for combined

OCs in the general OC-using population. Treatment with CERAZETTE leads to decreased

oestradiol levels, to a level corresponding to the early follicular phase. No clinically relevant

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

5.2 Pharmacokinetic properties

Absorption

After oral dosing of CERAZETTE, desogestrel is rapidly absorbed and converted into its

biologically active metabolite etonogestrel (ENG). Under steady-state conditions, peak serum

levels are reached 1.8 hours after tablet intake and the absolute bioavailability of etonogestrel

is approximately 70%.

Distribution

Etonogestrel is 95.5-99% bound to serum proteins, predominantly to albumin and to a lesser

extent to SHBG.

Biotransformation

Desogestrel is metabolised via hydroxylation and dehydrogenation to the active metabolite

etonogestrel. Etonogestrel is metabolised via sulphate and glucuronide conjugation.

Elimination

Etonogestrel 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 etonogestrel is approximately 10 litres per

hour. Excretion of etonogestrel and its metabolites either as free steroid or as conjugates, is

with urine and faeces (ratio 1.5:1). In lactating women, etonogestrel is excreted in breast milk

with a milk/serum ratio of 0.37-0.55. Based on these data and on an estimated milk intake of

150 mL/kg/day, 0.01-0.05 microgram etonogestrel per kg bodyweight per day may be ingested

by the infant.

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.

6

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet Core

Silica, colloidal anhydrous; dl-α-tocopherol, lactose monohydrate, maize starch, povidone,

stearic acid.

Film Coating

Hypromellose, macrogol 400, purified talc, titanium dioxide (E 171).

6.2 Incompatibilities

None known.

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6.3 Shelf life

The shelf-life of CERAZETTE is 36 months.

6.4 Special precautions for storage

Store at 2°C-30°C, protected from light and moisture.

6.5 Nature and contents of container

Each strip contains 28 tablets.

Cartons contain 1, 3 or 6 strips.

6.6 Special precautions for disposal and other handling

Any unused material should be disposed of in accordance with local requirements.

7

MEDICINE SCHEDULE

Prescription Medicine.

8

SPONSOR

Merck Sharp & Dohme (New Zealand) Limited

P O Box 99851

Newmarket

Auckland 1149

New Zealand

Tel: 0800 500 673

9

DATE OF FIRST APPROVAL

13 May 1997

10

DATE OF REVISION OF THE TEXT

26 February 2019

SUMMARY TABLE OF CHANGES

Section

Changed

Summary of new information

Data sheet reformat.

Updated Undesirable effects with text regarding hypersensitivity reactions

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