Document: Cerazette film-coated tablet ENG PL change

• Cerazette film-coated tablet PL
• Cerazette film-coated tablet ENG PL

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Package leaflet: Information for the user

Cerazette Tablets for oral uses

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:

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 severe 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).

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

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.

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.

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

Start using Cerazettewhen your next injection is due or on the day that your implant or your IUD is removed. You need not take extra contraceptive precautions.

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.

Your doctor will advise you.

If you forget to take Cerazette

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 or use medical charcoal 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.

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 (occurring in more than one per 100 users) are:	Uncommon (occurring in more than one per 1,000 users but not more than one per 100 users) are:	Rare (occurring in less than one per 1,000 users) is:
mood altered, depressed mood, decreased sexual drive (libido)	infection of the vagina	rash, hives, painful blue-red skin lumps (erythema nodosum) (these are skin conditions)
headache	difficulties in wearing contact lenses
nausea	vomiting
acne	hair loss
breast pain, irregular or no menstruation	painful menstruation, ovarian cyst
increased body weight	tiredness

Apart from these side effects, breast secretion may occur.

You should see your doctor immediately if you experience symptoms of angioedema, such as (i) swollen face, tongue or pharynx; (ii) difficulty to swallow; or (iii) hives and difficulties to breathe.

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 the national reporting system listed in Appendix V . 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 etonogestrel 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

OneblisterpackofCerazettecontains28 whiteroundfilm-coatedtablets.ThetabletsarecodedKV above2ononesideandORGANON*onthereverseside.Eachcartoncontains1,3,6or13 blister packs,eachseparatelypackedinasachet.

Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

[to be completed nationally]

Manufacturer:

N.V. Organon, P.O. Box 20, 5340 BH Oss, The Netherlands.

Organon (Ireland) Ltd., Drynam Road, P.O. Box 2857, Swords, Co. Dublin, Ireland

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 2016-10-28