75 micrograms film-coated tablets 
desogestrel

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again. If you have any further questions, ask your doctor, midwife, or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Cerazette is and what it is used for 
2. What you need to know before you use Cerazette 
3. How to use Cerazette 
4. Possible side effects 
5. How to store Cerazette 
6. Contents of the packaging and other information 

1. What Cerazette is and what it is used for

Cerazette is used to prevent pregnancy.

Cerazette contains small amounts of a type of female sex hormone, progestin and desogestrel . Cerazette is therefore called a progestogen on pills . Unlike combined contraceptive pills , these do not contain any estrogen as a supplement to progestogen .

Most progestogen pills work primarily by preventing sperm from reaching the uterus. They do not always prevent egg cells from maturing, which is the main effect of combined birth control pills . Cerazette differs from most progestogenic contraceptives by having a high enough dose to prevent egg cells from maturing in the vast majority of cases. Therefore, Cerazette provides good protection against pregnancy.

Unlike combined contraceptive pills , Cerazette can be used by women who do not tolerate estrogen or women who are breastfeeding. One disadvantage is that the bleeding may become more irregular when using Cerazette. You may also not experience any bleeding at all.

2. What you need to know before using Cerazette

Do not use Cerazette

Like other hormonal contraceptives protects Cerazette not against HIV – infection ( AIDS ) or other sexually transmitted diseases.

Do not use Cerazette

  • if you are allergic (hypersensitive) to desogestrel other ingredient in Cerazette (listed in section 6).
  • if you have an ongoing thrombotic disease. Thrombosis is the formation of a blood clot in a blood vessel (eg in the legs [deep vein thrombosis] or in the lungs [pulmonary embolism]).
  • if you have or have had jaundice (yellowing skin) or a serious liver disease and your liver values ​​have not returned to normal.
  • if you have or are suspected of having cancer that is sensitive to sex hormones, such as certain types of breast cancer.
  • if you have genital bleeding that has not been investigated.

Tell your doctor / midwife before using Cerazette if any of these apply to you. You may be advised to use a contraceptive method that does not contain hormones . Contact your doctor / midwife immediately if any of these conditions occur for the first time when you use Cerazette.

Warnings and cautions

Tell your doctor / midwife before you start using Cerazette if:

  • you have or have had breast cancer
  • you have liver cancer, as a possible effect of Cerazette can not be ruled out
  • you have thrombotic disease
  • you have diabetes
  • you have epilepsy (see section “Other medicines and Cerazette”)
  • you have tuberculosis (see section “Other medicines and Cerazette”)
  • you have high blood pressure
  • you have or have had chloasma (yellow-brown pigment spots on the skin, especially on the face), in which case you should avoid too much sunlight and ultraviolet rays.

When Cerazette is used in the presence of any of the above conditions, you may need to go for extra checks. Your doctor / midwife will inform you.

Breast cancer

Examine your breasts regularly and contact your doctor / midwife as soon as possible if you notice a lump in your breasts.

Breast cancer has been detected somewhat more often in women who use birth control pills than in women of the same age who do not. If women stop taking birth control pills , the risk gradually decreases so that after 10 years it is the same as in women who have never used birth control pills . Breast cancer is rare in women under the age of 40, but the risk increases with increasing age. Therefore, the extra cases of diagnosed breast cancer will be more at an older age. How long the woman has used the contraceptive pill is less important.

For every 10,000 women who use the contraceptive pill for up to five years and who stop at the age of 20, there will be less than 1 extra case of breast cancer up to 10 years after the end of the treatment, except for the 4 that are normally detected in this age group. In the same way, for 10,000 women who have used the contraceptive pill up to the age of five and who stop at the age of 30, 5 extra cases will be detected in addition to the 44 cases that are normally detected. In 10,000 women who have used the contraceptive pill for up to five years and stop at the age of 40, 20 extra cases will be detected in addition to the 160 that are normally diagnosed.

The risk of breast cancer in women who use progestogens on pills such as Cerazette is considered comparable to the risk in women who use birth control pills that also contain estrogen (combined birth control pills ), but the evidence is not as strong.

Breast cancer detected in women using birth control pills seems to be less likely to have spread than breast cancer detected in women not using birth control pills . It is not known whether the difference in breast cancer risk is caused by the contraceptive pill. It may be that women who use birth control pills are examined more often and that breast cancer is then detected earlier.

Thrombosis 
See your doctor / midwife immediately if you notice any signs of thrombosis (see also “Regular check-ups”).

Thrombosis is the formation of a blood clot, which can block a blood vessel. Thrombosis sometimes occurs in the deep veins of the legs (deep vein thrombosis ). If this blood clot breaks away from the veins where it is formed, it can come to the artery are in the lungs, blocking them and causing what is known as pulmonary embolism . Pulmonary embolism can be a life-threatening condition. Deep vein thrombosis is uncommon. It can occur whether you use birth control pills or not. It can also occur during a pregnancy.

The risk of developing thrombosis is higher if you use birth control pills than if you do not.

The risk of developing thrombosis is believed to be lower when using progestogen -based birth control pills such as Cerazette, compared to birth control pills that also contain estrogen (combined birth control pills ).

Mental disorders

Some women who use hormonal contraceptives, including Cerazette, have

reported depression or depression. Depression can be severe and can sometimes lead to suicidal thoughts. If you experience mood swings and symptoms of depression, you should contact a doctor as soon as possible for advice.

Children and young people

No data are available regarding safety and efficacy in adolescents under 18 years of age.

Other medicines and Cerazette

Tell your doctor / midwife if you are taking, have recently taken or might take any other medicines or (traditional) herbal medicines. Also tell other doctors and dentists who prescribe medicines (or pharmacists) that you are using Cerazette. They can tell you if you need to use additional contraceptive protection (such as a condom) and if so, for how long or if the use of any other medicine you need needs to be changed.

Some drugs

  • may have an effect on the levels of Cerazette in the blood
  • may make it less effective in preventing pregnancy
  • may cause unexpected bleeding.

This applies to medicines used in the treatment of:

  • epilepsy (eg primidone, phenytoin , carbamazepine, oxcarbazepine, felbamate, topiramate and phenobarbital),
  • tuberculosis (eg rifampicin, rifabutin),
  • HIV – infection (for example, ritonavir, nelfinavir, nevirapine, efavirenz),
  • Hepatitis C virus infections (eg boceprevir, telaprevir),
  • other infectious diseases (eg griseofulvin),
  • high blood pressure in the blood vessels of the lungs ( bosentan ),
  • depression ((traditional) herbal medicines containing St. John’s wort [ Hypericum perforatum ]),
  • certain bacterial infections (eg clarithromycin, erythromycin),
  • fungal infections (eg ketoconazole , itraconazole, fluconazole ),
  • high blood pressure ( hypertension ), angina pectoris (angina) or certain heart rhythm disorders (eg diltiazem ).

If you are using medicines or (traditional) herbal medicines that may make Cerazette less effective, use a barrier method (such as a condom). As the effect of another drug on Cerazette may persist for up to 28 days after stopping treatment with the drug, it is necessary to use a barrier method throughout this time. Your doctor / midwife can tell you if you need additional protection and if so, for how long.

Cerazette may also affect the effect of other medicines, either by increasing the effect (eg medicines containing ciclosporin) or reducing the effect (eg lamotrigine).

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

Pregnancy and breastfeeding

Pregnancy

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

Breast-feeding

Cerazette can be used by breast-feeding women. Cerazette does not appear to affect breast milk production or quality. However, occasional reports have described a decrease in breast milk production using Cerazette. Admittedly, small amounts of the active substance in Cerazette pass into breast milk.

The health of children of women who have used Cerazette during breastfeeding for 7 months has been monitored until the child is 2.5 years old. No adverse effects on the child’s growth and development were detected.

Talk to your doctor / midwife if you are breast-feeding and want to use Cerazette.

Driving and using machines

There is no evidence that the ability to react or concentrate is affected by the treatment.

Cerazette contains lactose

Cerazette contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor / midwife before taking this medicine.

Regular checks

When using Cerazette, your doctor / midwife will tell you when to come back for a check-up. How often you need to go for a checkup and what it contains varies from person to person.

Contact your doctor / midwife as soon as possible if:you have severe pain or swelling in one of the legs, unexplained chest pain, shortness of breath, unusual cough especially in combination with blood-mixed saliva (which may be a sign of thrombosis )you get sudden, severe pain in the abdomen or if the skin becomes yellow (which may be a sign of liver problems )you feel a lump in your breast (which may be a sign of breast cancer )you get sudden, severe pain in the lower abdomen (it may be a sign of an ectopic pregnancy , ie an ectopic pregnancy)you are in bed or undergoing major surgery (consult your doctor at least four weeks before)you get unusual, heavy bleeding from the abdomenyou think you are pregnant .

3. How to use Cerazette

When and how to take the tablets

Each map contains 28 tablets. On the front of the map there are arrows printed, between the tablets. The foil is printed on the back of the map on weekdays. Each tablet corresponds to one day a week. Each time you start a new map, take a tablet from the top row. Do not start with any tablet. For example, if you start on a Wednesday, take the tablet from the top row marked “Wed”. Continue to take one tablet daily until the map is blank, always following the direction of the arrows. By checking on the back of the map, you can always easily see if you have already taken today’s tablet. Take your tablets at about the same time each day. The tablets should be swallowed whole with water. You may experience bleeding while using Cerazette, but you should continue to take the tablets as usual.

The first Cerazette map

  • If you have not used any hormonal contraceptives in the last month, 
    wait until menstruation begins. Take the first tablet of Cerazette on the first day of bleeding. You do not need to use any extra protection. You can also start on days 2-5 of your period, but then you must use extra protection (eg condoms) for the first seven days.
  • Changing from a combined pill , contraceptive ring or contraceptive patch 
    You can start with the first tablet of Cerazette the day after you take the last tablet of your combined oral contraceptive , or on the same day as your contraceptivering or your p- patches are removed (this means that you should not have a tablet-free, ring-free or patch-free week). If your contraceptive pill also contains hormone-free tablets (28-card), you can start taking Cerazette the day after you take the last active tablet (if you are not sure which tablet it is, ask your doctor / midwife or pharmacist). If you follow the instructions, you do not need to use any extra protection.
    You can also start no later than the last day of the tablet-free, ring-free or patch-free week, but then you must use extra protection (eg condoms) for the first seven days.
  • Switching from another progestogen pill 
    You can stop taking progestogen pills any day and then start taking Cerazette. You do not need any extra protection.
  • Changing from p syringe , implants or IUS 
    Start Cerazette on the day you would have gotten your next p syringe or on the day that your contraceptive implant or IUD is removed. You do not need any extra protection.
  • After giving birth 
    You can start Cerazette 21 to 28 days after giving birth. If you start later, you will need to use extra protection for the first seven days of taking the tablets. If you have had intercourse, you should make sure that you are not pregnant before starting Cerazette. Information on breastfeeding can be found under the heading “Pregnancy and breastfeeding”. Your doctor / midwife can also give you advice.
  • After a miscarriage or abortion 
    Your doctor / midwife will give you advice.

If you forget to take Cerazette

  • If you are less than 12 hours late with your tablet, you are still protected against pregnancy. Take the missed tablet as soon as you remember and then take the next tablet at the usual time.
  • If you are more than 12 hours late with your tablet, the protection against pregnancy may be impaired. The more tablets you have forgotten in succession, the more the protection deteriorates. Take the missed tablet as soon as you remember and then take the following tablets at the usual time. Also use extra protection (eg condom) for the next 7 days. If you missed one or more tablets during the very first week of treatment and you had intercourse the week before you forgot the tablets, there is a risk that you have become pregnant. 
    Ask your doctor / midwife for advice.

If you have stomach problems (vomiting, severe diarrhea)

Follow the same advice as for a forgotten tablet. If you have vomited within 3-4 hours after taking your Cerazette tablet or have severe diarrhea, the active substance may not have been absorbed by your body.

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, midwife or pharmacist.

4. Possible side effects

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

Serious side effects associated with the use of Cerazette are described in the sections “Breast cancer” and “Thrombosis” in section 2 “What you need to know before using Cerazette”. You should read these paragraphs and contact your doctor for further advice if necessary.

Seek medical attention immediately if you experience allergic reactions ( hypersensitivity reactions ), including swelling of the face, lips, tongue, and / or throat that causes difficulty breathing or swallowing ( angioedema and / or anaphylaxis ).

Bleeding often becomes irregular when using Cerazette. It can be a splash bleeding that does not even require bandaging, or bleeding that is similar to a sparse menstruation and requires menstrual protection. It can also happen that menstruation is completely absent. The irregular bleeding is not a sign that pregnancy protection with Cerazette has deteriorated. In general, you do not need to do anything, just keep taking Cerazette. If, on the other hand, the bleeding is heavy and prolonged, you should contact your doctor / midwife.

Cerazette users have reported the following side effects:

Common: (may affect up to 1 in 10 women)

  • mood swings, depression, decreased sexual desire ( libido )
  • headache
  • nausea
  • acne
  • chest tightness, irregular or missed periods
  • weight gain

Uncommon: (may affect up to 1 in 100 women)

  • infection is in the abdomen
  • difficulty using contact lenses
  • vomiting
  • hair loss
  • painful menstruation, fluid-filled blisters on the ovaries (cysts)
  • fatigue

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

  • skin rash, hives , painful blue-red rash (tuberculosis or erythema nodosum)

No known frequency: (cannot be calculated from the available data)

  • allergic reaction

Regardless of these side effects , fluid from the breasts may be present.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Cerazette

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

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.

No special temperature instructions. Store the blister pack in the original bag. Sensitive to light. Moisture sensitive. Used within 1 month from the day the bag is opened.

The active substance poses an environmental risk to fish.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is desogestrel (75 micrograms).

The other ingredients are: colloidal anhydrous silica, all ‑ rac-α ‑ tocopherol, maize starch, povidone, stearic acid, hypromellose, macrogol 400, talc, titanium dioxide (E171) and lactose monohydrate (see also “Cerazette contains lactose” in section 2).

What the medicine looks like and contents of the pack

Pressure pack with 28 film-coated tablets. The tablets are white and round and marked with KV / 2 on one side and ORGANON * on the other. Each pack contains 1, 3, 6 or 13 maps, each of which is packed in an aluminum bag.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Merck Sharp & Dohme BV

Box 581

2003 PC Haarlem

Netherlands

Manufacturer

NV Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands

Information is provided by

Box 45192

104 30 Stockholm

Tel: 077-570 04 88

This medicinal product is authorized under the European Economic Area under the names:

Belgium, Denmark, Finland, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, United Kingdom, , Germany, Austria: Cerazette.

Spain: Cerazet.

Muhammad Nadeem

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