0.5 mg tablets 
lynestrenol

1. What Exlutena is and what it is used for

Exlutena contains a low dose of a type of female sex hormone, a corpus luteum hormone called lynestrenol. That is why Exlutena is a so-called mini-pill. Unlike combined contraceptive pills, mini-pills do not contain any estrogen. Exlutena inhibits fertilization by:

  • prevent the sperm from entering the uterus due to the mucus in the cervix becoming thick and difficult to penetrate.
  • most women (70%) do not ovulate.

Unlike combined contraceptive pills, women who do not tolerate estrogen or women who are breastfeeding can use Exlutena. A disadvantage can be that you can get irregular bleeding, it can also happen that you do not get any bleeding at all.

Exlutena is used to prevent unwanted pregnancies. When you take Exlutena correctly (without forgetting any tablets), the risk of getting pregnant is very small.

2. What you need to know before taking Exlutena

Do not take Exlutena

Do not take Exlutena if you have or have had any of the conditions below. If any of these apply to you, talk to your doctor/midwife before starting Exlutena. You may be advised to use a contraceptive that does not contain hormones.

  • If you have thrombosis. Thrombosis is when a blood clot forms in a blood vessel [eg in the legs (deep vein thrombosis ) or the lungs ( pulmonary embolism )]
  • If you have jaundice (yellow skin) or severe liver disease
  • If you have or have had a tumor that is sensitive to sex hormones, such as certain forms of breast cancer
  • If you have abnormal genital bleeding
  • If you are allergic (hypersensitive) to the active substance or any of the other ingredients of Exlutena.

If you get any of this for the first time, if it gets worse or comes back when you use Exlutena, contact your doctor/midwife

Warnings and cautions

This leaflet describes several situations when you should stop using Exlutena, or when the protection against pregnancy with Exlutena may be reduced. In such situations, you should not have sex or you should protect yourself with a non-hormonal contraceptive, such as a condom or some other barrier method. Do not use safe periods or temperature methods. These methods may be unsafe because Exlutena affects the normal changes in the temperature and mucus in the cervix that occur during the menstrual cycle.

Remember that Exlutena, like other oral contraceptives, does not protect against HIV- infection ( AIDS ) or another sexually transmitted disease.

What do you need to know before you start with Exlutena?

If you take Exlutena when you have any of the conditions below, you may need to check more closely. Your doctor/midwife will explain how to do this. Therefore, consult your doctor/midwife before starting Exlutena if you:

  • have or have had breast cancer
  • have liver cancer
  • have had a blood clot
  • have diabetes
  • have had a pregnancy that has developed outside the womb (ectopic pregnancy)
  • have or had an infection or an operation in the fallopian tubes
  • have epilepsy
  • have tuberculosis
  • have high blood pressure
  • have or have had chloasma (yellow-brown pigment spots on the skin, especially on the face); in this case, avoid too much sunlight or ultraviolet radiation.

If you get any of this for the first time if it gets worse or recurs when you use Exlutena, contact your doctor/midwife

Birth control pills and breast cancer

Every woman is at risk of getting breast cancer whether she uses birth control pills or not. 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 use birth control pills. If the woman stops taking the pill, the risk gradually decreases, so that 10 years after the end of treatment, the risk is the same as in women who have never used the pill. Breast cancer is rare among women under the age of 40, but the risk increases as you get older. Therefore, there will be more extra cases of breast cancer if the woman is older, but how long you have used the contraceptive pill is less important.

In 10,000 women who have used birth control pills for up to 5 years but stop when they are 20 years old, there will be less than one extra case of breast cancer, in addition to the four cases that are normally diagnosed in this age group. This applies up to 10 years after they have stopped taking the contraceptive pill. Correspondingly, there will be 5 extra cases in 10,000 women who have used the contraceptive pill for 5 years and stop when they are 30 years old, in addition to the 44 cases that normally occur. In 10,000 women who quit when they are 40 years old, there will be 20 extra cases in addition to the 160 that are normally diagnosed.

The breast cancer cases diagnosed in women who use birth control pills tend to be less advanced than in those who have not used birth control pills. It is not known if this difference is due to the contraceptive pill. It may be that the woman goes for more check-ups so that the breast cancer is detected earlier.

Birth control pills and thrombosis (blood clot)

Thrombosis is the formation of a blood clot, which can block a blood vessel. A 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, causing a so-called 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 when using combined contraceptive pills is greater than if you do not use oral contraceptives. The risk with mini-pills, such as Exlutena, is considered to be lower than with the contraceptive pills that contain estrogen (combined oral contraceptives ). If you notice signs of a blood clot, contact a doctor immediately (see section “When should you contact a doctor?”).

Cysts on the ovaries

When using mini-pills, small fluid-filled blisters can form in the ovaries. These are called ovarian cysts. They usually disappear on their own, but can sometimes cause abdominal pain. It is very rare for cysts to cause major problems.

Mental disorders

Some women who use hormonal contraceptives, including Exlutena, 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.

Other medicines and Exlutena

Some other medicines may affect Exlutena so that the tablets do not work properly. Such drugs are drugs against epilepsy (e.g., primidone, phenytoin, barbiturates s, carbamazepine, oxcarbazepine, topiramate, felbamate), against tuberculosis (e.g., rifampicin), against HIV – infection (for example, ritonavir, nelfinavir) or other infectious s ( griseofulvin), medicinal charcoal for temporary diarrhea and herbal medicine containing St. John’s wort (Hypericum perforatum) which is mainly used for depression. Exlutene can also affect the effectiveness of other drugs.

Tell your doctor/midwife or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your doctor/midwife can tell you if you need additional protection and if so, for how long.

Pregnancy and breastfeeding

Pregnancy

Exlutena should not be used by women who are pregnant or those who suspect that they may be pregnant.

Breast-feeding

Exlutena does not affect the quality or quantity of breast milk. Small amounts (approximately 0.14% of the mother’s dose ) of the active substance pass into breast milk, but there is no evidence of any risk to breastfed infants. However, if you want to use Exlutena during breast-feeding you should contact your doctor/midwife.

Driving and using machines

No effects were observed.

Exlutena contains lactose

Exlutena contains lactose . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor/midwife before taking Exlutena.

When should you contact a doctor?

Regular checks
When you use Exlutena, 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 get any signs of thrombosis (eg severe pain or swelling in one of the legs, unexplained chest pain, shortness of breath, unusual cough especially if it is mixed with blood)you get sudden, severe pain in the abdomen or if the skin turns yellow (it may be a sign of liver problems)if you feel a lump in your chest if you experience 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)if you experience unusual, heavy bleeding from the abdomen you suspect you are pregnant.
The situations and symptoms mentioned here are described and explained elsewhere in the package leaflet.

3. How to take Exlutena

When and how to take the tablets

Each Exlutena map contains 28 tablets. On the back of the map, the days of the week are printed on the foil with arrows in between. Each table corresponds to one day a week. Each time you start a new map, take a tablet from the top row. For example, if you start on a Wednesday, take the tablet from the top row marked “ONS”. Keep taking one tablet every day 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 Exlutena, but you should continue to take the tablets as usual.

The first Exlutena map

If you have not used any hormonal contraceptives in the last month

Take the first tablet on the first day of bleeding. Take the tablet marked with the correct day of the week. The extent will affect from the first day, so 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 a condom) for the first seven days.

If you change from a combined contraceptive pill, contraceptive ring, or contraceptive patch

You can start with Exlutena the day after you take the last tablet of your combined contraceptive pill, or on the same day as you take out your contraceptive ring or remove your contraceptive patch (this means that you should not have any tablet-free, ring-free, or patch-free week). If your contraceptive pill also contains hormone-free tablets (28-card), you can start with Exlutena 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.

If you switch from another mini-pill

You can stop taking mini-pills and start taking Exlutena any day. You do not need any extra protection.

If you change from a contraceptive syringe, contraceptive rod, or hormonal IUD

Start with Exlutena on the day you should have received your next contraceptive syringe or on the day your contraceptive pill or hormonal IUD is removed.

If you have just given birth

If you have just given birth, your doctor/midwife may tell you to wait until you have had your first normal period before starting Exlutena. You can also start earlier, your doctor/midwife will tell you how to do it.

If you have just had a miscarriage or had an abortion

Your doctor/midwife will give you advice.

If you take more Exlutena then you should

There are no reports of serious side effects if you take too many Exlutena tablets at the same time. The symptoms that can be experienced are nausea, vomiting, and young girls may experience minor bleeding.

If you forget to take Exlutena

If you are less than 3 hours late with your tablet, the protection against pregnancy with Exlutena will not be affected. Take the missed tablet as soon as you remember and then take the next tablet at the usual time.

If you are more than 3 hours late with your tablet, the protection against pregnancy with Exlutena may have decreased. The more tablets you have forgotten in succession, the more the protection decreases. 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)

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

If you experience unexpected bleeding

You may experience irregular bleeding when using Exlutena. It can be just a small splash of bleeding or bleeding that is more like menstrual bleeding. You may also not experience any bleeding at all. The irregular bleeding does not mean that the protection against pregnancy is worse. In general, you do not need to do anything about the bleeding, just continue to take Exlutena. If the bleeding becomes heavy or prolonged, contact your doctor/midwife.

If you stop taking Exlutena

You can stop using Exlutena whenever you want. If you stop because you want to try to get pregnant, it is usually recommended that you wait to try to get pregnant until after the first normal menstrual period.

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, this medicine can cause side effects, although not everybody gets them.

Serious side effects associated with birth control pills are described in more detail under the heading Take special care with Exlutena. Read that section carefully and contact a doctor/midwife if necessary.

Other side effects that have been reported with Exlutena or hormonal contraceptives in general are:

Common (more than 1 in 100 users): Irregular bleeding, missed periods, chest tightness, chest pain, watery breasts, weight gain, headache, migraine, nausea, abdominal pain, skin rash, hives, painful bluish-red rash (tuberculosis or erythema nodosum), kloas spots on the skin), accumulation of fluid ( fluid retention ), depression, mood swings and decreased sex drive.

Uncommon (less than 1 in 100 users): difficulty using contact lenses, vomiting, diarrhea, discharge, and enlarged breasts.

Rare (less than 1 in 1000 users): weight loss, hypersensitivity, and increased sex drive.

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 pharmacist.

5. How to store Exlutena

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.

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 lynestrenol (progestogen hormone ) 0.5 mg.
  • The other ingredients are potato starch, amylopectin, lactose monohydrate (about 43 mg), and magnesium stearate.

What the medicine looks like and the contents of the pack

One map contains 28 white round tablets.

The tablets are marked with TT2 on one side and ORGANON * on the other. Each pack contains 1 or 3 maps.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Merck Sharp & Dohme BV

Box 581

2003 PC Haarlem

Netherlands

Manufacturer

NV Organon,

PO Box 20,

NL-5340 BH Oss,

Netherlands

Muhammad Nadeem

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