Exluton Progestogen Lynestrenol Contraceptive Tablet

Exluton®

Tablet, 500 microgram

 

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.

• This leaflet will provide information about the benefits and risks of Exluton. It will also advise you about how to take Exluton 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.

 

In this leaflet

1. What is Exluton and what it is used for?

2. Before you start to take Exluton

2.1 When should you not take Exluton

2.2 When do you need to take special care with Exluton?

2.3 When should you contact your doctor?

3. How do you take Exluton?

3.1 When and how to take the tablets?

3.2 Starting your first pack of Exluton

3.3 If too many Exluton tablets are taken (overdose)

3.4 What to do if…

3.5 When do you want to stop taking Exluton

4. Possible side effects

4.1 Serious side effects

4.2 Other possible side effects

5. How to store Exluton

6. Further information

6.1 What Exluton contains

6.2 What Exluton looks like and contents of the pack

6.3 This leaflet was revised in

 

1. WHAT IS EXLUTON AND WHAT IS IT USED FOR?

How does Exluton work?

Exluton contains a small amount of one type of female sex hormone, the progestogen lynestrenol. For this reason Exluton is called a progestoge-only pill (POP), or a mini-pill. Contrary to combined pills, mini-pills do not contain an estrogen hormone next to the progestogen. The two main ways of action of Exluton are:

• Prevention of the sperm cells from entering the womb.

• Mostly (in 70% of the women) no monthly release of an egg from the ovary occurs.

In contrast to the combined pill, Exluton can be used by women who do not tolerate estrogens and by women who give breast-feeding. A disadvantage is that vaginal bleeding may occur at irregular intervals during the use of Exluton. You also may not have any bleeding at all.

Why is Exluton used?

To prevent pregnancy.

When Exluton is taken correctly (without missing tablets), the chance of becoming pregnant is very low.

 

2. BEFORE YOU START TO TAKE EXLUTON

2.1 When should you not take Exluton?

Do not use Exluton if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use Exluton. 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 or if you 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.

• If you are allergic to any of the ingredients of Exluton.

• If you are pregnant or think you might be pregnant.

If any of these conditions appear for the first time while using Exluton you should consult your doctor promptly.

2.2 When do you need to take special care with Exluton?

2.2.1 General notes
In this leaflet, several situations are described where you should stop taking Exluton, or where the reliability of Exluton may be decreased. In such situations you should not have sex or you should take extra non-hormonal contraceptive precautions, e.g., use a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because Exluton alters the usual changes in temperature and cervical mucus that occur during the menstrual cycle.

Exluton, like all hormonal contraceptives, does not protect against HIV infections (AIDS) or any other sexually transmitted disease.

2.2.2 What do you need to know before using Exluton?

If Exluton 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 Exluton:

• You have or have had breast cancer;

• You have liver cancer;

• You have ever had a thrombosis;

• You have diabetes;

• You have ever had a pregnancy outside the womb;

• You have or have had an infection or surgery of the fallopian tube;

• 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.
If any of the above conditions appear for the first time, recur or worsen while using Exluton, you should contact your doctor.

2.2.3 The Pill and 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 was noticed earlier.

2.2.4 The Pill and 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 of thrombosis is higher in Pill-users than in non- users, but it is not as high as the risk during pregnancy. The risk with progestogen-only pills like Exluton is believed to be lower than in users of Pills that also contain estrogens (combined Pills). If you notice possible signs of a thrombosis, you should see your doctor immediately. (See also ‘When should you contact your doctor’?)

2.2.5 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.

2.2.6 The Pill and Other Medicines

Some medicines may stop Exluton from working properly. These include medicines used for the treatment of epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate); tuberculosis (e.g. rifampicin) and HIV infections (e.g., ritonavir, nelfinavir), or other infectious diseases (e.g., griseofulvin); medical charcoal used for stomach upset; and the herbal remedy St. John’s wort (primarily used for the treatment of depressive moods). Exluton may also interfere with the working of other medicines.

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines or herbal products, even those not prescribed. Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you use Exluton. They can tell you if you need to take additional contraceptive precautions and if so, for how long.

2.2.7 The Pill and Pregnancy

Exluton must not be used by women who are pregnant, or who think they may be pregnant.

2.2.8 The Pill and Breastfeeding

Exluton does not influence the production or the quality of breast milk. Small amounts (0.14% of the amount ingested by the mother) of the active substance in Exluton pass over in breast milk and there are no indications of any risk for the baby. Tell your doctor if your baby shows any signs or symptoms which you think might be related to the use of Exluton.

2.2.9 The Pill and Driving and Using machines

There are no observed effects.

2.2.10 Important information about some of the ingredients of Exluton

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before starting with Exluton.

2.3 When should you contact your doctor?

Regular check-ups

When you are using Exluton, your doctor will tell you to return for your regular 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 on 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 ot the stomach area (possibly indicating an ectopic pregnancy, this is a pregnancy outside the womb);

• You are to be immobilized (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.

The situations and symptoms mentioned above are described and explained in more details elsewhere in this leaflet.

 

3. HOW DO YOU TAKE EXLUTON?

3.1 When and how to take the tablets?

The Exluton pack contains 28 tablets. On the back side of the pack, the days of the week are printed on the foil, with arrows printed between them. Each day corresponds with one tablet. Each time you start a new pack of Exluton, take a tablet in 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. You 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 the pack, you can easily check whether you have taken your daily tablet. Take your tablet at about the same time each day. Swallow each tablet whole, with water. You may have some bleeding during the use of Exluton, but you must continue to take your tablets as normal. When a pack is empty, you must start with a new pack of Exluton on the next day – thus without interruption and without waiting for a bleed.

3.2 Starting your first pack of Exluton

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

Start taking Exluton on the first day of your cycle, i.e. the first day of menstrual bleeding. Take a tablet marked with that day of the week. Exluton will work immediately, it is not necessary to use an additional contraceptive method. 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 changing from another combined hormonal contraceptive (combined oral contraceptive pill (COC), vaginal ring, or transdermal patch)

You can start taking Exluton 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 Exluton 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.

• When changing from another progestogen-only pill (mini- pill)

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

• When changing from an injectable or implant or a progestoden-releasing intrauterine device (IUD)

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

• After having a baby

If you have just had a baby, your doctor may tell yo to wait until after your first normal period before you start taking Exluton. Sometimes it is possible to start sooner. Your doctor will advise you.

• After a miscarriage, or an abortion

Your doctor will advise you.

3.3 If too many Exluton tablets are taken (overdose)

There have been no reports of serious harmful effects from taking too many Exluton 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.

3.4 What to do if…

You forget tablets

• If you are less than 3 hours late in taking a tablet, the reliability of Exluton is maintained. Take the missed tablet as soon as you remember and take the next tablets at the usual times.

• If you are more than 3 hours late in taking any tablet, the reliability of Exluton may be reduced. The more consecutive tablets yo have missed, the higher the risk that the contraceptive efficacy is decreased. Take the last missed tablets as soon as you remember and take the next tablets at the usual times. 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 possibility of becoming pregnant. Ask your doctor for advice.

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

If you vomit, have severe diarrhoea or take medical charcoal, the active ingredients of your Exluton tablet may not have been completely absorbed. If you vomit or take medical charcoal within 3-4 hours after taking your tablet this is like missing a tablet. You need to take extra tablet, and follow the advice for missed tablets.

You have unexpected bleeding

Vaginal bleeding may occur at irregular intervals during the use of Exluton. 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 Exluton is decreased. In general, you need not take any action; just continue to take Exluton. If, however, bleeding is heavy or prolonged consult your doctor.

3.5 When you want to stop taking Exluton

You can stop taking Exluton at any time you want. If you stop 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 to work out when the baby will be due.

If you do not want to become pregnant, ask your doctor about other methods of birth control.

 

4. POSSIBLE SIDE EFFECTS

Like all medicines, Exluton can have side effects, although not everyone 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 Exluton.

4.1 Serious Side Effects

Serious undesirable effects associated with the use of contraceptive Pills are described in section 2.2 ‘When do you need to take special care with Exluton?’ Please read this section for additional information and consult your doctor at once where appropriate.

4.2 Other possible side effects

Other side effects reported by users of Exluton or of hormonal contraceptives in general are:

• Increase in body weight, decrease in body weight;

• Headache, migraine;

• Contact lens intolerance;

• Nausea, vomiting, abdominal pain, diarrhoea;

• Rash, urticaria, erythema nodosum, erythema multiforme, chloasma (these are skin conditions);

• Fluid retention;

• Hypersensitivity;

• Irregular bleeding, changes in vaginal secretion;

• Breast tenderness, breast pain, beast enlargement and breast secretion;

• Changes in sexual drive; depressive mood/mood changes;

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

 

5. HOW TO STORE EXLUTON

Do not use after the expiry date stated on the package.

Do not store above 30oC; do not refrigerate or freeze.

Store protected from light and moisture.

Keep your tablets out of reach of children!

 

6. FURTHER INFORMATION

6.1 What Exluton contains

• The active substance is; lynestrenol (500 microgram)

• The other ingredients are; potato starch, amylopectin, lactose monohydrate and magnesium stearate.

6.2 What Exluton looks like and contents of the pack

One blister pack of Exluton contains 28 white round tablets.

The tablets are coded TT above 2 on one side and ORGANON* on the reverse. Each carton contains 1, 3 or 6 blister packs. Not all pack sizes may be available.

6.3 This leaflet was last revised in

November 2007

 

N.V. Organon,

Kloosterstraat 6,

5349 AB Oss,

The Netherlands.

2 Replies to “Exluton Progestogen Lynestrenol Contraceptive Tablet”

  1. when using exlusion,i discover a lump beside my breast and after a week it started decreasing,but doctor said i should go for FNAC test.
    can i still go for the test

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