Bredicon

Desogestrel.

Each tablet contains desogestrel (0.075 mg).
Excipients/Inactive Ingredients: The other ingredients are: colloidal silicon dioxide, polyvinyl pyrrolidone (Povidone K-30), maize starch, lactose monohydrate, pre-gelatinized maize starch (Grade 1500), magnesium stearate, DL-α-Tocopherol.

There are 2 main kinds of hormone contraceptive: The combined pill, "The Pill", which contains 2 types of female sex hormone, an oestrogen and a progestogen; The progestogen-only pill, POP, which doesn't contain an oestrogen.
Bredicon is a progestogen-only pill (POP).
Bredicon contains a small amount of one type of female sex hormone, the progestogen desogestrel.
Most POPs work primarily by preventing the sperm cells from entering the womb, but they do not always prevent the egg cell from ripening, which is the main way that combined pills work.
Bredicon is different from most POPs in having a dose that in most cases prevents the egg cell from ripening. As a result, Bredicon is a highly effective contraceptive.
A disadvantage is that vaginal bleeding may occur at irregular intervals during the use of Bredicon. On the other hand, any bleeding may not occur at all.

Bredicon is used to prevent pregnancy. In contrast to the combined pill, Bredicon can be used by women who do not tolerate oestrogens and by women who are breastfeeding.

When and how to take the tablets: Each strip of Bredicon contains 28 tablets (4 weeks supply).
Take the tablet each day at about the same time. Swallow the tablet whole, with water.
Arrows are printed on the the strip, between the tablets. The days of the week are printed on the strip. Each day corresponds with one tablet.
Every time a new strip of Bredicon is started, a tablet must be taken from the top row. Don't start with just any tablet. For example, if starting on a Wednesday, the tablet from the top row marked with Wed must be taken.
Continue to take one tablet every day until the pack is empty, always following the direction indicated by the arrows. By looking at the pack, it can be easily checked if the tablet has already been taken on a particular day.
Some vaginal bleeding may occur during the use of Bredicon (see Side Effects), but taking the tablets must be continued as normal.
When a strip is empty, a new strip of Bredicon must be started on the next day - without interruption and without waiting for a bleed.
Starting the first pack of Bredicon: If not using hormonal contraception at present (or in the past month): Wait for the period to begin. On the first day of the period, take the first Bredicon tablet. Additional contraceptive precautions are not necessary. If taking the first tablet on days 2-5 of the period, use an additional barrier method of contraception for the first 7 days of tablet-taking.
When changing from a combined pill (COC), vaginal ring, or transdermal patch: If without a tablet-, ring- or patch-free break: Start taking Bredicon on the day after taking the last tablet from the present Pill pack, or on the day of removal of the vaginal ring or patch (this means no tablet-, ring- or patch-free break). If the present Pill pack also contains inactive (placebo) tablets, Bredicon can be started on the day after taking the last active tablet (if unsure which this is, ask the doctor or pharmacist).
If these instructions are followed, additional contraceptive precautions are not necessary.
If with a tablet-, ring- or patch-free break: Start on the day following the tablet-, ring- or patch-free break, or when all the inactive (placebo) tablets of the present contraceptive have been taken.
If these instructions are followed, make sure to use an additional barrier method of contraception for the first 7 days of tablet-taking.
When changing from another progestogen-only pill: Switch on any day from another mini-pill. Additional contraceptive precautions are not necessary.
When changing from an injection or implant or a hormonal IUS: Start using Bredicon when the next injection is due or on the day that the implant or IUS is removed. Additional contraceptive precautions are not necessary.
After having a baby: Bredicon can be started between 21 to 28 days after the birth of the baby. If starting later, make sure that an additional barrier method of contraception is used until the first 7 days of tablet-taking has been completed. However, if sex had already taken place, check that there is no pregnancy before starting Bredicon. Information for breastfeeding women can be found in Use in Pregnancy & Lactation. The doctor can also advise.
After a miscarriage or an abortion: The doctor will advise.
If forgotten to take Bredicon: If less than 12 hours late: Take the missed tablet as soon as it is remembered and take the next one at the usual time. Bredicon will still protect from pregnancy.
If more than 12 hours late: If more than 12 hours late in taking any tablet, there may not be complete protection against pregnancy. The more consecutive tablets missed, the higher the risk that pregnancy may happen. Take a tablet as soon as it is remembered and take the next one at the usual time. This may mean taking two in one day. This is not harmful. If more than one tablet has been forgotten, there is no need to take the earlier missed ones. Continue taking the tablets as usual, but an extra method, such as a condom, must be used for the next 7 days.
If more than 12 hours late taking the tablet and had sex, it is safe to use emergency contraception; consult the pharmacist or doctor.
If one or more tablets are missed in the very first week of starting the tablet and had intercourse in the week before missing the tablets, pregnancy may happen.
Ask the doctor for advice.
If vomiting: If vomiting within 3-4 hours after taking Bredicon tablet or having severe diarrhoea, the active ingredient may not have been completely absorbed. Follow the advice for forgotten tablets as previously mentioned.
If stopping Bredicon intake: Taking Bredicon can be stopped whenever wanted. From the day it is stopped, protection against pregnancy is no longer there.
If there are any further questions on the use of this product, ask the doctor or pharmacist.

There have been no reports of serious harmful effects from taking too many Bredicon tablets at one time. Symptoms that may occur are nausea, vomiting and in young girls, slight vaginal bleeding. For more information, ask the doctor for advice.

Do not take Bredicon: if allergic to desogestrel, or any of the other ingredients of Bredicon (listed in Description); if with a thrombosis [the formation of a blood clot in a blood vessel, e.g. of the legs (deep venous thrombosis) or the lungs (pulmonary embolism)]; if with existing or history of jaundice (yellowing of the skin) or severe liver disease and the liver is still not working normally; if with a confirmed or suspected cancer that grows under the influence of sex-steroids, such as certain types of breast cancer; if with any unexplained vaginal bleeding.
If any of these conditions apply, tell the doctor before starting Bredicon use. The doctor may advise to use a non-hormonal method of birth control.
If any of these conditions appear for the first time while using Bredicon, consult the doctor immediately.

Bredicon, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
Before starting Bredicon, tell the doctor: if with history of breast cancer; if with liver cancer, since a possible effect of Bredicon cannot be excluded; if with history of a thrombosis; if with diabetes; if suffering from epilepsy (see Interactions); if with tuberculosis (see Interactions); if with high blood pressure; if with existing or history of 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 Bredicon is used in the presence of any of these conditions, there may be a need to be kept under close observation. The doctor can explain what to do.
Breast cancer: It is important to regularly check the breasts and the doctor should be contacted as soon as possible if any lump is felt in the 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, this reduces the risk, so that 10 years after stopping the Pill, 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 a woman continues to take the Pill when she is older. How long the Pill is taken 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.
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 Bredicon 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 certain whether the Pill causes the increased risk of breast cancer. It may be that the women were examined more often, so that the breast cancer is noticed earlier.
Thrombosis: See the doctor immediately if noticing possible signs of a thrombosis (see also Regular check-ups as follows). 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". A pulmonary embolism can cause chest pain, breathlessness, collapse or even death.
Deep venous thrombosis is a rare occurrence. It can develop whether or not the Pill is being taken. It can also happen if pregnancy occurs.
The risk is higher in Pill-users than in non-users. The risk with progestogen-only pills like Bredicon is believed to be lower than in users of Pills that also contain oestrogens (combined Pills).
Psychiatric disorders: Some women using hormonal contraceptives including Bredicon have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If experiencing mood changes and depressive symptoms, contact the doctor for further medical advice as soon as possible.
Bredicon contains lactose: Bredicon contains lactose (milk sugar). Contact the doctor before taking Bredicon if the doctor has told that there is intolerance to some sugars.
Regular check-ups: When using Bredicon, the doctor will tell to return for regular check-ups. In general, the frequency and nature of these check-ups will depend on personal situation.
Contact the doctor as soon as possible: if noticing possible signs of a blood clot e.g. severe pain or swelling in either of the legs, unexplained pains in the chest, breathlessness, an unusual cough, especially when coughing up blood (possibly a sign of a thrombosis); if experiencing a sudden, severe stomachache or jaundice (yellowing of the skin, the whites of the eyes, or dark urine may be noticed, possibly a sign of liver problems); if feeling a lump in the breast (possibly a sign of breast cancer); if experiencing a sudden or severe pain in the lower abdomen or stomach area (possibly a sign of an ectopic pregnancy - a pregnancy outside the womb); if to be immobilised or undergoing surgery (consult the doctor at least four weeks in advance); if experiencing unusual, heavy vaginal bleeding; if suspecting pregnancy.
Driving and using machines: Bredicon has no known effect on the ability to drive or use machines.
Use in Children: No clinical data on efficacy and safety are available in adolescents below 18 years.

Pregnancy: Do not use Bredicon if pregnant, or thinking may be pregnant.
Breastfeeding: Bredicon may be used while breastfeeding. Bredicon does not influence the production or the quality of breast milk. However, there have been infrequent reports of a decrease in breast milk production while using Bredicon. A small amount of the active substance of Bredicon passes over into the milk.
The health of children who were breastfed for 7 months while their mothers were using Bredicon has been studied up until they were 2½ years of age. No effects on the growth and development of the children were observed.
If breastfeeding and Bredicon use is wanted, please contact the doctor.

Like all medicines, Bredicon can cause side effects, although not everybody gets them. Tell the doctor if noticing any unwanted effect, especially if severe or persistent. Serious side effects associated with the use of Bredicon are described in Precautions. Read the following for additional information on Breast cancer and Thrombosis and consult the doctor at once where appropriate.
The doctor should be seen immediately if allergic reactions (hypersensitivity) are experienced, including swelling of the face, lips, tongue, and/or throat causing difficulty in breathing or swallowing (angioedema and/or anaphylaxis).
Vaginal bleeding may occur at irregular intervals while using Bredicon. This may be just slight staining which may not even require a pad, or heavier bleeding, which looks rather like a scanty period. Tampons or sanitary towels may need to be used. Any bleeding may also not occur at all. Irregular bleeding is not a sign that Bredicon is not working. In general, any action need not be taken; just continue to take Bredicon. If bleeding is heavy or prolonged, the doctor should be consulted.
How often other possible side effects are seen: Common (may affect up to 1 in 10 women): mood altered, depressed mood, decreased sexual drive (libido); headache; nausea; acne; breast pain, irregular or no menstruation; increased body weight.
Uncommon (may affect up to 1 in 100 women): infection of the vagina; difficulties in wearing contact lenses; vomiting; hair loss; painful menstruation, ovarian cyst; tiredness.
Rare (may affect up to 1 in 1,000 women): rash, hives, painful blue-red skin lumps (erythema nodosum) (these are skin conditions).
Not known (cannot be estimated from the available data): allergic reaction.
Apart from these side effects, breast secretion or leakage may occur.
Reporting of side effects: If any side effects occur, talk to the doctor or pharmacist. This includes any possible side effects not previously listed.

Tell the doctor or pharmacist if 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 pharmacist) that Bredicon is being taken. They can tell if additional contraceptive precautions (for example condoms) need to be taken and if so, for how long or whether the use of another medicine needed must be changed.
Some medicines: can have an influence on the blood levels of Bredicon; 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 infections (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 taking medicines or herbal products that might make Bredicon less effective, a barrier contraceptive method should also be used. Since the effect of another medicine on Bredicon may last up to 28 days after stopping the medicine, it is necessary to use the additional barrier contraceptive method for that long. The doctor can tell if additional contraceptive precautions need to be taken and if so, for how long.
Bredicon may also interfere with how other medicines work, causing either an increase in effect (e.g. medicines containing cyclosporine) or a decrease in effect (e.g. lamotrigine).
Ask the doctor or pharmacist for advice before taking any medicine.

The active substance shows an environmental risk to fish. Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help to protect the environment.

Store in a cool (below 30°C) & dry place. Store the blister pack in the original sachet in order to protect from light and moisture.

Oral Contraceptives

G03AC09 - desogestrel ; Belongs to the class of progestogens. Used as systemic contraceptives.

NP