Desogestrel 0.075mg Film-Coated Tablets
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Read all of this leaflet carefully before you start taking 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others.
• 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 Desogestrel is and what it is used for
2. What you need to know before you take Desogestrel
3. How to take Desogestrel
4. Possible side effects
5. How to store Desogestrel
6. Contents of the pack and other information
Desogestrel is a contraceptive pill that is used to prevent pregnancy. Each tablet contains a small amount of one type of female hormone, the progestogen desogestrel. Such types of contraceptive pills are called progestogen-only-pills (POP), or mini-pills. Contrary to the combined pill, it does not contain an oestrogen hormone.
Like other mini-pills, Desogestrel prevents the sperm cells from entering the womb. Distinct from other mini-pills it prevents also the egg cell from ripening.
In contrast to the combined pill, Desogestrel 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 Desogestrel. You also may not have any bleeding at all.
Desogestrel, like other hormonal contraceptives, does not protect against HIV infection or any other sexually transmitted disease.
Do not take Desogestrel
• if you are allergic to desogestrel or any of the other ingredients of this medicine (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 jaundice (yellowing of the skin) or severe liver disease and your liver function is still not normal, or you have had this in the past.
• if you have cancer that is sensitive to sex hormones, such as breast cancer.
Do not take this medicine if you have or are suspected to have this.
• if you have any unexplained bleeding from the vagina.
Tell your doctor before you start to use Desogestrel 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 Desogestrel.
Warnings and precautions
Inform your doctor before taking this medicine if you develop, have or have worsening symptoms of any of the following:
• had breast cancer in the past.
Do not take Desogestrel if you have breast cancer.
• liver cancer since a possible effect of Desogestrel on liver cancer cannot be excluded.
• had a blood clot in a blood vessel in the past.
Do not take Desogestrel if you have a blood clot.
• diabetes.
• epilepsy (see section “Using other medicines”).
• tuberculosis (see section “Using other medicines”).
• high blood pressure.
• golden brown pigment patches, so called “pregnancy patches”, especially on the face (Chloasma), or ever have had these.
Avoid direct exposure to sunlight or ultraviolet light in this case.
When Desogestrel 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 a combined pill than in women of the same age who do not take a combined pill. If women stop taking a combined pill, the risk gradually decreases, so that 10 years after stopping the risk is the same as for women who have never taken a combined 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 a combined pill is higher. How long she takes a combined pill is less important.
In every 10,000 women who take a combined 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 a combined 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 a combined 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 progestogen-only pills like Desogestrel is believed to be similar to that in women who use a combined pill, but the evidence is less conclusive.
Breast cancers found in women who take a combined pill, seem less likely to have spread than breast cancers found in women who do not take a combined pill. It is not known whether the difference in breast cancer risk is caused by a combined pill. It may be that the women were examined more often, so that the breast cancer is noticed earlier.
Blood clots (Thrombosis)
Contact your doctor immediately if you notice possible signs of a blood clot, please see “Contact your doctor as soon as possible if you”.
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. 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 you are taking the Pill.
It can also happen if you become pregnant.
Using a combined pill increases a woman’s risk of a blood clot in a vein. The risk with progestogen-only pills like Desogestrel is believed to be lower than in users of combined pills.
Using Other medicines and Desogestrel
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. They can tell you if you need to take additional contraceptive precautions.
The following medicines can reduce the contraceptive effect of Desogestrel:
• medicines to treat epilepsy, such as:
- primidone, phenytoin
- phenobarbital
- carbamazepine, oxcarbazepine
- topiramate, felbamate.
• medicines to treat HIV infections, such as ritonavir, nelfinavir.
• medicines to treat tuberculosis, such as rifampicin, rifabutin, or other infections, such as griseofulvin.
• medical charcoal, a medicine to treat stomach upset.
See chapter 3 under “Vomiting or severe diarrhoea”.
• St. John’s wort, a herbal medicine to treat depression.
Desogestrel can influence the effect of other medicines, e.g.
• cyclosporin, a medicine to suppress the immune system or treat other diseases.
Pregnancy and breast-feeding Pregnancy
Do not take Desogestrel if you are pregnant, or think you may be pregnant.
Breast-feeding
Desogestrel may be used while you are breast-feeding. Contact your doctor if you want to take Desogestrel while you are breast-feeding.
Desogestrel does not influence the production or the quality of breast milk. However, a small amount of the active substance of Desogestrel passes over into the milk.
No effects on the growth and development of the children were observed.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Desogestrel is not known to affect the ability to drive or use machines. Desogestrel contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Regular Check-ups
When you are using Desogestrel, 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.
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Contact your doctor as soon as possible if you:
• notice possible signs of a blood clot, such as:
- severe pain or swelling in either of your legs
- unexplained pains in the chest
- breathlessness
- unusual cough, especially when you cough up blood.
• have a sign of liver problems: you have a sudden, severe stomach ache or jaundice (signs of jaundice are yellowing of the skin, the whites of eyes, or dark urine).
• you feel a lump in your breast. This could be a sign of breast cancer.
• you have a sudden or severe pain in the lower abdomen or stomach area. This could be a sign of a pregnancy outside the womb called ectopic pregnancy.
• you are to be immobilised or are to have surgery.
Contact your doctor at least four weeks in advance.
• you have unusual, heavy bleeding from the vagina.
• you suspect that you are pregnant.
possible or 12 hours have passed, follow the advice given under “If you forget to take Desogestrel”.
If you stop taking Desogestrel
You can stop taking Desogestrel 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.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Method of use
Take 1 tablet once daily, with some water. You should take the tablets every day around the same time.
The strip contains 28 tablets. Next to each tablet is printed the day of the week that it should be taken. For example, if you start on a Wednesday, take a tablet with “WED” next to it. Follow the direction of the arrow on the strip until all 28 tablets have been taken.
When a strip is empty, you must start a new strip on the next day -thus without interruption and without waiting for a bleed.
You may have some bleeding during the use of Desogestrel. However, you must continue to take your tablets as normal.
Starting time of the first strip
• if you have not used a contraceptive with hormones in the previous month
Begin with Desogestrel on the first day of the cycle. This is the first day of your menstruation. You will then be immediately protected against pregnancy.
You may also begin on days 2-5 of the cycle. However, then you must use extra protective measures for 7 days, such as a condom.
• changing from a combination pill, vaginal ring or patch
You can start Desogestrel on the day after the last active substance containing tablet of your previous pill.
When changing from a vaginal ring or patch, you can start on the day of removal. If you follow these instructions, you need not take extra protective measures.
However, you must start at the latest
- on the day after the tablet free days or
- after the last inactive tablet of your previous pill or
- when the next application of the vaginal ring or patch would be due.
However, then you must use extra protective measures for 7 days, such as a condom.
• changing from another progestogen-only pill, an injection, implant or an intra uterine device
You may switch on any day from the progestogen-only pill and start taking Desogestrel on the day after the last intake.
You may switch from an implant or intra uterine device on the day of its removal; from an injection when it is time for the next injection. You need not take extra protective measures.
• after a miscarriage or an abortion Follow the advice of your doctor.
• after birth
You can start Desogestrel between 21 and 28 days after having a baby. If you start later than day 21, use extra protective methods, such as a condom, during the first 7 days of Desogestrel use. If you have had intercourse before re-starting Desogestrel, be sure that you are not pregnant.
If you are breast-feeding, read chapter 2 under “Breast feeding”.
Use in children and adolescents
No clinical data on efficacy and safety are available in adolescents below 18 years.
If you take more Desogestrel than you should
Ask your doctor or pharmacist for advice if you have taken too many Desogestrel tablets or a child has taken tablets.
There are no reports of serious harm from taking too many tablets. Taking more tablets may cause nausea or vomiting. Young girls may have bleeding from the vagina.
If you forget to take Desogestrel
• Less than 12 hours late taking a tablet
The protection from pregnancy is not reduced. Take the tablet as soon as you remember and then take the following tablets again at the usual time.
• More than 12 hours late taking a tablet
The protection from pregnancy may be reduced. The more tablets you have forgotten, the greater the protection from pregnancy is reduced. Take the forgotten tablet as soon as you remember and take the next tablets at the usual time. Use extra precautions for the next 7 days, for example, a condom.
Contact your doctor if you forgot one ore more tablets in the first week of tablet-intake and had intercourse in the week before the oversight. You must realise that there is a risk of pregnancy.
Vomiting or severe diarrhoea
Vomiting or intake of medical charcoal within 3-4 hours after tablet intake or severe diarrhoea reduces the absorption of the active substance into your body. The situation is similar to when you forget a tablet. You must take another tablet as soon as possible. If possible take it within 12 hours of when you normally take your pill. If this is not
Like all medicines, this medicine can cause side effects although not everybody gets them.
Serious side effects
The serious side effects which have been associated with use of Desogestrel are described in chapter 2 under “Breast cancer” and “Blood clots”. Please read this chapter for additional information and consult your doctor at once where appropriate.
Irregular bleeding
Vaginal bleeding may occur at irregular intervals during the use of Desogestrel. This may be just slight staining or heavier bleeding, which looks rather like a scanty period. You may also not have any bleeding at all. The irregular bleedings are not a sign that the contraceptive protection of Desogestrel is decreased. In general, you need not take any action; just continue to take Desogestrel. If, however, bleeding is heavy or prolonged you should consult your doctor.
Other side effects can occur with the following frequencies: Common, affects more than 1 per 100 women
• mood altered
• depressed mood
• decreased sexual desire
• headache
• nausea
• acne
• breast pain
• irregular or no menstruation
• weight gain.
Uncommon, affects 1 to 10 per 1,000 women
• infection of the vagina
• contact lens intolerance
• vomiting
• hair loss
• painful menstruation
• ovarian cyst
• tiredness.
Rare, affects 1 to 10 per 10,000 women
• rash
• hives
• skin disorder (erythema nodosum)
• ectopic pregnancy.
Apart from these side effects, breast discharge may occur.
You should see your doctor immediately if you experience symptoms of angioedema, such as swollen face, tongue or pharynx; difficulty to swallow; or hives and difficulties to breathe.
If you get any of the side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
Keep this medicine out of the sight and reach of children.
This medical product does not require any special storage conditions.
Do not use Desogestrel after the expiry date which is stated on the carton and blister strip. The expiry date refers to the last day of the month.
Do not use this medicine if you notice the visible signs of deterioration.
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.
What Desogestrel contains
• The active substance is desogestrel.
• The other ingredients are:
lactose monohydrate, maize starch, povidone K30, stearic acid, all-rac-alpha-tocopherol, silica colloidal anhydrous, hypromellose, macrogol, titanium dioxide (E171), polysorbate 80.
What Desogestrel looks like and contents of the pack
Desogestrel 0.075 mg Film-coated Tablet is a white, round film-coated tablet.
It is available in packs of 1, 3, 6 and 13 blisters packed separately in an aluminium laminated sachet each with 28 film-coated tablets.
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK. Manufacturer
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia or Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia or LEK S.A., ul. Podlipie 16, 95-010 Strykow, Poland or LEK S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland or Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,39179 Barleben, Germany or S.C. Sandoz, S.R.L., Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Romania.