75 micrograms desogestrel tablets
1. What Desogestrel STADA is and what it is used for
Desogestrel Stada is used to prevent pregnancy. Desogestrel Stada contains small amounts of a type of female sex hormone, progestogen, and desogestrel. Desogestrel Stada is therefore called a progestogen pill. Unlike combined contraceptive pills, these do not contain any estrogen as a supplement to progestogen.
Most progestogenic birth control pills work primarily by preventing the sperm from reaching the uterus, but they do not always prevent egg cells from maturing, which is the main effect of combined birth control pills. Desogestrel Stada differs from other progestagen pills by having a high enough dose to prevent egg cells from maturing in the vast majority of cases. Therefore, Desogestrel Stada provides good protection against pregnancy.
Unlike combined contraceptive pills, Desogestrel Stada can be used by women who do not tolerate estrogen or women who are breastfeeding. A disadvantage is that the bleeding may become more irregular when using Desogestrel Stada. You may also not experience any bleeding at all.
Desogestrel contained in Desogestrel Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Desogestrel STADA
Do not use Desogestrel STADA
Like other hormonal contraceptives protects desogestrel STADA not against HIV – infection ( AIDS ) or other sexually transmitted diseases.
Do not take Desogestrel Stada:
- if you are allergic to desogestrel or any of the other ingredients of this medicine (listed in section 6)
- if you have the ongoing thrombotic disease. Thrombosis is the formation of a blood clot in a blood vessel [e.g. in the legs (deep vein thrombosis ) or in the lungs ( pulmonary embolism )]
- if you have or have had jaundice (yellow skin) or 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 before you start using Desogestrel Stada if any of these apply to you. You may be advised to use a contraceptive method that does not contain hormones.
Contact your doctor immediately if any of these conditions occur for the first time when you use Desogestrel Stada.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Desogestrel Stada, especially:
- if you have or have had breast cancer
- if you have liver cancer, then a possible effect of Desogestrel Stada can not be ruled out.
- if you have the thrombotic disease
- if you have diabetes
- if you have epilepsy (see section “Other medicines and Desogestrel Stada”)
- if you have tuberculosis (see section “Other medicines and Desogestrel Stada”)
- if you have high blood pressure
- if you have or have had chloasma (yellow-brown spots on the skin, especially on the face); in that case, avoid too much sunlight and ultraviolet rays.
When Desogestrel Stada is used at the same time as any of the above conditions, you may need to go for extra checks. Your doctor will explain to you what applies.
Breast cancer
Examine your breasts regularly and contact your doctor as soon as possible if you notice any 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. For those who 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 the woman’s age. Therefore, the extra cases of diagnosed breast cancer will be more if the age at which the woman took the contraceptive pill was higher. 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, less than one extra case of breast cancer will be found up to 10 years after the end of treatment, except for the 4 who normally occur 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 normally occur. 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 using progestogen-based contraceptives such as Desogestrel Stada is considered comparable to the risk in women using combined oral contraceptives, 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 so that breast cancer is detected earlier.
Thrombosis
See your doctor 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. 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 be brought 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 form during pregnancy.
The risk when using combined contraceptive pills is greater than if you do not use oral contraceptives. The risk with progestogen-based birth control pills, such as Desogestrel Stada, is considered to be lower than with estrogen-containing birth control pills (combined birth control pills ).
Mental disorders:
Some women using hormonal contraceptives, including Desogestrel Stada, 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 efficacy and safety in adolescents under 18 years of age.
Other medicines and Desogestrel STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some other medicines can affect birth control pills so they do not work properly. They include medicines for:
- epilepsy (eg primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, and phenobarbital)
- tuberculosis (eg rifampicin,)
- HIV – infection (ritonavir) or other infectious s (griseofulvin)
- temporary diarrhea (medical charcoal)
- depression (herbal medicine containing St. John’s wort ).
Your doctor will tell you if you need additional protection and if so, for how long.
Desogestrel Stada can also affect the effectiveness of other medicines, either by increasing the effect (eg medicines containing cyclosporine) or reducing the effect.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, consult a doctor or a pharmacist before using this medicine.
Pregnancy
Do not use Desogestrel Stada if you are pregnant or think you may be pregnant.
Breast-feeding
Desogestrel Stada can be used while you are breast-feeding. Desogestrel Stada does not appear to affect breast milk production or quality. However, occasional reports have described a decrease in breast milk production using desogestrel. A small amount of the active substance in Desogestrel Stada passes into breast milk.
The health of children of women who have used Desogestrel Stada during breast-feeding for 7 months has been monitored until the children are 2.5 years old. No adverse effects on their growth and development were detected.
Talk to your doctor if you are breast-feeding and want to use Desogestrel Stada.
Driving and using machines
There is no evidence that the ability to react or the concentration is affected by the treatment.
Desogestrel STADA contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Desogestrel STADA
Regular checks
When you use Desogestrel Stada, your doctor 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 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 turns yellow (which may be a sign of liver problems ).
- if you feel a lump in a breast (which may be a sign of breast cancer ).
- if you experience sudden, severe pain in the lower abdomen (this 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.
- if you suspect you are pregnant.
When and how to take the tablets
Each Desogestrel Stada map contains 28 tablets. Arrows are printed on the front of the map, between the tablets. The foil is printed on the back of the map on weekdays. Each table 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. If you e.g. start on a Wednesday, then take the tablet from the top row marked “ONS”. 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 taking Desogestrel Stada, but you should continue to take the tablets as usual. When a map is finished, you should continue with a new map with Desogestrel Stada the next day – without a tablet break and without waiting for bleeding.
The first Desogestrel Stada map
- If you have not used any hormonal contraceptives in the last month
Wait until menstruation begins. Take the first Desogestrel Stada tablet 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.
- If you change from a combined contraceptive pill, contraceptive ring, or contraceptive patch
You can start with the first Desogestrel Stada tablet the day after you take the last tablet of your combined contraceptive pill, or on the same day as you take your contraceptive ring or remove your contraceptive patch (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-map), you can start with Desogestrel Stada the day after you take the last active tablet (if you are not sure which tablet it is, ask your doctor or pharmacy staff). 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, or hormone-free week of your current contraceptive. If you follow these instructions, you must use extra protection (eg condoms) for the first seven days.
- If you are switching from another progestogen pill
You can stop taking progestogen pills any day and then immediately start taking Desogestrel Stada. You do not need any extra protection.
- If you change from a contraceptive syringe, contraceptive rod, or hormonal IUD
Start with Desogestrel Stada on the day you should have received your next contraceptive injection or on the day your contraceptive pill or hormonal IUD is removed. You do not need any extra protection.
- After giving birth
You can start with Desogestrel Stada 21 to 28 days after delivery. If you start later, you must use extra protection the first 7 days you take the tablets. If you have had intercourse, you must make sure that you are not pregnant before starting Desogestrel Stada. Information about breastfeeding can be found under the heading “Pregnancy and breastfeeding” in section 2. Your doctor can also give you advice.
- If you have just had a miscarriage or had an abortion
Your doctor will advise you.
If you forget to take Desogestrel Stada
- If you are less than 12 hours late, you are still protected against pregnancy with Desogestrel Stada. 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 with Desogestrel Stada 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 condoms) 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 for advice.
If you have stomach problems (eg vomiting, severe diarrhea)
Follow the same advice as for a forgotten tablet in the section above. If you have vomited or used medical charcoal within 3-4 hours after taking your Desogestrel Stada tablet or have severe diarrhea, the active substance may not have been absorbed by your body.
If you use more Desogestrel STADA then you should
There are no reports of serious harmful effects if you take several Desogestrel Stada tablets at one time. The symptoms that may occur are nausea and vomiting and in young girls slight genital bleeding.
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you stop using Desogestrel STADA
You can stop taking Desogestrel Stada 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
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are that have been associated with the use of desogestrel STADA is described in the paragraphs “Breast cancer” and “Thrombosis” in section 2 “What you need to know before you use desogestrel Stada”. You should read that information and contact your doctor for further advice if necessary.
Genital bleeding often becomes irregular when using Desogestrel Stada. It can be splash bleeding that does not even require bandaging or bleeding that resembles sparse menstruation and requires menstrual protection. It can also happen that menstruation is completely absent. The irregular bleeding is not a sign that the pregnancy protection with Desogestrel Stada has deteriorated. In general, you do not need to do anything, just continue taking Desogestrel Stada. If, on the other hand, the bleeding is heavy and prolonged, you should contact your doctor
Desogestrel Stada users have reported the following side effects:
Common (may affect up to 1 in 10 people):
- 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 people):
- 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 people):
- skin rash, hives, painful bluish-red rash (tuberculosis or erythema nodosum)
In addition to these side effects, fluid secretion from the breasts may occur.
Stop taking Desogestrel Stada and contact your doctor immediately if you get any of the following symptoms ( angioedema ): swelling of the face, tongue, or throat; difficulty swallowing; hives, and difficulty breathing.
5. How to store Desogestrel STADA
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. The expiration date is the last day of the specified month.
Desogestrel Stada does not require any special storage instructions.
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. Each tablet contains 75 micrograms of desogestrel.
The other ingredients are: Anhydrous lactose, all-rac-α-tocopherol, povidone, potato starch, colloidal anhydrous silica, stearic acid
(See also “Desogestrel Stada contains lactose” in section 2).
What the medicine looks like and the contents of the pack
The tablet is round, white to off-white, uncoated, biconvex, 5 mm in diameter, embossed on one side with “152” and the other side smooth.
Each carton of Desogestrel Stada contains 1, 3, 6, or 13 blisters of 28 tablets.
Each carton contains blisters that are packaged separately in an aluminum laminated sachet.
The packages will be marketed with or without desiccant.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2 – 18
61118 Bad Vilbel
Germany
Other manufactures
STADA Arzneimittel GmbH
Muthgasse 36
1190 Vienna
Austria
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark