75 microgram tablet
desogestrel
What Vinelle is and what it is used for
Vinelle is used to prevent pregnancy. Vinelle contains small amounts of a type of female sex hormone, gestagen et desogestrel. Vinelle is therefore called a progestagen birth control pill or mini pill. In contrast to combined birth control pills, these do not contain any estrogen as a complement to progestin.
Most progestogen birth control pills work primarily by preventing the sperm from reaching the uterus. They do not always prevent eggs from maturing, unlike combined oral contraceptives.
Vinelle differs from most progestagen birth control pills by having a high enough dose to prevent egg cells from maturing in the vast majority of cases. Vinelle, therefore, provides good protection against pregnancy.
Unlike combined oral contraceptives, Vinelle can be used by women who cannot tolerate estrogen or women who are breastfeeding. A disadvantage is that the bleeding can become more irregular when using Vinelle. You may also not have any bleeding at all.
The desogestrel contained in Vinelle may also be approved to treat 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 using Vinelle
Like other hormonal contraceptives, Vinelle does not protect against HIV infection ( AIDS ) or other sexually transmitted diseases.
Do not use Vinelle
- if you are allergic to desogestrel or any of the other ingredients of this medicine (listed in section 6).
- if you have an ongoing thrombotic disease. Thrombosis is the formation of a blood clot in a blood vessel (eg 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 abdominal bleeding that has not been investigated.
Tell your doctor/midwife before you start using Vinelle if any of these apply to you. You may be recommended to use a contraceptive method that does not contain hormones.
Contact your doctor/midwife immediately if any of these conditions occur for the first time while using Vinelle.
Warnings and precautions
Before you start using Vinelle, tell your doctor/midwife if:
- you have or have had breast cancer
- you have liver cancer, as a possible effect of Vinelle cannot be excluded
- you have the thrombotic disease
- you have diabetes
- you have epilepsy (see section “Other medicines and Vinelle”)
- you have tuberculosis (see section “Other medicines and Vinelle”)
- you have high blood pressure
- you have or have had chloasma (yellow-brown pigment spots on the skin, especially on the face), in which case you should avoid too much sunlight and ultraviolet rays.
When Vinelle is used in the presence of any of the conditions above, you may need to go for extra checks. Your doctor/midwife will inform you.
Breast cancer
- You must examine your breasts regularly and contact your doctor/midwife as soon as possible if you discover a lump in your breasts.
- Breast cancer has been detected slightly more often in women who use birth control pills than in women of the same age who do not. If the women stop using birth control pills, the risk gradually decreases so that after 10 years it is the same as in women who never used birth control pills. Breast cancer is rare in women under 40, but the risk increases with age. Therefore, the extra cases of diagnosed breast cancer will be more at older ages. How long the woman has been using birth control pills is less important.
For every 10,000 women who use the pill for up to five years and who stop at age 20, there will be less than 1 extra case of breast cancer up to 10 years after treatment ends, in addition to the 4 normally detected in this age group. Similarly, for 10,000 women who have used birth control pills for up to five years and who stop at the age of 30, 5 extra cases will be detected in addition to the 44 cases that are normally detected. In 10,000 women who have used the pill for up to five years and stopped 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 contraceptives such as Vinelle is considered to be comparable to the risk in women using contraceptives that also contain estrogen (combined contraceptives ), but the evidence is not as strong.
Breast cancer detected in women using oral contraceptives appears to be less likely to have spread than breast cancer detected in women not using oral contraceptives. It is not known whether the difference in breast cancer risk is caused by the pill. It may be that women who use birth control pills are examined more often and that breast cancer is then detected earlier.
Thrombosis
See your doctor/midwife immediately if you notice possible signs of thrombosis (see also “Regular check-ups”).
Thrombosis is the formation of a blood clot, which can block a blood vessel. Thrombosis sometimes occurs in the deep veins of the legs (deep vein thrombosis ). If such a blood clot detaches from the vein, where it has formed, it can travel to the arteries in the lungs, block them and cause 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 pregnancy.
The risk of suffering from thrombosis is higher if you use birth control pills than if you don’t.
The risk of suffering from thrombosis is thought to be lower when using progestogen contraceptives such as Vinelle, compared to contraceptives that also contain estrogen (combined contraceptives ).
Mental disorders
Some women using hormonal contraceptives, including Vinelle, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If you experience mood changes and symptoms of depression, you should contact a doctor for advice as soon as possible.
Children and young people
No data are available regarding safety and efficacy in adolescents under 18 years of age.
Other medicines and Vinelle
Tell your doctor/midwife or pharmacist if you are taking, have recently taken, or might be taking other medicines or (traditional) herbal medicines. Also, tell other doctors and dentists who prescribe medicines (or pharmacists) that you are using Vinelle. They can tell you if you need to use additional contraceptive protection (for example condoms) and if so for how long or if the use of any other medicine you need needs to be changed.
Certain medicines
- may have an impact on the levels of Vinelle in the blood
- may make it less effective in preventing pregnancy
- may cause unexpected bleeding.
It applies to medicines used in the treatment of:
- epilepsy (eg primidone, phenytoin , carbamazepine, oxcarbazepine, felbamate, topiramate and phenobarbital)
- tuberculosis (eg rifampicin, rifabutin)
- HIV – infection (eg ritonavir, nelfinavir, nevirapine, efavirenz)
- Hepatitis C virus infections (eg boceprevir, telaprevir)
- other infectious diseases (eg griseofulvin)
- high blood pressure in the blood vessels of the lungs ( bosentan )
- depressed mood ((traditional) herbal medicines containing St. John’s wort [ Hypericum perforatum ])
- certain bacterial infections (eg clarithromycin, erythromycin)
- fungal infections (eg ketoconazole , itraconazole, fluconazole )
- high blood pressure ( hypertension ), angina (angina), or certain heart rhythm disorders (e.g. diltiazem ).
If you use medicines or (traditional) herbal medicines that can make Vinelle less effective, a barrier method (for example a condom) should be used. Since the effect of another drug on Vinelle can remain for up to 28 days after the end of treatment with the drug, it is necessary to use a barrier method throughout this time. Your doctor/midwife can tell you if you need additional protection and if so for how long.
Vinelle can also affect the effectiveness of other medicines, either by increasing the effect (e.g. medicines containing ciclosporin) or reducing the effect (e.g. lamotrigine).
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy and breastfeeding
Pregnancy
Do not use Vinelle if you are pregnant or if you think you may be pregnant.
Breast-feeding
Vinelle can be used while breastfeeding. Vinelle does not seem to affect the production or quality of breast milk. However, isolated reports have described a decrease in breast milk production while using Vinelle. A small amount of the active substance in Vinelle passes into breast milk.
The health of children of women who have used Vinelle while breastfeeding for 7 months has been followed until the child is 2.5 years old. No negative effects on the child’s growth and development were detected.
Talk to your doctor/midwife if you are breastfeeding and want to use Vinelle.
Driving ability and use of machinery
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
There is no indication that the ability to react or concentrate is affected by the treatment.
Vinelle contains lactose
If you have an intolerance to certain sugars, you should contact your doctor/midwife before taking this medicine.
Regular checks
When you use Vinelle, your doctor/midwife will tell you when to come back for a check-up. How often you need to go for a check-up and what it contains varies from person to person.
| Contact your doctor/midwife as soon as possible if: you have severe pain or swelling in one of the legs, unexplained pain in the chest, shortness of breath, or unusual cough especially in combination with blood-tinged saliva (which may be a sign of thrombosis )you get sudden, severe pain in your stomach or if your skin turns yellow (which could be a sign of liver problems )you feel a lump in your breast (which could be a sign of breast cancer )you get sudden, severe pain in the lower part of the abdomen (this may be a sign of an ectopic pregnancy, i.e. a pregnancy outside the uterus)you are bedridden or about to undergo a major operation (consult your doctor at least four weeks before)you have unusual, heavy bleeding from the abdomen you think you are pregnant. |
How to use Vinelle
When and how to take the tablets
Each card contains 28 tablets. This is 4 weeks of treatment. Take your tablets at about the same time each day. The tablets should be swallowed whole with water. On the front of the map, arrows are printed, between the tablets. On the back of the map, the days of the week are printed on the foil. Each tablet corresponds to one day of the week. Each time you start a new map, take a tablet from the top row. Don’t start with just any tablet. For example, if you start on a Wednesday, you should take the tablet from the top row marked with “O/K”. Continue taking one tablet daily until the chart is empty, 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.
You may have bleeding while using Vinelle, but you should continue to take the tablets as usual. When a map is finished, you must continue with a new map the next day – i.e. without any tablet break and without waiting for bleeding.
The first Vinelle map
- If you have not used any hormonal contraceptive in the last month wait until menstruation begins. Take the first tablet of Vinelle on the first day of bleeding. You do not need to use any additional protection. You can also start on days 2-5 of your period, but then you must use extra protection (e.g. a condom) during the first seven days.
- Changing from a combined birth control pill, birth control ring, or birth control patch you can start with the first tablet of Vinelle the day after you have taken the last tablet of your combined oral contraceptive pill, or on the same day that your contraceptive ring or contraceptive patch is removed (this means that you should not have a pill-free, ring-free or patch-free week). If your pill also contains hormone-free tablets, you can start Vinelle 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 additional protection.
You can also start no later than the last day of the pill-free, ring-free, or patch-free week, but then you must use extra protection (e.g. a condom) for the first seven days. - Switching from another progestagen birth control pill ( minipill )You can stop minipills any day and then start Vinelle. You don’t need extra protection.
- Change from birth control syringe, birth control stick, or hormonal coilStart Vinelle on the day you would have had your next contraceptive injection or on the day your contraceptive rod or hormonal coil is removed. You don’t need extra protection.
- After giving birth you can start Vinelle 21 to 28 days after delivery. If you start later, you must use extra protection for the first seven days that you take the tablets. If you have had sexual intercourse, you should make sure you are not pregnant before starting Vinelle.
You can find information about breastfeeding in section 2 “What you need to know before using Vinelle” under the heading “Pregnancy and breastfeeding”. Your doctor/midwife can also give you advice. - After a miscarriage or abortion, you doctor/midwife will advise you.
If you forget to take Vinelle
- If you are less than 12 hours late: Take the missed tablet as soon as you remember and then take the next tablet at the usual time. Vinelle still protects you against pregnancy.
- If you are more than 12 hours late: If you are more than 12 hours late taking the pill, you may not be fully protected against pregnancy. The more tablets you have missed in a row, the greater the risk that you might become pregnant. Take the tablet as soon as you remember and take the next dose at the usual time. This may mean that you may take two tablets in one day. Then continue to take the tablets as usual but you must also use an additional method of contraception, such as a condom, for the next 7 days. If you have missed one or more tablets during the very first week of treatment and have had intercourse during the week before you forgot to take the tablet, you may become pregnant. Ask your doctor for advice.
If you have stomach problems (e.g. vomiting, severe diarrhea)
Follow the same advice as for forgotten tablets (see above). If you have vomited within 3-4 hours of taking your Vinelle tablet or have severe diarrhea, it may be that the active substance has not been absorbed by the body.
If you have taken too much Vinelle
There are no reports of serious adverse effects if too many tablets are taken at one time. Symptoms that may occur are nausea and vomiting and, in young girls, light bleeding.
But if you have ingested too much medicine or if e.g. a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you stop taking Vinelle
You can stop taking Vinelle whenever you want. From the day you stop, you are no longer protected against pregnancy.
If you have any further questions about the use of this medicine, contact your doctor, midwife, or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor if you notice any unwanted effects, especially if it is severe or persistent.
Serious side effects that have been associated with the use of Vinelle have been described in the paragraphs “Breast cancer” and “Thrombosis” in Section 2 “What you need to know before you use Vinelle”. You should read these paragraphs and contact your doctor for further advice if necessary.
Seek medical attention immediately if you experience allergic reactions ( hypersensitivity reaction er), including swelling of the face, lips, tongue, and/or throat causing breathing or swallowing difficulties ( angioedema and/or anaphylaxis ).
Bleeding often becomes irregular when using Vinelle. It can be spotting that doesn’t even require a pad or bleeding that resembles a sparing period and requires menstrual protection. It may also happen that menstruation does not occur completely. The irregular bleeding is not a sign that pregnancy protection with Vinelle has deteriorated. In general, you don’t need to do anything, just keep taking Vinelle.
If, however, the bleeding is heavy and prolonged, you should contact your doctor/midwife.
Other side effects are
Common (may affect up to 1 in 10 women)
- Mood swings
- Depression,
- decreased sexual desire ( libido )
- headache, nausea
- acne
- chest tension
- irregular or absent menstruation
- weight gain
Uncommon (may affect up to 1 in 100 women)
- infection in your vagina
- 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 women)
- rash
- hives
- painful bluish-red rash (rubella or erythema nodosum)
Frequency not known (cannot be calculated from available data)
- allergic reaction
Regardless of these side effects, fluid from the breasts may occur.
How to store Vinelle
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton after “EXP”. The expiration date is the last day of the specified month.
Vinelle does not require special storage conditions.
The active substance poses an environmental risk to fish.
The medicine must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is desogestrel. Each tablet contains 75 micrograms of desogestrel.
Other ingredients are:
Lactose monohydrate
Potato starch
Povidone
All-rac-α-tocopherol
Colloidal anhydrous silica
Stearic acid
(See also the heading “Vinelle contains lactose” in section 2.)
Appearance and package sizes of the medicine
Pressed packaging with 28 tablets. The tablets are white to off-white, round, and marked with “152” on one side and smooth on the other. Each pack contains 1, 3, 6, or 13 maps, each packed in an aluminum pouch. The packages can be marketed with or without desiccant.