150 micrograms / 30 micrograms coated tablets
levonorgestrel and Ethinyl estradiol
What Rigevidoncont is and what it is used for
Rigevidoncont is a combined oral contraceptive, also called a birth control pill. It contains two different female sex hormones: an estrogen; Ethinyl estradiol, and a progestogen; levonorgestrel, in low doses.
The combined contraceptive pill protects against pregnancy in three ways. These hormones:
- prevents the ovary from releasing an egg every month (ovulation)
- also thickens the secretion (in the cervix) and thus makes it more difficult for the sperm to reach the egg
- changes the lining of the uterus so that it becomes more difficult to receive a fertilized egg.
If the pill is taken correctly, it is an effective reversible contraceptive method (you can get pregnant if you stop taking the pill). In some situations, however, the effect of the tablets may be reduced, or you may need to stop taking the pill (see other sections of this information). In these cases, you should not have sex or you should use another non-hormonal method of contraception (such as a condom or other barrier method ) during intercourse to be sure that you are protected.
Remember that combined contraceptive pills such as Rigevidoncont do not protect against sexually transmitted diseases (such as AIDS ). Only condoms do that.
Levonorgestrel and Ethinyl estradiol contained in Rigevidoncont 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 using Rigevidoncont
Do not use Rigevidoncont
- if you are allergic to levonorgestrel or Ethinyl estradiol or any of the other ingredients of this medicine (listed in section 6).
- if you have (or have had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), the lungs ( pulmonary embolism ), or any other organ
- if you know you have a disease that affects blood coagulation – e.g. protein C deficiency, protein S deficiency, antithrombin ‑ III ‑ deficiency, Factor V Leiden or antiphospholipid antibodies
- if you need surgery or if you are in bed for a long time
- if you have (or have had) a heart attack or a stroke (stroke)
- if you have (or have had) angina (a condition that causes severe chest pain and maybe the first sign of a heart attack) or transient ischemic attack ( TIA – transient stroke symptoms)
- if you have (or have had) a type of migraine called “migraine with aura”.
- if you have any of the following conditions that may increase the risk of a blood clot in your arteries:
- severe diabetes with damaged blood vessels
- very high blood pressure
- a very high level of fat in the blood ( cholesterol or triglycerides )
- a condition called hyperhomocysteinemia
- if you have or have had a migraine with illnesses that affect your perception, feeling, or mobility
- if you have (or have had) or suspect you may have breast or genital cancer
- if you have or have had a liver disease and your liver function is still not normal
- if you have or have had a liver tumor
- if you have unexplained vaginal bleeding
Do not use Rigevidoncont if you have hepatitis C and are being treated with medicines containing ombitasvir / paritaprevir / ritonavir, dasabuvir, glekaprevir / pibrentasvir and sofosbuvir / velpatasvir / voxilaprevir (see also section “Other medicines and Rigevidoncont”).
St. John’s wort should not be used in combination with Rigevidoncont as the effect of the contraceptive may be reduced.
Warnings and cautions
Talk to your doctor or pharmacist before taking Rigevidoncont.
|When should you contact a doctor?|
Seek medical attention immediatelyif you notice any possible signs of a blood clot that may indicate a blood clot in your leg (ie deep vein thrombosis ), a blood clot in your lung (ie pulmonary embolism ), a heart attack, or a stroke (see section “Blood clots” below).
For a description of the symptoms of these serious side effects, go to “How to recognize a blood clot”.
Contact a doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives, possibly with difficulty breathing. Products containing estrogen can cause or worsen the symptoms of hereditary or acquired angioedema.
Before you can start taking Rigevidoncont, your doctor/midwife will ask you some questions about your health and the health of your close relatives. The doctor/midwife will also measure your blood pressure and, depending on your health, may also perform some other tests.
If you get any of the following conditions or diseases, only take Rigevidoncont under close supervision as these conditions may worsen when you take the pill.
Tell your doctor before using Rigevidoncont about :
- you have a disease in your blood fat metabolism or some other very rare blood disease
- you have high blood pressure
- you have a migraine
- you have diabetes
- you have Crohn’s disease or ulcerative colitis ( chronic inflammatory bowel disease)
- You have an inherited form of deafness called otosclerosis
- you have a depression or mood swings
- you have a disease of the musculoskeletal system called Sydenham’s Korea
- you have a disease of the liver and/or gallbladder (yellowing of the skin, gallstones )
- you have a hereditary disease called porphyria
- you have sickle cell anemia (a hereditary blood disorder)
- you have hemolytic-uremic syndrome (HUS, a disease in which blood clots cause kidney failure )
- you have systemic lupus erythematosus – SLE (an inflammatory disease that can affect many parts of the body including the skin, joints, and internal organs)
- you have itching ( pruritus )
- You have a rash called herpes gestationis
- you have brown spots on your face and body (chloasma), which you can avoid by staying away from the sun and not using tanning beds and sun lamps.
The above conditions can be aggravated when using birth control pills; you should therefore go for regular medical check-ups while using birth control pills.
Before starting Rigevidoncont, you should also tell your doctor about :
- you are smoking
- if you are severely overweight ( obesity ).
If you use combined hormonal contraceptives such as Rigevidoncont, the risk of blood clots increases compared to if you do not use these drugs. In rare cases, a blood clot can block the blood vessels and cause serious problems.
Blood clots can form
- in veins (called venous thrombosis, venous thromboembolism, or VTE)
- in the artery (called arterial thrombosis, arterial thromboembolism, or ATE).
It is not always possible to fully recover from blood clots. In rare cases, they can have serious lasting effects and, in very rare cases, be fatal.
It is important to remember that the overall risk of a dangerous blood clot due to Rigevidoncont is small.
How to recognize a blood clot
Seek medical attention immediately if you notice any of the following signs or symptoms.
|Do you experience any of these signs?||What can you possibly suffer from?|
|swelling of a leg or along a vein in the leg or foot, especially if you also get:|
pain or tenderness in the leg that is only felt when you stand or walk increased heat in the affected leg discoloration of the skin on the leg, e.g. pale, red or blue
|Deep vein thrombosis|
|sudden unexplained shortness of breath or rapid breathing sudden cough for no apparent reason that could cause you to cough up blood severe chest pain that may increase with deep breathing severe instability or dizziness fast or irregular heartbeat severe pain in the abdomen you are not sure, talk to a doctor because some of these symptoms, e.g. cough and shortness of breath, can be mistakenly interpreted as a milder condition such as a respiratory infection (such as a common cold).||Pulmonary embolism|
|Symptoms that usually occur in one eye: immediate loss of vision or blurred vision without pain that can lead to vision loss||Retinal venous thrombosis (blood clot in the eye)|
|chest pain, discomfort, pressure, heavinesspressure or feeling of fullness in the chest, arm, or below the sternum feeling full, indigestion or feeling of suffocationdiscomfort in the upper body that radiates to the back, jaw, neck, arm and abdomensweating, nausea, vomiting or dizziness extreme weakness, anxiety or shortness of breakfast or irregular heartbeat||Myocardial infarction|
|sudden weakness or numbness in the face, arms or legs, especially on one side of the bodysudden confusion, difficulty speaking or understandingsudden vision problems in one or both eyessudden difficulty walking, dizziness, loss of balance or coordinationsudden, severe or prolonged headache without known causeunconsciousness or fainting with or without seizures sometimes the symptoms of a stroke can be short-lived with almost immediate or complete recovery, but you should still seek medical attention immediately because you are at risk of having a new stroke .||Stroke|
|swelling and slight blue discoloration of an arm or leg severe pain in the abdomen ( acute abdomen)||Blood clots that block other blood vessels|
BLOOD CLOTS IN A FRIEND
What can happen if a blood clot forms in a vein?
- The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the vein (venous thrombosis ). However, these side effects are rare. They usually occur during the first year of using a combined hormonal contraceptive.
- If a blood clot forms in a vein in the leg or foot, it can lead to deep vein thrombosis (DVT).
- If a blood clot moves from the bone and stays in the lung, it can lead to a pulmonary embolism.
- In very rare cases, a blood clot can form in a vein in another organ such as the eye ( retinal venous thrombosis ).
When is the risk of developing a blood clot in a vein greatest?
The risk of developing a blood clot in a vein is greatest during the first year that you use combined hormonal contraceptives for the first time. The risk can also be higher if you start again with a combined hormonal contraceptive (same product or another product) after a break of 4 weeks or longer.
After the first year, the risk decreases, but it is always slightly higher than if you did not use a combined hormonal contraceptive.
When you stop using Rigevidoncont, the risk of a blood clot returns to normal within a few weeks.
How big is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.
The total risk of a blood clot in the leg or lungs with Rigevidoncont is small.
- Of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 develop a blood clot in one year.
- Of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, e.g. Rigevidoncont, develops about 5-7 a blood clot during a year.
- The risk of blood clots varies depending on your medical history (see “Factors that may increase the risk of a blood clot” below).
|Risk of developing a blood clot during a year|
|Women who do not use combined pills/patches/rings and who are not pregnant||About 2 out of 10,000 women|
|Women using a combined hormonal contraceptive containing levonorgestrel||About 5-7 out of 10,000 women|
|Women using Rigevidoncont||About 5-7 out of 10,000 women|
Factors that may increase the risk of a blood clot in a vein
The risk of a blood clot with Rigevidoncont is small, but certain conditions increase the risk. The risk is higher:
- if you are overweight (body mass index or BMI over 30 kg / m 2 )
- if a close relative has had a blood clot in the bones, lungs, or another organ at a young age (eg under 50 years). In this case, you may have a hereditary blood clotting disease
- if you need to undergo surgery or stay in bed for a long period due to injury or illness, or if your leg is plastered. The use of Rigevidoncont may need to be stopped for several weeks before an operation or while you are less mobile. If you have to stop taking Rigevidoncont, ask your doctor when you can start taking it again
- with increasing age (especially if you are over about 35 years old)
- if you have given birth within a few weeks
The more conditions you have, the greater the risk of developing a blood clot.
Air travel (> 4 hours) can temporarily increase the risk of a blood clot, especially if you have any of the other factors listed here.
You must tell your doctor if any of these conditions apply to you, even if you are unsure. Your doctor may decide that you must stop taking Rigevidoncont.
If any of the above conditions change when you use Rigevidoncont, e.g. a close relative suffers from a blood clot with an unknown cause, or you gain a lot of weight, talk to your doctor.
BLOOD CLOTS IN AN ART
What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a clot in an artery can lead to serious problems. It can e.g. cause a heart attack or stroke.
Factors that may increase the risk of a blood clot in an artery
It is important to know that the risk of a heart attack or stroke due to the use of Rigevidoncont is very small but may increase:
- with increasing age (after about 35 years of age)
- if you smoke. When using combined hormonal contraceptives such as Rigevidoncont, you should stop smoking. If you can not stop smoking and are over 35 years old, your doctor may advise you to use another type of contraceptive
- if you are overweight
- if you have high blood pressure that is not controlled with treatment
- if a close relative has had a heart attack or stroke at a young age (younger than 50 years). In this case, you may also be at greater risk for a heart attack or stroke
- if you or a close relative have high blood fats ( cholesterol or triglycerides )
- if you get migraines, especially migraines with an aura
- if you have heart problems (valve disease, a heart rhythm disorder called atrial fibrillation )
- if you have diabetes.
If you have more than one of these conditions or if any of them are particularly severe, the risk of developing a blood clot can be even greater.
If any of the above conditions change when you use Rigevidoncont, e.g. If you start smoking, a close relative suffers from thrombosis of unknown cause, or you gain a lot of weight, talk to your doctor.
Birth control pills and cancer
Breast cancer has been seen slightly more often in women who use combined contraceptive pills than in women of the same age who do not use oral contraceptives. If women stop taking the pill, the risk decreases so that 10 years after stopping the pill, the risk of breast cancer is the same as for women who have never taken the pill. It is not known whether the increased risk of being diagnosed with breast cancer is due to the contraceptive pill. It may be that women who use birth control pills are examined more often and thus any cancer is detected earlier.
Benign and malignant liver tumors have been reported in users of birth control pills. Liver tumors can lead to life-threatening internal bleeding. Contact a doctor if you have pain in the upper abdomen that does not go away soon.
An increased risk of cervical cancer with long-term use of birth control pills has been reported in some studies. It is uncertain whether this increased risk is caused by the contraceptive pill as it could also be due to the effects of sexual behavior and other factors.
Some women who use hormonal contraceptives, including Rigevidoncont, 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.
Once you have started using Rigevidoncont, your doctor/midwife will want to see you again for regular annual check-ups, or if you have any problems, you can see your doctor at any time.
Other medicines and Rigevidoncont
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Also, tell other doctors or dentists who prescribe other medicines (or pharmacists) that you are using Rigevidoncont. They can tell you if you need to use additional contraceptives (eg condoms), and if so, for how long.
Do not use Rigevidoncont if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir / pibrentasvir, and sofosbuvir / velpatasvir / voxilaprevir, as treatment with these products may lead to elevated liver values (elevation of alanzamin ). Your doctor will prescribe another contraceptive before starting treatment with this combination of medicines, Rigevidoncont can be started again about 2 weeks after the end of treatment, see section “Do not use Rigevidoncont”.
Some medicines can affect the level of Rigevidoncont in the blood and make it less effective in preventing pregnancy or causing unexpected bleeding. This includes drugs used to treat:
- epilepsy (eg primidone, phenytoin , barbiturates , carbamazepine, oxcarbazepine, topiramate, felbamate, rufinamide, perampanel);
- tuberculosis (eg rifampicin);
- HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz);
- fungal infections (eg griseofulvin);
- high blood pressure in the blood vessels of the lungs ( bosentan );
- narcolepsy (modafinil);
- a certain type of skin cancer (vemurafenib);
- treatment of symptoms of osteoarthritis (etoricoxib).
- uterine fibroids (ulipristal)
- If you are taking or want to take (traditional) herbal medicines containing St. John’s wort (Hypericum perforatum), consult your doctor, as Rigevidoncont may not be suitable for you.
Rigevidoncont may affect the effectiveness of other medicines, e.g.
- ciclosporin (a medicine used to prevent transplant rejection after an organ transplant);
- the epilepsy drug lamotrigine (this may lead to an increased number of seizures).
Effects on laboratory samples
If you have to take blood samples, tell your doctor or laboratory staff that you are taking birth control pills because birth control pills can affect the results of certain tests.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
You should not use Rigevidoncont when you are pregnant. If you become pregnant or think you may be pregnant, stop taking Rigevidoncont and talk to your doctor immediately.
Rigevidoncont should not be used during breastfeeding. If you are breastfeeding and want to take birth control pills, discuss this with your doctor.
Driving and using machines
You can both drive and use machines while using Rigevidoncont.
Rigevidoncont contains lactose, sucrose, para-orange (E110) and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The green inactive ( placebo ) film-coated tablets contain para-orange (E110) which may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to use Rigevidoncont
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
If you have taken another contraceptive pill before Rigevidoncont, you know that most contraceptive pills contain 21 tablets where you take one tablet for 21 days and then follow a week break where you do not take any tablets (tablet-free period). Rigevidoncont works differently. After taking the 21 active white tablets, you should continue to take 7 placebo tablets instead of a tablet-free period. There is no tablet-free period without a “placebo week”. Because you have to take one tablet every day without a break between packs, it becomes more consistent and routine, and the risk of forgetting a tablet decreases.
Two different types of colored tablets are available in the Rigevidoncont package containing 28 tablets.
Do not mix the tablets: take one white tablet every day for the first 21 days, then one green tablet for the next 7 days. Then start with a new pack (21 white tablets and 7 green tablets). There is no tablet-free interval between packages.
Due to the different compositions of the tablets, you must start with the first tablet at position 1 on the adhesive strip, marked “Start”, and then take one tablet every day. Follow the direction of the arrows and the numbers on the adhesive strip to take the tablets in the correct order.
Attach the adhesive strip:
To help you keep track of which tablet to take, seven adhesive strips marked with the seven days of the week are included. Select the adhesive strip that starts with the day you start taking the tablets. For example, if you start on a Wednesday, use the sticker that begins with “Wed.”
Place the arrow “→” on the adhesive strip next to the same symbol on the blister map and place the strip in the area surrounded by a black line. For each day, there will now be a row of tablets.
Above each tablet is now a day of the week and you can see if you have taken a tablet on a particular day. Follow the direction of the arrow until you have taken all 28 tablets.
The white tablets must be taken every day at about the same time, if necessary with some liquid, in the order indicated by the arrow on the tablet map. The day after you take the last active tablet, continue with the 7 green tablets from the separate row on the same tablet chart. The tablets should be taken continuously. Taking the medicine in this way will help you remember to take the tablets on time.
Your period (also called dropout bleeding) will usually start during the 7 days you take the placebo tablets (placebo week). Your period will usually start on the second or third day after you take the last active white Rigevidoncont tablet. After taking the last green tablet, start on the next map even if you have not stopped bleeding. This means that you start the next map on the same day of the week as you started with the previous map, as your period should occur at the same time each month.
If you take Rigevidoncont correctly, you will be protected against pregnancy even during the 7 days you take the placebo tablets.
How to start with the first package
- When no hormonal contraceptive method has been used in the last month start taking Rigevidoncont on the first day of the menstrual cycle (that is, the first day of your period). If you start taking Rigevidoncont on the first day of your period, you will receive immediate protection against pregnancy. You can also start on days 2-5 of the cycle, but then you must use additional contraceptive methods (eg condoms) for the first 7 days.
- Change from another combination type of contraceptive, vaginal ring, or patch you can start taking Rigevidoncont the day after you have taken the last active tablet (the last tablet containing active substances) of the previous type of combined hormonal contraceptive, but no later than the day after the usual tablet break or placebo tablet (after taking the last inactive tablet) combined hormonal contraceptives.
When changing from a vaginal ring or patch, follow your doctor’s recommendations.
- Switching from progestogen-only contraceptives (mini-pills, injection, implants, or an IUD)You can change from mini- pills any day (from implants or IUDs on the same day as it is removed, from the injectable method when the next injection is to take place). In all these cases, it is recommended that you use additional contraceptives during the first 7 days that you take the contraceptive pill (for example, a condom).
- After abortion or miscarriage, you can start using Rigevidoncont immediately after a miscarriage or miscarriage that occurs during the first three months of pregnancy. In these cases, you do not need extra protection.
- After childbirth, you have given birth or had an abortion during the second trimester, and your doctor will advise you on birth control pills.
The duration of treatment has no time limit, but regular health checks are recommended.
- If you are breastfeeding and want to start taking Rigevidoncont after giving birth. See section “Breastfeeding”.
If you use too much Rigevidoncont
If you have taken more tablets than you should, it is unlikely to cause any harm, but you may experience nausea, vomiting, abdominal pain, chest pain, numbness, drowsiness/fatigue, or slight vaginal bleeding in young girls. If you have any of these symptoms, talk to your doctor who can tell you what, if anything, you need to do.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you have forgotten to use Rigevidoncont
If you forget to take the placebo tablets (the green ones) it does not affect the effect of Rigevidoncont. You should discard the forgotten tablets to avoid prolonging the placebo week, as this would hurt the effect of Rigevidone Cont.
If you have forgotten any of the active tablets (white), follow these recommendations:
- If less than 12 hours have passed since you should have taken your tablet, the protection against pregnancy has not diminished. Take the tablet as soon as you remember and take the next tablet at the usual time.
- If more than 12 hours have passed, the effect of the contraceptive pill may be reduced. The more tablets in a row that you have missed, the higher the risk that the preventive effect has decreased.
The risk of getting pregnant is especially high if you forget tablets at the beginning of the tablet chart or the end of week 3. Follow the instructions given below:
- More than 1 tablet in the tablet map has been forgotten contact your doctor/midwife for advice.
- 1 tablet forgotten during week 1Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Take the following tablets at the usual time, and use extra contraceptives such as condoms for the next 7 days. If you have had intercourse during the week before the forgotten tablet, there is a risk that you will become pregnant. Ask your doctor/midwife for advice.
- 1 tablet forgotten during week 2Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Take the following tablets at the usual time. Provided that Rigevidoncont is then taken correctly during the 7 following days, you do not need to use extra preventive protection. If this is not the case or if more than 1 tablet is forgotten, supplementary contraceptive protection should be used for 7 days.
- 1 tablet was forgotten during week 3The risk of a reduced effect is great due to the coming period of placebo tablets. However, the reduced protective effect can be prevented by adjusting the tablet intake. By following one of the following two options, it is therefore not necessary to use an additional protection. This is provided that all Rigevidoncont tablets have been taken correctly during the 7 days before the first forgotten tablet. If you have not taken Rigevidoncont correctly during the 7 days before the first forgotten tablet, you should follow the first of the two options. A barrier method (eg condom) must also be used at the same time for the next 7 days.
- Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue to take the following tablets at the usual time. Instead of taking placebo tablets, discard them and continue with the next tablet chart. You will probably have a loss of bleeding when you get to the end of the second map when you take the placebo tablets. You may also experience splashing and breakthrough bleeding on the days you take tablets from the other tablet chart.
- You can stop taking the active white tablets and immediately switch to the 7 green placebo tablets. Remember to note which day you forgot to take the tablet before starting the placebo week). If you want to start a new pack on a certain day, you can take the placebo tablets for less than 7 days.
If you follow either of these two recommendations, you will continue to be protected against pregnancy.
- If you forgot to take tablets in a tablet chart and you do not get the expected menstruation during the placebo week, you may be pregnant. Consult your doctor/midwife before starting the next tablet chart.
If you stop using Rigevidoncont
You can stop taking Rigevidoncont at any time. If you stop taking Rigevidoncont to have a baby, use another method of contraception until you have had a proper menstrual period, as this will make it easier for your doctor to tell you when your baby will be born.
What to do if you have an upset stomach
If you have vomited or had diarrhea within 3-4 hours after taking your contraceptive pill, the active substances in the pill will not be completely absorbed into your body. In these cases, the advice on forgotten tablets described above should be followed. In case of vomiting or diarrhea, use extra protection, e.g. condoms, during intercourse during stomach upset and for the next seven days.
What do you do if you want to delay or move your period
Contact your doctor/midwife for advice if you want to delay or move your period.
If you want to delay your period
Although it is not recommended, it is possible to delay your period (loss of bleeding) until the end of a new pack if you do not take the green placebo tablets but start taking the second pack of Rigevidoncont. You may experience spotting (blood drops or stains) or bleeding. After the usual placebo period when you take 7 green tablets of the second pack, start the next pack.
If you want to move your period to another day of the week
If you take the tablets according to the instructions, your menstruation/bleeding will start during the placebo week. If you want to change the day, do so by shortening the placebo week (but not more than 7 days!). Example: If your placebo week normally starts on a Friday, and you want to change it to a Tuesday (3 days earlier), you must start with a new tablet chart 3 days earlier than usual. If you make the placebo week/period very short (eg 3 days or less) you may not experience any bleeding during the placebo period. You may then have splashing bleeding (drops or stains of blood) or breakthrough bleeding.
Contact your doctor and ask for advice if you do not know how to do it.
If you have bleeding between periods
A small number of women may experience a small breakthrough or spotting bleed while taking Rigevidoncont, especially during the first months. Normally, this bleeding is nothing to worry about, and they stop after a day or two. Continue to take the tablets, as usual, the bleeding should disappear after the first packs.
Talk to your doctor if the bleeding continues to return, is irritating, or is prolonged.
If your period is absent
If you have taken all your tablets correctly, and you have not had an upset stomach, or used other medicines, it is very unlikely that you will become pregnant. Continue to take Rigevidoncont as usual.
If you have not had your period twice in a row, you may be pregnant and you should see a doctor immediately. You should only continue to take birth control pills after taking a pregnancy test and on the doctor’s advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat and/or difficulty swallowing, hives, and possibly with difficulty breathing (see also section “Warnings and precautions”).
If you get any side effects, especially if they are difficult or persistent, or if your health changes and you think it may be due to Rigevidoncont, talk to your doctor.
An increased risk of blood clots in the veins (venous thromboembolism, VTE) or blood clots in the arteries ( arterial thrombosis, ATE) is present for all women taking hormonal combined contraceptives. For more information on the different risks of using combined hormonal contraceptives, see section 2 “What you need to know before using Rigevidoncont”.
The most commonly reported adverse reactions (> 10%) in clinical trials and follow-up after market introduction were irregular bleeding and headaches, e.g. migraine.
Common side effects ( may affect up to 1 in 10 people):
Inflammation of the vagina (eg candidiasis of the vagina), mood swings (eg depression), altered sex drive, nervousness, dizziness, nausea, vomiting, abdominal pain, acne, sore breasts, pain in the breasts, enlarged breasts, secretion from the breasts, painful menstruation, change in the cervix (change in cervical ectropion) and change in vaginal secretions, absent or reduced bleeding, fluid retention/swelling, weight changes.
Uncommon side effects ( may affect up to 1 in 100 people):
Altered appetite, high blood pressure, stomach cramps, bloating, rash, liver spots (yellow-brown spots on the skin) which may be long-lasting, excessive hair growth, hair loss, and altered blood fat levels (eg too high triglyceride content).
Rare side effects ( may affect up to 1 in 1,000 people):
Severe allergic reaction ( anaphylactic reaction with very rare cases of hives, swelling of the face and tongue, severe circulatory disease, and severe respiratory disease), glucose intolerance, eye irritation with contact lenses, yellowing of the skin (jaundice), skin disease tuberculosis (painful) dangerous blood clots in a vein or artery, eg:
- in one leg or foot (ie DVT)
- in the lungs
- myocardial infarction
- stroke, mini-stroke, or transient stroke-like symptoms, called transient ischemic attack ( TIA )
- blood clots in the liver, stomach/intestines, kidneys, or eyes.
The risk of developing a blood clot may be higher if you have other conditions that increase this risk (see section 2 for more information on the conditions that increase the risk of blood clots and the symptoms of a blood clot).
Very rare side effects ( may affect up to 1 in 10,000 people):
Benign or malignant liver tumor, aggravated lupus (disease of the immune system), aggravated porphyria (blood disease), aggravated Korea (a disease with involuntary movements), inflammation of the optic nerve, blood clots in the blood vessels of the eye, worsening varicose veins, colitis, ischemic colitis, gallbladder problems (eg gallstones ), erythema multiforme (rash with annular redness or sores), blood disease called hemolytic-uremic syndrome (a condition in which blood clots cause kidney failure ), decreased folate content in serum.
No known frequency (can not be calculated from the available data):
Inflammatory bowel disease ( Crohn’s disease, ulcerative colitis ), liver damage (eg hepatitis, abnormal liver function).
Before taking blood samples
Tell your doctor or laboratory staff that you are taking birth control pills as oral contraceptives may affect the results of some tests.
How to store Rigevidoncont
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Do not use this medicine after the expiry date which is stated on the carton and the tablet card after EXP. The expiration date is the last day of the specified month.
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.
Contents of the package and other information
The active substances are levonorgestrel and Ethinyl estradiol. Each white-coated tablet contains 150 micrograms of levonorgestrel and 30 micrograms of Ethinyl estradiol
Other ingredients are:
Colloidal anhydrous silica, magnesium stearate, talc, corn starch, lactose monohydrate.
Colloidal anhydrous silica, talc, sucrose, calcium carbonate, titanium dioxide (E 171), povidone K-28, macrogol 6000, Povidone K-30, croscarmellose sodium.
Lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal anhydrous silica, and magnesium stearate.
Povidone K-90, titanium dioxide (E 171), macrogol 6000, sucrose, indigo carmine aluminum lacquer (E132), quinoline yellow aluminum lacquer (E104), sodium benzoate (E211), para-orange aluminum lacquer (E110), talc, calcium carbonate.
What the medicine looks like and the contents of the pack
The active coated tablets are white, round, biconvex sugar-coated tablets with a diameter of about 6 mm.
The placebo tablets are green, round, biconvex sugar-coated tablets with a diameter of about 7 mm.
Rigevidoncont 150 micrograms / 30 micrograms coated tablets are packed in PVC / PVDC / Aluminum blister cards. The blisters are packed in cardboard boxes together with a package leaflet, a case for blister cards, and stickers for the weekdays.
Each carton contains 1, 3, 6, or 13 calendar packs containing 21 white active coated tablets + 7 coated placebo tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Gedeon Richter Plc.
Gyömrõi out 19-21
This medicinal product is authorized under the European Economic Area under the names:
Belgium: Levorichter 30 Continuous
Denmark: Rigevidon 28