2 mg / 0.03 mg film-coated tablets
dienogest / ethinyl estradiol
Important information about combined hormonal contraceptives
- They are one of the most reliable contraceptives available if used properly
- The risk of blood clots in the veins and arteries increases slightly, especially during the first year or when combined hormonal contraceptives start to be used again after a break of 4 weeks or longer
- Pay attention and consult a doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”)
Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.
- Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to yours.
- If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.
In this leaflet:
1. What Dienorette is and what it is used for
2. What you need to know before you use Dienorette
3. How to use Dienorette
4. Possible side effects
5. How to store Dienorette
6. Contents of the packaging and other information
1. What Dienorette is and what it is used for
Dienorette contains the hormones Ethinyl estradiol (an estrogen ) and dienogest (a progestogen ) and is a so-called combined contraceptive pill.
- Dienorette is used for:
- to prevent pregnancy
- treatment of moderate acne when topical treatment or antibiotics have not improved the skin problems, in women who choose to use birth control pills.
- The 21 white tablets contain low amounts of Ethinyl estradiol and dienogest.
- The 7 green tablets do not contain any medicine, they are also called placebo tablets.
- Clinical tests have shown that in women, Dienorette relieves acne caused by male hormones (so-called androgens ).
Ethinyl estradiol and dienogest contained in Dienorette 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.
2. What you need to know before using Dienorette
Do not use Dienorette
You should not use Dienorette if you have any of the conditions listed below. If you have any of these conditions, you must tell your doctor. The doctor will discuss what other type of contraception may be more appropriate.
- if you have (or have had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs ( pulmonary embolism ), or any other organ
- if you know you have a disease that affects blood clotting – e.g. protein C ‑ deficiency, protein S ‑ deficiency, antithrombin ‑ III ‑ deficiency, Factor V Leiden or antiphospholipid antibodies
- if you need to have an operation or if you stay in bed for a long period of time (see section “Blood clots”)
- if you have had an hour järtinfarkt 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 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 type of migraine called “migraine with aura”
- if you have (or have had) inflammation of the pancreas ( pancreatitis ) together with very high blood fats (high lipid levels or hypertriglyceridemia ).
- if you have (or have had) liver disease and your liver function has not yet returned to normal
- if you have (or have had) benign or malignant liver tumor
- if you have (or have had), or are suspected of having, breast or genital cancer that is sensitive to sex hormones (eg cancer of the uterine lining)
- if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ ritonavir and dasabuvir as this may affect test results of liver function (increase in ALT liver enzyme). Your doctor may prescribe another type of contraceptive before starting treatment with these drugs. Dienorette can be used 2 weeks after stopping treatment. See also section “Other medicines and Dienorette”.
- if you have unexplained vaginal bleeding
- if you are allergic to Ethinyl estradiol, dienogest, or any of the other ingredients of this medicine (listed in section 6).
If any of the above occur while taking Dienorette, stop taking Dienorette immediately and contact your doctor. In the meantime, you should use another, non-hormonal contraceptive. For further information, see section “Warnings and precautions”.
Before you start using Dienorette, read the information on blood clots in section 2. It is especially important that you read about the symptoms of blood clots – see section 2, “Blood clots”.
Before you can start using Dienorette, your doctor will ask you some questions about your and your immediate relatives’ medical history. Your doctor will also measure your blood pressure and may also, depending on your situation, perform some other tests.
This leaflet describes several situations in which you should stop taking Dienorette or where the effect of Dienorette may decrease. In these situations, you should not have intercourse, or you should take extra measures in the form of non-hormonal methods, e.g. condom or any other barrier method. Do not use “safe periods” based on the menstrual cycle or temperature changes. These methods are unreliable because Dienorette changes the normal temperature changes and cervical secretions during the menstrual cycle.
Dienorette protection, like other hormonal contraceptives, is not against HIV – infection ( AIDS ) or other sexually transmitted diseases.
In the treatment of acne, this usually improves after 3-6 months of treatment and can continue to improve even after 6 months. You should discuss the need to continue your treatment with your doctor after 3-6 months from the start and regularly thereafter.
Warnings and cautions
When should you contact a doctor?
Seek medical attention immediately
- if you notice possible signs of a blood clot that may mean you have 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”.
Tell your doctor if any of the following conditions apply to you.
In some situations, you need to be especially careful when taking Dienorette or other combined pills, and it may be necessary to check with your doctor regularly.
If any of the following conditions occur or worsen while you are using Dienorette, you should also consult a doctor:
- if you have Crohn’s disease or ulcerative colitis ( chronic inflammatory bowel disease)
- if you have systemic lupus erythematosus ( SLE – a disease that affects your natural immune system)
- if you have hemolytic uremic syndrome (HUS – a disorder of blood coagulation that leads to kidney failure )
- if you have sickle cell anemia (a hereditary disease of the red blood cells )
- if you have increased blood fats ( hypertriglyceridemia ) or a hereditary condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas)
- if you need to have an operation or stay in bed for a longer period (see section 2 “Blood clots”)
- if you have just given birth, you are at increased risk of getting blood clots. Ask your doctor how soon after giving birth you can start using Dienorette
- if you have an inflammation of the veins under the skin (superficial thrombophlebitis )
- if you have varicose veins
- if a close relative has or has had breast cancer
- if you have liver or biliary tract disease, gallstones
- if you have jaundice (your skin or whites of the eyes turn yellow, your urine turns brown or your stools become extremely pale) or itching due to a blockage in the bile duct (the skin all over your body itches)
- if you have (or have had) golden brown pigment spots, especially on the face (chloasma or so-called pregnancy spots). If you have previously suffered from this, you should avoid exposing yourself to sunlight or ultraviolet light
- if you have certain problems with hemoglobin formation ( porphyria – a blood disease)
- if you suffer from depression
- if you have epilepsy
- if you have a nerve disease that causes sudden twitching in the body (Sydenhams Korea)
- if you have had a skin rash with blisters during a previous pregnancy (gestational herpes)
- if you have a hearing loss (otosclerosis-related hearing loss)
- if you have hereditary angioedema, administration of estrogen (such as Ethinyl estradiol – one of the substances in Dienorette) can cause or worsen the symptoms of angioedema. Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing.
If you use combined hormonal contraceptives such as Dienorette, 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 arteries (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 Dienorette is small.
How to recognize a blood clot
|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 soreness 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 breathingsevere 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
|sudden weakness or numbness in the face, arms, or legs, especially on one side of the body sudden confusion, difficulty speaking or understanding sudden vision problems in one or both eyes sudden difficulty walking, dizziness, loss of balance or coordinationsudden, severe or prolonged headache without known cause unconsciousness 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 may also be higher if you start again with a combined hormonal contraceptive (the 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 Dienorette, 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 Dienorette is small.
- Of 10,000 women who do not use a combined hormonal contraceptive and who 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, norethisterone, or norgestimate, approximately 5‑7 develop a blood clot in one year.
- Of 10,000 women who use a combined hormonal contraceptive that contains dienogest and Ethinyl estradiol, such as Dienorette, between 8 and 11 develop a blood clot in one year.
- The risk of developing a blood clot will vary depending on your medical history (see “Factors that may increase the risk of a blood clot in a vein” below)
|Risk of developing a blood clot during a year|
|Women who do not use combined pills who are not pregnant||About 2 out of 10,000 women|
|Women using a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate||About 5-7 out of 10,000 women|
|Women using Dienorette||About 8‑11 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 Dienorette is small but some conditions increase the risk. The risk is higher:
- if you are overweight (body mass index or BMI over 30 kg / m2)
- if someone in your family has had a blood clot in their bones, lungs, or another organ at a young age (eg for about 50 years). In this case, you may have a hereditary blood-clotting disease
- if you need to have surgery or stay in bed for a long period of time due to injury or illness, or if your leg is plastered. The use of Dienorette may need to be stopped for several weeks before an operation or while you are less mobile. If you have to stop taking Dienorette, ask your doctor when you can start taking it again
- with increasing age (especially if you are over about 35 years old)
- if you gave birth a few weeks ago
The risk of developing a blood clot increases the more conditions you have.
Air travel (over 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 need to stop taking Dienorette.
If any of the above conditions change when you use Dienorette, e.g. A close relative suffers from a blood clot with an unknown cause, or if you gain a lot of weight, talk to your doctor.
Blood clots in an artery
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 Dienorette 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 Dienorette, 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
- 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 of 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 serious, the risk of developing a blood clot can be even greater.
If any of the above conditions change when you use Dienorette, e.g. If you start smoking, a close relative suffers from thrombosis of unknown cause, or if you gain a lot of weight, talk to your doctor.
Dienorette and cancer
Breast cancer has been observed somewhat more frequently in women using combined oral contraceptives but it is not known if this is caused by the treatment. It may be that women who use birth control pills are examined more often and that more tumors are detected. The risk of developing a tumor gradually decreases after discontinuation of use. It is important to examine your breasts regularly and consult a doctor if you notice any lumps in your breasts.
In rare cases, benign liver tumors, and in even fewer cases malignant liver tumors, have been reported in birth control pill users. In rare cases, these tumors have led to life-threatening internal bleeding. In some clinical studies, cervical cancer has been reported in association with the ng-term use of birth control pills. However, it is not clear to what extent this is due to sexual habits (e.g. number of partners) or other factors such as infection by the human papillomavirus (HPV).
Some women who use hormonal contraceptives, including Dienorette, 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.
When should you contact your doctor?
If you use birth control pills, you will be examined regularly. You should normally contact your doctor at least once a year.
Contact your doctor immediately
• if you notice any changes in your health, especially those mentioned in the section “Do not take Dienorette.” Do not forget illnesses that have affected other family members.
• if you notice a lump in your chest
• if you are also taking other medicines (see also section “Other medicines and Dienorette”);
• if you are in bed for a long time or if you are going to have an operation (ask your doctor at least four weeks in advance);
• if you experience an unexpected, heavier vaginal bleeding between periods
• if you forgot to take tablets during week 1 (first line on the tablet map) and you had intercourse during the 7 days before
If you miss two periods in a row even though you take the tablets regularly and you suspect that you are pregnant.
During the first few months of using Dienorette, you may experience unexpected bleeding. This irregular bleeding stops when your body has adapted to the contraceptive pill (usually after 3 months). Contact your doctor if the bleeding becomes heavier (like a regular period) or if it lasts for several days.
If menstruation is absent
If you have taken all the tablets correctly, have not had vomiting or severe diarrhea and you have not taken any other medicines, it is very unlikely that you are pregnant. Continue to take Dienorette as usual.
If you have taken the tablets incorrectly or if the expected bleeding does not occur twice in a row, you may be pregnant. Contact your doctor immediately. Do not use Dienorette until you are sure you are not pregnant.
Children and young people
Dienorette is not intended for use before the first menstrual period ( menarche ).
Other medicines and Dienorette
Other medicines may affect the effect of Dienorette
Tell your doctor if you are taking, have recently taken, or might take any other medicines or herbal remedies. Also, tell other doctors or dentists who prescribe other medicines (or the pharmacy staff from whom you are taking the medicine) that you are taking Dienorette. They can tell you if you need to use additional contraceptives (eg condoms), and if so, for how long or if you need to adjust the use of other medicines.
- may affect the levels of Dienorette in the blood
- can make it less effective in preventing pregnancy
- may cause unexpected bleeding
This includes treatment with drugs for:
- epilepsy (eg primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, or felbamate)
- tuberculosis (eg rifampicin)
- HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz) or other infections (griseofulvin)
- arthritis, osteoarthritis (etoricoxib)
- traditional herbal medicines containing St. John’s wort
If you are being treated with any of the above medicines, you should also use a barrier method (eg a condom) temporarily or choose another contraceptive. When you use other medicines with Dienorette, you may need to use another contraceptive during that time and for a further 28 days after stopping treatment.
If your treatment extends beyond a blister card Dienorette, start on the next card immediately without using the placebo tablets. If long-term treatment is required (with any of the above medicines), you should choose another reliable non-hormonal contraceptive.
Dienorette may affect the effectiveness of other medicines
Dienorette may also affect the effectiveness of other medicines, for example:
- lamotrigine, a medicine for epilepsy (this may lead to an increased frequency of seizures)
- theophylline (used to treat respiratory problems)
- tizanidine (used to treat muscle pain or cramps)
Do not use Dienorette if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir as it may lead to elevated liver function levels in the blood (an increase in the liver enzyme ALT ).
Your doctor will prescribe another type of contraceptive before you start treatment with these drugs.
Dienorette can be used approximately 2 weeks after the end of this treatment. See section “Do not use Dienorette”.
Also, note the package leaflet for other medicines. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The use of Dienorette may affect the results of certain laboratory tests, including values of the liver, adrenal, kidney, and thyroid function, as well as the number of certain proteins in the blood, e.g. protein that affects the metabolism of fats and carbohydrates, blood coagulation and fibrinolysis. However, the impact is usually not so great that the test results deviate from the normal values. Tell healthcare professionals that you are taking birth control pills.
Dienorette with food, drink, and alcohol
Dienorette can be taken with or without food, with a little water if needed.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant,t or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Dienorette should not be used by pregnant women. If you become pregnant while taking Dienorette, stop treatment immediately and contact your doctor. If you want to get pregnant, you can stop the treatment at any time (see also the section “If you stop using Dienorette”).
You should generally not use Dienorette while breast-feeding as milk production may decrease and small amounts of the active substance may be excreted in human milk. If you want to use birth control pills while you are breastfeeding, you should consult your doctor or pharmacist.
Driving and using machines
Dienorette has no or negligible influence on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Dienorette contains excipients
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to use Dienorette
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Take one tablet of Dienorette daily. Swallow the tablet whole, with a little water if needed. You can take the tablets with or without food, but you should take the tablets at about the same time each day.
One tablet map contains 28 tablets. Next to each tablet is a day of the week, take one tablet every day.
Take a tablet marked with the current day of the week (indicated on the adhesive strip that you attach to the tablet map according to the instructions). For example, if you are starting on a Friday, take a tablet marked FRE (for Friday) by pushing the tablet through the aluminum foil. Take one tablet every day, in the order in which they appear on the adhesive strip on the tablet map.
The time of day for taking the tablet does not matter, but the tablet should be taken at approximately the same time each day. Follow the direction of the arrow until the tablet map is finished. Do not mix the tablets: take one white tablet once a day for the first 21 days and then one green tablet once a day for the last 7 days. You must start a new tablet immediately (21 white tablets and then 7 green tablets). There should be no tablet-free period between two tablet maps.
During the 7 days when you take the green placebo tablets ( placebo days), the bleeding should start (so-called dropout bleeding). The bleeding usually starts 2 or 3 days after you take the last white (active) tablet. After taking the last green tablet, start with the following tablet chart, regardless of whether the bleeding has stopped or not. This means that you should start each tablet chart on the same day of the week and that dropout bleeding should occur on the same days each month.
If you use Dienorette in this way, you will also be protected against pregnancy during the 7 days when you take a green placebo tablet.
How to start with your first tablet map
If you have not used a hormonal contraceptive in the last month
Start taking Dienorette on the first day of the menstrual cycle (ie the same day as your period begins).
When changing from another combined contraceptive pill
You should preferably start taking Dienorette the day after the last active tablet of your previous pill (the last tablet containing the medicine).
The last day you can start is after the tablet-free period with your previous pill or after the last placebo tablet of your previous pill.
Changing from a vaginal ring or contraceptive patch to Dienorette
You should preferably start taking Dienorette on the day the ring or patch is removed, but never later than when a new ring would have been inserted or a new patch would have been applied.
When changing from contraceptives with only progestogens mini-ill, contraceptive syringe, contraceptive rod, or IUD)
You can stop taking the mini-pills any day and start taking Dienorette. For the contraceptive rod or IUD, the change must take place on the day the IUD or IUD is removed. For the syringe, start taking Dienorette on the day you should have received a new syringe. In all these cases, you must use an additional contraceptive (such as a condom) during the first seven days of taking the tablet.
After an abortion or miscarriage during the first trimester of pregnancy
Ask your doctor for advice. In principle, you can start taking Dienorette right away.
After miscarriage during the second trimester of pregnancy or after childbirth
If you want to start taking Dienorette after giving birth or after a miscarriage in the second trimester, your doctor will advise you to wait between 21 and 28 days. If you start after day 28, use a so-called barrier method (eg condom) for the first seven days you use Dienorette.
If you have had intercourse after giving birth but before you start taking Dienorette, then make sure you are not pregnant or wait until your next period.
If you are breast-feeding and want to start treatment with Dienorette after giving birth,
Read the section “Breastfeeding”.
If you use more Dienorette then you should
There are no reports of serious side effects from taking too many Dienorette tablets.
If you have taken several tablets at the same time, you may experience nausea or vomiting. Younger women may experience vaginal bleeding.
If you have ingested too much medicine or if a child has accidentally ingested the medicine: contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to use Dienorette
The green tablets from the fourth row on the tablet map are placebo tablets (do not contain any medicine). If you forget to take one of these, it does not affect the effect of Dienorette. Throw away forgotten placebo tablets.
If you forget to take a white tablet (containing medicines) (tablets in rows 1-3 on the tablet map) you must:
- If less than 12 hours have passed since you should have taken your hormone tablet, you are still protected against pregnancy. 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 hormone 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 (first line) or the end (third line). Therefore, always follow these instructions.
More than 1 tablet on the tablet map has been forgotten: Contact your doctor for advice.
- 1 tablet forgotten during week 1 (first line)
Take 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, but do not forget to use extra contraceptive protection (eg condoms) for the next seven days. If you have had intercourse during the week before the forgotten tablet, there is a risk that you will become pregnant. In this case, inform your doctor immediately.
- 1 tablet forgotten during week 2 (second line)
Take 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. The contraceptive pill still has the desired effect provided that you have taken the tablets as you should during the 7 days before you forgot to take the tablet, and you do not need to use extra preventive protection. However, if you have missed more than one tablet, you must use a supplemental contraceptive for 7 days.
- 1 tablet forgotten during week 3 (third line)
You can choose between one of the following two options. You do not need to use extra contraceptive protection, provided you have taken the tablets as you should during the 7 days before you forgot to take the tablet:
- Take 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. Instead of taking the green placebo tablets on this map, throw them away and start on the next map. It is unlikely that you will menstruate until the end of the second map, but you may have breakthrough bleeding or spotting during the second map. OR
- You can also stop the treatment with the active white tablets and go directly to the green placebo tablets (from the day you forgot to take your tablet). Then start on a new tablet map. If you want to start a new map on your regular start day, use the placebo tablets for less than 7 days.
If you have forgotten to take tablets in a tablet chart and you do not get your expected period during the placebo week (the period with green tablets), you may be pregnant. Consult your doctor before starting the next tablet chart.
If you suffer from diarrhea or severe vomiting
If you vomit within 3-4 hours after taking the tablet or if you have severe diarrhea, the active ingredients in Dienorette may not be fully absorbed. This situation is pretty much the same as if you forgot a tablet. After vomiting or diarrhea, you must take a new tablet from a spare card as soon as possible. If possible, take it within 12 hours after you normally take your tablet. If this is not possible or if 12 hours have passed, you should follow the recommendations given under “If you forget to take Dienorette”.
If you want to postpone a period: What you need to know
Although not recommended, you can delay your period by not taking any green placebo tablets and immediately start a new Dienorette tablet chart. You can continue to take the active tablets on the other tablet chart until you want your period to begin, but no longer than until the tablet chart ends. Under the second tablet map, you may experience breakthrough bleeding or spotting.
After the following regular placebo days, you can continue to take Dienorette as usual.
You can consult your doctor before deciding to postpone your period
If you want to change the start day of the month for your period: What you need to know
If you take the tablets according to the instructions, your period will start every four weeks on about the same day. If you want to change this day, you can reduce the number of placebo days (the period when you take the green placebo tablets), but never extend the period. For example, if you usually start a new map on a Friday, and you want to change it to a Tuesday (3 days earlier) take only 4 of the green placebo tablets and start with the first white tablet from a new map 3 days earlier than usual. If the period of placebo tablets becomes very short (eg 3 days or less) then you may not experience any bleeding during this time. You may then experience breakthrough bleeding or spotting.
If you are not sure how to proceed, consult your doctor.
If you stop using Dienorette
You can stop taking Dienorette whenever you want. If you do not want to get pregnant, consult your doctor about other reliable contraceptives.
If you want to get pregnant, stop taking Dienorette and wait for your period before trying to conceive. You will then be able to more easily calculate the expected date of birth.
Additional information on special patient groups
Use in children and adolescents
Dienorette should only be used after the first menstrual period ( menarche ).
Dienorette should only be used by women before menopause.
Patients with hepatic impairment
Dienorette must not be used by women with severe liver disease (see section 2 “Do not take Dienorette”).
Patients with renal impairment
The use of Dienorette in women with renal impairment has not been studied. The knowledge that exists about the product does not indicate that the treatment needs to be changed.
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. If you get any side effects, especially if they are serious or persistent, or if your health changes and you think it may be due to Dienorette, talk to your doctor.
An increased risk of blood clots in your veins (venous thromboembolism, VTE) or blood clots in your arteries ( arterial thrombosis, ATE) is present in 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 Dienorette”.
Serious side effects are
Serious side effects associated with the use of birth control pills and related symptoms are described in the following sections: “Blood clots” and “Dienorette and cancer”. Read these sections carefully and contact your doctor immediately if necessary.
Other possible side effects are
The following side effects have been linked with the use of Dienorette:
Common side effects are (may affect up to 1 in 10):
- chest pain (includes chest discomfort and breast tenderness)
Less common side effects are (may affect up to 1 in 100):
- inflammation of the vagina and/or inflammation of the vulva and vagina (vaginitis/vulvovaginitis), fungal infections of the abdomen (candidiasis/candidiasis, other infection of the vulva and vagina).
- increased appetite
- migraine, dizziness
- high blood pressure, low blood pressure
- abdominal pain (including bloating), nausea, vomiting, diarrhea
- acne, hair loss ( alopecia ), skin rash, itching
- menstrual disorders including heavy menstruation ( menorrhagia ), small/sparse menstruation (hypomenorrhea), sparse menstruation ( oligomenorrhea ), and missed periods ( amenorrhea )
- menstrual bleeding (intermittent bleeding) such as vaginal bleeding, irregular menstrual bleeding ( metrorrhagia ), and painful bleeding ( dysmenorrhea )
- Abdominal discharge, cysts (blisters) on the ovaries, pain in the internal genitals, enlarged breasts, breast edema (tension in the breasts)
- fatigue, weakness, general malaise
- weight gain
Rare side effects are (may affect up to 1 in 1000):
- inflammation of the ovaries or fallopian tubes, urinary tract, bladder infection ( cystitis ), mammary gland inflammation ( mastitis ), inflammation of the cervix (cervicitis), fungal infections (eg candidiasis ), viral infections (e.g. cold sores), influenza, bronchitis ( bronchitis ), sinusitis, infection s in the upper respiratory tract
- benign tumor of the uterus ( myoma ), benign tumor of breast tissue (lipoma)
- decreased number of red blood cells ( anemia )
- allergic reactions
- enhancement of male traits (virilism)
- loss of appetite ( anorexia )
- depression, mental disorders, sleep problems, aggression
- stroke, disturbance in blood or heart blood circulation, muscle diseases that can cause abnormal postures ( dystonia )
- dry or irritated eyes, eye problems, blurred vision
- sudden hearing loss, tinnitus or noise ( tinnitus ), dizziness, hearing loss
- fast heartbeat
- inflammation of veins, high blood pressure (diastolic), dizziness or fainting e.g. when you stand up after sitting or lying down ( orthostatic dysregulation), hot flashes, varicose veins, venous diseases, pain in the veins
- harmful blood clots in a vein or artery, for example:
- in one leg or foot (so-called DVT)
- in the lungs ( pulmonary embolism)
- myocardial infarction
- 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 any other conditions that increase this risk (see section 2 for more information on the conditions that increase the risk of blood clots and symptoms of a blood clot).
- asthma, rapid or deep breathing (hyperventilation)
- inflammation of the gastric mucosa ( gastritis ), inflammation of the intestine ( enteritis ), sensitive stomach ( dyspepsia )
- Allergic inflammation of the skin ( dermatitis ), rash (e.g. neurodermatitis), psoriasis (disease-causing red thickened patches of skin), sweating ( hyperhidrosis), pigmentation in the skin (chloasma), increased talgkörtelutsöndring ( seborrhoea ), dandruff, cellulitis s, spider-like blood vessel malformation with a central red spot on the skin (spider nevus).
- back pain, skeletal pain, joint and muscle pain (eg myalgia ), pain in arms and legs
- cervical changes in the cervix (cervical dysplasia), pain or cysts (blisters) on the fallopian tubes and ovaries, cyst (blisters) in the breasts, pain/cramps during intercourse (dyspareunia), milk secretion from the mammary glands ( galactorrhea ), problems related to menstruation
- chest pain, swelling of the hands, ankles, or feet (peripheral edema ), flu-like symptoms, inflammation, fever, irritability
- high blood fats ( triglycerides and cholesterol ), weight loss, weight fluctuations
- swelling in (congenital) breast tissue outside the breasts (asymptomatic accessory breast)
Other side effects that have been reported (affects an unknown number of users):
Mood swings increased or decreased sex drive ( libido ), intolerance to contact lenses, hives, skin and/or mucous membrane reactions with rash, skin nodules, blisters or dead tissue (erythema nodosum or multiforme), secretion from the breasts, fluid accumulation in the breasts ( edema ).
The tumor is
- The incidence of breast cancer increases slightly with the use of Dienorette. As breast cancer rarely occurs in women under the age of 40, the risk of developing breast cancer with the overall risk is low. For more information, see the section “Dienorette and cancer”.
- liver tumors (benign and malignant)
- cervical cancer
- elevated levels of blood fats (hypertriglyceridemia; leading to an increased risk of pancreatitis when using combined oral contraceptives ).
- high blood pressure
- onset or worsening of disease/condition where it is not known for sure if it is caused by combined birth control pills::
- jaundice and/or pruritus related to cholestasis (blocked bile flow), gallstone formation, a metabolic condition called porphyria, systemic lupus erythematosus (a chronic autoimmune disease), hemolytic uremic syndrome(a blood clot disease ), a neurological condition called Sydenham’s chorea, herpes gestation (a type of skin rash that occurs during pregnancy), otosclerosis-related hearing loss
- in women with hereditary angioedema (which is characterized by sudden swelling of eg eyes, mouth, throat, etc.), estrogen in combined contraceptive pills can cause or worsen the symptoms of angioedema
- impaired liver function
- changes in the body’s ability to metabolize glucose (glucose tolerance) or that the body’s cells become less sensitive to insulin ( peripheral insulin resistance)
- Crohn’s disease, ulcerative colitis ( chronic inflammatory bowel disease)
- Pigment changes in the skin (chloasma)
Unexpected bleeding and/or no effect of birth control pills may be due to interactions with other medicines (eg herbal medicines containing St. John’s wort, or medicines for epilepsy, tuberculosis, HIV, and other infections ). See section “Other medicines and Dienorette”. Other serious reactions and symptoms are described in the section “Warnings and precautions”.
5. How to store Dienorette
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 and tablet carton after EXP.
The expiration date is the last day of the specified month.
Do not store above 25 ° C. Store in the original package. Sensitive to light.
The medicine 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
Each tablet with Dienorette contains 21 white active tablets on rows 1, 2, and 3 and 7 green placebo tablets on row 4.
- The active substances are dienogest and Ethinylestradiol. One white active tablet contains 2 mg dienogest and 0.03 mg Ethinylestradiol.
- Other ingredients are Tablet core: lactose monohydrate, magnesium stearate, corn starch, povidone. Tablet coating: hypromellose, macrogol, and titanium dioxide (E171).
Tablet core: lactose monohydrate, magnesium stearate, corn starch, povidone, colloidal anhydrous silicon.
Tablet coating: hypromellose, triacetin, polysorbate, titanium dioxide (E171), indigo carmine aluminum lacquer (E 132), and yellow iron oxide (E172).
What the medicine looks like and the contents of the pack
The active tablets are white, round, and film-coated.
The placebo tablets are green, round, and film-coated.
Dienorette is available in packs of 1, 3, or 6 tablets, and each tablet contains 28 tablets (21 active tablets and 7 placebo tablets).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Healthcare SL
Av.Miralcampo 7-Poligono Ind.Miralcampo
19200 Azuqueca de Henares
Laboratories León Farma, SA
Poligono Industrial Navatejera, La Vallina S / N
24008 Navatejera (Leon)