Active ingredient
- ethinylestradiol
- drospirenone
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00010/0575.
ELOINE 0.02 mg / 3 mg film coated tablets
Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.
Package leaflet: Information for the user
ELOINE 0.02 mg / 3 mg film-coated tablets
Ethinylestradiol / Drospirenone
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Important things to know about combined hormonal contraceptives (CHCs):
What is in this leaflet
1. What ELOINE is and what it is used for
2. What you need to know before you take ELOINE
When you should not use ELOINE
Warnings and precautions
BLOOD CLOTS
ELOINE and cancer
Psychiatric disorders
Bleeding between periods
What you must do if no bleeding occurs during the placebo days
Other medicines and ELOINE
ELOINE with food and drink
Laboratory tests
Pregnancy
Breast-feeding
Driving and using machines
ELOINE contains lactose
3. How to take ELOINE
Preparation of the strip
When can you start with the first strip?
If you take more ELOINE than you should
If you forget to take ELOINE
What to do in the case of vomiting or severe diarrhoea
Delaying your period: what you need to know
Changing the first day of your period: what you need to know
If you stop taking ELOINE
4. Possible side effects
5. How to store ELOINE
6. Contents of the pack and other information
1. What ELOINE is and what it is used for
2. What you need to know before you take ELOINE
General notes
Before you start using ELOINE, you should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot – see section 2 “Blood clots”.
Before you can begin taking ELOINE, your doctor will ask you some questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure and, depending upon your personal situation, may also carry out some other tests.
In this leaflet, several situations are described where you should stop using ELOINE, or where the reliability of ELOINE may be decreased. In such situations you should either not have sex or you should take extra non-hormonal contraceptive precautions, e.g., use a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because ELOINE alters the monthly changes of body temperature and of cervical mucus.
ELOINE, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
When you should not use ELOINE
You should not use ELOINE if you have any of the conditions listed below. If you do have any of the conditions listed below, you must tell your doctor. Your doctor will discuss with you what other form of birth control would be more appropriate.
Do not use ELOINE:
Do not use ELOINE if you have hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also in section “Other medicines and ELOINE”).
Additional information on special populations
Children and adolescents
ELOINE is not intended for use in females whose periods have not yet started.
Older women
ELOINE is not intended for use after the menopause.
Women with liver impairment
Do not take ELOINE if you suffer from liver disease. See also sections ‘Do not use ELOINE’ and ‘Warnings and precautions’.
Women with kidney impairment
Do not take ELOINE if you are suffering from poorly functioning kidneys or acute kidney failure. See also sections ‘Do not use ELOINE’ and ‘Warnings and precautions’.
Warnings and precautions
When should you contact your doctor?
Seek urgent medical attention
For a description of the symptoms of these serious side effects please go to “How to recognise a blood clot”.
Tell your doctor if any of the following conditions apply to you
In some situations you need to take special care while using ELOINE or any other combination pill, and your doctor may need to examine you regularly. If the condition develops, or gets worse while you are using ELOINE, you should also tell your doctor.
Talk to your doctor before taking ELOINE.
BLOOD CLOTS
Using a combined hormonal contraceptive such as ELOINE increases your risk of developing a blood clot compared with not using one. In rare cases a blood clot can block vessels and cause serious problems.
Blood clots can develop
Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or, very rarely, they may be fatal;
It is important to remember that the overall risk of a harmful blood clot due to ELOINE is small.
HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or symptoms.
Are you experiencing any of these signs?
What are you possibly suffering from?
Deep vein thrombosis
Are you experiencing any of these signs?
If you are unsure, talk to a doctor as some of these symptoms such as coughing or being short of breath may be mistaken for a milder condition such as a respiratory tract infection (e.g. a ‘common cold’).
What are you possibly suffering from?
Pulmonary embolism
Are you experiencing any of these signs?
Symptoms most commonly occur in one eye:
What are you possibly suffering from?
Retinal vein thrombosis (blood clot in the eye)
Are you experiencing any of these signs?
What are you possibly suffering from?
Heart attack
Are you experiencing any of these signs?
Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.
What are you possibly suffering from?
Stroke
Are you experiencing any of these signs?
What are you possibly suffering from?
Blood clots blocking other blood vessels
BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more.
After the first year, the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive.
When you stop ELOINE your risk of a blood clot returns to normal within a few weeks.
What 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 overall risk of a blood clot in the leg or lung (DVT or PE) with ELOINE is small.
Women who are not using a combined hormonal pill and are not pregnant
Risk of developing a blood clot in a year - About 2 out of 10,000 women
Women using a combined hormonal contraceptive pill containing levonorgestrel, norethisterone or norgestimate
Risk of developing a blood clot in a year - About 5-7 out of 10,000 women
Women using ELOINE
Risk of developing a blood clot in a year - About 9-12 out of 10,000 women
Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with ELOINE is small but some conditions will increase the risk. Your risk is higher:
The risk of developing a blood clot increases the more conditions you have.
Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if you have some of the other factors listed.
It is important to tell your doctor if any of these conditions apply to you, even if you are unsure. Your doctor may decide that ELOINE needs to be stopped.
If any of the above conditions change while you are using ELOINE, for example a close family member experiences a thrombosis for no known reason; or you gain a lot of weight, tell 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 cause serious problems. For example, it can cause a heart attack or a stroke.
Factors that increase your risk of a blood clot in an artery
It is important to note that the risk of a heart attack or stroke from using ELOINE is very small but can increase:
If you have more than one of these conditions or if any of them are particularly severe the risk of developing a blood clot may be increased even more.
If any of the above conditions change while you are using ELOINE, for example you start smoking, a close family member experiences a thrombosis for no known reason; or you gain a lot of weight, tell your doctor.
ELOINE and cancer
Breast cancer has been observed slightly more often in women using combination pills, but it is not known whether this is caused by the treatment. For example it may be that more tumours are detected in women on combination pills because they are examined by their doctor more often. The occurrence of breast tumours becomes gradually less after stopping the combination hormonal contraceptives. It is important to regularly check your breasts and you should contact your doctor if you feel any lump.
In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours have been reported in pill users. Contact your doctor if you have unusually severe abdominal pain.
Psychiatric disorders
Some women using hormonal contraceptives including ELOINE have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.
Bleeding between periods
During the first few months that you are taking ELOINE, you may have unexpected bleeding (bleeding outside the placebo days). If this bleeding occurs for more than a few months, or if it begins after some months, your doctor must find out what is wrong.
What you must do if no bleeding occurs during the placebo days
If you have taken all the light pink active tablets correctly, have not had vomiting or severe diarrhoea and you have not taken any other medicines, it is highly unlikely that you are pregnant.
If the expected bleeding does not happen twice in succession, you may be pregnant. Contact your doctor immediately. Only start the next strip if you are sure that you are not pregnant.
Other medicines and ELOINE
Always tell your doctor which medicines or herbal products you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you take ELOINE. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long, or, whether the use of another medicine you need must be changed.
Some medicines
These include
ELOINE may influence the effect of other medicines, e.g.
Do not use ELOINE if you have hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir as this may cause increases in liver function blood test results (increase in ALT liver enzyme). Your doctor will prescribe another type of contraceptive prior to start of the treatment with these medicinal products. ELOINE can be restarted approximately 2 weeks after completion of this treatment. See section “Do not use ELOINE”.
Ask your doctor or pharmacist for advice before taking any medicine.
ELOINE with food and drink
ELOINE may be taken with or without food, if necessary with a small amount of water.
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are taking the pill, because hormonal contraceptives can affect the results of some tests.
Pregnancy
If you are pregnant, you must not take ELOINE. If you become pregnant while taking ELOINE you must stop immediately and contact your doctor. If you want to become pregnant, you can stop taking ELOINE at any time (see also page 17 “If you stop taking ELOINE”).
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Use of ELOINE is generally not advisable when a woman is breast-feeding. If you want to take the pill while you are breast-feeding you should contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There is no information suggesting that use of ELOINE affects driving or use of machines.
ELOINE contains lactose
If you cannot tolerate certain sugars, contact your doctor before you take ELOINE.
3. How to take ELOINE
Each blister contains 24 active light pink film-coated tablets and 4 white placebo film-coated tablets.
The two differently coloured tablets of ELOINE are arranged in order. A strip contains 28 tablets.
Take one tablet of ELOINE every day, if necessary with a small amount of water. You may take the tablets with or without food, but you should take the tablets every day around the same time.
Do not confuse the tablets: take a light pink tablet for the first 24 days and then a white tablet for the last 4 days. You must then start a new strip straightaway (24 light pink and then 4 white tablets). There is therefore no gap between two strips.
Because of the different composition of the tablets it is necessary to begin with the first tablet on the upper left and that you take the tablets every day. For the correct order, follow the direction of the arrows on the strip.
Preparation of the strip
To help you keep track, there are 7 stickers each with the 7 days of the week for each strip of ELOINE. Choose the week sticker that starts with the day you begin taking the tablets. For example, if you start on a Wednesday, use the week sticker that starts with “WED”.
Stick the week sticker along the top of the ELOINE strip where it reads “Place week sticker here”, so that the first day is above the tablet marked “1”.
There is now a day indicated above every tablet and you can see whether you have taken a certain pill. The arrows show the order you are to take the pills.
During the 4 days when you are taking the white placebo tablets (the placebo days), bleeding should begin (so-called withdrawal bleeding). This usually starts on the 2nd or 3rd day after the last light pink active tablet of ELOINE. Once you have taken the last white tablet, you should start with the following strip, whether your bleeding has stopped or not. This means that you should start every strip on the same day of the week, and that the withdrawal bleed should occur on the same days each month.
If you use ELOINE in this manner, you are protected against pregnancy also during the 4 days when you are taking a placebo tablet.
When can you start with the first strip?
Ask your doctor what to do if you are not sure when to start.
If you take more ELOINE than you should
There are no reports of serious harmful results of taking too many ELOINE tablets.
If you take several tablets at once then you may feel sick or vomit or bleed from the vagina. Even girls who have not yet started to menstruate but have accidentally taken this medicine may experience such bleeding.
If you have taken too many ELOINE tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.
If you forget to take ELOINE
The last 4 tablets in the 4th row of the strip are the placebo tablets. If you forget one of these tablets, this has no effect on the reliability of ELOINE. Throw away the forgotten placebo tablet.
If you miss a light pink, active tablet (tablets 1-24 of your blister-strip), you must do the following:
The risk of incomplete protection against pregnancy is greatest if you forget a light pink tablet at the beginning or at the end of the strip. Therefore, you should keep to the following rules (see also the diagram on page 16):
Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time and use extra precautions for the next 7 days, for example, a condom. If you have had sex in the week before forgetting the tablet you must realize that there is a risk of pregnancy. In that case, contact your doctor.
Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time. The protection against pregnancy is not reduced, and you do not need to take extra precautions.
If you follow one of these two recommendations, you will remain protected against pregnancy.
What to do in the case of vomiting or severe diarrhoea
If you vomit within 3-4 hours of taking an active light pink tablet or you have severe diarrhoea, there is a risk that the active substances in the pill will not be fully taken up by your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhoea, you must take another light pink tablet from a reserve strip as soon as possible. If possible take it within 24 hours of when you normally take your pill. If this is not possible or 24 hours have passed, you should follow the advice given under “If you forget to take ELOINE”, page 13.
Delaying your period: what you need to know
Even if it is not recommended, you can delay your period by not taking the white placebo tablets from the 4th row and going straight to a new strip of ELOINE and finishing it. You may experience light or menstruation-like bleeding while using this second strip. Finish this second strip by taking the 4 white tablets from the 4th row. Then start your next strip.
You might ask your doctor for advice before deciding to delay your menstrual period.
Changing the first day of your period: what you need to know
If you take the tablets according to the instructions, then your period will begin during the placebo days. If you have to change this day, reduce the number of placebo days – when you take the white placebo tablets – (but never increase them – 4 is the maximum!). For example, if you start taking the placebo tablets on a Friday, and you want to change this to a Tuesday (3 days earlier) you must start a new strip 3 days earlier than usual. You may not have any bleeding during this time. You may then experience light or menstruation-like bleeding.
If you are not sure what to do, consult your doctor.
If you stop taking ELOINE
You can stop taking ELOINE whenever you want. If you do not want to become pregnant, ask your doctor for advice about other reliable methods of birth control. If you want to become pregnant, stop taking ELOINE and wait for a menstrual period before trying to become pregnant. You will be able to calculate the expected delivery date more easily.
If you have any further questions on the use of this medicine, 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 effect, particularly if severe and persistent, or have any change to your health that you think may be due to ELOINE, please talk to your doctor.
An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives. For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 “What you need to know before you take ELOINE”.
The following is a list of the side effects that have been linked with the use of ELOINE:
Common side effects (between 1 and 10 in every 100 users may be affected):
Uncommon side effects (between 1 and 10 in every 1,000 users may be affected):
Rare side effects (between 1 and 10 in every 10,000 users may be affected):
The chance of having 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 risk for blood clots and the symptoms of a blood clot).
The following side effects have also been reported, but their frequency cannot be estimated from the available data: hypersensitivity, erythema multiforme (rash with target-shaped reddening or sores).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App store.
5. How to store ELOINE
Keep this medicine out of the sight and reach of children.
This medical product does not require any special storage conditions
Do not use this medicine after the expiry date which is stated on the packaging after ”Do not use after:” or “ EXP.:” The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What ELOINE contains
What ELOINE looks like and content of the pack
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
and
This medicinal product is authorised in the Member States of the EEA under the following names:
This leaflet was last revised in June 2021.
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