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The product code(s) for this leaflet is: PL00025/0598.
Mercilon
Mercilon®
desogestrel (150 micrograms)
ethinyl estradiol (20 micrograms)
1. What Mercilon is and what it is used for
2. What you need to know before you use Mercilon
3. How to take Mercilon
4. Possible side effects
5. How to store Mercilon
6. Contents of the pack and other information
Mercilon is a combined oral contraceptive pill (‘the Pill’). You take it to prevent pregnancy.
This low-dose contraceptive contains two types of female sex hormones, oestrogen and progestogen. These hormones prevent an egg being released from your ovaries so you can’t get pregnant. Mercilon also makes the fluid (mucus) in your cervix thicker which makes it more difficult for sperm to enter the womb.
Mercilon is a 21-day pill - you take one each day for 21 days, followed by 7 days when you take no pills.
The benefits of taking the Pill include:
Mercilon will not protect you against sexually transmitted infections, such as Chlamydia or HIV. Only condoms can help to do this.
Mercilon needs to be taken as directed to prevent pregnancy.
Before you start using Mercilon 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”.
It’s important that you understand the benefits and risks of taking the Pill before you start taking it, or when deciding whether to carry on taking it. Although the Pill is suitable for most healthy women, it isn’t suitable for everyone.
You should not use Mercilon 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. See also section 2.2 ‘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.
If the condition develops, or gets worse while you are using Mercilon, you should also tell your doctor.
2.2.1. The Pill and Thrombosis
Blood Clots
Using a combined hormonal contraceptive such as Mercilon, increases your risk of developing a blood clot compared with not using one. In rare cases a blood clot can block blood 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 Mercilon 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?
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 Mercilon 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 Mercilon is small.
Risk of developing a blood clot in a year
Women who are not using a combined hormonal pill/patch/ring and are not pregnant:
About 2 out of 10,000 women
Women using a combined hormonal contraceptive pill containing levonorgestrel, norethisterone or norgestimate:
About 5-7 out of 10,000 women
Women using Mercilon:
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 Mercilon 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 Mercilon needs to be stopped.
If any of the above conditions change while you are using Mercilon, 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 Mercilon 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 Mercilon, 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.
2.2.2 The Pill and cancer
The Pill reduces your risk of cancer of the ovary and womb if used in the long term. However, it also seems to slightly increase your risk of cancer of the cervix - although this may be due to having sex without a condom rather than the Pill itself. All women should have regular smear tests.
If you have breast cancer, or have had it in the past, you should not take the Pill. The Pill slightly increases your risk of breast cancer. This risk goes up the longer you’re on the Pill, but returns to normal within about 10 years of stopping it. Because breast cancer is rare in women under the age of 40 the extra number of cases of breast cancer in current and recent users of the Pill is small.
For example:
Your risk of breast cancer is higher:
Taking the Pill has also been linked to liver diseases, such as jaundice and non-cancer liver tumours, but this is rare. Very rarely, the Pill has also been linked with some forms of liver cancer in women who have taken it for a long time.
2.2.3 Psychiatric disorders
Some women using hormonal contraceptives including Mercilon 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.
Tell your doctor, pharmacist or family planning nurse if you are using, have recently used or might use any other medicines or herbal products, even those not prescribed. Also tell any other doctor or dentist who prescribes another medicine (or your pharmacist) that you use Mercilon. This is because Mercilon can also affect how well other medicines work, causing either an increase in effect (e.g., ciclosporin) or a decrease in effect (e.g., lamotrigine). Remind your doctor if you are taking these in case your treatment needs to be adjusted.
Also check the leaflets that come with all your medicines to see if they can be taken with hormonal contraceptives.
Some medicines may stop Mercilon from working properly. These include medicines used for the treatment of:
If you are taking medicines or herbal products that might make Mercilon less effective, a barrier contraceptive method should also be used. Since the effect of another medicine on Mercilon may last up to 28 days after stopping the medicine, it is necessary to use the additional barrier contraceptive method for that long.
Do not use Mercilon if you have Hepatitis C and are taking 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.
Mercilon can be restarted approximately 2 weeks after completion of this treatment.
See section 2.1 “Do not use Mercilon”.
There are no special instructions about food and drink while on Mercilon.
Do not use Mercilon if you are pregnant. If you think you might be pregnant, do a pregnancy test to confirm that you are before you stop taking Mercilon.
Mercilon is not recommended for use during breast-feeding. Ask your doctor or family planning nurse about alternative contraception. Breast-feeding may not stop you getting pregnant.
Mercilon has no known effect on the ability to drive or use machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using Mercilon.
No clinical data on efficacy and safety are available in adolescents below 18 years.
To prevent pregnancy, always take this medicine exactly as described in this leaflet or as your doctor, family planning nurse or pharmacist has told you. Check with your doctor, family planning nurse or pharmacist if you are not sure.
Take Mercilon every day for 21 days.
Mercilon comes in strips of 21 pills, each marked with a day of the week.
Then have seven pill-free days.
After you have taken all 21 pills in the strip, you have seven days when you take no pills. So if you take the last pill of one pack on a Friday, you will take the first pill of your next pack on the Saturday of the following week.
Within a few days of taking the last pill from the strip, you should have a withdrawal bleed like a period. This bleed may not have finished when it is time to start your next strip of pills.
You don’t need to use extra contraception during these seven pill-free days - as long as you have taken your pills correctly and start the next strip of pills on time.
Then start your next strip
Start taking your next strip of Mercilon after the seven pill-free days - even if you are still bleeding. Always start the new strip on time.
As long as you take Mercilon correctly, you will always start each new strip on the same day of the week.
As a new user or starting the Pill again after a break
Either take your first Mercilon pill on the first day of your next period. By starting in this way, you will have contraceptive protection with your first pill.
Or if your period has already begun start taking Mercilon on day 5 (counting the first day of your period as day 1) whether or not your bleeding has stopped. You must also use extra contraception, such as condoms, until you have taken the first seven pills correctly.
Changing to Mercilon from another contraceptive Pill
Changing to Mercilon from a progestogen-only injection, implant or progestogen releasing intrauterine device (IUD)
Start taking Mercilon when your next injection is due or on the day that your implant or IUD is removed. Make sure you also use an additional contraceptive method, such as a condom, for the first 7 days that you are taking Mercilon.
Starting Mercilon after a miscarriage or abortion
If you have had a miscarriage or an abortion, your doctor may tell you to start taking Mercilon straight away. This means that you will have contraceptive protection with your first pill.
Contraception after having a baby
If you have just had a baby, ask your doctor for advice about contraception.
If you are not breast-feeding:
If you miss a pill, follow these instructions:
When were you due to take the missed Pill?
Less than 12 hours ago
More than 12 hours ago, or you have missed more than one Pill
7 or more pills left in the pack
Fewer than 7 pills left in the pack
If you have missed any of the pills in a strip, and you do not bleed in the first pill-free break, you may be pregnant. Contact your doctor or family planning clinic, or do a pregnancy test yourself.
If you start a new strip of pills late, or make your “week off” longer than seven days, you may not be protected from pregnancy. If you had sex in the last seven days, ask your doctor, family planning nurse or pharmacist for advice. You may need to consider emergency contraception. You should also use extra contraception, such as a condom, for seven days.
If you lose a pill,
Either take the last pill of the strip in place of the lost pill. Then take all the other pills on their proper days. Your cycle will be one day shorter than normal, but your contraceptive protection won’t be affected. After your seven pill-free days you will have a new starting day, one day earlier than before.
Or if you do not want to change the starting day of your cycle, take a pill from a spare strip. Then take all the other pills from your current strip as usual.
You can then keep the opened spare strip in case you lose any more pills.
If you are sick (vomit) or have very bad diarrhoea your body may not get its usual dose of hormones from that pill.
If you vomit within 3 to 4 hours after taking your pill, this is like missing a pill. You must follow the advice for missed pills - see section 3.3, A missed pill.
If you have severe diarrhoea for more than 12 hours after taking Mercilon follow the instructions for if you are more than 12 hours late - see section 3.3, A missed pill.
Occasionally, you may miss a withdrawal bleed. This could mean that you are pregnant, but that is very unlikely if you have taken your pills correctly. Start your next strip at the normal time. If you think that you might have put yourself at risk of pregnancy (for example, by missing pills or taking other medicines), or if you miss a second bleed, you should do a pregnancy test. You can buy these from the chemist or get a free test at your family planning clinic or doctors surgery. If you are pregnant, stop taking Mercilon and see your doctor.
It is unlikely that taking more than one pill will do you any harm, but you may feel sick, vomit or have some vaginal bleeding. Talk to your doctor if you have any of these symptoms.
If you want to delay having a period, finish the strip of pills you are taking. Start the next strip the next day without a break. Take this strip the usual way. After the second strip, leave seven pill-free days as usual, then start your next strip of pills in the normal way. When you use the second strip, you may have some unexpected bleeding or spotting on the days that you take the pill, but don’t worry.
If you are planning a baby, it’s best to use another method of contraception after stopping Mercilon until you have had a proper period. Your doctor or midwife relies on the date of your last natural period before you get pregnant to tell you when your baby is due. However, it will not cause you or the baby any harm if you get pregnant straight away.
Like all medicines, Mercilon 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 Mercilon, 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 use Mercilon”.
Contact a doctor immediately if you experience any of the following symptoms of angioedema: swollen face, tongue and/or throat and/or difficulty swallowing or hives potentially with difficulty breathing (see also section 2 “What you need to know before you use Mercilon”)
Signs of deep vein thrombosis include;
Signs of a pulmonary embolism:
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’).
Signs of retinal vein thrombosis (blood clot in the eye):
Signs of heart attack:
Signs of a stroke:
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.
Signs of blood clots blocking other blood vessels:
Signs of a severe allergic reaction to Mercilon
Signs of breast cancer include:
Signs of cancer of the cervix include:
Signs of severe liver problems include:
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1000 people)
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.)
Unknown (frequency cannot be estimated from the available data):
A few women have a little unexpected bleeding or spotting while they are taking Mercilon, especially during the first few months. Normally, this bleeding is nothing to worry about and will stop after a day or two. Keep taking Mercilon as usual; the problem should disappear after the first few strips.
You may also have unexpected bleeding if you are not taking your pills regularly, so try to take your pill at the same time every day. Also, unexpected bleeding can sometimes be caused by other medicines.
If you get any side effects, talk to your doctor, family planning nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use Mercilon after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store Mercilon below 25°C but not in the fridge. Store it in the original package, in order to protect from light and moisture.
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.
The active substances are desogestrel and ethinyl estradiol. Each tablet contains: 150 micrograms of the progestogen desogestrel, and 20 micrograms of the oestrogen ethinyl estradiol.
The other ingredients are: dl-alpha-tocopherol, potato starch, povidone, stearic acid, aerosol and lactose.
Each box of Mercilon contains three strips of 21 tablets.
Each strip of Mercilon contains 21 white tablets.
The tablets are biconvex, round and 6 mm in diameter. Each tablet is marked TR4 on one side and Organon* on the reverse side.
Marketing Authorization Holder
Manufacturer
This leaflet was last revised in November 2022.
In correspondence please quote packing number.
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Product name: Mercilon
Reference Number: PL 00025/0598
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