Seasonique

This leaflet answers some common questions about Seasonique.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will provide.

You may need to read it again.

Seasonique is used to prevent pregnancy.

Seasonique is a combined oral contraceptive (COC), commonly known as a 'birth control pill' or 'the Pill.' It is an extended-dosing cycle taken continuously for 91 days. This means whilst taking Seasonique you may not have your monthly periods for up to 3 months (equivalent to 1 period every 3 months).

When taken correctly Seasonique prevents pregnancy in several ways:

When the Pill is taken correctly by women under close observation in clinical trials, it is more than 99% effective in preventing pregnancy. However in real life the failure rate may increase if tablets are missed or taken incorrectly.

Like all other oral contraceptives Seasonique does not protect against HIV and other sexually transmitted infections (STIs). To protect yourself against STIs you need to use additional barrier contraceptives (e.g. condoms).

Your doctor may have prescribed it for another purpose.

This medicine is only available with a doctor's prescription.

Pregnancy must be excluded before you start taking Seasonique.

If it is expired or damaged, return it to your pharmacist for disposal.

Oral contraceptives increase your risk of having a stroke or heart attack. The risk of serious side effects on the heart and blood vessels is even greater if you smoke and take oral contraceptives. The risk increases with age and with heavy smoking (15 or more cigarettes per day), especially in women older than 35 years. If you take Seasonique, you should not smoke.

The use of any combined hormonal contraceptive (CHC) increases the risk of VTE compared with no use. The VTE risk is highest in the first ever year of use. There is some evidence that the risk is increased when a CHC is re-started after a break in use of four weeks or more.

There is some evidence that the use of CHCs may be associated with an increased risk of ATE.

If you have any of these conditions you should have regular check-ups with your doctor to make sure that taking Seasonique is not making the conditions worse.

Some women have an increased chance of blood clots due to factors such as age, family history of VTE, high body weight and smoking. Women assessed by their doctor as being at increased risk of VTE should not use Seasonique.

The risk of developing blood clots in the deep veins of your legs, which can break away and block a blood vessel elsewhere in your body, are increased if you have any of these conditions and use an oral contraceptive. Blood clots are a rare occurrence and can develop whether or not you are taking an oral contraceptive. They can also happen during pregnancy. The risk of having a blood clot is higher in oral contraceptive users than in non-users, but not as high as during pregnancy or just after having a baby.

VTE with any combined hormonal method of contraception is much less common than VTE in pregnancy and the period immediately after having a baby.

Pills containing levonorgestrel (such as Seasonique) or norethisterone appear to have lower VTE risk.

The risk of VTE with the COC is greatest for products containing over 50 micrograms of ethinyloestradiol. There is less risk for products containing less than 35 micrograms of ethinyloestradiol such as Seasonique. It is not known how Seasonique, with its 91-day cycle, influences the occurrence of such events in comparison to other levonorgestrel containing COCs, which are based on a 28-day cycle.

If you are at risk of prolonged immobilisation, due to major surgery or, any surgery to the legs or pelvis or major trauma), you should discuss this with your doctor. It is recommended to discontinue the use of Seasonique and not resume until two weeks after complete remobilisation. Another method of contraception should be used during this time to avoid unintentional pregnancy.

You should discuss this with your doctor before discontinuing the use of Seasonique.

Your doctor can discuss the risks and benefits involved with you.

Some medicines may be affected by Seasonique or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor will advise you.

If you take rifampicin and some other medicines, you may need to use additional non-hormonal contraception for four weeks after finishing the course of treatment.

Concomitant use with products containing ombitasvir, paritaprevir, ritonavir or dasabuvir with or without ribavirin may increase liver enzymes.

If you are taking or begin taking these medicines while taking Seasonique, you must switch to an alternative method of contraception (e.g. progestogen-only contraception or non-hormonal methods) prior to commencing therapy.

Seasonique can be restarted 2 weeks following completion of treatment with this combination regimen.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while you are taking this medicine.

These directions may differ from the information contained in this leaflet.

Seasonique pack consists of 84 pink tablets of 150 micrograms levonorgestrel and 30 micrograms ethinyloestradiol and 7 white tablets containing 10 micrograms of ethinyloestradiol

The daily dosing regimen should start with the first tablet (#1) of Month 1 blister.

Take one tablet about the same time every day. Tablet taking is continuous for 91 days. You may take the tablets with or without food, and if necessary with a little liquid in the order shown at the blister pack.

To help you keep track, there are 7 weekday sticker strips marked with the 7 days of the week. 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 Seasonique pack 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. Usually, so-called withdrawal bleeding starts when you are taking white tablets. Once you have taken the last white tablet, you should start with the following Seasonique pack, whether your bleeding has stopped or not. This means that you should start every pack on the same day of the week, and that the withdrawal bleed should occur on the same days each time. If you use Seasonique in this manner, you are protected against pregnancy during the whole 91 days. For continued protection against pregnancy make sure you have a new pack of Seasonique ready to start.

One pink tablet containing levonorgestrel and ethinyloestradiol is taken daily for 84 consecutive days, followed by one white ethinyloestradiol tablet for 7 days.

The tablets must be taken every day at about the same time, if necessary with a little liquid, in the order shown on the blister pack. One tablet is to be taken daily for 91 consecutive days.

Each subsequent 91-day cycle should be started without interruption on the same day of the week as you began your first dose of Seasonique, following the same schedule.

Follow the advice of your doctor. You should start with Seasonique on the day after the last active tablet (the last tablet containing the active substances) of your previous COC.

Follow the advice of your doctor. You should start using Seasonique on the day of removal but at the latest when the next application would have been due.

You may switch any day from the progestogen-only pill (from an implant or the IUD on the day of its removal, from an injectable when the next injection would be due). In all of these cases you must use a barrier method of contraception (e.g. a condom) for the first 7 days of tablet-taking.

Follow the advice of your doctor.

If you have just had a baby, talk to your doctor before you start taking Seasonique.

Your doctor may prescribe Seasonique for long periods, until you no longer need or want contraception.

Take the pink tablets according to the following principles:

 

Take the tablet as soon as you remember even if this means taking two tablets at the same time. Continue taking the following tablets at the usual time. The protection against pregnancy is not reduced and you do not need to take extra contraceptive precautions.

 

If two pink tablets are missed, take two tablets as soon as you remember and additional two on the next day. Continue taking the following tablets at the usual time.

If 3 or more pink tablets are missed, do not take the forgotten tablets and continue taking the following tablets at the usual time. You may experience bleeding during the week following the missed tablets.

In any case use additional contraceptive precautions for the following 7 days e.g. a barrier method such as a condom. If you have had sex in the week before forgetting tablets there is a possibility of pregnancy. So contact your doctor immediately.

If two pink tablets are missed, take two tablets as soon as you remember and additional two on the next day. Continue taking the following tablets at the usual time. Use additional contraceptive precautions for the following 7 days e.g. a barrier method such as a condom.

If 3 or more pink tablets are missed, do not take the forgotten tablets and continue taking the following tablets at the usual time. You may experience bleeding during the week following the missed tablets. Use additional contraceptive precautions for the following 7 days e.g. a barrier method such as a condom. If you have had sex during the days of missed tablets there is a possibility of pregnancy. So contact your doctor immediately.

If you vomit within 3-4 hours of taking a tablet or you have severe diarrhoea, there is a risk that the active substances in the pill are not fully absorbed into your body. The situation is similar to if you forget a tablet. After vomiting or diarrhoea, you must take another tablet as soon as possible. The advice given under "If you forget to take your tablets" should be followed.

If you don't want to change your normal tablet-taking pattern take the extra pink tablet from the last row in the pack.

Symptoms of an overdose may include:

Oral contraceptives should not be prescribed for longer than one year without your doctor carrying out a check-up. Your doctor will advise you how often you need a Pap smear. A Pap smear can detect abnormal cells lining the cervix. Sometimes abnormal cells can progress to cervical cancer. The most important risk factor for cervical cancer is persistent human papillomavirus (HPV) infection. However, cervical cancer has been reported to occur more often in women using an oral contraceptive for a long time. This finding may not be caused by the oral contraceptive, but may be related to sexual behaviour and other reasons.

Risk factors for the development of breast cancer include increasing age, family history, obesity, never having had a baby, and late age for first full term pregnancy. Breast cancer has also been found slightly more often in women who use oral contraceptives than in women of the same age who do not use them. This slight increase in the number of breast cancer cases gradually disappears during the course of the 10 years after stopping use of oral contraceptives. It is not known whether the oral contraceptive causes the difference. It may be that the women were examined more often, so that the breast cancer was noticed earlier.

Seasonique will not protect you from HIV-AIDS or any other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, human papilloma virus and syphilis. To help protect yourself from STDs, you need to use a barrier contraceptive such as a condom.

 

When you take Seasonique, which has a 91-day extended dosing cycle, you should expect to have 4 scheduled periods per year (bleeding when you are taking the 7 white pills). Each period is likely to last about 3 days.

During the first few months that you are taking Seasonique, you may have unexpected bleeding. This bleeding or spotting tends to decrease with time. Do not stop taking Seasonique because of this bleeding or spotting. If the spotting continues for more than 7 consecutive days or if the bleeding is heavy, contact your doctor.

If you stop taking Seasonique or do not take a tablet every day, without using another form of contraception, you may become pregnant.

All medicines can have side effects. Sometimes they are serious, but most of the time they are not. You may need medical treatment if you get some of the side effects.

It can be difficult to tell whether side effects are the result of taking Seasonique or are side effects of another medicine you are taking.

You may not experience any of them.

The above list includes the more common side effects of your medicine.

The above list includes serious side effects that may require medical attention. Serious side effects are rare.

Whilst these side effects are rare, they are serious. You may need urgent medical attention or hospitalisation.

Other side effects not listed above may also occur in some patients.

If you take the tablets out of the blister pack they may not keep well.

Keep your tablets in a cool, dry place where the temperature stays below 30°C and is away from light. Do not store Seasonique or any other medicine, in a bathroom or near a sink. Do not leave Seasonique in the car on hot days or on window sills. Heat and dampness can destroy some medicines. Keep it where children cannot reach it. A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines.

Seasonique pack contains 3 blisters in total: 2 blisters each holding 28 pink tablets and 1 blister holding 35 tablets in total- 28 pink tablets and 7 white tablets.

The pink tablets contain 150 micrograms levonorgestrel and 30 micrograms ethinyloestradiol. The white tablets contain 10 micrograms ethinyloestradiol.

The pink tablet is round, biconvex tablet, around 5.7 mm in diameter, embossed "172" on one side and "T" on the other side.

The white tablet is round, biconvex tablet, around 5.7 mm in diameter, embossed "173" on one side and "T" on the other side

Each pink film-coated tablet contains 150 micrograms of levonorgestrel and 30 micrograms ethinyloestradiol.

Each white tablet contains 10 micrograms ethinyloestradiol.

The pink tablets contain the following inactive ingredients:

The pink tablets contain the colouring agents:

The white tablets contain the following inactive ingredients:

Seasonique does not contain gluten or tartrazine.