Morningside Healthcare Contraceptives

Yacella^® is a contraceptive pill and is used to prevent pregnancy. Each tablet contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol. Contraceptive pills that contain two hormones are called “combination” pills.

Before you start using Yacella^® you should read the patient information leaflet that came inside the box with your Yacella^® tablets. It is particularly important to read about the symptoms of a blood clot. In the patient information leaflet several situations are also described where you should stop using Yacella^®, or where the reliability of Yacella^® 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 Yacella^® alters the monthly changes of body temperature and cervical mucus.You should not use Yacella 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 take Yacella

• if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs
• if you know you have a disorder affecting your blood clotting – for instance, protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies
• if you need an operation or if you are off your feet for a long time (see section ‘Blood clots’)
• if you have ever had a heart attack or a stroke
• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack (TIA – temporary stroke symptoms)
• if you have any of the following diseases that may increase your risk of a clot in the arteries:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • a very high level of fat in the blood (cholesterol or triglycerides)
  • a condition known as hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called ‘migraine with aura
• if you have (or have ever had) an inflammation of the pancreas (pancreatitis)
• if you have (or have ever had) a liver disease and your liver function is still not normal
• if your kidneys are not working well (renal failure)
• if you have (or have ever had) a tumour in the liver
• if you have (or have ever had) or if you are suspected of having breast cancer or cancer of the genital organs
• if you have any unexplained bleeding from the vagina
• if you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of this medicine (listed in section 6 of your Patient Information Leaflet). This may cause itching, rash or swelling

When should you contact your doctor?

Seek urgent medical attention if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack or a stroke (see ‘Blood clots’ section below). For a description of the symptoms of these serious side effects please go to “How to recognise a blood clot” contained in your Patient Information Leaflet.

Yacella^®, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Take one tablet of Yacella^® 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. The strip contains 21 tablets. Next to each tablet is printed the day of the week that it should be taken. If, for example you start on a Wednesday, take a tablet with “WED” next to it. Follow the direction of the arrow on the strip until all 21 tablets have been taken. Then take no tablets for 7 days. In the course of these 7 tablet-free days (otherwise called a stop or gap week) bleeding should begin. This so-called “withdrawal bleeding” usually starts on the 2nd or 3rd day of the gap week. On the 8th day after the last Yacella^® tablet (that is, after the 7-day gap week), 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 Yacella^® in this manner, you are also protected against pregnancy during the 7 days when you are not taking a tablet.When can you start with the first strip?

• If you have not used a contraceptive with hormones in the previous month
  Begin with Yacella^® on the first day of your cycle (that is the first day of your period). If you start Yacella^® on the first day of your period you are immediately protected against pregnancy. You may also begin on day 2-5 of the cycle, but then you must use extra protective measures (for example, a condom) for the first 7 days.
• Changing from a combined hormonal contraceptive, or combined contraceptive vaginal ring or patch.
  You can start Yacella^® preferably on the day after the last active tablet (the last tablet containing the active substances) of your previous pill, but at the latest on the day after the tablet-free days of your previous pill finish (or after the last inactive tablet of your previous pill). When changing from a combined contraceptive vaginal ring or a transdermal patch, follow the advice of your doctor.
• Changing from a progestogen-only-method (progestogen only pill, injection, implant or a progestogen-releasing intrauterine system (IUS))
  You may switch any day from the progestogen-only pill (from an implant or an IUS on the day of its removal, from an injectable when the next injection would be due) but in all of these cases use extra protective measures (for example, a condom) for the first 7 days of taking Yacella^®.
• After a miscarriage or abortion
  Follow the advice of your doctor.
• After having a baby
  You can start taking Yacella^® between 21 and 28 days after having a baby. If you start later than day 28, use a so-called barrier method (for example, a condom) during the first seven days of taking Yacella^®.
  If, after having a baby, you have had sex before starting Yacella^® (again), you must first be sure that you are not pregnant or you must wait until your next period.

Ask your doctor what to do if you are not sure when to start.

Bleeding between periods

During the first few months that you are taking Yacella, you may have unexpected bleeding (bleeding outside the gap week). If this bleeding occurs for more than a few months, or if it begins after some months, contact your doctor so that they can find out if anything is wrong.

What to do if no bleeding occurs during the seven pill-free days

If you have taken all the 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

What to do in case of vomiting or severe diarrhoea 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 will not be fully taken up by your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhoea, take another tablet from a reserve strip as soon as possible. If possible take it within 12 hours of when you normally take your pill. If that is not possible or 12 hours have passed, you should follow the advice given under “If you forget to take Yacella”.

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.

Other medicines and Yacella

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you are taking this medicine. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long. Some medicines can make Yacella less effective in preventing pregnancy, or can cause unexpected bleeding.

These include medicines used for the treatment of

• epilepsy (e.g. barbiturates, carbamazepine, phenytoin, primidone, oxcarbazepine),
• tuberculosis (e.g. rifampicin),
• HIV infections (e.g. ritonavir, nevirapine) or other infections(antibiotics such as griseofulvin, penicillin, tetracycline),
• high blood pressure in the blood vessels in the lungs (bosentan),
• the herbal remedy St. John’s wort. Yacella may influence the effect of other medicines, e.g.
• medicines containing ciclosporin,
• the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures).

Ask your doctor or pharmacist for advice before taking any medicine.

• If you are less than 12 hours late taking a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then take the following tablets again at the usual time.
• If you are more than 12 hours late taking a tablet, the protection against pregnancy may be reduced. The greater the number of tablets that you have forgotten, the greater is the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or at the end of the strip. Therefore, you should keep to the following rules:

More than one tablet forgotten in this strip
Contact your doctor.

One tablet is forgotten in week 1
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 may be pregnant. In that case, contact your doctor.

One tablet is forgotten in week 2
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 forget more than one tablet use an additional barrier method such as a condom for 7 days.

One tablet is forgotten in week 3
You can choose between two possibilities:

1. 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. Instead of having seven pill-free days start the next strip as soon as you have taken the last tablet.

Most likely, you will have a period at the end of the second strip – but you may also have light or menstruation-like bleeding during the second strip.

2. You can also stop the strip and go directly to the tablet-free period (record the day on which you forgot your tablet). If you want to start a new strip the day you always start, make the tablet-free period less than 7 days.

If you follow one of these two recommendations, you will remain protected against pregnancy.

• If you have forgotten any of the tablets in a strip, and you do not have bleeding in the first tablet-free period, you may be pregnant. Contact your doctor before you start the next strip.

Like all medicines, Yacella^® 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 Yacella^®, 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 Yacella” in your Patient Information Leaflet.The following is a list of the side effects that have been linked with the use of Yacella^® tablets:Common side effects(between 1 and 10 in every 100 users may be affected):

• menstrual disorders, bleeding between periods, breast pain, breast tenderness
• headache, depressive mood
• migraine
• nausea
• thick, whitish vaginal discharge and vaginal yeast infection

Uncommon side effects(between 1 and 10 in every 1,000 users may be affected):

• breast enlargement, changes in interest in sex
• high blood pressure, low blood pressure
• vomiting, diarrhoea
• acne, skin rash, severe itching, hair loss (alopecia)
• infection of the vagina
• fluid retention and body weight changes

Rare side effects(between 1 and 10 in every 10,000 users may be affected):

• allergic reactions (hypersensitivity), asthma
• breast secretion
• hearing impairment
• the skin conditions erythema nodosum (characterized by painful reddish skin nodules) or erythema multiforme (characterized by rash with target-shaped reddening or sores)
• harmful blood clots in a vein or artery for example:
  • in a leg or foot (i.e. DVT)
  • in a lung (i.e. PE)
  • heart attack
  • stroke
  • mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA)
  • blood clots in the liver, stomach/intestine, kidneys or eye

The chance of having a blood clot may be higher if you have any other conditions that increase this risk.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in your Patient Information Leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard 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. This medicinal product does not require any special storage conditions.Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.Do not throw away any medicines via wastewater or household waste. Ask you pharmacist to throw away medicines you no longer use. These measures will help protect the environment.

Yacella^® is a round, yellow, uncoated biconvex tablet with ‘143’ debossed on one side and other side plain.
They are supplied in blister packs containing 21, 63, 126 or 273 tablets. Each carton contains blisters packed separately in an aluminium laminated sachet.
Not all pack sizes may be marketed.Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road
Leicester, LE3 0PA
United Kingdom