Ortho Cyclen
(Ethinyl Estradiol/Norgestimate)

Prescription Settings Edit

Brand Name Choices

Ortho Cyclen-21 0.035/0.25mg
Ortho Cyclen-21 0.035/0.25mg

Marketed as Cilest 0.035/0.25mg in United Kingdom

Manufactured by Janssen-Cilag Ltd

Product of United Kingdom

Dispensed by a licensed pharmacy in the United Kingdom

* Ortho-Cyclen goes by the trade name Cilest in the UK.

Prescription Required

Parallel Import

Ortho Cyclen-28 0.035/0.25mg
Ortho Cyclen-28 0.035/0.25mg

Marketed as Cyclen Discreet 0.035/0.25mg in Canada

Manufactured by Janssen Inc

Product of Canada

Dispensed by an approved Canadian pharmacy partner

Prescription Required

Generic Choices

Ethinyl Estradiol/Norgestimate 0.035/0.25mg
Ethinyl Estradiol/Norgestimate 0.035/0.25mg

Marketed as Cilique 0.035/0.25mg in United Kingdom

Generic Equivalent of Ortho Cyclen 0.035/0.25mg

Manufactured by Consilient Health

Product of United Kingdom

Dispensed by a licensed pharmacy in the United Kingdom

Prescription Required

What Ortho Cyclen is and what it is used for

Cilest is a combined hormonal contraceptive pill (‘the Pill’). You take it to stop getting pregnant.
•2 - This 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. Also, Cilest makes the fluid (mucus) in your cervix thicker which makes it more difficult for sperm to enter the womb. Cilest 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:
• it is one of the most reliable reversible methods of contraception if used correctly
• it doesn’t interrupt sex
• it usually makes your periods regular, lighter and less painful
• it may help with pre-menstrual symptoms Cilest will not protect you against sexually transmitted infections, such as Chlamydia or HIV. Only condoms can help to do this. Cilest needs to be taken as directed to prevent pregnancy.

How to take Ortho Cyclen

3.1 How to take it To prevent pregnancy, always take Cilest as described below. Check with your doctor or family planning nurse if you are not sure. Take Cilest every day for 21 days Cilest comes in a strip of 21 pills, each marked with a day of the week.
• Take your pill at the same time every day.
• Start by taking a pill marked with the correct day of the week.
• Follow the direction of the arrows on the strip. Take one pill each day.
• Swallow each pill whole, with water if necessary. Do not chew the pill. 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 Cilest after the seven pill-free days – even if you are still bleeding. Always start the new strip on time. As long as you take Cilest correctly, you will always start each new strip on the same day of the week. 3.2 Starting Cilest As a new user or starting the Pill again after a break Either take your first Cilest pill up to and including day 5 of your next period (counting the first day of your period as day 1). This way, you will have contraceptive protection with your first pill. Or start taking Cilest at any time, if you are sure you are not already pregnant. But then you must use extra contraception, such as condoms, until you have taken the first 7 pills correctly.
•12 - Changing to Cilest from another contraceptive If you are currently taking another Pill and you are taking it correctly, you can start Cilest at any time, if you are sure you are not already pregnant. There is no need to wait for your next period to start and you don’t need extra contraception. If you are currently using a non-hormonal method and your period started more than 5 days ago, you must use extra contraception, such as condoms, until you have taken the first 7 pills correctly. Starting Cilest after a miscarriage or abortion If you have had a miscarriage or an abortion, your doctor may tell you to start taking Cilest 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, you are more at risk of blood clots (see Section 2.1 ‘The Pill and blood clots’). Ask your doctor when you can start taking Cilest again. If it is 21 days after the birth, you will have contraceptive protection with your first pill. If you start Cilest after this, you must use extra contraception, such as condoms, until you have taken the first 7 pills correctly. If you have sex before you start taking Cilest or before your first period, wait until your period starts before you take Cilest and then take it on the first day of bleeding.
•13 - _____________________________________________________________ 3.3 A missed pill Missing pills or starting a strip late may make your pill less effective. The chance of pregnancy after missing pills depends on when pills are missed and how many pills are missed. Missing one pill anywhere in your strip or starting a new strip one day late is not a problem. Missing more than one or starting a strip more than one day late may affect your contraceptive cover. It is more risky to start a strip late and miss more than one pill. 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 eight 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. _____________________________________________________________ 3.4 A lost pill How many pills have you missed? One pill Two or more pills
• Take the missed pill straight away, and further pills as usual. This may mean taking two pills in one day.
• Continue taking the rest of the strip as usual.
• Don’t worry
•your contraceptive protection should not be reduced.
• Take the most recently missed pill straight away
• Leave any earlier missed pills in the strip
• Take your next pill at the usual time. This may mean taking two pills in one day.
• Continue taking the rest of the strip as usual.
• Use extra precautions (condoms, for instance) for the next 7 days.
• Check how many pills are left in the strip after the most recently missed pill Fewer than 7 pills left in the pack
• Use extra precautions for the next 7 days
• When you finish the strip, start the next strip the next day without a break.
• If you do not have a withdrawal bleed after you have finished the second strip, do a pregnancy test 7 or more pills left in the pack
• Use extra precautions for the next 7 days
• When you have finished the strip, leave the usual 7-day break before starting the next strip.
• If you have missed any pills from the first week of your strip and you had sex in that week, you could become pregnant. Contact your doctor, family planning nurse or pharmacist for advice as soon as possible. They may recommend you use emergency contraception.
•14 - If you lose a pill, just 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. _____________________________________________________________ 3.5 If you are sick or have diarrhoea If you are sick or have very bad diarrhoea, your body may not get its usual dose of hormones from that pill. If you have been sick within 2 hours of taking Cilest, just take a pill from a spare strip. Carry on taking your pills as normal if you can. You won’t need to use extra contraception. If you are still sick or have diarrhoea for more than 1 day, follow the instructions for a missed pill – see section 3.3, A missed pill. Talk to your doctor if your stomach upset carries on or gets worse. He or she may recommend another form of contraception. ____________________________________________________________ 3.6 Missed a period – could you be pregnant? 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 doctor’s surgery. If you are pregnant, stop taking Cilest and see your doctor. _____________________________________________________________ 3.7 Taking more than one pill should not cause harm 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. _____________________________________________________________ 3.8 You can delay a period 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. Pill taking should then continue as usual. 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. Take the next strip after the usual 7 day break even if you are still bleeding or spotting. ____________________________________________________________ 3.9 When you want to get pregnant If you are planning a baby, it’s best to use another method of contraception after stopping Cilest until you have had a proper period. Your doctor or midwife relies on the date of your last natural period to tell you when your baby is due. The Pill may reduce the levels of folic acid in the blood. Talk to your doctor, nurse or pharmacist as this could be important if you get pregnant straight after stopping the Pill.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor, pharmacist or family planning nurse if you get any side effect particularly if they are severe and persistent, or you have any change in your health which you think may be due to Cilest. 4.1 Serious side effects – see a doctor straight away Harmful blood clots in a vein or artery (frequency not known) for example:
•in a leg or foot (DVT)
•in a lung (PE)
•heart attack
•stroke
•mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA)
•blood clots in the stomach/intestines, kidneys or eye
•blood clots in the liver, which can cause an enlarged liver, pain and swelling (Budd-Chiari syndrome). An increased risk of blood clots in your veins (venous thromboembolism, VTE) or arteries (arterial thromboembolism, ATE) is present for all women taking the Pill. For more detailed information on the different risks from taking the Pill, please see Section 2 ‘Make sure Cilest is OK for you’. The chance of having a blood clot may be higher if you have any other conditions that increase this risk (see Section 2.1 ‘The Pill and blood clots’ for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot). Breast cancer (frequency not known) Signs include:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel. Severe liver problems (rare
•affects fewer than 1 in 1000 patients) Signs include:
• severe pain in your upper abdomen
• yellow skin or eyes (jaundice). Other serious side effects include:
• increased blood pressure (uncommon
•affects fewer than 1 in 100 patients)
• fits (convulsions) (frequency not known)
• hives (urticaria) (uncommon
•affects fewer than 1 in 100 patients), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing. These may be signs of allergy. If you think you may have any of these, see a doctor straight away. You may need to stop taking Cilest. ___________________________________________________________
•16 - 4.2 Other possible side effects – tell your doctor

Very common side effects (affects more than 1 in 10 patients)
• Headache (but if severe, unusual or long lasting, see a doctor as soon as possible)
• Stomach problems such as nausea, vomiting and diarrhoea
• Bleeding and spotting between your periods for the first few months (though this usually stops when your body adjusts to Cilest) – see section 4.3, Bleeding between periods should not last long
• Painful or unusual periods

Common side effects (affects more than 1 in 100 patients)
• Migraine (see a doctor as soon as possible if this is your first migraine or it’s worse than usual)
• Swollen hands, ankles or feet
• Depression; mood changes; feeling nervous or dizzy
• Difficulty sleeping (insomnia)
• Stomach ache and bloating; constipation; wind
• Acne; rash
• Muscle spasms; pain in the legs, arms and back
• Painful breasts
• Urinary tract infections (pain on passing urine)
• Vaginal infections such as thrush
• Vaginal discharge
• No menstrual periods
• Feeling weak
• Weight gain.

Uncommon side effects (affects fewer than 1 in 100 patients)
• Breast problems, such as fuller breasts; producing fluid from the nipples
• Abnormal cells in the cervix (identified by a smear test)
• Feeling anxious or faint; tingling sensation or numbness
• Changes in skin colour
• Skin problems such as redness and itchiness
• Hair thinning (alopecia), excessive hair growth
• Changes in appetite
• Weight may vary
• Change in sex drive
• Dry eyes
• Changes in vision
• Palpitations (feeling your heart beat)
• Hot flushes
• Muscle pain
• Vaginal dryness
• Ovarian cysts (may cause pain and swelling of the abdomen, changes in periods)

Rare side effects (affects fewer than 1 in 1000 patients)
• Lumpy breasts
•17 -
• Loss of sex drive
• Feeling giddy
• Faster heart beat
• Pancreatitis (inflammation of the pancreas, which causes severe pain in the abdomen and back)
• Increased sweating
• Sensitivity to light Frequency not known
• Reduced amount of breast milk (if breast feeding)
• Contact lenses may feel uncomfortable
• Red painful lumpy swellings on the legs
• Changes in fat levels in the blood (seen by blood tests)
• Night sweats.

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. 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 By reporting side effects you can help provide more information on the safety of this medicine. Also tell your doctor, pharmacist or nurse if any existing conditions get worse while you are taking Cilest. ______________________________________________________________ 4.3 Bleeding between periods should not last long Usually you should only have a withdrawal bleed like a period during the seven pill-free days. However, a few women have a little unexpected bleeding or spotting while they are taking Cilest, especially during the first few months. Normally, this bleeding is nothing to worry about and will stop after a day or two. Keep taking Cilest 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. Make an appointment to see your doctor if you get breakthrough bleeding or spotting that:
• carries on for more than the first few months
• starts after you’ve been taking Cilest for a while
• carries on even after you’ve stopped taking Cilest.

How to Store Ortho Cyclen

Keep this medicines out of the sight and reach of children. This medicine does not require any special temperature storage conditions. Store strips in the original package in order to protect from light. Do not use Cilest after the expiry date shown on the strip. The expiry date refers to the last day of that month.
•18 - Do not throw away any medicines down a drain or into a bin. Ask your pharmacist what to do with any medicines you do not want. This will help to protect the environment.

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