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Brand Names: Cilest
Generic name: Norgestimate+Eethinylestradiol
Each tablet contains:
Norgestimate 0.25 mg
Ethinylestradiol 0.035 mg
What is it used for?
• Menstrual disorders such as painful periods (dysmenorrhoea), heavy periods (menorrhagia), irregular periods, continuous, heavy menstrual bleeding or premenstrual tension.
How does it work?
Cilest tablets are a type of hormonal contraception commonly known as 'the pill' or combined oral contraceptive pill. Cilest tablets contain two active ingredients, ethinylestradiol and norgestimate. These are synthetic versions of the naturally occurring female sex hormones, oestrogen and progesterone. Ethinylestradiol (previously spelt ethinyloestradiol in the UK) is a synthetic version of oestrogen and norgestimate is a synthetic form of progesterone.
Combined oral contraceptives like Cilest work by over-riding the normal menstrual cycle. In a woman's normal menstrual cycle, levels of the sex hormones change throughout each month. The hormones cause an egg to be released from the ovaries (ovulation) and prepare the lining of the womb for a possible pregnancy. At the end of each cycle, if the egg has not been fertilised the levels of the hormones fall, causing the womb lining to be shed as a monthly period.
The daily dose of hormones taken in the pill work mainly by tricking your body into thinking that ovulation has already happened. This prevents an egg from ripening and being released from the ovaries each month.
The hormones also increase the thickness of the natural mucus at the neck of the womb, which makes it more difficult for sperm to cross from the vagina into the womb and reach an egg. They also change the quality of the womb lining (endometrium), making it less likely that a fertilised egg can implant there.
Cilest is a monophasic pill. This means that each tablet has the same dose of hormones in it. One tablet is taken every day for 21 days and you then have a seven day break from pill-taking. During your seven day break, the levels of the hormones in your blood drop, which results in a withdrawal bleed that is similar to your normal period. You start the next pack after the seven pill-free days are up, even if you are still bleeding.
The tablets come in a calender pack marked with days of the week to help you remember to take a pill every day for three weeks, followed by a week off. You will still be protected against pregnancy in your pill-free week, provided you took all the pills correctly, you start the next packet on time and nothing else happened that could make the pill less effective (eg sickness, diarrhoea, or taking certain other medicines - see below).
The contraceptive pill results in lighter, less painful and more regular menstrual bleeding. This means it is sometimes prescribed for women who have problems with particularly heavy, painful or irregular periods.
When can I start taking it?
Ideally, you should start taking this pill on day one of your menstrual cycle (the first day of your period). This will protect you from pregnancy immediately and you won't need to use any additional methods of contraception. If necessary, you can also start taking it up to day five of your cycle without needing to use additional contraception when you start. However, if you have a short menstrual cycle (with your period coming every 23 days or less), starting as late as the fifth day of your cycle may not provide you with immediate contraceptive protection. You should talk to your doctor or nurse about this and whether you need to use an additional contraceptive method for the first seven days.
You can also start taking this pill at any other time in your cycle if your doctor is reasonably sure that you are not pregnant. However, if you start taking this pill at any other time in your cycle, you won't be protected from pregnancy straight away and you will need to use additional contraception, eg condoms (or not have sex) for the first seven days of pill taking.
If you have given birth and are not breastfeeding, you can start taking this pill on day 21 after the birth. You will be protected against pregnancy immediately and do not need to use extra contraception. If you start taking it later than 21 days after giving birth, you will need to use extra contraception for the first seven days.
If you are starting this pill immediately after a miscarriage or abortion at under 24 weeks, you will protected against pregnancy immediately. If you start taking it more than seven days after the miscarriage or abortion, you should use extra contraception for the first seven days of pill taking.
What do I do if I miss a pill?
You should try and take your pill at the same time every day to help you remember to take it. If you forget to take a pill, you should take it as soon as you remember (even if that means taking two pills in one day) and then continue to take your pills, one every day, as normal.
With Cilest, if you have missed ONE or TWO pills anywhere in the packet, you will still be protected against pregnancy and you don't need to use extra contraception. Take the last pill you missed as soon as you remember, then continue taking your pills as normal.
If you forget to take THREE or more pills, you won't be protected against pregnancy. You should take the last pill you missed as soon as you remember, forget the other missed ones and then continue to take your pills, one every day, as normal. You should then either not have sex, or use an extra barrier method of contraception, eg condoms, until you have taken a pill correctly for next seven days in a row. If the pills you missed were in the third week of your packet, you should skip the pill-free week and start a new packet straight away. If the pills you you missed were in the first week of your packet and you had unprotected sex in that week, or in the pill-free week before, it may be recommended that you take emergency contraception (the morning after pill). Ask for medical advice.
If you are confused about any of this, you can get individual advice for your circumstances from your doctor, pharmacist, local family planning clinic, or by calling the fpa helpline on 0845 122 8690.
• The information and advice that we give here is likely to conflict with the information you will find in the manufacturer's leaflet provided with your pills. This is particularly the case with regards starting the pill and what to do if you miss a pill. The reason for the differences is because the manufacturer's leaflets are out of date and unfortunately are not likely to be updated in the near future. The information and advice we give here are the same as the UK fpa (formerly The Family Planning Association) recommendations, which are based on systematic reviews of the currently available evidence. If you are concerned or have any questions, you can ask your doctor, nurse, pharmacist or local family planning centre for advice.
• If you vomit within two hours of taking a pill, it may not have been fully absorbed into your bloodstream. You should take another pill as soon as you feel well enough and take your next pill at your usual time. You should still be protected from pregnancy. However, if you continue to be you sick you may not be protected and you should seek medical advice.
• If you have very severe diarrhoea for more than 24 hours, this may make your pill less effective. You should keep taking your pill at your normal time, but treat each day that you have severe diarrhoea as if you had forgotten to take a pill and follow the instructions under "what do I do if I miss a pill" above.
• This contraceptive pill will not protect you against sexually transmitted infections, so you may still need to use condoms as well.
• Women using this contraceptive for the first time may experience menstrual irregularities such as spotting, breakthrough bleeding or missed periods. Consult your doctor if any breakthrough bleeding persists. If you don't have a withdrawal bleed for two consecutive months you should do a pregnancy test before starting the next month's contraceptive cycle.
• It is important to be aware that, compared with women who do not use these contraceptives, women taking the combined pill appear to have a small increase in the risk of developing a blood clot in a vein, eg in the leg (deep vein thrombosis) or in the lungs (pulmonary embolism), or a blood clot in an artery, eg causing a stroke or a heart attack. This risk is greater in certain groups of women, particularly smokers and women who are obese - see cautions and not to be used in below). However, pregnancy carries a much higher risk of blood clots than any pill, so the potential risk must be weighed against the benefits of the contraceptive. You should discuss this with your doctor.
• The risk of blood clots forming in the veins (venous thromboembolism) while taking the pill may be temporarily increased if you are immobile for prolonged periods of time, for example if you have a major accident or major surgery. For this reason, your doctor will usually recommend that you stop taking this pill for a period of time (usually four to six weeks) prior to any planned surgery, particularly abdominal surgery or orthopaedic surgery on the lower limbs (but not before minor surgery like teeth extraction). You will also need to stop taking this pill if you are going to be immobile for long periods, for example because you are confined to bed or have a leg in a plaster cast. You should not start taking the pill again until at least two weeks after you are fully mobile. There may also be an increased risk of blood clots in the veins if you are travelling for long periods of time where you will be sat still (over five hours). The risk of blood clots during long journeys may be reduced by appropriate exercise during the journey and possibly by wearing elastic hosiery. Discuss this with your doctor.
• It is important to be aware that women using hormonal contraceptives appear to have a small increase in the risk of being diagnosed with breast cancer, compared with women who do not use these contraceptives. Women who use oral contraceptives for longer than five years may also have a small increase in the risk of being diagnosed with cervical cancer. However, these risks must be weighed against the benefits of using the contraceptive, which include a decrease in the risk of cancers of the ovaries and endometrium (womb). You should discuss the risks and benefits of the pill with your doctor before you start taking it.
• Stop taking this medicine and inform your doctor immediately if you get any of the following symptoms while taking the medicine: stabbing pains and/or unusual swelling in one leg, pain on breathing or coughing, coughing up blood, sudden breathlessness, sudden severe chest pain, migraine or severe headaches, sudden disturbance in vision, hearing or speech, sudden weakness or numbness on one side of the body, fainting, collapse, epileptic seizure, significant rise in blood pressure, itching of the whole body, yellowing of the skin or whites of the eyes (jaundice), severe stomach pain, severe depression, or if you think you could be pregnant.
Use with caution in
• Women aged over 35 years.
• Women whose parent, brother or sister had a stroke caused by a blood clot or a heart attack before the age of 45.
• Women with a parent, brother or sister who has had a blood clot in a vein (venous thromboembolism), eg in the leg (deep vein thrombosis) or in the lungs (pulmonary embolism) before the age of 45.
• Diabetes mellitus.
• High blood pressure (hypertension).
• Women who use a wheelchair.
• Varicose veins.
• Hereditary blood disorder called sickle cell disease.
• History of severe depression.
• History of migraines.
• Inflammatory bowel disease, eg Crohn's disease or ulcerative colitis.
• History of liver disease.
• Decreased kidney function.
• Heart failure.
• History of gallstones.
• Close family history of breast cancer (eg mother or sister has had the disease).
• History of irregular brown patches appearing on the skin, usually of the face, during pregnancy or previous use of a contraceptive pill (chloasma). Women with a tendency to this condition should minimise their exposure to the sun or UV light while taking this contraceptive.
Not to be used in
• Known or suspected pregnancy.
• Breastfeeding (until weaning or for six months after birth).
• Women who have ever had a blood clot in a vein (venous thromboembolism), eg in the leg (deep vein thrombosis) or in the lungs (pulmonary embolism).
• Blood disorders that increase the risk of blood clots in the veins, eg antiphospholipid syndrome or factor V Leiden.
• Long-term condition called systemic lupus erythematosus (SLE).
• Excess of urea in the blood causing damaged red blood cells (haemolytic uraemic syndrome).
• Women with two or more other risk factors for getting a blood clot in a vein, eg family history of deep vein thrombosis or pulmonary embolism before the age of 45 (parent, brother or sister), obesity, varicose veins, long-term immobility.
• Women who have ever had a blood clot in an artery, eg a stroke or mini-stroke caused by a blood clot, or a heart attack.
• Heart valve disease.
• Irregular heartbeat caused by very rapid contraction of the top two chambers of the heart (atrial fibrillation).
• Moderate to severe high blood pressure (hypertension).
• High cholesterol levels.
• Severe diabetes with complications, eg affecting the eyes, kidneys or nerves.
• Women who smoke more than 40 cigarettes per day.
• Women over 50 years of age.
• Women with two or more other risk factors for getting a blood clot in an artery, eg family history of heart attack or stroke before the age of 45 (parent, brother or sister), diabetes, high blood pressure, smoking, age over 35 years, obesity, migraines.
• Women who get migraines with aura, severe migraines regularly lasting over 72 hours despite treatment, or migraines that are treated with ergot derivatives.
• History of breast cancer.
• Cancer involving the genital tract.
• Vaginal bleeding of unknown cause.
• Severe liver disease, eg liver cancer, hepatitis.
• History of liver disease when liver function has not returned to normal.
• Disorders of bile excretion that cause jaundice (eg Dubin-Johnson or Rotor syndrome).
• Gallstones (cholelithiasis).
• History of jaundice, severe itching, hearing disorder called otosclerosis, or rash called pemphigoid gestationis during a previous pregnancy, or previous use of sex hormones.
• Hereditary blood disorders known as porphyrias.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
• This medicine is used to prevent pregnancy and should not be taken during pregnancy. If you think you could be pregnant while taking this pill you should stop taking it and consult your doctor immediately. However, if the pill fails and you do become pregnant while taking it, there is no evidence to suggest that it will harm the baby.
• The hormones in this pill can reduce the production of breast milk. For this reason, it is not recommended for women who are breastfeeding. It should not be used until weaning, or at least six months after the birth. Other methods of contraception are more suitable for women who are breastfeeding. Ask your doctor for advice.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. See also the warnings above. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
• Nausea and vomiting.
• Breast tenderness, enlargement.
• Weight changes.
• Retention of water in the body tissues (fluid retention).
• Vaginal thrush (candidiasis).
• Change in menstrual bleeding.
• Menstrual spotting or breakthrough bleeding.
• Skin reactions.
• Decreased sex drive.
• Rise in blood pressure.
• Irregular brown patches on the skin, usually of the face (chloasma).
• Steepening of corneal curvature which may make contact lenses uncomfortable.
• Disturbance in liver function.
• Blood clots in the blood vessels (eg, DVT, pulmonary embolism, heart attack, stroke - see warnings above).
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start taking this contraceptive. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to ensure that the combination is safe.
The following medicines speed up the breakdown of the hormones in this contraceptive by the liver, which makes it less effective at preventing pregnancy:
• antiepileptic medicines, eg phenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine, topiramate
• the herbal remedy St John's wort (Hypericum perforatum).
If you regularly take any of these medicines, this contraceptive is not recommended for you, because these medicines are likely to make this contraceptive ineffective at preventing pregnancy. You should talk to your doctor about other contraceptive options. You should keep using the alternative contraception that you choose for four to eight weeks after stopping treatment with any of these medicines.
If you are prescribed a short course of any of these medicines, your doctor may prescribe you another pill to take in combination with this one. (This is unlicensed.) You should also use an additional method of contraception (eg condoms), while you take the medicine and for at least four weeks after stopping it.
If you are prescribed rifampicin or rifabutin, an alternative method of contraception is usually always recommended, because these particular antibiotics make the pill so ineffective.
Other antibiotics do not affect the breakdown of the pill by the liver. However, if you are prescribed another antibiotic medicine (eg amoxicillin, doxycycline) while taking this contraceptive, there is a very low risk that the antibiotic may make your pill less effective at preventing pregnancy. Although the risk of this is very low, the personal and ethical consequences of an unwanted pregnancy can be very serious. For this reason, it is recommended that you use an extra method of contraception (eg condoms) while you are taking the antibiotic and for seven days after finishing the course. If these seven days run beyond the end of a pill packet, a new packet should be started without a break. For more information talk to your pharmacist.
If you are prescribed an antibiotic for longer than three weeks, eg for treating acne, then you don't need to use extra contraception after you have been taking that antibiotic for three weeks or longer. But, if you are then also prescribed a short course of a different antibiotic, you will need to use extra contraception again, as above. For more information talk to your pharmacist.
This pill may increase the blood level of the immunosuppressant medicine ciclosporin.
Some women with diabetes may need small adjustments in their dose of insulin or antidiabetic tablets while taking this contraceptive. You should monitor your blood sugar and seek advice from your doctor or pharmacist if your blood sugar control seems to be altered after starting this contraceptive.