Cilest (Ethinylestradiol, norgestimate)

What is it used for?

• Contraception.

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 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.

Taking the contraceptive pill usually results in lighter, less painful and more regular menstrual bleeding. This means it is sometimes also prescribed for women who have problems with particularly heavy, painful or irregular periods.

How do I take it?

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 calendar 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).

Warning!

• 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 vomiting continues 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 vomiting as if you had forgotten to take a pill and follow the instructions under "what do I do if I miss a pill" above.
• 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.

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.
• Angina.
• 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.

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.
• Obesity.
• Smokers.
• Diabetes mellitus.
• High blood pressure (hypertension).
• Women who use a wheelchair.
• Varicose veins.
• History of inflammation of a vein caused by a superficial blood clot (thrombophlebitis).
• Anaemia caused by a hereditary blood disorder where abnormal haemoglobin is produced (sickle cell anaemia).
• 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.
• Personal or family history of raised levels of fats called triglycerides in the blood (hypertriglyceridaemia).
• History of gallstones.
• Close family history of breast cancer (eg mother or sister has had the disease), or women with gene mutations that are associated with breast cancer, eg BRCA1.
• 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.

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. However, if the pill fails or you miss pills and you do get pregnant while taking it, there is no evidence to suggest that the pills you have already taken will harm the baby. If you think you could be pregnant while taking this pill you should stop taking it and consult your doctor immediately.
• 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.

Side effects

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.
• Headache/migraine.
• 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.
• Depression.
• 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.
• Gallstones.
• 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:

• aprepitant
• bosentan
• barbiturates
• carbamazepine
• eslicarbazepine
• modafinil
• nevirapine
• oxcarbazepine
• phenobarbital
• phenytoin
• primidone
• rifampicin
• rifabutin
• ritonavir
• the herbal remedy St John's wort (Hypericum perforatum)
• topiramate.

If you regularly take any of these medicines they are likely to make this contraceptive ineffective at preventing pregnancy. It is important that you talk to your doctor about this. Your doctor may recommend that you use a different form of contraception altogether. However, if you want to use the pill (and you are not taking rifampicin or rifabutin - see below), your doctor can prescribe you an additional pill to take in combination with this one, which would give you a higher dose of hormones. (This is unlicensed). If you do this, your doctor will also ask you to take three packets back to back without a break, have only a four day pill-free break and then take three packets back to back again. (This is called tricycling and is also unlicensed.) The purpose of this is to reduce the number and duration of hormone free periods in which ovulation could happen and thus minimise the chances of the pill failing.

If you are prescribed a short course (up to two months) of any of the above medicines they will also make this contraceptive less effective. Your doctor may recommend that you temporarily use a different form of contraception to prevent pregnancy. However, if you want to keep taking this pill, your doctor will probably advise you to take three packets back to back without a break, then have only a four day pill-free break, then take three packets back to back again. (This is called tricycling and is unlicensed.) You will also need to use an additional method of contraception (eg condoms), while you are doing this, for as long as you take the liver-affecting medicine and for at least four weeks after stopping it. Alternatively, your doctor could prescribe an additional pill to take in combination with this one, as above. Discuss your options with your doctor.

If you are prescribed rifampicin or rifabutin, an alternative method of contraception will always be recommended, because these two antibiotics make the pill so ineffective.

In the past, if you were prescribed an antibiotic other than rifampicin or rifabutin (eg amoxicillin, erythromycin, doxycycline) while taking the pill, the advice used to be that you use an extra method of contraception (eg condoms) while you were taking the antibiotic and for seven days after finishing the course. However, this advice has now changed. You no longer need to use an extra method of contraception with the pill while you take a course of antibiotics. This change in advice comes because to date there is no evidence to prove that antibiotics (other than rifampicin or rifabutin) affect the pill. This is the latest guidance from the Faculty of Sexual & Reproductive Healthcare. However, if you experience vomiting or diarrhoea as a result of taking an antibiotic you should follow the instructions for vomiting and diarrhoea described in the warning section above.

The emergency contraceptive ulipristal (Ellaone) has the potential to make the pill less effective. If you take Ellaone as an emergency contraceptive while you are taking Cilest, you should use an additional method of contraception such as condoms for 14 days after you take it.

The weight loss medicine orlistat (bought without a prescription as Alli and prescribed as Xenical) can cause severe diarrhoea. If you take either of these medicines while taking Cilest and get diarrhoea that lasts for more than 24 hours, you should follow the instructions for missed pills described above.

The pill may antagonise the blood sugar lowering effect of medicines for diabetes. If you have diabetes 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.

The pill may antagonise the effect of medicines used to lower high blood pressure. Your blood pressure will usually be checked periodically while you are taking the pill, but this is particularly important if you are also taking medicines for high blood pressure.

The pill may also antagonise the fluid-losing effect of diuretic medicines.

If you have an underactive thyroid gland (hypothyroidism) you may need an increased dose of your thyroid hormones while taking the pill. Your thyroid hormone levels should be regularly checked.

The pill may decrease the amount of the antiepileptic medicine lamotrigine in the blood. As this could increase the risk of seizures coming back or getting worse, the pill may not be recommended for women who take lamotrigine on its own for epilepsy.

The pill may increase the blood levels of the following medicines and this could possibly increase the risk of their side effects:

• melatonin
• selegiline (should be avoided in combination with the pill)
• tacrolimus
• theophylline (reduced dose of theophylline may be needed)
• tizanidine
• voriconazole.

Other medicines containing the same active ingredients

There are currently no other contraceptives in the UK that contain this combination of hormones.