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General notes: In this monograph, several situations are described where the patient should stop taking the Pill, or where the reliability of the Pill may be decreased. In such situations the patient should not have sexual intercourse or she 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 the Pill alters the usual changes in temperature and cervical mucus that occur during the menstrual cycle.
Mercilon/Mercilon 28, like all contraceptive Pills, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
Mercilon/Mercilon 28 has been prescribed for the patient personally. Do not share it with others.
What the patient needs to know before using Mercilon/Mercilon 28: If the combined Pill is used in the presence of any of the conditions listed as follows the patient may need to be kept under close observation. The doctor can explain this to the patient. Therefore, if any of these apply to the patient, tell the doctor before starting to use Mercilon/Mercilon 28: the patient smokes.
The patient has diabetes.
The patient is overweight.
The patient has high blood pressure.
The patient has a heart valve disorder or a certain heart rhythm disorder.
The patient has an inflammation of the veins (superficial phlebitis).
The patient has varicose veins.
Anyone in the immediate family has had a thrombosis, a heart attack or a stroke.
The patient suffers from migraine.
The patient suffers from epilepsy.
The patient or someone in the immediate family has or has had high cholesterol or triglycerides (fats in the blood).
Anyone in the immediate family has had breast cancer.
The patient has liver or gallbladder disease.
The patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
The patient has systemic lupus erythematosus (SLE; a chronic connective tissue disease affecting the skin all over the body).
The patient has haemolytic uraemic syndrome (HUS; a disorder of blood clotting causing failure of the kidneys).
The patient has sickle cell disease (a rare blood disease).
The patient has an operation, or if the ability to move around is limited for a long period of time (see 'The Pill and Thrombosis' as follows).
If the patient has recently given birth she is at an increased risk of blood clots. The patient should ask the doctor how soon after delivery she can start using Mercilon/Mercilon 28 (see 'The Pill and Thrombosis' as follows).
The patient has a condition that occurred for the first time or got worse during pregnancy or previous use of sex hormones (e.g., hearing loss, a disease called porphyria, a skin disease called herpes gestationis, a disease called Sydenham's chorea); hereditary and acquired angioedema [the patient should see her doctor immediately if she experiences symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or hives, potentially with difficulty breathing]. Products containing estrogens may cause or worsen hereditary and acquired angioedema.
The patient has or has had chloasma (yellowish-brown pigmentation patches on the skin,
particularly of the face); if so, avoid too much exposure to the sun or ultraviolet light.
If any of the previously mentioned conditions appear for the first time, come back or get worse while using the Pill, the patient should contact the doctor.
The Pill and Thrombosis: A thrombosis is the formation of a blood clot which may block a blood vessel.
A thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this blood clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called 'pulmonary embolism'. Deep venous thrombosis is a rare occurrence. It can develop whether or not the patient is taking the Pill. The risk is higher in Pill users than in non-users. The chance of getting a thrombosis is highest during the first year after the patient starts using the Pill for the very first time. The risk is also higher if the patient restarts using the Pill (the same product or a different product) after a break of 4 weeks or more.
The risk is not as high as the risk of developing a thrombosis during pregnancy.
The risk of getting a deep venous thrombosis for women using Pills with desogestrel may be slightly higher than for women using Pills with levonorgestrel. The absolute numbers remain very small. If 10,000 women use a Pill with levonorgestrel for one year, 2 women would get a thrombosis. If 10,000 women use a Pill with desogestrel for a year approximately 3 to 4 women would get a thrombosis. For comparison, if 10,000 women get pregnant, approximately 5-20 would get a thrombosis. These findings are based on the results of some studies. Other studies did not find a higher risk for Pills with desogestrel.
Blood clots can also occur very rarely in an artery (arterial thrombosis): for example in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke).
Extremely rarely blood clots can occur in the liver, gut, kidney or eye.
Very occasionally thrombosis may cause serious permanent disabilities or may even be fatal.
The risk of venous thrombosis in users of combined pills increases: with increasing age.
If the patient is overweight.
If one of the patient's close relatives has had a blood clot (thrombosis) in the leg, lung, or other organ at a young age.
If the patient must have an operation, if the ability to move around is limited for long period of time, or if the patient has had a serious accident. It is important to tell the doctor in advance that the patient is using Mercilon/Mercilon 28 as the treatment may have to be stopped. The doctor will tell the patient when to start Mercilon/Mercilon 28 again. This is usually about two weeks after the patient is able to move around. See also 'Contraindications'.
If the patient gave birth less than a few weeks ago.
The risk of arterial thrombosis in users of combined pills increases: if the patient smokes. The patient is strongly advised to stop smoking when using Mercilon/Mercilon 28, especially if she is older than 35 years.
If the patient has an increased fat content in the blood (cholesterol or triglycerides).
If the patient has high blood pressure.
If the patient has migraine.
If the patient has a problem with the heart (valve disorder, a disturbance of the heart rhythm).
If the patient notices possible signs of a thrombosis, stop taking the Pill and consult the doctor immediately (see also 'Patient Counselling Information').
The Pill and Cancer: The information given as follows was obtained from studies of women who used combined oral hormonal contraceptives, such as the combined pill, and from an additional study that included both oral and non-oral hormonal contraceptive-users.
In studies with the combined pill, breast cancer has been diagnosed slightly more often in women who use the Pill than in women of the same age who do not use the Pill. This slight increase in the numbers of breast cancer diagnoses gradually disappears during the course of the 10 years after stopping use of the Pill. It is not known whether the difference is caused by the Pill. It may be that the women were examined more often, so that the breast cancer was noticed earlier.
In the additional study that included both oral and non-oral hormonal contraceptive-users, the occurrence of breast cancer was reported to increase the longer the women used the contraceptive. The difference in the reported risk of breast cancer between women who had never used the contraceptive and those who had used the contraceptive was small: 13 additional cases of breast cancer per 100,000 women-years.
In rare cases benign liver tumours and even more rarely, malignant liver tumours have been reported in users of the Pill. These tumours may lead to internal bleeding. Contact the doctor immediately if the patient has severe pain in the abdomen.
Cervical cancer is caused by an infection with the human papilloma virus. It has been reported to occur more often in women using the Pill for a long time. It is unknown if this finding is due to the use of hormonal contraceptives or to sexual behaviour and other factors (such as better cervical screening).
Important information about some of the ingredients of Mercilon/Mercilon 28: If the patient has been told by the doctor that she has an intolerance to some sugars, contact the doctor before starting with Mercilon/Mercilon 28.
The Pill and Driving and Using Machines: There are no observed effects.
Use in Pregnancy: Mercilon/Mercilon 28 must not be used by women who are pregnant, or who think they may be pregnant. If the patient suspects that she is pregnant while already using Mercilon/Mercilon 28, she should tell the doctor as soon as possible.
Use in Lactation: Mercilon/Mercilon 28 is not usually recommended for use during breast-feeding. If the patient wishes to take the Pill while breast-feeding, please ask the doctor.
