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Prempak-C Conjugated oestrogens &amp; norgestrel
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Please read this leaflet carefully before you start to take your tablets. The leaflet contains some information about Prempak-C, which has been prescribed for you by your doctor. If you have any questions or are unsure about anything, ask your doctor or pharmacist.
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What is in my tablets?
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The name of your medicine is Prempak-C. It contains two types of tablets: the set of 28 maroon or yellow tablets each contain a mixture of natural hormones called conjugated oestrogens, and the set of 12 light brown tablets each contain 0.15 mg of norgestrel, which acts in the same way as the hormone progesterone produced by your own body.
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The colour of the 28 oestrogen tablets will depend upon which dose of oestrogen your doctor has prescribed for you: maroon tablets contain 0.625 mg conjugated oestrogens, and yellow tablets contain 1.25 mg of conjugated oestrogens.
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Prempak-C also contains inactive ingredients. The oestrogen tablets contain lactose, methylcellulose, magnesium stearate, sucrose, glyceryl mono-oleate, polyethylene glycol, carnauba wax, calcium sulphate anhydrous, polyvinylpyrrolidone, sodium benzoate, microcrystalline cellulose, pharmaceutical glaze (shellac) and titanium dioxide (E171).
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The norgestrel tablets contain: lactose, starch, polyvinylpyrrolidone, talc, magnesium stearate, sucrose, polyethylene glycol, calcium carbonate, bleached wax, carnauba wax, titanium dioxide(E171).
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Dyes are used to colour the tablets:
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maroon oestrogen tablets: E110, E132, E127.
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yellow oestrogen tablets: E104, E110.
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light brown norgestrel tablets: E 172.
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Prempak-C is presented in a carton containing three calendar packs. Each calendar pack contains 28 days' treatment: 28 oestrogen tablets with 12 norgestrel tablets to take with the last 12 oestrogen tablets in each pack. The calendar pack has days 1 to 28 printed on it to help you keep track of your tablets.
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Prempak-C is one of a group of medicines called Hormone Replacement Therapy (HRT), and is used to treat some of the symptoms of the menopause or "change of life".
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Product licence holder:
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 John Wyeth &amp; Brother Limited trading as Wyeth Laboratories, Taplow, Maidenhead, Berkshire SL6 0PH.
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Manufacturer:
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 Wyeth Medica Ireland, Little Connell, Newbridge, Co. Kildare, Republic of Ireland.
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What are my tablets used for?
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During the menopause, the level of the oestrogen in your body will decrease. Oestrogen is one of the main hormones responsible for maintaining your normal periods. As the amount of oestrogen produced by your body decreases, your periods may become irregular and may only occur once every few months. Eventually your periods will stop altogether.
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Oestrogen is also responsible for helping to keep many parts of the body healthy, such as the skin, bones, urinary system and the lining of the vagina. The lack of oestrogen which causes the menopause is also responsible for many of the symptoms you have at this time, such as hot flushes, night sweats and vaginal dryness. By replacing the oestrogen that your body no longer produces Prempak-C can relieve some of these symptoms. It can also help to prevent bone thinning (osteoporosis).
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Women who still have their womb (uterus) should not take oestrogen tablets alone for HRT. The reason for this is that the oestrogen can make the lining of the womb grow too much and cause irregular bleeding. Your Prempak-C contains norgestrel which protects the lining of the womb and prevents too much <CB n=2> growth. It is very important that you take a norgestrel tablet each day from day 17 to day 28 as shown on the pack. (please see the section "What should I know before taking my tablets?")
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Are there reasons for not taking HRT?
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You should not take Prempak-C if:
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You know or suspect you are pregnant, or you are breast feeding.
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You have or have had breast cancer.
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You are suffering from a disorder which causes clotting in the blood vessels.
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You have any unusual vaginal bleeding which has not been diagnosed.
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You have serious liver disease.
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You have serious heart disease or kidney disease.
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You are allergic to any of the ingredients of Prempak C (see page 2).
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You have, or your doctor suspects you might have, a cancer which is made worse by oestrogens.
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What should I know before taking my tablets?
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Some studies with HRT have shown a small increased risk of breast cancer when HRT has been used over a long period of time. Other studies, however, have not shown this link. Whilst taking HRT you should regularly check your breasts and tell your doctor if you find any lumps.
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If you have had breast lumps in the past, your doctor will regularly check your breasts for any changes.
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There is an increased risk of cancer of the lining of the womb (endometrium) if you take oestrogen-only HRT. However, taking tablets of a progestogen such as norgestrel for twelve days each month reduces this additional risk. Prempak-C contains norgestrel tablets for this reason.
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If you have suffered from blood clots in your legs or lungs, a stroke or heart attack, your doctor will monitor you closely.
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It is unlikely that HRT will affect your blood pressure. Your doctor will monitor your blood pressure at your regular check ups, especially if you are already being treated for high blood pressure.
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You will probably have a regular monthly bleed at the end of each month. This is often at about the time you are taking the last few norgestrel tablets. This is quite normal and helps to keep the lining of the womb healthy. It does not mean that your periods have started again or that you could become pregnant.
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It is possible that these monthly bleeds will eventually stop whilst taking Prempak-C. This is also normal: however you should tell your doctor if your bleeding pattern changes, or if any unusual bleeding occurs once you have become settled on Prempak-C.
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Special warnings
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Certain diseases may be made worse by HRT. If you have any of the following conditions your doctor will monitor you closely: otosclerosis, multiple sclerosis, systemic lupus erythematosis, porphyria, melanoma, diabetes, depression asthma, migraine, epilepsy, fibroids or endometriosis. Tell your doctor if you notice any change in your condition whilst taking Prempak-C.
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The risk of gall bladder disease is slightly increased in women taking HRT.
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HRT may affect some medical tests. If you visit a hospital or clinic for any medical tests you should tell the doctor concerned that you are taking HRT.
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Is Prempak-C like the contraceptive Pill?
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No. The contraceptive Pill uses higher doses of synthetic (man-made) hormones to prevent ovulation and fertilisation of eggs. Prempak-C is NOT a contraceptive. It is important that you use a reliable form of non-hormonal contraception (such as a condom) if there is any possibility that you may still become pregnant. You should discuss this with your doctor.
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Will Prempak-C affect my driving?
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There is no evidence to suggest that taking Prempak-C will affect your ability to drive or to operate machinery.
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How do I take my tablets?
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Start your pack with the tablet marked "Day 1". You will see that the days of the week have been printed on the top of your pack. Make a hole through the day of the week on which you take your first pill. Pills 8,15 and 22 will also be taken on this day of the week, so if you are not sure if you have taken your pill(s) you can count backwards, as a reminder.
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The usual dose is one oestrogen tablet every day until Day 16. You should then take one oestrogen tablet every day plus one norgestrel tablet every day from days 17-28 as marked on the pack. Swallow the tablet(s) with a drink of water. Take your tablet(s) at about the same time each day.
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Do not leave a break between packs unless your doctor tells you to. Do not stop taking Prempak-C without first discussing it with your doctor.
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How long do I need to take Prempak-C for?
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That really depends on why you and your doctor have decided on a course of treatment. If you are taking HRT to relieve your immediate menopausal symptoms, such as hot flushes and night sweats, you may be prescribed HRT for between three to twelve months or longer. If, however, you or your doctor are worried about osteoporosis (bone thinning) and you wish to protect yourself now for the future, you may be prescribed HRT for between five to ten years or even longer.
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What if I miss a tablet or tablets?
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If you forget to take a dose, take it as soon as you remember, then go on as before. If more than one or two doses have been missed, consult your doctor.
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If you do forget to take your tablets, you may have some slight bleeding or spotting.
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What if I take too many tablets?
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Do not worry. It is unlikely that serious problems will occur. You may feel some nausea (sickness), or experience a short period of vaginal bleeding if you take too many tablets. If in any doubt, consult your doctor or pharmacist.
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Can I wash off the coating or crush the tablets?
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It is best not to try to take off the coating or crush the tablets, as this could affect the way Prempak-C works. The dyes used are approved for use as food colourings. They are needed so that Prempak-C can beidentified from other tablets, and so that the different strengths of Prempak-C can be easily recognised.
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Are there any side effects?
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Report these or any other unusual side effects to your doctor immediately:
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a sudden loss or change in vision.
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a first migraine attack.
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shortness of breath.
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sharp pains in the chest.
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jaundice.
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red, painful, swollen calves.
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Prempak-C may cause other unwanted effects, most of which are not serious and you need only tell your doctor if you are troubled by any of the following symptoms:
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Irregular bleeding, spotting, pain or discomfort during your monthly bleed, pre-menstrual tension.
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Swollen, tender breasts.
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A tendency to thrush, vaginal discharge and urinary infections such as cystitis.
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Mild stomach upsets, feeling or being sick, a feeling of being bloated stomach cramps.
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Rashes or discolouration swellings or red patches on the skin, loss of or increase in hair.
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Minor eye changes which may cause difficulties if you wear contact lenses.
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Headaches, dizziness, mood changes, muscular twitches.
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Weight changes, changes in appetite.
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Changes in sex drive (libido).
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Leg cramps.
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You should also tell your doctor or pharmacist if you notice any other unwanted effects whilst you are taking Prempak-C.
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How do I store my tablets?
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Keep them out of the reach of children.
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Do not use these tablets after the date stated on the packaging.
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If the pack has been opened or damaged return it to your pharmacist.
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Do not let anyone else take your Prempak-C tablets even if they seem to have the same problem as you.
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Return any unused tablets to your pharmacist. Only keep them if your doctor tells you to.
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Date of preparation:
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 October 1995.
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