Please read this leaflet carefully before you start to take your tablets. The leaflet contains basic information about Premarin tablets which have been prescribed for you by your doctor. If you have any questions or are unsure about anything, ask your doctor or pharmacist.

The name of your medicine is Premarin. It contains a mixture of natural hormones called conjugated oestrogens. Premarin is available in three different strengths: the maroon tablets contain 0.625 mg conjugated oestrogens, the yellow tablets contain 1.25 mg conjugated oestrogens and the purple tablets contain 2.5 mg conjugated oestrogens.

Premarin tablets also contain lactose, methylcellulose, magnesium stearate, sucrose, glyceryl monoleate, polyethylene glycol, carnauba wax, calcium sulphate anhydrous, microcrystalline cellulose, pharmaceutical glaze (shellac), sodium benzoate, polyvinylpyrrolidone and titanium dioxide(E171).

Dyes are used to colour the tablets:

maroon tablets: E110, E132, E127.

yellow tablets: E104, E110.

purple tablets: E127, E132.

The maroon tablets (0.625 mg) and the yellow tablets (1.25 mg)are supplied in calendar blister packs each pack containing three strips of 28 tablets of the same colour.

Premarin 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".

Product licence holder: John Wyeth and Brother Limited trading as Wyeth Laboratories, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH.

Manufacturer: Wyeth Medical Ireland, Little Connell Newbridge, Co. Kildare, Republic of Ireland.

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 menstrual cycle. As the amount of oestrogen produced by your body decreases, the menstrual cycle may become irregular and a period may only occur once every few months. Eventually your periods will stop altogether.

Oestrogen is also responsible for helping to keep many tissues in 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 unpleasant symptoms you have at this time. By replacing the oestrogen that your body no longer produces, Premarin can relieve some of these symptoms, such as hot flushes, night sweats and vaginal dryness. It can also help to prevent bone thinning (osteoporosis).

Premarin is usually prescribed for women who have had their womb removed (hysterectomy). However, women who have not had this operation can still take Premarin and their doctor will prescribe a second type of tablet containing another hormone called a progestogen, to be taken 12-14 days per month as well as the Premarin tablets.

• You know or suspect you are pregnant, or you are breast feeding.
• You have or have had breast cancer.
• You are suffering from a disorder which causes clotting in the blood vessels.
• You have any abnormal vaginal bleeding.
• You have serious liver disease.
• You have serious heart or kidney disease.
• You are allergic to any of the ingredients of Premarin tablets.

Some studies with HRT have shown a small increased risk of breast cancer where 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.

If you have a history of breast lumps, your doctor will regularly check your breasts for any changes.

If you have not had a hysterectomy you should be aware that there is an increased risk of cancer of the lining of the womb (endometrium) associated with taking oestrogen-only HRT like Premarin. Your doctor will prescribe additional tablets containing a progestogen for 12-14 days each month to remove this risk.

If you have suffered from blood clots in your legs or lungs, a stroke or heart attack, your doctor will monitor you closely.

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.

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 thyrotoxicosis, diabetes, depression, asthma, migraine, epilepsy, fibroids or endometriosis. Tell your doctor if you notice any change in your condition whilst taking Premarin.

The risk of gall bladder disease is slightly increased in women taking HRT.

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.

No. The contraceptive Pill uses higher doses of synthetic hormones to prevent ovulation and fertilisation of eggs. Premarin is NOT a contraceptive. It is important that you use a reliable form of non hormonal contraception if there is any possibility that you may still become pregnant. You should discuss this with your doctor.

No not if you have had a hysterectomy, you will be taking an additional progestogen tablet for 12-14 days each month, and you will probably have a "period", or withdrawal bleed, each month, at about the time you finish the additional progestogen tablets. This is caused by the hormones and is perfectly natural. Some women taking "combined HRT" (oestrogen plus the additional progestogen) may experience a gradual reduction in withdrawal bleeding and it may eventually stop, this is quite normal. If you have heavy or irregular bleeding you should tell your doctor.

There is no evidence to suggest that taking Premarin will affect your ability to drive or to operate machinery.

You may start your first pack at any convenient time. The usual dose is one tablet per day, to be swallowed with a drink of water.

If you forget to take a dose, take it as soon as you remember, then go on as before. If more than one tablet has been missed take the tablet for the day that you remember and continue as normal.

Do not worry. Premarin contains natural hormones and it is unlikely that serious problems will occur. If in any doubt, consult your doctor or pharmacist.

You may feel some nausea (sickness), or experience a short period of vaginal bleeding (unless you have had a hysterectomy) if you take too many tablets.

It is best not to try to take off the coating or crush the tablets, as this could affect the way Premarin works. The dyes used are approved for use as food colourings. They are needed so that Premarin can be identified from other tablets, and so that the different strengths of Premarin can be easily recognised.

Report these or any other unusual side effects to your doctor immediately:

Premarin may cause some 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.

• Swollen, tender breasts.
• A tendency to thrush, vaginal discharge and urinary infections such as cystitis.
• Mild stomach upsets, feeling or being sick, a feeling of being bloated, stomach cramps.
• Rashes or discolouration, swellings or red patches on the skin, loss of or increases in hair.
• Minor eye changes which may cause difficulties if you wear contact lenses.
• Headaches, dizziness, mood changes, muscular twitches.
• Weight changes, changes in appetite.
• Changes in sex drive (libido).
• Leg cramps.

You should also tell your doctor or pharmacist if

you notice any other unwanted effects whilst you are taking Premarin.

Keep out of reach of children.

Do not use this medicine after the date stated on

the packaging.

If the pack has been opened or damaged return it to

your pharmacist.

Do not let anyone else take your Premarin tablets

even if they seem to have the same problem as you— it may harm them.

Return any unused medicine to your pharmacist.

Only keep it if your doctor tells you to.