USAGE

Premarin is a Hormone Replacement Therapy (HRT). It contains the female hormone estrogen. Premarin is used to treat some of the symptoms and conditions associated with the menopause.

Premarin is used for:

1) Relief of symptoms occurring after menopause:

During the menopause, the amount of the estrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Premarin alleviates these symptoms after menopause. You will only be prescribed Premarin if your symptoms seriously hinder your daily life.

2) Prevention of osteoporosis:

After the menopause some women may be at risk of developing fragile bones (osteoporosis). You should discuss all available treatment options with your doctor. If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Premarin 0.625 mg Coated Tablets to prevent osteoporosis after menopause.

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 may prescribe a second type of tablet containing another hormone called a progestogen to be taken for 12-14 days per month as well as the Premarin tablets.

WHAT YOU NEED TO KNOW BEFORE STARTING TAKING PREMARIN

The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.

The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT may be different. Please talk to your doctor.

Before you start (or restart) HRT, your doctor will ask about your own and your family’s medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and/or an internal examination, if necessary.

Once you have started on Premarin you should see your doctor for regular check-ups (at least once a year).

At these check-ups, discuss with your doctor the benefits and risks of continuing with Premarin.

Go for regular breast screening, as recommended by your doctor.

DO NOT TAKE PREMARIN

If any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before taking Premarin.

Do not take Premarin:

▪ If you are allergic (hypersensitive) to conjugated estrogens or any of the other ingredients of this medicine.

▪ If you have or have ever had breast cancer, or if you are suspected of having it.

▪ If you have cancer which is sensitive to estrogens such as cancer of the lining of the womb (endometrium) or if you are suspected of having it.

▪ If you have any unexplained vaginal bleeding.

▪ If you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated.

▪ If you have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism).

▪ If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency).

▪ If you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina.

▪ If you have or have previously had liver disease.

▪ If you have a rare blood problem called “porphyria” which is passed down in families (inherited).

▪ If you are pregnant, or you are breast-feeding.

If any of the above conditions appear for the first time while taking Premarin, stop taking it at once and consult your doctor immediately.

WARNINGS AND PRECAUTIONS

Talk to your doctor, pharmacist or nurse before taking Premarin if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Premarin. If so, you should see your doctor more often for check-ups:

• fibroids inside your womb

• growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia)

• increased risk of developing blood clots

• increased risk of getting estrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer)

• high blood pressure

• heart disease

• a liver disorder (e.g. a benign liver tumour)

• kidney disease

• fluid retention due to cardiac or kidney problems

• diabetes

• gallbladder disease or gallstones

• migraine or severe headaches

• a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)

• epilepsy

• asthma

• a disease affecting the eardrum and hearing (otosclerosis)

• low blood calcium levels (hypocalcaemia)

• a very high level of fat in your blood (triglycerides).

STOP TAKING PREMARIN AND SEE A DOCTOR IMMEDIATELY

If you notice any of the following when taking HRT:

• any of the conditions mentioned in the “DO NOT TAKE PREMARIN” section

• yellowing of the skin or the whites of your eyes (jaundice). These may be signs of a liver disease

• a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)

• migraine-like headaches which happen for the first time

• if you become pregnant

• have an allergic reaction, signs of which include a rash, itching, shortness of breath, difficulty in breathing and a swollen face

• if you notice signs of a blood clot, such as:

- painful swelling and redness of the legs;

- sudden chest pain;

- difficulty in breathing.

is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice.

HRT AND CANCER

Taking estrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer).

Taking a progestogen in addition to the estrogen for at least 12 days of each 28 day cycle protects you from this extra risk. So your doctor will prescribe a progestogen separately if you still have your womb. If you have had your womb removed (a hysterectomy), discuss with your doctor whether you can safely take this product without a progestogen.

In women who still have a womb and who are not taking HRT, on average, 5 in 1000 will be diagnosed with endometrial cancer between the ages of 50 and 65.

For women aged 50 to 65 who still have a womb and who take estrogen-only HRT, between 10 and 60 women in 1000 will be diagnosed with endometrial cancer (i.e. between 5 and 55 extra cases), depending on the dose and for how long it is taken.

Premarin 0.625 mg tablets contain a higher dose of estrogens than other estrogen-only HRT products. The risk of endometrium cancer when using Premarin 0.625 mg tablets together with a progestogen is not known.

If you still have your womb, your doctor may prescribe a progestogen as well as estrogen. If so, these may be prescribed separately, or as a combined HRT product.

If you have had your womb removed (a hysterectomy), your doctor will discuss with you whether you can safely take estrogen without a progestogen.

If you’ve had your womb removed because of endometriosis, any endometrium left in your body may be at risk. So your doctor may prescribe HRT that includes a progestogen as well as an estrogen.

Your product, Premarin, is an estrogen-only product.

Looking at women who still have a uterus and who are not taking HRT - on average 5 in 1000 will be diagnosed with endometrial cancer between the ages of 50 and 65.

For women who take estrogen-only HRT, the number will be 2 to 12 times higher, depending on the dose and how long you take it. After stopping treatment risk may remain elevated for at least 10 years. In women with a uterus, use of estrogen-only HRT is not recommended because it increases the risk of endometrial cancer.

Irregular bleeding

If you get break-through bleeding or spotting, it’s usually nothing to worry about, especially during the first 3-6 months of taking HRT.

But if the bleeding or spotting:

▪ carries on for more than the first 6 months

▪ starts after you’ve been taking Premarin for more than 6 months

▪ carries on even after you’ve stopped taking Premarin

Make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.

Breast Cancer

Women who have breast cancer, or have had breast cancer in the past, should not take HRT.

Evidence shows that taking combined estrogen-progestogen or estrogen-only hormone replacement therapy (HRT) increases the risk of breast cancer. The extra risk depends on how long you use HRT. The additional risk becomes clear within 3 years of use. After stopping HRT the extra risk will decrease with time, but the risk may persist for 10 years or more if you have used HRT for more than 5 years.

Your risk of breast cancer is also higher:

▪ if you have a close relative (mother, sister or grandmother) who has had breast cancer;

▪ if you are seriously overweight.

The information given above is a summary. Your doctor, pharmacist or health care provider can give more information about Premarin. Do not share this medicine with the others who it was not prescribed for. Do not use this medicine for other health conditions. Do not store the medication with an end term of its storage.