This leaflet answers some common questions about the menopause (the "change of life"), hormone replacement therapy and Estalis Continuous.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.

Those updates may contain important information about the medicine and its use of which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will provide.

You may need to read it again.

A study called the Women's Health Initiative indicated increased risk of heart attack, stroke, breast cancer, and blood clots in the legs or lungs in women receiving treatment with a product containing conjugated oestrogens 0.625 mg and the progestogen medroxyprogesterone acetate (MPA). The researchers stopped the study after 5 years when it was determined the risks were greater than the benefits in this group. The Women's Health Initiative Memory Study indicated increased risk of dementia in women aged 65-79 years taking conjugated oestrogens and MPA. There are no comparable data currently available for other doses of conjugated oestrogens and MPA or other combinations of oestrogens and progestogens. Therefore, you should assume the risks will be similar for other medicines containing oestrogen and progestogen combinations.

Treatment with oestrogens, with or without progestogens should be used at the lowest effective dose and for the shortest period of time.

Estalis Continuous is a type of treatment called hormone replacement therapy (HRT). It is a stick-on patch that contains the hormones, oestradiol and norethisterone acetate (NETA).

Estalis Continuous is used for the short-term relief of symptoms of the menopause. It can also be used to prevent thinning of the bones in women with a high risk of fractures due to osteoporosis who cannot use other treatments. Estalis Continuous is used only for women who still have a uterus (womb).

HRT should not be used for the long-term maintenance of general health or to prevent heart disease or dementia.

Estalis Continuous is not suitable for birth control and it will not restore fertility.

Oestradiol is a natural female sex hormone called an oestrogen. It is the same hormone that your ovaries were producing before the menopause. NETA is a hormone called a progestogen. It has effects similar to the female hormone, progesterone, which your ovaries also produced before the menopause.

The menopause occurs naturally in the course of a woman's life, usually between the ages of 45 and 55. After menopause, your body produces much less oestrogen than it did before. This can cause unpleasant symptoms such as a feeling of warmth in the face, neck and chest, "hot flushes" (sudden, intense feelings of heat and sweating throughout the body), sleep problems, irritability and depression. Some women also have problems with dryness of the vagina causing discomfort during or after sex. Oestrogens can be given to reduce or eliminate these symptoms.

After the age of 40, and especially after the menopause, some women develop osteoporosis. This is a thinning of the bones that makes them weaker and more likely to break, especially the bones of the spine, hip and wrist. Exercise, calcium and vitamin D can help reduce the risk of osteoporosis.

Women who still have a uterus must take both oestrogen and progestogen as part of HRT. This is because oestrogen stimulates the growth of the lining of the uterus (called the endometrium). Before menopause this lining is removed during your period through the action of a natural progestogen. After menopause, taking oestrogen on its own as HRT may lead to irregular bleeding and to a disorder called endometrial hyperplasia. Progestogens such as NETA help to protect the lining of the uterus from developing this disorder.

Estalis Continuous patches release oestradiol and NETA in a continuous and controlled way just as your ovaries were doing before. Because the medicine does not have to pass through your stomach and liver, it allows you to take a much lower dose than would be needed in a tablet and helps to avoid some unpleasant side effects.

Your doctor may have prescribed it for another purpose.

This medicine is available only with a doctor's prescription. It is not habit-forming.

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

If you had a severe skin reaction in the past, you could have a very serious reaction if you use any type of oestrogen or progestogen (patch, tablet, cream, etc.) again in the future.

If you are not sure whether any of the above conditions apply to you, your doctor can advise you.

It may affect your baby.

In that case, return it to your pharmacist.

Estalis Continuous is not a contraceptive. Since pregnancy may be possible early in the menopause while you are still having menstrual periods, you should ask your doctor to suggest another (non-hormonal) method of birth control.

Some medicines and Estalis Continuous may interfere with each other. These include:

You may need to take different amounts of your medicines or to take different medicines while you are using Estalis Continuous. Your doctor and pharmacist have more information.

Some laboratory tests, such as tests for glucose tolerance or thyroid function, may be affected by Estalis Sequi therapy.

These instructions may differ from the information contained in this leaflet.

If you are not already using HRT, you can start Estalis Continuous at a convenient time for you. If you are already using a different type of HRT, your doctor can advise you when to switch to Estalis Continuous.

The patches come in two strengths. You will usually start with the Estalis Continuous 50/250 patch. Your doctor will check your progress and may change to the lower strength 50/140 patch.

A leaflet in the carton contains pictures and information on how to apply the patch properly.

You will have a patch on all the time. You will apply a new patch twice weekly (every 3 or 4 days). There are 8 patches in the carton, enough for a 4-week cycle.

You will probably have some bleeding or spotting at odd times during the first few months. This can be a nuisance but is quite normal and not a cause for concern. The bleeding usually becomes lighter and less frequent over time and eventually stops. If you have heavy bleeding, tell your doctor.

You may have an increased risk of developing breast cancer, heart disease, stroke, blood clots on the lungs and dementia. On the other hand, the risk of hip fractures and bowel cancer may be reduced. Women taking estrogens, alone or in combination with progestogens, may have a higher risk of ovarian cancer that may appear within 5 years of use and slowly diminishes over time after discontinuation. Your doctor can discuss these risks and benefits with you, taking into account your particular circumstances.

Because of the way this medicine is used, an intentional overdose is unlikely. Swallowing a patch may cause nausea and vomiting.

It should not be used while you are pregnant or if you want to become pregnant.

Your doctor or nurse can show you how to check your breasts properly.

The risk of developing blood clots in your blood vessels may be temporarily increased as a result of an operation, serious injury or having to stay in bed for a prolonged period. If possible, this medicine should be stopped at least 4 weeks before surgery and it should not be restarted until you are fully mobile.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Some people may have other side effects not yet known or mentioned in this leaflet. Some side effects can only be found when laboratory tests are done.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Used patches still contain some oestradiol and NETA which could harm a child.

Estalis Continuous patches come in two strengths: 50/140 and 50/250. They are clear round patches sealed in individual pouches. Each carton contains 8 patches (enough for 4 weeks of treatment.)

The patch is made up of three layers:

Estalis Continuous patches release approximately 50 micrograms of oestradiol and 140 or 250 micrograms of NETA in 24 hours.

The following inactive ingredients are also used to make the patch: