Climara - 50, - 100 Consumer Medicine Information

Estradiol transdermal systems

What is in this leaflet

Please read this leaflet carefully before you start using CLIMARA. This leaflet will provide information about the benefits and risks of using CLIMARA. It will also advise you about how to apply CLIMARA properly and when to tell your doctor about health-related conditions. If you have any questions or need more advice, ask your doctor, professional health care provider or pharmacist. This product has been prescribed for you personally and you should not pass it on to others.

What is CLIMARA used for and how does it work

CLIMARA is a transparent oval transdermal system (patch) for hormone replacement therapy (HRT) and contains estradiol as the active ingredient.

CLIMARA-50 is a patch with an area of 12.5 square centimetres containing 3.8mg of estradiol (formed from 3.9mg estradiol hemihydrate) and releasing 50mcg (micrograms) per 24 hours.

CLIMARA-100 is a patch with an area of 25.0 square centimetres containing 7.6mg of estradiol (formed from 7.8mg estradiol hemihydrate) and releasing 100mcg (micrograms) per 24 hours.

How does CLIMARA work?

CLIMARA contains the estrogen estradiol, identical to the natural human hormone called estradiol. The estradiol is absorbed from the patch through the skin into the bloodstream. As the medicine does not have to pass through your stomach and liver, it allows you to take a much lower dose of estrogen than would be needed in a tablet.

During the menopause ('the change of life') the estradiol production of the ovaries declines. Although the change of life is natural, it often causes distressing symptoms, which are connected with the gradual loss of the hormones produced by the ovaries.

CLIMARA replaces the hormone estradiol that the body no longer makes. The estradiol prevents or relieves troublesome symptoms (menopausal complaints) such as hot flushes, sweats, sleep disturbances, nervousness, irritability, dizziness, headaches, as well as involuntary loss of urine, vaginal dryness and burning, and pain during sexual intercourse.

In addition, the loss of the hormones produced by the ovaries leads to thinning of the bones. In some women this effect may be extensive (postmenopausal osteoporosis) resulting in fractures of the bones in later life.

The use of estrogens alone over a prolonged period can lead to excessive development of the lining of the womb and, in this connection, can increase the incidence of cancer of the womb. This increase in risk can be avoided by the additional administration of a progestogen. This results in regular shedding of the lining of the womb and, therefore, menstruation-like bleeding. If you have not had a hysterectomy (removal of the uterus/womb), your doctor should prescribe a progestogen hormone for you to take while you are taking CLIMARA.

What is CLIMARA used for?

CLIMARA provides hormone replacement therapy for the treatment of menopausal complaints after the cessation of monthly bleeding or after removal of the ovaries (ovariectomy).

Some women are more likely than others to develop osteoporosis in later life depending on their medical history and lifestyle. If it is appropriate, you may be prescribed CLIMARA to prevent osteoporosis. Your doctor will be able to advise you further.

Before you use CLIMARA

Do not use CLIMARA if you have any of the conditions listed below. If any of these apply to you, tell your doctor who will be able to advise you further.

You must not use CLIMARA if:

  • you are pregnant or breast-feeding
  • you have undiagnosed vaginal bleeding
  • you recently had a heart attack and/or stroke
  • you have or there is a suspicion of cancer of the breast
  • you have or there is a suspicion of other cancers influenced by sex hormones
  • you have or have had a liver tumour (benign or malignant)
  • you have severe liver disease
  • you have or have had a thrombosis (the formation of a blood clot) in the blood vessels of the legs (deep venous thrombosis) or the lungs (pulmonary embolism) or thrombophlebitis (inflammation of a vein)
  • you have an inherited or acquired predisposition to venous thrombosis (formation of a blood clot in a vein) e.g. antithrombin III deficiency
  • you have severely elevated blood levels of triglycerides (special type of blood lipids)
  • you are allergic to any of the ingredients of CLIMARA.

If any of these conditions appear for the first time while using CLIMARA, stop taking it at once and consult your doctor.

Tell your doctor if:

If HRT is used in the presence of any of the conditions listed below or they appear for the first time or recur or worsen during treatment, you may need to be kept under close observation. Your doctor can explain this to you. Therefore, tell your doctor before starting to use CLIMARA if:

  • you have an increased risk of thrombosis (blood clot formation) in your veins; the risk increases with age and may also be higher:
    • if anyone in your immediate family has ever had a thrombosis in the blood vessels of the legs or lungs
    • if you are overweight
    • if you have severe varicose veins
    If you are already using CLIMARA, tell your doctor well in advance of any expected hospitalisation or surgery. This is because the risk of deep venous thrombosis is temporarily increased as a result of an operation or immobilisation (for example, when you have your leg or legs in plaster or splints) and may be further increased by the use of CLIMARA. Your doctor may tell you to stop taking CLIMARA several weeks before surgery or at the time of immobilisation. Your doctor will also tell you when you can start taking CLIMARA again after you are back on your feet.

  • you have fibroids of the womb
  • you have or have had endometriosis (the presence of tissue of the lining of the womb in places in the body where it is not normally found)
  • you have liver or gall-bladder disease
  • you have had jaundice during pregnancy or previous use of sex steroids
  • you suffer from diabetes
  • you have moderately elevated levels of triglycerides (a special type of blood lipids)
  • you have high blood levels of calcium (hypercalcaemia)
  • you have high blood pressure
  • you have or have had chloasma (yellow brown pigmentation patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation
  • you suffer from epilepsy
  • you have lumpy or painful breasts (benign breast disease)
  • you suffer from asthma
  • you suffer from migraine
  • you have the inherited disease called porphyria
  • you suffer from inherited deafness (otosclerosis)
  • you have systemic lupus erythematosus (SLE; a disease affecting the skin all over the body)
  • you suffer from chorea minor (Sydenham's chorea)

What else you should know

CLIMARA is not a contraceptive.

If you still have the ability to become pregnant, CLIMARA is unlikely to alter it. If you are taking contraceptive precautions other than oral (or other hormonal) contraceptives when you start CLIMARA, continue to do so until your doctor tells you that you no longer require contraceptive protection. If you have been taking an oral (or other hormonal) contraceptive, you must change to a non-hormonal form of contraception (but not the rhythm or temperature methods) before starting CLIMARA. However, if your doctor has already advised you that you need no longer use any contraceptive, you need not do so while taking CLIMARA.

The use of hormone replacement therapy (HRT) can increase the risk of a blood clot occurring in the deep veins of the legs. This is known as deep venous thrombosis. Blood clots occur rarely and can develop whether or not you are taking HRT. Very occasionally, such as when a blood clot breaks away from the veins and blocks the arteries of the lungs (pulmonary embolism), a blood clot may cause serious permanent disability or may even be fatal. The warning signs of a blood clot are listed under the section "When using CLIMARA".

Oestrogens with or without progestogens should not be used for the long-term maintenance of general health, including the primary prevention of cardiovascular disease as the risks of long-term treatment with HRT in most circumstances, outweigh the benefits.

All prospective and current users of HRT should be advised of the risks and benefits of oestrogens and progestogens and the need for treatment with HRT should be reviewed on a yearly basis.

If there is a suspicion of an adenoma of the anterior lobe of the pituitary gland, this should be ruled out by your doctor before starting treatment.

Your doctor will carry out gynaecological, blood pressure and other examinations as appropriate. Your doctor will examine your breasts periodically during treatment, particularly if there is a history of breast cancer in your family.

If you are known to have any liver disease, your doctor will arrange for your liver function to be checked periodically.

HRT and cancer

The risk of cancer of the lining of the womb (endometrial cancer) increases when estrogens are used alone for prolonged periods. Estrogen treatments such as CLIMARA should not be used alone in women who have not had a hysterectomy. If you are using CLIMARA and have not had a hysterectomy, you will need additional progestogen hormone treatment. Your doctor will advise you about this. Please inform your doctor if you frequently have bleeding irregularities or persistent bleeding during treatment with CLIMARA.

In some studies breast cancer has been found slightly more often in women who have used HRT for more than 5 years compared to women of the same age who have never used HRT. The risk of having breast cancer diagnosed increases with length of treatment but this is comparable to the increased risk observed in women with a delayed menopause. If women stop taking HRT this increased risk decreases so that 5 years after stopping HRT, the risk of finding breast cancer is the same as for women who have never used HRT. Breast cancer seems less likely to have spread when found in women who have used HRT compared to women who have never used HRT. It is not known whether the difference is caused by HRT. It may be that women using HRT are examined more often, so that breast cancer is noticed earlier.

Ovarian cancer has been reported to occur slightly more often in women who had been on estrogen therapy for longer than 10 years, however, a survey of 15 studies did not find an increased risk for women on estrogen therapy.

During or after the use of hormones such as those that are contained in CLIMARA, benign liver tumors have rarely occurred, and malignant liver tumors even more rarely. In isolated cases, bleeding from such tumours into the abdominal cavity has endangered life. Although such events are extremely improbable, you should inform your doctor about any unusual feelings in your upper abdomen that do not disappear within a short time.

How to use CLIMARA properly

  • Each patch covers 7 days of treatment.
  • If you are not currently using an HRT preparation, you can start to use CLIMARA immediately.
  • If you are already using another type of HRT, start CLIMARA the day after stopping your treatment or when your doctor has told you to.
  • If you have not had a hysterectomy (removal of the uterus/womb), your doctor will prescribe an additional progestogen hormone and will advise you how to take this.

Mode of application

The sticky, thin, pliable patch should be applied to a clean, dry area of skin, preferably on the trunk or buttocks. Never put CLIMARA patches on or near your breasts. The area chosen should not be oily, damaged or irritated, and the waistline should be avoided since tight clothing may rub the patch off.

Take the patch out of its packaging by tearing open the pouch at the notched corner. Do not use scissors as you may accidentally cut the patch. Remove half of the firm, clear plastic backing which is slightly larger than the patch itself. Do not touch the sticky side of the patch. The exposed half patch should then immediately be pressed firmly in place with the palm of the hand for about 10 seconds. Remove the second half of the firm, clear plastic backing, smoothing out the patch from the centre to avoid trapping any air bubbles between the patch and the skin. The whole patch should then be pressed with the palm of the hand for another 10 seconds. Make sure that there is good contact with the skin, especially around the edges. Throw away the firm, clear plastic backing.

The patch should be left in place for 7 days, then removed and replaced with a new patch which should be applied to a different area. Do not put the patch on the same area of skin each week.

If the patch is applied correctly, you can bath, shower or swim as usual. The patch might, however, become detached from the skin in very hot water or in the sauna.

Although the patches should usually be applied continuously, your doctor may tell you to apply the patches on a cyclical basis. In this case, a patch should be applied weekly for 3 weeks followed by a 7-day interval without a patch application before the next course.

In women with a womb, bleeding usually occurs 2 - 3 days after the end of additional hormone progestogen use.

Please observe these instructions for use, otherwise you will not fully benefit from CLIMARA.

What to do if you miss or lose a patch

If a patch falls off before 7 days are up, it may be reapplied. If necessary a new patch may be used if it is not possible to reattach the old patch properly. If a new patch is used, it should then be kept on for the remainder of the 7-day dosing interval.

If you forget to replace a patch, do so as soon as possible after you remember. Use the next patch after the normal 7-day interval.

If you lose a patch or forget to replace it for several days, irregular bleeding may occur.

Overdosage

In the unlikely event of overdosage, nausea and vomiting may occur. There may be some bleeding from the vagina after removal of the patch(es). No specific treatment is necessary but you should consult your doctor if you are concerned.

When using CLIMARA

Tell your doctor immediately

You should stop treatment and see your doctor immediately if you get a blood clot while you are taking CLIMARA. Warning signs to look for are:

  • an unusual cough or coughing blood
  • unusual pains or swelling of your arm or leg
  • severe pain in the chest which may reach the left arm
  • breathlessness
  • your very first attack of migraine (typically a throbbing headache and nausea preceded by visual disturbances)
  • worsening of pre-existing migraine; any unusually frequent or severe headaches
  • partial or complete loss of vision, or double vision
  • slurring or speech disability
  • sudden changes to your hearing, sense of smell, or taste
  • dizziness or fainting
  • weakness or numbness in any part of your body
  • severe pain in your abdomen
  • inflamed veins (phlebitis)

CLIMARA must also be stopped at once if you become pregnant or if you develop jaundice. If you think that you may be pregnant, remove your CLIMARA patch and do not start using CLIMARA again until pregnancy has been ruled out.

Tell your doctor if:

Contact your doctor as soon as possible if:

you notice any changes in your own health, especially involving any of the items mentioned in this leaflet; do not forget about the items related to your immediate family

you feel a lump in your breast

you are to be immobilised or are to have surgery (consult your doctor at least four weeks in advance; see information on deep venous thrombosis in the "Before you use CLIMARA" section).

Tell your doctor if you are taking any other medications

Oral contraceptives should not be used. Consult your doctor for contraceptive advice, if required.

Some medicinal products may prevent HRT from working properly. These include medicinal products used for the treatment of epilepsy (e.g. hydantoins, barbiturates, primidone, carbamazepine) and tuberculosis (e.g. rifampicin). Always tell the doctor who prescribes HRT which medicinal products you are already using. Also tell any other doctor or dentist who prescribes another medicinal product (or the dispensing pharmacist) that you use CLIMARA.

If you are in doubt about any medicinal products you are taking, ask your doctor.

Excess intake of alcohol may raise blood levels of estradiol.

The use of HRT may affect the results of certain laboratory tests. Always tell your doctor or the laboratory staff that you are using CLIMARA patches.

Side effects

Serious side effects

Serious reactions associated with the use of HRT preparations such as CLIMARA, as well as the related symptoms, are described in the sections "Before you use CLIMARA" and "When using CLIMARA". Please read these sections carefully and consult your doctor where appropriate.

Other possible side effects

The most commonly reported side effect is skin irritation at the application site. Other possible side effects are:

Genitourinary system: changes in uterine bleeding pattern, breakthrough bleeding and spotting, increase in size of uterine fibroids, alterations in the amount of cervical secretion

Breasts: tenderness, enlargement

Gastrointestinal disorders: nausea, vomiting, gastric pain, abdominal pain, bloating, cholestatic jaundice

Skin disorders: chloasma or melasma (darkened patches on the skin, particularly of the face) which may be persistent. In rare cases an allergic contact dermatitis, a post-inflammatory pruritus (itching) and a generalised exanthema (rash) may occur.

Nervous system disorders: headache, migraine, dizziness

Miscellaneous: changes in body weight, worsening of porphyria, oedema, changes in libido (sex drive), muscle cramps.

If you notice any unwanted effects not mentioned in this leaflet, or if you are unsure about the effect of this product, please inform your doctor or pharmacist.

Storage

Do not use after the expiry date stated on the package.

Store the cardboard carton in a cool dry place. Do not store in the bathroom or any other place that is hot and steamy.

Keep out of reach of children. When disposing of patches, make sure that children cannot reach them.

Do not remove the patch from the protective pouch until you are ready to apply it.

Further information

CLIMARA patches contain:

active substance (per patch)

estradiol hemihydrate (either 3.9mg or 7.8mg)

other substances

ethyl oleate, isopropyl myristate, glycerol monolaurate, acrylate copolymer

If you have any further questions, please consult your doctor or pharmacist.

This leaflet was last revised on 10 August 2003