Medroxyprogesterone acetate is a progestogen and has actions similar to the naturally occurring hormone progesterone. Progesterone is produced by the ovaries and is important in the natural monthly ovarian (menstrual) cycle. Climanor is often used in conditions in which progesterone is either not being produced at all, or in insufficient amounts.

Climanor is used for a variety of medical conditions. Climanor may be prescribed:

• As part of hormone replacement therapy. Levels of female hormones decline during and after the menopause. Estrogens are given to relieve symptoms such as hot flushes and sweats. Estrogens also stimulate the lining of the womb (the endometrium). Climanor is taken to stop the endometrium from becoming too thick, and to make sure it is shed during the regular vaginal bleeds.
• For a condition in which abnormal vaginal bleeding occurs called dysfunctional uterine bleeding.
• When normal menstrual periods have unexpectedly stopped, even though they were normal in the past. This is called secondary amenorrhoea.
• When some of the lining of the womb (the endometrium) has spread to other parts of the abdomen. This is called endometriosis. Climanor is used for mild to moderate cases of this condition.

Medical check-ups  

Do you have?

• Epilepsy
• Migraine or severe headaches
• Asthma
• High blood pressure (see ‘Safety of HRT – Effects on your heart or circulation’’ below)
• A family history of breast or endometrial cancer (see ‘Safety of HRT - Effects on your risk of developing cancer ’ below)
• Fibroids or endometriosis
• Diabetes

If you are suffering from any of these conditions or have suffered from these conditions in the past, please tell your doctor.

Safety of HRT

As well as benefits, HRT has some risks which you need to consider when you’re deciding whether to take it, or whether to carry on taking it.

Heart disease

HRT is not recommended for women who have heart disease, or have had heart disease recently.

HRT will not help to prevent heart disease.

Studies with one type of HRT (containing conjugated estrogen plus the progestogen MPA) have shown that women may be slightly more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar, although this is not yet certain.

Stroke

Recent research suggests that HRT slightly increase the risk of having a stroke. Other things that can increase the risk of stroke include:

• getting older
• high blood pressure
• smoking
• drinking too much alcohol
• an irregular heartbeat

If you are worried about any of these things, or if you have had a stroke in the past, talk to your doctor to see if you should take HRT.

If you get:
Unexplained migraine-type headaches, with or without disturbed vision
See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These headaches may be an early warning sign of a stroke.

Blood clots

HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis or DVT), especially during the first year of taking it.
These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death. This condition is called pulmonary embolism, or PE.

You are more likely to get a blood clot:

• if you are seriously overweight
• if you have had a blood clot before
• if any of your close family have had blood clots
• if you have had one or more miscarriages
• if you have any blood clotting problem that needs treatment with a medicine such as warfarin
• if you’re off your feet for a long time because of major surgery, injury or illness

If any of these things apply to you, talk to your doctor to see if you should take HRT.

If you’re going to have surgery, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.

Breast cancer

Women who have breast cancer, or have had breast cancer in the past, should not take HRT.
Taking HRT slightly increases the risk of breast cancer; so does having a later menopause.
For all kinds of HRT, the extra risk of breast cancer goes up the longer you take it, but returns to normal within about 5 years after stopping HRT.

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

If you notice any changes in your breast, such as:

• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel

Make an appointment to see your doctor as soon as possible.

Endometrial cancer (cancer of the lining of the womb)

Taking estrogen-only HRT for a long time can increase the risk of cancer of the lining of the womb (the endometrium). Taking a progestogen as well as the estrogen helps to lower the extra risk.

If you still have your womb, your doctor will usually 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.

CLIMANOR contains a progestogen.

If you get breakthrough bleeding or spotting, it’s usually nothing to worry about, especially during the first few months of taking HRT.
But if the bleeding or spotting:

• carries on for more than the first few months
• starts after you’ve been on HRT for a while
• carries on even after you’ve stopped taking HRT

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

Can Climanor be taken while taking other medicines?

You should tell your doctor if you are taking any other preparation, even medicines you can purchase from your pharmacist, without prescription including herbal preparations such as St Johns Wort, anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz, ritonavir and nelfinavir) and aminoglutethimide.

Climanor Use:

When should I take the tablets?

Your doctor will advise you about the dose of Climanor most suitable for your clinical condition. You should take the tablets at regular times each day. Always follow your doctor’s instructions on taking Climanor precisely.

As part of hormone replacement therapy
If you are taking an estrogen preparation as hormone replacement for menopausal symptoms, the usual dose of Climanor is two tablets a day (10mg a day), for 12–14 days out of every 28-day cycle.

Your doctor will usually prescribe a 28-day cycle of treatment of either 14 or 16 days of the estrogen preparation on its own followed by both the estrogen and Climanor until the end of the cycle. You should take the estrogen preparation alone for the first 14 or 16 days of the cycle and then start Climanor on day 15 or 17 and continue taking both the estrogen preparation and Climanor until the end of each 28-day cycle.

For dysfunctional uterine bleeding
If you are taking Climanor for abnormal vaginal bleeding, the usual dose is one or two tablets (5 or 10mg) daily for 5 to 10 days for two consecutive cycles.

Start taking the tablets between the sixteenth and twenty-first day of your normal menstrual cycle according to your doctor’s instructions.

For secondary amenorrhoea
If you are taking Climanor because your periods have stopped (even though in the past they were normal) the usual dose is one or two tablets (5 or 10mg) daily for 5 to 10 days for three consecutive cycles.

Start taking the tablets between the sixteenth and twenty-first day of your normal menstrual cycle according to your doctor’s instructions.

For endometriosis
If you are taking Climanor because of endometriosis (the condition in which the lining of the womb has spread to other parts of the abdomen), the usual dose is two tablets (10mg) three times a day for 90 days.

Start taking the tablets on the first day of your normal menstrual cycle.

What should you do if you take too many tablets?

If you accidentally take too many Climanor tablets, stop taking the therapy and inform your doctor.
Severe reactions to Climanor after overdose are rare.

What should you do if you forget a dose?

If you do forget to take your Climanor dose at the usual time of day, take it as soon as you remember. However if it is time to take your next dose, do not take the missed tablet(s), but continue taking the remaining tablets as usual to the end of your prescribed course. You might notice some bleeding or spotting if you miss a dose.

 WHILST USING CLIMANOR

What vaginal bleeding should you expect if you are taking Climanor for hormone replacement?

If you have been prescribed Climanor because you are taking estrogen for hormone replacement therapy you will usually experience a vaginal bleed (similar to your usual period) after taking Climanor tablets for 10 to 14 days or soon after finishing Climanor. This bleed will tend to become less and less as you continue with the therapy and in some patients it may disappear altogether. However, if you experience any unusual bleeding, you should inform your doctor.

What vaginal bleeding should you expect if you are taking Climanor for other conditions?

If you are taking Climanor to correct abnormal bleeding or because your periods have stopped, treatment with Climanor will help to make your menstrual bleeds more regular. The time taken for this will vary from person to person.

If you are receiving Climanor for endometriosis, you may experience some breakthrough bleeding.

If you have a blood test whilst you are taking Climanor

Climanor may affect the results of certain laboratory tests, so you should tell the person taking the sample that you are on Climanor.

What might happen while you are using Climanor (side effects)?

Climanor may cause weight gain or swelling because of fluid being retained. This may make epilepsy, migraine, asthma, kidney disease or heart disease worse. You should tell your doctor if you notice any change in your condition while you are taking Climanor.

Climanor may cause feelings of depression in some women and this may be similar to pre-menstrual depression.

You may also experience:

• In the nervous system - nervousness, insomnia, sleepiness, tiredness, dizziness, headache
• In the skin - skin rash or itching, acne, excessive facial or body hair (hirsutism), loss of hair
• In the breast - breast tenderness or secretion of milk
• In the stomach - nausea
• In other parts of the body - change in weight.

These side effects are also usually mild and disappear with continuing therapy. If they are severe, or if you experience any other side effects with Climanor you should inform your doctor.

Blood clots have been reported on rare occasions, but whether these are caused by Climanor when used alone is not known.

If you are taking Climanor because you are taking estrogen for hormone replacement therapy, then you might also experience symptoms associated with estrogen. HRT will not prevent memory loss. In one study of women who started using combined HRT after the age of 65, a small increase in the risk of dementia was observed.

REASONS TO STOP TAKING CLIMANOR

You should stop taking Climanor and tell your doctor immediately if you experience:

• Jaundice (yellowing of the skin or eyes)
• Unexplained migraine-type headaches, with or without disturbed vision.
• Signs of heart disease e.g. pain in your chest that spreads to your arm or neck
• Signs of a blood clot e.g. sudden chest pain, a painful swelling in your leg, or difficulty breathing.

Any condition listed in the section above ‘You should not use Climanor if’

• Increased blood pressure (your doctor may advise you to stop treatment if your blood pressure rises)
• You know or suspect you are pregnant

Storing your medicine

You will see that an expiry date is embossed on the pack. You should not use the product after this date.
Always store the Climanor tablets below 25°C in a dry, dark place out of the reach of children.

Patient Information Leaflet

Registered in: United Kingdom