Climagest is a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an oestrogen and a progestogen. Climagest is used in postmenopausal women with at least 6 months since their last natural period.
Oestradiol valerate is identical to the natural female hormone oestrogen. This hormone is produced by the ovaries before the menopause. Norethisterone belongs to the group of hormones known as progestogens. It has effects similar to the natural female hormone progesterone, also produced by the ovaries before the menopause.
Climagest is used for:
Relief of symptoms occurring after menopause
Menopause occurs naturally in all women, usually between the ages of 45 and 55 years. It occurs also in younger women who have their ovaries removed by surgery.
During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause unpleasant symptoms such as hot face, neck and chest (“hot flushes”), sleep problems, irritability and depression. Some women also have problems with urine control or dryness of the vagina, which may cause discomfort during or after sexual intercourse.
Climagest alleviates these symptoms after menopause. You will only be prescribed Climagest if your symptoms seriously hinder your daily life.
If oestrogen is taken on its own, there is a greater risk of abnormal growth of the womb lining (endometrial hyperplasia) and endometrial cancer. The norethisterone in the white Climagest tablet reduces these risks in women who still have their womb.
) How to take Climagest
Always use this medicine exactly as your doctor has told you. Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary. Speak to your doctor if you think this dose is too strong or not strong enough. During the treatment your doctor may adjust the dose according to your individual needs.
When to start treatment
Climagest is a continuous sequential HRT. This means that oestrogen is given continuously, and progestogen is added for 12 days of the cycle.
? If you are not currently taking HRT and still having periods, it is
advisable to take the first tablet on the first day of your period (first day of the bleed) unless your doctor tells you otherwise. If your periods are infrequent, or have stopped, your doctor may suggest that you start immediately.
? If you are changing from a sequential HRT or cyclic HRT, you should complete your treatment cycle and then start taking Climagest immediately.
? If you are changing from a continuous combined HRT and your periods have stopped, you can start taking Climagest at any time. If you still have periods, start taking Climagest on the first day of your period.
How to take Climagest
Take one tablet each day by following the sequence of numbers and arrows on the calendar pack.
Swallow your tablets whole with a glass of water.
The pack has been designed specifically to help you take the tablets correctly.
Write the name of the day you take your first tablet in the box below. For example, if you start your tablets on a Wednesday, then write “Wednesday” in the box. This day will also be the day on which you will take tablets 8, 15 and 22. This will help you check that you have taken each tablet on the right day.
When you finish one blister pack, start the new one the next day whether or not you experience bleeding. This will normally be the same day of the week as you started the previous blister pack. Do not take a break between blister packs unless your doctor tells you.
The tablets are best taken at the same time every day; try to get into a routine.
Follow your doctor’s instructions as to how and when you should take Climagest tablets and never change the dose yourself, however well you feel.
If you are unsure about how much medicine to take or when to take it, ask your doctor or pharmacist.
How long to take Climagest
From time to time, you will need to discuss with your doctor the possible risks and benefits associated with Climagest and whether you still need the treatment. It is important that you take the lowest possible effective dose and only for as long as needed.
If you have taken more Climagest than you should
Contact your doctor or pharmacist immediately if you have taken too much Climagest.
If you forget to take Climagest
If you forget to take a tablet at your usual time, try to take it within 12 hours. If this is not possible, leave the forgotten tablet and continue to take the remaining tablets at the usual time.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking Climagest. You may need to stop taking Climagest about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots in a vein). Ask your doctor when you can start taking Climagest again.
If you stop taking Climagest
Stopping Climagest may increase the risk of breakthrough bleeding or spotting. If this occurs after you stop treatment, contact your doctor immediately. Your doctor will need to work out the reasons for this.
After a long treatment break, consult your doctor before starting to take Climagest again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Climagest 1mg Tablets: The active ingredient of the grey-blue tablets is 1mg estradiol valerate. The active ingredients of the white tablets are 1mg estradiol valerate and 1mg norethisterone.
Climagest 2mg Tablets: The active ingredient of the blue tablets is 2mg estradiol valerate. The active ingredients of the pale yellow tablets are 2mg estradiol valerate and 1mg norethisterone.
The other ingredients of the grey-blue or blue tablets are lactose monohydrate, maize starch, povidone K30, magnesium stearate, hypromellose, propylene glycol, indigo aluminium carmine lake (E132), sodium dodecyl sulphate, sodium edentate, titanium dioxide (E171), and talc.
The other ingredients of the white or pale yellow tablets are lactose monohydrate, maize starch, povidone K30, magnesium stearate, hypromellose, propylene glycol, indigo aluminium carmine lake (E132), titanium dioxide (E171), yellow iron oxide (E172) and talc.
The following diseases are reported more often in women using HRT compared to women not using HRT:
? breast cancer
? abnormal growth or cancer of the lining of the womb (endometrial
hyperplasia or cancer)
? ovarian cancer
? blood clots in the veins of the legs or lungs (venous thromboembolism)
? heart disease
? probable memory loss if HRT is started over the age of 65
Medical history and regular check-ups
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) Climagest, your doctor will ask you 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. He/she should tell you what kind of changes in the breast you should look out for and may advise you to have a breast X-ray (a mammogram).
Once you have started on Climagest 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 Climagest.
Go for regular breast screening, as recommended by your doctor.
Do not take Climagest
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 Climagest,
? if you have or have ever had breast cancer, or if you are suspected of
? if you have cancer which is sensitive to oestrogens, such as cancer of
the womb lining (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 severe kidney disease;
? if you have or 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
? 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 ever had a liver disease and your liver function tests
have not returned to normal;
? if you have a rare blood problem called “porphyria” which is passed down
in families (inherited);
? if you are allergic (hypersensitive) to oestradiol valerate or norethisterone
or any of the other ingredients of Climagest (listed in section 6);
? if you are pregnant, or think you might be.
If any of the above conditions appear for the first time while taking Climagest, stop taking it at once and consult your doctor immediately.
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