Climaval 1mg Film-Coated Tablets
Out of date information, search another1. What Climaval is and what it is used for
2. What you need to know before you take Climaval
PACKAGE LEAFLET: INFORMATION FOR THE USER CLIMAVAL® 1mg film-coated tablets CLIMAVAL® 2mg film-coated tablets
estradiol valerate
Your medicine is available as one of the above names but will be referred to as Climaval throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Climaval is and what it is used for
2. Before you use Climaval
3. How to use Climaval
4. Possible side-effects
5. How to store Climaval
6. Further information
Climaval is a Hormone Replacement Therapy (HRT). It contains the female hormone oestrogen.
Estradiol valerate is identical to the natural female hormone oestrogen. This hormone is produced by the ovaries before the menopause.
Climaval 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 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. Climaval alleviates these symptoms after menopause. You will only be prescribed Climaval if your symptoms seriously hinder your daily life.
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) Climaval, 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. 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 Climaval, you should see your doctor for regular check-ups (at least once a year). At these checkups, discuss with your doctor the benefits and risks of continuing with Climaval.
Go for regular breast screening, as recommended by your doctor.
Do not take Climaval
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 Climaval,
• 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 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 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 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 any of the other ingredients of Climaval (listed in section 6);
If any of the above conditions appear for the first time while taking
Climaval, stop taking it at once and consult your doctor immediately.
When to take special care with Climaval
Tell your doctor 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 Climaval. 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 (see “Blood clots in a vein (thrombosis)”)
• Increased risk of getting an oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer)
• High blood pressure
• A liver disorder, such as a benign liver tumour (liver adenoma)
• Diabetes
• Gallstones
• Migraine or severe headaches
• A disease of the immune system that affects many organs of the body (Systemic lupus erythematosus, SLE), an autoimmune disorder
• Epilepsy
• Asthma
• A disease affecting the eardrum and hearing (otosclerosis)
• A very high level of fat in your blood (triglycerides)
• Fluid retention due to cardiac or kidney problems
• Hypothyroidism (a condition in which your thyroid gland fails to produce enough thyroid hormone and for which you are treated with thyroid hormone replacement therapy)
• Hereditary angioedema or episodes of rapid swelling of the hands, feet, face, lips, eyes, tongue, throat (airway blockage) or digestive tract.
Stop taking Climaval 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 Climaval' section
- Yellowing of your 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, with or without disturbed vision. Headaches like these can be an early sign of a stroke. If you have already had a stroke, talk with your doctor about whether the benefits of the treatment outweigh the possibly increased risk.
- If you get pain in your chest that spreads to your arm or neck. This pain may be a sign of heart disease.
- If you notice signs of a blood clot, such as:
■ painful swelling and redness of the legs
■ sudden chest pain
■ difficulty in breathing
For more information, see 'Blood clots in a vein (thrombosis)'.
HRT and cancer
Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
Taking oestrogen-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 oestrogen 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 oestrogen-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.
Unexpected bleeding
You will have a bleed once a month (so-called withdrawal bleed) while taking Climaval. But, if you have unexpected bleeding or drops of blood (spotting) besides your monthly bleeding, which:
- carries on for more than the first 6 months
- starts after you have been taking Climaval for more than 6 months
- carries on after you have stopped taking Climaval
- if you have painful menstrual periods
See your doctor as soon as possible.
Breast cancer
Evidence suggests that taking combined oestrogen-progestogen and possibly also oestrogen-only HRT increases the risk of breast cancer. The extra risk depends on how long you take HRT. The additional risk becomes clear within a few years. However, it returns to normal within a few years (at most 5) after stopping treatment.
For women who have had their womb removed and who are using oestrogen-only HRT for 5 years, little or no increase in breast cancer risk is shown.
Compare
Women aged 50 to 79 who are not taking HRT, on average, 9 to 14 in 1000 will be diagnosed with breast cancer over a 5-year period. For women aged 50 to 79 who are taking oestrogen-progestogen HRT over 5 years, there will be 13 to 20 cases in 1000 users (i.e. an extra 4 to 6 cases).
Regularly check your breasts. See your doctor if you notice any changes such as:
• dimpling of the skin
• change in the nipple
• any lump you can see or feel
Ovarian cancer
Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.
Women aged 50 to 69 who are not taking HRT, on average about 2 women in 1000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be between 2 and 3 cases per 1000 users (i.e. up to 1 extra case).
Effect of HRT on heart and circulation Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3- times higher in HRT users than in non-users, especially during the first year of taking it.
Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.
You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you. Inform your doctor if any of these situations applies to you:
• you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, If you need to have surgery)
• you are seriously overweight (BMI >30 kg/m2)
• you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots
• if any of your close relatives has ever had a blood clot in the leg, lung or an other organ
• you have systemic lupus erythematosus (SLE)
• you have cancer.
For signs of a blood clot, see “Stop taking Climaval and see a doctor immediately”.
Compare
Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.
For women in their 50s who have been taking oestrogen-progestogen HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e. an extra 5 cases).
For women in their 50s who have had their womb removed and have been taking oestrogen-only HRT for over 5 years, there will be 5 to 8 cases in 1000 users (i.e. 1 extra case).
