3. HOW TO USE KLIOFEM®
Always take Kliofem® exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure.
Take one tablet once a day, at about the same time each day
Take the tablet with a glass of water.
Take a tablet every day without stopping. After you have used all 28 tablets in a calendar pack, go straight to using the next pack.
See “USER INSTRUCTIONS” at the end of the package leaflet.
You may start treatment with Kliofem® on any convenient day.
However, if you are switching from an HRT product where you have a monthly bleed, start your treatment straight after the bleeding has ended.
Your doctor should aim to prescribe the lowest dose for the shortest time that gives you relief from your symptoms. Talk to your doctor if your symptoms are not better after three months.
If you take more Kliofem® than you should
If you have taken more Kliofem® than you should, talk to your doctor or pharmacist. An overdose of Kliofem® could make you feel sick or vomit.
If you forget to take Kliofem®
If you forget to take your tablet at the usual time, try and take it within the next 12 hours. If more than 12 hours have gone by, start again as normal the next day. Do not take a double dose to make up for a forgotten tablet.
Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting.
If you stop taking Kliofem®
If you want to stop taking Kliofem®, talk to your doctor first. Your doctor will explain the effects of stopping treatment and discuss other possibilities with you.
If you have any further questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Kliofem® can have side effects, although not everybody gets them.
Bleeding with Kliofem®
Kliofem® will not cause regular monthly bleeding, but when first starting the tablets, some women experience slight vaginal bleeding or spotting.
If you get breakthrough bleeding or spotting, it is usually nothing to worry about, especially during the first few months of taking HRT.
But contact your doctor as soon as possible:
- If bleeding carries on for more than the first few months
- If bleeding starts after taking HRT for a while
- If bleeding continues after stopping HRT.
Your doctor may ask you about any vaginal bleeding with Kliofem® at your regular check-ups. You may find it helpful to make a note of any bleedings in a diary.
Very common effects
May affect more than 1 in 10 women
- Breast pain or breast tenderness
- Irregular menstrual periods or excessive bleeding during your periods.
May affect up to 1 in 10 women
- Fungal infection of the genitals or vaginal inflammation (thrush)
- Fluid retention
- Depression or worsening of existing depression
- Migraine or existing migraine made worse
- Feeling sick (nausea)
- Pain, swelling or discomfort of the abdomen (stomach)
- Back pain
- Leg cramps
- Enlargement or swelling of the breasts (breast oedema)
- Uterine fibroids (benign tumour of the womb): aggravation or re-occurrence
- Swelling of arms or legs (Peripheral oedema)
- Weight increase.
May affect up to 1 in 100 women
- Allergic reaction (hypersensitivity)
- Inflammation of a vein (superficial thrombophlebitis)
- Flatulence (wind) or bloating
- Hair loss or increased facial or body hair or acne
- Hives (urticaria)
- Painful periods
- Excessive growth of the lining of the womb (endometrial hyperplasia)
- No relief of symptoms (Drug ineffective)
May affect up to 1 in 1,000 women
- Blood clots in the blood vessels of the legs or the lungs (deep vein thrombosis, lung embolism). See also section “Other side effects of HRT”
- Breast cancer. See also section “Other side effects of HRT”
Very Rare Effects
May affect up to 1 in 10,000 women
- Cancer of the lining of the womb (endometrial cancer). See also section “Other side effects of HRT”
- Changes in sexual desire
- Visual disturbances
- Increase in blood pressure or worsening of high blood pressure
- Heart attack or stroke (see also section “Other side effects of HRT”)
- Heartburn or vomiting
- Gallbladder disease
- Gallstones, aggravation, occurrence or re-occurrence
- Greasy skin
- Swelling of the skin or other tissues of sudden onset
- Vaginal and genital itching
- Weight decrease.
Effects on the skin
Brown patches on the face, skin rashes including red inflammation on the hands or the legs (erythema multiforme), formation of tender, red nodules on the front of the legs/- knees (erythema nodosum) or a bruise-like rash.
Other side effects of combined 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.
Effects on your risk of developing 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. The risk for a postmenopausal woman taking oestrogen-only HRT for 5 years is about the same as for a woman of the same age who’s still having periods over that time and not taking HRT. The risk for a woman who is taking oestrogen plus progestogen HRT is higher than for oestrogen-only HRT (but oestrogen plus progestogen HRT is beneficial for the endometrium, see ‘Endometrial cancer’ below).
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.
Looking at women aged 50 who are not taking HRT – on average, 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 65.
For women who start taking oestrogen-only HRT at age 50 and take it for 5 years, the figure will be between 33 and 34 in 1000 (i.e. an extra 1-2 cases).
If they take oestrogen-only HRT for 10 years, the figure will be 37 in 1000 (i.e. an extra 5 cases).
For women who start taking oestrogen plus progestogen HRT at age 50 and take it for 5 years, the figure will be 38 in 1000 (i.e. an extra 6 cases).
If they take oestrogen plus progestogen HRT for 10 years, the figure will be 51 in 1000 (i.e. an extra 19 cases)
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 oestrogen-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 oestrogen helps to lower the extra risk.
If you still have your womb, your doctor may prescribe a progestogen as well as oestrogen. 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 oestrogen 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 oestrogen.
Your product, Kliofem®, contains a progestogen.
Looking at women who still have a uterus 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 who take oestrogen-only HRT, the number will be 2 to 12 times higher, depending on the dose and how long you take it.
The addition of a progestogen to oestrogen-only HRT substantially reduces the risk of endometrial cancer.
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.
Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease.
Some studies have indicated that taking HRT for more than 5 years may increase the risk of ovarian cancer.
Effects on your heart or circulation
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.
DVT and PE are examples of a condition called venous thromboembolism, or VTE.
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 you have a rare condition called SLE.
If any of these things apply to you, talk to your doctor to see if you should take HRT.
Looking at women in their 50s who are not taking HRT – on average, over a 5-year period, 3 in 1000 would be expected to get a blood clot.
For women in their 50s who are taking HRT, the figure would be 7 in 1000.
Looking at women in their 60s who are not taking HRT – on average, over a 5-year period, 8 in 1000 would be expected to get a blood clot.
For women in their 60s who are taking HRT, the figure would be 17 in 1000.
If you get:
- Painful swelling in your leg
- Sudden chest pain
- Difficulty breathing.
See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These may be signs of a blood clot.
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.
HRT is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart disease, talk to your doctor to see if you should be taking HRT.
HRT will not help to prevent heart disease.
Studies with one type of HRT (containing conjugated oestrogen 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.
If you get:
- A pain in your chest that spreads to your arm or neck.
See a doctor as soon as possible and do not take any more HRT until your doctor says you can. This pain could be a sign of heart disease.
Recent research suggests that HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include:
- Getting older
- High blood pressure
- 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.
Looking at women in their 50s who are not taking HRT – on average, over a 5-year period, 3 in 1000 would be expected to have a stroke.
For women in their 50s who are taking HRT, the figure would be 4 in 1000.
Looking at women in their 60s who are not taking HRT – on average, over a 5-year period, 11 in 1000 would be expected to have a stroke.
For women in their 60s who are taking HRT, the figure would be 15 in 1000.
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
There is no evidence that HRT improves processes of knowing, thinking, learning and judging (cognitive function). From a clinical study there is some evidence for an increased risk of dementia among women older than 65 years, who were using another oestrogen/progestogen combination than the one in Kliofem®. It is not known whether this applies to younger women and to women taking other HRT preparations.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.