Read the following warnings carefully to ensure you are selecting an appropriate product.
Treatment with HRT carries risks which you should consider before deciding to start it or to continue taking it.
There is limited experience in treating women with premature menopause. If you have premature menopause, the risks of using HRT may be different for you, so it’s best to talk to your doctor first.
Before starting or restarting HRT, your doctor will ask about your and your family’s medical history. You may need to have a physical examination of your breasts and/or an internal examination, if necessary.
Once you have started on Kliofem you should see your doctor at least once a year. At these check-ups, discuss with your doctor the benefits and risks of continuing with Kliofem.
Schedule regular breast screenings, as recommended by your doctor.
Do not take Kliofem if any of the following applies to you:
- If you have, have had or suspect that you have breast cancer
- If you have, have had or suspect that you have cancer of the uterus lining (endometrial cancer), or any other oestrogen- dependent cancer
- If you have unexplained vaginal bleeding
- If you have excessive thickening of the uterus lining that is untreated
- If you have or have ever had a blood clot in a vein such as in the legs or the lungs.
- If you have a blood clotting disorder
- If you have had a angina, heart attack, or stroke
- 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, hereditary blood problem called porphyria
- If you are allergic to any of the other ingredients of Kliofem.
Before you start treatment, inform your doctor if you have or have had any of the following conditions since they may return or worsen during treatment with Kliofem:
- Fibroids inside your uterus
- Endometriosis or a history of excessive growth of the uterus lining
- Elevated risk of developing blood clots
- Elevated risk of developing an oestrogen-sensitive cancer
- A liver disorder
- High blood pressure
- Migraine or severe headaches
- Systemic lupus erythematosus, SLE
- A very high level of triglycerides in your blood.
- Fluid retention as part of cardiac or kidney problems
- If you take medication for an underactive thyroid gland, your doctor will test you during your treatment with HRT to ensure that your hormone levels remain acceptable
- A hereditary condition causing recurrent episodes of severe swelling or if you have experienced rapid swelling of the hands, face, lips, feet, eyes, throat, tongue, or digestive tract
- Lactose intolerance.
Stop taking Kliofem and see a doctor immediately if you notice any of the following:
- Any of the conditions mentioned in the ‘Warnings’ section
- Signs of jaundice. This may signal liver disease
- A significant rise in your blood pressure. Symptoms include headache, tiredness, dizziness.
- Headaches which happen for the first time that resemble migraines
- If you become pregnant
- If you notice signs of a blood clot, such as:
- Painful swelling and redness in the legs
- Pain in the chest which comes on suddenly
- Difficulty in breathing
Note: Kliofem is not a contraceptive. If it has been less than a year since your last menstrual period or you are under 50 years old, you may still need additional contraception. Consult your doctor for advice.
HRT and cancer
Excessive thickening of the lining of the uterus (endometrial hyperplasia) and cancer of the lining of uterus (endometrial cancer). Taking an HRT with oestrogen only will increase your risk of developing excessive thickening of endometrium and endometrial endometrium.
The progestagen in Kliofem® protects you from this extra risk.
On average, in women who have not had a hysterectomy and do not take HRT, 0.5% will be diagnosed with endometrial cancer between the ages of 50 and 65.
For women aged 50 to 65 who have not had a hysterectomy and who take oestrogen-only HRT, between 1% and 1.6% will be diagnosed with endometrial cancer, depending on the dose and the length of treatment.
Evidence suggests that taking combined oestrogen-progestagen and possibly oestrogen-only HRT increase patients’ risk of developing breast cancer. This risk depends on how long you take HRT. However, the risk returns to normal a few years after stopping treatment.
On average, of women aged 50 to 79, 9 to 17 women in 1,000 women who are not taking HRT will be diagnosed with breast cancer over a 5-year period. There will be 13 to 23 cases in 1,00 women aged 50 to 79 who take oestrogen-progestagen HRT for over 5 years.
Check your breasts regularly. Talk to your doctor if you notice any changes such as:
- dimpling of the skin
- changes in the nipple
- lumps you can see or feel.
Additionally, you are advised to schedule regular mammogram screenings During the screening, inform the nurse or healthcare professional about your use of HRT, as this medication may increase the density of your breasts and affect the mammogram’s outcome. Where breast has increased density, mammography may not detect all lumps.
Ovarian cancer is rare, however the use of oestrogen-only or combined oestrogen-progestagen HRT has been associated with a slight increase in the risk of ovarian cancer.
The risk varies with age. For example, about 2 women in 2,000 aged 50 to 54 who are not taking HRT will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be about 3 cases per 2,000 users.
HRT’s effect on heart and circulation
The risk of developing blood clots in the veins is higher in HRT users than in non-users, especially during the first year of taking the medication.
Blood clots can be serious, and if a clot enters the lungs, it can cause chest pain, breathlessness, fainting or even death.
You are more likely to develop a blood clot in your veins as you age and if any of the following applies to you:
- You are unable to walk for an extended period of time due to major surgery, injury or illness.
- If any of your close relatives has had a blood clot in the leg, lung or another organ
- You are overweight (BMI > 30 kg/m2)
- You have systemic lupus erythematosus (SLE)
- You have a blood clotting problem that requires long-term treatment with a medication used to prevent blood clots
- You have cancer
Talk to your doctor if you have any of these conditions prior to taking Kliofem.
For signs of a blood clot, see Stop taking Kliofem® and see a doctor immediately.
On average, 4 to 7 women in 1,000 in their 50s who are not taking HRT, would be expected to get a blood clot in a vein over a 5-year period.
For women in their 50s who have been taking oestrogen-progestagen HRT for over 5 years, there are 9 to 12 cases in 1,000 users.
Heart disease (heart attack)
Women over the age of 60 who take oestrogen-progestagen HRT have a slightly higher risk of developing heart disease than those not taking HRT. There is no evidence that HRT will prevent a heart attack.
The risk of getting stroke is about 1.5 times higher for HRT users than non-users. The number of extra cases of stroke linked to HRT use will increase with age.
On average, 8 in 1,000 women in their 50s who are not taking HRT are likely to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases of stroke in 1,000 users over 5 years.
You may experience irregular bleeding or spotting during the first 3-6 months of taking Kliofem. However, if the irregular bleeding:
- continues after the first 6 months,
- begins after you have been taking Kliofem for over 6 months
- continues after you have stopped Kliofem
If you experience any of the above contact your doctor as soon as possible.
HRT will not prevent memory loss. There is some evidence of memory loss in women who start using HRT after the age of 65. Consult your doctor for advice.
Using other medications
Some medicines may interfere with Kliofem. This might lead to irregular bleeding and applies to the following medications:
- Medications for epilepsy
- Medications for tuberculosis
- Medications for HIV infection (
- Medications for hepatitis C infections
- remedies containing St John’s Wort (Hypericum perforatum).
Some medicines increase the effects of Kilofem these include:
- Medicines containing ketoconazole.
You should tell your doctor or pharmacist if you take or have recently taken any other medications, including over-the-counter, herbal medications or other natural products.
Taking Kliofem with food and drink
Kliofem tablets can be taken with or without food and drink.
If you need to take a blood test, tell your doctor or the laboratory staff that you are taking Kliofem, since it can affect the results of some tests.
Pregnancy and breastfeeding
Pregnancy: If you become pregnant speak to your doctor. Kilofem is to be used in postmenopausal women only.
Breastfeeding: do not take Kliofem if you are breast-feeding.
Driving and operating machinery
Kliofem has no studied effect on a person’s ability to drive or operate machinery.