Kliofem

What is Kliofem?

Kliofem is a continuous, combined hormone replacement therapy (HRT) treatment for postmenopausal women who have not had their womb removed and have not had a natural period in the last 12 months. It contains two synthetic hormones called estradiol and norethisterone acetate, which are similar to the natural sex hormones oestrogen and progesterone, respectively. Together, the synthetic hormones counteract menopause symptoms by restoring the declining hormone levels.

Kliofem is available as an oral pill that you swallow. Each pill contains 2 mg of estradiol and 1 mg of norethisterone acetate to help restore hormonal balance, relieve symptoms, and protect your womb lining.

What is Kliofem Used For?

Kliofem is a type of HRT for postmenopausal women who have not had their womb removed and have not had a period for at least 12 months. It is used to relieve menopause symptoms caused by declining oestrogen levels, such as hot flushes, night sweats, sleep difficulties, and mood changes. Kliofem can also prevent osteoporosis in postmenopausal women who have a high risk of fractures when other treatments are not suitable.

Menopause is the time in a woman’s life when her body stops preparing itself for pregnancy. Menstruation cycles and ovulation both slow down before stopping completely. During the menopause, oestrogen levels in the body fall, which causes a number of symptoms such as:

• Difficulty sleeping
• Hot flushes
• Lower sex drive (libido)
• Mood swings
• Night Sweats
• Vaginal dryness

Typically, these symptoms begin between the ages of 45 and 55, with many women experiencing symptoms around the age of 51, according to the NHS. If a woman particularly suffers from these symptoms, HRT can be prescribed to balance the hormones in the body.

How Do Kliofem Tablets Work?

Kliofem works by replacing the oestrogen that’s lost during menopause. As you get older, your ovaries stop producing oestrogen, so Kliofem helps to restore these levels to relieve symptoms. Each pill contains synthetic versions of oestrogen and progesterone to help manage menopause symptoms.

Estradiol is a synthetic version of oestrogen to restore declining levels and treat symptoms like hot flushes, night sweats, sleep issues, vaginal dryness, and mood changes. Oestrogen also has an important role in maintaining bone density, so the inclusion of estradiol helps to prevent weak bones (osteoporosis) in postmenopausal women. It is thought that up to 20% of bone loss happens during menopause and that the lifetime risk of bone fractures in women aged 60 is 44% compared to just 25% in men of the same age.

Norethisterone acetate is a synthetic progestogen that protects the womb. When you take oestrogen on its own, it can cause the womb lining to grow and increase the risk of womb (endometrial) cancer. Norethisterone acetate helps to keep the womb lining stable and helps it to shed safely.

How Long Does Kliofem Take to Work?

It can take up to 3 months for Kliofem to fully improve your symptoms and for you to feel better. However, some people may notice an improvement in their symptoms within the first two weeks of starting treatment.

How quickly Kliofem will work for you depends on several factors, but if you do not feel better after 3 months, you should speak to your doctor, as you may need a different dose or switch to an alternative type of HRT.

Is Kliofem a Good HRT?

Kliofem is an effective form of HRT that is taken continuously every day without a break, which means you will not get a withdrawal bleed like you would expect with cyclic or sequential HRT. During months 10 to 12 of treatment, 94% of people did not experience bleeding or spotting while using Kliofem.

Research also shows that 91% of women taking Kliofem maintained or gained bone mineral density after 2 years of treatment. This demonstrates that Kliofem can effectively help to limit the risk of osteoporosis.

How to Take Kliofem Tablets

Kliofem is taken every day without a break and should be taken at the same time every day to keep hormone levels consistent. You should always take Kliofem exactly as your clinician has told you to. If you are unsure, you should contact your doctor or pharmacist for help.

To take Kliofem, you should:

1. Take one Kliofem tablet at the same time every day. You can swallow the pill whole with a glass of water.
2. Take one pill a day every day without a break.
3. When you have taken all 28 tablets in the strip, start a new strip the next day.

You can start treatment with Kliofem on any day that suits you, as long as you take it at the same time each day. If you are switching from a different type of HRT that causes you to have a monthly bleed, you should start Kliofem as soon as the bleeding has finished.

You will usually be prescribed the lowest dose to manage your symptoms effectively and for as long as necessary. If you think the dose you have been prescribed is too strong or not strong enough, you should contact your clinician for advice.

If You Forget to Take Kliofem HRT

If you forget to take your Kliofem tablet at the usual time, take it as soon as you remember within the next 12 hours. If it has been more than 12 hours since you should have taken your Kliofem pill, skip the dose and take your next dose at the usual time the next day. Don’t take a double dose to try to make up for the missed tablet.

It’s important to note that forgetting a dose of Kliofem could increase the likelihood of spotting and breakthrough bleeding if you still have your womb.

If You Take Too Much Kliofem

If you take too many Kliofem tablets, consult a clinician or doctor as soon as possible. Taking more oestrogens than prescribed could cause adverse effects such as nausea, vomiting, breast tenderness, and/or irregular vaginal bleeding. Meanwhile, taking too many progestogens may lead to fatigue, acne, and body or facial hair growth.

Can You Just Stop Taking Kliofem?

Talk to your clinician or doctor before stopping Kliofem. They will discuss what happens when you stop treatment and outline other options that you could take.

Kliofem Side Effects and Cautions

Because Kliofem can cause side effects, it is important to understand what they are and how they could affect you. Knowing what they are before you start Kliofem will help you understand what to look out for and when you may need to get medical advice.

Side Effects of Kliofem HRT

Like all medications, Kliofem can cause side effects, but not everyone will get them. For most people, Kliofem side effects are mild and temporary and will improve as your body gets used to the hormones.

The table below shows the different potential Kliofem side effects.

Please note that the above information is not a full list of potential Kliofem side effects. More details can be found in the Patient Information Leaflet that comes with the medication. If you experience any adverse reactions to the treatment, you can report them via the MHRA Yellow Card Scheme.

Serious Side Effects of Kliofem HRT

Although it is uncommon, Kliofem can cause serious side effects like allergic reactions. If you get any of the following side effects while taking Kliofem, stop taking it and get immediate medical help:

• Yellowing of the skin or whites of your eyes
• Swollen face, tongue and/or throat, and/or difficulty swallowing or hives, together with difficulty breathing, rapid heartbeat)
• Large rise in blood pressure (headache, tiredness, dizziness)
• A migraine-like headache for the first time
• If you get pregnant
• Signs of a blood clot

Other Side Effects of Combined HRT

There are several other side effects that have been reported while taking combined HRT, like Kliofem. They include:

• Skin disorders, such as skin discolouration, especially on the face and neck, known as pregnancy patches (chloasma), painful reddish skin nodules (erythema nodosum), rash with target-shaped reddening or sores (erythema multiforme), red or purple discolourations of the skin and/or mucous membranes (vascular purpura)
• Dry eyes
• Tear film composition changes

Kliofem Warnings and Interactions

Although Kliofem tablets are an effective form of HRT, they are not suitable for everyone. The medication may interact with other treatments you’re taking or exacerbate existing medical conditions. It’s therefore essential to pay close attention to any warnings or precautions to ensure you make an informed decision about whether Kliofem is suitable for you.

Do not take Kliofem if you:

• Are allergic to estradiol, norethisterone acetate, or any other ingredients listed in the medication
• Have, have had, or suspect you have breast cancer
• Have, have had, or suspect you have cancer of the womb lining or any other oestrogen-dependent cancer
• Have any unexplained vaginal bleeding
• Have untreated excessive thickening of the womb lining
• Have or have ever had a blood clot in a vein in the legs or lungs
• Have a blood-clotting disorder
• Have or have previously had a disease caused by blood clots in the arteries, such as a heart attack, stroke, or angina
• Have or have ever had a liver disease, and your liver function tests have not yet returned to normal
• Have a rare blood problem called ‘porphyria’

Precautions Before Taking Kliofem

Before taking Kliofem, let the clinician know if you have ever had any of the following:

• Fibroids inside your womb
• Growth of the womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia)
• Increased risk of developing blood clots
• 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
• Diabetes
• Gallstones
• Migraine or severe headaches
• A disease of the immune system that affects many organs of the body (systemic lupus erythematosus (SLE)
• Epilepsy
• Asthma
• A disease affecting the eardrum and hearing (otosclerosis)
• A very high level of fat in your blood (triglycerides)
• Fluid retention
• A hereditary condition that causes recurrent episodes of severe swelling, or if you have had episodes of rapid swelling of the hands, feet, face, lips, eyes, tongue, throat, or digestive tract
• Lactose intolerance

Other Medicines and Kliofem

You should let the clinician know if you are taking any prescribed, over-the-counter, or herbal medications before starting Kliofem. Some medicines can interact with Kliofem, which may cause irregular bleeding. These include:

• Epilepsy medications
• Tuberculosis medications
• HIV infection medications
• Hepatitis C infection medications
• St John’s Wort

HRT can affect the way some other medicines work, such as:

• Lamotrigine for epilepsy
• Medicines for hepatitis C virus (such as combination regimens ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin; glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir)

A fungicide medicine called ketoconazole can increase the effects of Kliofem, while Kliofem can impact concomitant treatment with cyclosporine.

Laboratory Tests

If you need a blood test, tell your doctor or laboratory staff that you are taking Kliofem, as this HRT can affect some test results.

Risk of Breast Cancer

Research shows that both combined hormone replacement therapy (HRT), which contains oestrogen and a progestogen, and oestrogen-only HRT can increase the risk of breast cancer. The increase in risk is linked to the duration of HRT use. In general, the risk begins to rise after about 3 years of treatment and increases with longer-term use.

Once HRT is stopped, the risk gradually falls over time. However, for women who have used HRT for more than five years, a small increase in breast cancer risk may remain for 10 years or longer after treatment ends.

Blood Clot Risk

Research shows that the risk of blood clots in the veins is 1.3 to 3 times higher in people taking HRT than in non-users, especially during the first year of taking it.

The risk of blood clots is as follows:

• Women in their 50s who are not taking HRT, 4 to 7 in 1000 people, on average, would be expected to get a blood clot in a vein
• For women in their 50s who have been taking combined HRT for over 5 years, there will be 9 to 12 cases of blood clots in 1000 users

You are more likely to get a blood clot in a vein as you age, and if any of the following apply to you:

• You are going to be off your feet for a while because of major surgery, illness, or injury
• You are seriously overweight (BMI of 30 or above)
• You have a blood-clotting issue that needs long-term treatment with a medicine to prevent blood clots
• You have any close relatives who have ever had a blood clot in the leg, lung, or any other organ
• You have SLE
• You have cancer

Pregnancy and Breastfeeding

Kliofem is for postmenopausal women only. If you become pregnant while taking Kliofem, stop taking it and contact your doctor.

Do not take Kliofem if you are breastfeeding.

Frequently Asked Questions About Kliofem HRT