Kliovance

What is Kliovance?

Kliovance is a type of hormone replacement therapy (HRT) for postmenopausal women who have not had a natural period for at least 12 months and have not undergone a hysterectomy (an operation to remove the womb). Kliovance contains two hormones: 1 mg of estradiol, which is a type of oestrogen, and 0.5 mg of norethisterone, a progestogen to help restore the declining hormone levels during menopause. The medicine is used in hormone replacement therapy.

During the menopause, the levels of oestrogen in a woman's body gradually diminish, which can cause various undesired symptoms such as hot flushes, night sweats, vaginal dryness, sleep disturbances, mood swings and changes in sex drive (libido).

For some women, these symptoms can significantly impact their lifestyle and overall well-being. If this is the case, HRT can be prescribed to balance hormones in the body and relieve the unwanted symptoms of menopause.

How Do Kliovance Tablets Work?

Kliovance works by restoring the oestrogen and progesterone that your body stops producing after menopause. Estradiol helps to restore oestrogen levels to ease symptoms, including hot flushes, night sweats, and vaginal dryness. It can also help prevent bone loss, which is common in postmenopausal women because of dwindling oestrogen levels, and helps to prevent osteoporosis.

Because Kliovance contains oestrogen, the norethisterone acetate helps to protect the womb lining from becoming too thick, a condition called endometrial hyperplasia, and reduces the risk of developing womb cancer.

How Long Does Kliovance Take to Work?

It can take up to 3 months for you to notice the full benefits of Kliovance for your menopause symptoms. However, some people may notice an improvement within the first 2 weeks of starting treatment.

How quickly Kliovance will work for you depends on several factors, but if you are not feeling better within 3 months, speak to a doctor, as you may need an alternative type of HRT.

Kliovance Results: Is Kliovance a Good HRT?

Clinical trials have demonstrated that the combination of estradiol and norethisterone enhances its effectiveness in managing symptoms such as hot flushes and night sweats, with relief achieved within the first few weeks of treatment. Kliovance has also been shown to help 87% of people maintain or gain bone mineral density after 2 years of treatment, which could positively prevent osteoporosis.

One study comparing the effectiveness of low-dose HRT (1 mg estradiol/0.5 mg norethisterone) with high-dose HRT (2 mg estradiol/1 mg norethisterone) for 6 months found the following:

Although the results of this study show that the reduction of bone resorption markers and cholesterol was greater in the high-dose HRT group, the results from the low-dose HRT group were still promising and had a lower incidence of vaginal bleeding.

How to Take Kliovance HRT

Kliovance is a continuous, combined HRT pill, which means you should take one tablet at the same time each day, and when you have finished all 28 pills in the strip, start a new pack without having a break. You should always take Kliovance exactly as prescribed and check with your clinician if you are unsure.

You can start taking Kliovance on any convenient day. If you are switching from an HRT product that causes you to have a monthly bleed, start Kliovance straight after the bleeding has finished.

If You Miss a Dose of Kliovance

If you forget your tablet at the usual time, take it within the next 12 hours. If more than 12 hours have gone by, skip the missed dose and take the next tablet at the usual time. Do not take a double dose. Forgetting a dose of Kliovance HRT could also increase the likelihood of breakthrough bleeding and spotting if you still have a womb.

If You Take Too Many Kliovance Tablets

If you have taken too many Kliovance tablets, consult your doctor or clinician. An overdose of this medication could make you feel nauseous or cause you to vomit.

Stopping Kliovance Suddenly

If you would like to stop Kliovance treatment, or are considering it, it's important to talk to your doctor or clinician first. They will explain the effects of doing so and discuss other possibilities with you.

Kliovance Side Effects and Cautions

Because Kliovance can cause side effects, it is important to understand what they are and how they could affect you. This will help you understand what to look out for, how to manage them, and when you may need to seek medical advice.

Potential Side Effects of Kliovance Tablets

Kliovance HRT has the potential to cause side effects, though not everyone will experience them. You should therefore have a thorough understanding of the possibilities before starting treatment, and speak to a clinician if you are ever unsure about whether the medication is suitable for your circumstances.

Possible Kliovance side effects include:

It's important to note that the above does not cover all the potential side effects of Kliovance tablets. More information can be found within the Patient Information Leaflet that comes with the medication.

Hypersensitivity or Allergies

Although uncommon, hypersensitivity or an allergic reaction may occur with Kliovance. If you get any of the following symptoms, stop taking Kliovance and get medical help immediately:

• Hives
• Itching
• Swelling
• Difficulty breathing
• Low blood pressure
• Feeling dizzy
• Sweating

When to Stop Treatment

There are some situations where you will need to stop taking Kliovance and see a doctor straight away. These include if you notice any of the following:

• Any of the conditions listed in the 'Do not take Kliovance' section of the Patient Information Leaflet
• Yellowing of the skin or whites of the eyes, which could be a sign of liver disease
• Swollen face, tongue and/or throat and/or difficulty swallowing or hives, with difficulty breathing
• A large rise in blood pressure, symptoms include headache, tiredness, and dizziness
• Migraine-like headaches which happen for the first time
• Signs of a blood clot, such as painful swelling and redness in your legs, sudden chest pain, and difficulty breathing

Kliovance is not a form of contraception. If it has been less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your clinician for advice. If you become pregnant while taking Kliovance, stop taking it immediately and contact your doctor.

Other Side Effects of Combined HRT

Some of the other potential side effects associated with taking HRT are:

• Gall bladder disease
• Skin disorders, including discolouration of the skin, especially on the face or neck, known as pregnancy patches (chloasma), painful reddish skin nodules (erythema nodosum), rash with target-shaped reddening or sores (erythema multiforme), and red or purple discolourations of the skin and/or mucous membranes (vascular purpura)

If you experience any side effects while taking Kliovance, tell your doctor or report them to the Yellow Card Scheme. This will help clinicians better understand the safety of Kliovance.

Kliovance Interactions and Warnings

Kliovance is an effective form of HRT, but it is not suitable for everyone. It may interact with other medications you are taking or worsen some existing medical conditions. Therefore, you must pay close attention to any warnings or precautions to ensure you make an informed decision about whether Kliovance is suitable for you.

Do not take Kliovance if you have:

• Had or suspect you might have breast cancer
• Or have had cancer which is sensitive to oestrogens, such as cancer of the womb lining, or you are suspected of having it
• Any unexplained vaginal bleeding
• Excessive thickening of the womb lining, called endometrial hyperplasia, that is not being treated
• Or have ever had a blood clot in a vein, such as in the legs or lungs
• A blood-clotting disorder
• Or previously had a disease caused by blood clots in the arteries, such as heart attack, stroke, or angina
• Or have ever had a liver disease, and your liver function tests have not yet returned to normal
• A rare blood problem called porphyria
• Are allergic to estradiol, norethisterone acetate, or any other ingredients listed in this medication

If you are unsure whether Kliovance tablets are suitable for you, speak to your doctor or one of our online prescribers.

Risk of Blood Clots

In HRT users, the risk of blood clots in the veins is around 1.3 to 3 times higher than in non-HRT users, especially during the first year of treatment. Research shows that women in their 50s who:

• Are not taking HRT, on average over a 5-year period, 4 to 7 in 1000 will get a blood clot in a vein
• Have been taking combined HRT for over 5 years, 9 to 12 per 1000 people will get a blood clot in their veins

Risk of Breast Cancer

Research suggests that the risk of breast cancer is increased in people who take either combined or oestrogen-only HRT. However, the extra risk depends on how long you take HRT. Generally, the risk increases after 3 years of treatment and increases with longer-term use.

Once you stop taking HRT, the risk falls over time. But for people who have used HRT for more than 5 years, the risk can continue for 10 years or more.

For more information about the risks associated with taking Kliovance, please see the Patient Information Leaflet that comes with your medication.

Precautions Before Taking Kliovance HRT

Before taking Kliovance to manage your menopause symptoms, tell your clinician 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

Kliovance and Other Medicines

Before starting Kliovance, it is important to let the clinician know about any prescribed, over-the-counter, or herbal medications you are taking. Some medicines can interact with Kliovance, causing irregular bleeding, such as:

• Epilepsy medicines
• Tuberculosis medicines
• Medications used to treat HIV infections
• Medications for hepatitis C
• St John's Wort

HRT can also affect how some other medicines work, including:

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

It is also important to note that medicines containing ketoconazole, a type of fungicide, can increase the effects of Kliovance. Meanwhile, Kliovance may also interact with concomitant cyclosporine therapy.

Pregnancy and Breastfeeding

Kliovance is only for use in postmenopausal women, so if you become pregnant while taking Kliovance, stop taking it and contact your doctor straight away. Do not take Kliovance if you are breastfeeding.

Frequently Asked Questions About Kliovance Tablets