Kliofem Tablets

What is Kliofem?

Kliofem tablets are a type of hormone replacement therapy (HRT) prescribed to women after menopause to replace the oestrogen no longer produced by the body. This relieves menopause symptoms and restores the oestrogen’s protective effect against cardiovascular disease.

Kliofem is a continuous combined HRT used to treat postmenopausal women who have not had their natural period for at least 12 months. Kliofem is only intended for women who have not had a hysterectomy. Women who have undergone a hysterectomy should seek an HRT that does not contain progestogen.

Kliofem is manufactured by Novo Nordisk and contains two female hormones, estradiol 2mg (a synthetic form of oestrogen) and norethisterone acetate 1mg (a synthetic form of progesterone). These hormones behave similarly to the natural hormones produced by the female body.

What is Kliofem used for?

During the menopause, the oestrogen levels in a woman's body drop, which can cause women to experience some unwanted symptoms. Taking Novofem can help to alleviate these symptoms to help you to continue to enjoy your daily life.

Menopause symptoms include:

• Hot flushes & night sweats
• Disturbed sleep
• Reduced sex drive
• Difficulty remembering or concentrating
• Vaginal dryness
• Headaches
• Low mood or anxiety
• Fragile bones (osteoporosis)

After menopause, many women are diagnosed with osteoporosis. The condition is marked by weak bones and an increased risk of fractures.

How does Kliofem work?

Women's ovaries gradually produce less oestrogen as they approach the menopause, and oestrogen levels in the blood decline as a result. These declining levels can cause distressing symptoms.

Oestrogen in the form of estradiol can be given as a supplement to replace the falling hormonal levels in the body and help reduce symptoms. This is known as HRT. HRT is usually only required for short-term relief from menopausal symptoms. You should review your use at least once a year with your doctor.

Women who have not had a hysterectomy need a progestogen as part of their HRT. This is because, in women with an intact uterus, oestrogen stimulates the growth of the endometrium (uterine lining), which can increase the chance of endometrial cancer occurring if the growth goes unrestricted. Progestogen opposes oestrogen’s effect on the endometrium and reduces the risk of cancer though does not eliminate it entirely. This is known as combined HRT.

Kliofem and weight gain

Although Kliofem, like other HRT, has been reported to cause weight gain in some women, research suggests that this is more likely to be fluid retention and bloating rather than true weight gain.

During the menopause generally, it is not uncommon for women to gain weight, especially around their abdomen. It is thought that this is partly due to the imbalance in hormones but is also a natural part of ageing for both males and females as you start to lose muscle mass and your metabolism slows.

Most importantly for both men and women, it is therefore essential that you always try to get enough sleep, eat healthily and exercise regularly as you get older to reduce unwanted weight gain.

Alternatives to Kliofem

The Independent Pharmacy offers a wide range of HRT in the form of tablets, patches and vaginal creams. The closest direct alternative HRT medications to Kliofem are Kliovance and Livial.

If you are currently prescribed Kliofem or HRT shortages affect your prescribed HRT and you would like a suitable alternative to Kliofem, you can start a free online consultation with The Independent Pharmacy. It’s quick and easy to do: just answer a few questions and one of our qualified prescribers can issue your treatment for next day delivery.

Non-medicinal alternatives for the symptoms of menopause

For Night Sweats and Hot Flushes

• Using A fan
• Cool Showers
• Wearing light clothing

Vaginal Dryness

• Lubricants

Other Alternatives

• A healthy diet and regular exercise
• Stopping Smoking

Sources

• Kliofem Tablets, Patient Information Leaflet: https://www.medicines.org.uk/e...
• https://patient.info/medicine/oestrogen-and-progestogen-for-hrt
• https://www.nhs.uk/conditions/hormone-replacement-therapy-hrt/types/
• https://www.nhs.uk/conditions/menopause/symptoms/
• https://www.nhs.uk/conditions/blood-clots/
• https://www.nhs.uk/conditions/stroke/symptoms/

Kliofem warnings

Read the following warnings carefully to ensure you are selecting an appropriate product.

Treatment with HRT carries risks that you should consider before deciding to start it or continue taking it. 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.

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 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
• Diabetes
• Gallstones
• Migraine or severe headaches
• Systemic lupus erythematosus, SLE
• Epilepsy
• Asthma
• Otosclerosis
• 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 that 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.

Kliofem and cancer

While taking HRT you are at an increased risk of developing an excessive thickening of the lining of the uterus (endometrial hyperplasia), cancer of the lining of the uterus (endometrial cancer) and a slight increase in risk of developing ovarian cancer. The synthetic progesterone in Kliofem protects you from this extra risk.

This risk of developing breast cancer appears to increase the longer you take HRT but does return to normal up to 5 years after stopping treatment. For this reason, it is recommended that you only take HRT for the shortest amount of time to manage your symptoms.

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 the breast has increased density, mammography may not detect all lumps.

HRT’s effect on heart and circulation

Blood clots

The risk of developing blood clots in the veins is higher in HRT users than in non-users, especially during the medication's first year.

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 have 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

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.

Stroke

The risk of having a 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.

Kliofem and 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.

Kliofem, Pregnancy and breastfeeding

Kliofem is only suitable in postmenopausal women and is not a contraceptive. If you have had a menstrual period in the last 12 months or are under 50 years old you should discuss contraception with your doctor before taking Kliofem.

If you become pregnant while taking Kliofem stop taking it straight away and contact your doctor. You should also not take Kliofem while breastfeeding.

Before taking Kliofem it is important that you read the Patient Information Leaflet thoroughly.

How to take Kliofem

Read the Patient Information Leaflet carefully before starting Kliofem tablets for full details on how to set up the Kliofem calendar pack and how to take this medication.

Take 1 tablet each day, at around the same time, either before or after eating. Take the tablets continuously, without a break between packs.

Kliofem ingredients

The active ingredients in each Kliofem tablet are: Estradiol 2 mg (as estradiol hemihydrate) and norethisterone acetate 1 mg.

The inactive ingredients in each tablet are: lactose monohydrate, maize starch, talc, hydroxypropylcellulose and magnesium stearate, hypromellose, triacetin and talc.

Important information about some of the ingredients in Kliofem

If you have an intolerance to some sugars, you should be aware that Kliofem contains lactose monohydrate contact your doctor before taking Kliofem.

Kliofem side effects

Kliofem, like other medications, may cause some people to experience side effects.

If you experience severe side effects or an allergic reaction when taking Kliofem, you must seek medical advice or attend your nearest emergency department as soon as possible. If you are concerned about side effects or they are bothering you, please speak to a pharmacist or doctor for advice.

You should also take time to familiarise yourself with all the warnings and precautions as Kliofem, like other HRT, may increase your chances of getting certain health conditions. You should discuss any questions you have with your doctor before taking this medicine.

The most commonly reported side effects can include:

• vaginal bleeding
• breast tenderness or pain
• headache
• weight gain caused by water retention
• vaginal inflammation
• migraine, new or worse than before
• fungal vaginal infection
• depression, new or worse than before
• nausea
• abdominal pain, swelling or discomfort
• breast enlargement or swelling
• leg cramps
• back pain
• Uterine fibroid aggravation, occurrence or recurrence
• swollen arms and legs
• weight gain

If you are concerned about these effects, or if the product affects you in a different way, stop using it and talk to your doctor or pharmacist.

For more detail read our full guide on Kliofem side effects.