Kliofem Tablets

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.