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The product code for this leaflet is: PL 03132/0080

 

Kliofem

Company Details

Novo Nordisk Limited


3 City PlaceBeehive Ring RoadGatwickWest SussexRH6 0PA
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Medical Information e-mail:ukmedicalinfo@novonordisk.com
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PACKAGE LEAFLET: INFORMATION FOR THE USER

Kliofem® 2 mg/1 mg film-coated tablets

Estradiol/norethisterone acetate

Read this entire leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Kliofem® is and what it is used for
2.What you need to know before you take Kliofem®
3. How to take Kliofem®
4. Possible side effects
5. How to store Kliofem®
6. Contents of the pack and other information

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1. What Kliofem® is and what it is used for

Kliofem® is a continuous combined Hormone Replacement Therapy (HRT) which is taken every day without interruption. Kliofem® is used in postmenopausal women with at least 1 year since their last natural period.

The tablets contain 2 hormones: estradiol 2 mg (an oestrogen identical to the one made in the ovaries) and norethisterone acetate 1 mg (a progestagen that acts in a similar way to the body’s own hormone progesterone).

Kliofem® is used for:

Relief of symptoms occurring after menopause

During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest (‘hot flushes’).

Kliofem® alleviates these symptoms after menopause. You will only be prescribed Kliofem® if your symptoms seriously hinder your daily life.

Prevention of osteoporosis

After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor.

If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Kliofem® to prevent osteoporosis after menopause.

Kliofem® is prescribed for women who have not had their womb removed, and whose periods stopped more than a year ago.

The experience of treating women older than 65 years is limited.

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2. What you need to know before you take Kliofem®

Medical history and regular check-ups

The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.

The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT may be different. Please talk to your doctor.

Before you start (or restart) HRT, your doctor will ask about your own and your family’s medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and/or an internal examination, if necessary.

Once you have started on Kliofem® you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Kliofem®.

Go for regular breast screening, as recommended by your doctor.

Do not take Kliofem®

If any of the following apply to you. If you are not sure about any of the points below, talk to your doctor before taking Kliofem®.

Do not take Kliofem®:

  • If you have, have had or suspect having breast cancer.
  • If you have, have had or suspect having cancer of the womb lining (endometrial cancer), or any other oestrogen dependent cancer.
  • If you have any abnormal vaginal bleeding.
  • If you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated.
  • If you have or have ever had a blood clot in a vein (venous thromboembolism), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism).
  • If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency).
  • If you have or previously have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina.
  • 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 blood problem called ‘porphyria’ which is passed down in families (inherited).
  • If you are allergic (hypersensitive) to estradiol, norethisterone acetate or any of the other ingredients of Kliofem® (listed in section 6 Contents of the pack and other information).

Warnings and precautions

Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Kliofem®. If so, you should see your doctor more often for check-ups:

  • 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 (see Blood clots in a vein (venous thromboembolism)).
  • increased risk of getting a 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 due to cardiac or kidney problems.
  • lactose intolerance.

Stop taking Kliofem® and see a doctor immediately

If you notice any of the following when taking HRT:

  • any of the conditions mentioned in the Do not take Kliofem® section.
  • yellowing of your skin or the whites of your eyes (jaundice).
    These may be signs of a liver disease.
  • a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness).
  • migraine-like headaches which happen for the first time.
  • if you become pregnant.
  • if you notice signs of a blood clot, such as:
    • painful swelling and redness of the legs.
    • sudden chest pain.
    • difficulty in breathing.

For more information, see Blood clots in a vein (venous thromboembolism)

Note: Kliofem® is not a contraceptive. If it is 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 doctor for advice.

HRT and cancer

Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)

Taking oestrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer).

The progestogen in Kliofem® protects you from this extra risk.

Compare

In women who still have a womb and who are not taking HRT, on average, 5 in 1,000 will be diagnosed with endometrial cancer between the ages of 50 and 65.

For women aged 50 to 65 who still have a womb and who take oestrogen-only HRT, between 10 and 60 women in 1,000 will be diagnosed with endometrial cancer (i.e. between 5 and 55 extra cases), depending on the dose and for how long it is taken.

Irregular bleeding

You may have irregular bleeding or drops of blood (spotting) during the first 3-6 months of taking Kliofem®.

However, if the irregular bleeding:

  • carries on for more than the first 6 months
  • starts after you have been taking Kliofem® for more than 6 months
  • carries on after you have stopped taking Kliofem®

see your doctor as soon as possible.

Breast cancer

Evidence suggests that taking combined oestrogen-progestogen and possibly also oestrogen-only HRT increases the risk of breast cancer.

The extra risk depends on how long you take HRT. The additional risk becomes clear within a few years.

However, it returns to normal within a few years (at most 5) after stopping treatment.

Compare

Women aged 50 to 79 who are not taking HRT, on average, 9 to 17 in 1,000 will be diagnosed with breast cancer over a 5-year period. For women aged 50 to 79 who are taking oestrogen-progestogen HRT over 5 years, there will be 13 to 23 cases in 1,000 users (i.e. an extra 4 to 6 cases).

  • Regularly check your breasts. See your doctor if you notice any changes such as:
    • dimpling of the skin
    • changes in the nipple
    • any lumps you can see or feel

Ovarian cancer

Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.

Compare

Women aged 50 to 69 who are not taking HRT, on average about 2 women in 1,000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be between 2 and 3 cases per 1,000 users (i.e. up to 1 extra case).

Effect of HRT on heart and circulation

Blood clots in a vein (venous thromboembolism)

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

Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.

You are more likely to get a blood clot in your veins as you get older and if any of the following apply to you. Inform your doctor if any of these situations apply to you:

  • you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, If you need to have surgery)
  • you are seriously overweight (BMI >30 kg/m2)
  • you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots
  • if any of your close relatives has ever had a blood clot in the leg, lung or another organ
  • you have systemic lupus erythematosus (SLE)
  • you have cancer.

For signs of a blood clot, see Stop taking Kliofem® and see a doctor immediately.

Compare

Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1,000 would be expected to get a blood clot in a vein.

For women in their 50s who have been taking oestrogen-progestogen HRT for over 5 years, there will be 9 to 12 cases in 1,000 users (i.e. an extra 5 cases).

Heart disease (heart attack)

There is no evidence that HRT will prevent a heart attack. Women over the age of 60 years who use oestrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT.

Stroke

The risk of getting stroke is about 1.5 times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT will increase with age.

Compare

Looking at women in their 50s who are not taking HRT, on average, 8 in 1,000 would be expected to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases in 1,000 users, over 5 years (i.e. an extra 3 cases).

Other conditions

HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Speak to your doctor for advice.

Using other medicines

Some medicines may interfere with the effect of Kliofem®. This might lead to irregular bleeding. This applies to the following medicines:

  • Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepine)
  • Medicines for tuberculosis (such as rifampicin and rifabutin)
  • Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelfinavir)
  • Herbal remedies containing St John’s Wort (Hypericum perforatum).

Other medicines may increase the effects of Kliofem®:

  • Medicines containing ketoconazole (a fungicide).

Kliofem® may have an impact on a concomitant treatment with cyclosporine.

Please tell your doctor or pharmacist, if you are taking or have recently taken any other medicines including medicines obtained without a prescription, herbal medicines or other natural products.

Taking Kliofem® with food and drink

The tablets can be taken with or without food and drink.

Laboratory tests

If you need a blood test, tell your doctor or the laboratory staff that you are taking Kliofem®, because this medicine can affect the results of some tests.

Pregnancy and breast-feeding

Pregnancy: Kliofem® is for use in postmenopausal women only. If you become pregnant, stop taking Kliofem® and contact your doctor.

Breast-feeding: You should not take Kliofem® if you are breast-feeding.

Driving and using machines

Kliofem® has no known effect on the ability to drive or use machines.

Important information about some of the ingredients in Kliofem®

Kliofem® contains lactose monohydrate. If you have an intolerance to some sugars, contact your doctor before taking Kliofem®.

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3. How to take Kliofem®

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure.

Take one tablet once a day, at about the same time each day. Take the tablet with a glass of water.

Take a tablet every day without stopping. After you have used all 28 tablets in a calendar pack, go straight to using the next pack.

For further information on the use of the calendar pack, see USER INSTRUCTIONS at the end of the package leaflet.

You may start treatment with Kliofem® on any convenient day.

However, if you are switching from an HRT product when you have monthly bleeding, start your treatment straight after the bleeding has ended.

Your doctor should aim to prescribe the lowest dose to treat your symptoms for as short as necessary. Speak to your doctor if you think this dose is too strong or not strong enough.

If you take more Kliofem® than you should

If you have taken more Kliofem® than you should, talk to your doctor or pharmacist. An overdose of Kliofem® could make you feel sick or vomit.

If you forget to take Kliofem®

If you forget to take your tablet at the usual time, take it within the next 12 hours. If more than 12 hours have gone by, start again as normal the next day. Do not take a double dose to make up for a forgotten tablet.

Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting if you still have your womb.

If you stop taking Kliofem®

If you would like to stop taking Kliofem®, talk to your doctor first. Your doctor will explain the effects of stopping treatment and discuss other possibilities with you.

If you need to have surgery

If you are going to have surgery, tell the surgeon that you are taking Kliofem®. You may need to stop taking Kliofem® about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots in a vein (venous thromboembolism)). Ask your doctor when you can start taking Kliofem® again.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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4. Possible side effects

Like all medicines, this medicine can have side effects, although not everybody gets them.

The following diseases are reported more often in women using HRT compared to women not using HRT:

  • breast cancer
  • abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer)
  • ovarian cancer
  • blood clots in the veins of the legs or lungs (venous thromboembolism)
  • heart disease
  • stroke
  • probable memory loss if HRT is started over the age of 65

For more information about these side effects, see Section 2, What you need to know before you take Kliofem®.

Hypersensitivity/allergy (uncommon side effect – affects 1 to 10 users in 1,000)

Though it is an uncommon event, hypersensitivity/allergy may occur.

Signs of hypersensitivity/allergy may include one or more of the following symptoms: hives, itching, swelling, difficulty in breathing, low blood pressure (paleness and coldness of skin, rapid heartbeat), feeling dizzy, sweating, which could be signs of anaphylactic reaction/shock. If one of the mentioned symptoms appears, stop taking Kliofem® and seek immediate medical help.

Very common side effects

  • Breast pain or breast tenderness
  • Vaginal bleeding.

Common side effects

  • Headache
  • Weight gain caused by fluid retention
  • Vaginal inflammation
  • Migraine, new or worse than before
  • Vaginal infection with a fungus
  • Depression, new or worse than before
  • Nausea
  • Abdominal pain, swelling or discomfort
  • Enlargement or swelling of the breasts (breast oedema)
  • Back pain
  • Leg cramps
  • Uterine fibroid (benign tumour), aggravation, occurrence or recurrence
  • Swelling of arms and legs (peripheral oedema)
  • Weight increase.

Uncommon side effects

  • Bloating or flatulence
  • Acne
  • Hair loss (alopecia)
  • Abnormal (male pattern) hair growth
  • Itching or hives (urticaria)
  • Inflammation of a vein (superficial thrombophlebitis)
  • Drug ineffective
  • Allergic reaction
  • Nervousness.

Rare side effects

  • Blood clots in the blood vessels of the legs or the lungs (deep vein thrombosis, lung embolism).

Very rare side effects

  • Cancer of the lining of the womb (endometrial cancer)
  • Excessive growth of the lining of the womb (endometrial hyperplasia)
  • Increase in blood pressure or worsening of high blood pressure
  • Gallbladder disease, gallstones occurrence/recurrence or aggravated
  • Excessive secretion of sebum, skin eruption
  • Acute or recurring attack of oedema (angioneurotic oedema)
  • Insomnia, dizziness, anxiety
  • Change in sexual desire
  • Visual disturbances
  • Weight decreased
  • Vomiting
  • Heartburn
  • Vaginal and genital itching
  • Heart attack and stroke.

The frequency of possible side effects listed below is defined using the following convention:

Very common (affects more than 1 user in 10)

Common (affects 1 to 10 users in 100)

Uncommon (affects 1 to 10 users in 1,000)

Rare (affects 1 to 10 users in 10,000)

Very rare (affects less than 1 user in 10,000)

Not known (frequency cannot be estimated from the available data).

Other side effects of combined HRT

The following side effects have been reported with other HRTs:

  • various skin disorders:
    • discoloration of the skin especially of the face or neck known as ‘pregnancy patches’ (chloasma)
    • painful reddish skin nodules (erythema nodosum)
    • rash with target-shaped reddening or sores (erythema multiforme)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard . By reporting side effects you can help provide more information on the safety of this medicine.

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5. How to store Kliofem®

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the label and carton.

Do not refrigerate.

Keep the container in the outer carton in order to protect it from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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6. Contents of the pack and other information

What Kliofem® contains

The active substances are estradiol 2 mg (as estradiol hemihydrate) and norethisterone acetate 1 mg.

The other ingredients are: lactose monohydrate, maize starch, hydroxypropylcellulose, talc and magnesium stearate.

The film-coating contains: hypromellose, triacetin and talc.

What Kliofem® looks like and contents of the pack

The film-coated tablets are white, round with a diameter of 6 mm. The tablets are engraved NOVO 281.

Pack sizes available:

  • 1×28 film-coated tablets
  • 3×28 film-coated tablets

Not all pack sizes may be marketed.

Marketing authorisation holder

Novo Nordisk Limited
3 City Place
Beehive Ring Road
Gatwick
West Sussex
RH6 0PA

Manufacturer

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

This leaflet was last approved: 08/2014

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USER INSTRUCTIONS

How to use the calendar pack

1. Set the day reminder
Turn the inner disc to set the day of the week opposite the little plastic tab.

2. Take the first day’s tablet
Break the plastic tab and tip out the first tablet.

3. Move the dial every day
On the next day, simply move the transparent dial clockwise 1 space as indicated by the arrow. Tip out the next tablet. Remember to take only 1 tablet once a day.

You can only turn the transparent dial after the tablet in the opening has been removed.

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Kliofem®is a trademark owned by Novo Nordisk FemCare AG, Switzerland

© 2014

Novo Nordisk A/S

8-2850-01-001-3


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