Activelle (Kliovance)

During the menopausal transition, the amount of oestrogen produced by a woman’s body gradually drops until it stops altogether. For many women, this causes symptoms such as hot flashes and night sweats. Some women may also develop fragile bones (osteoporosis).

Hormone replacement therapy (HRT) restores hormonal balance to alleviate these symptoms. Many medicines for menopause relief, such as Activelle, contain synthetic hormones. Activelle, also known under the brand name Kliovance, contains estradiol and norethisterone acetate. One tablet is taken once a day. There is no tablet-free week.

Take one tablet once a day, at about the same time each day. Once you have finished all the 28 tablets in the calendar pack, start a new pack continuing the treatment without interruption.

Activelle (Kliovance) is supplied in calendar dial packs marked with the days of the week. For more information on how to use the calendar dial packs, see the package leaflet.

You may begin treatment with Activelle on any day that is convenient. However, if you switch from a sequential HRT product, treatment should start right after withdrawal bleeding has ended.

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

Dosage

The usual dose of Activelle (Kliovance) is:

• Adult women: one tablet once daily.

Alcohol/driving

This medicine does not interact with alcohol. Activelle (Kliovance) has no known effect on the ability to drive or use machines.

Taken too much/forgot to take/stop taking Activelle (Kliovance)

If you take more tablets than you should, contact your doctor or pharmacist.

If you forget to take a tablet at the usual time, the tablet should be taken as soon as possible within the next 12 hours. After 12 hours the tablet should be discarded and the next dose should be taken the next day at the normal time. 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.

Do not stop using Activelle (Kliovance) without consulting a doctor first.

Activelle (Kliovance) is not suitable for everyone. Do not take this medicine if:

• You have, or have had, breast cancer, or if you are suspected of having it.
• You have, or have had, cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium) or if you are suspected of having it.
• You have any unexplained vaginal bleeding.
• You have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated.
• You have, or have had, a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or lungs (pulmonary embolism).
• You have a blood clotting disorder.
• You have, or recently have had, a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina.
• You have, or have had, a liver disease and your liver function tests have not returned to normal.
• You have a rare blood problem called ‘porphyria’ which is passed down in families (inherited).
• You are allergic to any of the ingredients in this medicine (see section 'What Activelle contains').

If any of the above conditions appear for the first time while using Activelle, stop using it at once and consult your doctor immediately.

Stop taking Activelle and see a doctor immediately If you notice any of the following:

• Yellow discolouration of the skin and white of the eye (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.
• You become pregnant.
• You notice signs of a blood clot (see the package leaflet for more information).

If you are going to have surgery, tell the surgeon that you are taking Activelle (Kliovance). You may need to stop taking Activelle about four to six weeks before the operation to reduce the risk of a blood clot.

When should this medicine be used with caution?

The use of HRT tablets is linked to a slight increased risk of number serious side effects, such as certain types of cancer and heart and cardiovascular disease. See the package leaflet for details.

In certain situations, your doctor will need to monitor you closely during treatment with this medicine. See the package leaflet for a list of situations.

Pregnancy and breastfeeding

Pregnancy

Activelle (Kliovance) is for use in postmenopausal women only. If you become pregnant, stop using Activelle immediately and contact your doctor.

Note: Activelle (Kliovance) 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.

Breastfeeding

You should not take Activelle (Kliovance) if you are breastfeeding.

Other medicines and Activelle

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

Some medicines may interfere with the effect of Activelle (Kliovance). This might lead to irregular bleeding. This applies to the following medicines:

• Medicines for epilepsy.
• Medicines for tuberculosis.
• Medicines for HIV infections.
• Herbal remedies containing St John’s Wort.
• Medicines for hepatitis C infections.

Other medicines may increase the effects of Activelle:

• Medicines containing ketoconazole (a fungicide).

Activelle may have an impact on a concomitant treatment with cyclosporine.

Like all medicines, this medicine can cause side effects, although some people may not experience any. Side effects that are known to be associated with Activelle (Kliovance) include:

Very common (may affect more than 1 in 10 users):

• Breast tenderness or soreness.
• Vaginal bleeding.

Common (may affect up to 1 in 10 users):

• Headache.
• Weight gain caused by fluid retention.
• Vaginal inflammation.
• Migraine, new or worse than before.
• Vaginal yeast infection.
• Depression, new or worse than before.
• Nausea.
• Enlargement or swelling of the breasts (breast oedema).
• Back pain.
• Uterine fibroid (benign tumour), aggravation, occurrence or reoccurrence.
• Swelling of arms and legs (peripheral oedema).
• Weight gain.

For a list of uncommon or rare side effects, please see the package leaflet. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Get emergency medical help if you have signs of a severe allergic reaction.

The active substances are estradiol 1 mg (as estradiol hemihydrate) and norethisterone acetate 0.5 mg.