Frequently asked questions​

Women who suffer from idiopathic menorrhagia or require endometrial protection during oestrogen replacement therapy may benefit from Mirena® (52 mg intrauterine delivery system levonorgestrel), which is indicated as a contraceptive option that prevents pregnancy and as a treatment option for both conditions.

Mirena® is a long-acting reversible contraceptive device that may be particularly useful in women with idiopathic menorrhagia (also known as heavy menstrual bleeding) who also require (reversible) contraception. Mirena® would also be an option for a woman requiring the progestogenic component of hormone replacement therapy (HRT).

Mirena is indicated for contraceptive use for up to 8 years, as a treatment for menorrhagia for up to 5 years (If symptoms have not returned after 5 years of use, continued use of the system may be considered. Mirena should be removed or replaced after 8 years at the latest.) and as protection from endometrial hyperplasia during oestrogen replacement therapy for up to 5 years. If the patient wishes to continue using the same method, it can be replaced by a new system at any time of the cycle at the same time, in which case no additional protection is required.​

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The intrauterine device Mirena® contains levonorgestrel 52 mg. Levonorgestrel is a well-established progestogen with antioestrogenic activity.​

The effect of hormonal contraceptives such as Mirena® may be reduced by medicines that increase the amounts of enzymes made by the liver. These include:​

• Medicines used to treat epilepsy​

• Antifungal medicines (e.g. griseofulvin, fluconazole, itraconazole, ketoconazole, voriconazole)​

• Certain antibiotics (rifampicin & macrolides [e.g. clarithromycin, erythromycin])​

• Medicines used to treat HIV and Hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors)​

• Certain sedatives (called barbiturates)​

• Medicines used to treat chest pain (angina) and/or high blood pressure​

• Products containing St John’s Wort (a herbal remedy)​

For a full list of medicinal interactions with Mirena® and contraindications, refer to the Summary of Product Characteristics.​

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Undesirable effects are more common during the first months after the insertion of Mirena® (52 mg intrauterine delivery system levonorgestrel) and subside during prolonged use.​

In less than 1 in 10 women, common side effects of Mirena® include:

• ovarian cysts
• painful periods
• weight gain
• depression, nervousness
• headache
• migraine
• abdominal, pelvic or back pain
• nausea
• acne
• increased growth of hair on the face and body
• reduced sex drive
• increased vaginal discharge
• inflammation of the vulva and vagina
• tender, painful breasts
• Mirena® expulsion

Very common undesirable effects (occurring in more than 10% of users) include uterine/vaginal bleeding including spotting, oligomenorrhoea (infrequent periods) and amenorrhoea (an absence of periods).

For a full list of potential side effects, refer to the Summary of Product Characteristics.​

If the patient does experience side effects, they should speak to a doctor, pharmacist or nurse. This includes any possible side effects not listed in the contraception package leaflet.

Weight gain has been reported as common (can occur in less than 1 in 10 women) in women fitted with Mirena® (52 mg intrauterine delivery system levonorgestrel).

Depression has been reported in fewer than 1 in 10 women fitted with Mirena® (52 mg intrauterine delivery system levonorgestrel).​

There is no clear data to establish whether there is an increased risk of suicidal thoughts and behaviour associated with the use of hormonal contraceptives. Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use. Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide. Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment.

Mirena® (52 mg intrauterine delivery system levonorgestrel) will affect the patient’s menstrual cycle.​

Patients fitted with the Mirena® coil may experience lighter bleeding or some spotting (light bleeding in between periods) and irregular bleeding during the first 3–6 months after it is fitted.​

Some patients may have prolonged or heavy bleeding or an increase in the frequency of bleeding, usually in the first 2–3 months, before a reduction in blood loss is achieved.​

However, overall patients are likely to have fewer days bleeding in each month and might eventually have no periods at all. This is due to the effect of the hormone (levonorgestrel) on the lining of the womb.​

For women with menorrhagia, Mirena® usually results in lighter periods and can decrease blood loss by up to 94% at 3 cycles and 88% at 6 cycles.

Fertility is restored immediately and conception can occur from the first cycle following removal of the system.​

Studies have suggested that in women who discontinue Mirena® (52 mg intrauterine delivery system levonorgestrel) for planned pregnancy the pregnancy rate at one year is similar to those who do not use contraception.

If a patient becomes pregnant while Mirena® (52 mg intrauterine delivery system levonorgestrel) is in place, ectopic pregnancy should be excluded, the system must be removed and termination of the pregnancy should be considered.​

Accordingly, removal of the intrauterine device (IUD) Mirena® or probing of the uterus may also result in spontaneous miscarriage. If the patient wishes to continue the pregnancy and the system cannot be withdrawn, she should be informed about the increased risks and the possible consequences of premature birth to the infant. Such pregnancies should be closely monitored. The patient should be instructed to report all symptoms that suggest complications of the pregnancy, like cramping abdominal pain with fever.​

For more information and a complete list of contraindications, refer to the Mirena® Summary of Product Characteristics.

In women of fertile age, Mirena® (52 mg intrauterine delivery system levonorgestrel) is inserted into the uterine cavity within 7 days of the onset of menstruation. It can be replaced by a new system at any time of the cycle.​

Mirena® should be inserted during the patient’s menstrual cycle or within 7 days from the beginning of the period.​

Some patients may find the fitting of a Mirena® coil uncomfortable. Managing your patient’s expectations with regards to pain is important and many healthcare professionals have found that talking to the patient throughout the fitting helps to reduce anxiety and make them more comfortable. However, it is important to check with your patient if this would be helpful.​

The UK National Institute for Health and Care Excellence (NICE) guidelines for long-acting reversible contraceptives (LARC) recommends: 'insertion of an intrauterine device/intrauterine system may cause pain and discomfort for a few hours and light bleeding for a few days, and they should be informed about appropriate pain relief'.