Qlaira

• Contraceptive pill
• Also used for the treatment of heavy menstrual bleeding
• Combined pill
• Not to be used while breastfeeding

Qlaira is a contraceptive pill. The active ingredients estradiol valerate and dienogest protect against pregnancy. Qlaira is also used for the treatment of heavy menstrual bleeding (not caused by any disease of the womb) in women who wish to use oral contraception.

Qlaira comes in blister packs containing 28 tablets: four types of active tablets, (two dark yellow, five medium red, 17 light yellow, and two dark red) as well as two white tablets. Each coloured, active tablet contains a small amount of female hormones, either estradiol valerate or estradiol valerate combined with dienogest. The different doses of hormones mimic the body’s natural menstrual cycle. Therefore, Qlaira is also referred to as a four-phasic birth control pill. The two white tablets contain no active substances and are called inactive tablets.

The tablets must be taken in a certain order. To help you keep track, there are seven weekday sticker strips marked with the days of the week. Stick the weekday sticker strip along the top of the Qlaira wallet where it reads 'Place weekday sticker strip here', so that the first day is above the tablet marked '1'.

Take your tablet at about the same time every day, with a drink of water if necessary. Start a new strip immediately after the last tablet. There is no tablet-free week. Usually, so-called withdrawal bleeding starts when you are taking the second dark red tablet or the white tablets and may not have finished before you start the next strip.

Dosage

Take one tablet of Qlaira every day around the same time each day.

Alcohol/driving

Not applicable.

If you use too much/forget to use/or vomit or have severe diarrhoea

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

Missed a tablet?

• If it is less than 12 hours ago, you can still take the forgotten tablet without an increased risk of falling pregnant.
• If you are more than 12 hours late the protection against pregnancy may be reduced. Please refer to the package leaflet for details.

If you vomit within three to four hours after taking your tablet or have severe diarrhoea, the active ingredient may not have been completely absorbed. Refer to the package leaflet for instructions or consult a doctor or pharmacist.

Do not take Qlaira if:

• You have, or have had, a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs.
• You have, or have had, a heart attack or stroke.
• You have, or have had, angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack (TIA).
• You have, or have had, a type of migraine associated with focal neurological symptoms (migraine with aura).
• You have a disease that may increase your risk of a clot in the arteries, such as severe diabetes with blood vessel damage, very high blood pressure, or a very high level of fat in the blood.
• You have a disorder affecting your blood clotting.
• You have, or have had, inflammation of the pancreas.
• You have, or have had, a liver disease and your liver function tests have not returned to normal.
• You have, or have had, a liver tumour.
• You have, have had, or may have cancer of the breast or the genital organs.
• You have any unexplained vaginal bleeding.
• You are allergic (hypersensitive) to estradiol valerate, dienogest, or any other ingredient of Qlaira.

When should this medicine be used with caution?

In some situations you need to take special care while taking Qlaira or any other combined pill, and your doctor may need to examine you regularly. For more information, see the package leaflet.

Pregnancy and breastfeeding

Do not take Qlaira if you are pregnant. If you become pregnant while taking Qlaira, stop taking it immediately and contact your doctor.

In general you should not take Qlaira while you are breastfeeding. If you want to take the pill while you are breastfeeding you should contact your doctor.

Other medicines and Qlaira

Always tell your doctor which medicines or herbal products you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist from whom you got the medicine) that you take Qlaira. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long.

Some medicines may make Qlaira less effective at preventing pregnancy or cause unexpected bleeding. These include:

• Medicines used for the treatment of epilepsy, tuberculosis, HIV and other inflammatory diseases (see the package leaflet for examples).
• The herbal medicine St John's Wort.

Some medicines can increase the levels of the hormonal substances of Qlaira in the blood. Tell your doctor or pharmacist if you are taking any of the following medicines:

• Antifungal medicines containing ketoconazole).
• Antibiotics containing erythromycin.

Qlaira may influence the effect of other medicines, including:

• Medicines containing ciclosporin.
• The antiepileptic lamotrigine (this could lead to an increased frequency of seizures).

Like all medicines, Qlaira can cause side effects, although not everyone gets them.

Serious side effects
Serious reactions associated with the use of the pill, as well as the related symptoms, are described in the official package leaflet (see sections 'Qlaira and venous/arterial thrombosis' and 'Qlaira and cancer'. Please read these sections carefully and consult your doctor at once where appropriate.

Other possible side effects
Common side effects (between 1 and 10 in every 100 users may be affected):

• Headache.
• Abdominal pain, nausea.
• Acne.
• No periods, breast discomfort, painful periods, irregular bleeding (heavy irregular bleeding).
• Weight gain.

Uncommon side effects (between 1 and 10 in every 1,000 users may be affected):

• Fungal infections, fungal infection of the vulva and vagina, vaginal infection.
• Increased appetite.
• Depression, depressed mood, emotional disorder, problems sleeping, decreased interest in sex, mental disorder, mood swings.
• Dizziness, migraine.
• Hot flush, high blood pressure.
• Diarrhoea, vomiting.
• Elevated liver enzymes.
• Hair loss, excessive sweating (hyperhidrosis), itching, rash.
• Muscle cramps.
• Side effects affecting breasts and genitals (see the package leaflet).
• Fatigue, irritability, swelling of parts of your body, such as ankles (oedema).
• Weight loss, blood pressure changes.

For more side effects associated with the use of Qlaira, please see the package leaflet. Talk to your doctor or pharmacist if the side effects are severe or if you experience side effects that are not listed in the package leaflet.

The active substances are estradiol valerate, or estradiol valerate combined with dienogest (see the package leaflet for tablet specifications).

Read the package leaflet before use. The official package leaflet of Qlaira is available for download here.