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Seek urgent medical attention: If possible signs of a blood clot are noticed, that may mean the patient is suffering from a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack or a stroke (see Blood clots as follows).
For a description of the symptoms of these serious side effects, see "How to recognise a blood clot".
In some situations the patient needs to take special care while taking Qlaira or any other combined pill, and the doctor may need to examine the patient regularly.
Consult the doctor if any of the following conditions apply to the patient or if any of these conditions develop or worsen while taking Qlaira: a close relative has or has ever had breast cancer; disease of the liver or gall bladder; jaundice; diabetes; depression; Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease); systemic lupus erythematosus (SLE - a disease affecting the natural defence system); haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing failure of the kidneys); sickle cell disease (an inherited disease of the red blood cells); elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas); if an operation is needed, or the patient is off her feet for a long time (see 'Blood clots'); has just given birth, the patient is at an increased risk of blood clots. Should ask the doctor how soon after delivery can the patient start taking Qlaira; inflammation in the veins under the skin (superficial thrombophlebitis); varicose veins; epilepsy (see Interactions); has a disease that first appeared during pregnancy or earlier use of sex hormones (e.g. hearing loss, porphyria [a disease of the blood], gestational herpes [skin rash with blisters during pregnancy], Sydenham's chorea [a nerve disease causing sudden movements of the body]); has (or has ever had) golden brown pigment patches so-called "pregnancy patches" especially on the face (Chloasma). If this is the case, avoid direct exposure to sunlight or ultraviolet light; hereditary angioedema. Consult the doctor immediately if experiencing symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or hives, together with difficulty breathing. Products containing oestrogens may induce or worsen symptoms of angioedema; cardiac or renal insufficiency.
Consult the doctor before taking Qlaira.
Blood clots: Using a combined hormonal contraceptive such as Qlaira increases the risk of developing a blood clot compared with not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop in veins (referred to as a 'venous thrombosis', 'venous thromboembolism' or VTE); in the arteries (referred to as an 'arterial thrombosis', 'arterial thromboembolism' or ATE).
Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or, very rarely, they may be fatal.
It is important to remember that the overall risk of a harmful blood clot due to Qlaira is small.
How to recognise a blood clot: Seek urgent medical attention if any of the following signs or symptoms are noticed. (See Table 1.)
Click on icon to see table/diagram/imageBlood clots in a vein: The use of combined hormonal contraceptives has been connected with an increase in the risk of blood clots in the vein (venous thrombosis). However, these side effects are rare. Most frequently, they occur in the first year of use of a combined hormonal contraceptive.
If a blood clot forms in a vein in the leg or foot it can cause a deep vein thrombosis (DVT).
If a blood clot travels from the leg and lodges in the lung it can cause a pulmonary embolism.
Very rarely a clot may form in a vein in another organ such as the eye (retinal vein thrombosis).
Highest risk of developing a blood clot in a vein: The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if the patient restarts taking a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more.
After the first year, the risk gets smaller but is always slightly higher than if not using a combined hormonal contraceptive.
When stopping Qlaira, the risk of a blood clot returns to normal within a few weeks.
Risk of developing a blood clot: The risk depends on the natural risk of VTE and the type of combined hormonal contraceptive the patient is taking.
The overall risk of a blood clot in the leg or lung (DVT or PE) with Qlaira is small.
Out of 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will develop a blood clot in a year.
The risk of a blood clot with Qlaira is about the same as with other combined hormonal contraceptives including contraceptives containing levonorgestrel.
The risk of having a blood clot will vary according to personal medical history (see "Factors that increase the risk of a blood clot" as follows). (See Table 2.)
Click on icon to see table/diagram/imageFactors that increase the risk of a blood clot in a vein: The risk of a blood clot with Qlaira is small but some conditions will increase the risk. The risk is higher: if very overweight (body mass index or BMI over 30 kg/m2); if one of the immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g. below the age of about 50). In this case the patient could have a hereditary blood clotting disorder; if there is a need to have an operation, or if she is off the feet for a long time because of an injury or illness, or have the leg in a cast. The use of Qlaira may need to be stopped several weeks before surgery or while less mobile. If there is a need to stop Qlaira, ask the doctor when to start using it again; as getting older (particularly above about 35 years); if the patient gave birth less than a few weeks ago.
The risk of developing a blood clot increases the more conditions the patient has.
Air travel (>4 hours) may temporarily increase the risk of a blood clot, particularly if having some of the other factors listed.
It is important to tell the doctor if any of these conditions apply to the patient, even if unsure. The doctor may decide that Qlaira needs to be stopped.
If any of the previous conditions change while using Qlaira, for example a close family member experiences a thrombosis for no known reason; or gain a lot of weight, tell the doctor.
Blood clots in an artery: Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.
Factors that increase the risk of a blood clot in an artery: It is important to note that the risk of a heart attack or stroke from using Qlaira is very small but can increase: with increasing age (beyond about 35 years); if the patient smokes [When using a combined hormonal contraceptive like Qlaira, it is advised to stop smoking. If unable to stop smoking and are older than 35, the doctor may advise to use a different type of contraceptive]; if overweight; have high blood pressure; if a member of the immediate family has had a heart attack or stroke at a young age (less than about 50) [In this case, the patient could also have a higher risk of having a heart attack or stroke]; if the patient, or someone in the immediate family, have a high level of fat in the blood (cholesterol or triglycerides); if getting migraines, especially migraines with aura; if having a problem with the heart (valve disorder, disturbance of the rhythm called atrial fibrillation); if the patient has diabetes.
If the patient has more than one of these conditions or if any of them are particularly severe, the risk of developing a blood clot may be increased even more.
If any of the previous conditions change while using Qlaira, for example, start smoking, a close family member experiences a thrombosis for no known reason; or gain a lot of weight, tell the doctor.
Qlaira and cancer: Breast cancer has been observed slightly more often in women using combined pills, but it is not known whether this is caused by the treatment itself. For example, it may be that more tumours are detected in women on combined pills because they are examined by their doctor more often. The risk of breast tumours becomes gradually less after stopping the combination hormonal contraceptives. It is important to regularly check the breasts and should contact the doctor if any lump is felt.
In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours have been reported in contraceptive pill users. In isolated cases, these tumours have led to life-threatening internal bleeding. Contact the doctor if having unusually severe abdominal pain.
Some studies suggest that long-term use of the pill increases a woman's risk of developing cervical cancer. However, it is not clear to what extent sexual behaviour or other factors such as Human Papilloma Virus (HPV) increases this risk.
Psychiatric disorders: Some women using hormonal contraceptives including Qlaira have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If mood changes and depressive symptoms are experienced contact the doctor for further medical advice as soon as possible.
Bleeding between periods: During the first few months of taking Qlaira, the patient may have unexpected bleeding. Usually bleeding starts on day 26, the day the second dark red tablet was taken, or the following day(s). The information provided by women in the diaries they kept during a clinical study of Qlaira shows that it is not unusual to experience unexpected bleeding in a given cycle (10-18 % of users). If unexpected bleeding occurs more than 3 months in a row, or if it begins after some months, the doctor will have to investigate the cause.
What to do if no bleeding occurs on day 26 or the following day(s): The information provided by women in the diaries they kept during a clinical study of Qlaira shows that it is not unusual to miss the regular bleeding after day 26 (observed in about 15 % of cycles).
If all the tablets are taken correctly, have not had any vomiting or severe diarrhoea and have not taken any other medicines, it is highly unlikely that the patient is pregnant.
If the expected bleeding does not happen twice in a row or have taken the tablets incorrectly, the patient may be pregnant. Contact the doctor immediately. Do not start the next wallet until sure that the patient is not pregnant.
What to do if the patient vomits or has severe diarrhoea: If the patient throws up within 3-4 hours of taking an active tablet or have severe diarrhoea, there is a risk that the active substances in the pill are not fully absorbed by the body.
The situation is almost the same as forgetting a tablet. After throwing up or having diarrhoea, take the next tablet as soon as possible. If possible, take it within 12 hours of when the pill was taken normally. If this is not possible or 12 hours have passed, follow the advice given under Dosage & Administration. If the patient does not want to change the normal tablet-taking pattern, take the corresponding tablet from another wallet.
Laboratory tests: If a blood test or other laboratory tests are needed, the doctor or the laboratory staff must know that the patient is taking the pill because oral contraceptives can affect the results of some tests.
Qlaira contains lactose: If the patient has intolerance to some sugars, the doctor must be contacted before taking Qlaira.
Driving and using machines: There is nothing to suggest that the use of Qlaira affects driving or use of machines.
Use in children: Qlaira is not intended for use in females whose periods have not yet started.
