Qlaira

Qlaira is a fourth-generation combined oral contraceptive containing two female synthetic hormones: oestrogen and progesterone. Unlike other combined oral contraceptives Qlaira is a quadriphasic pill which means there are four hormone doses over one menstrual cycle. Each coloured, active tablet contains a small amount of female hormones, either estradiol valerate, or estradiol valerate combined with dienogest. This means that each Qlaira pill does not contain the same amount of oestrogen and progesterone, and therefore the dose of each pill changes during the month.

Dienogest is a new progestogen which is more ‘target organ’-specific, producing fewer nuisance side effects and inhibiting ovulation effectively. Dienogest (DNG) inhibits ovulation at doses of 2 mg mainly by peripheral action on the ovarian granulosa cell.

Qlaira is a novel combined oral contraceptive with the potential to have fewer side effects compared to current ethinylestradiol contraceptives. Qlaira may be suitable for women who frequently ask for the ‘the lowest dose pill’ as it contains estradiol which is nearly identical to the female hormone to ethinylestradiol. Qlaira may also be suitable for those complaining of estrogen withdrawal symptoms such as headaches, mood changes or pelvic pain during the hormone-free week of conventional pill taking. Since about 20% of women each month have no withdrawal bleeding when using Qlaira, it may offer hope for those with regular heavy menstrual bleeding.

Oestrogen and progesterone stop you from getting pregnant in three ways.

1. Preventing an egg from being released from the ovaries.
2. Making the fluid in your cervix thicker, minimising the penetration of sperm.
3. Preventing the lining of your womb from thickening enough to allow an egg to grow in it.

Combined oral contraceptives provide one of the most reliable methods of contraception if used correctly. Other benefits include making your periods regular, lighter, and less painful, and it may help with pre-menstrual symptoms such as flushing and mood changes.

Qlaira is less androgenic or anti-androgenic and has a lesser effect on these hormone receptors within the body, lowering the number of side effects you experience. Many women tend to produce few androgens. However some women may produce more than others. Women with Polycystic ovary syndrome tend to have higher androgen levels which can cause excess hair growth, acne and ovulation problems. An example of an androgen is testosterone which is present in higher levels in men. Qlaira can help patients with symptoms such as acne and hair growth.

Can you get Qlaira over the counter?

No, you cannot get Qlaira over the counter. Qlaira is a prescription-only medication that can be purchased from The Family Chemist privately or by visiting your doctor.

Qlaira can be taken at any point in your menstrual cycle. However, you may need to take additional contraceptive methods.

Each wallet contains 26 coloured active tablets and two white inactive tablets. Take one tablet of Qlaira daily with a small amount of water. You may take the tablets with or without food, but you should take the tablets at around the same time every day.

To help you keep track, there are 7-weekday sticker strips marked with the 7 days of the week.

Choose the weekday sticker strip that starts with the day you begin taking the tablets. For example, if you start on a Wednesday, use the weekday sticker strip that starts with “WED”.

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”.

There is now a day shown above every tablet, and you can see whether you have taken a pill on a particular day. Follow the direction of the arrow on the wallet until all 28 tablets have been taken.

Usually, withdrawal bleeding starts when you take the second dark red or white tablet, and the bleeding may not have finished before you start the next wallet. Some women still experience bleeding after taking the first tablets of the new wallet. Start the following wallet without a gap or pill-free period. The withdrawal bleed should occur on the same weekdays each month. If you use Qlaira in this manner, you are protected against pregnancy even during the two days you take inactive tablets.

If you have not used a contraceptive with hormones during the previous month. Start taking Qlaira on the first day of the cycle (the first day of your period). If you start on any other day of your cycle you will need additional contraception like condoms for the first 9 days.

Changing from another combined hormonal contraceptive pill, or combined contraceptive vaginal ring or patch.
Start Qlaira the day after taking the last active tablet (the last tablet containing the active substance) of your previous pill. When changing from a combined contraceptive vaginal ring or patch, start using Qlaira on the day of removal or, follow the advice of your doctor.

Changing from a progestogen-only-method (progestogen-only pill, injection, implant or a progestogen-releasing ‘IUS’, intrauterine system).
You may switch from the progestogen-only pill any day (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due) but in all of these cases, you must use extra protective measures (for example, a condom) during the first 9 days of Qlaira use.

After having a baby.
You can start Qlaira between 21 and 28 days after having a baby. If you start later than day 28, use a barrier method (for example, a condom) during the first 9 days of Qlaira use.

If, after having a baby, you have had sex before re-starting Qlaira, be sure that you are not pregnant or wait until the next menstrual period.

If it has been less than 12 hours since you have missed a pill: you are still protected against pregnancy. Take the pill as soon as you remember and continue retaking the tablets at the usual time.

If it has been more than 12 hours since you missed a pill: you may not be protected against pregnancy. Depending on the day of the cycle the tablet was missed you may need to use additional contraceptive methods such as condoms. The patient information leaflet in your pack provides more information on what to do if you have missed more than one coloured pill or forgot to start a new wallet. If unsure, contact your doctor or The Family Chemist clinician.

If you miss a white tablet, you do not need to take it later as it contains no active hormones. Continue with the next tablet at the usual time.

Do not take more than two active tablets on a given day.

Many patients take Qlaira free of side effects however, like all medicines, some people may experience some side effects. The severity can vary from person to person.

Side effects such as bleeding between periods or feeling nausea are more common in the first three months. However, they should soon disappear. If the side effects become intolerable, worsen, or continue beyond three months, you should contact your doctor or The Family Chemist clinician.

Qlaira does carry a slightly higher blood clot risk. 9-12 per 10,000 women per year compared to 5-7 per 10,000 per year in patients taking second-generation contraceptive pills.

A rare side effect (1 in 10 in every 10,000 users) can occur in women taking Yasmin: a harmful blood clot in a vein or artery. Seek urgent medical attention if you notice any swelling of one leg, pain or tenderness, increased warmth in the affected leg, change in colour of the skin on the leg, sudden unexplained breathlessness or rapid breathing, sharp chest pain, severe lightheadedness, rapid or irregular heartbeat or severe pain in your stomach. The patient information leaflet contains more information regarding recognising a blood clot.

Common side effects of Qlaira include:

• 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
• increased liver enzymes
• hair loss, excessive sweating (hyperhidrosis), itching, rash
• muscle cramps
• swollen breasts, lumps in the breast, abnormal cell growth on the neck of the womb (cervical dysplasia), dysfunctional genital bleeding, pain with intercourse, fibrocystic breast disease, heavy periods, menstrual disorders, ovarian cyst, pelvic pain, premenstrual syndrome, growth in the uterus, contractions of the uterus, uterine/vaginal bleeding incl. spotting, vaginal discharge, vulvovaginal dryness
• fatigue, irritability, swelling of parts of your body, e.g. ankles (oedema)
• weight loss, blood pressure changes.

The patient information leaflet contains a full list of side effects.

Most patients can take Qlaira. However, there may be occasions where an alternative pill may suit you better. You must fill in the consultation form accurately so the clinician can make sure your treatment is safe for you.

Do not use Qlaira:

• If you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs.
• If you know, you have a disorder affecting your blood clotting – for instance, protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies.
• If you need an operation or are off your feet for a long time.
• If you have ever had a heart attack or stroke
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and maybe a first sign of a heart attack) or transient ischaemic attack (TIA – temporary stroke symptoms)
• If you have any of the following diseases that may increase your risk of a clot in the arteries: severe diabetes with blood vessel damage, very high blood pressure, a very high level of fat in the blood (cholesterol or triglycerides) – a condition known as hyperhomocysteinaemia.
• If you have (or have ever had) a type of migraine called ‘migraine with aura.’
• If you have or have ever had breast cancer
• If you have ever had severe liver disease, and your doctor has told you that your liver function test results are not yet back to normal
• If you have ever had liver tumours
• If you are allergic (hypersensitive) to any ingredients in Yasmin
• Do not use Qlaira if you have hepatitis C and are taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir.
• If you have ever had problems with your heart, circulation or blood clotting.
• If you have diabetes
• If you have ever had kidney or liver problems.
• If you have ever had severe depression.
• If you have Crohn’s disease or ulcerative colitis
• If you have systemic lupus erythematosus.
• If you have sickle cell anaemia.

The list is not exhaustive and you should consult the patient information leaflet.

Progesterone only pill may be more suitable for you if you smoke and are 35 or older, stopped smoking less than a year ago and are 35 or older, are overweight or breastfeeding.