Qlaira Contraceptive Pill

Qlaira Combined Oral Contraceptive Pill

What is Qlaira used for?

Qlaira is a combined contraceptive pill used to prevent pregnancy. It’s also licensed to treat heavy menstrual bleeding (known medically as heavy menstrual bleeding or HMB) in women who want to use oral contraception at the same time.

Unlike most contraceptive pills, which contain a fixed dose of hormones in every active tablet, Qlaira uses a quadriphasic dose schedule. This means the hormone levels in each tablet change across the 28-day wallet, more closely mimicking the natural hormonal fluctuations of the menstrual cycle.

Each wallet contains 28 pills: 26 coloured pills in four different shades, each with a different hormone combination, plus 2 white inactive tablets. Tablets are taken in a set order every day without a break between wallets.

How does Qlaira work?

Qlaira contains two hormones, estradiol valerate (an oestrogen) and dienogest (a progestogen), which work together to prevent pregnancy in three ways:

1. Stopping ovulation: the hormones prevent your ovaries from releasing an egg each month. Without an egg, pregnancy can’t occur.
2. Thickening cervical mucus: this makes it much harder for sperm to reach an egg.
3. Thinning the womb lining: this reduces the chance of a fertilised egg implanting and developing.

For heavy menstrual bleeding, the hormonal combination helps regulate and thin the womb lining, which reduces the volume of bleeding each cycle.

Who can take the Qlaira contraceptive pill?

Qlaira is suitable for women of reproductive age who want a combined oral contraceptive pill, and who may also want to manage heavy menstrual bleeding at the same time.

It isn’t suitable for everyone. Don’t use Qlaira if you:

• Have or have ever had a blood clot in your legs, lungs, or other organs
• Have a blood clotting disorder such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies
• Have ever had a heart attack or stroke
• Have ever had angina or a transient ischaemic attack (TIA)
• Have severe diabetes with blood vessel damage, very high blood pressure, very high cholesterol or triglycerides, or hyperhomocysteinaemia
• Have or have ever had migraines with aura
• Have liver disease where your liver function hasn’t returned to normal, or have ever had a liver tumour
• Have or are suspected of having breast cancer or cancer of the genital organs
• Have unexplained vaginal bleeding
• Are allergic to estradiol valerate, dienogest, or any other ingredient in Qlaira

Speak to your doctor before using Qlaira if you have a family history of breast cancer, diabetes, depression, Crohn’s disease, ulcerative colitis, epilepsy, varicose veins, or if you have recently given birth. Your doctor will assess if Qlaira is appropriate based on your medical history and any risk factors you may have.

How to Take Qlaira

Take 1 pill every day at roughly the same time every day, following the direction of the arrow on the wallet. You can take it with or without food.

1. Before you start your first wallet, attach the weekday sticker strip that begins on the day you plan to start. This lets you see at a glance whether you’ve taken your tablet each day.
2. Start with tablet 1 and take one tablet each day in order, following the arrows.
3. When you finish the wallet, start a new one the very next day with no break, even if you are still bleeding.

Each wallet contains 28 pills: 26 active pill tablets in four colours (each with a different hormone combination) and 2 white inactive tablets at the end. Take all 28 in order.

Withdrawal bleeding usually starts when you reach the second dark red tablet or the white inactive tablets. It’s not unusual for some bleeding to continue into the first days of your next wallet.

If you’re starting Qlaira for the first time and haven’t used hormonal contraception in the past month, begin on the first day of your period. If you’re switching from another combined pill, ring, or patch, or from a progestogen-only method (sometimes called the mini pill), speak to your doctor or pharmacist for guidance on when to start and if you need additional contraception during the changeover.

Qlaira Pill Side Effects

Like all medicines, Qlaira can cause side effects, though not everyone will experience side effects. Most are mild and tend to settle after the first few months of use.

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

• Headache
• Abdominal pain or nausea
• Acne
• Breast discomfort or painful periods
• Irregular bleeding or no periods
• Weight gain

Uncommon side effects (may affect up to 1 in 100 users):

• Fungal infections, including vaginal thrush
• Mood changes, depression, decreased interest in sex, or difficulty sleeping
• Dizziness or migraine
• Hot flushes or high blood pressure
• Diarrhoea or vomiting
• Hair loss, itching, rash or excessive sweating
• Muscle cramps
• Swollen or lumpy breasts, pelvic pain, ovarian cysts, vaginal dryness or discharge
• Fatigue, irritability or swelling of the ankles

Rare side effects (may affect up to 1 in 10,000 users):

• Blood clots in a vein or artery, including deep vein thrombosis (DVT), pulmonary embolism, heart attack or stroke
• Liver nodules or gallbladder inflammation
• Chloasma (golden brown pigment patches on the skin)
• Changes in blood pressure or blood fat levels

If you experience any severe or persistent side effects, or any signs of a blood clot such as sudden leg pain or swelling, breathlessness, chest pain, or sudden changes in vision or speech, seek urgent medical attention.

You can report side effects directly via the MHRA Yellow Card Scheme.

Qlaira Ingredients

Active ingredients: Estradiol valerate and dienogest, in varying amounts across the 4 types of active pills:

• 2 dark yellow tablets: estradiol valerate 3mg
• 5 medium red tablets: estradiol valerate 2mg and dienogest 2mg
• 17 light yellow tablets: estradiol valerate 2mg and dienogest 3mg
• 2 dark red tablets: estradiol valerate 1mg
• The 2 white pills contain no active ingredients.

Other ingredients in the active tablets: lactose monohydrate, maize starch, pregelatinised maize starch, povidone K25 (E1201), magnesium stearate (E572), hypromellose type 2910 (E464), macrogol 6000, talc (E553b), titanium dioxide (E171), iron oxide yellow (E172) and/or iron oxide red (E172).

Other ingredients in the white inactive tablets: lactose monohydrate, maize starch, povidone K25 (E1201), magnesium stearate (E572), hypromellose type 2910 (E464), talc (E553b), titanium dioxide (E171).

Qlaira contains lactose. If you have been told you have an intolerance to some sugars, speak to your doctor before taking this medicine.

Warnings and Precautions

• Using a combined hormonal contraceptive like Qlaira slightly increases the risk of developing a blood clot in a vein or artery. The risk is highest in the first year of use and when restarting after a break of 4 or more weeks. Seek urgent medical attention if you notice signs of a blood clot, including leg pain or swelling, sudden breathlessness, chest pain, or sudden changes in vision or speech.
• Qlaira doesn’t protect against HIV or any other sexually transmitted infection. Use condoms if there is any risk of infection.
• Some medicines can make Qlaira less effective, including certain epilepsy medications (such as phenytoin, carbamazepine and barbiturates), rifampicin for tuberculosis, some HIV and hepatitis C treatments, antifungals such as griseofulvin, and the herbal remedy St John’s Wort. Always tell your doctor or pharmacist you are taking Qlaira if any new medicines are prescribed.
• If you vomit within 3 to 4 hours of taking a tablet or have severe diarrhoea, the tablet may not have been fully absorbed. Follow the missed pill guidance in the patient information leaflet and use additional contraception if needed.
• Tell your doctor you are taking Qlaira if you need surgery or will be immobile for a long period, as it may need to be temporarily stopped to reduce the risk of blood clots.
• Some women experience mood changes or depression while using hormonal contraceptives. If you notice changes in your mood, speak to your doctor.
• The pill may cause irregular bleeding, particularly in the first few months. If unexpected bleeding occurs for more than 3 months in a row or starts after several months of regular cycles, speak to your doctor.
• Tell your doctor or laboratory staff you are taking Qlaira before any blood tests, as oral contraceptives can affect the results of some tests.
• Keep Qlaira out of the sight and reach of children. No special storage conditions are required. Don’t use after the expiry date shown on the wallet.
• Don’t dispose of Qlaira via wastewater or household waste. Ask your pharmacist for advice on safe disposal.