Qlaira Tablets

What is Qlaira?

Qlaira is a combined hormonal contraceptive (CHC) pill containing two active ingredients: estradiol valerate (an estrogen) and dienogest (a progestogen). Unlike many traditional combined pills which contain ethinylestradiol, Qlaira contains estradiol valerate, which is converted in the body to 17β-estradiol – the same estrogen naturally produced by the ovaries.

Mechanism of Action

Qlaira works through several complementary mechanisms to prevent pregnancy:

1. Ovulation inhibition: The hormones suppress the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) from the pituitary gland, preventing egg development and release.
2. Cervical mucus thickening: The progestogen component (dienogest) causes cervical mucus to become thicker, creating a barrier that sperm cannot easily penetrate.
3. Endometrial changes: The hormones alter the lining of the uterus (endometrium), making it less receptive to a fertilised egg for implantation.

Think of Qlaira as creating a multi-layered defence system: it stops egg production, blocks sperm entry, and makes the uterus inhospitable for implantation – providing triple protection against pregnancy.

Biological Pathway

When taken orally, estradiol valerate is converted to estradiol in the body. This, together with dienogest, exerts negative feedback on the hypothalamus and pituitary gland. This feedback reduces the secretion of gonadotropin-releasing hormone (GnRH), which in turn decreases FSH and LH production. Without the FSH and LH surge needed for ovulation, the ovarian follicles do not mature, and ovulation is prevented.

What is Qlaira Used For?

Qlaira is licensed for two main purposes:

1. Contraception (Pregnancy Prevention)

Qlaira is a highly effective reversible contraceptive method when taken correctly. According to the NHS guidelines, combined contraceptive pills like Qlaira are over 99% effective with perfect use.

2. Treatment of Heavy Menstrual Bleeding

Qlaira is also approved for the treatment of heavy menstrual bleeding (menorrhagia) that is not caused by any underlying disease of the womb, in women who wish to use oral contraception. Clinical studies have shown that Qlaira significantly reduces menstrual blood loss.

Before Using Qlaira

Before starting Qlaira, a comprehensive medical assessment is essential to ensure it is safe and appropriate for you.

Medical History Assessment Checklist

Your doctor will ask about and assess the following:

• Personal medical history: Including past or current conditions, especially those related to blood clotting, cardiovascular health, liver function, migraines, and depression
• Family medical history: Particularly regarding blood clots, heart attacks, or strokes in close relatives at a young age (under 50)
• Medication history: Current and recent medications, including over-the-counter drugs and herbal supplements
• Smoking status: Current smoking habits (particularly important for women over 35)
• Reproductive history: Menstrual cycle patterns, previous pregnancies, and breastfeeding status

Required Baseline Tests

1. Measure blood pressure: Essential before starting and periodically during use
2. Perform physical examination: Including breast examination if indicated by history or age
3. Consider additional tests: Such as liver function tests, lipid profile, or cervical screening based on individual risk factors
4. Body Mass Index (BMI) calculation: Obesity (BMI ≥30 kg/m²) increases thrombosis risk

Qlaira Contraindications

Qlaira must not be used in certain circumstances due to unacceptable health risks.

Absolute Contraindications (Must Not Use)

Do not take Qlaira if you have any of the following conditions:

Relative Contraindications (Use With Caution)

• Diabetes with vascular complications
• Severe hypertension
• Hypertriglyceridemia
• Conditions predisposing to thrombosis (e.g., major surgery, prolonged immobilization)
• History of pregnancy-related conditions (e.g., cholestasis, hearing loss)
• Depression
• Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
• Systemic lupus erythematosus (SLE)
• Sickle cell anaemia

Special Population Considerations

Adolescents (Under 18)

Qlaira can be used by adolescents once menstruation has started. However, no specific data are available for adolescents below 18 years. The prescribing decision should be made based on individual sexual maturity and after discussing the benefits and risks.

Women Over 35

For women over 35, careful risk-benefit assessment is required, especially regarding cardiovascular risk factors:

• Non-smokers over 35 may continue Qlaira if they have no other risk factors
• Smokers over 35 should generally not use combined hormonal contraceptives due to increased cardiovascular risk
• Regular monitoring of blood pressure and other cardiovascular risk factors is recommended

Obesity (BMI ≥30 kg/m²)

Obesity increases the risk of venous thromboembolism with combined hormonal contraceptives. The benefits may still outweigh risks for many obese women, but individual assessment is crucial. Weight should be monitored during treatment.

Qlaira and Other Medicines

Certain medications can interact with Qlaira, potentially reducing its effectiveness or increasing side effects.

Medications That Reduce Qlaira's Effectiveness

The following medications may decrease Qlaira's contraceptive effect. Additional contraceptive precautions (barrier methods) are required during and after treatment:

Medications Affected by Qlaira

• Cyclosporin: Qlaira may increase cyclosporin levels - monitoring recommended
• Lamotrigine: Qlaira may reduce lamotrigine levels, potentially increasing seizure frequency in epileptic patients
• Laboratory tests: Qlaira may affect results of some laboratory tests (thyroid, adrenal, liver function) - inform laboratory staff you are taking Qlaira

Pregnancy & Breastfeeding

Pregnancy

• Qlaira is contraindicated during pregnancy. If you become pregnant while taking Qlaira, stop taking it immediately and contact your doctor.
• Extensive epidemiological studies have shown no increased risk of birth defects in children born to women who used combined oral contraceptives before pregnancy.
• However, Qlaira should not be used during pregnancy as it offers no benefit and there is a theoretical risk to the foetus.

Breastfeeding

• Qlaira is generally not recommended during breastfeeding, especially during the first 6 weeks postpartum.
• Small amounts of contraceptive hormones pass into breast milk and may affect milk production and composition.
• If contraception is needed while breastfeeding, progestogen-only methods are usually preferred.

Driving & Machine Operation

• Qlaira has no known effects on the ability to drive or operate machinery
• Clinical studies and extensive patient use have shown no impairment of cognitive function or psychomotor performance
• Some women may experience dizziness or migraine when starting Qlaira
• If you experience visual disturbances (which can occur with migraine with aura), you should not drive or operate machinery

Qlaira Ingredients

Active Ingredients

• Estradiol valerate: An estrogen converted to 17β-estradiol (natural human estrogen)
• Dienogest: A progestogen with antiandrogenic properties

Excipients (Inactive Ingredients)

Allergen Warnings

How to Use Qlaira

Proper administration is crucial for Qlaira's effectiveness. Follow these steps carefully:

Step-by-Step Administration

1. Start your first wallet: Begin on the first day of your menstrual period (day 1 of your cycle). This provides immediate contraceptive protection.
2. Daily routine: Take one tablet every day at approximately the same time, with or without food, with a small amount of water if needed.
3. Follow the wallet direction: Take tablets in the order indicated by the arrows on the wallet, starting with tablet marked "1".
4. Complete the cycle: After taking all 28 tablets (26 active coloured tablets + 2 white inactive tablets), start a new wallet the next day without a break, even if you are still bleeding.
5. Weekday stickers: Use the provided weekday sticker strip to track your daily intake. Place the strip so the first day aligns with tablet "1".

Starting Scenarios

Qlaira Dosage Guidelines

Qlaira has a unique dynamic dosing regimen across the 28-day cycle:

Titration Schedule

Unlike fixed-dose combined pills, Qlaira uses a step-down estrogen and step-up progestogen approach:

1. High estrogen phase (days 1-2): 3 mg estradiol valerate only to promote endometrial proliferation
2. Transition phase (days 3-7): 2 mg estradiol valerate + 2 mg dienogest to begin endometrial stabilization
3. Maintenance phase (days 8-24): 2 mg estradiol valerate + 3 mg dienogest for consistent contraceptive effect
4. Withdrawal phase (days 25-26): 1 mg estradiol valerate only to trigger endometrial breakdown
5. Hormone-free interval (days 27-28): Placebo tablets allowing withdrawal bleed

Administration Instructions

Detailed Administration Guide

1. Prepare your wallet:
   • Select the weekday sticker strip starting with the day you begin taking Qlaira
   • Place the sticker strip along the top of the wallet where indicated
   • Ensure the first day sticker aligns with tablet marked "1"
2. Daily administration:
   • Take one tablet daily at approximately the same time
   • Tablets can be taken with or without food
   • If needed, take with a small amount of water
   • Check off each day on the wallet to track your intake
3. Bleeding expectations:
   • Withdrawal bleeding usually starts when taking the second dark red tablet (day 26) or the white inactive tablets
   • Bleeding may not have finished before you start the next wallet - this is normal
   • Start the next wallet the day after finishing the current one, regardless of bleeding status

Missed Dose Management

If you forget to take Qlaira, follow these guidelines based on when you remember:

General Principles

• If less than 12 hours late: Take the missed tablet immediately, then continue at usual time. Contraceptive protection is not reduced.
• If more than 12 hours late: Contraceptive protection may be reduced. Take the missed tablet immediately and use additional precautions (condoms) as needed.
• Never take more than 2 active tablets in one day.

Detailed Missed Tablet Guidelines

Overdose Information

Symptoms of Overdose

• Nausea and vomiting
• Vaginal bleeding (especially in young girls)
• Breast tenderness
• Dizziness

Management

1. Do not induce vomiting unless instructed by medical personnel
2. Contact your doctor, pharmacist, or nearest hospital for advice
3. If a child has taken Qlaira, seek medical attention immediately
4. Bring the medication packaging with you to medical appointments

Possible Side Effects

Like all medicines, Qlaira can cause side effects, although not everyone experiences them:

Very Common (more than 1 in 10 people)

• Headache
• Abdominal pain, nausea
• Acne
• Absence of periods, breast discomfort, painful periods, irregular bleeding
• Weight gain

Common (1 in 10 to 1 in 100 people)

• Depression, depressed mood, emotional disorder, insomnia, decreased libido
• Dizziness, migraine
• Hot flush, hypertension
• Increased liver enzymes
• Alopecia, hyperhidrosis, pruritus, rash

Serious Side Effects

How to Store Qlaira

Storage Conditions

• Store in the original packaging to protect from light and moisture
• Keep at room temperature (below 25°C)
• Keep out of sight and reach of children
• Do not use Qlaira after the expiry date printed on the wallet (EXP)

Disposal

• Do not throw away medicines via wastewater or household waste
• Return unused or expired medicines to your pharmacy for proper disposal

Pack Information

What Each Pack Contains

• Each Qlaira wallet contains 28 film-coated tablets
• 26 coloured active tablets in 4 different colours
• 2 white inactive tablets
• Weekday sticker strips (7 options) for tracking

Available Pack Sizes

• 1 wallet (28 tablets) - 1 month supply
• 3 wallets (84 tablets) - 3 month supply
• 6 wallets (168 tablets) - 6 month supply

Marketing Authorisation Holder: Bayer plc, 400 South Oak Way, Reading, RG2 6AD, UK

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