Qlaira® (Estradiol Valerate, Dienogest) 28 film-coated tablets

What is Qlaira®?

Qlaira® is an oral contraceptive containing a combination of hormones, estradiol valerate and dienogest. It is designed to prevent pregnancy and treat heavy menstrual bleeding in women without organic pathology. Qlaira® is composed of 28 film-coated tablets in different colors, each with specific active ingredients to regulate the menstrual cycle effectively.

How does Qlaira® work?

Qlaira® operates through a multifaceted mechanism involving the suppression of ovulation, alteration of cervical mucus, and modification of the endometrial lining. These actions collectively help prevent pregnancy and manage menstrual bleeding. The sequential hormonal dosing mimics the natural menstrual cycle, thereby reducing the risk of hormone-related side effects.

What are the components of Qlaira®?

Each Qlaira® pack contains:

• 2 dark yellow tablets: 3 mg estradiol valerate
• 5 red tablets: 2 mg estradiol valerate and 2 mg dienogest
• 17 light yellow tablets: 2 mg estradiol valerate and 3 mg dienogest
• 2 dark red tablets: 1 mg estradiol valerate
• 2 white tablets: Placebo

How should Qlaira® be taken?

Qlaira® tablets should be taken daily, following the order specified on the pack. It is important to take the tablet at the same time each day with a small amount of liquid if needed. Continuous daily intake is crucial, and each pack starts immediately after finishing the previous one. Typically, withdrawal bleeding occurs during the intake of the last few tablets of the pack.

What should be done if a tablet is missed?

• If less than 12 hours late: Take the missed tablet immediately and continue as usual.
• If more than 12 hours late: The contraceptive effect may be reduced. Take the missed tablet as soon as possible and continue the pack as normal. Additional barrier contraception should be used for the next 9 days.

Who should not use Qlaira®?

Qlaira® is contraindicated in women with:

• Current or history of venous thromboembolism
• Arterial thromboembolic disorders
• Severe liver disease
• Known or suspected hormone-dependent cancers
• Unexplained vaginal bleeding
• Hypersensitivity to any of the ingredients

What are the potential side effects of Qlaira®?

Common side effects include:

• Acne
• Breast discomfort
• Headache
• Nausea
• Weight gain

Serious side effects may involve venous or arterial thromboembolism. If any severe symptoms occur, immediate medical attention is necessary.

How does Qlaira® affect menstrual bleeding?

Qlaira® has been shown to significantly reduce menstrual blood loss. In clinical studies, women using Qlaira® experienced an 88% reduction in menstrual blood volume compared to a 24% reduction in the placebo group. Some women may experience amenorrhea (absence of menstruation) while on Qlaira®.

Can Qlaira® be used while breastfeeding?

Qlaira® is generally not recommended during breastfeeding as it may affect milk production and composition. Small amounts of the hormones can pass into breast milk, potentially affecting the infant.

How should Qlaira® be stored?

Store Qlaira® at a temperature not exceeding 30°C (86°F) in a place out of reach of children. Ensure the tablets are kept in their original packaging to protect them from light and moisture.

For more detailed information on potential interactions, pharmacokinetics, and specific use cases, always refer to the patient leaflet or consult with a healthcare provider.