Oral contraception.
Treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception.
The decision to prescribe Qlaira should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Qlaira compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
Oral use.
Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. Tablet taking is continuous. One tablet is to be taken daily for 28 consecutive days. Each subsequent pack is started the day after the last tablet of the previous wallet. Withdrawal bleeding usually starts during the intake of the last tablets of a wallet and may not have finished before the next wallet is started. In some women, the bleeding starts after the first tablets of the new wallet are taken.
Tablet-taking has to start on day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bleeding).
The woman should start with Qlaira on the day after the last active tablet (the last tablet containing the active substances) of her previous COC. In case a vaginal ring or transdermal patch has been used, the woman should start using Qlaira on the day of removal.
The woman may switch any day from the progestogen-only pill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due), but should in all of these cases be advised to additionally use a barrier method for the first 9 days of tablet-taking.
The woman may start immediately. When doing so, she needs not take additional contraceptive measures.
For breastfeeding women see section 4.6.
Women should be advised to start at day 21 to 28 after delivery or second-trimester abortion. When starting later, the woman should be advised to additionally use a barrier method for the first 9 days of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of COC use or the woman has to wait for her first menstrual period.
Missed (white) placebo tablets can be disregarded. However, they should be discarded to avoid unintentionally prolonging the interval between active-tablet taking.
The following advice only refers to missed active tablets:
If the woman is less than 12 hours late in taking any tablet, contraceptive protection is not reduced. The woman should take the tablet as soon as she remembers and should take further tablets at the usual time.
If she is more than 12 hours late in taking any tablet, contraceptive protection may be reduced. The woman should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. She then continues to take tablets at her usual time.
Depending on the day of the cycle on which the tablet has been missed (see chart below for details), back-up contraceptive measures (e.g. a barrier method such as a condom) have to be used according to the following principles:
| DAY | Color Content of estradiol valerate (EV)/dienogest (DNG) | Principles to follow if missing one tablet for more than 12 hours: |
| 1 – 2 | Dark yellow tablets (3.0 mg EV) | - Take missed tablet immediately and the following tablet as usual (even if this means taking two tablets on the same day) - Continue with tablet-taking in the normal way - Use back-up contraception for the next 9 days |
| 3 – 7 | Medium red tablets (2.0 mg EV + 2.0 mg DNG) | |
| 8 – 17 | Light yellow tablets (2.0 mg EV + 3.0 mg DNG) | |
| 18 – 24 | Light yellow tablets (2.0 mg EV + 3.0 mg DNG) | - Discard current wallet, and start immediately with the first pill of a new wallet - Continue with tablet-taking in the normal way - Back-up contraception for the next 9 days |
| 25 – 26 | Dark red tablets (1.0 mg EV) | - Take missed tablet immediately and the following tablet as usual (even if this means taking two tablets on the same day) - No back-up contraception necessary |
| 27-28 | White tablets (Placebos) | - Discard missed tablet and continue tablet-taking in the normal way - No back-up contraception necessary |
Not more than two tablets are to be taken on a given day.
If a woman has forgotten to start a new wallet, or if she has missed one or more tablets during days 3-9 of the wallet, she may already be pregnant (provided she has had intercourse in the 7 days before the oversight). The more tablets (of those with the two combined active ingredients on days 3–24) that are missed and the closer they are to the placebo tablet phase, the higher the risk of a pregnancy.
If the woman missed tablets and subsequently has no withdrawal bleed at the end of the wallet /beginning of new wallet, the possibility of a pregnancy should be considered.
In case of severe gastro-intestinal disturbances (e.g., vomiting or diarrhoea), absorption may not be complete and additional contraceptive measures should be taken.
If vomiting occurs within 3-4 hours after active tablet-taking, the next tablet should be taken as soon as possible. This tablet should be taken within 12 hours of the usual time of tablet-taking, if possible. If more than 12 hours elapse, the advice concerning missed tablets, as given in section 4.2 “Management of missed tablets”, is applicable. If the woman does not want to change her normal tablet-taking schedule, she has to take the corresponding tablet(s) needed from another pack.
Children and adolescents
No data available for use in adolescents below 18 years.
Geriatric patients
Qlaira is not indicated after menopause.
Patients with hepatic impairment
Qlaira is contraindicated in women with severe hepatic diseases. See also section 4.3.
Patients with renal impairment
Qlaira has not been specifically studied in renally impaired patients.
There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in case of taking an overdose of active tablets are: nausea, vomiting and, in young girls, slight vaginal bleeding. There are no antidotes and further treatment should be symptomatic.
5 years.
This medicinal product does not require any special storage conditions.
Transparent PVC/Aluminium blister in a cardboard wallet
Pack sizes:
1 × 28 film-coated tablets
3 × 28 film-coated tablets
6 × 28 film-coated tablets
Each wallet (28 film-coated tablets) contains in the following order: 2 dark yellow tablets and 5 medium red tablets and 17 light yellow tablets and 2 dark red tablets and 2 white tablets
Not all pack sizes may be marketed.
Any unused product or waste material should be disposed of in accordance with local requirements.
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