Posology : מינונים

4.2     Posology and method of administration

Method of administration
Oral use

Posology

How to take Qlair
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.

How to start Qlair

• No preceding hormonal contraceptive use (in the past month)
Tablet-taking has to start on day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bleeding).

• Changing from a combined hormonal contraceptive (combined oral contraceptive /COC), vaginal ring, or transdermal patch
The woman should start with Qlair 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 Qlair on the day of removal.
• Changing from a progestogen-only method (progestogen-only pill, injection, implant) or from a progestogen-releasing intrauterine system (IUS)
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.

• Following first-trimester abortion
The woman may start immediately. When doing so, she needs not take additional contraceptive measures.

• Following delivery or second-trimester abortion

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.

Management of missed tablets

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                     Principles to follow if missing one tablet for more Content of estradiol      than 12 hours: valerate
(EV)/dienogest (DNG)
1–2        Dark yellow tablets
(3.0 mg EV)
-   Take missed tablet immediately and the following tablet as usual (even if this means
3-7        Medium red tablets             taking two tablets on the same day) (2.0 mg EV + 2.0 mg
DNG)                       -   Continue with tablet-taking in the normal way 8 – 17     Light yellow tablets       -   Use back-up contraception for the next 9 days (2.0 mg EV + 3.0 mg
DNG)
18 – 24    Light yellow tablets       -   Discard current wallet, and start immediately (2.0 mg EV + 3.0 mg            with the first pill of a new wallet
DNG)
-   Continue with tablet-taking in the normal way
-   Back-up contraception for the next 9 days
25 – 26    Dark red tablets           -   Take missed tablet immediately and the
(1.0 mg EV)                    following tablet as usual (even if this means taking two tablets on the same day)
-   No back-up contraception necessary
27-28      White tablets              -   Discard missed tablet and continue tablet-taking
(Placebos)                     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.



Advice in case of gastro-intestinal disturbances

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.

Additional information on special populations

Children and adolescents
No data available for use in adolescents below 18 years.

Geriatric patients
Qlair is not indicated after menopause.

Patients with hepatic impairment
Qlair is contraindicated in women with severe hepatic diseases. See also section 4.3.


Patients with renal impairment
Qlair has not been specifically studied in renally impaired patients.