Well-Plan^® Lily

Rx

Indications

• Oral contraception.

How to take Well-Plan^® Lily

• Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed.
• One tablet is to be taken daily for 21 consecutive days.
• Each subsequent pack is started after a 7-day tablet-free interval, during which time a withdrawal bleed usually occurs.
• This usually starts on day 2 – 3 after the last tablet and may not have finished before the next pack is started.

How to start taking Well-Plan^® Lily

• 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). Starting on days 2 – 5 is allowed, but during the first cycle a barrier method is recommended in addition for the first 7 days of tablet-taking.
• Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), viginal ring, or transdermal patch).
  The woman should start with Well-Plan^® Lily preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet of interval her previous COC. In case a vaginal ring or transdermal patch has been used, the woman should start using Well-Plan^® Lily preferably on the day of removal, but at the latest when the next application would have been due.
  If the woman has been using her previous method consistently and correctly and if it is reasonably certain that she is not pregnant she may also switch from her previous combined hormonal contraceptive on any day of the cycle.
  The hormone-free interval of the previous method should never be extended beyond its recommended length.
• Changing from a progestogen-only-method (minipill, injection, implant) or from a progestogen-releasing intrauterine system [IUS]
  The woman may switch any day from the minipill (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 7 days of tablet-taking.
• Following first-trimeter abortion
  The woman may start immediately. When dosing so, she need not take additional contraceptive measures.
• Following delivery or second-trimester abortion
  For berastfeeding women.
  Wonmen should be advised to start at day 21 to 28 after delivery or secondtrimester abortion. When starting later, the woman should be advised to additionally use a barrier method for the first 7 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.
  The increased risk of venous thromboembolism during the postpartum perod should be cousidered when restaring Well-Plan^® Lily.

Management of missed tablets

• If the user in 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 management of missed tablets can be guided by the following two basic rules:
  + Tablet-taking must never be discontinued for longer than 7 days.
  + 7 days of uninterrupted tablet-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian-axis.

Accordingly, the following advice can be given in daily practice:

Week 1

• The user 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. In addition, a barrier method such as a condom should be used for the next 7 days. If intercourse took place in the preceding 7 days, the possibility of a pregnancy should be considered. The more tablets are missed and the closer they are to the reqular tablet-free interval, the higher the risk of a pregnancy.

Week 2

• The user 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. Provided that the woman has taken her tablets correctly in the 7 days preceding the first missed tablet, there is no need to use extra contraceptive precautions. However, if this is not the case, or if she missed more than 1 tablet, the woman should be advised to use extra precautions for 7 days.

Week 3

• The risk of reduced reliability is imminent because of the forthcoming tablet-free interval. However, by adjusting the tablet-intake schedule, reduced contraceptive protection can stillbe prevented. By adhering to either of the following two options, there is therefore no need to use extra contraceptive precautions, provided that in the 7 days preceding the first missed tablet the woman has taken all tablets correctly. If this is not the case, the woman should be advised to follow the first of these two options and to use extra precautions for the next 7 days as well.
  -The user 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. The next pack must be started as soon as the current pack is finished, i.e., no qap should be left between packs. The user is unlikely to have a withdrawal bleed until the end of the second pack, but she may experience spotting or breakthrough bleeding on tablet-taking days.
  The woman may also be advised to discontinue tablet-taking from the current pack. She should then have a tablet-free interval of up to 7 days, including the days she missed tablets, and subsequently continue with the next pack.

If the woman missed tablets arnd subsequently has no withdrawal bleed in the first normal tablet free interval, the possibility of a pregnancy should be considered.

Advice in case of gastro-intestinal disturbances

• In case of severe gastro-intestinal disturbance, absorption may not be complete and additional Contraceptive measures should be taken.
• If vomiting occurs within 3 – 4 hours after tablet-taking, the advice concerning missed tablets, as given in section “Management of missed tablets”, is applicable. If the woman does not want to change her normal tablet-taking schedule, she has to take the extra tablet(s) needed from anothe pack.

How to shift periods or how to delay a period

• To delay a period the woman should continue with another pack of Well-Plan^® Lily without a tablet-free interval. The extension can be carried on for as long as wished until the end of the second pack. During the extension the woman may experience breakthrough bleeding or spotting. Regular intake of Well-Plan^® Lily  is then resumed after the usual 7-day tablet-frep interval.
• To shift her period to another day of the week than the woman is used to with her current scheme, she can be advised to shorten her forthcoming tablet-free interval by as many days as she likes. The shorter the interval, the higher the risk that she does not have a withdrawal bleed and will experience breakthrough bleeding and spotting during the second pack (just a when delaying a period).

Well-Plan^® Lily should not be used in the presence of any of the conditions listed below:

• Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia.
• Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
• Presence or history of liver tumours (benign or malignant).
• Known or suspected estrogen-dependent tumours.
• Endometrial hyperplasia.
• Undiagnosed vaginal bleeding.
• Known or suspected pregnancy.
• Hypersensitivity to any ingredient of the drug.
• Well-Plan^® Lily is contraindicated for concomitant use with medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir or medicinal products containing glecaprevir/pibrentasvir.

• Changes in vaginal bleeding patterns may occur, especially during the first months of use. These may include changes in bleeding frequency (absent, less, more frequent or continuous), intensity (reduced or increased) or duration.
• An increased risk of arterial and venous thrombotic and thromboembolic events, including myocardial infarction, stroke, transient ischaemic attacks, venous thrombosis and pulmonary embolism has been observed.

Common

• Depression, mood swings,
• Headache,
• Nausea, stomach ache,
• Breast pain, breast tenderness,
• Weight gain.

• Combined hormonal contraceptives (CHCs) increase the risk of venous thromboembolism (VTE) and arterial thromboembolism (ATE), especially in women over 35 years of age, obese, smoking, or with underlying cardiovascular disease.
• There may be a slight increase in the risk of breast and cervical cancer; liver tumors are rare. Conversely, it helps reduce the risk of ovarian and endometrial cancer.
• Liver and metabolic effects: May cause elevated liver enzymes, jaundice, and pancreatitis in individuals with hypertriglyceridemia.
• Other effects: Risk of melasma, blood pressure disturbances, menstrual cycle changes, reduced effectiveness with missed doses or drug interactions.
• May cause or worsen depression.
• Well-Plan^® Lily should not be used in patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption due to containing lactose as an excipient.
• Do not use Well-Plan^® Lily during pregnancy.
• No effects of the medication on the ability to drive and operate machinery have been observed.