LOVIMA

How to take Lovima Tablets must be taken every day at about the same time so that the interval between two tablets always is 24 hours. The first tablet should be taken on the first day of menstrual bleeding. Thereafter one tablet each day is to be taken continuously, without taking any notice of possible bleeding.

A new blister is started directly the day after the previous one. How to start Lovima No preceding hormonal contraceptive use [in the past month] Tablet taking has to start on day 1 of the woman's natural cycle (day 1 is the first day of her menstrual bleeding).

Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended for the first 7 days of tablet-taking.

Following miscarriage or abortion:

It is recommended to start tablet-taking immediately or within 5 days after miscarriage or abortion. In that case there is no need to use an additional method of contraception.

Following delivery:

Contraceptive treatment with Lovima after delivery can be initiated before the menstruations have returned. If more than 21 days have elapsed since delivery, pregnancy ought to be ruled out and an additional method of contraception should be used for the first week.

6. How to start Lovima when changing from other contraceptive methods Changing from a combined oral contraceptive (combined hormonal contraceptive (COC), vaginal ring, or transdermal patch). The woman should start with Lovima preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC or on the day of removal of her vaginal ring or transdermal patch.

In these cases, the use of an additional contraceptive is not necessary. The woman may also start at the latest on the day following the usual tablet-free, patch-free, ring-free, or placebo tablet interval of her previous combined hormonal contraceptive, but during the first 7 days of tablet-taking an additional barrier method is recommended.

Changing from a progestogen-only-method (minipill, injection, implant or from a progestogen-releasing intrauterine system (IUS)). The woman may switch • from the minipill: on any day • from an implant or the IUS: on the day of its removal • from an injectable: when the next injection would be due.

Use after Emergency Contraception If a woman wishes to start Lovima after using emergency hormonal contraception, it is advisable to start tablet taking on day 1 of the woman’s natural cycle. If it is considered necessary to start sooner or if Lovima is being resumed after inconsistent use, the following advice should be noted: Levonorgestrel Lovima can be started or restarted on the same day as emergency contraception containing levonorgestrel.

Additional contraceptive measures (abstinence or barrier methods) are required for the first 7 days of Lovima use. Ulipristal acetate Lovima should be started or restarted no sooner than 5 days (120 hours) after emergency contraception containing ulipristal acetate, because the effectiveness of ulipristal can be reduced.

) Ulipristal acetate may conversely reduce the effectiveness of Lovima. Concomitant use is therefore not recommended. 5) Management of missed tablets Contraceptive protection may be reduced if more than 36 hours have elapsed between two tablets.

If the user is less than 12 hours late from her usual time of taking any tablet, she should take the missed tablet as soon as she remembers and take the next tablet at the usual. time, even if it leads to taking two tablets in one day.

If she is more than 12 hours late from her usual tablet taking time, the woman should immediately take the forgotten tablet and take the next tablet at the usual time, even if it leads to taking two tablets in one day. If more than one tablet has been missed, only one of the missed tablets should be taken immediately.

In addition, she should use an additional barrier method of contraception for the next 7 days. Missed tablets at any time in the cycle can reduce the efficacy of Lovima and risk pregnancy, but missing a tablet in the first week after initiation of Lovima is an especially vulnerable time.

The need for emergency contraception must be considered for any missed pills. Advice in case of gastrointestinal disturbances If vomiting occurs within 3-4 hours of tablet-taking, then the pill should be considered ‘missed’ and the advice for a missed tablet should be followed.

In the case of severe or persistent gastro-intestinal disturbance (vomiting or diarrhoea), absorption of Lovima may not be complete and contraceptive efficacy may be reduced. Additional contraceptive measures will be required for the duration of the illness and for the first 7 days of normal tablet-taking..

Treatment surveillance Assessment of women prior to starting oral contraceptives (and at regular intervals thereafter) should include a personal and family medical history of each woman. 4 and bleeding disturbances, such as oligomenorrhoea and amenorrhoea should be investigated by a physician before pharmacy supply can be considered.

4). 4), re-evaluation of supply should be timed accordingly. 3) and warnings […]

The most commonly reported undesirable effect in the clinical trials is bleeding irregularity. Some kind of bleeding irregularity has been reported in up to 50% of women using desogestrel. Since desogestrel causes ovulation inhibition close to 100%, in contrast to other progestogen-only pills, irregular bleeding is more common than with other progestogen-only pills.

In 20 - 30% of the women, bleeding may become more frequent, whereas in another 20% bleeding may become less frequent or totally absent. Vaginal bleeding may also be of longer duration. After a couple of months of treatment, bleedings tend to become less frequent.

Information, counselling, and a bleeding diary can improve the woman's acceptance of the bleeding pattern. 5%) were acne, mood changes, breast pain, nausea and weight increase. The undesirable effects are mentioned in the table below.

000 to <1/1,000). 0 Breast discharge may occur during use of Lovima. 4). 4). In women using (combined) oral contraceptives a number of (serious) undesirable effects have been reported. g. 4. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Before any supply of Lovima from a pharmacy (initial or repeat supply) pregnancy in the woman concerned should be excluded. Pregnancy can be ruled out with reasonable certainty if the woman has no symptoms or signs of pregnancy and if she meets one or more of the following conditions: • Has not had sexual intercourse since the last normal (natural) menstrual period, since childbirth, abortion, miscarriage, ectopic pregnancy or uterine evacuation for gestational trophoblastic disease.

• Has used a reliable alternative method of contraception correctly and consistently. • Is within the first 5 days of the onset of a normal menstrual period. • Is less than 21 days postpartum (non-breastfeeding women) • Is fully breastfeeding, amenorrhoeic AND less than 6 months postpartum.

• Is within the first 5 days after abortion, miscarriage, ectopic pregnancy or uterine evacuation for gestational trophoblastic disease. • Has not had intercourse for >21 days AND has a negative high-sensitivity urine pregnancy test (able to detect hCG levels around 20 mIU/ml).

If any of the conditions/risk factors mentioned below is present the benefits of progestogen use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start Lovima.

In the event of aggravation, exacerbation, or first appearance of any of these conditions, the woman should contact her physician. The physician should then decide on whether the use of Lovima should be discontinued. The risk for breast cancer increases in general with increasing age.

During the use of combined oral contraceptives (COCs) the risk of having breast cancer diagnosed is slightly increased. This increased risk disappears gradually within 10 years after discontinuation of COC use and is not related to the duration of use, but to the age of the woman when using the COC.

The expected number of cases diagnosed per 10,000 women who use combined COCs (up to 10 years after stopping) relative to never users over the same period has been calculated for the respective age groups and is presented in the table below.

7 44 30-34 years 110 100 35-39 years 180 160 40-44 years 260 230 The risk in users of progestogen-only contraceptives (POCs), such as Lovima, is possibly of similar magnitude as that associated with COCs. However, for POCs the evidence is less conclusive.

Compared to the risk of getting breast cancer ever in life, the increased risk associated with COCs is low. The cases of breast cancer diagnosed in COC users tend to be less advanced than in those who have not used COCs. The increased risk in COC users may be due to an earlier diagnosis, biological effects of the pill or a combination of both.

Since a biological effect of progestogens on liver cancer cannot be excluded an individual benefit/risk assessment should be made by a doctor in women with liver cancer. When acute or chronic disturbances of liver function occur the woman should be referred to a specialist for examination and advice.

Epidemiological investigations have associated the use of COCs with an increased incidence of venous thromboembolism (VTE, deep venous thrombosis and pulmonary embolism). Although the clinical relevance of this finding for desogestrel used as a contraceptive in the absence of an oestrogenic component is unknown, Lovima should be discontinued in the event of a thrombosis.

Discontinuation of Lovima should also be considered in case of long- term immobilisation due to surgery or illness. Women with a history of thrombo-embolic disorders should be made aware of the possibility of a recurrence on Lovima and should be alerted to seek urgent medical attention if they develop symptoms suggestive of VTE.

Lovima should be stopped if VTE is confirmed or is strongly suspected pending the results of investigations. Although progestogens may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics using progestogen-only pills.

However, diabetic patients should consult their doctor before starting treatment and should be carefully observed during the first months of use. If a sustained hypertension occurs during the use of Lovima, or if a significant increase in blood pressure does not adequately respond to antihypertensive therapy, the discontinuation of Lovima should be considered.

Treatment with desogestrel leads to decreased estradiol serum levels, to a level corresponding with the early follicular phase. It is as yet unknown whether the decrease has any clinically relevant effect on bone mineral density. The protection with traditional progestogen-only pills against ectopic pregnancies is not as good as with combined oral contraceptives, which has been associated with the frequent occurrence of ovulations during the use of progestogen-only pills.

Despite the fact that desogestrel consistently inhibits ovulation, ectopic pregnancy should be taken into account in the differential diagnosis if the woman presents with abdominal pain with or without amenorrhoea and with or without vaginal bleeding.

Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking Lovima. The following conditions have been reported both during pregnancy and during sex steroid use, but an association with the use of progestogens has not been established: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestations; otosclerosis-related hearing loss; (hereditary) angioedema.

8). Depression can be […]

• Active venous thromboembolic disorder. • Presence or history of severe hepatic disease as long as liver function values have not returned to normal. • Known or suspected sex-steroid sensitive malignancies. • Undiagnosed vaginal bleeding.

1. • Known allergy to peanut or soya.