Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Lovima 75 microgram film-coated tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Desogestrel may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Lovima is a daily hormonal contraceptive used to prevent pregnancy in women and adolescents of child bearing age. There are 2 main kinds of hormonal contraceptive: •
The combined pill (COC), which contains 2 types of female sex hormone – an oestrogen and a progestogen
•
The progestogen-only pill, POP or mini-pill, which doesn't contain an oestrogen.
Lovima is a progestogen-only pill (POP) or a mini-pill. It contains a small amount of one type of female sex hormone, the progestogen desogestrel. •
Most POPs or mini-pills work primarily by preventing the sperm cells from entering the womb but do not always prevent the egg cell from ripening, which is the main way that combined pills work
•
Desogestrel is different from other mini-pills in that it works primarily by inhibition of ovulation (preventing the egg cell from ripening)
•
In contrast to the combined pill, Lovima can be used by women who do not tolerate oestrogens and by women who are breastfeeding
•
A disadvantage is that vaginal bleeding may occur at irregular intervals during the use of Lovima. On the other hand, you may not have any bleeding at all. For further information see section 4 'Vaginal bleeding'.
What you need to know before you take it
e Lovima Lovima, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
X Do not take Lovima if you •
are pregnant or think you may be pregnant. If you are unsure talk to your pharmacist
•
have a thrombosis. Thrombosis is the formation of a blood clot, which may block a blood vessel. A thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called "pulmonary embolism". Signs of a thrombosis include severe pain or swelling in either of your legs, unexplained pains in the chest, breathlessness, an unusual cough, especially if you cough up blood
•
have or have had jaundice (yellowing of the skin) or severe liver disease and you have been told that your liver is still not working normally
•
have or if you are suspected of having cancer that grows under the influence of sexsteroids, such as certain types of breast, uterine or ovarian cancer
•
have any unexplained vaginal bleeding
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•
are allergic to desogestrel, peanut, soya or any of the other ingredients of this medicine (listed in section 6).
If any of these conditions apply to you, you should consult your doctor before taking Lovima.
! Warnings and precautions Talk to your pharmacist, doctor or family planning nurse before using Lovima if you: •
have ever had breast cancer
•
have liver cancer or other liver problems
•
have ever had a thrombosis
•
have diabetes
•
suffer from epilepsy (see section 2 'Other medicines and Lovima')
•
suffer from tuberculosis (see section 2 'Other medicines and Lovima')
•
have high blood pressure
•
have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation.
These are important conditions that your doctor may need to monitor carefully. Breast cancer It is important to regularly check your breasts, and you should contact your doctor as soon as possible if you feel any lump in your breasts. Breast cancer has been found slightly more often in women who take the combined oestrogen/progestogen pill (COC) than in women of the same age who do not take the COC pill. If women stop taking the COC pill, this reduces the risk, so that 10 years after stopping the COC pill, the risk is the same as for women who have never taken the COC pill. Breast cancer is rare under 40 years of age, but the risk increases as the woman gets older. Therefore, the extra number of breast cancers diagnosed is higher if a woman continues to take the COC pill when she is older. How long she takes the COC pill is less important. In every 10,000 women who take the COC pill for up to 5 years but stop taking it by: •
the age of 20, there would be fewer than 1 extra case of breast cancer found up to 10 years after stopping, in addition to the 4 cases normally diagnosed in this age group
•
the age of 30, there would be 5 extra cases in addition to the 44 cases normally diagnosed
•
the age of 40, there would be 20 extra cases in addition to the 160 cases normally diagnosed.
The risk of breast cancer in users of progestogen-only pills like Lovima is believed to be similar to that in women who use the COC pill, but the evidence is less conclusive. Breast cancers found in women who take the COC pill seem less likely to have spread than breast cancers found in women who do not take the COC pill. It is not certain whether the COC pill causes the increased risk of breast cancer. It may be that the women were examined more often, so that the breast cancer is noticed earlier.
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Thrombosis See your doctor immediately if you notice possible signs of a thrombosis (see also 'Regular check ups'). Signs of a thrombosis include e.g. severe pain or swelling in either of your legs, unexplained pains in the chest, breathlessness, an unusual cough, especially if you cough up blood. Thrombosis is the formation of a blood clot, which may block a blood vessel. A thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called "pulmonary embolism". A pulmonary embolism can cause chest pain, breathlessness, collapse or even death. Deep venous thrombosis is a rare occurrence. It can develop whether or not you are taking the Pill. It can also happen if you become pregnant. The risk is higher in users of the combined oestrogen/progesterone pill (COC) than in nonusers. However, the risk with progestogen-only pills, like Lovima has not been established. Ectopic pregnancy Although desogestrel consistently inhibits ovulation and is an effective contraceptive, pregnancies and in some cases ectopic pregnancies (pregnancies where the fertilised egg attaches itself outside the womb) have been reported. Contact your doctor immediately if you have a sudden or severe pain in the lower abdomen or stomach area with or without vaginal bleeding, even if you don't think you are pregnant. Psychiatric disorders Some women using hormonal contraceptives including desogestrel have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for further medical advice as soon as possible. High blood pressure If you develop high blood pressure while taking Lovima seek medical advice as soon as possible. You may need to stop taking Lovima. Diabetes The active ingredient (desogestrel) in Lovima may have an effect on the control of diabetes. If you are diabetic consult your doctor before starting treatment with Lovima. Bone strength Treatment with desogestrel leads to decreased oestrogen levels in the blood to levels similar to those which occur naturally during the menstrual cycle. There is no evidence to show that this reduction has any effect on bone strength. Children and adolescents No clinical data on efficacy and safety are available in adolescents below 18 years.
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Other medicines and Lovima Tell your pharmacist, doctor or family planning nurse if you are taking, have recently taken or might take any other medicines or herbal products. Also tell any other doctor or dentist who prescribes another medicine (or your pharmacist) that you take Lovima. Some medicines can make Lovima less effective at preventing pregnancy. If you are using one of these medicines or herbal products for short-term treatment, you can continue using Lovima, but you must also use additional contraception (for example, condoms) every time you have sex during treatment and for 28 days after stopping the last dose of the other medicine or herbal product. If you are using any of these medicines or herbal products either chronically or for long-term treatment you should consult your doctor for advice, as an alternative method of contraception may be more appropriate for you. Medicines classed as enzyme-inducers which can make Lovima less effective include those used for the treatment of: •
epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate, and phenobarbital)
•
tuberculosis (e.g. rifampicin and rifabutin)
•
depressive moods (the herbal remedy St John's wort).
Medicinal charcoal used to treat drug poisoning or overdose may reduce the absorption of Lovima and can make it less effective at preventing pregnancy. Some other medicines may also reduce the efficacy of Lovima or have variable effects such as medicines for the treatment of HIV infections (e.g. ritonavir, nelfinavir and nevirapine), or Hepatitis C virus infections (e.g. boceprevir and telaprevir). Medicines classed as enzyme-inhibitors which can increase hormone levels with Lovima include those used for the treatment of: •
certain bacterial infections (e.g. clarithromycin, erythromycin)
•
fungal infections (e.g. ketoconazole, itraconazole, fluconazole and griseofulvin)
•
high blood pressure (hypertension), angina or certain heart rhythm disorders (e.g. diltiazem).
Lovima may also interfere with how certain medicines work, causing either an increase in effect (e.g. medicines containing cyclosporine used to prevent organ rejection following transplant) or a decrease in effect. Tell your pharmacist about all medicines you are taking so that the pharmacist can advise you what to do. Taking emergency contraception containing ulipristal acetate Using Lovima and emergency contraception containing ulipristal acetate together can alter the effect of both these medicines, resulting in reduced contraceptive effect and increased risk of pregnancy. If you have used emergency contraception containing ulipristal acetate during your cycle, you must wait 5 days after taking ulipristal acetate before taking Lovima. You must also use additional contraception (for example, condoms) every time you have sex during the 5 days while you wait to start or resume taking Lovima and for the first 7 days of taking Lovima (ie. for a total of 12 days).
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Pregnancy and breastfeeding
X Pregnancy Do not use Lovima if you are pregnant or think you may be pregnant. Take a pregnancy test or talk to your pharmacist, doctor or family planning nurse if your period is late after missing any tablets in the last month, or if you think you may be pregnant. Stop taking Lovima and see your doctor if you become pregnant. Breastfeeding Lovima may be used while you are breastfeeding. Desogestrel (the active substance in Lovima) does not appear to influence the production or the quality of breast milk. However, there have been infrequent reports of a decrease in breast milk production while using desogestrel. A small amount of desogestrel passes over into the milk. If you are breastfeeding, let your pharmacist know. The health of children breast-fed for 7 months while their mothers were using desogestrel has been studied up until they were 2.5 years of age. No effects on the growth and development of the children were observed. Driving and using machines This medicine has no known effect on the ability to drive or use machines. Lovima contains soybean oil and lactose. If you are allergic to peanut or soya, do not use this medicinal product. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Regular check ups When you are using Lovima, your pharmacist will check that it is still suitable for you every time you need a new supply. How often you need these checks and what the pharmacist needs to know will depend on your personal medical details.
! Contact your doctor immediately if you: •
notice possible signs of a blood clot (e.g. severe pain or swelling in either of your legs, unexplained pains in the chest, breathlessness, an unusual cough, especially if you cough up blood)
•
have a sudden, severe stomach ache or jaundice (you may notice yellowing of the skin or the whites of the eyes, or dark urine, possibly a sign of liver problems)
•
have a sudden or severe pain in the lower abdomen or stomach area (possibly a sign of a pregnancy outside the womb).
! Contact your doctor as soon as possible if you: •
feel a lump in your breast (possibly a sign of breast cancer)
•
are unable to get out of bed or a chair for more than a few days, for example, due to surgery or illness as this may increase the risk of a blood clot while using Lovima
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•
have unusual, heavy vaginal bleeding
•
suspect that you are pregnant.
How to take it
Lovima When and how to take the tablets Always use this medicine exactly as described in this leaflet or as your pharmacist has told you. Check with your pharmacist if you are not sure. Each blister strip of Lovima contains 28 tablets – 4 weeks supply. One tablet should be taken each day at the same time without a break between packs. The days of the week are printed on both sides of the blister strip. Arrows are also printed on the blister strip indicating the order in which to take the pills. Each day corresponds to one tablet. Every time you start a new pack of Lovima, take a tablet from the top row. Don't start with just any tablet. For example, if you start on a Wednesday, you must take the tablet from the top row marked with 'WED' (Wednesday). How you first start taking Lovima will depend on whether you have previously used other contraception or if you have recently been pregnant. You may also need to use additional contraception for the first 7 days. Read the following information carefully to see which applies to you. If you are not sure what to do, talk to your pharmacist. If you are starting or resuming Lovima following emergency contraception Ask your pharmacist for advice on how to start taking or resume taking Lovima following emergency contraception. If you have taken emergency contraception, it is advisable to wait until day 1 of your next menstrual cycle before taking Lovima. •
Emergency contraception containing levonorgestrel can be used with Lovima. If you have used emergency contraception containing levonorgestrel during your cycle, you can start or continue taking Lovima the same day. You need to use additional barrier contraception (condom) every time you have sex for the next 7 days
•
Using Lovima and emergency contraception containing ulipristal acetate together can alter the effect of both medicines, resulting in reduced contraceptive effect and increased risk of pregnancy. If you have used emergency contraception containing ulipristal acetate during your cycle, you must wait 5 days after taking ulipristal acetate before taking Lovima. You need to use additional barrier contraception (condom) for 5 days after taking ulipristal acetate while you wait to start or resume taking Lovima and then for the first 7 days after starting Lovima. (i.e. for a total of 12 days).
If you are not using hormonal contraception at present or have not used it in the past month •
Wait for your period to begin and start taking Lovima on the first day of your period. You do not need additional contraception
•
You can also start on day 2-5 of your period. You need to use additional barrier contraception (condom) for 7 days.
If you are changing from a combined pill (COC)
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•
Start taking Lovima on the day after the last active tablet from your present Pill pack. Some COC packs have inactive pills so if you are not sure what is the last active tablet, check with the pharmacist. You do not need additional contraception
•
If there is a break between when you took your last COC pill and when you start taking Lovima (i.e. you do not start taking Lovima the day immediately after taking the last active tablet). You need to use additional barrier contraception (condom) for 7 days.
If you are changing from a vaginal ring or transdermal patch •
Start taking Lovima on the day your vaginal ring or patch is removed. You do not need additional contraception
•
If there is a break between removal of your ring or patch before you start taking Lovima (i.e. you do not take it on the same day). You need to use additional (barrier) contraception (condom) for 7 days.
If you are changing from another progestogen-only pill (mini-pill) including another desogestrel mini-pill which your doctor may have prescribed for you •
Start taking Lovima without a break. You do not need additional contraception.
If you are changing from an injection or implant or hormonal IUS •
Start taking Lovima when your next injection is due or on the day your implant or IUS is removed. You do not need additional contraception.
If you have recently given birth and your period has not started again •
You can start Lovima before your period starts
•
If you start taking Lovima more than 21 days after giving birth, you need to use additional contraception (condom) for 7 days. If you have had sex check that you are not pregnant before taking Lovima
•
If your period has started again, refer to section "If you are not using hormonal contraception at present or have not used it in the past month".
Information on breastfeeding can be found in section 2. If you have recently had a miscarriage or abortion •
Start taking Lovima immediately or within 5 days after a miscarriage or abortion. You do not need additional contraception.
Continuing to use Lovima Once you have started taking Lovima continue to take one tablet every day at about the same time until the pack is empty. Always follow the direction indicated by the arrows on the pack. Swallow the tablet whole, with water. When one blister strip is empty, you must start with a new strip of Lovima on the next day – that is without interruption and without waiting for a bleed.
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You may have some vaginal bleeding during the use of Lovima, but you must continue to take your tablets as normal.
! If you forget to take Lovima If you are less than 12 hours late: •
Take the missed tablet as soon as you remember and take the next tablet at the usual time. Lovima will still protect you from pregnancy.
If you are more than 12 hours late: •
If you are more than 12 hours late in taking any tablet, you may not be completely protected against pregnancy. The more consecutive tablets you have missed, the higher the risk that you might fall pregnant
•
Take a tablet as soon as you remember and take the next one at the usual time. This may mean taking two in one day. This is not harmful. If you have forgotten more than one tablet, you don't need to take the earlier missed ones. Continue to take your tablets as usual but you must also use additional barrier contraception (condom) for the next 7 days
•
If you are more than 12 hours late taking your tablet and have sex consult your pharmacist for advice
•
Missing tablets at any time in the cycle can reduce the efficacy of Lovima and risk pregnancy but if you have missed one or more tablets in the first week of taking Lovima and had sex in the week before missing the tablets, the risk that you may get pregnant is higher. Ask your pharmacist for advice and if you need to use emergency contraception.
If you vomit or have severe diarrhoea If you vomit within 3 – 4 hours of taking Lovima, then the tablet should be considered 'missed' and the advice under 'If you forget to take Lovima' should be followed. If you have severe or persistent vomiting or diarrhoea, Lovima may not have been completely absorbed and the contraceptive effect may be reduced. You should use an additional method of contraception (for example, condoms) for the duration of your illness and for the first 7 days of normal tablet-taking. If you are not sure what to do talk to your pharmacist. If you take more Lovima than you should There have been no reports of serious harmful effects from taking too many Lovima tablets at one time. Symptoms that may occur are nausea, vomiting and in young girls, slight vaginal bleeding. For more information, ask your pharmacist for advice. If you stop taking Lovima You can stop taking Lovima whenever you want. From the day you stop, you are no longer protected against pregnancy. If you have any further questions on the use of this medicine, ask your pharmacist, doctor or family planning nurse.
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Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor or pharmacist if you notice any unwanted effect, especially if severe or persistent. Serious side effects associated with the use of Lovima are described in section 2 "What you need to know before you take Lovima". Please read this section for additional information on "Thrombosis" and "Ectopic pregnancy" and consult your doctor immediately where appropriate. You should seek medical advice immediately if you experience symptoms of angioedema (rapid swelling of area under skin or mucous membranes usually caused by an allergic reaction). Symptoms of angioedema include swollen face, tongue or throat, difficulty in swallowing, or hives and difficulty in breathing. Vaginal bleeding may occur at irregular intervals while using this medicine. This may be just slight staining which may not even require a pad, or heavier bleeding, which looks rather like a scanty period. You may need to use tampons or sanitary towels. You may also not have any bleeding at all. After a few months of treatment bleeding tends to become less frequent or stop altogether. Irregular bleeding is not a sign that Lovima is not working. In general, you do not need to take any action; just continue to take Lovima. If bleeding is frequent, heavy or prolonged, or if you are worried by any changes in bleeding, you should talk to your doctor.
How often are other possible side effects seen? Common (may affect up to 1 in 10 women): mood changes, depressed mood (see section 2 Psychiatric disorders), decreased sexual drive (libido), headache, nausea, acne, breast pain, irregular or no periods, weight increase. Uncommon (may affect up to 1 in 100 women): infection of the vagina, difficulties in wearing contact lenses, vomiting, hair loss, painful periods, ovarian cyst, tiredness. Rare (may affect up to 1 in 1,000 women): skin conditions such as rash, hives, erythema nodosum (painful rounded blue-red skin lumps usually on the shin and ankles, or sometimes thighs or forearms). Breast secretion or leakage may occur. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or family planning nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects, you can help provide more information on the safety of this medicine.
How to store it
Lovima Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after "EXP:". The expiry date refers to the last day of that month. Store below 30°C and store in the original package.
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Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Lovima contains The active substance is desogestrel (75 microgram). The other ingredients are: lactose monohydrate, maize starch, povidone (E1201), d-α-tocopherol ((E307), containing soybean oil), colloidal hydrated silica (E551), colloidal anhydrous silica (E551), stearic acid (E570), hypromellose (E464), polyethylene glycol, titanium dioxide (E171) (see also "Lovima contains soybean oil and lactose" in section 2). What Lovima looks like and contents of the pack Each blister strip of Lovima contains 28 white round film-coated tablets. Each carton contains 1, 3 or 6 blister strips. Not all pack sizes may be marketed. Marketing Authorisation Holder: Maxwellia Ltd, Alderley Park, Alderley Edge, England, SK10 4TG, UK. Manufacturer: Laboratorios León Farma, S.A., Pol. Ind. Navatejera, C/ La Vallina s/n, 24193 – Villaquilambre, León, Spain This leaflet was last revised in September 2025. Contraceptive choices Other contraceptive options are available from GPs, pharmacies, family planning services and other healthcare providers. These include long acting reversible contraceptives (e.g. intrauterine device (IUD) or implant), other oral hormonal contraceptives (e.g. COC); topical hormonal contraceptives (e.g. transdermal patch); barrier-type contraceptives (e.g. condoms). Remember to attend your cervical screening test and regularly check your breasts. For more information on these checks, sexual health and other contraception options available to you, please visit the NHS website.
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Frequently asked questions about Lovima 75 microgram film-coated tablets
How do I take Lovima 75 microgram film-coated tablets?
Lovima 75 microgram film-coated tablets comes as tablet containing 75mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Lovima 75 microgram film-coated tablets?
The active substance in Lovima 75 microgram film-coated tablets is desogestrel.
Are there equivalent medicines to Lovima 75 microgram film-coated tablets?
Medicines with the same active substance, strength and form include: Cerazette 75 microgram film-coated tablet, Cerelle 75 microgram film-coated tablets, Feanolla 75 microgram film-coated tablets. In total there are 5 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Lovima 75 microgram film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Lovima 75 microgram film-coated tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: desogestrel
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Oral contraception for women of child bearing age including adolescents.
4.2. Posology and method of administration
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.
For additional information for breastfeeding women see section 4.6.
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. (See section 4.5) Additional contraceptive measures (abstinence or barrier methods) are required during the 5 day delay before starting or restarting Lovima and for an additional 7 days after starting or restarting Lovima (12 days in total.)
Ulipristal acetate may conversely reduce the effectiveness of Lovima. Concomitant use is therefore not recommended. (see section 4.5)
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. Pregnancy should be excluded using the criteria given in section 4.4 and bleeding disturbances, such as oligomenorrhoea and amenorrhoea should be investigated by a physician before pharmacy supply can be considered. The interval between assessments to determine suitability for re-supply in pharmacy depends on the circumstances in each individual case but should not exceed 3 months for a first supply of Lovima and 12 months thereafter (see section 4.4). If the product may conceivably influence latent or manifest disease (see section 4.4), re-evaluation of supply should be timed accordingly.
The need for physical examination or further assessment by a doctor should be guided by the patient and family history and by the contraindications (section 4.3) and warnings (section 4.4) for this product. Gynaecological examination is rarely required prior to commencement or oral contraception, but may be indicated in cases of menstrual bleeding disturbances or other gynaecological symptoms e.g. pain or discharge. Breast examination is indicated for breast symptoms e.g. undiagnosed breast lumps.
All women should be encouraged to be 'breast aware' and report any changes noticed. All women should be advised of the importance of taking part in routine cervical screening.
Despite the fact that Lovima is taken regularly, bleeding disturbances may occur. If bleeding is troublesome (for example if it becomes very frequent and irregular) another contraceptive method should be considered. If the symptoms persist, an organic cause should be ruled out.
Management of amenorrhoea during treatment depends on whether or not the tablets have been taken in accordance with the instructions and may include a pregnancy test.
The treatment should be stopped if a pregnancy occurs.
Women should be advised that Lovima does not protect against HIV (AIDS) and other sexually transmitted diseases. Condoms are the only contraceptive method which protect against sexually transmitted diseases.
Special populations
Renal impairment
No clinical studies have been performed in patients with renal impairment. There is no evidence that dose adjustment is required.
Hepatic impairment
No clinical studies have been performed in patients with hepatic insufficiency. Since the metabolism of steroid hormones might be impaired in patients with severe hepatic disease, the use of Lovima in these women is not indicated. (see section 4.3).
Paediatric population
The safety and efficacy of Lovima in adolescents below 18 years has not been established. No data are available. The benefits and risks of supply to adolescents under 16 years should be carefully considered.
Method of administration
Oral use.
4.3. Contraindications
• 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.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Known allergy to peanut or soya.
4.4. Special warnings and precautions for use
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.
Age group
Expected cases COC-users
Expected cases non-users
16-19 years
4.5
4
20-24 years
17.5
16
25-29 years
48.7
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.
Depressed mood and depression are well known undesirable effects of hormonal contraceptive use (see section 4.8). Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide. Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment.
The efficacy of Lovima may be reduced in the event of missed tablets (Section 4.2), gastro-intestinal disturbances (Section 4.2), or concomitant medications that decrease the plasma concentration of etonogestrel, the active metabolite of desogestrel (Section 4.5).
Each tablet of this medicinal product contains 55.07 mg of lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
Interactions
Effect of other medicinal products on Lovima
Interactions between hormonal contraceptives and other medicinal products may lead to breakthrough bleeding and/or contraceptive failure. The following interactions have been reported in the literature (mainly with combined contraceptives but occasionally also with progestogen-only contraceptives).
During treatment with medical charcoal, the absorption of the steroid in the tablet may be reduced and thereby the contraceptive efficacy may also be reduced. Under these circumstances, the advice as given for missed pills in section 4.2 is applicable.
Substances increasing the clearance of contraceptive hormones (diminished contraceptive efficacy by enzyme induction):
Hepatic metabolism: Interactions can occur with medicinal products that induce microsomal enzymes, which can result in increased clearance of sex hormones. Such products include: hydantoins, (e.g. phenytoin), barbiturates (e.g. phenobarbital), primidone, carbamazepine, rifampicin, and possibly also for oxcarbazepine, topiramate, rifabutin, felbamate, griseofulvin and products containing St. John's wort (Hypericum perforatum).
Maximal enzyme induction is not seen for 2-3 weeks, but may then be sustained for at least 4 weeks after cessation of drug therapy.
Women on treatment with any of these medicinal products should temporarily use a barrier method in addition to desogestrel.
With microsomal enzyme-inducing drugs, the barrier method should be used during the time of concomitant drug administration and for 28 days after their discontinuation. Women on long-term or chronic treatment with hepatic enzyme inducers should be referred to their doctor and a non-hormonal method of contraception should be considered.
Substances with variable effects on the clearance of contraceptive hormones:
When co-administered with hormonal contraceptives, many combinations of HIV protease inhibitors (e.g. ritonavir, nelfinavir) and non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine) and/or combinations with Hepatitis C virus (HCV) medicinal products (e.g. boceprevir, telaprevir), can increase or decrease plasma concentrations of progestins. The net effect of these changes may be clinically relevant in some cases.
Therefore, the prescribing information of concomitant HIV/HCV medications should be consulted to identify potential interactions and any related recommendations. In case of any doubt, an additional barrier contraceptive method should be used by women on protease inhibitor or non-nucleoside reverse transcriptase inhibitor therapy.
Substances decreasing the clearance of contraceptive hormones (enzyme inhibitors )
Concomitant administration of strong (e.g. ketoconazole, itraconazole, clarithromycin) or moderate (e.g. fluconazole, diltiazem, erythromycin) CYP3A4 inhibitors may increase the serum concentrations of progestins, including etonogestrel, the active metabolites of desogestrel.
Effect of Lovima on other medicinal products
Hormonal contraceptives may interfere with the metabolism of other drugs. Accordingly, plasma and tissue concentrations may either increase (e.g. cyclosporin) or decrease.
Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.
Laboratory tests
Data obtained with COCs have shown that contraceptive steroids may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, serum levels of (carrier) proteins, e.g. corticosteroid binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. The changes generally remain within the normal range. To what extent this also applies to progestogen-only contraceptives is not known.
Emergency contraception containing ulipristal acetate
Lovima and the emergency contraceptive ulipristal acetate both bind to the progesterone receptor. Concomitant use may result in reduced efficacy of both Lovima and ulipristal, and is therefore not recommended. Lovima should be started or restarted no sooner than 5 days (120 hours) after emergency contraception with ulipristal acetate (see section 4.2).
4.6. Fertility, pregnancy and lactation
Pregnancy
Lovima is not indicated during pregnancy. If pregnancy occurs during use of Lovima, further intake should be stopped.
Animal studies have shown that very high doses of progestogenic substances may cause masculinisation of female foetuses.
Extensive epidemiological studies have revealed neither an increased risk of birth defects in children born to women who used COCs prior to pregnancy, nor a teratogenic effect when COCs were taken inadvertently during early pregnancy. Pharmacovigilance data collected with various desogestrel-containing COCs also do not indicate an increased risk.
Breastfeeding
Based on clinical study data, desogestrel does not appear to influence the production or the quality (protein, lactose, or fat concentrations) of breast milk. However, there have been infrequent postmarketing reports of a decrease in breast milk production while using desogestrel. Small amounts of etonogestrel are excreted in the breast milk. As a result, 0.01 - 0.05 microgram etonogestrel per kg body weight per day may be ingested by the child (based on an estimated milk ingestion of 150 ml/kg/day). Like other progestogen-only pills, Lovima can be used during breast feeding.
Limited long-term follow-up data are available on children, whose mothers started using desogestrel during the 4th to 8th weeks post-partum. They were breast-fed for 7 months and followed up to 1.5 years (n=32) or to 2.5 years (n=14) of age. Evaluation of growth and physical and psychomotor development did not indicate any differences in comparison to nursing infants, whose mother used a copper-IUD.
Based on the available data Lovima may be used during lactation. The development and growth of a nursing infant, whose mother uses Lovima should, however, be carefully observed.
Fertility
Lovima is indicated for the prevention of pregnancy. For information on return to fertility (ovulation), see section 5.1.
4.7. Effects on ability to drive and use machines
Desogestrel has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
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.
The most commonly reported other undesirable effects in the clinical trials with desogestrel (> 2.5%) were acne, mood changes, breast pain, nausea and weight increase. The undesirable effects are mentioned in the table below.
All undesirable effects are listed by system organ class and frequency; common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10.000 to <1/1,000).
System Organ Class
(MedDRA)*
Frequency of adverse reactions
Common
Uncommon
Rare
Infections and infestations
Vaginal infection
Psychiatric disorders
Mood altered, Depressed mood, Libido decreased
Nervous system disorders
Headache
Eye disorders
Contact lens intolerance
Gastrointestinal disorders
Nausea
Vomiting
Skin and subcutaneous tissue disorders
Acne
Alopecia
Rash, Urticaria, Erythema nodosum
Reproductive system and breast disorders
Breast pain, Menstruation irregular, Amenorrhoea
Dysmenorrhoea, Ovarian cyst
General disorders and administration site condition
Fatigue
Investigations
Weight increased
* MedDRA version 9.0
Breast discharge may occur during use of Lovima. On rare occasions, ectopic pregnancies have been reported (see section 4.4). In addition, (aggravation of) angioedema and/or aggravation of hereditary angioedema may occur (see section 4.4).
In women using (combined) oral contraceptives a number of (serious) undesirable effects have been reported. These include venous thromboembolic disorders, arterial thromboembolic disorders, hormone-dependent tumours (e.g. liver tumours, breast cancer), and chloasma, some of which are discussed in more detail in section 4.4.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
There have been no reports of serious adverse effects from overdose. Symptoms that may occur in this case are nausea, vomiting and, in young girls, slight vaginal bleeding. There are no antidotes and the treatment should be symptomatic.
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