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Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Desogestrel 75 micrograms 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.

Active substance: Desogestrel

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

How to take it

Desogestrel 75 micrograms Tablets 4. Possible side effects 5. How to store Desogestrel 75 micrograms Tablets 6. Contents of the pack and other information 1. What Desogestrel 75 micrograms Tablets are and what they are used for Desogestrel 75 micrograms Tablets are used to prevent pregnancy. Desogestrel 75 micrograms Tablets contains a small amount of one type of female sex hormone, the progestogen desogestrel. For this reason Desogestrel 75 micrograms Tablets are called a progestogen-only-pill (POP), or a mini-pill. Contrary to the combined pill, the POP or mini-pill does not contain an oestrogen hormone next to the progestogen.

Desogestrel 75 micrograms Tablets

  • you  have ever had a thrombosis.
  • you have diabetes.
  • you  suffer from epilepsy (See section 'Taking other medicines').
  • you  suffer from tuberculosis (See section 'Taking other medicines').
  • you  have high blood pressure.
  • you  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. When Desogestrel 75 micrograms Tablets are used in the presence of any of these conditions, you may need to be kept under close observation. Your doctor can explain what to do. 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. 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 Pill than in women of the same age who do not take the Pill. If women stop taking the Pill, the risk gradually decreases, so that 10 years after stopping the Pill, the risk is the same as for women who have never taken the 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 the age until which the woman continues to take the Pill is higher. How long she takes the Pill is less important.

Most POPs or minipills work primarily by preventing the sperm cells from entering the womb but they do not always prevent the egg cell from ripening, which is the main way that combined pills. Desogestrel 75 micrograms Tablets is distinct from other mini-pills in having a dose that in most cases is high enough to prevent the egg cell from ripening. As a result, Desogestrel 75 micrograms Tablets provide high contraceptive efficacy.

In every 10 000 women who take the Pill for up to 5 years but stop taking it by the age of 20, there would be less 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. In 10 000 women who take the Pill for up to 5 years but stop taking it by the age of 30, there would be 5 extra cases in addition to the 44 cases normally diagnosed. In 10 000 women who take the Pill for up to 5 years but stop taking it by the age of 40, there would be 20 extra cases in addition to the 160 cases normally diagnosed.

In contrast to the combined pill, Desogestrel 75 micrograms Tablets can be used by women who do not tolerate oestrogens and by women who are breast feeding. A disadvantage is that vaginal bleeding may occur at irregular intervals during the use of Desogestrel 75 micrograms Tablets. You also may not have any bleeding at all.

The risk of breast cancer in users of progestogen-only pills like Desogestrel 75 micrograms Tablets is believed to be similar to that in women who use the Pill, but the evidence is less conclusive.

You must talk to your doctor if you do not feel better or if you feel worse after taking the pill. 2. What you need to know before you take Desogestrel 75 micrograms Tablets Desogestrel 75 micrograms Tablets, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease. Do not take Desogestrel 75 micrograms Tablets

  • if  you are allergic to any of the ingredients of Desogestrel 75 micrograms Tablets.
  • if  you have a thrombosis. Thrombosis is the formation of a blood clot in a blood vessel e.g. of the legs (deep venous thrombosis) or the lungs (pulmonary embolism).
  • if  you have or have had jaundice (yellowing of the skin) or severe liver disease and your liver is still not working normally.
  • if  you have or if you are suspected of to have a cancer that is sensitive to sex-steroids, such as certain types of breast cancer.
  • if  you have any unexplained vaginal bleeding. Tell your doctor before you start to use Desogestrel 75 micrograms Tablets if any of these conditions apply to you. Consult your doctor immediately if any of these conditions appear for the first time while using Desogestrel 75 micrograms Tablets. Children and adolescents No clinical data on efficacy and safety are available in adolescents below 18 years. Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Desogestrel 75 micrograms Tablets.
  • you  have ever had breast cancer.
  • you  have liver cancer, since a possible effect of Desogestrel 75 micrograms Tablets cannot be excluded.

Breast cancers found in women who take the Pill, seem less likely to have spread than breast cancers found in women who do not take the Pill. It is not known whether the difference in breast cancer risk is caused by the pill. It may be that the women were examined more often, so that the breast cancer is noticed earlier. Thrombosis See your doctor immediately if you notice possible signs of a thrombosis (see also 'Regular check-ups'). 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". As a result, fatal situations may occur. 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 Pill-users than in non-users. The risk with progestogen-only pills like Desogestrel 75 micrograms Tablets is believed to be lower than in users of Pills that also contain oestrogens (combined Pills). Other medicines and Desogestrel 75 micrograms Tablets Tell your doctor or pharmacist, 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 Desogestrel 75 micrograms Tablets. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long or whether the use of another medicine you need must be changed. Some medicines:

  • Can  have an influence on the blood levels of Desogestrel 75 micrograms tablets.
  • Can make it less effective in preventing pregnancy.
  • Can cause unexpected bleeding. These include medicines used for the treatment of:
  • epilepsy  (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate and phenobarbital)
  • tuberculosis  (e.g. rifampicin, rifabutin)
  • HIV  infections (e.g. ritonavir, nelfinavir, nevirapine, efavirenz)
  • Hepatitis  C virus infections (e.g. boceprevir, telaprevir)
  • or  other infectious diseases (e.g. griseofulvin)
  • high  blood pressure in the blood vessels of the lungs (bosentan)
  • certain  bacterial infections (e.g. clarithromycin, erythromycin)
  • fungal  infections (e.g. ketoconazole, itraconazole, fluconazole)
  • stomach  upset (medical charcoal)
  • depressive  moods (the herbal remedy St. John's Wort)
  • High  blood pressure (hypertension), angina or certain heart rhythm disorders (e.g. diltiazem). If you are taking medicines or herbal products that might make Desogestrel 75 micrograms Tablets less effective, a barrier contraceptive method should also be used. Since the effect of another medicine on Desogestrel 75 micrograms Tablets may last up to 28 days after stopping the medicine, it is necessary to use the additional barrier contraceptive method for that long. Your doctor can tell you if you need to take additional contraceptive precautions and if so, for how long. Desogestrel 75 micrograms Tablets may also interfere with how certain medicines work, causing either an increase in effect (e.g. medicines containing ciclosporine) or a decrease in effect. Pregnancy, breast-feeding and fertility Pregnancy Do not use Desogestrel 75 micrograms Tablets if you are pregnant, or think you may be pregnant. Breast-feeding Desogestrel 75 micrograms Tablets may be used while you are breast-feeding. Desogestrel 75 micrograms Tablets 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 75 micrograms Tablets. A small amount of the active substance of Desogestrel 75 micrograms Tablets passes over into the milk. The health of children who were breast-fed for 7 months while their mothers were using another desogestrel-only pill has been studied up to 2.5 years of age. No effects on the growth and development of the children were observed. If you are breast feeding and want to use Desogestrel 75 micrograms Tablets, please contact your doctor. Driving and Using Machines There are no indications of any effect of the use of Desogestrel 75 micrograms Tablets on alertness and concentration. Desogestrel 75 micrograms Tablets contain lactose Desogestrel 75 micrograms Tablets contains lactose (milk sugar). Please contact your doctor before taking Desogestrel 75 micrograms Tablets if you have been told by your doctor that you are intolerant to some sugars. Regular Check-ups When you are using Desogestrel 75 micrograms Tablets, your doctor will tell you to return for regular check-ups. In general, the frequency and nature of these check-ups will depend on your personal situation. Contact your doctor as soon as possible if:
  • you  have severe pain or swelling in either of your legs, unexplained pains in the chest, breathlessness, an unusual cough, especially when you cough up blood (possible signs of a blood clot); possibly indicating a thrombosis
  • you  have a sudden, severe stomach ache or jaundice (possibly indicating liver problems);
  • you  feel a lump in your breast; (possibly indicating breast cancer)
  • you  have a sudden or severe pain in the lower abdomen or stomach area (possibly indicating an ectopic pregnancy, this is a pregnancy outside the womb);
  • you  are to be immobilised or are to have surgery (consult your doctor at least four weeks in advance);
  • you  have unusual, heavy vaginal bleeding
  • you  suspect that you are pregnant.

3. How to take Desogestrel 75 micrograms Tablets When and how to take the tablets? Each strip of Desogestrel 75 micrograms Tablets contains 28 tablets. Arrows are printed on the front of the strip, between the tablets. The days of the week are printed on the back of the strip. Each day corresponds with one tablet. Every time you start a new strip of Desogestrel 75 micrograms Tablets, 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 (on the back) with WED. Continue to take one tablet every day until the pack is empty, always following the direction indicated by the arrows. By looking at the back of your pack you can easily check if you have already taken your tablet on a particular day. Take your tablet each day at about the same time. Swallow the tablet whole, with water. You may have some bleeding during the use of Desogestrel 75 micrograms Tablets, but you must continue to take your tablets as normal. When a strip is empty, you must start with a new strip of Desogestrel 75 micrograms Tablets on the next day – without interruption and without waiting for a bleed. Starting your first pack of Desogestrel 75 micrograms Tablets When no hormonal contraceptive has been used in the past month. Wait for your period to begin. On the first day of your period take the first Desogestrel 75 micrograms Tablets. Additional contraceptive precautions are not necessary. If you take your first tablet on days 2 to 5 of your period use an additional barrier method of contraception for the first 7 days of tablet-taking. When changing from a combined pill, vaginal ring, or transdermal patch. You can start taking Desogestrel 75 micrograms Tablets on the day after you take the last tablet from the present Pill pack, or on the day of removal of your vaginal ring or patch (this means no tablet-, ring- or patch-free break). If your present Pill pack also contains inactive tablets you can start Desogestrel 75 micrograms Tablets on the day after taking the last active tablet (if you are not sure which this is, ask your doctor or pharmacist). If you follow these instructions, you need not take extra contraceptive precautions. You can also start at the latest the day following the tablet-, ring-, patch-free break, or placebo tablet interval, of your present contraceptive. If you follow these instructions, make sure you use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking. When you change from another progestogen-only pill (mini-pill) Switch on any day from another mini pill. Additional contraceptive precautions are not necessary. When you change from an injection, implant or a hormonal Intrauterine device (IUS) Start using Desogestrel 75 micrograms Tablets when your next injection is due or on the day that your implant or your IUS is removed. Additional contraceptive precautions are not necessary. After you have a baby You can start Desogestrel 75 micrograms Tablets between 21 to 28 days after the birth of your baby. If you start later, make sure that during the first cycle you use an additional barrier method of contraception for the first 7 days of tablet-taking. However, if you have already had sex, check that you are not pregnant before starting Desogestrel 75 micrograms Tablets. Information for breast-feeding women can be found in section 2 "Before you take Desogestrel 75 micrograms Tablets" in the paragraph "Pregnancy and breast-feeding". Your doctor can also advise you. After a miscarriage or an abortion Your doctor will advise you. If you forget to take Desogestrel 75 micrograms Tablets

  • If  you are less than 12 hours late: Take the missed tablet as soon as you remember and take the next one at the usual time. Desogestrel 75 micrograms Tablets 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. Continue to take your tablets as usual but you must also use an extra method, such as a condom, for the next 7 days. If you missed one or more tablets in the very first week of tablet-intake and had intercourse in the week before missing the tablets, you may fall pregnant. Ask your doctor for advice.

If you vomit or have diarrhoea Follow the advice for forgotten tablets in the section above. If you vomit within 3-4 hours after taking your Desogestrel 75 micrograms Tablets or have severe diarrhoea, the active ingredient may not have been completely absorbed. If you take more Desogestrel 75 micrograms Tablets than you should There have been no reports of serious harmful effects from taking too many Desogestrel 75 micrograms Tablets at one time. Symptoms that may occur are nausea, vomiting and in young girls, slight vaginal bleeding. For more information ask your doctor for advice. If you stop taking Desogestrel 75 micrograms Tablets You can stop taking Desogestrel 75 micrograms Tablets 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 product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Desogestrel 75 micrograms Tablets can cause side effects, although not everybody gets them. Tell your doctor if you notice any unwanted effect, especially if severe or persistent. Serious side effects associated with the use of Desogestrel 75 micrograms Tablets are described in section 2 "Before you take Desogestrel 75 micrograms Tablets". Please read this section for additional information on 'Breast cancer' and 'Thrombosis', and consult your doctor at once where appropriate. Vaginal bleeding may occur at irregular intervals while using Desogestrel 75 micrograms Tablets. 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. Irregular bleeding is not a sign that Desogestrel 75 micrograms Tablets is not working. In general, you need not take any action; just continue to take Desogestrel 75 micrograms Tablets. If bleeding is heavy or prolonged you should consult your doctor. How often are other possible side effects seen? Common (affecting less than 1 in 10 women): mood changes, depressed mood, decreased sexual drive (libido), headache, nausea, acne, breast pain, irregular or no periods, weight increase.

How to store it

Desogestrel 75 micrograms Tablets Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of that month. Desogestrel 75 micrograms Tablets do not require any special storage conditions. 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.

MPL13996-P2.1 921226-01

Contents of the pack and other information

What Desogestrel 75 micrograms Tablets contains The active substance is desogestrel. Each tablet contains 75 micrograms of desogestrel. The other ingredients are: Lactose anhydrous, all-rac-α-tocopherol, Povidone, Potato starch, Silica colloidal anhydrous, Stearic acid. (See also 'Important information about some of the ingredients of Desogestrel 75 micrograms Tablets' in section 2). What Desogestrel 75 micrograms Tablets look like and contents of the pack Each tablet is round, uncoated, biconvex, debossed with '152' on one side and other side plain. Each box of Desogestrel 75 micrograms Tablets contains 1, 3, 6 or 13 strips of 28 tablets each. Each carton contains blisters packed separately in an aluminium laminated sachet. Packs may be marketed with or without a desiccant. Not all pack sizes may be marketed. Marketing Authorisation Holder Morningside Healthcare Ltd. Unit C, Harcourt Way Leicester, LE19 1WP Manufacturer Morningside Pharmaceuticals Limited 5 Pavilion Way, Loughborough LE11 5GW UK Morningside Pharmaceuticals Limited & Aspire Pharma Limited Second Floor, Boss Court 7 Barton Close, Grove Park Leicester, LE19 1SJ, UK Aspire Pharma Limited Unit 4, Rotherbrook Court Bedford Road, Petersfield GU32 3QG, UK This leaflet was last revised in June 2025.

Uncommon (affecting less than 1 in 100 women) infection of the vagina, difficulties in wearing contact lenses, vomiting, hair loss, painful periods, ovarian cysts, tiredness. Rare (affecting less than 1 in 1000 women) skin conditions such as: rash, hives, painful blue-red skin lumps (erythema nodosum) Not known (cannot be estimated from the available data) allergic reaction Apart from these side effects, breast secretion or leakage may occur. You should see your doctor immediately if you experience symptoms of angioedema, such as (i) swollen face, tongue or pharynx; (ii) difficulty to swallow; or (iii) hives and difficulties to breathe If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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.

Frequently asked questions about Desogestrel 75 micrograms Tablets

How do I take Desogestrel 75 micrograms Tablets?

Desogestrel 75 micrograms 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 Desogestrel 75 micrograms Tablets?

The active substance in Desogestrel 75 micrograms Tablets is desogestrel.

Are there equivalent medicines to Desogestrel 75 micrograms 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 Desogestrel 75 micrograms 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 Desogestrel 75 micrograms 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.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Desogestrel (12 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Oral Contraception

4.2. Posology and method of administration

Posology

“The safety and efficacy of desogestrel in adolescents below 18 years has not yet been established. No data are available.”

Paediatric population

“The safety and efficacy of desogestrel in adolescents below 18 years has not yet been established. No data are available."

Method of Administration

Desogestrel 75 micrograms 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 on possible bleeding. A new blister is started directly the day after the previous one.

How to start Desogestrel 75 micrograms Tablets.

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 first-trimester abortion

After first-trimester abortion it is recommended to start immediately. In that case there is no need to use an additional method of contraception.

Following delivery or second-trimester abortion

Contraceptive treatment with Desogestrel 75 micrograms Tablets after delivery can be initiated before the menstruations have returned. If more than 21 days have elapsed 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 Desogestrel 75 micrograms Tablets when changing from other contraceptive methods

Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch)

The woman should start with Desogestrel 75 micrograms Tablets 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. Not all contraceptive methods may be available in all EU countries.

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 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);

Management of missed tablet

Contraceptive protection may be reduced if more than 36 hours have elapsed between two tablets. If the user is less than 12 hours late in taking any tablet, the missed tablet should be taken as soon as it is remembered and the next tablet should be taken at the usual time. If she is more than 12 hours late, she should use an additional method of contraception for the next 7 days. If tablets were missed in the first week and intercourse took place in the week before the tablets were missed, the possibility of a pregnancy should be considered.

Advice in case of gastrointestinal 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, absorption may not complete. The same advice is applicable as for a missed tablet.

Treatment surveillance

Before prescription, a thorough case history should be taken and a thorough gynaecological examination is recommended to exclude pregnancy. Bleeding disturbances, such as oligomenorrhoea and amenorrhoea should be investigated before prescription. The interval between check-ups depends on the circumstances in each individual case. If the prescribed product may conceivably influence latent or manifest disease (see Section 4.4), the control examinations should be timed accordingly.

Despite the fact that Desogestrel 75 micrograms Tablets are taken regularly, bleeding disturbances may occur. If bleeding is 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 Desogestrel 75 micrograms Tablets do not protect against HIV (AIDS) and other sexually transmitted diseases.

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 active substance or to any of the excipients listed in section 6.1

4.4. Special warnings and precautions for use

If any of the conditions/risk factors mentioned below is present, the benefits of progesterone use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start with Desogestrel 75 micrograms Tablets. 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 Desogestrel 75 micrograms Tablets 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 OCs (up to 10 years after stopping) relative to never users over the same period have been calculated for the respective age groups and is presented in the table below.

Age category combined

Expected cases OC-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 Desogestrel 75 micrograms Tablets is possibly of similar magnitude as that associated with combined OCs. 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 in woman 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 combined OCs 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, Desogestrel 75 micrograms Tablets should be discontinued in the event of a thrombosis. Discontinuation of Desogestrel 75 micrograms Tablets 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 aware of the possibility of a recurrence.

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 be carefully observed during the first months of use.

If a sustained hypertension develops during the use of Desogestrel 75 micrograms Tablets, or if a significant increase in blood pressure does not adequately respond to antihypertensive therapy, discontinuation of Desogestrel 75 micrograms Tablets should be considered.

Treatment with Desogestrel 75 micrograms Tablets 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 75 micrograms tablets consistently inhibits ovulation, ectopic pregnancy should be taken into account in the differential diagnosis if the woman gets amenorrhoea or abdominal pain.

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 Desogestrel 75 micrograms Tablets.

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 gestationis; otosclerosis-related hearing loss; (hereditary) angioedema.

Desogestrel 75 micrograms Tablets contain 58.22 mg lactose (as Lactose Anhydrous) and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.

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 Desogestrel 75 micrograms Tablets 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).

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.

4.5. Interaction with other medicinal products and other forms of interaction

Interactions

Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.

Effect of other medicinal products on Desogestrel 75 micrograms Tablets

Interactions can occur with medicinal products that induce microsomal enzymes, which can result in increased clearance of sex hormones and may lead to breakthrough bleeding and/or contraceptive failure.

Management

Enzyme induction can occur after a few days of treatment. Maximum enzyme induction is generally observed within a few weeks. After drug therapy is discontinued, enzyme induction can last for about 4 weeks.

Short-term treatment

Women on treatment with hepatic enzyme-inducing medicinal or herbal products should be advised that the efficacy of Desogestrel 75 micrograms Tablets may be reduced. A barrier contraceptive method should be used in addition to Desogestrel 75 micrograms Tablets. The barrier method must be used during the whole time of concomitant drug therapy and for 28 days after discontinuation of the hepatic enzyme-inducing medicinal product.

Long-term treatment

For women on long-term therapy with enzyme-inducing medicinal products, an alternative method of contraception unaffected by enzyme-inducing medicinal products should be considered.

Substances increasing the clearance of contraceptive hormones (diminished contraceptive efficacy by enzyme induction) e.g.:

Barbiturates, bosentan, carbamazepine, phenytoin, primidone, rifampicin, efavirenz and possibly also felbamate, griseofulvin, oxcarbazepine, topiramate, rifabutin and products containing the herbal remedy St. John's Wort (hypericum perforatum).

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 metabolite of desogestrel.

Effects of Desogestrel 75 micrograms Tablets on other medicinal products

Hormonal contraceptives may interfere with the metabolism of other drugs. Accordingly, plasma and tissue concentrations of other active substances may either increase (e.g. ciclosporine) or decrease (e.g. lamotrigine).

4.6. Fertility, pregnancy and lactation

Pregnancy:

Desogestrel 75 micrograms Tablets are not indicated during pregnancy. When pregnancy occurs during treatment with Desogestrel 75 micrograms Tablets, 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 OCs prior to pregnancy, nor a teratogenic effect when OCs were taken inadvertently during early pregnancy.

Pharmacovigilance data collected with various desogestrel-containing combined OCs also do not indicate an increased risk.

Breastfeeding:

Based on clinical study data, Desogestrel 75 micrograms Tablets 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 75 micrograms. 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, Desogestrel 75 micrograms Tablets can be used during breast feeding.

Limited long-term follow-up data are available on children, whose mothers started using another desogestrel-only pill during the 4th to 8th week 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, Desogestrel 75 micrograms Tablets may be used during lactation. The development and growth of the nursing infant, whose mother uses Desogestrel 75 micrograms Tablets, should, however, be carefully observed.

Please refer Section 4.3 for information on contraindications.

Fertility

Desogestrel 75 micrograms Tablets 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 75 micrograms Tablets has no or neglible 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 ADRs 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 ≥ 1/100

Uncommon <1/100, ≥1/1000

Rare <1/1000

Infections and infestations

Vaginal infection

Psychiatric disorders

Mood altered

Libido decreased

Depressed mood

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 12.1;

Breast discharge may occur during use of Desogestrel 75 micrograms Tablets. 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.

Breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers) with hormonal contraceptives (see section 4.5).

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 at: 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 deleterious 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 further treatment should be symptomatic.

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