ZELLETA 75 MICROGRAMS TABLETS, DESOGESTREL 75 MICROGRAMS TABLETS - patient leaflet, side effects, dosage

Patient leaflet - ZELLETA 75 MICROGRAMS TABLETS, DESOGESTREL 75 MICROGRAMS TABLETS

Desogestrel 75 micrograms Tablets

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
1. What Desogestrel 75 micrograms Tablets are and what they are used for
2. What you need to know before you take Desogestrel75 micrograms Tablets
3. How to take 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.

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 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.

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.
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.

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.

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.

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 (e.g. lamotrigine)..

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 tabletswhen 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:

4. 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.

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: 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.

5. how to store 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.

6. contents of the pack and other informationwhat desogestrel 75 micrograms tablets containsthe active substance is desogestrel. each tablet contains 75 micrograms of desogestrel.

The other ingredients are: Lactose anhydrous, all-rac-a-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

This leaflet was last revised in August 2020.