Simonette

Leaflet accompanying the packaging: information for the user

Symonette, 75 micrograms, coated tablets

Desogestrel

Please read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Symonette and what is it used for
• 2. Important information before taking Symonette
• 3. How to take Symonette
• 4. Possible side effects
• 5. How to store Symonette
• 6. Contents of the packaging and other information

1. What is Symonette and what is it used for

Symonette is used to prevent pregnancy. Symonette contains a small amount of the female sex hormone, progestogen, called desogestrel. For this reason, Symonette is called a progestogen-only pill. Unlike the combined contraceptive pill, the progestogen-only pill does not contain the sex hormone estrogen in combination with progestogen.
The mechanism of action of most progestogen-only pills is mainly based on preventing sperm from migrating to the uterus, but it does not always inhibit the maturation of the egg cell, which is the primary action of the combined contraceptive pill. Symonette differs from other progestogen-only pills in that its dose is usually high enough to prevent the maturation of the egg cell. As a result, Symonette is a very effective contraceptive.
Unlike the combined contraceptive pill, Symonette can be used by women who are intolerant to estrogens and by breastfeeding women. A disadvantage of using Symonette may be irregular bleeding. Bleeding may also not occur at all.

2. Important information before taking Symonette

Symonette, like other hormonal contraceptives, does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

When not to take Symonette

• if the patient is allergic to desogestrel or any of the other ingredients of this medicine (listed in section 6).
• current venous thromboembolic disease. Venous thromboembolic disease is the formation of blood clots that block veins [e.g. in the legs (deep vein thrombosis) or lungs (pulmonary embolism)].
• current or history of jaundice (yellowing of the skin) or severe liver disease, when liver function tests are still not normal.
• if the patient has or is suspected of having a hormone-dependent tumor, such as certain types of breast cancer.
• bleeding from the vagina of unknown cause.

If any of the above situations apply to the patient, they should inform their doctor before starting to take Symonette. The doctor may advise the use of a non-hormonal contraceptive method.
If any of the above symptoms occur for the first time while taking Symonette, the patient should consult their doctor immediately.

Warnings and precautions

Before starting to take Symonette, the patient should inform their doctor or pharmacist about:

• current or history of breast cancer;
• current or history of liver cancer, as the potential harmful effect of Symonette cannot be excluded;
• current or history of venous thromboembolic disease;
• current or history of diabetes;
• current or history of epilepsy (see "Symonette and other medicines");
• current or history of tuberculosis (see "Symonette and other medicines");
• current or history of high blood pressure;
• current or history of chloasma (brown spots on the skin, especially on the face); in these cases, the patient should avoid sun exposure or ultraviolet radiation.

In the event of taking Symonette in any of the above cases, close medical supervision may be required. The doctor will explain what measures to take.
Symonette and breast cancer
The patient should regularly examine their breasts and immediately contact their doctor if they feel any lump in their breasts.
Breast cancer occurs slightly more often in women taking the contraceptive pill than in women of the same age who do not take it. After stopping the contraceptive pill, the risk gradually decreases and after 10 years of stopping the pill, it is the same as for women who have taken the pill and those who have never taken it. Breast cancer occurs less often in women under 40, but the risk increases with the woman's age. Therefore, more cases of breast cancer occur in women taking the contraceptive pill at an older age. The duration of taking the contraceptive pill is not as important.
For every 10,000 women taking the contraceptive pill for no more than 5 years up to the age of 20, there is less than 1 additional case of breast cancer within 10 years of stopping the pill, compared to 4 cases of breast cancer normally diagnosed in this age group. Similarly, for every 10,000 women taking the contraceptive pill for up to 5 years up to the age of 30, there are 5 additional cases of breast cancer, compared to 44 cases normally diagnosed in this age group. For every 10,000 women taking the contraceptive pill for up to 5 years up to the age of 40, there are 20 more cases of breast cancer, compared to 160 cases normally diagnosed.
The risk of breast cancer in women taking progestogen-only pills, such as Symonette, is similar to the risk of breast cancer in women taking combined pills, but the evidence is not as conclusive.
Cases of breast cancer diagnosed in patients taking the contraceptive pill seem to be less advanced than those found in women who do not take it. It is not known whether this difference is related to the use of the contraceptive pill. It may be related to the more frequent medical check-ups of patients taking contraception and thus earlier diagnosis of breast cancer.
Symonette and venous thromboembolic disease
If symptoms of venous thromboembolic disease occur, the patient should immediately contact their doctor (see "Regular check-ups").
Venous thromboembolic disease is the formation of a blood clot that can block a blood vessel. Venous thromboembolic disease can occur in the deep veins of the legs (deep vein thrombosis). If the clot breaks loose from the place where it formed, it can travel to the lungs and block a pulmonary artery, causing a pulmonary embolism. This can lead to death.
Deep vein thrombosis is very rare. It can also develop if the patient is not taking the contraceptive pill. It can also occur during pregnancy.
The risk of venous thromboembolic disease is higher in women taking contraceptive pills than in those who do not take them. It is suspected that the risk of venous thromboembolic disease in women taking progestogen-only pills, such as Symonette, is lower than in women taking combined contraceptive pills containing estrogen.
Symonette and mental disorders
Some women taking hormonal contraceptives, including Symonette, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, the patient should contact their doctor as soon as possible for further medical advice.

Children and adolescents

There are no clinical data available on the efficacy and safety of Symonette in adolescents under 18 years of age.

Symonette and other medicines

The patient should tell their doctor about all medicines or herbal products they are currently taking or have recently taken, as well as any medicines they plan to take. The patient should also inform their doctor of another specialty or dentist prescribing other medicines (or pharmacist) about taking Symonette. They may inform the patient about the possible need to use additional contraceptive methods (e.g. condoms) and the duration of their use, as well as whether it is necessary to modify the use of the prescribed medicine.
Some medicines:

• may affect the level of Symonette in the blood,
• may reduce its contraceptive effectiveness,
• may cause unexpected bleeding. This applies to medicines used to treat:
• epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate, and phenobarbital),
• tuberculosis (e.g. rifampicin, rifabutin),
• HIV infection (e.g. ritonavir, nelfinavir, nevirapine, efavirenz),
• hepatitis C virus infection (e.g. boceprevir, telaprevir),
• other infectious diseases (e.g. griseofulvin),
• high blood pressure in the pulmonary blood vessels (bosentan),
• depressive moods (St. John's wort (Hypericum perforatum)),
• certain bacterial infections (e.g. clarithromycin, erythromycin),
• fungal infections (e.g. ketoconazole, itraconazole, fluconazole),
• high blood pressure (hypertension), angina pectoris, or certain heart rhythm disorders (e.g. diltiazem).

If the patient is taking medicines or herbal products that may reduce the effectiveness of Symonette, they should also use a barrier contraceptive method. Due to the fact that the effect of another medicine on Symonette may persist for up to 28 days after stopping the medicine, it is necessary to use additional barrier contraception during this time. The doctor will inform the patient about the possible need to use additional contraceptive methods and the duration of their use.
Symonette may also interfere with the action of other medicines, causing an increase (e.g. medicines containing cyclosporin) or decrease (e.g. lamotrigine) in their action.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Pregnancy and breastfeeding

Pregnancy
Symonette should not be taken if the patient is pregnant or thinks they may be pregnant.
Breastfeeding
Symonette can be used during breastfeeding. It does not appear to affect milk production or quality. However, a decrease in milk production has been reported in some cases during Symonette treatment. Small amounts of the active substance of Symonette pass into breast milk.
There are observations of the health of children up to 2.5 years of age whose mothers took desogestrel for 7 months. No effect on the child's growth and development has been observed.
In case of breastfeeding and the desire to take Symonette, the patient should consult their doctor.

Driving and using machines

It has not been found that Symonette affects alertness and concentration.

Symonette contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking Symonette.

Regular check-ups

The patient taking Symonette should be informed by their doctor about the need for regular check-ups. Usually, the frequency and type of check-ups depend on the patient's state of health.
The patient should immediately contact their doctor in the following cases:

• if the patient experiences severe pain or swelling in any of the legs, unexplained chest pain, shortness of breath, unusual cough, especially coughing up blood (indicating a possible venous thromboembolic disease);
• if the patient experiences sudden, severe abdominal pain or yellowing of the skin (indicating a possible liver disorder);
• if the patient finds a lump in their breast (indicating a possible breast cancer);
• if the patient experiences sudden or severe pain in the lower abdomen or stomach area (indicating a possible ectopic pregnancy, which is a pregnancy developing outside the uterus);
• if the patient is to be immobilized or have surgery (they should consult their doctor at least 4 weeks in advance);
• if the patient experiences unusual or heavy vaginal bleeding;
• if the patient suspects they are pregnant.

3. How to take Symonette

When and how to take the tablets

The packaging of Symonette contains 28 tablets. On the blister pack, each tablet is marked with the day of the week on which it should be taken.
Each time a new packaging of Symonette is started, the patient should begin with the first tablet from the top row of the blister pack. The patient should not start with any tablet. For example, if the patient starts taking the tablets on a Wednesday, they should take the first tablet from the top row marked with "Wed" on the back of the blister pack. The patient should continue taking the tablets in the direction of the arrows, one tablet per day, until the packaging is empty. Looking at the back of the blister pack, it is easy to check if the tablet has been taken on that day.
The tablets should be taken at the same time every day. The tablet should be swallowed whole with water. During Symonette treatment, slight bleeding may occur, but the patient should continue taking the tablets as usual. After finishing the tablets in the packaging, the patient should start taking the tablets from a new packaging the next day, without interruption and without waiting for bleeding to occur.

Starting the first packaging of Symonette

• If the patient is not currently taking any contraceptive pills:The patient should wait until their next menstrual period. The patient should start taking Symonette tablets on the first day of their menstrual period. No additional contraceptive methods are needed. The patient can also start taking the tablets between the 2nd and 5th day of their cycle, but in this case, they should use an additional contraceptive method (barrier methods) for the first 7 days of tablet intake.
• If the patient has previously taken combined contraceptive pills, a vaginal ring, or a contraceptive patch:The patient can start taking Symonette tablets the next day after taking the last tablet of their current contraceptive or after removing the vaginal ring or contraceptive patch (without interrupting the use of the contraceptive method). If the currently used contraceptive contains inactive tablets, the patient can start taking Symonette the next day after taking the last active tablet (if in doubt, the patient should ask their doctor or pharmacist). If the patient follows the above instructions, there is no need to use additional contraceptive methods.

The patient can also start taking Symonette on the first day after the break in taking the tablets, vaginal ring, or contraceptive patch, or after the period of taking the placebo tablet of the previously used contraceptive. If the patient follows the instructions, they should use an additional contraceptive method (barrier methods) for the first 7 days of tablet intake.

• If the patient has previously taken another progestogen-only pill:The patient can stop taking the previous pill at any time and start taking Symonette tablets the next day. No additional contraceptive methods are needed.
• If the patient has previously used injectable contraception, an implant, or an intrauterine system releasing progestogen:The patient should start taking Symonette tablets on the day they would have had their next injection or on the day the implant or intrauterine system is removed. No additional contraceptive methods are needed.
• After childbirth:After childbirth, the patient should start taking the tablets between the 21st and 28th day after giving birth. If the patient starts taking the tablets later, they should use an additional contraceptive method (barrier methods) for the first 7 days of tablet intake. However, if the patient has had sexual intercourse before starting Symonette, they should make sure they are not pregnant. Additional information for breastfeeding women can be found in the "Pregnancy and breastfeeding" section in point 2. The doctor will also provide advice.

After a miscarriage or abortion:As advised by the doctor.

Missing a dose of Symonette

• If the delay in taking the tablets is less than 12 hours, the effectiveness of Symonette is maintained. The patient should take the missed tablet as soon as possible and continue taking the remaining tablets as usual.
• If the delay in taking the tablets is more than 12 hours, the effectiveness of Symonette may be reduced. The more missed tablets, the higher the risk of reduced contraceptive effectiveness. The patient should take the last missed tablet as soon as possible and continue taking the remaining tablets as usual. The patient should use an additional contraceptive method (e.g. condoms) for the next 7 days. If the patient misses one or more tablets in the first week of starting the tablets and has had sexual intercourse in the week before missing the tablets, there is a possibility of pregnancy. The patient should consult their doctor.

Procedure in case of gastrointestinal disorders (e.g. vomiting, severe diarrhea)

The patient should follow the same procedure as in the case of a missed tablet, as described above. If vomiting or severe diarrhea occurs within 3 to 4 hours after taking a Symonette tablet, the absorption of the active substance may have been reduced.

Use of a higher dose of Symonette than recommended

No serious harmful effects have been observed after taking multiple Symonette tablets at the same time. The symptoms that may occur are nausea, vomiting, and in young girls, slight vaginal bleeding. For further information, the patient should consult their doctor.

Stopping Symonette treatment

The patient can stop taking Symonette at any time. From the day they stop taking the medicine, the patient is no longer protected against pregnancy.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Symonette can cause side effects, although not everybody gets them.
Severe side effects related to the use of Symonette are described in the "Breast cancer" and "Venous thromboembolic disease" sections in point 2 "Important information before taking Symonette". The patient should read this section to obtain additional information and, if necessary, consult their doctor immediately.
The patient should immediately contact their doctor if they experience an allergic reaction (hypersensitivity), including swelling of the face, lips, tongue, and/or throat, causing difficulty in breathing or swallowing (angioedema and/or anaphylactic reaction).
During Symonette treatment, vaginal bleeding may occur irregularly. This may be slight spotting that does not require the use of sanitary pads or more heavy bleeding that looks like a scanty menstrual period, when sanitary pads are needed. Bleeding may also not occur at all.
Irrregular bleeding does not mean that the contraceptive effectiveness of Symonette is reduced. Usually, no action is necessary, and the patient should continue taking Symonette. However, if the bleeding is very heavy or prolonged, the patient should contact their doctor.
Women taking Symonette have reported the following side effects:

• Frequent: may occur in up to 1 in 10 women
• mood changes, depressive mood, reduced sexual desire (libido),
• headache,
• nausea,
• acne,
• breast pain; irregular menstrual bleeding or its absence,
• weight gain.

Uncommon: may occur in up to 1 in 100 women

• vaginal infection,
• difficulty wearing contact lenses,
• vomiting,
• excessive hair loss,
• painful menstruation, ovarian cysts,
• feeling tired.

Rare: may occur in up to 1 in 1,000 women

• rash, urticaria, painful blue-red nodules (erythema nodosum) (these are skin diseases).

Frequency not known (frequency cannot be estimated from the available data)

• allergic reaction.

Besides the above-mentioned side effects, breast discharge may also occur.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Symonette

There are no special recommendations for the storage temperature of Symonette. The blister pack should be stored in the original sachet to protect it from light.
Shelf life after first opening the sachet: 28 days.
The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month.
The active substance has a risk of environmental hazard in relation to fish. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Symonette contains

• The active substance of Symonette is desogestrel in a dose of 75 micrograms.
• The other ingredients are: povidone (K-30), cornstarch, lactose monohydrate, all-rac-α-tocopherol, colloidal anhydrous silica, stearic acid, hypromellose, macrogol 6000, propylene glycol, talc, titanium dioxide (E171).

What Symonette looks like and contents of the packaging

The tablets are white, cylindrical, and biconvex, with a height of about 6.00 ± 0.10 mm and a width of 2.45 ± 0.10 mm.
The blister pack (PVC/Aluminum) contains 28 coated tablets. Each blister pack is packaged in a sachet made of laminated aluminum foil (PE/Aluminum/PETR). The sachet is packaged in a cardboard box. The cardboard box contains 1, 3, or 6 blister packs.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel.: +48 22 822 93 06
e-mail: biuro@farmakinternational.pl

Manufacturer

Cyndea Pharma S. L.
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda 31
42110, Ólvega (Soria)
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland: Symonette
Date of last revision of the leaflet:April 2025