Simonette

Package Leaflet: Information for the User

Symonette, 75 micrograms, coated tablets

Desogestrel

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 pack and other information

1. What is Symonette and what is it used for

How does Symonette work?

Symonette is used to prevent pregnancy. The tablets contain a small amount of the female sex hormone, progestogen, called desogestrel. For this reason, Symonette is called a progestogen-only pill. Unlike combined oral contraceptives, progestogen-only pills do not contain estrogen, the other female sex hormone.
The mechanism of action of most progestogen-only pills is mainly based on preventing sperm from migrating through the cervix. Unlike combined oral contraceptives, they do not always inhibit ovulation. Symonette differs from other progestogen-only pills in that it usually inhibits ovulation, just like combined pills. As a result, Symonette is a very effective contraceptive.
Unlike combined products, it can be used by women who are intolerant to estrogens and by breastfeeding women. The biggest inconvenience when using Symonette may be irregular bleeding. Bleeding may also not occur at all.
The possibility of becoming pregnant while taking Symonette (provided that no tablet is missed) is very low.

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

Do not take Symonette if you have any of the conditions listed below. If you have any of these conditions, you should inform your doctor before starting to take Symonette. Your doctor may advise you to use a non-hormonal method of contraception.

• If you are 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 in the lungs (pulmonary embolism)].
• Current or past liver disease, until liver function tests have returned to normal.
• Current or past hormone-dependent tumors (e.g. certain types of breast cancer).
• Unexplained vaginal bleeding.

If any of the above conditions occur for the first time while taking Symonette, you should immediately consult a doctor.

Warnings and precautions

When taking Symonette in any of the following situations, close medical supervision is required. Before starting to take Symonette, you should inform your doctor about:

• current or past breast cancer;
• liver tumor, as the potentially harmful effect of Symonette cannot be excluded;
• past venous thromboembolic disease;
• diabetes;
• epilepsy (see section 2 "Symonette and other medicines");
• tuberculosis (see section 2 "Symonette and other medicines");
• high blood pressure;
• current or past chloasma (brown patches on the skin, especially on the face); in these cases, you should avoid exposure to the sun or ultraviolet radiation.

Possible serious diseases
Decreased bone mass
Estrogens play an important role in maintaining normal bone mass. During treatment with Symonette, the concentration of natural estrogen - estradiol - in the blood is comparable to its concentration in the first half of the natural menstrual cycle, but decreased compared to its concentration in the second half of the natural menstrual cycle. It is not known whether this has an effect on bone mass.
Breast cancer
Every woman is exposed to the risk of breast cancer, regardless of whether she is taking oral contraceptives or not. In women taking oral contraceptives, breast cancer occurs slightly more often than in women of the same age who do not take them.
After stopping oral contraceptives, the risk gradually decreases to become the same as for women who have never taken oral contraceptives after 10 years of stopping oral contraceptives. Breast cancer occurs less frequently in women under 40 years of age, but the risk increases with the age of the woman. Therefore, more cases of breast cancer occur in women taking oral contraceptives at an older age. The duration of oral contraceptive use does not matter.
For every 10,000 women taking oral contraceptives for no more than 5 years, up to the age of 20, fewer than 1 additional case of breast cancer is diagnosed within 10 years of stopping oral contraceptives, compared to 4 cases of breast cancer usually diagnosed in this age group. Similarly, for every 10,000 women taking oral contraceptives for up to 5 years, up to the age of 30, 5 additional cases of breast cancer are diagnosed, compared to 44 cases usually diagnosed in this age group. For every 10,000 women taking oral contraceptives for up to 5 years, up to the age of 40, 20 additional cases of breast cancer are diagnosed, compared to 160 cases usually diagnosed in this age group.
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 data are not conclusive.
Breast cancer cases diagnosed in patients taking oral contraceptives seem to be less advanced than those found in women who do not take them. It is not known whether this difference is related to the use of oral contraceptives. It may be related to more frequent medical check-ups for women taking oral contraceptives and thus earlier diagnosis of breast cancer.
Venous thromboembolic disease
Venous thromboembolic disease is the formation of a blood clot that can block a blood vessel. Sometimes it 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 reach the lungs and block the pulmonary artery, forming a so-called "pulmonary embolism". This can lead to death.
Deep vein thrombosis is very rare. It can also develop if oral contraceptives are not taken. It can also occur during pregnancy.
The risk of venous thromboembolic disease is higher in women taking oral contraceptives than in those not taking them. It is assumed that the risk of venous thromboembolic disease in women taking oral contraceptives containing only progestogen, such as Symonette, is lower than in women taking oral contraceptives that also contain estrogen in their composition (combined pills). If symptoms of venous thromboembolic disease occur, you should immediately contact a doctor (see the section "Regular check-ups").
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, you should contact a doctor as soon as possible to receive further medical advice.
Children and adolescents
There are no available clinical data on the efficacy and safety of Symonette in adolescents under 18 years of age.

Symonette and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You should also inform your doctor or other healthcare professional prescribing other medicines (or pharmacist) that you are taking Symonette. They may inform you 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 (HCV) infection (e.g. boceprevir, telaprevir),
• other infectious diseases (e.g. griseofulvin),
• high blood pressure in the blood vessels of the lungs (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 you are taking medicines, including herbal medicines, that may reduce the effectiveness of Symonette, you should also use additional mechanical contraception. 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 mechanical contraception during this time. Your doctor will inform you 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 cyclosporine) or decrease (e.g. lamotrigine) in their effect.
Before taking any medicine, you should consult a doctor or pharmacist.

Vaginal bleeding

During treatment with Symonette, vaginal bleeding may occur irregularly. This may be slight spotting or heavy bleeding. Bleeding may also not occur at all.
Irregular bleeding does not mean that the contraceptive effectiveness of Symonette is reduced. Usually, no action is required, and you should continue taking Symonette. You should contact a doctor if the bleeding is very heavy and prolonged.

Functional ovarian cysts

During treatment with all hormonal contraceptives that contain small amounts of hormones, small fluid-filled blisters called functional ovarian cysts may develop in the ovaries. They usually disappear on their own. In some cases, they may cause slight abdominal pain. Rarely, they may require surgical intervention.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Taking Symonette is contraindicated in pregnancy or if pregnancy is suspected.
Breastfeeding
Symonette can be used during breastfeeding. It does not affect the amount or quality of milk produced. 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 growth and development of the child has been observed.
If you are breastfeeding and want to take Symonette, you should consult a doctor.

Driving and using machines

Symonette has no effect on driving or using machines.

Symonette contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should consult a doctor before taking Symonette.

When to consult a doctor Regular check-ups

A woman taking Symonette should be informed by her doctor about the need for regular check-ups. Usually, the frequency and type of check-ups depend on the individual characteristics of the woman.
You should immediately consult a doctor in the following cases:

• If symptoms suggesting a thrombosis occur (e.g. severe pain or swelling of the legs, unusual chest pain, shortness of breath, unusual cough, especially coughing up blood).
• Sudden severe abdominal pain with jaundice (indicating possible liver disease).
• A lump in the breast is felt.
• Sudden or severe pain in the lower abdomen or pelvic area (indicating possible ectopic pregnancy).
• Immobility (e.g. bed rest) or planned surgery; you should consult a doctor at least 4 weeks in advance.
• If irregular, heavy vaginal bleeding occurs.
• If you are or may be pregnant.

3. How to take Symonette

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult a doctor or pharmacist.

When and how to take the tablets

The Symonette blister pack contains 28 tablets. Arrows and the day of the week are printed on the front of the blister pack, which allows for proper use of the medicine. Each day corresponds to one tablet. Each time you start taking tablets from a new pack of Symonette, you should start with the upper row of the blister pack, taking the tablets in the direction of the arrows, one per day, until the pack is empty, e.g. if you start taking the tablets on Wednesday, you should take the first tablet from the upper row marked "Wed". This allows you to easily check if the tablet marked with a given day of the week 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 treatment with Symonette, slight bleeding may occur. In this case, however, you should continue taking the tablets. After finishing the tablets in the pack, you should start taking the tablets from a new pack of Symonette the next day - without a break and without waiting for bleeding to occur.
Taking Symonette tablets can be stopped at any time. The contraceptive effect ends on the day you stop taking the tablets.

Starting the first pack of Symonette

• If you are not currently taking any oral contraceptives:You should wait until your next menstrual period. You should start taking Symonette tablets on the first day of your menstrual period. You do not need to use additional contraceptive methods. You can also start taking the tablets between the 2nd and 5th day of your cycle, but in this case, you should use an additional contraceptive method (mechanical contraceptive methods, e.g. a condom) for the first 7 days of taking the tablets in the first cycle.
• If you have been taking a combined oral contraceptive (combined oral contraceptives, vaginal ring, contraceptive patch):You can start taking Symonette tablets the next day after taking the last tablet of your current medicine or on the day you remove the vaginal ring or contraceptive patch (without a break in taking the tablets, using the vaginal ring or contraceptive patch). You do not need to use additional contraceptive methods. If your current medicine also contains tablets that do not contain active substances, you can start taking Symonette tablets the next day after taking the last tablet that contains hormones (if in doubt, which tablet this is, you should ask your doctor or pharmacist). There is no need to use additional contraceptive methods if you follow the above instructions.

You can also start taking Symonette tablets later, no later than on the first day following the break in taking your current medicine, on the day you would normally apply the next vaginal ring or contraceptive patch, or on the day after taking the last placebo tablet of your current medicine.
In these cases, you should use an additional contraceptive method (mechanical) for the first 7 days of taking Symonette tablets.

• If you have been taking another progestogen-only medicine:You can stop taking the tablets at any time and start taking Symonette tablets the next day. You do not need to use additional contraceptive methods.
• If you have been using injectable contraception, an implant, or an intrauterine system releasing progestogen:You should start taking Symonette tablets on the day you would normally have your next injection or on the day you remove the implant or intrauterine system. You do not need to use additional contraceptive methods.
• After childbirthYou should start taking the tablets between the 21st and 28th day after childbirth. If you start taking the tablets later, you should use an additional contraceptive method (mechanical contraceptive methods) for the first 7 days of taking the tablets. After having sex before starting to take the tablets, you should check if you are not pregnant or wait for your first menstrual period. More information about breastfeeding can be found in the section "Breastfeeding". Your doctor will also advise you.
• After a miscarriageAs advised by your doctor.

Overdose of Symonette

No serious, harmful effects have been observed after taking more than one Symonette tablet at the same time. Nausea, vomiting, and slight vaginal bleeding may occur in both women and young girls. You should consult a doctor to get more information.

Missed dose of Symonette

If the delay in taking the tablets is less than 12 hours, the effectiveness of the tablet is maintained. You should take the missed tablet as soon as possible, and take 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.
You should take the last missed tablet as soon as possible, and take the remaining tablets as usual. This may mean taking two tablets at the same time. For the next 7 days, you should use an additional contraceptive method (e.g. a condom). There is a possibility of becoming pregnant if you miss one or more tablets in the first week of taking the tablets, if you had sex in the week before missing the tablet. You should consult a doctor.

What to do in case of gastrointestinal disorders (e.g. vomiting, severe diarrhea)

If vomiting or severe diarrhea occur within 3 to 4 hours after taking a Symonette tablet, the absorption of the active substance may be reduced. You should follow the same procedure as in the case of a missed tablet (see the section "Missed dose of Symonette").
In the case of severe diarrhea, you should contact a doctor.

Stopping Symonette

You can stop taking Symonette at any time. If you do not plan to become pregnant, you should ask your doctor for another contraceptive method.
If you plan to become pregnant, it is usually recommended to wait until your first natural menstrual period before becoming pregnant. This will make it easier to determine the expected date of delivery.
To get more information about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Symonette can cause side effects, although not everybody gets them.
You should inform your doctor about any unwanted changes in your health, especially if they are severe and prolonged, and about changes in your health that seem to be caused by taking Symonette tablets.

Serious side effects

Serious side effects associated with Symonette are described in the sections "Breast cancer" and "Venous thromboembolic disease" in section 2 "Important information before taking Symonette". You should read this section, and if necessary, you should immediately consult a doctor.

Other possible side effects

Side effects that may occur in women taking Symonette:

Aside from the above-mentioned side effects, breast discharge may also occur. You should immediately contact a doctor if symptoms of angioedema occur, such as swelling of the face, tongue, and throat, difficulty swallowing, or urticaria and difficulty breathing.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your 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, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Symonette

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 carton after EXP. The expiry date refers to the last day of the month stated.
Unpackaged product: Do not store above 30°C.
Packaged product: No special storage precautions.
Likewise, medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Symonette contains

• The active substance of Symonette is desogestrel (75 micrograms).
• The other ingredients are: lactose monohydrate, cornstarch, povidone K30, stearic acid, all-rac-α-tocopherol (E 307), colloidal anhydrous silica, hypromellose, macrogol 400, talc, titanium dioxide (E 171).

What Symonette looks like and contents of the pack

Symonette is a round, biconvex, white to off-white coated tablet, 5.4-5.8 mm in diameter, without markings.
One Symonette blister pack contains 28 coated tablets. Each carton contains 1, 3, or 6 blister packs.
Not all pack sizes may be marketed.

Marketing authorization holder

Symphar Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw

Manufacturer/Importer

Symphar Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw

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

Poland:
Symonette
Date of last revision of the leaflet:July 2019