Symonette

Patient Information Leaflet

Symonette, 75 micrograms, coated tablets
Desogestrel
Please read all of this leaflet carefully before taking 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Symonette is and what it is used for
2. What you need to know before you take 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 Symonette is and what it is used for

Symonette is used to prevent pregnancy. Symonette contains a small amount of a female sex hormone called desogestrel, a type of progestogen. For this reason, Symonette is known as a 'progestogen-only pill'. Unlike the combined oral contraceptive pill, the progestogen-only pill does not contain the sex hormone oestrogen in combination with a progestogen.

The main mechanism of action of most progestogen-only pills is primarily to prevent sperm from entering the womb, but they do not always inhibit the maturation of the egg cell, which is the primary mechanism of the combined oral contraceptive pill. Symonette differs from other progestogen-only pills in that its dose is high enough in most cases to prevent the maturation of the egg cell. As a result, Symonette is a highly effective contraceptive method.

Unlike the combined oral contraceptive pill, Symonette can be used by women who cannot tolerate oestrogens and by women who are breastfeeding. A possible disadvantage during treatment with Symonette is irregular bleeding. Bleeding may also not occur at all.

2. Important information before using Symonette

Symonette, like other hormonal contraceptives, does not protect against infection with the
HIV virus (AIDS) or other sexually transmitted diseases.
When not to use 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 involves the formation of blood clots blocking veins [e.g. in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism)].
• current or past occurrence of jaundice (yellowing of the skin) or severe liver disease, when liver function parameters are still abnormal.
• if the patient has or is suspected of having a hormone-dependent tumour, such as certain types of breast cancer.
• vaginal bleeding of unknown cause.

If any of the above situations apply to the patient, she must inform her doctor before starting
to use Symonette. The doctor may recommend using a non-hormonal method of contraception.
If any of the symptoms listed above occur for the first time during use of Symonette, medical
advice should be sought immediately.
Warnings and precautions
Before starting to use Symonette, inform your doctor or pharmacist if:

• you currently have or have had breast cancer;
• you have liver cancer, as a potentially harmful effect of Symonette cannot be excluded;
• you have had venous thromboembolic disease in the past;
• you have diabetes;
• you have epilepsy (see section “Symonette with other medicines”);
• you have tuberculosis (see section “Symonette with other medicines”);
• you have high blood pressure;
• you currently have or have had chloasma (brownish pigmentation of the skin, especially on the face); in such cases, exposure to sunlight or ultraviolet radiation should be avoided.

If Symonette is used in any of the above conditions, close medical supervision may be required.
Your doctor will explain what measures should be taken.
Symonette and breast cancer
You should regularly examine your breasts and contact your doctor immediately if you detect any lump.
Breast cancer occurs slightly more frequently in women using oral contraceptives than in women of the same age who do not use them. After stopping the oral contraceptive, this risk gradually decreases, and after 10 years of discontinuation, the risk is the same for women who used the pill and those who never used it. Breast cancer is less common in women under 40 years of age, but the risk increases with age. Therefore, a higher number of breast cancer cases occurs in older women using oral contraceptives. The duration of use of the oral contraceptive is less significant.
Among 10,000 women using an oral contraceptive for no longer than 5 years, in the age group under 20 years, there will be less than 1 additional case of breast cancer over 10 years after stopping the pill, compared to 4 cases usually diagnosed in this age group. Similarly, among 10,000 women using an oral contraceptive for up to 5 years in the age group under 30 years, there are 5 additional cases of breast cancer compared to 44 cases usually diagnosed in this group. Among 10,000 women using an oral contraceptive for up to 5 years in the age group under 40 years, there are 20 more cases of breast cancer compared to 160 cases usually diagnosed.
The occurrence of breast cancer in women using progestogen-only pills, such as Symonette, is similar to the risk in women using combined oral contraceptives, although the evidence is not as conclusive.
Cases of breast cancer diagnosed in women using oral contraceptives appear to be less advanced than those in women not using them. It is not known whether this difference is related to oral contraceptive use. It may be due to more frequent monitoring of women using contraception, leading to earlier detection of breast cancer.
Symonette and venous thromboembolic disease
If symptoms of venous thromboembolic disease occur, contact your doctor immediately (see section “Regular check-ups”).
Venous thromboembolic disease involves the formation of a blood clot that may block a blood vessel. Venous thromboembolic disease may occur in the deep veins of the lower limbs (deep vein thrombosis). If the clot detaches from its site of origin, it may travel to the lungs and block the pulmonary artery, causing a pulmonary embolism. This may lead to death.
Deep vein thrombosis is very rare. It may also develop in women not using oral contraceptives and may occur during pregnancy.
The risk of venous thromboembolic disease is higher in women using oral contraceptives than in those who do not. It is believed that the risk of venous thromboembolic disease in women using progestogen-only oral contraceptives, such as Symonette, is lower than in women using combined oral contraceptives containing oestrogens.
Symonette and psychiatric disorders
Some women using hormonal contraceptives, including Symonette, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact your doctor as soon as possible for further medical advice.
Children and adolescents
There are no clinical data available on the efficacy and safety of use in adolescents under 18 years of age.
Symonette with other medicines
Inform your doctor about all medicines or herbal products you are currently using, have recently used, or plan to use. You should also inform any other specialist doctor or dentist prescribing medicines (or a pharmacist) that you are taking Symonette. They may advise you on whether additional contraceptive methods (e.g. condoms) are needed and for how long, and whether any adjustment of the prescribed medicine is required.
Some medicines:

• may affect the blood concentration of Symonette,
• may reduce its contraceptive effectiveness,
• may cause unexpected bleeding. These include 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 infections (e.g. griseofulvin),
• pulmonary arterial hypertension (bosentan),
• depressive mood disorders (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 or certain heart rhythm disorders (e.g. diltiazem).

If you are taking medicines or herbal remedies that may reduce the effectiveness of Symonette,
you should also use barrier contraception. Because the effect of another medicine on Symonette
may persist for up to 28 days after stopping the medicine, additional barrier contraception is necessary during this period. Your doctor will inform you if additional contraceptive methods are needed and for how long they should be used.
Symonette may also interfere with the action of other medicines, leading to increased (e.g. medicines containing cyclosporine) or decreased (e.g. lamotrigine) effects.
Before taking any medicine, consult your doctor or pharmacist.
Pregnancy and breastfeeding
Pregnancy
Do not use Symonette if you are pregnant or suspect you may be pregnant.
Breastfeeding
Symonette may be used during breastfeeding. It does not appear to affect the production or quality of breast milk. However, a decrease in milk production has been reported occasionally during use of Symonette. Small amounts of the active substance in Symonette pass into breast milk.
Health observations of children up to 2.5 years of age whose mothers used desogestrel for 7 months have shown no effect on the child's growth and development.
If you are breastfeeding and wish to use Symonette, consult your doctor.
Driving and using machines
No effects of Symonette on alertness and concentration have been observed.
Symonette contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.
Regular check-ups
The patient using Symonette should be informed by the doctor about the need for regular check-ups. The frequency and type of examinations usually depend on the patient's health status.
Contact your doctor immediately if:

• you experience severe pain or swelling in either of your lower limbs, unexplained chest pain, shortness of breath, or unusual cough, especially coughing up blood (indicating possible venous thromboembolic disease);
• you have sudden, severe stomach pain or yellowing of the skin (indicating possible liver disorders);
• you detect a lump in your breast (indicating possible breast cancer);
• you experience sudden or severe pain in the lower abdomen or stomach area (indicating possible ectopic pregnancy, a pregnancy developing outside the uterus);
• you are to be immobilised or undergo surgery (consult your doctor at least four weeks in advance);
• you have unusual, heavy bleeding from the genital tract;
• you suspect you are pregnant.

3. How to use Symonette

When and how to take the tablets
The Symonette pack contains 28 tablets. Each tablet on the blister is marked with the day of the week on which it should be taken.
Tablets from a new Symonette pack should always be started from the top row of the blister. Do not start taking tablets from any random tablet. For example, if starting the tablets on Wednesday, the first tablet taken should be the one in the top row marked (on the back of the blister) with "Śr". Continue taking the tablets in the direction of the arrows, one tablet per day, until the pack is finished. By looking at the back of the blister, it is easy to check whether a tablet has been taken on that particular day.
Tablets should be taken at the same time each day. Swallow the tablet whole with water. During treatment with Symonette tablets, slight bleeding may occur, but you should continue taking the tablets as usual. After finishing all tablets in the pack, start taking tablets from a new pack the next day, without a break and without waiting for bleeding to occur.

Starting the first pack of Symonette

• If the patient is currently not taking any oral contraceptives: Wait for the next menstrual period. Begin taking Symonette tablets on the first day of menstruation. There is no need to use additional contraceptive methods. Tablets may also be started between day 2 and day 5 of the cycle; however, in this case, an additional contraceptive method (barrier method) must be used for the first 7 days of tablet-taking.
• If previously taking combined oral contraceptives, vaginal ring, or contraceptive patch: You may start taking Symonette tablets the day after taking the last active tablet of the current contraceptive, or on the day of removal of the vaginal ring or contraceptive patch (without a break from taking tablets, using the ring, or patch). If the currently used product also includes placebo tablets, you may start taking Symonette the day after taking the last hormone-containing tablet (if in doubt about which tablet this is, consult your doctor or pharmacist). If the patient follows this instruction, there is no need to use an additional contraceptive method.

Alternatively, you may start taking Symonette no later than the first day following the tablet-free, ring-free, or patch-free interval, or after the placebo tablet period of the previously used contraceptive. If the patient follows this instruction, an additional contraceptive method (barrier method) must be used for the first 7 days of tablet-taking.

• If previously taking a progestogen-only contraceptive: You may stop taking the tablets on any day and start taking Symonette the next day. There is no need to use additional contraceptive methods.
• If previously using a progestogen-releasing contraceptive injection, implant, or intrauterine system: Start taking Symonette tablets on the day the next injection would have been due, or on the day of removal of the implant or system. There is no need to use additional contraceptive methods.
• After childbirth: Begin taking tablets between day 21 and day 28 after childbirth. If starting later than this, use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking. However, if sexual intercourse has occurred before starting Symonette, ensure that the patient is not pregnant. Additional information for breastfeeding women is provided in section 2, "Pregnancy and breastfeeding". Your doctor can also provide advice.
• After spontaneous or induced abortion: As directed by your doctor.

Missed dose of Symonette

• If the delay in taking a tablet is less than 12 hours, the effectiveness of Symonette is maintained. Take the missed tablet as soon as possible and continue taking the remaining tablets as usual.
• If the delay in taking a tablet is more than 12 hours, the effectiveness of Symonette may be reduced. The more tablets missed, the greater the risk of reduced contraceptive effectiveness. Take the last missed tablet as soon as possible and continue taking the remaining tablets as usual. Use an additional contraceptive method (e.g., condom) for the next 7 days. If one or more tablets were missed during the first week of starting the tablets, and sexual intercourse occurred in the week preceding the missed tablets, there is a possibility of pregnancy. Consult your doctor.

Gastrointestinal disturbances (e.g. vomiting, severe diarrhoea)
In case of gastrointestinal disturbances, follow the same instructions as for a missed tablet, as described above. If vomiting or severe diarrhoea occurs within 3 to 4 hours after taking a Symonette tablet, absorption of the active ingredient may have been reduced.

Taking more than the recommended dose of Symonette
No serious harmful effects have been observed after taking multiple Symonette tablets at once. Symptoms that may occur include nausea, vomiting, and, in young girls, slight vaginal bleeding. For further information, consult your doctor.

Stopping treatment with Symonette
You may stop taking Symonette at any time. From the day treatment is discontinued, the patient is no longer protected against pregnancy.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions associated with the use of Symonette are described in the sections
"Breast cancer" and "Venous thromboembolic disease" in section 2 "Important information before
using Symonette". Please read this section for additional information and seek immediate medical advice if necessary.
Seek immediate medical attention if allergic reactions (hypersensitivity) occur, including facial swelling, lips, tongue and (or) throat causing difficulty in breathing or swallowing (angioedema and (or) anaphylactic reaction).
During treatment with Symonette, vaginal bleeding may occur irregularly. This may be light spotting not requiring sanitary pads, or heavier bleeding resembling a light menstrual period, when use of sanitary pads is necessary.
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 it is sufficient to continue taking Symonette. However, if bleeding is very heavy or prolonged, consult your doctor.
Women using Symonette have reported the following adverse reactions:
Common: may affect up to 1 in 10 women

• mood changes, depressive mood, decreased sex drive (libido),
• headache,
• nausea,
• acne,
• breast pain; irregular menstrual bleeding or absence of periods,
• increased body weight.

Uncommon: may affect up to 1 in 100 women

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

Rare: may affect up to 1 in 1000 women

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

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

• allergic reaction.

In addition to the adverse reactions listed above, breast discharge may occur.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 .
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Symonette

No special storage temperature requirements. Store the blister pack
in the original sachet to protect from light.
Shelf life after first opening the sachet: 28 days.
Keep the medicine 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 stated month.
The active substance poses an environmental risk to fish. Medicines should not
be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Symonette contains

• The active substance is desogestrel in an amount of 75 micrograms.
• The other ingredients are: povidone (K-30), maize starch, 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 pack
The coated tablets are white, cylindrical, biconvex, with a height of approximately 6.00 ± 0.10 mm and width of 2.45 ± 0.10 mm.
The blister (PVC/Aluminium) contains 28 coated tablets. Each blister is packed in a sachet made of laminated aluminium foil (PE/Aluminium/PETR). The sachet is packed in a cardboard box. The cardboard box contains 1, 3 or 6 blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel.: +48 22 822 93 06
e-mail: [email protected]

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

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Symonette