Slinda

Package leaflet: Information for the patient

Slinda, 4 mg, film-coated tablets
drospirenonum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Slinda is and what it is used for

Slinda is a contraceptive tablet used to prevent pregnancy. Each Slinda blister pack contains 24 white tablets, called active tablets, and 4 green tablets, called placebo tablets, which do not contain any active substance. The tablets are marked with two different colours and arranged in a specific order.
Each of the 24 white, active tablets contains a small amount of a female sex hormone, a progestogen called drospirenone. For this reason, Slinda is referred to as a progestogen-only pill (POP). Unlike combined oral contraceptives, progestogen-only pills do not contain oestrogen. Therefore, Slinda may be used by women who do not tolerate oestrogens.
Slinda has a high contraceptive efficacy. The contraceptive action of Slinda involves inhibition of ovulation, changes in cervical mucus, and effects on the endometrium, which becomes thinner.
An inconvenience that may occur during treatment with Slinda is irregular vaginal bleeding while taking the medicine. Bleeding may also not occur at all.

2. Important information before using Slinda

When not to use Slinda:

• if the patient is allergic to drospirenone or any of the other ingredients of this medicine (listed in section 6);
• if the patient has blood clots in blood vessels, e.g. in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism);
• if the patient has or has had liver disease and liver function is still abnormal;
• if the patient has kidney function disorders (kidney failure);
• if the patient has cancer or suspected cancer whose growth is dependent on sex hormones, such as certain types of breast cancer;
• if the patient has vaginal bleeding of unknown cause.

If any of the conditions listed above occurs during treatment with Slinda, treatment must be
stopped immediately and the patient should consult a doctor.
Warnings and precautions
Slinda, like other hormonal contraceptives, does not protect against infection with the
HIV virus (AIDS) or other sexually transmitted diseases.
Before starting Slinda, the patient should discuss the following with her doctor:

• if she has ever had thrombosis (formation of blood clots in blood vessels) in the past;
• if she has liver cancer, jaundice (yellowing of the skin) or liver disease and liver function is abnormal;
• if she has ever been diagnosed with breast cancer in the past;
• if she has chloasma (brownish pigmented patches, especially on the face) or has had it in the past; in such cases, direct exposure of the skin to sunlight or ultraviolet radiation should be avoided during treatment with Slinda;
• if she has diabetes;
• if she has high blood pressure;
• if she has kidney function disorders. In such cases, the doctor may recommend monitoring serum potassium levels during the first treatment cycle.

If any of the conditions listed above worsens or occurs for the first time during
treatment with Slinda, the patient should contact her doctor. The doctor will decide whether treatment with Slinda should be discontinued and may recommend using a non-hormonal contraceptive method.
Breast cancer
Breasts should be examined regularly, and the patient should contact her doctor immediately if she detects any lump in the breasts.
Breast cancer occurs slightly more frequently in women using combined oral contraceptives than in women of the same age who do not use them. When women stop using combined oral contraceptives, the risk decreases, so that 10 years after stopping the medication, the risk is the same as in women who have never used combined oral contraceptives.
Breast cancer is rare in women under the age of 40. It appears that breast cancer diagnosed in women using combined oral contraceptives is usually less advanced than in women who have not used combined oral contraceptives. It is not known whether this difference is caused by the use of combined oral contraceptives. It may be due to earlier diagnosis of breast cancer, as women using contraceptives have been examined more frequently.
The risk of breast cancer in women using progestogen-only pills, such as Slinda, is considered to be similar to that in women using combined oral contraceptives, but available data are inconclusive.
Thrombosis (formation of blood clots in blood vessels)
The patient should contact her doctor immediately if she observes possible symptoms of thrombosis (see also "Regular check-ups").
Thrombosis is the formation of blood clots that may block a blood vessel. Thrombosis sometimes occurs in the deep veins of the legs (deep vein thrombosis). If a clot detaches from the site where it formed in the vein, it may travel to the lungs and block the arteries. This condition is called "pulmonary embolism" and may result in death.
The risk of thrombosis may be slightly higher when using progestogen-only pills. The risk of thrombosis is higher in the following situations: if a family member (sibling or parent) had thrombosis at a relatively young age, with increasing age, obesity, hypertension, prolonged immobilization, major surgery or severe trauma.
No increased risk of myocardial infarction or stroke (blood clots in the brain) has been observed with progestogen-only pills. This risk is rather associated with age, hypertension and smoking.
In women with hypertension taking progestogen-only pills, the risk of stroke may be slightly increased.
Psychiatric disorders
Some women using hormonal contraceptives, including Slinda, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, the patient should contact her doctor as soon as possible for further medical advice.
Medical examinations
Before starting Slinda for the first time or after a break in treatment, the doctor will perform a detailed medical history and a thorough physical examination, including a breast examination. The doctor will inform the patient how often she should attend follow-up visits.
Children and adolescents
Slinda is used after the onset of the first menstrual period (first menstruation in a woman).
Slinda and other medicines
The patient should inform her doctor or pharmacist about all medicines she is currently taking or has recently taken, as well as any medicines she plans to take.
The doctor will inform the patient whether additional contraceptive methods (e.g. condoms) are needed, and if so, for how long, and whether dosage adjustments of other medicines are necessary.
Some medicines:

• may affect the blood concentration of Slinda;
• may reduce contraceptive effectiveness;
• may cause unexpected bleeding.

These include medicines used to treat:

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate, topiramate);
• tuberculosis (e.g. rifampicin);
• HIV infection (e.g. ritonavir, nevirapine, efavirenz);
• hepatitis C virus infection (e.g. boceprevir, telaprevir);
• other infections (griseofulvin);
• high blood pressure in the pulmonary blood vessels (bosentan);
• depressive mood disorders (herbal product - St. John's wort Hypericum perforatum);
• certain bacterial infections (e.g. clarithromycin, erythromycin);
• fungal infections (e.g. fluconazole, itraconazole, ketoconazole, voriconazole);
• high blood pressure (hypertension), angina pectoris or certain cardiac arrhythmias (e.g. diltiazem). If the patient uses short-term medications that may reduce the effectiveness of Slinda, she should additionally use a mechanical contraceptive method. Since the effect of another medicine on Slinda may persist for up to 28 days after discontinuation of that medicine, the use of an additional mechanical contraceptive method is necessary for an equally long period. The doctor will inform the patient whether additional contraceptive methods are needed and, if so, for how long. If the use of medicines or herbal products continues after the end of the white, active tablets, the green placebo tablets should be skipped and the patient should immediately start taking tablets from the next pack.

If the patient uses long-term medications that may reduce the effectiveness of Slinda,
the doctor may recommend using a non-hormonal contraceptive method.
Slinda may also affect the action of other medicines, such as:

• cyclosporine, used to prevent rejection of transplanted organs (its effect may be increased);
• lamotrigine, used to treat epilepsy (its effect may be reduced);
• certain diuretics (aldosterone antagonists, potassium-sparing diuretics). The doctor may recommend monitoring serum potassium levels during the first treatment cycle.

Slinda with food and drink
The patient should avoid consuming grapefruit and grapefruit juice during treatment with Slinda.
Pregnancy and breastfeeding
Pregnancy
Slinda is contraindicated if the patient is pregnant or suspects she may be pregnant.
There is no evidence that using Slinda during pregnancy may increase the risk of congenital malformations in the child. However, adverse effects cannot be ruled out.
Breastfeeding
Slinda may be used during breastfeeding.
No effects on newborns and/or breastfed infants are expected. However, small
amounts of drospirenone pass into breast milk.
Driving and operating machinery
No effect on the ability to drive and operate machinery has been observed in women
using hormonal contraceptives; however, no studies have been conducted with this medicine.
Slinda contains 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
During treatment with Slinda, the doctor will recommend that the patient attend regular check-ups. The frequency and type of check-ups will depend on the patient's health status.
The patient should contact her doctor as soon as possible if:

• she experiences severe pain or swelling in one of the lower limbs, unexplained chest pain, shortness of breath, unusual cough, especially with coughing up blood (indicating possible thrombosis);
• she experiences sudden, severe stomach pain or jaundice (yellowing of the skin and whites of the eyes or dark urine may occur, which may indicate liver disorders);
• she detects a lump in the breast (indicating possible breast cancer);
• she experiences sudden or severe pain in the lower abdomen or stomach area (indicating possible ectopic pregnancy, i.e. a pregnancy developing outside the uterus);
• she will be immobilized or undergo surgery (she should consult her doctor at least four weeks in advance);
• she experiences unusual, heavy vaginal bleeding;
• she suspects she is pregnant.

3. How to take Slinda

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Each Slinda blister pack contains 24 white active tablets and 4 green tablets containing placebo. The tablets of different colours are arranged in the correct order. Take one tablet of Slinda every day, with a small amount of water if necessary. The tablet may be taken with or without food (see section "Slinda with food and drink"). Tablets should be taken daily at approximately the same time, so that the interval between two consecutive tablets is always 24 hours.

Do not confuse the tablets: Because of differences in tablet composition, it is essential to start taking the medicine from the first white tablet in the upper left corner of the blister and to take one tablet each day. To maintain the correct order of tablet intake, follow the direction of the arrows and the numbers on the blister.

Take the first tablet on the first day of menstrual bleeding. Then continue taking the tablets consecutively: take one white active tablet for the first 24 days, followed by one green tablet for the last 4 days. Then immediately start the next pack without interruption. Thus, there is no break between packs.

During treatment with Slinda, bleeding may occur or may not occur, but you should continue taking the tablets as usual, without interruption. When taken in this way, Slinda provides protection against pregnancy also during the 4 days when placebo tablets are taken.

Preparing the blister pack

To help you keep track of daily tablet intake, each blister pack includes 7 adhesive labels with days of the week. Choose the label where the first day of the week corresponds to the day you start taking the tablets (for example, if the first day of intake is Thursday, choose the label where "THU" is the first day) and apply it to the top of the blister, in the area marked "Apply label with days of the week here", so that the first day of tablet intake is positioned above the tablet marked "START". This way, each tablet will have a day symbol above it indicating the day it should be taken. Arrows and numbers indicate the order of tablet intake.

Starting the first pack of Slinda

• If no hormonal contraceptive has been used in the previous month Start taking Slinda on the first day of the menstrual cycle. When taken this way, the medicine provides immediate protection against pregnancy, and there is no need to use an additional contraceptive method (e.g. condoms).

• Switching from a combined hormonal contraceptive, vaginal ring, or transdermal patch Start taking Slinda the next day after taking the last active tablet (the last tablet containing active ingredients) of the previous contraceptive, or on the day of removal of the vaginal ring or transdermal patch (meaning no break in use of the tablet, vaginal ring, or patch). If these instructions are followed, there is no need to use an additional contraceptive method.

Alternatively, you may start taking Slinda no later than the next day after the usual tablet-free interval, after removal of the vaginal ring or transdermal patch, or after taking the last placebo tablet of the previously used combined oral contraceptive. In these cases, an additional mechanical contraceptive method (e.g. condoms) must be used for the first 7 days of taking Slinda.

• Switching from a progestogen-only pill (mini-pill) You may stop taking the progestogen-only pill on any day and start taking Slinda the next day. There is no need to use an additional contraceptive method.

• Switching from a progestogen-only injection, implant, or intrauterine system (IUS) releasing progestogen Start taking Slinda on the day when the next injection is due, or on the day of removal of the implant or intrauterine system. There is no need to use an additional contraceptive method.

• After childbirth You may start taking the medicine from day 21 to day 28 after delivery. If Slinda is started later than day 28 but before the first menstrual period, first confirm that the woman is not pregnant, and use mechanical contraception (e.g. condoms) for the first 7 days of tablet intake.

Information regarding breastfeeding can be found in section 2 ("Pregnancy and breastfeeding").

• After miscarriage or termination of pregnancy Follow your doctor's advice.

If you have any further doubts about when to start the first blister pack, consult your doctor.

Taking more Slinda than prescribed

There have been no reports of serious harmful effects after taking too many Slinda tablets. Symptoms that may occur include nausea, vomiting, or slight vaginal bleeding. However, in case of overdose, consult a doctor, as blood tests may be necessary.

Missed dose of Slinda

Tablets should be taken every day at approximately the same time, so that the interval between two consecutive tablets is always 24 hours. If you miss taking any single tablet by less than 24 hours, take it as soon as you remember, even if this means taking two tablets at the same time, and take the next tablet at the usual time. If you miss taking any white active tablet by more than 24 hours, take it as soon as you remember, even if this means taking two tablets at the same time. Use an additional contraceptive method (e.g. condoms) for the next 7 days, and continue taking the tablets at the usual time. The more consecutive tablets you miss, the greater the risk of reduced contraceptive effectiveness.

If you miss a tablet in the first week after starting treatment and have had sexual intercourse in the week before the missed tablet, you should be aware that there is a risk of pregnancy. In this case, consult your doctor.

If you miss a tablet between days 15 and 24 (third or fourth row of tablets in the blister), take it as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at the usual time. Instead of taking the green placebo tablets from the blister, skip them (discard them) and immediately start the next pack (the starting day will change). Skipping the placebo tablet period ensures continued contraceptive protection.

The last four green tablets in the fourth row of the blister are placebo tablets. If one of these tablets is missed, this will not affect the effectiveness of Slinda. Discard the missed placebo tablet.

What to do in case of vomiting or severe diarrhoea

If vomiting or severe diarrhoea occurs, there is a risk that the active ingredient from the tablet has not been completely absorbed. This situation is similar to missing tablets. In such a case, an additional contraceptive method may be necessary. Consult your doctor.

If vomiting or severe diarrhoea occurs within the first 3–4 hours after taking a Slinda tablet, take another white tablet from another pack as soon as possible. If possible, take it within 24 hours of your usual tablet-taking time. There is no need to use an additional contraceptive method. If this is not possible or more than 24 hours have passed, follow the instructions given under "Missed dose of Slinda".

Stopping treatment with Slinda

You may stop taking Slinda at any time. From the day you stop taking it, you are no longer protected against pregnancy.

If you have any further doubts about how to use 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 Slinda are described in
section 2 "Important information before taking Slinda", under the headings "Breast cancer"
and "Thrombosis". Please read these sections for additional information and consult your doctor if necessary.
Irregular vaginal bleeding may occur during treatment with Slinda. This may range from light spotting,
which may not even require the use of sanitary pads, to heavier bleeding resembling a light menstrual period
requiring the use of hygiene products. Bleeding may also not occur at all. Irregular bleeding is not a sign
of reduced contraceptive effectiveness of Slinda. Usually, no action is required and you should continue taking Slinda.
However, if bleeding is heavy or prolonged, consult your doctor.
If bleeding is very frequent and irregular, consider using another contraceptive method.
If no vaginal bleeding occurs during treatment, a pregnancy test may be necessary, especially if the tablets
have not been taken according to the instructions provided in section 3 "How to take Slinda".

The following adverse reactions have been associated with the use of Slinda:

Common: may affect up to 1 in 10 women

• headache
• nausea, abdominal pain
• changes in libido, mood changes
• acne
• breast discomfort, painful menstruation, bleeding and irregular menstrual cycles
• weight gain

Uncommon: may affect up to 1 in 100 women

• anaemia (reduced number of red blood cells), feeling tired, fluid retention
• dizziness
• vomiting, diarrhoea, constipation
• vaginal infections
• increase in the following parameters observed in blood tests: potassium concentration, liver enzyme activity (AlAT, AspAT, GGT), bilirubin concentration, creatine phosphokinase activity, triglyceride concentration
• changes in appetite
• uterine fibroids (benign uterine tumours)
• low mood, depression, anxiety
• absence of menstruation, changes in menstrual bleeding, pelvic pain, ovarian cysts, vaginal discharge, vaginal dryness
• hair loss, excessive sweating, itching, rash, seborrhoea (oily skin), skin inflammation
• increased blood pressure, hot flushes
• hypersensitivity

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

• intolerance to contact lenses
• weight loss
• excessive urine production
• breast cysts, breast discharge, abnormal cervical smear, genital itching

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of 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 provide more information on the safety of this medicine.

5. How to store the medicine Slinda

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
"EXP". The expiry date refers to the last day of the stated month. The batch number is indicated on
the packaging following "Lot".
Store below 25°C.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures help protect
the environment.

6. Contents of the pack and other information

What Slinda contains
White active coated tablets:

• The active substance is drospirenone. Each white active coated tablet contains 4 mg of drospirenone.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose, colloidal anhydrous silica (E 551), magnesium stearate (E 470b). Tablet coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc (E 553b).

Green placebo coated tablets:
Green placebo coated tablets do not contain any active substance.
Tablet core: monohydrate lactose, corn starch, povidone, colloidal anhydrous silica (E 551), magnesium stearate (E 470b).
Tablet coating: hypromellose (E 464), triacetin, polysorbate 80 (E 433), titanium dioxide (E 171), indigo carmine, lac (E 132), yellow iron oxide (E 172).

What Slinda looks like and contents of the pack
Each blister contains 24 active coated tablets and 4 placebo coated tablets.
The active tablet is a round, white tablet with a diameter of 5 mm, imprinted with the letters "E" and "D" on opposite sides of the tablet.
The placebo tablet is a round, green tablet with a diameter of 5 mm, imprinted with the letter "E" and the number "4" on opposite sides of the tablet.
Additionally, a cardboard blister holder is included in the cardboard outer box.
Slinda is available in calendar packs containing 1, 3 or 6 blisters, each blister containing 28 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Poland Sp. z o.o.
Szamocka 8 Street
01-748 Warsaw
Poland

Manufacturer
Laboratorios León Farma SA
Calle Vallina s/n
Polígono Industrial de Navatejera
Villaquilambre
24193 León
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Slinda
Czech Republic: Zlynda
Slovak Republic: Zlynda
Slovenia: Slinda
Sweden: Stelista
Hungary: Slinda

Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.