Slinda

Package Leaflet: Information for the Patient

Slinda, 4 mg, film-coated tablets

Drospirenone

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 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 pill used to prevent pregnancy. Each blister pack of Slinda contains 24 white active tablets and 4 green placebo tablets that do not contain any active substance. The tablets are marked with two different colors and are arranged in the correct order.

Each of the 24 white active tablets contains a small amount of one type of female sex hormone, progestogen - drospirenone. For this reason, Slinda is called a progestogen-only pill (POP). Unlike the combined pill, progestogen-only pills do not contain estrogen. Therefore, Slinda can be used by women who do not tolerate estrogens.

Slinda has a high contraceptive effectiveness. The contraceptive effect of Slinda is based on the inhibition of ovulation, changes in cervical mucus, and the effect on the endometrium, which becomes thinner.

A disadvantage that may occur during the use of Slinda is the occurrence of irregular bleeding from the genital tract during its use. Bleeding may also not occur at all.

2. Important information before taking Slinda

When not to take Slinda:

• if you are allergic to drospirenone or any of the other ingredients of this medicine (listed in section 6);
• if you have blood clots in the blood vessels, e.g., in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism);
• if you have or have had liver disease and liver function is still impaired;
• if you have kidney problems (renal insufficiency);
• if you have or are suspected of having a hormone-dependent cancer, such as some types of breast cancer;
• if you have bleeding from the genital tract of unknown cause.

If any of these conditions occur during the use of Slinda, you should stop taking the medicine immediately and consult a doctor.

Warnings and precautions

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

Before starting to use Slinda, you should discuss with your doctor:

• if you have ever had a blood clot in the past;
• if you have liver cancer, jaundice (yellowing of the skin), or liver disease and liver function is impaired;
• if you have ever had breast cancer;
• if you have or have had chloasma (brown patches on the skin, especially on the face); in this case, you should avoid direct exposure of the skin to sunlight or ultraviolet radiation during the use of Slinda;
• if you have diabetes;
• if you have high blood pressure;
• if you have kidney problems. In this case, your doctor may recommend monitoring potassium levels in the blood during the first cycle of using Slinda.

If any of these conditions worsen or occur for the first time during the use of Slinda, you should consult a doctor. The doctor will decide whether to stop taking Slinda and may recommend using a non-hormonal contraceptive method.

Children and adolescents

Slinda is used after the first menstrual period (first menstrual bleeding in women).

Slinda and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Your doctor will inform you whether there is a need to use an additional contraceptive method (e.g., a condom) and if so, for how long, and whether there is a need to change the dosage of other medicines you are taking.

Some medicines:

• may affect the level of Slinda in the blood;
• may reduce the effectiveness of Slinda in preventing pregnancy;
• may cause unexpected bleeding.

These are 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 infectious diseases (griseofulvin);
• high blood pressure in the blood vessels of the lungs (bosentan);
• depressive moods (herbal medicine - St. John's Wort Hypericum perforatum);
• some bacterial infections (e.g., clarithromycin, erythromycin);
• fungal infections (e.g., fluconazole, itraconazole, ketoconazole, voriconazole);
• high blood pressure (hypertension), angina pectoris, or certain heart rhythm disorders (e.g., diltiazem). If you are taking medicines that may make Slinda less effective, you should use an additional mechanical contraceptive method. Since the effect of another medicine on Slinda may last up to 28 days after stopping that medicine, it is also necessary to use an additional mechanical contraceptive method for the same amount of time. Your doctor will inform you whether you need to use additional contraceptive methods and if so, for how long.

If you are taking medicines that may make Slinda less effective for a long time, your 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 a transplanted organ (its action may be increased);
• lamotrigine, used to treat epilepsy (its action may be decreased);
• certain diuretics (aldosterone antagonists, potassium-sparing diuretics). Your doctor may recommend monitoring potassium levels in the blood during the first cycle of using Slinda.

Slinda with food and drink

You should avoid consuming grapefruits and grapefruit juice while taking Slinda.

Pregnancy and breastfeeding

Pregnancy

Slinda is contraindicated if you are pregnant or think you may be pregnant.

It has not been shown that the use of Slinda during pregnancy may increase the risk of congenital anomalies in the child. However, it cannot be ruled out that adverse reactions may occur.

Breastfeeding

Slinda can be used during breastfeeding.

No effect on newborns and (or) breastfed infants is expected. However, small amounts of drospirenone pass into human milk.

Driving and using machines

No effect on the ability to drive and use machines has been observed in women taking hormonal contraceptives, but no studies have been conducted with this medicine.

Slinda contains lactose

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking this medicine.

Regular check-ups

While taking Slinda, your doctor will recommend regular check-ups. The frequency and type of check-ups will depend on your health condition.

You should contact your doctor as soon as possible if:

• you experience severe pain or swelling in one of your legs, unexplained chest pain, shortness of breath, unusual cough, especially with bloody sputum (indicating a possible blood clot);
• you experience sudden, severe abdominal pain or jaundice (yellowing of the skin and whites of the eyes or dark urine, which may indicate liver problems);
• you feel a lump in your breast (indicating a possible breast cancer);
• you experience sudden, severe pain in the lower abdomen or pelvic area (indicating a possible ectopic pregnancy);
• you will be immobilized or have surgery (you should consult your doctor at least 4 weeks in advance);
• you experience unusual, heavy vaginal bleeding;
• you suspect you are pregnant.

3. How to take Slinda

Take this medicine always as directed by your doctor. If you are not sure, ask your doctor or pharmacist.

Each blister pack of Slinda contains 24 white active tablets and 4 green placebo tablets.

Take one Slinda tablet every day, if necessary with a small amount of water. You can take the tablet with or without food (see section "Slinda with food and drink"). Take the tablets every day at the same time, so that the time between taking two tablets is always 24 hours.

Do not confuse the tablets:Due to the differences in the composition of the tablets, it is necessary to start taking the medicine from the first white tablet in the top left corner of the blister pack and take one tablet every day. To maintain the correct order of taking the tablets, follow the direction of the arrows and the next numbers on the blister pack.

Take the first tablet on the first day of your menstrual period. Then, take the tablets continuously. Take one white active tablet for the first 24 days, and then one green placebo tablet for the last 4 days. Then, start a new pack immediately, without a break in taking the tablets. Therefore, there is no break between the two packs.

During the use of Slinda, bleeding may occur or may not occur, but you should continue taking the tablets as usual, without a break in taking the tablets.

Slinda, used in this way, also protects against pregnancy during the 4 days when you are taking the placebo tablets.

Preparing the blister pack

To help you control whether you are taking the tablets every day, each Slinda blister pack comes with 7 stickers with the days of the week. Choose the appropriate sticker, where the first day of the week corresponds to the day you start taking the tablets (e.g., if the first day of use is Thursday, choose the sticker where the first day of the week is "THU") and stick it on the top of the blister pack, in the place marked "Stick the sticker with the days of the week here", so that the first day of taking the tablets is above the tablet marked "START". Then, each tablet will have a symbol of the day, indicating the day on which you should take the tablet. The arrows and numbers show the order of taking the tablets.

Starting the first pack of Slinda

• If you are not using a hormonal contraceptive in the last monthYou should start taking Slinda on the first day of your menstrual period. If you do this, the medicine will immediately protect you against pregnancy, and you do not need to use an additional contraceptive method, such as a condom.
• Switching from a combined hormonal contraceptive, vaginal ring, or transdermal patchYou should start taking Slinda the next day after taking the last active tablet (the last tablet containing the active substance) of your previous contraceptive or on the day you remove the vaginal ring or transdermal patch (this means you do not take a break between taking the tablets, vaginal ring, or transdermal patch). If you follow these instructions, you do not need to use an additional contraceptive method.

You can also start taking Slinda no later than the day after you finish taking the usual break in taking the tablets, using the vaginal ring, or using the transdermal patch or after taking the placebo tablets of your previous combined oral contraceptive. In these cases, you should use an additional mechanical contraceptive method for the first 7 days of taking Slinda.

• Switching from another progestogen-only pill (minipill)You can stop taking another progestogen-only pill on any day and start taking Slinda the next day. You do not need to use an additional contraceptive method.
• Switching from an injection or implant containing only progestogen or from an intrauterine system (IUS) releasing progestogenYou should start taking Slinda on the day you would have your next injection or on the day you remove the implant or intrauterine system. You do not need to use an additional contraceptive method.
• After childbirthYou can start taking Slinda from the 21st to the 28th day after giving birth. If you start taking Slinda later than 28 days after giving birth but before your menstrual period, you should first make sure you are not pregnant and use a mechanical contraceptive method (e.g., a condom) for the first 7 days of taking the tablets.

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

• After miscarriage or abortionFollow your doctor's instructions.

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

Overdose

There are no reports of serious, harmful effects after taking too many Slinda tablets.

Symptoms that may occur are nausea, vomiting, or slight vaginal bleeding.

However, if you have taken too much of the medicine, you should consult your doctor, as a blood test may be necessary.

Missed tablets

Take the tablets every day at the same time, so that the time between taking two tablets is always 24 hours.

If you are late taking any single tablet by less than 24 hours, you should take it as soon as you remember, even if it means taking two tablets at the same time, and take the next tablet at the usual time.

If you are late taking any white active tablet by more than 24 hours, you should take it as soon as you remember, even if it means taking two tablets at the same time.

Use an additional contraceptive method (e.g., a condom) for the next 7 days and take the next tablets at the usual time.

The more tablets you miss, the higher the risk of reduced contraceptive effectiveness.

If you miss a tablet in the first weekof taking Slinda and you had sexual intercourse in the week before missing the tablets, you may be at risk of pregnancy.

In this case, you should consult your doctor.

If you miss a tablet between days 15 and 24 (third or fourth row of tablets in the blister pack), you should take it as soon as you remember, even if it 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 pack, you should skip them (discard them) and start a new pack.

Skipping the placebo tablets ensures that you maintain contraceptive protection.

The last four green tablets in the fourth rowof the blister pack are placebo tablets.

If you miss one of these tablets, it will not affect the effectiveness of Slinda.

Discard the missed placebo tablet.

Vomiting or severe diarrhea

If you vomit or have severe diarrhea, there is a risk that the active substance from the tablet may not have been completely absorbed into your body.

This situation is almost the same as missing a tablet.

In this case, you may need to use an additional contraceptive method.

Consult your doctor.

If you vomit or have severe diarrhea within 3-4 hours after taking a Slinda tablet, you should take another white tablet from a different pack as soon as possible.

If possible, take it within 24 hours of the normal time you take the tablet.

You do not need to use an additional contraceptive method.

If it is not possible or more than 24 hours have passed, follow the instructions in the section "Missed tablets".

Stopping Slinda

You can stop taking Slinda at any time.

From the day you stop taking the medicine, you are no longer protected against pregnancy.

If you have any further questions about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Slinda can cause side effects, although not everybody gets them.

Serious side effects related to the use of Slinda are described in section 2 "Important information before taking Slinda", in the sections "Breast cancer" and "Blood clots".

Read these sections to get more information and consult your doctor if necessary.

During the use of Slinda, irregular vaginal bleeding may occur.

They may be in the form of slight spotting, which may not even require the use of sanitary pads, or more intense bleeding, which may resemble a light menstrual period and require the use of sanitary products.

Bleeding may also not occur at all.

Irrregular bleeding is not a sign of reduced contraceptive effectiveness of Slinda.

Usually, there is no need to take any action; you should continue taking Slinda.

If the bleeding is heavy or prolonged, you should consult your doctor.

If the bleeding is very frequent and irregular, you should consider using another contraceptive method.

If you do not experience vaginal bleeding during treatment, you may need to have a pregnancy test if you have not taken the tablets as instructed in section 3 "How to take Slinda".

The following side effects have been associated with the use of Slinda:

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• anemia (reduced red blood cell count), feeling tired, fluid retention
• dizziness
• vomiting, diarrhea, constipation
• vaginal infections
• increased levels of potassium, liver enzymes (ALT, AST, GGT), bilirubin, creatine phosphokinase, triglycerides in blood tests
• changes in appetite
• uterine fibroids (benign tumors of the uterus)
• depression, anxiety
• absence of menstruation, changes in menstrual bleeding, pelvic pain, ovarian cysts, vaginal discharge, vaginal dryness
• hair loss, excessive sweating, itching, rash, seborrhea (oily skin), skin inflammation
• high blood pressure, hot flashes
• hypersensitivity

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

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

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, website: https://smz.ezdrowie.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 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 after "EXP".

The expiry date refers to the last day of the month stated.

The batch number is stated on the packaging after "Lot".

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

This will help protect the environment.

6. Contents of the pack and other information

What Slinda contains

White film-coated active tablets:

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

Green film-coated placebo tablets:

The green film-coated placebo tablets do not contain any active substance.

Tablet core: lactose monohydrate, corn starch, povidone, silica colloidal anhydrous (E 551), magnesium stearate (E 470b).

Tablet coating: hypromellose (E 464), triacetin, polysorbate 80 (E 433), titanium dioxide (E 171), indigo carmine, lake (E 132), yellow iron oxide (E 172).

What Slinda looks like and contents of the pack

Each blister pack contains 24 active film-coated tablets and 4 placebo film-coated tablets.

The active tablet is a white, round tablet with a diameter of 5 mm, with the letters "E" and "D" embossed on opposite sides of the tablet.

The placebo tablet is a green, round tablet with a diameter of 5 mm, with the letter "E" and the number "4" embossed on opposite sides of the tablet.

In addition to the carton, a cardboard case for the blister pack is provided.

Slinda is available in calendar packs, containing 1, 3, and 6 blisters, each with 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Exeltis Poland Sp. z o.o.

Szamocka 8

01-748 Warsaw

Manufacturer

Laboratorios León Farma SA

Calle Vallina s/n

Polígono Industrial de Navatejera

Villaquilambre

24193 León

Spain

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

Poland:

Slinda

Czech Republic:

Zlynda

Slovakia:

Zlynda

Slovenia:

Slinda

Sweden:

Stelista

Hungary:

Slinda

Date of last revision of the leaflet:20.05.2024

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