SLINDA 4 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Slinda 4 mg film-coated tablets

Drospirenone

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again. 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, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Slinda and what is it used for.
2. What you need to know before you start taking Slinda.
3. How to take Slinda.
4. Possible side effects.
5. Storage of Slinda.
6. Contents of the pack and further information

1. What is Slinda and what is it used for

Slinda is a contraceptive and is used to prevent pregnancy.

Each blister of Slinda contains 24 white tablets, also called active tablets, and 4 green tablets, also called placebo tablets, which do not contain active ingredients. The tablets of two different colors are arranged in order.

Each of the 24 active white tablets contains a small amount of a type of female sex hormone, the progestogen drospirenone. For this reason, Slinda is called a progestogen-only contraceptive (POP).

Unlike combined contraceptives, POPs do not contain any estrogenic hormone along with the progestogen. For this reason, Slinda can be used by women who do not tolerate estrogens.

Slinda provides high contraceptive efficacy. The contraceptive effect of Slinda is based on the inhibition of ovulation, changes in cervical mucus, and effects on the endometrium, which becomes thinner.

A disadvantage is that vaginal bleeding at irregular intervals may occur during treatment with Slinda. It is also possible that you may not have any bleeding.

2. What you need to know before you start taking Slinda

General considerations

Do not take Slinda:

• If you are allergic to drospirenone or any of the other ingredients of this medicine (listed in section 6).
• If you have a blood clot in a blood vessel, e.g. in the leg (deep vein thrombosis) or in the lungs (pulmonary embolism).
• If you have or have had a liver disease and your liver function is not yet normal.
• If your kidneys do not work well (renal insufficiency).
• If you have or suspect you have a hormone-sensitive cancer, such as certain types of breast cancer.
• If you have unexplained vaginal bleeding.

If any of these conditions occur while you are using Slinda, stop taking this medicine and contact your doctor immediately.

Warnings and precautions

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

Tell your doctor before you start taking Slinda if you have any of the following conditions:

• if you have ever had a thrombosis (formation of a blood clot in a blood vessel).
• if you have liver cancer, if you have jaundice (yellow skin) or a liver disease and your liver is not working normally.
• if you have ever had breast cancer.
• if you have or have had chloasma (brownish-yellow patches on the skin, particularly on the face); if this is the case, you should avoid exposure to the sun or ultraviolet radiation during treatment with Slinda.
• diabetes.
• if you have high blood pressure.
• if your kidneys do not work well, your doctor will perform a blood test to check your potassium levels during the first cycle.

If you experience a worsening or appearance for the first time of any of these conditions, you should contact your doctor. Your doctor will decide whether you should stop taking Slinda and may recommend that you use a non-hormonal contraceptive method.

Breast cancer

Regularly examine your breasts and contact your doctor as soon as possible if you notice any lump in your breasts.

Breast cancer has been observed with a slightly higher frequency in women taking the pill than in women of the same age who do not take it. If the woman stops taking the pill, the risk decreases gradually, so that 10 years after stopping it, the risk is the same as that of women who have never taken it.

Breast cancer is rare before the age of 40. The breast cancers found in women taking the combined pill seem to be less likely to spread than the breast cancers found in women who do not take the combined pill. It is not known whether the difference in breast cancer risk is caused by the combined pill. It may be that the women were examined more frequently, so that breast cancer was detected earlier.

It is believed that the risk of breast cancer in users of progestogen-only preparations like Slinda is similar to that of women taking the combined pill, but the evidence is less conclusive.

Thrombosis (formation of blood clots in blood vessels)

Contact your doctor immediately if you notice possible signs of thrombosis (see also “Regular checks”)

Thrombosis is the formation of a blood clot that can block a blood vessel. Thrombosis sometimes occurs in the deep veins of the legs (deep vein thrombosis). If the clot breaks loose from the veins where it has formed, it can reach and block the arteries of the lungs, causing what is known as a “pulmonary embolism”, which can be fatal.

The risk of thrombosis may be slightly higher with the progestogen-only preparation. The risk of thrombosis is higher if a family member (brother or father) has had thrombosis at a relatively early age, with increasing age, obesity, prolonged immobilization, major surgery, or major trauma.

There is no apparent risk of having a heart attack or stroke (a blood clot in the brain) with a progestogen-only preparation. The risk is more related to increasing age, increasing blood pressure, and smoking.

The risk of stroke may increase slightly in women with high blood pressure when taking progestogen-only preparations.

Psychiatric disorders

Some women using hormonal contraceptives, including Slinda, have reported depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for further medical advice as soon as possible.

Medical examination

Before you start taking Slinda for the first time or if you restart treatment after a period without taking it, your doctor will ask you some questions about your health and perform a complete physical examination, including blood pressure measurement. Your doctor will tell you how often you should have check-ups.

Children and adolescents

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

Taking Slinda with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

They can inform you if you need to take any additional contraceptive measures (e.g. condoms) and if so, for how long, or if you should modify the intake of the other medicine you need.

Some medicines:

• may have an influence on Slinda levels in the blood
• may make Slinda less effective in preventing pregnancy
• may cause unexpected bleeding.

These include medicines used for the treatment of:

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate, topiramate),
• tuberculosis (e.g. rifampicin),
• HIV infection (e.g. ritonavir, nelfinavir, nevirapine, efavirenz),
• Hepatitis C virus infection (e.g. boceprevir, telaprevir),
• other infections (griseofulvin),
• high blood pressure in the blood vessels of the lungs (bosentan),
• depressive mood (St. John's Wort),
• certain bacterial infections (e.g. clarithromycin, erythromycin),
• fungal infections (e.g. fluconazole, itraconazole, ketoconazole, and voriconazole),
• high blood pressure (hypertension), angina, or certain heart rhythm disorders (e.g. diltiazem).

If you are taking medicines in short-term treatments that may make Slinda less effective, you should also use a barrier contraceptive method. Since the effect of another medicine on Slinda may last up to 28 days after stopping the medicine, during this time, an additional barrier contraceptive method should be used. Your doctor may inform you if you need to take any additional contraceptive measures and if so, for how long. If you are taking medicines or herbal preparations beyond the end of the active white tablets, discard the green placebo tablets and start taking the next pack.

If you are taking medicines in long-term treatments that may make Slinda less effective, your doctor may recommend a non-hormonal contraceptive method.

Slinda may also interfere with the effect of other medicines, for example:

• Ciclosporin used to prevent organ rejection after transplantation (the effect may increase).
• Lamotrigine used for epilepsy (the effect may decrease).
• Certain diuretics (aldosterone antagonists, potassium-sparing diuretics). Your doctor may recommend a blood test to check your potassium levels during the first cycle of treatment with Slinda.

Taking Slinda with food and drinks

Avoid taking grapefruit or grapefruit juice while you are taking Slinda.

Pregnancy and breastfeeding

Pregnancy

Do not use Slinda if you are pregnant or if you think you may be pregnant.

The use of Slinda before pregnancy has not shown an increased risk of congenital defects. However, it cannot be ruled out that adverse effects may occur.

Breastfeeding

Slinda can be used during breastfeeding.

No effects on newborns/breastfed children are expected. However, very small amounts of drospirenone are excreted in breast milk.

Driving and using machines

No effects on the ability to drive and use machines have been observed in users of hormonal contraceptives, although no studies have been performed with Slinda.

Slinda contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Regular checks

During treatment with Slinda, your doctor will require you to undergo regular checks. In general, the frequency and characteristics of these checks will depend on your personal situation.

3. How to Take Slinda

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist.

Each Slinda blister pack contains 24 active white tablets and 4 green placebo tablets. The two different types of colored tablets are placed in order.

Take one Slinda tablet every day with a little water if necessary. You can take the tablets with or without food (see section "Taking Slinda with Food and Drink"). You should take the tablets every day at approximately the same time, with the interval between two tablets always being 24 hours.

Do not get the tablets mixed up: due to the different composition of the tablets, it is necessary to start with the first white tablet located in the top left corner and then take one tablet every day. To maintain the order, follow the direction of the arrows and the sequence of numbers on the blister pack.

The first tablet of the treatment should be taken on the first day of menstrual bleeding. Subsequently, take the rest of the tablets continuously. Take an active white tablet for the first 24 days and then a green placebo tablet for the last 4 days. Then, you should start a new pack immediately without leaving any days of rest in taking the tablets, so there will be no space between two packs.

It is possible that you may have some bleeding during the taking of Slinda, or you may not have bleeding, but you should continue taking the tablets without interruption.

If you use Slinda in this way, you will also be protected against pregnancy during the 4 days of taking the placebo tablets.

Preparing the Blister Pack

To help you with the daily intake of the contraceptive, each pack includes seven adhesive strips with the days of the week printed on them. Choose the strip that starts with the day of the week you started taking the tablets (for example, if you start on Thursday, stick the one that says "THU") and place it on the top left of the blister pack, in the "Start" position. This way, there is a day of the week indicated above each tablet and you can visually check if you have taken a particular tablet. The arrows show the order in which the tablets should be taken.

When can you start with the first pack of Slinda?

• If you have not taken any hormonal contraceptive in the previous month.

Start taking Slinda on the first day of your period. By doing so, you will be protected immediately against pregnancy and will not need to use additional contraceptive measures such as a condom.

• Switching from another combined hormonal contraceptive, vaginal ring, or transdermal patch.

You should start taking Slinda the day after the last active tablet (the last tablet that contains the active substance) of your previous hormonal contraceptive or the same day you remove the vaginal ring or transdermal patch (i.e., without taking a break without tablets, ring, or patch). If you follow these instructions, no additional contraceptive measures will be necessary.

You can also start Slinda the day after the week of rest without tablets, vaginal ring, patch, or placebo period of your previous contraceptive. In this case, make sure to use an additional barrier contraceptive method during the 7 days following the taking of Slinda.

• Switching from a progestin-only pill (POP)

You can switch from a progestin-only pill at any time and start taking Slinda the next day. No additional contraceptive measures will be necessary.

• Switching from a progestin-only injection or an implant or an intrauterine device that releases progestogens (IUD).

You should start Slinda on the day the next injection is due or the day the implant or IUD is removed. No additional contraceptive measures will be necessary.

• After childbirth.

You can start Slinda any day between the 21st and 28th day after having the baby. If you start later than the 28th day but before your menstruation returns, you must ensure you are not pregnant and should use a barrier contraceptive method such as a condom until you have completed the first 7 tablets.

You can find more information on breastfeeding in section 2 (Pregnancy and Breastfeeding).

• After an abortion.

Follow your doctor's recommendations.

Consult your doctor if you are unsure when to start.

If you take more Slinda than you should

No serious harmful effects have been described for taking too many Slinda tablets at once. The symptoms that may occur are nausea, vomiting, and mild vaginal bleeding.

However, in case of overdose, consult your doctor because a blood test should be performed.

In cases of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915620420, indicating the medication and the amount ingested.

If you forget to take Slinda

You should take the tablets every day at the same time so that the interval between two tablets is always 24 hours. If you forget to take only one tablet and less than 24 hours have passed, take the tablet as soon as you remember and take the next tablet at your usual time, even if it means taking two tablets at the same time. If more than 24 hours have passed since taking any active white tablet, take the tablet as soon as you remember, and use an additional contraceptive method (such as a condom) for the next 7 days. Then, continue taking the tablets at the usual time. The more consecutive tablets you forget, the greater the risk that the contraceptive efficacy will be reduced.

If you have forgotten to take a tablet during the first week of the cycle and have had sexual intercourse during the previous week, you should know that there is a risk of pregnancy. In this case, contact your doctor.

If you forgot to take a tablet between days 15-24 (third or fourth row), take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the active white tablets at your usual time. Instead of taking the green placebo tablets from this strip, remove them and start the next row (the start day will be different). By skipping the placebo interval, contraceptive protection is maintained.

The last 4 green tablets in the 4throw are the placebo tablets. If you forget to take any of these tablets, the reliability of Slinda will not be affected. Discard the forgotten placebo tablets.

What to do in case of vomiting or severe diarrhea?

If you have vomiting or severe diarrhea, there is a risk that the active ingredient of the pill will not be fully absorbed by the body. The situation is similar to when you forget a tablet. In these cases, an additional contraceptive method will be necessary. Consult your doctor.

If you have vomiting or severe diarrhea in the 3-4 hours following the taking of an active white Slinda tablet, you should take a white tablet from another pack as soon as possible. If possible, take it before 24 hours have passed since the usual time of taking your contraceptive. No additional contraceptive precautions will be necessary. If it is not possible or more than 24 hours have passed, follow the advice in the "If you forget to take Slinda" section.

If you interrupt treatment with Slinda

You can stop taking Slinda at any time you want. From the day you stop taking it, you will no longer be protected against pregnancy.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The serious side effects associated with the use of Slinda are described in the paragraph "Breast Cancer" and "Thrombosis" in section 2 "What you need to know before you start taking Slinda".

Read this section for more information and consult your doctor if necessary.

Irregular vaginal bleeding may occur during the use of Slinda, which can be a slight spotting that does not require a pad or a more intense bleeding, quite similar to a scarce menstruation that requires sanitary protection. It can also happen that you never have bleeding. Irregular bleeding is not a sign that the contraceptive protection of Slinda has decreased. In general, you do not need to do anything; simply continue taking Slinda. However, if the bleeding is intense 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 have vaginal bleeding during treatment, you should have a pregnancy test if you have not taken the tablets as indicated in section 3 "How to take Slinda".

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

Common side effects(may affect up to 1 in 10 people):

• Headache
• Nausea, abdominal pain
• Changes in sexual desire, mood changes
• Acne
• Breast tenderness, painful menstruation, irregular bleeding and menstruation
• Weight gain

Uncommon side effects(may affect up to 1 in 100 people):

• Anemia (decrease in red blood cell count), fatigue (tiredness), fluid retention
• Dizziness
• Vomiting, diarrhea, constipation
• Vaginal infections
• Increased blood levels of: potassium, liver enzymes (ALT, AST, GGT), bilirubin, creatine phosphokinase, triglycerides
• Appetite change
• Uterine leiomyoma (benign tumor in the uterus)
• Depressed mood, depression, anxiety
• Amenorrhea (absence of menstruation), altered menstrual bleeding, pelvic pain, ovarian cysts, vaginal discharge and dryness
• Hair loss, increased sweating, itching, rash, seborrhea (oily skin), dermatitis (skin inflammation)
• High blood pressure, hot flashes
• Hypersensitivity

Rare side effects(may affect up to 1 in 1,000 people):

• Intolerance to contact lenses
• Weight loss
• Excessive urination
• Breast cysts, breast discharge, abnormal cervical smear, genital itching

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Slinda

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and blister pack after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Slinda

Active white film-coated tablets:

• The active ingredient is drospirenone

Each active white film-coated tablet contains 4 mg of drospirenone.

• The other excipients are:

Core of the tablet:microcrystalline cellulose; lactose; colloidal silica (E551); magnesium stearate (E470b)

Coating:polyvinyl alcohol; titanium dioxide (E171); macrogol; talc (E553b)

Green placebo film-coated tablets:

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

Core of the tablet:lactose monohydrate; cornstarch; povidone; colloidal silica (E551); magnesium stearate (E470b)

Coating:hypromellose (E464); triacetin; polysorbate 80 (E433); titanium dioxide (E171); aluminum lake of carmine (E132); yellow iron oxide (E172)

Appearance of the Product and Package Contents

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

The active tablets are round, white, with the letters "E" and "D" on each face, with a diameter of 5 mm.

The placebo tablets are round, green, with the letter "E" and the number "4" engraved on each face, with a diameter of 5 mm.

In addition to the cardboard box, a cardboard case is included for the blister pack.

Slinda is available in calendarized packs with 1, 3, 6, and 13 blister packs of 28 tablets each.

Not all pack sizes may be marketed.

Marketing Authorization Holder:

Exeltis Healthcare, S.L.

Miralcampo Avenue, 7.

Miralcampo Industrial Estate.

19200 Azuqueca de Henares. Guadalajara.

Spain.

Manufacturer

Laboratorios León Farma, S.A.

Navatejera Industrial Estate;

La Vallina s/n;

24193-Villaquilambre, León

Spain.

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

Date of the last revision of this leaflet:March 2022

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es./)