Package Insert: Information for the User

Slinda 4 mg Film-Coated Tablets

Drospirenone

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
  If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Slinda and for what it is used.

2. What you need to know before starting to take Slinda.

3. How to take Slinda.

4. Possible adverse effects.

5. Storage of Slinda.

6. Contents of the package and additional information

Slinda is a contraceptive and is used to prevent pregnancy.

Each blister pack of Slinda contains 24 white tablets, also known as active tablets, and 4 green tablets, also known as placebo tablets, which do not contain an active ingredient. The tablets of 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 progestin drospirenone. For this reason, Slinda is called a progestin-only contraceptive (POP).

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

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

A disadvantage is that irregular vaginal bleeding may occur during treatment with Slinda. It is also possible that you will have no bleeding.

General Considerations

Do not take Slinda:

• If you are allergic to drospirenone or any of the other components of this medication (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 liver disease and your liver function is not yet normal.
• If your kidneys do not function properly (renal insufficiency).
• If you have or suspect you have cancer that is sensitive to sex steroids, such as certain types of breast cancer.
• If you have unexplained vaginal bleeding.

If any of these conditions appear while you are taking Slinda, stop taking this medication 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.

Inform your doctor before starting to take Slinda if you have any of the following conditions:

• If you have ever had a blood clot (formation of a blood clot in a blood vessel).
• If you have liver cancer, if you have jaundice (yellow skin) or liver disease and your liver is not functioning normally.
• If you have ever had breast cancer.
• If you have or have had melasma (brownish-yellow skin patches, 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 function properly, your doctor will perform a blood test to check your potassium levels during the first cycle.

If you experience a worsening or first-time occurrence 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

Have your breasts examined regularly and contact your doctor as soon as possible if you notice any lumps in your breasts.

There has been an observed slightly higher incidence of breast cancer in women taking the pill compared to women of the same age who are not taking 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 combined oral contraceptives appear to be less likely to spread than breast cancers found in women who are not taking the combined oral contraceptive. It is not known whether the difference in breast cancer risk is caused by the combined oral contraceptive. It may be that women were examined more frequently, so that breast cancer was detected earlier.

It is believed that the risk of breast cancer in users of preparations with only progestogen such as Slinda is similar to that of women taking the combined oral contraceptive, but the evidence is less conclusive.

Blood Clots (Formation of Blood Clots in Blood Vessels)

Contact your doctor immediately if you notice possible signs of blood clots (see also "Regular Checks").

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

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

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

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

Mental Health Disorders

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

Medical Examination

Before starting to take 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 of the woman).

Taking Slinda with Other Medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

They can inform you if you need to take additional contraceptive measures (e.g. condoms) and for how long, or if you need to modify the other medication you need.

Some medications:

• may affect the levels of Slinda in the blood.
• may make it less effective in preventing pregnancy.
• may cause unexpected bleeding.

These include medications used to treat:

• 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),
• Mood disorders (St. John's Wort plant),
• 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 medications in short-term treatments that may make Slinda less effective, you should also use a barrier contraceptive method. Since the effect of another medication on Slinda may last up to 28 days after stopping the medication, you will need to use the additional barrier contraceptive method during that time. Your doctor can inform you if you need to take additional contraceptive measures and for how long. If you are taking medications or herbal preparations beyond the end of the active white tablets, discard the green placebo tablets and start taking the next package.

If you are taking medications 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 medications, for example:

• Ciclosporin used to prevent organ rejection (the effect may increase).
• Lamotrigine used to treat 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 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 adverse effects are expected on the newborn/infants being breastfed. However, very small amounts of drospirenone are excreted in breast milk.

Driving and Operating Machines

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

Slinda Contains Lactose

If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

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.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Each blister of Slinda 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 must take the tablets every day approximately at the same time, with an interval of 24 hours between two tablets.

Do not confuse the tablets: due to the different composition of the tablets, you must start with the first white tablet located in the upper 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.

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

You may have some bleeding during the taking of Slinda, or you may not have bleeding, but you must 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.

Preparation of the blister

To help you in the daily taking of the contraceptive, each package includes seven adhesive strips that have the days of the week printed on them. Choose the strip that starts with the day of the week when you started taking the tablets (for example, if you start on Thursday, stick the one that indicates “THU”) and place it on the upper left corner of the blister, in the “Start” position. In this way, there is a day of the week indicated above each tablet and you can check visually if you have taken a certain tablet. The arrows show the order in which the tablets should be taken.

When can you start with the first package 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 immediately protected against pregnancy and you will not need to use additional contraceptive measures such as a condom.

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

You must 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 of removal of the vaginal ring or transdermal patch (that is, without performing the period of rest without tablets, ring, or patch). If you follow these instructions, additional contraceptive measures will not be necessary.

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

• Change from another progestin-only pill (POP)

You can change from the progestin-only pill at any time and start taking Slinda the next day. Additional contraceptive measures will not be necessary.

• Change from a progestin-only injection, implant, or intrauterine device (IUD) releasing progestins (SLI).

You must start with Slinda on the day corresponding to the next injection or the day the implant or SLI is removed. Additional contraceptive measures will not be necessary.

• After childbirth.

You can start with Slinda any day between the 21st and 28th day after giving birth. If you start later than the 28th day but before your menstrual period returns, make sure you are not pregnant and you should use an additional 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 adverse effects have been described for taking too many Slinda tablets at once. The symptoms you may experience are nausea, vomiting, and mild vaginal bleeding.

However, in case of overdose, consult your doctor because a blood test will be required.

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 must take the tablets every day at approximately 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 this means taking two tablets at once. 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 7 days following. Then, continue taking the tablets at your usual time. The more consecutive tablets you forget, the greater the risk of reduced contraceptive efficacy.

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

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

The last 4 green placebo tablets of the4throw are the placebo tablets. If you forget to take one of these tablets, the reliability of Slinda will not be affected. Discard the forgotten placebo tablets.

What to do in case of vomiting or intense diarrhea?

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

If you have vomiting or intense diarrhea in the 3-4 hours following the taking of an active white tablet of Slinda, you must take a white tablet from another package as soon as possible. If possible, take itbefore 24 hourshave passed since the usual time of taking your contraceptive. No additional precautions will be necessary. If it is not possible or more than 24 hours have passed, follow the instructions in the section “If you forget to take Slinda”.

If you interrupt the 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.

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

Severe side effects associated with the use of Slinda are described in the paragraph “Breast Cancer” and “Thrombosis” in the section 2 ‘What you need to know before starting to take Slinda’.

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

Irregular vaginal bleeding may occur during the use of Slinda, which can be a light spotting that does not require a pad or a more intense bleeding, quite similar to a light period and requires the use of sanitary protection. It may also occur 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 the use of another contraceptive method. If you do not have vaginal bleeding during treatment, a pregnancy test should be performed if you have not taken the pills as indicated in section 3 “How to take Slinda”.

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

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

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

Infrequent 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 concentrations of: potassium, liver enzymes (ALT, AST, GGT), bilirubin, creatine phosphokinase, triglycerides.
• Alteration of appetite
• Uterine leiomyoma (benign tumor in the uterus)
• Depressive mood, depression, anxiety
• Amenorrhea, altered menstrual bleeding, pelvic pain, ovarian cysts, vaginal secretion and dryness
• Hair loss, increased sweating, itching, rash, seborrhea (greasy skin), dermatitis (skin inflammation)
• High blood pressure, hot flashes
• Hypersensitivity

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

• Intolerance to contact lenses.
• Weight loss
• Excessive urination
• Chest cysts, nipple secretion, abnormal cervical smear, genital itching.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting these side effects, you can contribute to providing more information on the safety of this medication.

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 after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Slinda

Coated tablets with active film, white in color:

• The active ingredient is drospirenone

Each coated tablet with active film, white in color, contains 4 mg of drospirenone.

• The rest of the excipients are:

Tablet core:microcrystalline cellulose; lactose; colloidal silicon dioxide (E551); magnesium stearate (E470b)

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

Coated tablets with placebo film, green in color:

The coated tablets with placebo film, green in color, do not contain active ingredient.

Tablet core:lactose monohydrate; cornstarch; povidone; colloidal silicon dioxide (E551); magnesium stearate (E470b).

Coating:hypromellose (E464); triacetin; polisorbate 80 (E433), titanium dioxide (E171), indigo carmine lake (E132); yellow iron oxide (E172).

Appearance of the product and contents of the package

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

The active tablets are round, white in color, with the letters “E” and “D” each on one face, with a diameter of 5 mm.

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

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

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

You may not be marketed all package sizes.

Marketing authorization holder:

Exeltis Healthcare, S.L.

Avenida de Miralcampo, 7.

Industrial Park Miralcampo.

19200 Azuqueca de Henares. Guadalajara.

Spain.

Manufacturer

Laboratorios León Farma, S.A.

Navatejera Industrial Park;

La Vallina s/n;

24193-Villaquilambre, León

Spain.

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this prospectus:March 2022

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