Slinda 4 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Slinda 4 mg film-coated tablets

Drospirenone

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Leaflet contents

1. What Slinda is and what it is used for.
2. What you need to know before taking Slinda.
3. How to take Slinda.
4. Possible adverse 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 and is used to prevent pregnancy.

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

Each of the 24 white active 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 oestrogenic hormone along with the progestogen. For this reason, Slinda can be used by women who do not tolerate oestrogens.

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

One disadvantage is that irregular vaginal bleeding may occur during treatment with Slinda. It is also possible to have no bleeding at all.

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

General considerations

Do not take Slinda:

• If you are allergic to drospirenone or to any of the other components 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 liver disease and your liver function is not yet normal.
• If your kidneys do not work properly (renal insufficiency).
• If you have or suspect you have a steroid-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 infections.

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

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

If any of these conditions worsens or occurs for the first time, you must contact your doctor. Your doctor will decide whether you should stop taking Slinda and may recommend using a non-hormonal contraceptive method.

Breast cancer

Examine your breasts regularly and contact your doctor as soon as possible if you notice any lump in your breasts.

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

Breast cancer is rare before the age of 40. Breast cancers detected in women taking combined oral contraceptives appear to be less likely to spread than those found in women not taking combined oral contraceptives. It is not known whether the difference in breast cancer risk is caused by the combined pill. 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 progestogen-only preparations such as Slinda is similar to that in 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 check-ups”).

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

The risk of thrombosis may be slightly higher with progestogen-only preparations. The risk of thrombosis is higher if a family member (a sibling or parent) has had thrombosis at a relatively young age, with increasing age, obesity, prolonged immobility, major surgery, or major trauma.

There is no apparent risk of heart attack or stroke (a blood clot in the brain) with a progestogen-only preparation. The risk is rather related to increasing age, increased 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 who use hormonal contraceptives, including Slinda, have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or 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 restarting treatment after a break, your doctor will ask you some questions about your health and perform a complete physical examination, including measuring your blood pressure. Your doctor will tell you how often you should have check-ups.

Children and adolescents

Slinda is used after menarche (a woman’s first menstrual bleeding).

Taking Slinda with other medicines

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

They can advise you whether you need to use additional contraceptive measures (e.g., condoms) and, if so, for how long, or whether you need to adjust the dosage of the other medicine.

Some medicines:

• may affect the levels of Slinda in the blood,
• may make it less effective in preventing pregnancy,
• 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, nelfinavir, nevirapine, efavirenz),
• hepatitis C virus infection (e.g., boceprevir, telaprevir),
• other infections (griseofulvin),
• high blood pressure in the pulmonary vessels (bosentan),
• depression (St. John’s wort herbal remedy),
• certain bacterial infections (e.g., clarithromycin, erythromycin),
• fungal infections (e.g., fluconazole, itraconazole, ketoconazole, voriconazole),
• high blood pressure (hypertension), angina, or certain heart rhythm disorders (e.g., diltiazem).

If you are taking short-term treatments with medicines that could reduce the effectiveness of Slinda, you should also use a barrier contraceptive method. Because the effect of another medicine on Slinda may last up to 28 days after stopping the medicine, a barrier contraceptive method must be used during that time. Your doctor can advise you whether you need to take additional contraceptive measures and, if so, for how long. If you are taking medicines or herbal preparations beyond the end of the white active tablets, discard the green placebo tablets and start the next pack immediately.

If you are taking long-term treatments that could reduce the effectiveness of Slinda, your doctor may recommend a non-hormonal contraceptive method.

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

• Cyclosporine used to prevent organ transplant rejection (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 potassium levels during the first treatment cycle with Slinda.

Taking Slinda with food and drinks

Avoid consuming grapefruit or grapefruit juice while taking Slinda.

Pregnancy and breastfeeding

Pregnancy

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

The use of Slinda prior to pregnancy has not shown an increased risk of congenital malformations. However, the occurrence of adverse effects cannot be ruled out.

Breastfeeding

Slinda may 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 or use machines have been observed in users of oral hormonal contraceptives, although no studies have been conducted with Slinda.

Slinda contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

Regular check-ups

During treatment with Slinda, your doctor will require you to undergo regular check-ups. In general, the frequency and nature of these check-ups will depend on your individual circumstances.

Contact your doctor as soon as possible in the following cases: you have severe pain or swelling in one of your legs, unexplained chest pain, difficulty breathing, or an unusual cough, especially if accompanied by bloody sputum (this could indicate thrombosis); you have sudden and severe stomach pain or jaundice (you may notice yellowing of the skin or the whites of the eyes, or dark urine, which may indicate liver problems); you feel a lump in your breasts (which may indicate breast cancer); you experience sudden or severe pain in the lower abdomen or stomach area (this may indicate an ectopic pregnancy, i.e., a pregnancy outside the uterus); you need to remain immobile or are scheduled for surgery (consult your doctor at least four weeks in advance); you have unusual and heavy vaginal bleeding; you suspect you are pregnant.

3. How to take Slinda

Follow exactly the instructions for taking this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

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

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

Do not confuse the tablets: due to the different composition of the tablets, it is essential to start with the first white tablet located in the upper left corner, then take one tablet each day. To maintain the correct order, follow the direction of the arrows and the numbered sequence on the blister.

The first tablet of treatment should be taken on the first day of menstrual bleeding. Afterwards, continue taking the tablets consecutively. Take one white active tablet for the first 24 days, followed by one green placebo tablet for the last 4 days. Then, start a new pack immediately without any break between packs, so there is no gap between two packs.

You may experience some bleeding while taking Slinda, or you may not have any bleeding at all, 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 green placebo tablets.

Blister preparation

To help you take your contraceptive daily, each pack includes seven adhesive strips printed with the days of the week. Choose the sticker starting with the day of the week on which you began taking the tablets (for example, if you start on Thursday, apply the one marked "THU") and place it on the upper left corner of the blister, in the "Start" position. This way, each tablet will have a day of the week indicated above it, allowing you to visually check whether you have taken a particular tablet. The arrows show the order in which the tablets should be taken.

When can you start the first pack of Slinda?

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

Start taking Slinda on the first day of your period. By doing so, you will be protected against pregnancy immediately and will not need to use additional contraceptive methods 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 containing the active ingredient) of your previous hormonal contraceptive, or on the same day of removal of the vaginal ring or transdermal patch (i.e., without taking a tablet-free, ring-free, or patch-free break). If you follow these instructions, no additional contraceptive measures are needed.

Alternatively, you may start Slinda the day after the tablet-free, ring-free, patch-free, or placebo week of your previous contraceptive. In this case, make sure to use an additional barrier contraceptive method (such as a condom) for the first 7 days after starting Slinda.

• Switching from a progestogen-only pill (POP).

You may switch from a progestogen-only pill on any day and start taking Slinda the following day. No additional contraceptive measures are needed.

• Switching from a progestogen-only injection, implant, or intrauterine system releasing progestogen (IUS).

You should start Slinda on the day the next injection would have been due, or on the day the implant or IUS is removed. No additional contraceptive measures are needed.

• After childbirth.

You may start Slinda any day between day 21 and day 28 after giving birth. If you start later than day 28 but before your menstruation has returned, you must ensure you are not pregnant and should use a barrier contraceptive method such as a condom until you have taken the first 7 tablets.

For more information on breastfeeding, see section 2 (Pregnancy and breastfeeding).

• After an abortion.

Follow your doctor's recommendations.

Consult your doctor if you are unsure about when to start.

If you take more Slinda than you should

No serious harmful effects have been reported from taking too many Slinda tablets at once. Possible symptoms include nausea, vomiting, and slight vaginal bleeding.

However, in case of overdose, consult your doctor, as a blood test may be required.

In cases of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 only one tablet and less than 24 hours have passed, take the missed 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 the scheduled time for any white active tablet, take the missed 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 your usual time. The more consecutive tablets you miss, the greater the risk that contraceptive effectiveness will be reduced.

If you forgot to take a tablet during the first week of the cycle and had sexual intercourse during the week before the missed dose, you should be aware 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 missed tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the white active tablets at your usual time. Instead of taking the green placebo tablets from this row, remove them and start the next row (the starting day will be different). By skipping the placebo interval, contraceptive protection is maintained.

The last 4 green tablets in the 4th row are placebo tablets. If you forget to take any of these tablets, the reliability of Slinda is not affected. Discard any missed placebo tablets.

What to do in case of vomiting or severe diarrhea?

If you experience vomiting or severe diarrhea, there is a risk that the active ingredient of the tablet may not be fully absorbed by your body. This situation is similar to missing a tablet. In such cases, an additional contraceptive method should be used. Consult your doctor.

If you vomit or have severe diarrhea within 3–4 hours after taking a white active tablet of Slinda, take another white tablet from a different pack as soon as possible. If possible, take it within 24 hours of your usual dosing time. No additional contraceptive precautions are needed. If this is not possible or more than 24 hours have passed, follow the advice in the section "If you forget to take Slinda."

If you stop taking Slinda

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

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects associated with the use of Slinda are described in the paragraphs “Breast cancer” and “Thrombosis” in section 2, ‘What you need to know before starting to take Slinda’.

Please read this section for further information and consult your doctor if you consider it necessary.

Irregular vaginal bleeding may occur during the use of Slinda. This may be light spotting that does not require sanitary protection, or heavier bleeding, similar to a light menstruation, which 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, no action is needed; simply continue taking Slinda. However, if the bleeding is heavy or prolonged, you should consult your doctor.

If bleeding is very frequent and irregular, consideration should be given to using another contraceptive method. If you do not have vaginal bleeding during treatment, a pregnancy test should be performed, especially if you have not taken the tablets as indicated in section 3, “How to take Slinda”.

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

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

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

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

• Anaemia (reduced number of red blood cells), fatigue (tiredness), fluid retention
• Dizziness
• Vomiting, diarrhoea, constipation
• Vaginal infections
• Increased blood concentrations of: potassium, liver enzymes (ALT, AST, GGT), bilirubin, creatine phosphokinase, triglycerides
• Disturbance in appetite
• Uterine leiomyoma (benign tumour in the uterus)
• Depressed mood, depression, anxiety
• Absence of menstruation, altered menstrual bleeding, pelvic pain, ovarian cysts, genital discharge and vaginal dryness
• Hair loss, increased sweating, itching, rash, seborrhoea (oily skin), dermatitis (skin inflammation)
• High blood pressure, hot flushes
• Hypersensitivity

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Slinda

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Store below 25°C.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Slinda

Active white film-coated tablets:

• The active substance is drospirenone.

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

• The other components are:

Tablet core: microcrystalline cellulose; lactose; colloidal silicon dioxide (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 any active substance.

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

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

Appearance of the product and contents of the pack

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

The active tablets are round, white, marked with the letters “E” and “D” on each side, with a diameter of 5 mm.

The placebo tablets are round, green, marked with the letter “E” and the number “4” on each side, with a diameter of 5 mm.

In addition to the cardboard box, a cardboard blister holder is included.

Slinda is available in calendar packs containing 1, 3, 6 and 13 blisters of 28 tablets each.

Not all pack sizes may be marketed.

Marketing Authorization Holder:

Exeltis Healthcare, S.L.

Avenida de Miralcampo, 7.

Polígono Industrial Miralcampo.

19200 Azuqueca de Henares. Guadalajara.

Spain.

Manufacturer:

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera;

La Vallina s/n;

24193-Villaquilambre, León

Spain.

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

Date of the most recent review of this summary: March 2022

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