Slinda - Drospirenone uses, dose and side effects

Slinda is a birth control pill and is used to prevent pregnancy. Each blister card contains 24 white tablets, which are also called active tablets, and 4 green tablets, which are also called placebo tablets and which do not contain any active substance. The differently colored tablets are placed in order.

Each of the 24 white active tablets contains a small amount of a female sex hormone, gestagen et drospirenone. Slinda is a type of birth control pill called an intervening pill. Unlike combined birth control pills, intermediate pills do not contain any estrogen hormone but only progestin. Therefore, Slinda can be used by women who cannot tolerate estrogen.

Slinda provides good protection against pregnancy. The protection is due to inhibition of ovulation, changes in the secretion of the cervix, and the effect on the uterine lining, which becomes thinner.

A disadvantage is that you may have irregular vaginal bleeding while using Slinda. You may also not have any bleeding at all.

The drospirenone contained in Slinda may also be approved to treat other conditions not mentioned in this product information. Ask your doctor/midwife, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before taking Slinda

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 legs (deep vein thrombosis ) or the lungs ( pulmonary embolism ).
if you have or have had liver disease and your liver function still has not normalized.
if your kidneys are not working properly ( kidney failure ).
if you have or are suspected of having cancer that is sensitive to sex hormones, such as certain types of breast cancer.
if you have unexplained vaginal bleeding.

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

Warnings and precautions

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

Tell the doctor/midwife before you start using Slinda if any of the following apply to you:

If you have or have had thrombosis (blood clot formation in a blood vessel).
If you have liver cancer, if you have jaundice (yellowing of the skin) or liver disease and the liver does not work normally.
If you have had breast cancer.
If you have or have had chloasma (yellow-brown pigment spots on the skin, especially on the face). In such a case, you should avoid exposure to sunlight and ultraviolet radiation while you are using Slinda.
If you have diabetes.
If you have high blood pressure.
If your kidneys are not working well because then the doctor/midwife will take a blood test to check the potassium level while using the first blister card.

If any of these conditions worsen or occur for the first time, you should contact a doctor/midwife. The doctor/midwife will then decide whether you should stop taking Slinda and you may be advised to use a non-hormonal contraceptive.

Breast cancer

Check your breasts regularly and contact your doctor/midwife as soon as possible if you feel a lump in your breasts.

Breast cancer has been detected slightly more often in women taking combined oral contraceptives than in women of the same age not taking combined oral contraceptives. When treatment with combined oral contraceptives stops, the risk gradually decreases so that the risk after 10 years is the same as for women who have never taken combined oral contraceptives.

Breast cancer is rare under the age of 40. The likelihood of breast cancer that has spread appears to be lower in women taking combined oral contraceptives than in women not taking combined oral contraceptives. It is not known whether the difference in breast cancer risk is caused by combined oral contraceptives. It may happen that the breast cancer was detected earlier because the women were examined more often.

The risk of breast cancer in users of progestogen preparations, such as Slinda, is thought to be comparable to the risk in women using combined oral contraceptives, but the evidence is not as strong.

Thrombosis (blood clot formation in a blood vessel)

See a doctor/midwife immediately if you notice any signs of thrombosis (see also “Regular check-ups”).

Thrombosis means that a blood clot has formed that can block a blood vessel. Thrombosis sometimes occurs in the deep veins of the legs (deep vein thrombosis ). If the blood clot detaches from the vein where it has formed, it can travel to the pulmonary arteries where it can become stuck and cause a so-called pulmonary embolism. This can lead to life-threatening situations.

Progestogen preparations may be associated with a slightly increased risk of thrombosis. The risk of thrombosis is higher if a family member (a sibling or a parent) has had thrombosis at a relatively young age, as well as with increasing age, obesity if you are bedridden for a long time, major operations, or serious injury.

Progestogen preparations are not associated with any apparent risk of heart attack or stroke (a blood clot in the brain). The risk is rather related to increasing age, increased blood pressure, and smoking.

The risk of stroke may be slightly higher in women with high blood pressure who take

progestagen preparations.

Mental disorders

Some women using hormonal contraceptives, including Slinda, have reported depression or low mood. Depression can be a serious condition and can sometimes lead to suicidal thoughts. If you notice that your mood changes or if you get symptoms of depression, you should contact a doctor/midwife for medical advice as soon as possible.

Medical examination

Before you start taking Slinda for the first time, or if you start treatment again after not using it for a while, the doctor/midwife will ask you some questions about your health and do a health check and measure blood pressure, etc. The doctor/midwife will tell you how often you should go for check-ups.

Children and young people

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

Other medicines and Slinda

Tell your doctor/midwife or pharmacist if you have recently taken, or might be taking other medicines. They can tell you if you need to use extra protection (eg using a condom), and if so for how long, or if they use other medicines you need to change.

Certain medicines:

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

This applies to medicines used to treat:

epilepsy (eg primidone, phenytoin , barbiturates , carbamazepine, oxcarbazepine, felbamate, topiramate)
tuberculosis (eg rifampicin)
HIV infection (eg ritonavir, nelfinavir , nevirapine, efavirenz)
hepatitis C virus infections (eg boceprevir, telaprevir)
other infections (griseofulvin)
high blood pressure in the blood vessels of the lungs ( bosentan )
depression ((traditional) herbal medicines containing St. John’s wort )
certain bacterial infections (eg, clarithromycin, erythromycin)
fungal infections (eg, fluconazole, itraconazole, ketoconazole, voriconazole)
high blood pressure ( hypertension ), angina, or certain heart rhythm disorders (eg diltiazem ).

If you are treated for a shorter period with medicines that can make Slinda less effective, a barrier method (e.g. a condom) must also be used. Since the effect of other medicines on Slinda can remain for up to 28 days after the last dose of the medicine, the additional barrier method must be used for the same amount of time. The doctor/midwife can tell you if you need extra protection and, if so, for how long. If you are taking medicine or (traditional) herbal medicine and the white active tablets run out, throw away the green placebo tablets and continue directly with the next card.

If you are treated for a long time with medicines that can make Slinda less effective, the doctor/midwife may advise you to use a non-hormonal contraceptive.

Slinda can also affect how other medicines work, for example:

ciclosporin is used to prevent rejection of transplanted organs (effect may be increased)
lamotrigine is used for epilepsy (the effect may be reduced)
certain diuretics (aldosterone antagonists, potassium-sparing diuretics ). The doctor/midwife may recommend a blood test to check the potassium level during the use of the first blister card with Slinda.

Wrap with food and drink

Avoid grapefruit and grapefruit juice while taking Slinda.

Pregnancy and breastfeeding

Pregnancy

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

The use of Slinda before or during pregnancy has not been shown to increase the risk of congenital malformations. However, side effects cannot be ruled out.

Breast-feeding

Diapers can be used during breastfeeding.

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

Driving ability and use of machinery

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

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor/midwife or pharmacist if you are unsure.

Slinda contains lactose

If you are intolerant to certain sugars, you should contact your doctor/midwife before taking

this medicine.

Regular checks

When you use Slinda, your doctor/midwife will tell you when to come back for a check-up. How often you need to go for a check-up and what it contains varies from person to person.

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Contact a doctor/midwife as soon as possible if: you get severe pain or swelling in a leg, unexplained chest pain, shortness of breath, abnormal cough, especially if you cough up blood (may indicate thrombosis ).you suddenly have severe stomach pains or signs of 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 (may indicate breast cancer).you have sudden or severe pain in the lower abdomen or stomach (may indicate an ectopic pregnancy, i.e. a pregnancy outside the womb). you will be bedridden or have surgery (consult your doctor/midwife at least four weeks in advance).you have abnormal, heavy vaginal bleeding. you suspect you are pregnant.

How to take Slinda

Always take this medicine as directed by your doctor/midwife. Consult a doctor/midwife or pharmacist if you are unsure.

Each blister card contains 24 white active tablets and 4 green placebo tablets. The differently 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 the section “Slinda with food and drink”). You must take the tablets every day at the same time of day so that the time between two tablets is always 24 hours.

Do not mix the tablets: Because the tablets have different contents, start with the first white tablet in the upper left corner and take the tablets every day. Follow the direction of the arrows and the sequence of numbers on the blister card so that you take the tablets in the correct order.

The first tablet in the treatment should be taken on the first day of menstruation. After that, you must take the tablets continuously. Take a white active tablet for the first 24 days and then a green placebo tablet for the last 4 days. You should then start immediately with a new map without making any break in the daily tablet intake. You should therefore not take a break between two maps.

You may have some bleeding while using Slinda or you may not bleed at all, but you should continue to take the tablets as usual, without interruption.

If you use Slinda in this way, you are protected against pregnancy even during the 4 days when you take placebo tablets.

Prepare the blister card

To help you take the tablets every day, the pack contains 7 self-adhesive labels 7 days of aeand k. Choose the day of the week label that starts with the day you take the first tablet (for example, if you start on a Thursday, use the day of the week label that starts with TURS) and attach it to the blister card above the words “Attach the day of the week label here” so that on the first day stands above the tablet marked “START”. Now there is a day of the week above each tablet so you can see if you have taken that day’s tablet. The arrows and numbers show the order in which you should take the tablets.

When you start your first map with Slinda

If you have not used a hormonal contraceptive in the last month started with Slinda on the first bleeding day of the period. When you do this, you are directly protected against pregnancy and you do not need to use any additional protection, such as a condom.
If you change from a combined birth control pill, birth control ring, or birth control patch you should start Slinda the day after the last active tablet (the last tablet containing the active substances) of your previous pill or the day you take out the contraceptive ring or remove the contraceptive patch (this means you should not have any tablet-, ring- or patch-free break). If you follow these instructions, no extra protection is needed.
You can also start Slinda no later than the day after the usual tablet-, ring- or patch-free break for your previous contraceptive. In this case, you must also use a barrier method (e.g. a condom) during the first 7 days that you take Slinda.
If you switch from another intermediate pill you can switch at any time from another intermediate pill and start taking Slinda the next day.
If you change from a progestin-only contraceptive syringe or contraceptive rod or a hormonal coil you should start Slinda on the day you would take the next injection or on the day the birth control stick or IUD is removed.
After giving birth you can start Slinda for 21 to 28 days. If you start later than day 28 but before your period has returned, make sure you are not pregnant and use a barrier method, eg. a condom, until you have taken the first 7 tablets.

Information for breastfeeding women can be found in section 2 (“Pregnancy and breastfeeding”).
After a miscarriage or an abortion follow the doctor’s/midwife’s advice.

Ask the doctor/midwife if you are still unsure when to start.

If you have taken too much Slinda

There have been no reports of serious adverse effects from taking too many Slinda tablets at once. Symptoms that may occur are nausea, vomiting, and minor vaginal bleeding.

In case of overdose, consult a doctor/midwife as blood samples should be taken.

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor/midwife or hospital for an assessment of the risk and advice.

If you forget to use Slinda

You must take the tablets every day at the same time of day so that the time between two tablets is always 24 hours. If you have missed any single tablet by less than 24 hours, take the missed tablet as soon as you remember and then take the next tablet at the usual time, even if this means taking two tablets at the same time. If you have missed any white active tablet by more than 24 hours

you should take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time and also using extra contraceptive protection (such as a condom) for the next 7 days. Then continue taking the tablets at your usual time. The more tablets in a row you have forgotten, the greater the risk of contraceptive protection is reduced.

If you have forgotten a tablet in the first week after you started taking the tablets and you had intercourse in the week before you forgot the tablet, there is a risk that you have become pregnant. In that case, contact a doctor/midwife.

If you have forgotten a tablet between days 15 and 24 (third or fourth row), take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue to take the white active tablets at the usual time. Do not take the green placebo tablets, but throw them away and immediately start the next map (you will start on a different day of the week). By skipping the placebo tablets, you are still protected against pregnancy.

The last 4 green tablets in the 4th row of the blister card are placebo tablets. If you forget one of these tablets, protection is not impaired. Throw away the forgotten placebo tablet.

If you vomit or have severe diarrhea

If you vomit or have severe diarrhea, there is a risk that the body has not absorbed the active substance from the tablet. The situation is almost the same as if you forget a tablet. In these cases, you may need to protect yourself extra. Consult doctor/midwife.

If you vomit or have severe diarrhea within 3-4 hours after taking a white active tablet of Slinda, you should take a new white tablet from a different blister card as soon as possible. If possible, take the tablet within 24 hours of the usual time. No additional protection is needed. If this is not possible or if 24 hours have passed, follow the advice in the section “If you forget to take Slinda” above.

If you stop taking Slinda

You can stop taking Slinda whenever you want. From the day you stop taking Slinda, you are no longer protected against pregnancy.

If you have any further questions about this medicine, contact your doctor/midwife or pharmacist.

Possible side effects

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

Serious side effects in connection with the use of Slinda are described under the headings “Breast cancer” and “Thrombosis” in section 2 “What you need to know before taking Slinda”. Read that section for more information and consult your doctor/midwife immediately if necessary.

You may have irregular vaginal bleeding while using Slinda. It can be about minor spotting that may not even require a pad or heavier bleeding that resembles sparing periods and that requires menstrual protection. You may also not have any bleeding at all. Irregular bleeding is not a sign that Slinda has less protection against pregnancy. In general, you don’t need to do anything, just keep taking Slinda. However, if the bleeding is heavy or prolonged, you should consult a doctor/midwife.

If the bleeding is very frequent or irregular, another method of contraception should be considered. If you do not have any vaginal bleeding during treatment, you may need to take a pregnancy test if you have not taken the tablets by the instructions in section 3, “How to take Slinda”.

The following side effects have occurred in connection with the use of Slinda:

Common: may affect up to 1 in 10 people

headache
nausea, abdominal pain
changed sexual desire, mood changes
acne
breast discomfort, painful periods, bleeding, and irregular periods
weight gain.

Uncommon: may affect up to 1 in 100 people

anemia (reduced number of red blood cells ), fatigue, accumulation of fluid ( edema )
dizziness
vomiting, diarrhea, constipation
vaginal infection _
increased level of the following seen in blood tests: potassium, liver enzymes ( ALT, AST, GGT), bilirubin, creatine phosphokinase, triglycerides
appetite changes
uterine leiomyoma (benign tumor of the uterus)
low mood, depression, anxiety
missed period, change in period, pelvic pain, ovarian cysts, vaginal discharge, and dryness
hair loss, increased sweating, itching, skin rash, seborrhea (oily skin), dermatitis (skin inflammation)
increased blood pressure, hot flashes
hypersensitivity.

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

intolerance to contact lenses
weight loss
large urine volume
cyst in the breast, discharge from the breasts, abnormalities in cell samples from the cervix, genital itching.

How Slinda should be stored

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

Use before the expiry date stated on the carton and blister after EXP. The expiration date is the last day of the specified month.

Store at a maximum of 25 ºC.

Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

White active film-coated tablets: The active substance is drospirenone. Each white active film-coated tablet contains 4 mg drospirenone.
Other ingredients are: Tablet core: microcrystalline cellulose; lactose; colloidal silicon dioxide (E551); magnesium stearate (E470b).Tablet coating: polyvinyl alcohol; titanium dioxide (E171); macrogol; talc (E553b)
Green film-coated placebo tablets:
The green film-coated placebo tablets contain no active substance.
Tablet core: lactose monohydrate , corn starch; povidone; colloidal silicon dioxide (E551); magnesium stearate (E470b)Tablet coating: hypromellose (E464); triacetin; polysorbate 80 (E433); titanium dioxide (E171); indigo carmine aluminum lacquer (E132); yellow iron oxide (E172)

Appearance and package sizes of the medicine

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

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

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

The packaging also includes a cardboard case for the blister card.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Exeltis Healthcare SL

Avenida Miralcampo 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Manufacturer

Laboratorios León Farma, SA

C/ La Vallina s/n, Pol. Ind. Navatejera

24008 – Navatejera, León.