Esteretta 3 mg+15 mg 84 pcs

Name: Esteretta 3 mg+15 mg 84 pcs
SKU: 521236
Availability: InStock

€86.46

EAN: 5997001373422 SKU: 521236 Categories: Contraceptive, Gynecology and Obstetrics, Hormonal, Medicine

Description

Esteretta® is a CHC containing the progestogen drospirenone and the estrogen estrol.

The drug is used as a contraceptive for oral administration to protect against unwanted pregnancy.

Progestogen suppresses ovulation mainly through a central feedback mechanism, which leads to a decrease in the pituitary gland’s secretion of luteinizing hormone (LH). Drospirenone has pharmacological effects similar to those of the natural human hormone progesterone. Estrogen is also involved in providing contraceptive action by suppressing the production of follicle-stimulating hormone (FSH), but its main effect as part of CHC is to compensate for the effect of progestogen on the endometrium and ensure sufficient control of the bleeding cycle while taking the drug. Estetrol is identical in composition to the natural hormone that is produced during pregnancy by the human fetal liver.

Manufacturer

Haupt Pharma Münster GmbH, Germany

Composition

The active ingredients of Esteretta® are drospirenone and esthetrol (in the form of esthetrol monohydrate).

Each light pink , film-coated tablet contains 3.0 mg of drospirenone and 15.0 mg of esthetrol monohydrate.

Excipients are:

Tablet core: lactose monohydrate, sodium carboxymethyl starch, type A, corn starch, povidone K30, magnesium stearate.

Film shell: AquaPolish® Pink 044.08 MS (hypromellose, hydroxypropylcellulose, talc, hydrogenated cottonseed oil, titanium dioxide, red iron oxide dye).

Each white film-coated tablet (placebo) does not contain active ingredients.

The excipients are:

Tablet core: StarLac® (lactose monohydrate and corn starch), magnesium stearate.

Film shell: AquaPolish® White 014.17 MS (hypromellose, hydroxypropylcellulose, talc, hydrogenated cottonseed oil, titanium dioxide).

Esteretta® contains lactose monohydrate (see “Esteretta® contains” in section 2 of the leaflet).

Indications

Oral contraception in adult women (over 18 years of age).

Use during pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using Esteretta®.

Pregnant women and women who think they may be pregnant should not take Esteretta®.

If pregnancy occurs while using Esteretta®, you should immediately stop taking it and consult your doctor.

If you are planning a pregnancy, you can stop taking Esteretta® at any time (see also “If you stop taking Esteretta®” in section 3).

Breastfeeding
Taking Esteretta® is not recommended during breastfeeding. If you want to take the drug while breastfeeding, please consult your doctor.

Contraindications

If you have any of the following diseases, conditions, or risk factors, you should not take Esteretta®. You should tell your healthcare provider if you have any of these diseases, conditions or risk factors. Your doctor will discuss other more suitable methods of contraception with you.

Do not take Esteretta®:

• if you are allergic to drospirenone, esthetrol or any of the other ingredients of this medicine (listed in section 6 of the leaflet);

• if you have (or have ever had) thrombosis of blood vessels in the legs (deep vein thrombosis –
DVT), lungs (pulmonary embolism – PE) or other organs;

• if you have ever had a myocardial infarction or stroke, have (or have had before) attacks of angina (a condition characterized by severe chest pain and may be the first sign of a heart attack), or transient ischemic attack – TIA (transient symptoms of a stroke);

• if you know you have a medical condition that puts you at increased risk of blood clots, such as protein C deficiency, hyperhomocysteinemia, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;

• if you have significant or multiple high risk factors for blood clots (smoking over the age of 35, obesity with a body mass index [BMI] of 30 kg/m2 or more, any surgery on the lower extremities, pelvis or neurosurgical intervention, complicated heart valve defects, heart rhythm disturbances – atrial fibrillation), or any of the following diseases that may increase the risk of blood clots in the arteries:
– severe diabetes mellitus with vascular complications;
– very high blood pressure;
– very high levels of lipids in the blood (cholesterol or triglycerides);

• if you are planning to undergo surgery, or if you are forced to remain in bed for a long time (see the section “Thrombosis”);

• if you have (or have had before) the so-called “migraine with aura”;

• if you have impaired kidney function (renal failure);

• if you have (or have had in the past) liver disease, and your liver function tests have not yet returned to normal;

• if you have (or have had) a liver tumor (benign or malignant);

• if you have been diagnosed with (or have had in the past) or suspected of breast or genital cancer;

• if you have bleeding from the vagina of unknown origin.

If any of these diseases, conditions or risk factors occur for the first time while taking Esteretta®, stop taking it immediately and contact your doctor. When stopping the drug, non-hormonal methods of contraception should be used.

Side effects

Like all medicines, Esteretta ^® can cause side effects, although not everyone gets them.

If you experience any adverse reaction, especially if it is severe or persistent, or a change in your health that you think may be related to Esteretta ^® , tell your doctor.

An increased risk of blood clots in the veins and arteries (VTE and ATE) is typical for all women taking CHCs.

Your risk of thrombosis may be higher if you have other conditions that increase your risk (see section 2 for details about conditions that increase your risk of thrombosis and symptoms of thrombosis).

In rare cases, the formation of a blood clot can lead to the development of the following conditions:

blood clot in a vein in the leg or foot (i.e. DVT)
blood clot in the vessels of the lungs (i.e. PE)
myocardial infarction
stroke
microstroke or transient cerebrovascular accident (transient ischemic attack – TIA)
blood clots in the vessels of the liver, stomach/intestines, kidneys or eyes.

Interaction

Tell your doctor if you are taking, have recently taken, or may start taking any other drugs, including over-the-counter drugs and herbal products.

Also tell other doctors who prescribe you other medications, including dentists and pharmacists, that you are taking Esteretta ^® . The doctor will warn you about the need to use additional methods of contraception (for example, a condom), the timing of their use and the need to change the dose of the drug prescribed to you.

Some drugs may affect the concentration of the drug in the blood and reduce its contraceptive effectiveness or lead to unexpected bleeding. These may be drugs to treat:

epilepsy (eg, barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate);
tuberculosis (eg, rifampicin);
HIV infection and hepatitis C (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, for example, ritonavir, nevirapine, efavirenz);
fungal infections (griseofulvin);
pulmonary hypertension (bosentan).

Herbal preparations containing St. John’s wort (Hypericum perforatum) may also affect the effectiveness of Esteretta ^® . If you are already taking Esteretta ^® and want to start taking herbal preparations containing St. John’s wort (Hypericum perforatum), you must first consult with your doctor.

If you are taking the above medications or herbal preparations that may reduce the effectiveness of Esteretta ^® , it is recommended to additionally use barrier methods of contraception (for example, a condom). A barrier method of contraception (eg, a condom) should be used during the entire period of taking concomitant therapy and for 28 days after its cessation. If concomitant therapy is continued after you have finished taking the hormone tablets from the current blister of Esteretta ^® , the placebo tablets should be discarded and the hormone tablets from the next blister should be started immediately.

If long-term use of the above medications is necessary, the use of non-hormonal methods of contraception should be considered. Consult your doctor.

Interaction of Esteretta ^® with other drugs may lead to an increase in the frequency or severity of adverse reactions. The following drugs may adversely affect the tolerability of Esteretta ^® :

ketoconazole, itraconazole, fluconazole (used to treat fungal infections);
clarithromycin, erythromycin (antibiotics, used to treat bacterial infections);
diltiazem (used to treat certain heart conditions and high blood pressure).

Esteretta ^® may also affect the action of other medicines, such as:

cyclosporine (a drug used to prevent tissue rejection after transplantation);
lamotrigine (a drug to treat epilepsy).

A combination regimen for hepatitis C virus (HCV) treatment consisting of ombitasvir/paritaprevir/ritonavir with or without dasabuvir may result in increased liver function tests (increased alanine aminotransferase [ALT]) in women taking COCs containing ethinyl estradiol. The drug Esteretta ^® contains esthetrol instead of ethinyl estradiol. It is unknown whether the use of this combination of drugs for the treatment of hepatitis C simultaneously with the drug Esteretta ^® leads to an increase in ALT activity. In this situation, it is necessary to consult with your doctor.

Check with your doctor before you start taking other medications.

When and how to take Esteretta®

Each blister pack of Esteretta ^® contains 28 tablets: 24 light pink tablets with hormones (numbers 1-24), and 4 white placebo tablets without hormones (numbers 25-28).

Each time you start taking pills from a new blister, start with pill number 1 (the light pink hormone pill) located in the upper left corner of the blister (see “Start”). From the supplied adhesive labels with the names of the days of the week, select the strip in which the gray column begins with the day of the week on which you will start taking the pills. For example, if you take your first pill on Wednesday, choose the sticker that says “Wed.” Stick the strip onto the part of the package limited by the line, first aligning the “ð” symbol on the label with the similar symbol on the blister pack. After this, each day of the week on the label will correspond to a row of tablets. This will allow you to make sure that you took the pill on a specific day.

Take one tablet daily at approximately the same time with a small amount of water.

Follow the direction of the arrows on the blister so that you take all the light pink hormone pills first, followed by the white placebo pills.

Within 4 days of taking the white placebo tablets, you should begin to experience menstrual-like bleeding (called withdrawal bleeding). Withdrawal bleeding usually begins 2-4 days after taking the last light pink hormone pill, and may not stop until you start taking the next hormone pill pack.

Taking hormone tablets from the next blister should be started immediately, i.e. the day after taking the last placebo tablet from the previous blister, even if your withdrawal bleeding has not stopped yet. This means that you will always start taking pills from a new blister on the same day of the week, and that your withdrawal bleeding will occur on approximately the same days of the week each month.

Some women may not experience withdrawal bleeding every month while taking the white placebo pills. If you take Esteretta ^® every day exactly as directed, there is little chance of pregnancy (see also section 3

“If you are 1 or more menstrual cycles late”).

Starting the first package of Esteretta ^®

If you have not taken hormonal contraceptives in the previous month

Start taking Esteretta ^® on the first day of your menstrual cycle (i.e., the first day of menstrual bleeding). If you start taking Esteretta ^® on the first day, you will be immediately protected from pregnancy. In this case, there is no need to use additional methods of contraception.

You can also start taking the drug on days 2–5 of your cycle, in which case you must additionally use barrier methods of contraception (for example, condoms) during the first 7 days of taking Esteretta ^® .

When switching from another combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch)

You can start taking Esteretta ^® the day after you take the last tablet from the package of your previous oral contraceptive that you are currently taking (there is no need to take a break after stopping). If your previous oral contraceptive also included placebo pills, you can start taking Esteretta ^® the day after you take your last hormone pill (check with your doctor if you have any doubts). You can also start taking Esteretta ^® later, but no later than the next day after the end of the planned break in taking the previous contraceptive (or taking the last placebo tablet from the previous package). If you are using a vaginal ring or transdermal patch, it is advisable to start taking Esteretta ^® on the day the ring or patch is removed. You can start taking the drug later, but no later than the day when the next patch is to be applied or a new ring is inserted. If these recommendations are followed, there is no need to use additional methods of contraception.

When switching from progestogen-only pills (“mini-pills”)

You can stop taking the minipill any day and start taking Esteretta ^® the next day. In this case, it is recommended to additionally use barrier methods of contraception (for example, condoms) during the first 7 days of taking Esteretta ^® .

When switching from progestogen-only contraceptives (injectables, implants, or progestogen-releasing intrauterine system [IUD])

Taking Esteretta ^® should be started on the day of the next scheduled injection or on the day of removal of the IUD. In these cases, it is recommended to additionally use barrier contraceptive methods (for example, condoms) during the first 7 days of taking Esteretta ^® .

After childbirth

After the baby is born, you can start taking Esteretta ^® 21-28 days after birth (provided that the baby is not breastfed). If you start taking the drug later than 28 days after birth, you must additionally use barrier methods of contraception (for example, condoms) during the first 7 days of taking Esteretta ^® . If you have sexual intercourse before starting to take Esteretta ^®, you must make sure that you are not pregnant before starting to take the drug, or wait until menstrual bleeding begins.

After a miscarriage or abortion Follow your doctor’s instructions. Route and (or) method of administration

The drug is intended for oral administration.

Take 1 tablet daily, with or without food, in the order directed on the package, at approximately the same time of day, with a small amount of water.

If you are unsure when and how to start taking Esteretta ^® , consult your doctor.

^{If you take more Esteretta ®} tablets than you should

If you take several tablets at once, you may experience nausea, vomiting, or vaginal bleeding. If you have these symptoms, you should consult a doctor, who will inform you about the necessary measures.

If you forget to take Esteretta ^®

The following recommendations only apply to situations where you have missed a dose.

light pink pills with hormones.

If the delay in taking the pill is less than 24 hours , contraceptive protection is not reduced. Take the tablet as soon as you remember, and continue taking subsequent tablets at the usual time.
If the delay in taking the pill is more than 24 hours , contraceptive protection may be reduced. The more pills you miss, the higher the risk of getting pregnant. The risk of reduced contraceptive protection increases if you forget to take the light pink pill at the beginning or end of the blister. In this case, you must comply with the following rules:

If you miss 1 light pink tablet with hormones from days 1 to 7 (see diagram)

Take the last light pink hormone pill you missed as soon as you remember (even if that means taking 2 pills at the same time), and continue taking the pills at your usual time. It is necessary to additionally use barrier methods of contraception, such as condoms, until you take 7 tablets for 7 days in a row. If you had unprotected sex in the week before you missed a pill, there is a possibility that you may become or have already become pregnant. In this case, contact your doctor immediately.

If you miss 1 light pink hormone tablet between days 8 and 17 (see diagram) Take the last missed light pink hormone tablet as soon as you remember (even if this means taking 2 tablets at the same time) and continue taking the pills at the usual time. If you took the pills correctly for 7 days before missing the pill, the contraceptive effect of the drug is not reduced and you do not need to use additional methods of contraception. However, if you have missed more than 1 tablet, you must use additional barrier methods of contraception, such as condoms, until you have taken 7 tablets for 7 consecutive days. If you miss 1 light pink hormone pill between days 18 and 24 (see diagram) The risk of pregnancy is especially high if you miss taking a hormone pill that is in a blister pack close to the white placebo pills. You can reduce this risk by changing your pill regimen.

You can choose one of the following options. If you took the pills correctly for 7 days before missing the pill, the contraceptive effect of the drug is not reduced and you do not need to use additional methods of contraception. Otherwise, you need to stick to the first option and use additional barrier methods of contraception (for example, condoms) until you take 7 tablets for 7 days in a row.

Take the last light pink hormone pill you missed as soon as you remember (even if this means taking 2 pills at the same time) and continue taking the pills at your usual time. Start taking the tablets from the new blister pack immediately after you finish taking the hormone tablets from the current blister pack, i.e. Skip taking placebo tablets. In this case, you may not experience withdrawal bleeding until you start taking placebo tablets at the end of the second blister pack, but you may experience spotting (drops or spots of blood) or breakthrough bleeding while taking it light pink pills with hormones.
Stop taking the light pink hormone pills and start taking placebo pills for a maximum of 3 days so that the total number of placebo pills added to the missed light pink hormone pills is no more than 4 pills. When you finish taking the placebo tablets, start taking the tablets from the next blister pack.

If you can’t remember how many hormone pills you missed, follow the first option, use a barrier method such as a condom as an extra precaution until you have taken the pills correctly for 7 days in a row, and contact your doctor (as you may You were not protected from pregnancy).

If you forgot to take the light pink hormone pills from the blister, and you did not get your period while taking white placebo pills from the same blister, the possibility of pregnancy cannot be ruled out. Consult your doctor before taking tablets from the next blister pack.

Skipping white placebo pills

The last 4 tablets in the fourth row are placebo tablets and do not contain hormones. If you forget to take one of these pills, it will not affect the contraceptive effect of the drug. Throw away the white placebo tablet(s) that you forgot to take and continue taking the drug at your usual time.

If you miss more than 1 light pink hormone pill

Follow your doctor’s recommendations.

Active substance

Drospirenone, Estetrol

Additional information