Levonorgestrel, ethinyl estradiol, and ferrous bisglycinate (oral)

Levonorgestrel, ethinyl estradiol, and ferrous bisglycinate (oral)

Levonorgestrel, ethinyl estradiol and ferrous bisglycinate (oral) Oral route (kit)

Cigarette smoking increases the risk of serious cardiovascular events due to the use of combined oral contraceptives (COCs). The risk increases with age, especially in women over 35, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women over 35 years of age who smoke.

Used for levonorgestrel, ethinyl estradiol and ferrous bisglycinate

This medicine also contains iron bisglycinate. Ferric bisglycinate is an iron supplement.

No method of contraception is 100 percent effective. Contraceptive methods such as infertility surgery or abstaining from sex are more effective than birth control pills. Discuss your birth control options with your doctor.

This medicine does not protect against HIV infection or other sexually transmitted diseases. It does not help as emergency contraception, for example after unprotected sexual contact.

This medicine is only available with a doctor's prescription.

Before using levonorgestrel, ethinyl estradiol and ferrous bisglycinate

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

Appropriate studies on the association of age with the effects of the combination of levonorgestrel, ethinyl estradiol and ferrous bisglycinate have not been conducted in children and adolescents. However, child-specific problems that would limit the use of this medicine in adolescents are not expected. This medicine can be used for contraception in teenage women, but should not be used before menstruation begins.

geriatrics

Adequate studies on the association of age with the effects of the combination of levonorgestrel, ethinyl estradiol and ferrous glycinate have not been conducted in the geriatric population. This medicine is not suitable for use in older women.

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. If you are taking this medicine, it is particularly important that your doctor knows whether you are taking any of the medicines listed below. The following interactions were selected for their potential significance and are not necessarily exhaustive.

The use of this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or to change some of the other medications you are taking.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamsäure

Using this medicine with any of the following medicines is not usually recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Amifampridin
• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Anagrelid
• Apalutamid
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Baloxavir Marboxil
• Belzutifan
• Betamethason
• Bexaroten
• Bictegravir
• Boceprevir
• Bosentan
• Bupropion
• Butabarbital
• Butalbital
• Carbamazepin
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixim
• Cefpodoxim
• Cefprozil
• Ceftazidim
• Ceftibuten
• Cefuroxim
• Cenobamat
• Ceritinib
• Clobazam
• Cloxacillin
• Cobicistat
• Colesevelam
• Cyclacillin
• Cyclosporin
• Dabrafenib
• Darunavir
• Dexamethason
• Dicloxacillin
• Dimercaprol
• Dipyron
• Dolutegravir
• Donepezil
• Doxycyclin
• Efavirenz
• Elagolix
• Eltrombopag
• Elvitegravir
• Encorafenib
• Enzalutamid
• Eslicarbazepinacetat
• Ethinylestradiol
• Etravirin
• Felbamat
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fostemsavir
• Glecaprevir
• Grazoprevir
• Griseofulvin
• Guarkernmehl
• Indinavir
• Eisen
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatid
• Lopinavir
• Lorlatinib
• Lumacaftor
• Magnesiumsulfat
• Mavacamten
• Mephobarbital
• Meropenem
• Methohexital
• Minocyclin
• Mitapivat
• Mitotan
• Mobocertinib
• Modafinil
• Mycophenolatmofetil
• Mycophenolsäure
• Nafcillin
• Nelfinavir
• Nevirapin
• Nirmatrelvir
• Octreotid
• Oxacillin
• Oxcarbazepin
• Oxytetracyclin
• Paclitaxel
• Proteingebundenes Paclitaxel
• Penicillin G
• Penicillin G Procain
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazon
• Phenytoin
• Pibrentasvir
• Piperaquin
• Pitolisant
• Prednisolon
• Prednison
• Primidon
• Raltegravir
• Rotklee
• Rifabutin
• Rifampin
• Rifapentin
• Rilpivirin
• Ritonavir
• Rufinamid
• Saquinavir
• Secobarbital
• Simeprevir
• Somatrogon-ghla
• Johanniskraut
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracyclin
• Theophyllin
• Thiopental
• Thioridazin
• Ticarcillin
• Tigecyclin
• Tirzepatid
• Tizanidin
• Topiramat
• Troglitazon
• Ulipristal
• Valproinsäure
• Voxilaprevir

Using this medicine with any of the following medicines may result in an increased risk of certain side effects, but using both medicines may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Acitretin
• Amitriptylin
• Atazanavir
• Atorvastatin
• Carbidopa
• Cefdinir
• Ciprofloxacin
• Clomipramin
• Delafloxacin
• Demeclocyclin
• Diazepam
• Doxepin
• Doxycyclin
• Etoricoxib
• Gatifloxacin
• Ginseng
• Grepafloxacin
• Imipramin
• Lamotrigin
• Levodopa
• Levofloxacin
• Levothyroxin
• Lakritze
• Liothyronin
• Lomefloxacin
• Lorazepam
• Methyldopa
• Minocyclin
• Moxifloxacin
• Mycophenolatmofetil
• Mycophenolsäure
• Norfloxacin
• Ofloxacin
• Omadacyclin
• Omeprazol
• Parecoxib
• Penicillamin
• Perampanel
• Roflumilast
• Selegilin
• Tacrin
• Temafloxacin
• Temazepam
• Tetracyclin
• Tipranavir
• Triazolam
• Troleandomycin
• Trovafloxacinmesylat
• Valdecoxib
• Voriconazol
• Warfarin
• Zink

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. The following interactions were selected for their potential significance and are not necessarily exhaustive.

Using this medicine with any of the following medicines may result in an increased risk of certain side effects, but may be unavoidable in some cases. If used together, your doctor may change the dose or frequency of use of this medication, or give you special instructions about food, alcohol, or tobacco consumption.

• Koffein
• Milchprodukt
• Phytinsäurehaltige Lebensmittel

Other medical problems

The presence of other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Abnormale oder ungewöhnliche Vaginalblutungen oder
• Blutgerinnsel (z. B. tiefe Venenthrombose, Lungenembolie) oder Vorgeschichte von oder
• Brustkrebs, aktiv oder in der Vorgeschichte oder
• Diabetes mit Nieren-, Augen-, Nerven- oder Blutgefäßschäden oder
• Herzinfarkt, Geschichte von oder
• Erkrankungen des Herzens oder der Blutgefäße (z. B. koronare Herzkrankheit, Herzklappenprobleme) oder
• Herzrhythmusstörungen (Vorhofflimmern) oder
• Hypertonie (Bluthochdruck), unkontrollierte oder
• Lebererkrankungen, einschließlich Tumoren oder Krebs oder
• Migränekopfschmerz, neu oder schlimmer oder eine neue Art von Kopfschmerzen oder
• Kreislaufprobleme oder Blutgerinnsel, jetzt oder in der Vergangenheit oder
• Schlaganfall, Vorgeschichte: Sollte bei Patienten mit diesen Erkrankungen nicht angewendet werden.

• Angioödem (Schwellung des Gesichts, der Zunge oder des Rachens), vererbt oder
• Gebärmutterhalskrebs oder intraepitheliale Neoplasie oder
• Chloasma gravidarum (Hauterkrankung während der Schwangerschaft), Vorgeschichte von oder
• Cholestase (Gallenproblem) während der Schwangerschaft, Vorgeschichte von oder
• Depression, Geschichte von oder
• Diabetes bzw
• Dyslipidämie (hoher Cholesterin- oder Fettgehalt im Blut), unkontrolliert oder
• Gallenblasenerkrankung bzw
• Hypertonie (Bluthochdruck) – Mit Vorsicht anwenden. Kann diese Bedingungen verschlimmern.

• Durchfall bzw
• Erbrechen – Kann die Aufnahme der Kombination aus Levonorgestrel und Ethinylestradiol im Körper verringern.

Proper use of levonorgestrel, ethinyl estradiol and ferrous bisglycinate

It is very important that you use this medicine exactly as your doctor has told you. Do not use more of it, do not use it more often or for longer than prescribed by your doctor.

This medicine comes with instructions for use for the patient. Read and follow these instructions carefully. If you have any questions, contact your doctor or pharmacist.

This medicine is available in blister packs. Each blister pack contains 28 tablets of different colors, which must be taken in the same order as indicated on the blister pack.

When you start using this medicine, your body will need at least 7 days to adjust before pregnancy can be prevented. Use a second form of birth control (e.g. condom, spermicide, or diaphragm) for the first 7 days of your first pill cycle.

Take this medicine at the same time every day. Birth control pills work best when no more than 24 hours pass between doses.

Do not skip or delay taking your pill for more than 24 hours. If you miss a dose, you could become pregnant. Ask your doctor about options that can help you remember to take your pills or use another method of contraception.

You may experience light bleeding or spotting when you first take the pill.

You may experience nausea or nausea, especially in the first few months of taking this medication. If your nausea persists and doesn't go away, call your doctor.

If you have vomiting or diarrhea within 3 to 4 hours of taking this medicine, treat it as a missed dose and follow the instructions in the package leaflet or call your doctor.

If you are switching to Balcoltra™ from another method of contraception:

• Transdermales Pflaster, Vaginalring oder Injektion – Beginnen Sie mit Balcoltra™ an dem Tag, an dem Sie das Arzneimittel normalerweise anwenden, einführen oder injizieren würden.
• Implantat – Beginnen Sie mit Balcoltra™ am Tag der Entfernung des Implantats.
• Intrauterinpessar (IUP) – Beginnen Sie mit Balcoltra™ am Tag der Entfernung des IUP. Verwenden Sie in den ersten 7 Tagen eine zweite Form der Empfängnisverhütung, wenn das IUP nicht am ersten Tag Ihres Menstruationszyklus entfernt wurde.

If you have a miscarriage or abortion in the first trimester of your pregnancy, you can start using this medicine immediately. You do not need a second form of contraception. If you start taking this medication 5 days or more after the miscarriage or abortion, you should use a second form of non-hormonal contraception for the first 7 days of your first pill cycle. If you experience a miscarriage or abortion after the second trimester, you should wait 4 weeks before starting to take this medicine. If you take this medicine on a Sunday, use another form of birth control for the first 7 days of your first pill cycle.

Do not drink grapefruit juice while using this medicine. Grapefruit juice may change the amount of this medicine absorbed into the body.

dosage

The dose of this medicine is different for different patients. Follow your doctor's instructions or the label directions. The following information includes average doses of this medicine only. If your dose is different, do not change it unless your doctor tells you to.

The amount of medicine you take depends on the strength of the medicine. In addition, the number of doses you take each day, the time between doses, and how long you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to start taking the dose on the first day of your period (First Day Start) or on the first Sunday after your period starts (Sunday Start). If you start on a specific day, it is important that you stick to that schedule even if you miss a dose. Don't change your schedule on your own. If the schedule you are using is not suitable, contact your doctor to change it. If you start on Sunday, you must use another form of contraception (e.g. condom, diaphragm, spermicide) for the first 7 days.

• Für orale Darreichungsformen (Tabletten):
  • Zur Empfängnisverhütung (um eine Schwangerschaft zu verhindern):
    • Erwachsene und Jugendliche: Eine orangefarbene Tablette (aktiv), die an 21 aufeinanderfolgenden Tagen jeden Tag zur gleichen Zeit eingenommen wird, gefolgt von einer blauen (inerten) Tablette täglich an 7 Tagen pro Menstruationszyklus.
    • Kinder – Anwendung und Dosis müssen von Ihrem Arzt festgelegt werden.

Missed dose

Call your doctor or pharmacist for instructions.

• Wenn Sie in Woche 1, 2 oder 3 eine orangefarbene wirkstoffhaltige Tablette vergessen haben: Nehmen Sie die Tablette so schnell wie möglich ein und nehmen Sie die nächste Tablette wie gewohnt ein. Nehmen Sie weiterhin täglich eine Tablette ein, bis Sie die Packung aufgebraucht haben.
• Wenn Sie in Woche 1 oder 2 zwei orangefarbene wirkstoffhaltige Tabletten vergessen haben: Nehmen Sie die beiden Tabletten so bald wie möglich und die nächsten beiden Tabletten am nächsten Tag ein. Nehmen Sie weiterhin täglich eine Tablette ein, bis Sie die Packung aufgebraucht haben. Verwenden Sie 7 Tage lang eine zweite Form der Empfängnisverhütung (z. B. Kondom, Spermizid), nachdem Sie eine Dosis vergessen haben.
• Wenn Sie in Woche 3 zwei wirkstoffhaltige Orangentabletten vergessen haben oder in Woche 1, 2 oder 3 drei oder mehr wirkstofforange Tabletten hintereinander vergessen haben:
  • Beginn am ersten Tag: Werfen Sie den Rest der Packung weg und beginnen Sie noch am selben Tag mit einer neuen Packung. Verwenden Sie 7 Tage lang eine zweite Form der Empfängnisverhütung (z. B. Kondom, Spermizid), nachdem Sie eine Dosis vergessen haben.
  • Beginn am Sonntag: Nehmen Sie bis Sonntag weiterhin eine Tablette pro Tag ein, werfen Sie dann den Rest der Packung weg und beginnen Sie am selben Tag mit der Einnahme einer neuen Packung. Um eine Schwangerschaft zu verhindern, verwenden Sie sieben Tage lang eine zweite Form der Empfängnisverhütung (z. B. Kondom, Spermizid), nachdem Sie eine Dosis vergessen haben.
• Wenn Sie die Pille nicht rechtzeitig einnehmen, kann es zu leichten Blutungen oder Schmierblutungen kommen. Je mehr Pillen Sie vergessen, desto wahrscheinlicher ist es, dass Sie Blutungen bekommen.
• Stellen Sie sicher, dass Ihr Arzt Bescheid weiß, wenn Ihre Periode zwei Monate hintereinander ausbleibt, da dies bedeuten könnte, dass Sie schwanger sind.

storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Protect from freezing.

Keep away from children.

Do not keep medications that are outdated or no longer needed.

Ask your doctor how to throw away medicines you don't use.

Precautions when using levonorgestrel, ethinyl estradiol and ferrous bisglycinate

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for adverse effects.

Although you are using this medicine to prevent pregnancy, you should be aware that using this medicine during pregnancy may harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor immediately. Make sure your doctor knows whether you have given birth within 4 weeks before you start using this medicine.

Do not use this medicine with medicines used to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

Minor bleeding or spotting may occur during the first three months of use. This is usually normal and should not last long. However, if you have heavy bleeding or the bleeding continues for more than a few days in a row, call your doctor.

Do not use this medicine if you smoke cigarettes or are over 35 years old. If you smoke while using this medicine, your risk of a blood clot, heart attack, or stroke increases. Your risk is even higher if you are over 35, have diabetes, high blood pressure or high cholesterol, or are overweight. Talk to your doctor about ways to quit smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol levels.

Using this medicine may increase your risk of blood clotting problems. Contact your doctor immediately if you have chest, groin, or leg pain, especially in the calves, difficulty breathing, sudden, severe headache, slurred speech, sudden, unexplained shortness of breath, sudden loss of coordination, or vision problems while using this medication.

Contact your doctor immediately if you have pain or tenderness in your upper abdomen, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of serious liver disease.

This medicine may increase your risk of gallbladder disease. Consult your doctor if you experience stomach pain, nausea and vomiting.

This medicine may cause skin discoloration. Use sunscreen when you are outdoors. Avoid sun lamps and tanning beds.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop taking this medicine a few days before surgery or certain medical tests.

Do not take any other medicines unless you have discussed this with your doctor. This includes both prescription and non-prescription (over-the-counter [OTC]) medicines and herbal (e.g. St. John's wort) or vitamin supplements.

Side effects of levonorgestrel, ethinyl estradiol and ferrous bisglycinate

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

Consult your doctor immediately if any of the following side effects occur:

More common

• Krämpfe
• Kopfschmerzen
• starkes Bluten
• Schmerz

Less common

• Ausbleibende, versäumte oder unregelmäßige Menstruationsperioden
• Brustschmerzen
• Veränderung der Farbe, Menge oder des Geruchs des Vaginalausflusses

Incident not known

• Angst
• Brustschmerzen
• Husten
• Durchfall
• schwieriges oder erschwertes Atmen
• Schwindel oder Benommenheit
• Ohnmacht
• schneller, unregelmäßiger, hämmernder oder rasender Herzschlag oder Puls
• Gefühl von Wärme
• Fieber
• Kopfschmerzen, stark und pochend
• starke nicht-menstruelle Vaginalblutung
• Gelenk- oder Muskelschmerzen
• längere oder stärkere Menstruationsperioden
• Brechreiz
• Taubheitsgefühl oder Kribbeln im Gesicht, an Händen oder Füßen
• Schmerzen, Rötung oder Schwellung im Arm oder Bein
• Rötung und Schmerzen der Augen
• Rötung des Gesichts, des Halses, der Arme und gelegentlich der oberen Brust
• Hautausschlag
• Wunden im Mund
• Magenschmerzen
• plötzliches Schwitzen
• Schwellung der Füße oder Unterschenkel
• Engegefühl in der Brust
• Atembeschwerden
• Erbrechen

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

Less common

• Akne
• Weinen
• Verfolgungswahn, Misstrauen, Misstrauen oder Kampfbereitschaft
• Entmutigung
• falsches oder ungewöhnliches Wohlbefinden
• Gefühl der Unwirklichkeit
• sich traurig oder leer fühlen
• Reizbarkeit
• Appetitlosigkeit
• Verlust von Interesse oder Vergnügen
• schnell reagieren oder emotional überreagieren
• schnell wechselnde Stimmungen
• Gefühl der Loslösung von sich selbst oder dem Körper
• Müdigkeit
• Konzentrationsschwierigkeiten
• Schlafstörungen

Incident not known

• Rückenschmerzen
• Brennen, Krabbeln, Jucken, Taubheitsgefühl, Kribbeln, Kribbeln oder Kribbeln
• Schwierigkeiten beim Bewegen
• Kopfschmerzen
• Verletzung
• Muskelschmerzen, Krämpfe oder Steifheit
• Schmerzen in den Armen, Beinen oder Gelenken
• Schläfrigkeit oder ungewöhnliche Schläfrigkeit
• Halsentzündung
• verstopfte oder laufende Nase
• ungewöhnliche Müdigkeit oder Schwäche
• Gewicht nahm ab

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Commonly used brand names

In the USA

• Balcoltra

Available dosage forms:

• Tablette

More information