Aurovela Fe 1/20 is a microdose hormonal contraceptive which is used to prevent pregancy. The drug contains ethinyl estradiol and norethisterone.
Contents:
Indications for use
- Normalization of periods;
- Hormonal contraception;
- Painful periods or dysmenorrhea;
- Underdevelopment of the uterus;
- Psychological or functional sterility (when a healthy woman cannot become pregnant);
- Uterine bleeding if the menstrual cycle fails.
Mechanism of action
The drug inhibits the gonadotropic function of the pituitary gland, blocks the development of the follicle and interferes with the process of ovulation. The contraceptive effect is enhanced by increasing the viscosity of cervical mucus and reducing the susceptibility of the endometrium to the blastocyte.
Dosage and mode of application
Each pack of Aurovela Fe 1/20 contains 21 yellow tablets (norethindrone acetate + ethinyl estradiol) and 7 inert brown tablets (ferrous fumarate). Tablets should be taken daily at the same time of a day (preferably in the evening). You can start using the drug on the first day of your period or wait for Sunday following the onset of your period.
- Sunday-Start Regimen: Take the first tablet from the pack on the first Sunday after your period begins. When the period begins on Sunday, the first tablet is taken on the same day. Take 1 tablet per day for 28 days. Once you have finished this first course of tablets, begin a new course of Aurovela Fe 1/20, without breaks, the next day (Sunday);
- Day-1 Start Regimen: Start taking the drug on the first day of your period. Take tablets for 28 days in a row, without interruption, at the same time of a day (preferably in the evening). Once you have finished this first course of tablets, begin a new pack of the contraceptive.
In both cases, menstrual-like bleeding should be expected 2-3 days after you take the last yellow tablet in the blister.
Overdose
No serious adverse effects from an overdose of ethinyl estradiol and norethisterone have been reported. Excessive doses of the drug may lead to withdrawal bleeding and nausea.
Side effects
Aurovela Fe 1/20 can cause the following adverse reactions (especially in the first months of use):
- abnormal menses (absent, missed, or irregular);
- changed skin color;
- headache;
- hives;
- nausea;
- chest pain, chest discomfort;
- diarrhea;
- dizziness;
- fainting;
- accelerated heartbeat;
- fever;
- pain in the arms, jaw, back, neck, chest, groin;
- rash;
- red skin;
- constipation;
- cough;
- dark urine;
- painful sexual intercourse;
- tiredness;
- slow heartbeat;
- stomach ache;
- bloating;
- spots on the skin;
- breast enlargement;
- breast tenderness;
- slurred speech;
- sweating;
- breathing problems;
- vomiting;
- changes in mood;
- itching;
- swelling on the face or organs;
- changes in appetite;
- irritability;
- anxiety;
- vision disorders;
- itching of the vagina;
- low sex drive;
- poor concentration;
- sleeping problems;
- trouble wearing contact lenses;
- poor coordination.
If you experience any severe side effects after taking birth control tablets, contact your doctor immediately.
Contraindications
Do not use Aurovela Fe 1/20 if you are allergic to ethinyl estradiol and norethisterone and also in the following cases:
- jaundice;
- itching of the skin during a previous pregnancy;
- thrombophlebitis;
- age up to 16 years;
- herpes pregnant;
- thrombosis of arteries and veins;
- severe hypertension;
- various cardiovascular diseases;
- liver disease;
- tumors of the mammary glands, uterus.
If you have any of these contraindications, a comprehensive examination is necessary before taking birth control pills. This complex includes gynecologist and therapist’s consultation; mammography, a blood test to check the content of liver enzymes; control of arterial pressure.
Interactions
Do take Aurovela Fe 1/20 with the following medications:
- acitretin;
- Agenerase (amprenavir);
- Alkabel-SR (atropine / hyoscyamine / phenobarbital / scopolamine);
- Alunbrig (brigatinib);
- aminophylline / ephedrine / guaifenesin / phenobarbital;
- aminophylline / ephedrine / phenobarbital / potassium iodide;
- amprenavir;
- Antispas (atropine / hyoscyamine / phenobarbital / scopolamine);
- Antispasmodic (atropine / hyoscyamine / phenobarbital / scopolamine);
- Antrocol (atropine / phenobarbital);
- Aptiom (eslicarbazepine);
- atropine / hyoscyamine / phenobarbital / scopolamine;
- atropine / phenobarbital;
- B-Donna Tablets (atropine / hyoscyamine / phenobarbital / scopolamine);
- Barbidonna (atropine / hyoscyamine / phenobarbital / scopolamine);
- Bel-Phen-Ergot (belladonna / ergotamine / phenobarbital);
- Bel-Tabs (belladonna / ergotamine / phenobarbital);
- belladonna / ergotamine / phenobarbital;
- Bellalphen (atropine / hyoscyamine / phenobarbital / scopolamine);
- Bellamine (belladonna / ergotamine / phenobarbital);
- Bellamine S (belladonna / ergotamine / phenobarbital);
- Bellamor (belladonna / ergotamine / phenobarbital);
- Bellaphen-S (belladonna / ergotamine / phenobarbital);
- Bellaspas (belladonna / ergotamine / phenobarbital);
- Bellatal (atropine / hyoscyamine / phenobarbital / scopolamine);
- Bellatal ER (atropine / hyoscyamine / phenobarbital / scopolamine);
- Bellergal-S (belladonna / ergotamine / phenobarbital);
- bexarotene;
- boceprevir;
- bosentan;
- Braftovi (encorafenib);
- Bridion (sugammadex);
- brigatinib;
- carbamazepine;
- Carbatrol (carbamazepine);
- carfilzomib;
- Carnexiv (carbamazepine);
- CellCept (mycophenolate mofetil);
- Cerebyx (fosphenytoin);
- Chardonna-2 (atropine / hyoscyamine / phenobarbital / scopolamine);
- Cyklokapron (tranexamic acid);
- D-Tal (atropine / hyoscyamine / phenobarbital / scopolamine);
- dabrafenib;
- Dantrium (dantrolene);
- Dantrium Intravenous (dantrolene);
- dantrolene;
- dasabuvir / ombitasvir / paritaprevir / ritonavir;
- Di-Phen (phenytoin);
- Dilantin (phenytoin);
- Donnaphen (atropine / hyoscyamine / phenobarbital / scopolamine);
- Donnapine (atropine / hyoscyamine / phenobarbital / scopolamine);
- Donnatal (atropine / hyoscyamine / phenobarbital / scopolamine);
- Donnatal Extentabs (atropine / hyoscyamine / phenobarbital / scopolamine);
- Duragal-S (belladonna / ergotamine / phenobarbital);
- dyphylline / ephedrine / guaifenesin / phenobarbital;
- Elixiral (atropine / hyoscyamine / phenobarbital / scopolamine);
- encorafenib;
- Eperbel-S (belladonna / ergotamine / phenobarbital);
- ephedrine / phenobarbital / potassium iodide / theophylline;
- ephedrine / phenobarbital / theophylline;
- Epitol (carbamazepine);
- Equetro (carbamazepine);
- eslicarbazepine;
- etretinate;
- felbamate;
- Felbatol (felbamate);
- fosamprenavir;
- fosphenytoin;
- Fulvicin P / G (griseofulvin);
- Fulvicin U / F (griseofulvin);
- Grifulvin V (griseofulvin);
- Gris-PEG (griseofulvin);
- Grisactin 250 (griseofulvin);
- Grisactin 500 (griseofulvin);
- Grisactin Ultra (griseofulvin);
- Griseofulicin (griseofulvin);
- Griseofulvic (griseofulvin);
- griseofulvin;
- Haponal (atropine / hyoscyamine / phenobarbital / scopolamine);
- hemin;
- hyoscyamine / phenobarbital;
- Hyosophen (atropine / hyoscyamine / phenobarbital / scopolamine);
- Incivek (telaprevir);
- IsonaRif (isoniazid / rifampin);
- isoniazid / pyrazinamide / rifampin;
- isoniazid / rifampin;
- ivacaftor / lumacaftor;
- Kinesed (atropine / hyoscyamine / phenobarbital / scopolamine);
- Kyprolis (carfilzomib);
- lenalidomide;
- Levsin with Phenobarbital (hyoscyamine / phenobarbital);
- Lexiva (fosamprenavir);
- Lufyllin-EPG (dyphylline / ephedrine / guaifenesin / phenobarbital);
- Luminal (phenobarbital);
- Lysteda (tranexamic acid);
- Me-PB-Hyos (atropine / hyoscyamine / phenobarbital / scopolamine);
- Mudrane (aminophylline / ephedrine / phenobarbital / potassium iodide);
- Mudrane GG (aminophylline / ephedrine / guaifenesin / phenobarbital);
- Mycobutin (rifabutin);
- mycophenolate mofetil;
- mycophenolic acid;
- Myfortic (mycophenolic acid);
- Mysoline (primidone);
- ombitasvir / paritaprevir / ritonavir;
- Orkambi (ivacaftor / lumacaftor);
- oxcarbazepine;
- Oxtellar XR (oxcarbazepine);
- Panhematin (hemin);
- PB-Hyos (atropine / hyoscyamine / phenobarbital / scopolamine);
- phenobarbital;
- Phenohytro (atropine / hyoscyamine / phenobarbital / scopolamine);
- Phenytek (phenytoin);
- phenytoin;
- Phenytoin Sodium (phenytoin);
- Phenytoin Sodium, Extended Release (phenytoin);
- Phenytoin Sodium, Prompt (phenytoin);
- pomalidomide;
- Pomalyst (pomalidomide);
- Priftin (rifapentine);
- primidone;
- Quadrapax (atropine / hyoscyamine / phenobarbital / scopolamine);
- Quadrinal (ephedrine / phenobarbital / potassium iodide / theophylline);
- RE-PB Hyos Elixir (atropine / hyoscyamine / phenobarbital / scopolamine);
- Revlimid (lenalidomide);
- Revonto (dantrolene);
- rifabutin;
- Rifadin (rifampin);
- Rifadin IV (rifampin);
- Rifamate (isoniazid / rifampin);
- rifampin;
- rifapentine;
- Rifater (isoniazid / pyrazinamide / rifampin);
- Ryanodex (dantrolene);
- Se-Donna PB HYOS (atropine / hyoscyamine / phenobarbital / scopolamine);
- Servira (atropine / hyoscyamine / phenobarbital / scopolamine);
- Rimactane (rifampin);
- Solfoton (phenobarbital);
- Soriatane (acitretin);
- Soriatane CK (acitretin);
- Spasmolin (atropine / hyoscyamine / phenobarbital / scopolamine);
- Spasquid (atropine / hyoscyamine / phenobarbital / scopolamine);
- Spastrin (belladonna / ergotamine / phenobarbital);
- st. john’s wort;
- sugammadex;
- Tafinlar (dabrafenib);
- Targretin (bexarotene);
- Technivie (ombitasvir / paritaprevir / ritonavir);
- Tedrigen (ephedrine / phenobarbital / theophylline);
- Tegison (etretinate);
- Tegretol (carbamazepine);
- Tegretol XR (carbamazepine);
- telaprevir;
- Telzir (fosamprenavir);
- thalidomide;
- Thalomid (thalidomide);
- Theodrine (ephedrine / phenobarbital / theophylline);
- tizanidine;
- Tracleer (bosentan);
- tranexamic acid;
- Trileptal (oxcarbazepine);
- Victrelis (boceprevir);
- Viekira Pak (dasabuvir / ombitasvir / paritaprevir / ritonavir);
- Viekira XR (dasabuvir / ombitasvir / paritaprevir / ritonavir);
- Vitetal (atropine / hyoscyamine / phenobarbital / scopolamine);
- Zanaflex (tizanidine).
Pregnancy and breastfeeding
Use of the drug is contraindicated during pregnancy. A woman must exclude pregnancy prior to taking birth control pills. Discontinue hormonal contraception if pregnancy occurs when on the tablets.
Breastfeeding is not recommended during use of Aurovela Fe 1/20. According to some studies, its active substances are excreted into human milk.
What if I miss a pill?
If you forget to take active tablets (yellow), following the below guidelines:
If you miss 1 yellow tablet, take it as soon as you remember. The next tablet should be taken at your usual time.
If you miss 2 yellow tablets in a row (week 1 or 2), take 2 tablets as soon as you remember and 2 tablets the next day. Use an additional backup method of contraception for 7 days.
If you miss 2 yellow tablets in a row (week 3):
Sunday-Starters:
- keep taking 1 tablet each day until Sunday;
- on Sunday, throw out remaining tablets;
- start a new pack the same day;
- use an additional backup method of contraception for 7 days.
Day-1 Starters:
- throw out remaining tablets;
- start a new pack the same day;
- use an additional backup method of contraception for 7 days.
If you miss 3 or more yellow tablets in a row:
Sunday-Starters:
- keep taking 1 tablet each day until Sunday;
- on Sunday, throw out remaining tablets;
- start a new pack the same day;
- use an additional backup method of contraception for 7 days.
Day-1 Starters:
- throw out remaining tablets;
- start a new pack the same day;
- use an additional backup method of contraception for 7 days.
The risk of ovulation/spotting/bleeding increases with each missed tablet. The risk is particularly high if you miss 2 or more active tablets in a row.
If you forget to take any of the 7 brown tablets in week 4, discard them and keep taking 1 brown tablet per day until the pack is finished. An additional backup method of contraception is not needed during this time. Start a new pack of tablets after you take the last brow tablet.
Precautions
One pack of Aurovela Fe 1/20 is intended for use during one menstrual cycle.
Before starting hormonal contraception, as well as every 6 months, it’s recommended to undergo gynecological examinations.
Use of the drug must be discontinued if the following conditions occur: hepatitis, jaundice, itching, cholestasis, a increased frequency of epilepsy attacks, porphyria signs, early signs of phlebitis (vein wall inflammation), thrombosis, vascular impairment, chest pain when breathing or coughing, a feeling of tightness in the chest; first-time/intensified migraine- headaches, sudden impairment of hearing and vision, movement disorders.
The medication is canceled 6 weeks prior to the planned surgery.
The risk of thrombosis increases with high blood pressure.
The risk of cardiovascular complications increases with smoking (especially in women over the age of 35 years).
Women taking diabetes medications may experience a change in glucose tolerance.
Vomiting or diarrhea can reduce a contraceptive effect of the drug, therefore, in this case, you need to take one more pill and temporarily use an additional non-hormonal method of preventing pregnancy.