Blisovi Fe 1.5/30 is a medication which is used for hormonal contraception. The drug contains a combination of 2 female hormones: ethinyl estradiol and norethisterone.
Contents:
Indications for use
Blisovi Fe 1.5/30 is used to prevent pregnancy, treat acne. It can be used for other reasons under a doctor’s prescription.
Mechanism of action
The drug inhibits ovulation (the release of a mature egg from the ovary). In addition, it helps to increase the production of more viscous cervical mucus, which hampers the penetration of sperm into the uterus. Under the influence of ethinyl estradiol and norethisterone, unfavorable conditions are created for implantation of a fertilized egg in the endometrium (the inner layer of the uterus).
Dosage and mode of application
Each pack of Blisovi Fe 1.5/30 contains 21 pink tablets of ethinyl estradiol and norethisterone and 7 brown inert tablets containing ferrous fumarate. These 7 tablets do not have any therapeutic effect and serve as “reminders” to facilitate ease of daily drug administration.
To achieve the maximum contraceptive effect, the tablets must be taken according to the instructions, at intervals not exceeding 24 hours.
You can either start taking tablets on Sunday following the onset of your menstruation or on the first day of your period.
- Sunday-Starters: Taking the first pink tablet on the first Sunday after your menstruation begins. Takes 1 pink tablet per day for 21 days. Then take 1 brown tablet per day for 7 days. When the pack is empty, begin a new course of contraception, without breaks. Follow the same regimen, You will start all subsequent cycles on Sunday;
- Day-1 Starters: The first day of your period is considered to be Day 1. Place the week sticker that corresponds to your Day 1 over the printed days on the blister. Starts taking 1 pink tablet per day. Then take 1 brown tablet per day for 7 days. Once you’ve finished the first cycle of contraception, begin a new pack without interruption. Use this regimen for all subsequent cycles.
The drug should be taken with a meal or at bedtime. Try not to miss tablets since this can reduce the contraceptive effectiveness of Blisovi Fe 1.5/30.
Overdose
Serious negative reactions have not been reported following intake of large doses of ethinyl estradiol and norethisterone. Overdosage may cause vomiting, nausea, and vaginal bleeding.
Side effects
In some cases, Blisovi Fe 1.5/30 can cause side effects. Most of them are temporary and do not require discontinuation of the drug.
- General: headache, nausea, painful menstruations, breast tenderness, vaginal candidiasis, abdominal pain, changes in mood, bacterial vaginitis, acne, abnormal uterine bleeding, weight gain;
- Genitourinary: vaginal candidiasis, painful menstruations, breast tenderness/pain, bacterial vaginitis, abnormal vaginal bleeding, menorrhagia, metrorrhagia, vaginal hemorrhage, dysmenorrhea, dysfunctional uterine bleeding, ovarian vein thrombosis, amenorrhea, breakthrough bleeding, breast enlargement, vaginitis, breast secretion,, cervical secretion, diminution in lactation, spotting, cervical erosion changed, premenstrual syndrome, uterine fibroid disease exacerbated, vaginal infection, pollakiuria, dysuria, pelvic pain, ovarian cyst, pelvic fluid collection, nipple pain, nipple discharge, galactorrhea, fibrocystic breast change, breast disorder, breast mass, uterine leiomyomata size increased, cervical ectropion changed, endometrial hyperplasia, ovarian cyst, uterine enlargement;
- Cardiovascular: high blood pressure, vein thrombosis, myocardial infarction, hypertension, arterial thromboembolism, thrombophlebitis, coronary artery thrombosis, palpitation, tachycardia, angina pectoris, hot flush, irregular heart rate;
- Nervous system: headache, migraine, dizziness, cerebral hemorrhage, cerebral thrombosis, fainting, hyperesthesia, paresthesia, hypoesthesia, somnolence, sensory disturbance, transient ischemic attack, ischemic stroke, chorea, epilepsy exacerbated, dementia, hemiparesis;
- Oncologic: hepatic adenoma, hepatic carcinoma, benign liver tumor, hemangioma of the liver, breast cancer, ovarian cancer, endometrial cancer, uterine cancer;
- Endocrine: hypothyroidism, hyperthyroidism;
- Gastrointestinal: nausea, vomiting, abdominal pain/cramps, bloating, colitis, dyspepsia, inflammatory bowel disease, Crohn’s disease, ulcerative colitis, mesenteric thrombosis, constipation, pancreatitis;
- Hepatic: liver disease, gallbladder disease, cholestatic jaundice, Budd-Chiari syndrome, cholelithiasis, cholecystitis;
- Psychiatric: changes in mood, depression, anxiety, nervousness, sleep disorders, suicidal ideation, panic attack, libido changed, homicidal ideation, dissociation, bipolar disorder, mood disturbed, irritability;
- Dermatologic: acne, hirsutism, loss of scalp hair, melasma, chloasma, erythema multiforme, erythema nodosum, hemorrhagic eruption, photosensitivity, pruritus, alopecia, generalized rash, allergic rash, skin discoloration, urticaria, angioedema, night sweats, angioedema, hirsutism, skin burning sensation, generalized erythema;
- Respiratory: pulmonary embolism, asthma, dyspnea;
- Hematologic: hemolytic uremic syndrome, anemia;
- Immunologic: hypersensitivity reaction, anaphylactic/anaphylactoid reaction;
- Ocular: corneal curvature change/steepening, contact lens intolerance, cataracts, retinal thrombosis, vision disorders, corneal thinning, fungal infection;
- Musculoskeletal: leg cramp, backache, myalgia, arthralgia, back pain;
- Renal: impaired renal function, cystitis;
- Metabolic: weight fluctuation, poor tolerance to carbohydrates, increased/decreased appetite, diabetes mellitus, hypoglycemia, hypocalcemia, increased triglycerides, abnormal blood glucose;
- Other: cervical smear abnormal, weight gain, edema, fatigue, weakness, porphyria, Vitamin B6 deficiency, decreased weight, peripheral edema, malaise, chest pain.
Contraindications
Do not take Blisovi Fe 1.5/30 in the following cases:
- an allergy to ethinyl estradiol, norethindrone, or ferrous fumarate);
- an allergy to any other oral contraceptive, any other medications, products, or other substances;
- a history of rash, hives, itching, shortness of breath, wheezing, cough, swelling of the face, lips, tongue, or throat;
- a history of blood clots, breast cancer, diseased blood vessels in the brain or heart, a disease of a heart valve with problems, heart disease, angina, heart attack, stroke, liver disease, hypertension, liver tumor, severe headache or a migraine, diabetes;
- a history of endometrial cancer, cancer of the cervix or vagina, vaginal bleeding of unknown origin;
- 6 weeks before a scheduled surgery and prolonged bedrest;
- established or suspected pregnancy;
- breastfeeding period;
- if you are taking ombitasvir, paritaprevir, and ritonavir;
- a history of jaundice during pregnancy or jaundice caused by the use of hormonal contraceptives;
- if you have not had your first period.
Interactions
- acitretin;
- aminophylline / ephedrine / guaifenesin / phenobarbital;
- amprenavir;
- atropine / phenobarbital;
- eslicarbazepine;
- belladonna / ergotamine / phenobarbital;
- bosentan;
- encorafenib;
- sugammadex;
- brigatinib;
- carbamazepine;
- carfilzomib;
- mycophenolate mofetil;
- tranexamic acid;
- dabrafenib;
- dasabuvir / ombitasvir / paritaprevir / ritonavir;
- phenytoin;
- atropine / hyoscyamine / phenobarbital / scopolamine;
- dyphylline / ephedrine / guaifenesin / phenobarbital;
- ephedrine / phenobarbital / potassium iodide / theophylline;
- ephedrine / phenobarbital / theophylline;
- etretinate;
- felbamate;
- fosamprenavir;
- fosphenytoin;
- griseofulvin;
- hemin;
- hyoscyamine / phenobarbital;
- telaprevir;
- isoniazid / rifampin;
- isoniazid / pyrazinamide / rifampin;
- ivacaftor / lumacaftor;
- arfilzomib;
- lenalidomide;
- phenobarbital;
- aminophylline / ephedrine / phenobarbital / potassium iodide;
- rifabutin;
- mycophenolic acid;
- primidone;
- ombitasvir / paritaprevir / ritonavir;
- oxcarbazepine;
- pomalidomide;
- rifapentine;
- dantrolene;
- st. john’s wort;
- bexarotene;
- thalidomide;
- tizanidine;
- boceprevir.
Pregnancy and breastfeeding
Blisovi Fe 1.5/30 is contraindicated for use during pregnancy. Exclude pregnancy prior to taking combination oral contraceptives. Stop taking the drug if pregnancy occurs when on the pills.
Breastfeeding women should not use this medication for birth control since its active substances are excreted into human milk and may affect the baby.
What if I miss a pill?
If you forget to take 1 or more active pink tablets, follow the instructions listed below:
1 tablet is missed: take it as soon as you remember, the next tablet is taken at the regular time
2 tablets are missed in a row (week 1 or 2): take 2 tablets as soon as you remember, take 2 tablets the next day, use an additional method of contraception for 7 days following the missed tablets.
2 tablets are missed in a row (week 3):
- Sunday-Start: take 1 tablet per day until Sunday, then throw out the rest of the tablets and start a new pack immediately, use an additional method of contraception for 7 days following the missed tablets;
- Day-1 Start: throw out the rest of the tablets, start a new pack that same day, use an additional method of contraception for 7 days following the missed tablets.
3 or more tablets are missed in a row:
- Sunday-Start: keep taking 1 tablet per day until Sunday, then discard the rest of the tablets and a start new pack immediately, use an additional method of contraception for 7 days following the missed tablets;
- Day-1 Start: throw out the rest of the tablets, start a new pack that same day, use an additional method of contraception for 7 days following the missed tablets.
The possibility of pregnancy increases with each missed pink tablet. The possibility of spotting/vaginal bleeding is also increased, especially if 2 or more pink tablets are missed in a row.
If you miss any of the 7 brown tablets in week 4, discard the missed tablets and keep taking 1 tablet each day until the pack is finished. You do not need a barrier method of preventing pregnancy during this time. Begin a new pack of Blisovi Fe 1.5/30 the next day after taking the last brown tablet.
Precautions
Blisovi Fe 1.5/30 does not protect women from sexually-transmitted diseases.
The risk of cardiovascular complications increases with smoking (especially in heavy smokers over 35 years of age).
Before taking birth control pills, as well as every 6 months, you need to visit a gynecologist.
The drug must be discontinued immediately 6 weeks before the scheduled surgery and if the following symptoms appear: inflammation of the vein wall, vascular occlusion with a blood clot, distended veins, unusual pain in the legs, chest pain during breathing or coughing, tightness in the chest; severe migraine headaches, sudden hearing impairment, vision problems, movement disorders, hepatitis, jaundice, itching, cholestasis, aggravated epilepsy attacks, diseases associated with impaired metabolism of porphyrins/pigments), when you start taking barbiturates, rifampicin, ampicillin, griseofulvin, antiepileptic drugs, antidiabetic drugs.
The risk of thrombosis increases in women with high blood pressure.
Vomiting or diarrhea can lead to the withdrawal of ethinyl estradiol and norethisterone from the body, therefore, if you have vomiting or diarrhea 3-4 hours after taking a pink tablet, take an additional pill of Blisovi and use backup methods of contraception for 7 days.