Beyaz is a combination birth control pill containing drospirenone, ethinyl estradiol and levomefolate calcium, used to prevent pregnancy.
Contents:
Indications for use
- Contraception, intended primarily for women with symptoms of hormone-dependent fluid retention in the body;
- Contraception and treatment of a moderate form of acne (acne vulgaris);
- Contraception in women with folate deficiency;
- Contraception and treatment of a severe premenstrual syndrome.
Mechanism of action
Beyaz is a low-dose, monophasic oral combined estrogen-progestational medication that includes active tablets and auxiliaries containing calcium levomefolate.
The contraceptive effect of the preparation is mainly carried out by suppressing ovulation and increasing the viscosity of the secretion of the cervix.
In women taking combined oral contraceptives, the periods become more regular, the soreness, intensity and duration of menstrual bleeding decrease. There is also evidence of a reduced risk of endometrial and ovarian cancer.
Drospirenone, which is part of Beyaz tablets, has antimineralocorticoid activity and helps prevent hormone-dependent fluid retention, which can reduce body weight and the likelihood of peripheral edema. Drospirenone also has anti-androgenic activity and helps to reduce acne, oiliness of the skin and hair (seborrhea).
Dosage and mode of application
Beyaz 28-day pack contains 24 pink active pills (drospirenone 3mg, ethinyl estradiol 20 mcg, levomefolate calcium 0.451mg) and 4 light orange hormone-free pills (levomefolate calcium 0.451mg).
Take tablets daily in the order presented on the package, at the same time of a day, without chewing, with a small amount of water. Take 1 tablet/day continuously for 28 days. Begin using tablets from the next package immediately after you have taken the last pill from the previous package. Bleeding cancellation usually is expected 2-3 days after the start of taking hormone-free tablets and may not be completed before taking the tablets from the next package.
How to start Beyaz birth control pills:
If you have not used any hormonal contraceptives in the previous month:
Begin taking tablets on the 1st day of the period (on the 1st day of menstruation). On this day, it is necessary to take one pink (hormone-active) tablet, which is marked with the corresponding day of the week. Then take the pill in order. The drug starts to act immediately, so there is no need for additional barrier methods of contraception.
It is allowed to start taking the contraceptive on the 2nd-5th day of the menstrual period, but in this case, it is necessary to use an additional barrier method of contraception (for example, a condom) during the first 7 days of taking tablets from the first package.
When switching from other COCs, vaginal rings or contraceptive patches:
It is preferable to start taking Beyaz on the day after taking the last active hormone-containing tablet from the package of the previous birth control pills, but in no case later than the day after the usual 7-day break (for preparations containing 21 tablets) or after taking the last tablet that does not contain hormones (for preparations containing 28 tablets in a package). The preparation should be started as soon as the vaginal ring or patch are removed.
When switching from gestagen-only birth control means (“mini-pills”, injectable forms, implant), or from the intrauterine therapeutic system with the release of the progestogen:
You can switch from mini-pills to Beyaz any day, from an gestagen implant or IUD – as soon as they are removed, from the injection contraceptive – the day the next injection is to be made. In all cases, an additional contraception (a condom) must be used during the first 7 days of taking Beyaz pills.
After abortion (including spontaneous) in the first trimester of pregnancy:
You can start taking the drug immediately. In this case, additional contraceptive measures are not required.
After childbirth (in the absence of breastfeeding) or abortion (including spontaneous) in the II trimester of pregnancy:
It is recommended to start taking the drug on the 21-28th day after childbirth or abortion (including spontaneous) in the second trimester of pregnancy. If the drug is started later, it is necessary to use additional contraception during the first 7 days of taking the tablets. However, if sexual intercourse has occurred, pregnancy should be excluded before the drug is taken.
Rules for handling the packaging of Beyaz:
A blister pack contains 24 pink tablets and 4 auxiliary (light orange) tablets (the bottom row). The package also contains a sticker unit consisting of 7 self-adhesive strips with the names of the days of the week marked on them, necessary for the registration of the reception calendar. It is necessary to choose a strip with the first day of the week in which you start taking the tablets. For example, if you start taking pills on Wednesday, you should use a strip that starts with “Wed.” The strip is glued along the top of the package so that the designation of the first day is above the tablet on which the arrow with the inscription “Start” is directed. Thus, you will see on which day of the week you should take each pill.
Recommendations for gastrointestinal disorders:
In severe gastrointestinal disorders, absorption of the drug may be incomplete, therefore additional contraceptive measures should be taken.
If vomiting or diarrhea occurs within 3-4 hours after taking a pink (active) pill, you should be guided by recommendations when skipping tablets.
Overdose
No cases of Beyaz overdose were reported.
- Symptoms: nausea, vomiting, spotting or metrorrhagia (more often in young women).
- Treatment: there is no specific antidote for drospirenone / ethinyl estradiol / levomefolate calcium, it is necessary to carry out symptomatic treatment.
Calcium levomefolate and its metabolites are identical to folates, which are part of natural products, daily consumption of which does not harm the body. The intake of calcium levomefolate in a dose of 17 mg/day (a dose 37 times higher than that contained in 1 tablet of Beyaz) for up to 12 weeks was well tolerated.
Contraindications
Beyaz pills are contraindicated in the presence of any of the conditions/diseases listed below. If any of these conditions/diseases occur during treatment, the contraceptive should be discontinued.
Absolute contraindications:
- thrombosis (venous and arterial) and thromboembolism (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke),
- cerebrovascular disorders;
- conditions preceding thrombosis (transient ischemic attacks, angina pectoris);
- identified acquired or hereditary predisposition to venous or arterial thrombosis;
- a high risk of venous or arterial thrombosis;
- migraine with focal neurologic symptoms;
- pancreatitis with severe hypertriglyceridemia;
- diabetes mellitus with vascular complications;
- liver failure and severe liver disease;
- severe and/or acute renal failure;
- adrenal insufficiency;
- liver tumors (benign or malignant);
- identified hormone-dependent malignant neoplasms;
- bleeding from the vagina of unknown origin;
- pregnancy;
- breastfeeding;
- rare hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption;
- hypersensitivity or intolerance to any of the components of Beyaz.
With caution:
Potential risk and the expected use of birth control pills in each individual case should be assessed in the presence of the following diseases/conditions and risk factors:
- risk factors for thrombosis and thromboembolism: smoking, obesity, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated heart valve defects, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age);
- violations of peripheral circulation: diabetes mellitus without vascular complications, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn’s disease and ulcerative colitis, sickle cell anemia, phlebitis of superficial veins;
- hereditary angioedema;
- hypertriglyceridemia;
- liver disease, not related to contraindications;
- diseases that first occurred or worsened during pregnancy or against the background of the previous use of sex hormones ( jaundice and/or itching associated with cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, pregnant sores, Sydenham’s chorea);
- postpartum period (not earlier than 21-28 days after childbirth, in the absence of breastfeeding).
Side effects
The most common side effects of Beyaz are nausea, pain in the mammary glands, irregular uterine bleeding, bleeding from the genital tract of unspecified genesis (more than 3% of women who use the drug for “contraception” and “contraception and treatment of moderate form of acne (acne vulgaris)”; nausea, pain in the mammary glands, irregular uterine bleeding (more than 10% of women using the drug according to the indication “contraception and treatment of severe premenstrual syndrome”).
Other possible side effects include:
- candidiasis;
- weight gain;
- weight loss;
- increased appetite;
- anorexia;
- hyperkalemia;
- hyponatremia;
- disorders of the psyche;
- mood swings;
- decrease or loss of libido;
- drowsiness;
- depression / depressed mood;
- insomnia;
- anorgasmia;
- headache;
- dizziness;
- paresthesia;
- tachycardia;
- migraine;
- an increase of blood pressure;
- fainting;
- nasal bleeding;
- venous or arterial thromboembolism;
- conjunctivitis;
- dryness of the eye mucosa;
- blurred vision;
- nausea;
- stomach ache;
- vomiting;
- gastritis;
- diarrhea;
- flatulence;
- dyspepsia;
- bloating;
- constipation;
- dry mouth;
- pain in the right hypochondrium;
- allergic reactions;
- hypersensitivity;
- acne;
- rash;
- pruritus;
- alopecia;
- hypertrichosis;
- eczema;
- dry skin;
- contact dermatitis;
- acneform;
- dermatosis;
- erythema multiforme;
- backache;
- pain in the limbs;
- muscle cramps;
- pain in the mammary glands;
- tenderness of the mammary glands;
- acyclic bleeding/bleeding from the vagina;
- bleeding from the genital tract;
- an absence of menstrual bleeding;
- pelvic pain;
- fibrocystic mastopathy;
- vulvovaginal candidiasis;
- vaginal discharge;
- heavy menstrual bleeding;
- scanty menstrual-like spotting;
- rare menstrual bleeding;
- painful menstrual bleeding;
- dryness of the vaginal mucosa;
- a pathological result of the Pap test;
- mammary hyperplasia;
- cervical polyp;
- ovarian cyst;
- endometrial atrophy;
- anemia;
- thrombocythemia;
- asthenia;
- increased sweating;
- edema generalized or peripheral;
- malaise.
Interactions
Beyaz can interact with the following drugs:
phenytoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, preparations containing St. John’s Wort, many HIV protease or hepatitis C virus inhibitors, non-nucleicidic reverse transcriptase inhibitors, methotrexate, trimethoprim, sulfasalazine, triamterene, colestyramine, antiepileptic drugs – carbamazepine, phenytoin, phenobarbital, primidone and valproic acid, antifungal agents of the azole group (itraconazole, voriconazole, fluconazole), verapamil, macrolide antibiotics (clarithromycin, erythromycin), diltiazem and grapefruit juice.
If you combine Beyaz pills with the above-mentioned drugs, you should use additional methods of contraception during their simultaneous use and 7 days after it.
What if I miss a dose?
Missing hormone-free light-orange tablets can be ignored. However, the missed tablets should be discarded so as not to accidentally prolong the period of taking inactive pills. The following recommendations apply only to the omission of active pink tablets (tablets 1-24 in the package).
If the delay in taking any pink (active) pill is less than 24 hours, the contraceptive effect does not decrease. A woman should take the missed tablet as soon as possible and take the next pill at the usual time.
If the delay in taking any pink (active) pill is more than 24 hours, the contraceptive effect can be reduced. The more pills are missed and the closer the tablets pass to the phase of taking light orange (hormone-free) tablets, the higher the probability of pregnancy.
In this case, it is necessary to remember:
- taking Beyaz tablets should never be interrupted for more than 7 days (please note that the recommended interval for taking light orange (inert) tablets is 4 days);
- 7 days of continuous intake of pink (active) tablets are required to achieve satisfactory stoppage of the ovarian system.
Accordingly, if the delay in taking pink (active) tablets is more than 24 hours, you can do the following:
From the 1st to the 7th day:
A woman should take the last missed tablet immediately, as soon as she remembers it, even if it means taking two pills at the same time. The following tablets should be taken at the usual time. In addition, during the next 7 days, an additional contraception should be used. If sexual intercourse has occurred within 7 days before missing the pill, you should consider the possibility of pregnancy.
From the 8th to the 14th day:
A woman should take the last missed tablet immediately, as soon as she remembers it, even if it means taking two pills at the same time. The following tablets should be taken at the usual time.
In case of compliance with the regimen of taking the tablets within 7 days preceding the first missed tablet, you do not need to use additional birth control methods. Otherwise, you need to use additional means of contraception for the next 7 days (as well as when you missed two or more pink active pills).
From the 15th to the 24th day:
The contraceptive effect is reduced due to the approaching phase of taking hormone-free tablets. In this case, you must adhere to the following algorithms:
- If all tablets were taken correctly within 7 days preceding the first missed tablet, it is not necessary to use additional contraceptive methods. When taking the missed tablets, items 1 or 2 should be followed (below);
- If the tablets were taken incorrectly during the 7 days preceding the first missed tablet, then the barrier method of contraception (for example, a condom) should be used additionally within the next 7 days, in which case item 1 should be followed (below):
- Take the missed tablet as soon as possible (even if it means taking two tablets at the same time). The following tablets are taken at the usual time until the pink (active) tablets in the package run out. Discard 4 light orange (inert) tablets and begin taking pink (active) tablets from the new package immediately. As long as you take pink (active) tablets from the second package, bleeding cancellation is unlikely, but there may be spotting and/or breakthrough bleeding.
- Interrupt the intake of pink (active) tablets from the current package, take a break for 4 or fewer days (including the days of skipping the tablets), then start taking the drug from the new package.
If you miss a pink (active) tablets and during the use of light orange (inert) pills bleeding cancellation does not occur, you need to make sure that you are not pregnant.
It is allowed to take no more than two pills per day.
Beyaz and pregnancy
The drug is contraindicated in pregnancy. If pregnancy has occurred during the use of the drug, the treatment should be immediately discontinued. The available data on the use of Beyaz during pregnancy are limited and do not allow any conclusions about the negative effect of the drug on pregnancy, the health of the fetus and the newborn baby. At the same time, extensive epidemiological studies have not revealed an increased risk of developmental defects in children born to women taking COCs prior to pregnancy, or teratogenicity in cases of COCs due to negligence in the early stages of pregnancy. There were no specific epidemiological studies for the drug.
Beyaz is contraindicated in the period of breastfeeding. Taking drospirenone, ethinyl estradiol and levomefolate calcium can reduce the amount of breast milk and change its composition, so the use of the contraceptive is contraindicated until the end of breastfeeding. A small amount of sex hormones can penetrate into breast milk and influence the health of the child.
Special instructions
Risk factors for developing thrombosis and thromboembolism:
The risk of developing thrombosis (venous and/or arterial) and thromboembolism or cerebrovascular disorders is increased:
- with age;
- smokers (with the increase in the number of cigarettes, especially in women over 35).
An increase in the frequency and severity of a migraine during the use of Beyaz drug (which may precede cerebrovascular disorders) is the basis for immediate withdrawal of the drug.
Use in violations of liver function:
The drug is contraindicated in women with severe impairment of kidney function and with acute renal failure.
Use in violations of kidney function:
The drug is contraindicated for use in women with hepatic insufficiency and severe liver disease; liver tumors (benign or malignant).
With caution – liver disease, not related to contraindications.
Use in children:
The effectiveness and safety of Beyaz as a contraceptive was studied in women of reproductive age. The use of the drug in children and adolescents is contraindicated before the establishment of regular menstrual periods.
Use in old age:
Beyaz is not used after menopause.