Zumandimine (drospirenone and ethinyl estradiol) is an oral contraceptive indicated for use by women to prevent pregnancy.
Contents:
Indications for use
- Contraception;
- Contraception and treatment of acne (acne vulgaris) of moderate severity;
- Contraception and treatment of severe premenstrual syndrome (PMS).
Mechanism of action
Zumandimine is a monophasic combined oral contraceptive, which includes ethinyl estradiol and the progestogen drospirenone. The contraceptive effect of the drug is based on the interaction of various factors, the most important of which are the suppression of ovulation and the change in the properties of cervical secretions, as a result of which it becomes poorly permeable to sperm. In therapeutic doses, drospirenone also has antiandrogenic and moderate antimineralocorticoid properties, which gives drospirenone a pharmacological profile similar to that of natural progesterone. Drospirenone helps reduce the symptoms of acne, oily skin and hair, prevents weight gain and edema associated with estrogen-induced fluid retention. Drospirenone relieves the symptoms of severe premenstrual syndrome, such as severe psychoemotional disorders, engorgement of the mammary glands, headache, pain in the muscles and joints, weight gain, and other symptoms associated with the menstrual cycle. In combination with ethinyl estradiol, drospirenone exhibits a beneficial effect on the lipid profile, characterized by an increase in the concentration of high density lipoproteins (HDL) in blood plasma.
The pill makes your periods more regular, less painful and less abundant, which reduces the risk of anemia. In addition, according to epidemiological studies, it reduces the risk of endometrial cancer and ovarian cancer.
Dosage and mode of application
Each Zumandimine pack contains 28 pills (21 active pills and 7 inert pills)
The pill is taken orally, every day for 28 days without interruptions, at approximately the same time of day, with a small amount of water, in the order indicated on the blister pack. Menstruation should begin on week 4 (when you are taking inactive pills). Start a new package as soon as you finish the current one regardless of whether you still have your period or not.
How to use Zumandimine for the first time:
If you did not use any hormonal contraceptives in the previous month, start taking birth control pills on the first day of your period. It is allowed to start taking pill on the 2-5 day of your period, but in this case it is recommended to additionally use the back-up method of contraception during the first week (first pack only).
If you used any hormonal contraceptives in the previous month, consult a doctor about how to start taking this product.
Side effects
The product is usually well tolerated. However, in some cases, it can cause adverse effects:
- Infectious and parasitic diseases: candidiasis;
- Immune system disorders: allergic reactions, hypersensitivity reactions;
- Blood and lymphatic system disorders: anemia, thrombocytopenia;
- Metabolism and nutrition disorders: increased appetite, anorexia, hyperkalemia, hyponatremia;
- Mental disorders: emotional lability, depression, nervousness, drowsiness, anorgasmia, insomnia;
- Nervous system disorders: headache, paresthesia, dizziness, vergigo. tremor;
- Vision violations: conjunctivitis, dry eye syndrome, visual impairment;
- Heart disturbances: tachycardia;
- Vessel disorders: migraine, increased blood pressure (BP), varicose veins, arterial and venous thromboembolism, phlebitis, fainting, nosebleeds;
- Respiratory disorders: pharyngitis;
- Gastrointestinal disorders: nausea, vomiting, gastritis, diarrhea, dyspepsia, abdominal pain, flatulence, candidiasis of the oral mucosa, constipation, bloating, a feeling of heaviness in the abdomen, dry mouth. hiatal hernia diafragments;
- Liver and biliary tract violations: pain in the gallbladder, cholecystitis;
- Skin and subcutaneous tissue disorders: skin itching. skin rash, acne, chloasma. alopecia, dry skin, eczema, photodermatitis, acneform dermatosis, hypertrichosis, striae. erythema nodosum, contact dermatitis, skin nodule, erythema multiforme;
- Musculoskeletal and connective tissue disorders: back pain, pain in the limbs, muscle cramps;
- Disorders from the kidneys and urinary tract: cystitis;
- Genitals and mammary gland disorders: pain in the mammary gland, metrorrhagia. lack of menstrual bleeding; infrequently candidiasis vulvovaginitis, galactorrhea, “tides” of blood to the skin with a feeling of heat, whitening, dryness of the vaginal mucosa, pain in the pelvic area, bleeding from the uterus / vagina, changes in the results of the Pap test, decreased libido, vaginitis, enlarged mammary glands, fibro- cystic massopathy, painful menstrual-like bleeding, meager menstrual-like spotting, heavy menstrual-like bleeding, neoplasms of the mammary glands, breast hyperplasia, cervical polyp, ovarian cysts, cervical neoplasia, endometrial atrophy, dyspareunia, postcoital bleeding, an increase in the size of the uterus;
- Endocrine system disorders: changes in glucose tolerance or an effect on insulin resistance;
- General disorders and disorders at the injection site: weight gain, generalized swelling, peripheral edema, facial edema, asthenia, increased sweating, weight loss, malaise.
Contraindications
Do not take Zumandimine if you have any of any of the conditions listed below:
- current/history of thrombosis (venous and arterial) and thromboembolism, (including deep vein thrombosis (DVT), pulmonary thromboembolism (pulmonary embolism), myocardial infarction), cerebrovascular disorders;
- conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in the anamnesis;
- hereditary or acquired predisposition to venous or arterial thrombosis, such as resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant);
- current/history of migraine with focal neurological symptoms;
- multiple or severe risk factors for venous or arterial thrombosis, including uncontrolled arterial hypertension, severe dyslipoproteinemia, diabetes mellitus with vascular complications, serious surgery with prolonged immobilization, smoking over the age of 35 years, obesity, air travel lasting more than 4 hours, extensive injury;
- liver failure, severe liver disease;
- current/history of liver tumors (benign or malignant);
- severe renal failure, acute renal failure;
- adrenal insufficiency;
- current/history of pancreatitis with severe hypertriglyceridemia;
- current/history of hormone-dependent malignant neoplasms of the genitals or mammary gland;
- vaginal bleeding of unknown origin;
- pregnancy or suspicion of it;
- the period of breastfeeding;
- hypersensitivity to any of the components of the drug;
- lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
If you have any severe and/or lasting side effects after taking these pills, seek emergency medical attention.
Interactions
The use of drugs that induce microsomal liver enzymes can lead to an increase in the clearance of sex hormones. Such medicines include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John’s wort.
HIV proteases (ritonavir) and non-nucleoside reverse transcriptase inhibitors (nevirapine) and their combinations can also potentially affect hepatic metabolism.
According to some studies, some antibiotics (penicillins and tetracycline) can reduce the enterohepatic recirculation of estrogen, thereby lowering the concentration of ethinyl estradiol.
Pregnancy and breastfeeding
Zumandimine is contraindicated for use during pregnancy. If pregnancy occurs while taking these pills, you must immediately stop taking them. The conducted epidemiological studies did not reveal either an increased risk of birth defects in children born to mothers who took birth control pills before pregnancy, nor a teratogenic effect when birth control pills were taken with caution in the early stages of pregnancy.
The available data on the use of Zumandimine during pregnancy is too limited and does not allow us to conclude that it has a negative effect on pregnancy or on the health of the fetus or newborn.
Zumandimine is contraindicated for use during breastfeeding. The contraceptivs can reduce breast milk and change its quality. A small amount of sex hormones and / or their metabolites can pass into breast milk and affect the baby.
What if I miss a pill?
If you miss 1 active pill:
- Take it as soon as you realize your mistake. Take the next pill at your usual time. This means you may take 2 pills at once;
- You do not need to use an additional non-hormonal contraception method anytime you have sex.
If you miss 2 active pills in a row in Week 1 or Week 2:
- Take 2 pills on the day you realize your mistake and 2 pills the next day;
- Then return to your usual schedule – 1 pill a day;
- You must use an additional non-hormonal contraception method anytime you have sex during the next week.
If you miss 2 active pills in a row in Week 3 or Week 4:
- If you are a Day 1 Starter: Discard the remaining pills and start a new pack that same day. If you are a Sunday Starter: Continue to take 1 pill every day until Sunday. On Sunday, discard the remaining pills and start a new pack that same day;
- You must use an additional non-hormonal contraception method anytime you have sex during the next week;
- You may not have your period this month. However, if you get no period 2 months in a row, contact your doctor because you might be pregnant.
If you miss 3 or more active pills in a row during any week:
- If you are a Day 1 Starter: Discard the remaining pills and start a new pack that same day. If you are a Sunday Starter: Continue to take 1 pill every day until Sunday. On Sunday, discard the remaining pills and start a new pack that same day;
- You must use an additional non-hormonal contraception method anytime you have sex during the next week;
- You may not have your period this month. However, if you get no period 2 months in a row, contact your doctor because you might be pregnant.
If you miss any of the 7 inert pills in Week 4:
- Discard the pills you missed;
- Continue to take 1 pill a day until the pack is empty;
- You do not need an additional non-hormonal contraception method.
If you are still not sure what to do if you missed some pills:
- Use an additional non-hormonal contraception method anytime you have sex;
- Contact your doctor and continue taking one pill each day.
Precautions
A woman who is taking Zumandimine should have a yearly visit with her doctor for a blood pressure check and for other healthcare.
Stop Zumandimine if some negative adverse reactions occur.
The use of hormonal birth control pills may change the results of some laboratory tests, such as lipids, glucose tolerance, coagulation factors, and binding proteins.
If the patient has any of the diseases / conditions / risk factors listed below, the potential risk and expected benefits of using Zumandimine should be considered:
- risk factors for thrombosis and thromboembolism: smoking, a hereditary predisposition to thrombosis, controlled arterial hypertension, migraine without focal neurological symptoms, heart valve disease without complications, heart rhythm disturbance;
- other diseases associated with peripheral circulatory disorders: diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, Crohn’s disease and ulcerative colitis, sickle cell anemia, and phlebitis of superficial veins;
- hereditary angioedema;
- hypertriglyceridemia;
- liver disease;
- diseases that occurred or worsened during pregnancy or against the background of previous use of birth control pills (for example, bile duct, cholestasis, cholelithiasis, otosclerosis with impaired hearing, porphyria, herpes pregnant women, C-dengam chorea);
- postpartum period.
Severe gastrointestinal disorders can reduce the effectiveness of the contraceptive , therefore, a woman should take additional contraceptive measures. If vomiting occurs within 4 hours after taking the active pill of Zumandimine, you should focus on the recommendations given in the “What if I miss a pill?” section. If a woman does not want to change her usual regimen and postpone the onset of period to another day of the week, she should take an additional active pill from another package.
The product is indicated to women who already have periods and is not indicated to women who have reached menopause.
Cases of overdose are unknown. If you overdose on birth control pills, you may experience nausea, vomiting, spotting, or metrorrhagia. There is no antidote, the treatment is symptomatic. If an overdose is severe, seek emergency medical attention or call the Poison Center at 1-800-222-1222.
You may stop taking the contraceptive whenever you wish. It’s recommended that you consult your doctor before you stop taking the drug.
Keep the product out of the reach of children.