Pirmella 1/35 (ethinyl estradiol and norethindrone) is used as contraception to prevent pregnancy.
Contents:
Indications for use
- Pregnancy prevention.
Mechanism of action
The drug prevents ovulation (the release of an egg from an ovary), causes changes in the cervical mucus and uterine lining, making it difficult for sperm to enter the uterus and difficult for a fertilized egg to attach to the uterus.
Dosage and mode of application
Each pack of Pirmella 1/35 contains 28 tablets:
- 21 peach active tablets each containing 1 mg of norethindrone and 0.035 mg of ethinyl estradiol;
- 7 green tablet each containing only inert ingredients.
Follow the instruction for use given on the leaflet. Do not take this drug in larger or smaller amounts or for longer than recommended by a doctor.
You can take the first pill on the first day of your period (the day when menstrual bleeding begins) or on the first Sunday following the onset of your period. If you are a Sunday starter, you need to use an additional non-hormonal method of birth control (a condom or a spermicide).
Take one pill every day, at about the same hour, for 28 days in a row. When you take the last pill from the blister, start a new pack next day. You may become pregnant if you miss pills.
Some women have acyclic breakthrough bleeding, especially during the first three months. Consult your doctor if this bleeding continues or is very heavy.
Switching from other birth control pills:
- If the package of the previous oral contraceptive contained 28 pills, take the first pill of Pirmella 1/35 the next day after the end of the previous drug;
- If the package of the previous oral contraceptive contained 21 pills, take the first pill of Pirmella 1/35 the next day after the end of the previous drug or on the 8th day after a 7-day break.
Switching from a vaginal ring or a hormonal patch:
Take the first pill on the day when you need to use a new vaginal ring or a new patch.
Switching from an intrauterine device:
Take the first pill on the day your an intrauterine device is removed. Use an additional non-hormonal method of birth control for 7 days.
Use of Pirmella 1/35 after an abortion:
After an abortion up to 12 weeks, you can take the first pill on the day of the operation. If the abortion was late (more than 12 weeks), 6you can start taking pills 21-28 days after it. Use an additional non-hormonal method of birth control for 7 days. If you had unprotected sexual intercourse before you started taking pills, you can start hormonal contraception only after you make sure you are not pregnant.
Use of Pirmella 1/35 after childbirth:
Take the first pill 21-28 days after delivery. Use an additional non-hormonal method of birth control for 7 days. If you had unprotected sexual intercourse before you started taking pills, you can start hormonal contraception only after you make sure you are not pregnant. If you are breastfeeding, do not use this drug.
Overdose
Overdosage of ethinyl estradiol and norethindrone may cause nausea, vomiting, vaginal bleeding, spotting. There are no data on the occurrence of any severe adverse effects in the case of overdose. Treatment is symptomatic. There is no specific antidote.
Side effects
Pirmella 1/35 is usually tolerated well. In rare cases, the contraceptive may cause the following side effects (mostly mild and temporary):
- vaginal bleeding.
- mood changes;
- changes in libido
- migraine;
- pulmonary thromboembolism.
- hypersensitivity reactions
- nervousness
- myocardial infarction,
- stroke,
- transient ischemic attack,
- venous thrombosis
- headache,
- an increase in body weight,
- fluid retention;
- weight loss;
- exacerbation of porphyria;
- depression,
- abdominal pain,
- diarrhea;
- dizziness,
- exacerbation of chorea;
- discomfort when wearing contact lenses
- acne,
- hirsutism,
- optic neuritis;
- venous thromboembolism,
- arterial thromboembolism;
- nausea, vomiting;
- pancreatitis;
- bloating,
- colitis;
- cholelithiasis;
- skin rash
- erythema nodosum, erythema multiforme;
- a feeling of tension, tenderness of the mammary glands,
- chest pain.
- venous thromboembolic disorders;
- vaginal discharge
- an increase in the mammary glands
- discharge from the mammary glands;
- painful periods,
- vaginitis,
- vulvovaginal candidiasis,
- chloasma;
- jaundice and/or itching associated with cholestasis;
- gallstones;
- arterial thromboembolic disorders;
- cerebrovascular disorders;
- increase in blood pressure;
- hypertriglyceridemia;
- Crohn’s disease;
- ulcerative colitis;
- a decrease in glucose tolerance or effect on peripheral insulin resistance;
- liver tumors (benign and malignant);
- impaired liver function;
- hemolytic uremic syndrome;
- hearing loss associated with otosclerosis;
- cervical cancer.
If you experience any severe/lasting side effects, stop taking birth control pills and consult a doctor as soon as possible.
Contraindications
Do not use Pirmella 1/35 for birth control if you have any of the conditions/diseases listed below. If any of these conditions/diseases occur against the background of its use, hormonal contraception should be immediately discontinued.
- pregnancy;
- breastfeeding period;
- stroke, transient ischemic attacks in the anamnesis;
- valvular heart disease;
- atrial fibrillation;
- planned prolonged immobilization;
- surgery of the lower limbs and the pelvic organs;
- smoking and the age over 35 years;
- undiagnosed vaginal bleeding;
- obesity;
- congenital or acquired susceptibility to arterial or venous thrombosis;
- hypersensitivity to the drug components;
- severe dislipoproteinemia;
- uncontrolled hypertension;
- thrombosis and thromboembolism (including in the anamnesis);
- angina;
- antithrombin III deficiency;
- hyperhomocysteinemia;
- migraines with focal neurological symptoms, including in the anamnesis;
- diabetes with vascular complications;
- pancreatitis with severe hypertriglyceridemia, including in the anamnesis;
- liver failure/severe liver disease;
- liver tumors, including in the anamnesis;
- cerebral vascular disease or coronary arteries of the heart;
- scheduled major surgery in 6 weeks;
- identified hormone-dependent malignant neoplasms;
- protein C deficiency;
- protein S deficiency;
- children and adolescents who do not have periods yet;
- galactose intolerance, lactase deficiency, glucose-galactose malabsorption, fructose intolerance, sucrase-isomaltase deficiency.
With caution:
- postpartum period;
- diabetes mellitus;
- cancer;
- systemic lupus erythematosus;
- hemolytic uremic syndrome;
- depression;
- smoking;
- epilepsy;
- Crohn’s disease and ulcerative colitis;
- phlebitis of superficial veins;
- diseases that first occurred or worsened during the previous pregnancy or the previous use of sex hormones (jaundice, cholestasis, gallbladder disease,
- otosclerosis, porphyria, herpes pregnant Sydenham’s chorea);
- dislipoproteinemia;
- migraines without focal neurological symptoms;
- uncomplicated valvular defects;
- sickle cell anemia;
- genetic predisposition to thrombosis;
- hereditary angioedema;
- hypertriglyceridemia.
Interactions
Pirmella 1/35 may interact with some drugs. As a result, the clearance of sex hormones may increase, which may lead to acyclic breakthrough uterine bleeding and/or a decrease in the contraceptive effect.
Do not use this contraceptive with the following drugs:
- barbiturates;
- bosentan;
- carbamazepine;
- phenytoin;
- primidone;
- rifampicin;
- HIV drugs (ritonavir, nevirapine, efavirenz);
- oxcarbazepine;
- topiramate;
- nevirapine;
- nevirapine;
- efavirenz;
- oximidazine;
- preparations containing St. John’s wort;
- hepatitis C drugs;
- perampanel, vemurafenib, dabrafenib, modafinil or rufinamide;
- antimycotics (itraconazole, voriconazole, fluconazole);
- verapamil;
- macrolides (clarithromycin, erythromycin);
- diltiazem;
- grapefruit juice;
- etoricoxib;
- some antibiotics (penicillins, tetracycline);
- cyclosporine;
- lamotrigine;
- clozapine;
- mirtazapine;
- olanzapine;
- theophylline;
- zolmitriptan.
Pregnancy and breastfeeding
Do not use Pirmella 1/35 for birth control during pregnancy because there is no reason for that. If pregnancy occurs when on the pills, stop using hormonal contraception immediately and consult a doctor. However, epidemiological studies have not revealed an increased risk of defects in children born to women who used sex hormones before pregnancy or used these hormones in the early stages of pregnancy.
Taking drugs based on ethinyl estradiol and norethindrone can reduce the amount of breast milk and change its composition, therefore, the use of Pirmella 1/35 during breastfeeding is not recommended. Breastfeeding women should choose a non-hormonal method of birth control.
What if I miss a pill?
Try not to miss pills since this increases your risk of becoming pregnant.
- If you missed once active pill, take two pills on the day you remember. Then keep taking one pill each day until the pack is empty;
- If you missed two active pills in a row in Week 1 or 2, take two pills a day for two days in a row. Then keep taking one pill a day until the pack is empty. Use an additional non-hormonal method of birth control for at least 7 days following the missed pills;
- If you missed two active pills in a row in Week 3, discard the remaining pills and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, take one pill each day until Sunday, then discard the remaining pills and start a new pack that same day;
- If you missed three active pills in a row in Week 1, 2, or 3, discard the remaining pills and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, take one pill each day until Sunday, then discard the rest of the pills and start a new pack that same day.
If you miss two or more active pills in a row, you may not have menstrual-like bleeding during the month. If you miss menstrual-like bleeding for 2 months in a row, consult your doctor because you might be pregnant.
- If you missed any of the inert pills in Week 4, discard them and keep taking one pill per day until you finish the pack. You do not need an additional non-hormonal method of birth control if you miss an inert pill.
Precautions
While taking combination oral contraceptives, you will need to visit your doctor regularly (at least 2 times per year).
Pirmella 1/35 will not protect you from sexually transmitted diseases, such as HIV and AIDS. For this purpose, you need to use a condom.
Use a backup birth control method if you have severe vomiting or diarrhea.
Store at room temperature away from direct sunlight, moisture and heat.
Keep out of reach of children and pets.