Aurovela 24 Fe is a hormonal preparation whiich helps to prevent pregancy when taken daily. The drug contains ethinyl estradiol and norethisterone.
Contents:
Indications for use
- Hormonal contraception;
- Menstrual disorders.
Mechanism of action
The preparation blocks ovulation and changes the viscosity of the cervical mucus. As a result, the penetration of sperm into the uterine cavity becomes impossible. Like all combined oral contraceptives, Aurovela 24 Fe has a positive non-contraceptive effect: menses become shorter and less painful, which reduces the risk of developing anemia.
Dosage and mode of application
Each pack of Aurovela 24 Fe contains 28 pills:
- 24 active tablets (yellow);
- 4 inactive tablets (brown).
You may start using the drug either on the first day of your period or on Sunday. If you start taking tablets on Sunday, you should use additional methods of birth control during the first 7 days (the first cycle only).
First use of the drug
If you dod not use hormonal contraception in the previous month:
Day 1 Start:
- Take the first tablet on the first day of your period, regardless of meals;
- Keep taking 1 tablet per day at the same time for 28 days in a row;
- Begin a new pack on the day after taking the last tablet).
Sunday Start:
- Take the first tablet on the first Sunday after the onset of menstruation, regardless of meals. Use additional backup methods of contraception for the first 7 days of your first pack of the contraceptive;
- Keep taking 1 tablet per day at the same time for 28 days;
- Begin a new pack on the Sunday after taking the last tablet. Additional backup methods of preventing pregnancy are not needed.
Switching from another combination oral contraceptive:
- Take the first tablet on the day after you have finished the pack of the previous oral contraceptive.
Switching from another birth control method:
- Transdermal patch – on the day when a new patch should be applied.
- Vaginal ring – on the day when the next vaginal ring should be inserted;
- Injection – on the day when the next injection is planned;
- Intrauterine device (IUD) or implant – on the day of removal
Overdose
There are no reports of serious negative effects from an overdose of Aurovela 24 Fe. Excessive doses of ethinyl estradiol and norethisterone may cause withdrawal bleeding and nausea.
Side effects
Aurovela 24 Fe can cause the following side effects:
- menstrual disorders;
- anxiety;
- abnormal vision;
- changes in skin color;
- chest pain;
- redness of the skin;
- sudden headaches;
- rapid heartbeat;
- stomach pain;
- constipation;
- cough;
- dark urine;
- diarrhea;
- dizziness;
- fainting;
- fast heartbeat;
- lightheadedness;
- fever;
- headache;
- hives;
- bloating;
- spots on the skin;
- breast enlargement;
- breast tenderness;
- depressive mood;
- irritability;
- itching of the vagina or external genitals;
- pain during sex;
- unusual tiredness or weakness;
- stomach cramps;
- vaginal discharge;
- tiredness;
- trouble concentrating;
- insomnia;
- discomfort when wearing contact lenses;
- swelling on the face;
- changes in the appetite;
- vaginal bleeding between periods;
- nausea;
- pain or discomfort in the arms, jaw, back, neck, foot, leg, chest, groin;
- pounding in the ears;
- rash;
- slurred speech;
- sweating;
- troubled breathing;
- vomiting.
Contraindications
Do not use this drug if you are allergic to its active ingredients and also in the following cases:
- unusual vaginal bleeding;
- liver disease;
- bleeding disorders;
- heart attack, stroke, or blood clot in the anamnesis;
- hormone-related cancer, cancer of the breast, uterus/cervix, or vagina in the anamnesis;
- suspected or established pregnancy.
Use the drug with caution if you have or have ever had the following conditions:
- high blood pressure;
- diabetes;
- epilepsy;
- migraines;
- lupus;
- asthma;
- gallbladder disease;
- porphyria;
- high cholesterol;
- overweight;
- smoking;
- heart disease;
- high or low levels of calcium in your blood;
- liver problems;
- uterine fibroid tumors;
- jaundice;
- kidney disease;
- hereditary angioedema;
- bone cancer;
- endometriosis;
- a thyroid disorder.
Interactions
Do not use Aurovela 24 Fe in combination with the following medications/products:
- amphetamine / dextroamphetamine;
- baclofen;
- duloxetine;
- hydrochlorothiazide;
- ketamine;
- clonazepam;
- levothyroxine;
- topiramate;
- topiramate;
- trazodone;
- triamcinolone topical;
- omalizumab;
- tizanidine;
- grapefruit juice.
Pregnancy and breastfeeding
Use of Aurovela 24 Fe is contraindicated during pregnancy and lactation period.
Comments:
- Exclude pregnancy prior to using birth control pills;
- Stop taking the drug if pregnancy occurs;
- The active components can enter breast milk.
What if I miss a pill?
If 1 tablet is missed in Weeks 1, 2 or 3:
- Take the missed tablet as soon as you remember. Take the next pill according to your usual schedule, then keep taking 1 tablet per day until you finish the pack. Additional methods of birth control are not needed
If 2 tablets in a row are missed in Week 1, 2:
- Take 2 missed tablets as soon as you remember. Take 2 active tablets the next day. Then return to your regular schedule and keep taking 1 tablet per day until you finish the pack. You must use Additional non-hormonal contraception (such as condoms and spermicide) must be used additional methods of birth control if you have sex within 7 days after missing tablets.
If 2 tablets in a row are missed in Week 3, 4 or 3 or more tablets in a row are missed at any time:
- Day 1 Start: Discard the remaining tablets and start a new pack immediately;
- Sunday Start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Additional non-hormonal contraception (such as condoms and spermicide) must be used as a back-up if the patient has sex within 7 days after missing tablets.
If any of the 4 inactive tablets are missed:
- Discard the missed tablets and continue taking 1 tablet per day. Additional non-hormonal contraception is not needed.
Precautions
There is a slight increase in the incidence of venous and arterial thrombosis and thromboembolism when taking hormonal contraceptives.
In some case, venous thromboembolism can develop. The approximate frequency of venous thromboembolism in women taking COCs is up to 4 per 10 thousand women per year compared to 0.5-3 per 10 thousand women not using oral contraceptives. However, the frequency of venous thromboembolism, which develops in women taking COCs is less than the frequency associated with pregnancy.
There have been extremely rare reports of thrombosis of other blood vessels. The connection with the use of COCs is not proven.
You should stop taking the tablets and consult a doctor if you notice the symptoms of venous or arterial thrombosis; sudden severe chest pain; sudden shortness of breath; coughing attacks; any unusual headaches and migraines; sudden loss of vision; inarticulate speech; dizziness; fainting; weakness or a very significant loss of sensitivity, movement disorders; “sharp” abdomen.
The risk of thrombosis and thromboembolism increases: with age, among smokers especially in women older than 35 years), with a family history or arterial thromboembolism, obesity (body mass index more than 30), dyslipoproteinemia, arterial hypertension, diseases of the heart valves, atrial fibrillation, prolonged immobilization, major surgery or major trauma. In these situations, it is desirable to stop taking Aurovela 24 Fe and resume their use 2 weeks after the end of immobilization.
The increased risk of thromboembolism in the postpartum period should be considered.
Circulatory disorders can also occur in patients with diabetes mellitus, SLE, hemolyticoremic syndrome, chronic inflammatory bowel disease, and sickle cell anemia.
Biochemical parameters that may be a sign of hereditary or acquired susceptibility to venous or arterial thrombosis: resistance to activated protein C, hyperhomocysteinemia, deficiency of antithrombin III, deficiency of proteins C and S, antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant)
When considering the risk/benefit ratio, the doctor must take into account that adequate treatment of these diseases may reduce the associated risk of thrombosis and that the risk of thrombosis associated with pregnancy is higher than with oral contraceptives. An increased risk of developing cervical cancer with long-term use of the drug has been reported in several epidemiological studies. Its connection with the use of combined oral contraceptives has not been proven.
In rare cases, liver tumors were reported. In the event of severe abdominal pain, enlargement of the liver or signs of intra-abdominal bleeding, you should contact your doctor immediately.
Women with hypertriglyceridemia (including a family history) have an increased risk of developing pancreatitis.
Many women reported a small increase in blood pressure, clinically significant increases are very rare. The relationship between taking combined oral contraceptives and a clinically significant increase in blood pressure has not been established. However, if you observe a persistent, clinically significant increase in blood pressure during the use of Aurovela 24 Fe, the drug should be canceled. Use of the drug can be continued if normal blood pressure values are achieved with the help of antihypertensive therapy.
Although the contraceptive may have an effect on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using birth control pills. However, women with diabetes should be carefully monitored while taking such drugs.
Women with a tendency to chloasma should avoid prolonged exposure to the sun and UV radiation.
Ethinyl estradiol and norethisterone may affect the biochemical parameters of the liver, thyroid, adrenal glands and kidneys, the amount of transport plasma proteins, carbohydrate metabolism, coagulation, and fibrinolysis. Changes usually remain within laboratory norms.
Irregular bleeding/spotting may occur during the first months of use. This does not require discontinuation of the contraceptive.