Novynette: birth control pill

2021-06-08 09:01 PM

Novynette: Start taking the pill on the first day of your menstrual cycle, take 1 tablet daily for 21 days, preferably at the same time each day. Followed by 7 days without taking the pill, during this time will be menstruating.

Producer

Gedeon Richter.

Ingredient

Each tablet: Ethinylestradiol 0.02mg, Desogestrel 0.15mg.

Presentation and packaging

Film-coated tablets: box of 1 blister x 21 tablets, box of 3 blisters x 21 tablets.

Indications and uses

Contraceptive pills.

Dosage and Administration

Start taking the pill on the first day of your menstrual cycle, take 1 tablet daily for 21 days, preferably at the same time each day. Followed by 7 days without taking the pill, during this time will be menstruating. Use the next pack on the 8th day, after a 7-day break (the same day of the week as the first tablet, after 4 weeks) even if you are still menstruating. Continue this regimen for as long as there is a need for contraception. If you follow your doctor's instructions exactly, the contraceptive effect is still there on the days you don't take the pill.

Using Novynette for the first time

Start taking the pill on the first day of your menstrual cycle, in which case no other method of contraception is needed. It is also possible to start taking the pill on the 2nd to 5th day of the menstrual cycle, but in this case, additional contraception must be used for the first 7 days of the first cycle. After the 5th day of the menstrual cycle, it is advisable to wait until the next menstrual period to start taking Novynette.

Taking medicine after giving birth

After giving birth, if the mother is not breastfeeding, she can start taking oral contraceptives on the 21st day postpartum. In this case, there is no need to use another method of contraception. If intercourse has occurred postpartum, the drug should be postponed until the first menstrual period. If Novynette is started more than 21 days after delivery, use another method of contraception for the first 7 days.

Note: Breastfeeding mothers should not take combined oral contraceptives, as the drug may decrease lactation.

Miscarriage or abortion

After a miscarriage or abortion, Novynette can be started right away. In this case, there is no need to use another method of contraception.

Changing from another birth control pill to Novynette

Switching from a 21- or 22-day oral contraceptive to a Novynette film-coated tablet: Must take all the pills from the old pack and then take the first member of the Novynette pack, meaning there is no interval between the two pills. , the patient also does not need to wait until the start of a new menstrual cycle. No need to use another method of birth control.

Switching from 28-day oral contraceptives to Novynette film-coated tablets: Take the first tablet of the Novynette pack after you have finished the active (hormonal) tablet of the previous pack and there is no interval between the two pills. , the patient also does not need to wait until the start of a new menstrual cycle. No need to use another method of birth control.

Switching from a progestogen-only pill to a Novynette film-coated tablet: Start taking Novynette on the first day of your period. In this case, no other method of contraception is needed. If you don't get your period while taking a progestogen pill, start taking Novynette on any day of your cycle. However, additional contraception must be used for the first 7 days. In the above cases, when other methods of contraception must be used, the following measures should be used: using a spermicide cervical cap, condoms, or no intercourse. Do not use the menstrual cycle method.

Skipping a period

To skip a period, start a new Novynette pack as soon as you finish the current pack, without taking a day off. Take your medicine in the usual way. When a period is missed, spotting or bleeding outside the menstrual period may occur, which does not reduce the effectiveness of contraception. Start taking the medication again after a 7-day break.

Forget to take medicine

If you forget to take a pill at your usual time, you must take it within 12 hours. The next pill is to be taken at the usual time. In that case, no additional contraception is needed. If one or more pills are missed after more than 12 hours, the contraceptive effect is reduced. Patients should take the last missed tablet, even if they have to take 2 pills in a day, and continue taking the next pill at the usual time. In this case, another method of contraception must be used for the next 7 days.

What to do in case of vomiting and diarrhea

If vomiting and diarrhea occur after taking the drug, the absorption of the drug is reduced. If these symptoms resolve within 12 hours, the patient should take another tablet from the backup pack and continue taking the remainder as usual. If these symptoms persist for more than 12 hours, use another method of contraception for the duration of the gastrointestinal disturbance and for the next 7 days.

Warning

Before taking oral contraceptives, it is advisable to have a comprehensive health check-up and a gynecological examination to check for pregnancy and risk diseases.

During the period of use of oral contraceptives, if the disease worsens, flares up, or exhibits the following conditions, stop taking the pill immediately, use a non-hormonal method of birth control and consult a doctor:

Blood clotting disorder.

Other conditions are associated with an increased risk of circulatory diseases, such as manifest or latent heart failure, renal failure, or a history of these conditions.

Present or have a history of seizures.

Present or have a history of migraine headaches.

History of gallstones.

Having some risk factors for estrogen-dependent tumors, estrogen-sensitive gynecological diseases such as fibroids and endometriosis.

Diabetes.

Severe depression or a history of this condition. If this disease is accompanied by a disorder of tryptophan metabolism, vitamin B6 can be added.

Sickle cell anemia, because under certain conditions, for example during infection or hypoxia, estrogen-containing drugs can induce thromboembolism in these patients.

If liver function test results are abnormal, this drug should be discontinued.

When the following symptoms indicate the occurrence of thrombosis, the drug should be stopped immediately and consulted with a doctor:

Sudden, severe pain in the chest that radiates to the left arm;

Sudden loss of breath;

Headache that is persistent, unusually severe, especially for the first time or worse than usual, or accompanied by the following symptoms: sudden partial or total loss of vision or double vision, aphasia, dizziness, severe dizziness, syncope with or without partial seizures, very severe weakness or paralysis affecting one side or the whole body, dyskinesia, severe calf pain or acute abdominal pain.

The risk of blood clots (thrombosis) is increased with smoking. Do not smoke while taking birth control pills, especially if you are over 35 years old.

The effectiveness of birth control may be reduced if, after taking Novynette for several months, irregular bleeding, spotting, or bleeding outside the menstrual cycle occurs. If there is no period or menstrual irregularity without the tendency to become pregnant, continue taking until the pack is finished. If a period is still absent at the end of the 2nd cycle, or the menstrual disturbances have not resolved, the drug should be discontinued and pregnancy must be ascertained before continuing oral contraceptive use.

Changes in laboratory values: Due to the estrogen component, taking oral contraceptives may affect the results of some tests, including liver, kidney, adrenal, and thyroid function tests, parameters coagulation and fibrinolysis, plasma lipoprotein concentrations, and carrier proteins.

Effects on ability to drive and use machines: No studies have been conducted to determine the effects of Novynette on the ability to drive and use machines.

Overdose

No serious adverse effects were observed in overdose. Therefore, there is no need to treat Overdosage. However, if an overdose is detected or too many tablets have been taken, gastric lavage can be done. There is no antidote, treatment should be symptomatic.

Contraindications

Do not use oral contraceptives in the following cases:

A known or suspected pregnancy.

Moderate to severe hypertension.

Hyperlipoproteinemia.

Have or have a history of arterial thrombosis (eg, myocardial infarction, cerebrovascular accident).

There are risk factors for venous thromboembolism.

Personal or family history of thromboembolism.

Diabetic vascular disease.

Severe liver disease, cholestatic jaundice or hepatitis, or a history of these conditions, history of gestational jaundice, steroid-induced jaundice, Rotor syndrome, and Dubin-Johnson syndrome, hepatocellular neoplasms, and disorders porphyrin metabolism.

Gallstones.

Known or suspected estrogen-dependent tumor, endometrial hyperplasia, vaginal bleeding of unknown cause.

Systemic lupus erythematosus or a history of this disease.

History of pregnancy or previous steroid use with severe pruritus, genital herpes, jaundice, development or worsening of otosclerosis.

Hypersensitivity to any of the ingredients of the drug.

Use in pregnant and lactating women

Epidemiological studies show that oral contraceptive use in early pregnancy does not increase neonatal malformations and is not teratogenic.

Lactation: Oral contraceptives can reduce lactation and change the composition of milk, in addition, the drug also passes into breast milk, so it should not be used during this period.

Interactive

Some drugs can interfere with Novynette's effectiveness, for example, reducing the effectiveness of contraception or causing bleeding outside of the menstrual cycle. These drugs include the treatment group:

Seizures (eg, primidone, phenytoin, barbiturates, hydantoin, carbamazepine, oxcarbazepine, topiramate, felbamate)

Tuberculosis (eg, rifampicin, rifabutin, izoniazid)

Anti-inflammatory (dexamethasone, phenylbutazone)

HIV infection (ritonavir, nelfinavir, nevirapine, efavirenz) or other bacterial infections (ampicillin, chloramphenicol, neomycin, nitrofurantoin, penicillin V, sulfonamides, tetracyclines)

Fungal infections (griseofulvin, fluconazole, itraconazole and ketoconazole),

Pulmonary hypertension (bosentan),

Sleep disturbances (modafinil) or anxiety,

Migraine,

Popular herbal medicines like St John's grass (Hypericum perforatum).

Novynette may affect the effects of other medicines. For example:

Ciclosporin (medicine that suppresses the immune system),

Theophylline (medicine for asthma),

Metoprolol (a beta-blocker that treats certain heart conditions),

Tricyclic antidepressants,

oral anticoagulants,

Some antihypertensive drugs (guanethidine),

Vitamin,

Glucocorticoids (eg, hydrocortisone, to treat dermatitis)

Some benzodiazepines (to control seizures or anxiety) such as diazepam, lorazepam, alprazolam, clorazepat, flurazepam, halazepam and prazepam,

Temazepam (sleeping pill),

Salicylic acid (pain reliever and anti-inflammatory),

Guanethidine (treatment of hypertension),

Clofibrate and atorvastatin (to lower blood fats),

Morphine and meperidine (very strong pain relievers),

Lamotrigine (medicine for epilepsy),

Paracetamol (pain reliever, fever reducer),

Some laxatives.

Taking this medicine with troleandomycin (an antibiotic) may increase the risk of certain liver diseases (increased excretion of bile in the liver).

Oral contraceptives may decrease glucose tolerance and increase the need for insulin or oral antidiabetic drugs.

Side effects

Discontinue the use of oral contraceptives when serious adverse effects occur.

Epidemiological studies have shown rare events associated with oral contraceptive use with an increased risk of thrombotic and venous thromboembolic diseases such as myocardial infarction, stroke, and thrombosis. Deep vein thrombosis, pulmonary embolism.

Taking oral contraceptives can cause jaundice, cholestasis, or gallstones.

Very rarely, oral contraceptives can trigger a systemic lupus erythematosus response.

Common less serious side effects:

Reproductive system

Irregular bleeding, post-treatment amenorrhea, changes in cervical secretions, increased size of fibroids, exacerbation of endometriosis, and vaginal infections such as candida vagina.

Breast

Tightness, pain, breast enlargement, discharge.

Digestive

Nausea, vomiting, gallstones, cholestatic jaundice.

Skin

Erythema nodosum, rash, face pigmentation.

Eye

Corneal discomfort if contact lenses are used.

Central nervous system

Headaches, migraines, personality changes, depression.

Metabolic changes

Fluid retention, change in body weight, decreased glucose tolerance.

Melasma face

Melasma is sometimes encountered, especially in women with a history of pregnancy melasma. Women with a predisposition to melasma must avoid exposure to sunlight and ultraviolet radiation when taking oral contraceptives.

Preservation

Store at temperatures below 30°C.