Regulon: Oral contraceptive

2021-06-21 05:24 AM

Start taking Regulon 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 medication, during this time will be menstruating.

Producer

Gedeon Richter.

Ingredient

Each tablet: Ethinylestradiol 0.03mg, Desogestrel 0.15mg.

Indications and uses

Birth control 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. This followed by 7 days without taking the pill, during this time will be menstruating. Use the next pack on the 8th day, after 7 days off (the same day of the week as the first pill, after 4 weeks) even if you still have your period. Continue this regimen for as long as there is a need for contraception. If followed exactly as directed, the contraceptive effect is still there on the days when the pill is not taken.

Using Regulon for the first time

Start taking the pill on the first day of your menstrual cycle.

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 Regulon.

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 Regulon 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, Regulon can be started right away. In this case, there is no need to use another method of contraception.

Switching from another birth control pill to Regulon

Changing from a 21- or 22-day oral contraceptive to a Regulon film-coated tablet: All tablets of the previous pack must be taken and then the first member of the Regulon pack must be taken, 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. There is no need to use another method of birth control.

Switching from 28-day oral contraceptives to Regulon film-coated tablets: Take the first tablet of the Regulon 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. There is no need to use another method of birth control.

Switching from a progestogen-only pill to a Regulon film-coated tablet: Start taking Regulon 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 Regulon 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 Regulon pack as soon as you finish your 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 cycle may occur, which does not reduce the effectiveness of contraception. Start taking the medication again after the usual 7-day break.

Forgot 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 tablets 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, 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, patients should have a general physical examination and gynecological examination including blood pressure measurement, laboratory tests, breast examination, and vaginal smear. These checks should be repeated periodically.

During treatment, if the disease worsens, flares up, or manifests the following conditions, the drug should be stopped immediately, and a non-hormonal method of birth control should be used and consult a doctor:

Blood clotting disorders;

Other conditions 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;

Have any risk factors for estrogen-dependent tumors, estrogen-sensitive gynecological conditions such as fibroids and endometriosis;

Diabetes mellitus;

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 there are symptoms indicating the occurrence of thromboembolism, the drug should be stopped immediately and consult 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 face, 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 Regulon for several months, irregular bleeding, spotting, or bleeding outside the menstrual cycle occurs. If there is no menstrual 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 Regulon 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, take many tablets, gastric lavage can be done. There is no antidote, treatment should be symptomatic.

Contraindications

Do not use oral contraceptives in the following cases:

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 neoplasm, endometrial hyperplasia, vaginal bleeding of unknown cause;

Systemic lupus erythematosus or a history of it;

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 medicines can interfere with the effect of Regulon, 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),

TB (eg, rifampicin, rifabutin, izoniazid),

Anti-inflammatory (dexamethasone, phenylbutazone),

HIV infections (ritonavir, nelfinavir, nevirapine, efavirenz), other 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 such as St John's grass (Hypericum perforatum)

Regulon may affect how other medicines work. 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;

certain 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 (a sleeping pill);

salicylic acid (analgesic and anti-inflammatory);

guanethidine (treatment of hypertension);

clofibrate and atorvastatin (to lower blood lipids);

morphine and meperidine (very strong pain relievers);

lamotrigine (medicine for epilepsy);

paracetamol (analgesic, antipyretic);

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

When the following adverse effects occur, oral contraceptives should be discontinued and a physician consulted: Rare events associated with oral contraceptive use with an increased risk of thrombotic events and thromboembolism Arteriovenous obstruction such as myocardial infarction, stroke, 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.

Other common, but less severe, adverse effects:

Genitourinary system: irregular bleeding, post-medication amenorrhea, changes in cervical secretions, increased size of fibroids, exacerbation of endometriosis, and infection vagina such as vaginal candidiasis.

Breasts: tenderness, pain, increased breast size, discharge.

Digestive system: nausea, vomiting, gallstones, cholestatic jaundice.

Skin: erythema nodosum, rash, face pigmentation.

Eyes: corneal discomfort if contact lenses are used.

Central nervous system: headache, migraine, personality changes, depression.

Metabolic changes: fluid retention, changes in body weight, decreased glucose tolerance.

Melasma: Sometimes face melasma, 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.

Presentation and packaging

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