Rosina medicine 3mg/0.03mg Gedeon used for contraception (1 blister x 21 tablets)

Dosage form Box of 1 blister x 21 tablets
Specifications Drospirenone, Ethynyl Estradiol

Ingredient

Composition information	Content
Drospirenone	3mg
Ethynyl Estradiol	0.03mg

Uses

indications

Rosina 3 mg/0.03 mg drug is indicated in the following cases:

Hormonal contraceptives are used orally. The decision to prescribe Rosina should be considered based on the existing risk factors of each woman, especially the risk of venous thrombosis (VTE) and the risk of venous thrombosis associated with Rosina compared to other coordinated hormonal contraceptives (CHCS).

Pharmacokology

Hormonal pharmacological groups: Hormonal hormones and genital modulation, progestogen and estrogen, fixed coordination.

Pearl index: Regarding the failure of the 0.09 method (the above reliable limit on two sides 95%: 0.32).

Overall Pearl (failure of the method + Failure by patients): 0.57 (the above reliable limit on both sides 95%: 0.9).

Mechanism of action

Rosina's contraceptive effect is based on the interaction of many different factors, most importantly, the drug inhibits ovulation and changes endometrium.

Rosina is a oral contraceptive with ethinylelestradiol and progestogen is Drospirenon. At the dose of treatment, Drospirenon also has Androgen resistance and mineralocorticoid mild resistance. The drug does not have the activity of estrogen, glucocorticoid and glucocorticoid resistance. This makes Drospirenon have the same pharmacological properties as natural progesterone hormones.

There is evidence from clinical studies that show mild mineralocorticoid properties leading to mineralocorticoid minor resistance.

pharmacokinetic

Drospirenon

absorption

Drospirenon is used to be absorbed quickly and almost completely. The maximum active ingredient concentration in the serum is about 37 ng/ml reaching about 1-2 hours after taking the single dose. In a medication cycle, the maximum concentration of drospirenon in serum in a stable state is about 60 ng/ml achieved after about 7-14 hours. The bioavailability of Drospirenon is about 76 to 85%. Taking medicine with food does not affect the bioavailability of Drospirenon.

Distribution

After taking the medication, the serum drospirenon concentration decreased by 2 phases with the end phase half -phase selling time of 1.6 ± 0.7 and 27.0 ± 7.5 hours. Drospirenon is associated with serum albumin and is not linked to glubulin with sex hormones (SHBG) or globulin carrying corticoids (CBG). Only 3 - 5% of the serum active active ingredient in the form of free steroids. The increase in the SHBG caused by ethinylestradiol does not affect the cohesion of Drospirenon with serum protein. Dropirenon's average indicator distribution is 3.7 ± 1.2 l/kg.

Metabolism

Drospirenon is strongly metabolized after drinking. The main metabolites in plasma are the acid form of Drospirenon formed by opening a lactone ring. And 4, 5 - dihydrodrospirenon - 3 - sulfate, both forms are formed without the participation of the P450 enzyme system. A small amount of Drospirenon metabolized by cytochrome P450 3A4 enzyme and has been shown to inhibit this enzyme and cytochrom P450 1A1, Cytochrom P450 2C9 and Cytochrom P450 2C19 in vitro.

Elimination

The metabolic clearance rate of drospirenon in serum is 1.5 ± 0.2 ml/min/kg. Drospirenon is only eliminated in a very small amount in the form of unchanged. The metabolites of Drospirenon are eliminated through the part and urine at the rate of about 1.2 to 1.4. The sale time of metabolites through urine and feces is about 40 hours.

Stable state

In a medication cycle, the maximum concentration of drospirenon in the serum in a stable state is about 70 ng/ml, achieved after about 8 days of medication. The serum drospirenon concentration is accumulated with a coefficient of about 3 which is the result of the ratio between the semi -phase disposal time and the distance between the doses.

ethinylestradiol

absorption

Ethinylestradiol is absorbed quickly and completely after drinking. After taking the dose of 30 μg, the peak concentration in the serum is 100 PG/mL achieved after 1-2 hours of using the drug. Ethinylestradiol metabolizes strong head phase and has a major change between individuals. Absolute bioavailability of about 45%.

Distribution

EthinylesTradiol has an apparent distribution of 5 l/kg and about 98% binding to plasma proteins. Ethinylestradiol reduces SHBG and CBG synthesis in the liver. While using 30 μg of ethinylelestradiol plasma SHBG concentrations increased from 70 to about 350 nmol/l. A small amount of ethinylestradiol (0.02% of the dose) into breast milk.

Metabolism

Ethinylestradiol is completely metabolized (plasma metabolic clearance is 5 ml/min/kg).

Elimination

Ethinylestradiol is not eliminated in the form of unchanged in any significant concentration. The metabolites of ethinylelestradiol are excreted into urine and bile fluid with a ratio of 4: 6. The sale time of metabolites is about 1 day.

Stable state

Stable state is achieved throughout the second half of the medication cycle and the accumulation of ethinylestradiol in serum is from 1.4 to 2.1.

Before taking Rosina medicine 3mg/0.03mg Gedeon used for contraception (1 blister x 21 tablets)

How to use

Take oral use.

The pill must be taken daily at the same time according to the order indicated on the blister, taking medicine with a little liquid if needed. Take a tablet per day for 21 consecutive days. Start the subsequent drug after a period of 7 days of stopping the drug, during this period, the menstrual period occurs. The menstruation usually appears on the 2nd - 3rd day after taking the last tablet and may not end the menstruation before starting the next blister.

Dosage

Start using Rosina

In the previous case, there is no hormonal contraceptive (last month).

Start taking Rosina film tablets on the first day of the cycle (the first day of the menstrual period).

Cases of change from a combined hormonal contraceptive (combined oral oral tablet (COC), placement or skin sticker)

Should start taking the best Rosina tablet right after the day of taking the ultimate activity tablet of the previous coordinated hormonal contraceptive pills. In this case, Rosina should not start taking Rosina later than the next day after the period of stopping the drug or after all the tablets without the active ingredient of the previous contraceptive pills. When changing from the method of using an IUD or skin sticker, it should be started to take Rosina best on the day of stopping the contraceptive method, stopping in this case should not take Rosina tablets later than the date expected to use the previous measures.

Cases of changes from measures only use progestogen (tablets, injection or subcutaneous implants containing only progestogen) or progestogen release system in the uterus (IUS)

Can be converted into any day from a drug containing progestogen only (from the sticker or the progestogen release system in the uterus on the day of stopping these measures, from the type of injection on the expected date for the next injection) as in all these cases, women should use more contraceptive methods in the first 7 days of medication.

After the first 3 months of abortion

Can start taking the drug immediately (if abortion in the first 3 months of pregnancy). When used, it is not necessary to use other contraception.

After birth or abortion in 3 months

Women should be consulted to start taking Rosina tablets on the 28th to 28th after birth or after abortion if abortion in 3 months of pregnancy. If you start later, you should use an additional method of contraception within the first 7 days. However, if there is a intercourse, it is necessary to eliminate the possibility of pregnancy before starting to use oral contraceptive or should wait until the first period.

In case of digestive disorders

In case of serious digestive disorders (such as vomiting, or diarrhea) the drug may be absorbed inadequately, so the preventive contraception.

If vomiting is within 3-4 hours after taking the drug, taking a new pill (replacement tablet) as soon as possible. If possible, should take new tablets within 12 hours around the hour of taking regular medication. If more than 12 hours, apply the instructions in the forgotten part. If the user does not want to change the schedule of using regular drugs, can take a replacement tablet from another drug.

Delayed menstruation

To delay menstruation, continue using other Rosina blisters without the time to stop the drug.

The delayed period may last as expected until the end of the 2nd drug. During this delay, stopping use may bleed or hemorrhage in the middle of the period. Re -use Rosina tablets as usual after a 7 -day vacation period.

To transfer menstruation to another day of the week than the present, you can advise users to shorten the time to stop the drug with the desired number of days. The shorter the time to stop the drug, the higher the risk of not seeing menstruation and will bleeding or the midterm bleeding when using the next drug (as in the case of delaying menstruation).

Special population

Children and adolescents

The use of Rosina tablets is designated after the first menstrual period, there is no data on the need for dose adjustment.

Elderly

Not applicable. Do not only use Rosina after menopause.

Liver function impairment

Contraindicated to use Rosina for women impaired liver function.

Renal function impairment

LATEST WITH ROSINA FOR WOMEN DISCUSSION SO MACHINE FUNCTIONS OR GENERAL EUBLISE.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? On the basis of common experiences with oral contraceptives, symptoms may appear in this case, including nausea, vomiting and in young women with mild vaginal bleeding.

There is no antidote and treatment when overdose is symptomatic treatment.

What to do when forgetting 1 dose? Should take medicine as soon as you remember and take the next tablet at usual time.

If you forget to take medicine for more than 12 hours, the contraceptive effect may decrease. Handling forgotten doses can be guided in the following two basic principles:

Do not stop the drug for more than 7 days.

week 1

Should take the last forgotten pills as soon as you remember, even use 2 tablets at the same time. After that, continue taking medicine at usual time. In addition, an additional method of contraception is like a condom in the next 7 days. If intercourse in the previous 7 days, the possibility of pregnancy should be considered. The more you forget a tablet and the closer you forgot the medication with the time of stopping the medication, the higher the risk of pregnancy.

week 2

Should take the last forgotten tablet as soon as you remember, you can even take 2 capsules at the same time. Then continue taking the medication at usual time. If you have taken medication on schedule for 7 days before forgetting the first pill, it is not necessary to use with preventive contraception. However, if you forget more than one pill, users should be recommended to touch the preventive contraception in 7 days.

Week 3

There is a risk of reducing contraception due to the upcoming 7 -day stop period. However, by adjusting the drug's use schedule, it can be prevented from reducing contraception. By making one of the two options below, there is no need to use preventive contraception, ensuring that 7 days before forgetting the first pill, users used the drug on schedule. If not so, users should follow the choice 1 and use the preventive contraception in the next 7 days.

Select 1

Take the tablet after forgotten as soon as you remember, even take 2 capsules at the same time. After that, continue taking medicine at usual time. The next blister must be started at the end of the blister, not to have the time to stop the drug between the two blisters. It is difficult for users to have a lot of menstruation until they use the second blister, but they can bleed or hemorrhage in the middle of the period during the medication days.

Select 2

Users may also be advised to stop taking drugs in the current blister. There should be a period of stopping the drug for 7 days, including the day to forget the drug and then continue using the next blister.

If you forget the drug and then do not have menstruation during the normal stop time, it is necessary to consider the possibility of pregnancy.

Side Effects

When using Rosina 3 mg/0.03 mg, you may experience unwanted effects (ADR).

Common (1/100 to

Mental disorders: emotional disorders.

Nervous system disorders: headache.

Digestive disorders: abdominal pain.

Skin and subcutaneous tissue disorders: folliculitis (acne).

Genital and breast disorders: chest pain, big chest, mammary pain, dysmenorrhea, haemorrhage.

Systemic and local disorders: weight gain.

Uncommon (1/1000 to

Infections and parasites: Candida infection, Herpes Simplex infection.

Immune system disorders: allergic reactions.

Disorders of metabolism and nutrition: Increasing appetite.

Mental disorders: depression, stress, sleep disorders.

Nervous system disorders: Perception, dizziness.

eye disorders: visual disorders.

Disorders on the heart: Extra systolic, tachycardia.

Disorders of blood vessel system: pulmonary embolism, hypertension, hypotension, migraine, venous insufficiency.

Respiratory disorders, chest and mediastinum: Sore throat.

Digestive disorders: Nausea, vomiting, gastritis, intestines, diarrhea, constipation, stomach and intestinal disorders.

Skin and subcutaneous tissue disorders: angiography, hair loss, eczema, itching, dry skin, increased sebum secretion, skin disorders.

musculoskeletal and connective tissue disorders: neck pain, headache, cramps.

Disorders of kidney and urinary: Cystitis.

Genital and breast disorders: Breast tumors, breast fibrosis, milk, ovarian cysts, abdominal severe, menstrual disorders, menstrual dysmenorrhea, vaginal Candida, vaginitis, vaginal disorders, vulva disorders, vaginal disorders, vaginal dryness, pelvic pain, suspected diagnostic cervical cancer diagnosis, pop bruises, reduced libido.

Systemic and topical disorders: edema, weakness, pain, thirst, increase sweating, weight loss.

Rare (1/10,000 to

The immune system disorder: bronchial asthma.

Disorders on ears and mesmerizing: hearing loss.

Vascular system disorders: venous thrombosis (VTE), arterial thrombosis (ATE).

Skin and subcutaneous tissue disorders: Pink button, diverse roses.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

should not use hormonal contraceptives in the case listed below. Should stop taking the drug immediately if these signs first appear in the process of using hormonal contraceptives.

are expensive or at risk of venous thrombosis (VTE).

Currently there is venous thrombosis (using anticoagulants) or a history of venous thrombosis (such as DVT deep vein embolism) or pulmonary embolism (PE).

Venous thrombosis due to genetic or potentially acquired such as APC resistance (including V Leiden factor), lack of thrombin resistance factors III, protein deficiency, protein deficiency S.

Surgery must be immobile.

The risk of venous thrombosis due to many risk factors.

arterial thrombosis or arterial thrombosis (ATE).

Currently there is arterial thrombosis or a history of arterial thrombosis (such as myocardial infarction) or signs of millions (such as angina).

Stroke due to cerebrovascular disease, a history of a stroke or a sign of millions (such as a glimpse of brain anemia).

Genetic or genetic arterial thrombosis, such as increased blood homocystein and anti -phospholipid antibodies (anti -cardilipin antibodies, lupus anticoagulants (lupus coagulant)).

History of migraine with local nerve symptoms. The risk of arterial thrombosis due to many risk factors or serious risk factors such as diabetes with vascular symptoms. Serious hypertension. Serious blood lipoprotein disorders.

Having severe liver disease or a history of severe liver disease, the liver function does not return to normal for a long time.

Serious renal function or acute renal failure.

There are tumors or history with liver tumors (benign or malignant).

There are malignant tumors or suspects that have malignant tumors affecting sex hormones (such as genital or breast).
Vaginal bleeding is not diagnosed.

Hypersensitivity to active ingredients or any excipients are listed.
Too hypersensitivity to peanuts or soybeans.
Be cautious when using

If there is any risk or risk factor mentioned below, it is necessary to discuss the suitability when using Rosina for a woman.
In case of severe or first -time conditions or risk factors, users need to be advised to contact the doctor to know whether to stop using Rosina or not.
In case of venous thrombosis or arterial thrombosis have been confirmed or still suspected, it should be stopped by hormonal contraceptives. In the case of starting treatment with anticoagulant drugs, it is advisable to use appropriate alternative contraceptive methods due to the ability to cause pregnancy defects of anticoagulants (COUMARIN).
Circulatory disorders - Veo thrombosis (VTE)
The use of any coordinated hormonal contraceptives (CHC) also increases the risk of venous thrombosis compared to no drugs. The drugs containing levonorrgestrel, norgestimat or norethinyleleolsterolsteron are associated with the lowest risk of venous thrombosis. Other drugs like Rosina may have double this risk. Only decision to use drugs other than drugs at the lowest risk of venous thrombosis after talking to users so that women understand the risk of rosina's veins, existing risk factors can affect this risk and the risk of venous thrombosis is the highest in the first year of taking the drug. There are also some evidence that this risk increases when the coordinated hormonal contraceptive is used after a period of stopping the drug for 4 weeks or more.
Very rarely, the thrombosis is reported on a combined hormonal contraceptive user that appears in artery blood vessels and liver veins, hanging, kidney or retina.
Risk factors for venous thrombosis
The risk of venous thrombosis in users of hormonal contraceptives can increase significantly in women with other risk factors, especially when there are simultaneously many other risk factors.
Symptoms of venous thrombosis (deep vein thrombosis and pulmonary embolism)
In case of the following symptoms, women need advice for emergency medical care and must notify health workers about the use of hormonal contraceptives.
Symptoms of deep vein thrombosis (DVT) may include:

swelling on one leg and/or foot or along the leg vein

Pain or pain in the foot can only feel when standing or walking.

The hot feeling increases on the side of the affected leg, red skin or discoloration in the leg.

Pulmonary embolism (PE) may include:

Difficulty breathing or rapidly starting out of unknown cause.

Sudden cough can be accompanied by bleeding.
Severe chest pain.
dizzy or dizziness.

Tachycardia or abnormalities.

Some symptoms (such as "shortness of breath", "cough") are not specific and may be confused with common and less serious diseases (such as respiratory infections).
Other signs of embolism may include: sudden pain, swelling and mild blue change at the head.
If the embolism occurs in the eye, it may be manifested from painless blurring to loss of vision. Sometimes vision loss may appear immediately.
Aortic thrombosis (ATE)
The epidemiological studies have shown the relationship between the use of hormonal contraceptives in combination with an increase in the risk of arterial thrombosis (myocardial infarction) or the risk of a stroke (such as transient anemia, stroke). Arterial thrombosis can be fatal.
tumor
The most important risk factor for cervical cancer is caused by human papilloma virus infection (HPV). The increase in the risk of cervical cancer in users of oral contraceptives (> 5 years) has been recorded in some epidemiological studies, but continues to be controversial about the extent of this finding due to being affected by other factors such as cervical cancer tests or sexual behaviors using contraceptive measures.
In rare cases, benign liver tumors and even more rare, malignant liver tumors have been recorded on people who use oral contraceptives. In single cases, these tumors have led to life -threatening bleeding. A liver tumor should be considered and has a distinct diagnosis when there is pain in the abdominal team on the liver or there is signs of abdominal bleeding in women using oral contraceptives.
Malignant tumors can be life -threatening or fatal.
Other conditions
The progestogen component in Rosina is an antagonist aldosteron with the effect of keeping potassium. Potassium concentration is expected to increase in most cases.
In women with genetic angiema, external estrogen can cause or worsen the symptoms of angioedema.
may need to stop using oral contraceptives if there is an acute or chronic liver dysfunction until the indicators of liver function evaluate return to normal. Oral contraceptives need to be stopped in the case of recurrent and/or itchy jaundice due to the previous cholestasis that has appeared during pregnancy or during the use of previous sex hormones.
Although oral contraceptives can affect peripheral insulin resistance and glucose tolerance, there is no evidence that the need to replace other diabetes treatment regimens when using low -dose oral oral contraceptives (containing
The worsening progress of endogenous depression, convulsions, Crohn's disease and colon ulcers have been reported in the use of oral contraceptive contraceptives.
Skin melasma can occasionally appear, especially in women with a history of pregnancy pigmentation. Women who tend to have skin pigmentation should avoid exposure to sunlight or ultraviolet rays while taking oral contraceptives.
Each pill contains 48.17 mg of lactose monohydrate. Users if there is a Galactose -free genetic problem, Lapp Lactose deficiency or Glucose - Galactose absorption should not be taken.
Each pill contains 0.07 mg of soybean lecithin. Users who are too hypersensitivity to peanuts or soy should not use this drug.
Testing/medical examination
Before starting to use or re -use Rosina, it is advisable to consider full medical history (including family history) and need to eliminate the possibility of pregnancy. Blood pressure should be measured and user entity examinations should be guided on contraindications and warnings. It is important to note that users information about thrombosis - veins, including Rosina's risk, when compared to other coordinated hormonal contraceptives, symptoms of venous thrombosis and arterial thrombosis, known risk factors and things to do in case of suspicion of thrombosis.
Users should also be carefully read the instruction sheet of the drug and follow the instructions. Frequency and tests should be done based on practical guidelines that have been established and suitable for each woman.
Women should be consulted that hormonal contraceptives do not protect against HIV infection (AIDS) and other genital transmission diseases.
Reduce effectiveness
The effectiveness of coordinated hormonal contraceptives can be reduced in cases such as forgetting drugs, digestive disorders or simultaneous use with other drugs.
Cycle control reduction
With all oral contraceptives, abnormal bleeding (hemorrhage or midtermic hemorrhage) may occur, especially in the first month of using the drug. However, the evaluation of any abnormal bleeding is only meaningful after a period of about 3 cycles.
The ability to drive and operate machinery

There are no studies on the effects of the drug on the ability to drive and operate machinery.
Pregnancy

does not specify using Rosina during pregnancy.
If pregnant while using ROISNA, stop taking the medication immediately. Epidemiological studies show that the drug does not increase the risk of birth defects in children with mothers who have used oral contraceptives before pregnancy as well as do not cause fetal defects when oral contraceptives are accidentally used during pregnancy.
The period of breastfeeding

Oral contraceptives can affect the breastfeeding process due to the drug that changes the quality and breast milk component. Therefore, it is generally not recommended to use oral contraceptives until the mother has completely weaned for the child. A small amount of steroidal contraceptives and/or its metabolites can excrete in breast milk during medication. This amount of medicine can affect breastfeeding.
Drug interaction

The effect of other drugs on Rosina
Interactions may appear with liver enzyme -causing drugs that can increase the clearance of sex hormones that can lead to mid -term bleeding and/or loss of contraception.
Handling
Enzyme induction can be recorded after a few days of treatment. Maximum enzyme induction usually observes within a few weeks. After stopping treatment with drugs, enzyme induction can be maintained for about 4 weeks.
Short -term treatment
Women who are treating short -term treatment with enzyme -causing drugs should temporarily use an additional barrier or other additional method of contraception. The barrier method needs to be used during the same time with the enzyme -causing drugs and 28 days after stopping the medication. If there is still medication after taking the final tablet in the contraceptive pill, the next birth control pills should be started shortly after that without the time to stop the drug.
Long -term treatment
If the drug is used simultaneously when using all Rosina tablets in the blister, it is advisable to start using the next blister without the time to stop the drug as usual.
The following interactions have been recorded in literature
Increased medications that increase the clearance of oral contraceptives (reduce the effectiveness of oral contraceptives caused by enzyme induction) such as: barbiturates, bosentan, carbamazepin, phenytoin, primidon, rifampicin and antichersis ritonavir, nevirapin, eFavirenz and can also occur with felbamat, granto, granty Oxacarbazepin, Topiramat and drugs containing herbal ingredients are St. John’s World (Hypericum Perforatum).
Medications that change the clearance of oral contraceptives
When used simultaneously with oral contraceptives, many combinations of HIV Protease inhibitors and enzyme inhibitors are not nucleosides, including combinations with HCV inhibitors that can increase or decrease the concentration of estrogen or progestin in plasma. The clear effect of these changes may manifest clinically in some cases.
The effect of Rosina on other drugs
Oral contraceptives may affect the metabolism of some other drugs, whereby plasma and tissue concentrations of these drugs may increase (such as ciclosporin) or decrease (such as lamotrigin).
Other types of interactions
On patients, there is no renal function, simultaneous use of drospirenon and transferred enzyme inhibitors or nonsteroidal anti -inflammatory drugs have not shown significant effects on serum potassium concentration. However, simultaneous use of Rosina with aldosteron antagonists or potassium diuretics has not been studied. In this case, serum potassium concentration should be tested in the first drug cycle.
Testing
Using steroidal contraceptives may affect some test results, including the biochemical parameters of the liver, thyroid, adrenal glands and kidney function, concentration of plasma proteins, such as corticosteroid globulin and liporotein liporotein segments of carbohydrate metabolism and blood coagulation parameters. Changes are generally still within normal limits.
Drospirenon increases plasma renin activity and plasma aldosteron due to the mild anti -mineralocorticoid effect of the drug.

Storage

Store in a dry place, under 300C in the original packaging, avoiding light.

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