Rigevidon 21+7 Gedeon medicine for contraception (3 blisters x 28 tablets)

Dosage form Box of 3 blisters x 28 tablets
Specifications Ethinylestradiol, levonorgestrel

Ingredient

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Composition information	Content
Ethinylestradiol	0.03mg
Levonorgestrel	0.15mg

Uses

Indications

RigeVidon 21.7 drugs are indicated in the following cases:

Rigevidon (21+7) belongs to the combined oral contraceptive group. Using the medication properly will have a recovery contraceptive effect. Rigevidon (21+7) contains 2 forms of hormones: estrogen (ethinylestradiol) and progestogen (levonorgestrel) at low doses. The drug has the effect of preventing conception like the natural hormone mechanism of the body to prevent pregnancy during pregnancy. Contraceptive contraceptive pills combine conception in 3 roads:

1. These hormones prevent monthly ovulation.

2. Thickening the layer of the cervix makes sperm difficult to move to meet eggs.

3. Change the uterus layer that makes the uterus difficult to receive fertilized eggs.

If used properly, Rigevidon (21+7) is an effective rehabilitation contraceptive. However, in some effective situations of the drug may decrease or you need to stop taking the drug (see the lower part). In these situations to ensure effective contraception, no sex or other non -hormone contraception (such as condoms or spermicide) when intercourse.

Remember to combine oral contraceptives like Rigevidon (21+7) does not protect you from sexually transmitted diseases (such as AIDS). Only condoms have this effect.

Pharmacokology

Pharmacological group: Genital hormone and genital regulating, systemic contraceptive pills, easily combining progestogen and estrogen.

ATC code: G03aao7.

The contraceptive effect of Rigevidon (21+7) is based on the interaction between different factors, the most important of which is inhibiting ovulation and changes in endometrium and cervical mucus.

pharmacokinetic

ethinylelestradiol

absorption

Ethinylestradiol absorbs quickly and completely through the gastrointestinal tract after drinking, reaching the peak concentration in plasma after 1.5 hours. After entering the general circulation and first metabolism, absolute bioavailability is 60%. AUC and CMAX values over time may increase slightly.

Distribution

ethinylelestradiol is connected to plasma proteins 98.8%, almost entirely connected to albumin.

Metabolism

Ethinylestradiol metabolizes through both the small intestinal and liver mucosa. The direct hydrolysis of ethinylestradiol by the intestinal flora that produces ethinylestradiol that can be reabsorbed, thus creating intestinal circulation. The metabolism of ethinylelestradiol is through hydroxylation through cytochrome p450 intermediaries, where the main metabolic is 2-oh-eginylestradiol and 2-methoxyethinylesiradiol. 2-OH-ETHINYLESTRADIOL continues to be metabolized through chemical reactions.

Elimination

Ethinylestradiol disappears in plasma with T ½ about 29 hours (26 - 33 hours), plasma clearance ranges from 10 - 30 l/hour. Ethinylestradiol and metabolites are excreted through feces and urine (ratio 1: 1).

levonorgestrel

absorption

levonorgestrel quickly and completely through the gastrointestinal tract after drinking. Birth is 100% and levonorgestrel is not metabolized for the first time.

Distribution

levonorgestrel strongly linked with albumin and SHBG (sex hormone binding globulin) in plasma

Metabolism

Metabolizes mainly by reducing the group Δ4-3-oxo and hydroxylation at 2α, 1β and 16β positions after bonding. The majority of blood circulation metabolites are sulphate salt of 3α, 5β tetrahydro-levonorgestrel while the excretion is mainly in the form of glucuronides. A part of levonorgestrel was originally circulating in the form of 17β-sulphate. The metabolic clearance is used to mark the difference between individuals, which can explain, for the concentration of levonorgestrel to be observed in patients.

Elimination

levonorgestrel has a half -life of about 30 hours in a stable state. Levonorgestrel and metabolites are excreted through urine (40 - 68%) and about 10 - 48% excreted in feces.

Before taking Rigevidon 21+7 Gedeon medicine for contraception (3 blisters x 28 tablets)

Dosage and how to use

Use the drug in accordance with the instructions. If you want to know more about this drug or something unknown, consult your doctor or pharmacist.

When and how to use it?

Each box of Rigevidon (21+7) contains 1 blister or 3 blisters with a numbered drug. This numbering design helps you remember the date of medication. The blister is marked with the week of each week for each tablet to take. According to the arrow instructions above because you need to take white tablets for 21 days and reddish brown tablets for 7 days until the end of the blister. During or taking reddish brown capsules, around the 2nd or Tuesday, you will be bleeding like menstruation, also known as "monthly cycle".

Start using the next 21 white tablets the next day after taking the last pill of the blister first and constantly, the cycle will end after taking 7 reddish brown tablets. When using Rigevidon (21+7) properly, you will always start a new blister on the same day of the week. Try to use the drug at the same time of the day. The easiest may be the first medication in the morning or the last tablet in the evening. Swallow the pills with drinking water if needed.

Start using Rigevidon (21+7) first.

If in the previous menstrual cycle has not used oral contraceptives

Use the first tablet on the first day of the menstrual cycle. The first day of the cycle is the day you start bleeding. Use the medication as directed by the arrow and continue taking the medication every day until the end of the blister. If you start taking Rigevidon (21+7) on the 2nd to 5th day of the cycle, you should use other contraception such as condoms or spermicide in the first 7 days but just use it with the first blister.

Change to Rigevidon (21+7) from another combined hormone contraceptive pills

Start using Rigevidon (21+7) on the day after you use the last tablet of the blister blister first. Do not leave the distance between 2 blisters. If the blister blisters also contain a placebo pill (a tablet without a hormone), you should start using Rigevidon (21+7) on the day after the last day of using a hormone, not later than the day after the use of a placebo pill (the pill does not have hormones) of the blister of the drug first (meaning that after the day of using the last placebo pill of the blister). If you are not sure or have more questions, consult your doctor or pharmacist.

Change to using Rigevidon (21+7) Fu blister only contains progestogen (oral, injection, subcutaneous implant or device in the uterus)

You can stop using tablets containing only progestogen at any time and start using Rigevidon (21+7) at the same time of the next day. But to be sure you should use another method of contraception (condoms or spermicide when intercourse in the first 7 days of taking the drug. Other fetuses (such as condoms or spermicide) when intercourse for the first 7 days of medication.

Start using Rigevidon (21+7) after giving birth or after miscarriage/abortion

After giving birth, miscarriage or abortion, the doctor should give you advice about using birth control pills. You can start using Rigevidon (21+7) immediately after miscarriage or abortion in the first 3 months of pregnancy. In this case you do not need to use other contraception.

If you have given birth or miscarriage in the middle 3 months of pregnancy and if you do not breastfeed, you can start using Rigevidon (21+7) from 21 to 28 days after birth or after miscarriage/abortion. However, you need to use a condom supplement or spermicide, when intercourse in the first 7 days of medication.

What to do when you have digestive disorders

If vomiting or diarrhea for 4 hours after taking the medication, your body may not absorb the tablet. In this case, it should be used as directed to forget to take medicine. In case of vomiting or diarrhea, other contraceptives should be used such as condoms or spermicide if intercourse during digestive disorders and in the next 7 days.

If you forget to take Rigevidon (21+7)

If you forget to use reddish brown tablets, this does not affect the contraceptive effect.

If you forget to take medicine less than or equal to 12 hours

You can still prevent pregnancy if you take the tablet immediately when you remember and use the next tablet in time as usual. This can make you use 2 capsules in a day.

If you forget to take medicine for more than 12 hours

If you have forgotten to take medicine for more than 12 hours, contraceptive effects may be reduced and you have to use other contraception. The more you forget the pills, the more effective contraception. If you forget to take more than 1 tablet, you need to consult a doctor.

What to do when you forget to take medicine for the first week

You need to take the tablet immediately when you remember, even take 2 tablets at once. After that, you should continue drinking Rigevidon (21+7) at the same time as usual. You have to use other contraceptives like condoms for the next 7 days. If intercourse in the next 7 days, it is necessary to consider the possibility of pregnancy. The more tablets are forgotten and the closer the time to forget the place of placebo, the higher the chances of getting pregnant.

What to do if you forget to take medicine in the 2nd week

You have to take the tablet immediately when you remember, even take 2 tablets at the same time. After that, you should continue taking the medication at usual time during the day. With the right use of Rigevidon (21+7) in the next 7 days, there is no additional contraceptive method. However, if you use it incorrectly or forget to take more than 1 tablet, you should use another contraception in 7 days.

What to do if you forget to take medicine in the 3rd week

The risk of contraception fails is high because this time is close to the place of placebo. The contraceptive ability may decrease, but it can be prevented by adjusting the medication. If you follow one of the following two ways, it is not necessary to use additional contraception other than the condition that all Rigevidon (21+7) tablets are used properly in the next 7 days after the forgotten pill. If you do not use the medication properly for the next 7 days, you need to follow the first way. Need to use additional contraception (such as condoms) continuously for the next 7 days:

Method 1: You should take the tablet immediately forgotten as soon as you remember, even take 2 tablets at the same time. After that, you continue to take other tablets at usual time during the day. You should start the next blister immediately after taking 21 white tablets (tablets with hormones) in the current blister without drinking reddish brown tablets. You will not have menstruation until the second blister is taken but may have bleeding or bleeding outside the menstrual cycle during the medication days.

Method 2: You can stop taking the drug in the current blister. In this case, you should leave a period of not taking medicine - or taking some tablets for 7 days including the day to forget the drug then continue to take the next blister.

If you forget a lot of tablets and then there is no menstruation during the place of placebo, need to consider the possibility of pregnancy.

What to do when you have digestive disorders

How to delay menstruation

If you want to postpone your period, you should consult your doctor. To slow menstruation, you should continue using the Rigevidon (21+7) blisters, after using 21 white tablets with active ingredients in the current blister and do not use reddish brown tablets. This case may last as expected until the end of 21 white tablets in the second blister blister. In this prolonged period you may experience hemorrhage or bleeding outside the menstrual cycle. Use Rigevidon (21+7) as usual after 7 days of not taking the drug or after 7 days of using reddish brown pills.

How to move menstruation to another day of the week

If using Rigevidon (21+7) properly, you will always have menstruation in the same day of the month. To move menstruation to a different day of the week than the normal cycle, you can shorten (but never be extended) The upcoming period of use: for example, the time you take reddish brown capsules. For example, if your cycle starts on Friday and you want the cycle to start on Tuesday (3 days earlier). You should start drinking the next blister 3 days earlier. If you leave the period of use is too short (for example: less than 3 days), you may not have menstruation during the place of placebo but may have hemorrhage or bleeding outside the menstrual cycle when drinking the second blister.

If you have bleeding between cycles

A few women may have bleeding outside the menstrual cycle or hemorrhage when using Rigevidon (21+7), especially in the first few months. Normally, no need to worry about this, bleeding will stop for 1 or 2 days. Using the medication as usual and these manifestations will take after the first few blisters (usually after 3 blisters). If you continue to bleed, prolonged or made you uncomfortable, consult your doctor.

If you don't have menstruation

If you have taken the whole blister, no digestive disorders or other drugs, it is very difficult for you to get pregnant. Continue to use Rigevidon (21+7) as usual.

If you do not have twice consecutive menstruation

If there is no period twice in a row, you may be pregnant and need to see a doctor immediately. You can only continue taking the medicine after pregnancy and the doctor's opinion.

If you stop drinking Rigevidon (21+7)

You can stop drinking Rigevidon (21+7) at any time. If you stop drinking Rigevidon (21+7) to give birth, should use other contraception until you have your own usual cycle. Using this method will help the doctor predict the time of giving birth to your baby more easily.

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? If you have any symptoms, you need to ask for your doctor's advice and follow the doctor's instructions.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when forgetting 1 dose?

Side Effects

When using Rigevidon 21.7, you may experience unwanted effects (ADR).

Notify the doctor with unwanted effects when using the drug.

Like other drugs, Rigevidon (21+7) can cause unwanted effects. If any unwanted effect becomes worse or if you find any effect not mentioned in this user manual, notify your doctor or pharmacist.

Common, (can be encountered at a rate of up to 1/10 people)

Vaginitis includes vaginal candidiasis, mood changes including depression, sexual desire, headache, stress, dizziness, nausea, vomiting, abdominal pain, acne, chest, chest pain, big chest and secretion, abnormal bleeding, abnormal uterine (changing uterine peanuts) and vaginal discharge, dysmenorrhea, dysmenorrhea, dysmenorrhea, dysmenorrhea, dysuria

less common, (can be encountered at 1/100 people)

Change in the feeling of eating delicious, loss of libido, hypertension, abdominal shrinkage, bloating, redness, skin pigmentation (yellow brown spots on the skin) can be prolonged, hair growth, hair loss, serum lipid concentration including hyperliglyceride.

rare, (may be encountered at 1/1000 people)

Severe allergic reactions (anaphylactic reactions with very rare cases of urticaria, face, tongue, respiratory disorders and severe circulation), glucose intolerant, increased sexual desire, eye irritation when wearing contact lenses, jaundice, nodes on the skin characterized by red spots causing pain on the skin.

Very rare, (can be encountered at 1/10000)

benign or malignant liver tumors, more severe autoimmune disease (lupus), more severe porphyrin metabolic disorders, dancing violence (spontaneous movement disorders), optic neuritis, blood clots in cerebral vessels, varicose veins, colitis (colitis of ischemic colitis), cholecystitis, hypercasses) HUS (a disorder in which blood clots damage kidney), reduce serum folat concentration.

Unknown (frequency is not estimated from existing data): Inflammation (Crohn's disease, colon ulcer), liver cell damage (for example: hepatitis, abnormal liver function).

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

RigeVidon 21.7 contraindications in the following cases:

If you have one of the following diseases, you need to notify your doctor. The doctor may decide that Rigevidon (21+7) is not suitable for you and recommends using other contraception.

If you or any family members have been disordered to blood circulation, or any condition, you have a higher risk of blood clots like thrombosis. The thrombosis is when you have blood clots clogged blood vessels. Blood clots sometimes form in deep veins in the leg (deep vein thrombosis). If this blood clot moves from the vein it forms, it can go and clog the pulmonary artery (causing pulmonary vasoconstriction). Blood clots can also be formed in the heart of the heart causing heart attack) or in the brain (causing stroke) or in the blood vessels of other organs.

If you've ever had a heart attack or angina or a mutant or a circulatory disorder when weak or throbbing on one side of the body.

If you have a disease that increases the risk of venous thrombosis or artery.

If you are or have had migraine.

If you have severe hypertension.

If you have severe diabetes with changes on blood vessels.

If you have a very high concentration of cholesterol (cholesterol or triglyceride).

If you are or have ever had eye disorders (for example, retinopathy).

If you are or have liver tumors, severe liver disease.

If you are or have had breast cancer or other forms of cancer such as ovarian cancer, cervical cancer or uterine cancer.

If you have abnormal bleeding in the vagina.

If you are or have been inflamed.

If you are allergic to ethinylelestradiol or levonorgestrel or any ingredients of the drug.

Do not use drugs simultaneously with the herbal herb (Hypericum Perforatum).

Be cautious when using

Before you start taking Rigevidon (21+7), the doctor should have a history of your disease by asking some questions about yourself and family members. You may need blood pressure and health examination.

If there is any of the following disease or condition, you can only use Rigevidon (21+7) with strict medical monitoring because these conditions may be worse when you take the medication.

Notice to the doctor before starting to use Rigevidon (21+7) if you are in the following cases:

Smoking. Colitis (Crohn's disease, ulcerative colon).

Liver or gallbladder disease (for example, jaundice, gallstones). In which blood clots damage the kidneys). skin). In case of genetic circuit. The following cases need to consult a doctor immediately: edema, tongue and/or throat and/or difficulty swallowing or urticaria accompanied by shortness of breath.

The above conditions may be worse when you take the medication, so you must regularly check your strength when taking the drug.

contraceptives and thrombosis

thrombosis is a condition with blood clots that clog blood vessels. Blood clots sometimes form in deep veins in the leg (deep vein thrombosis). If this blood clot moves out of the vein it forms, it can go and clog the pulmonary artery that causes pulmonary embolism). Blood clots can also form in the heart (causing heart attack) or brain (causing stroke). In extremely rare cases, blood clots can be formed in other places such as the liver, intestines, kidneys or eyes. Most blood clots can be treated without endangering in the long run. However, thrombosis can cause permanent paralysis and can be fatal even though this case is very rare.

Some studies propose the risk of diverse blood circulation disorders in women who use contraceptives combined to increase slightly than those who do not use drugs. The risk of thrombosis is the highest in the first year of using any combined contraceptive pills. Blood can also appear when you are pregnant.

Smoking increases the risk of unwanted effects on the heart and blood vessels when using oral contraceptives. This risk is particularly clear in women over 35 years old. All women use oral contraceptives in combination should not smoke, women over 35 years of age absolutely do not smoke.

The risk of deep venous thrombosis temporarily increases after surgery or the time you cannot move as usual (for example, when your legs are bundled or bone brace). If you are taking the drug, the risk may be higher. It is necessary to notify your doctor if you are taking the medication before you go to the hospital or have surgery. The doctor may advise you to stop taking the medication a few weeks before or after surgery. If you don't have time to do this, your doctor may give you a drug to reduce the risk of thrombosis. The doctor will also tell you when you can start taking the medicine again when your legs have recovered.

contraceptives and cancer

All women are at risk of breast cancer whether or not to take birth control pills.

Breast cancer is detected more often in women who take birth control pills than women of the same age without taking medicine. If a woman stops the drug, this reduces the risk and 10 years after stopping the risk of breast cancer detection is the same with women who never take medicine. It has not yet been confirmed whether oral contraceptive pills increased the risk of breast cancer or not. It is possible that women who take birth control pills check health more often, so breast cancer is detected earlier.

Rarely cases of drug use leading to benign liver tumors. Very rarely some types of malignant liver tumors (cancer) in people who take oral contraceptives for a long time. The liver tumor leads to life -threatening abdominal bleeding. So if you have upper abdominal pain without immediately, you need advice from your doctor.

Increased risk of cervical cancer in long -term drug users has been reported in some studies. It has not yet been confirmed whether or not to increase this risk or not because cervical cancer may be due to some effects of sexual behavior and other factors.

Use Rigevidon (21+7) with food and drink

Swallow the whole pill with a little water if needed.

affect tests

If you need a blood test, you need to notify your doctor or testing staff that you are taking birth control pills because oral contraceptives affect the results of some tests.

important information about some ingredients of the drug

Rigevidon (21+7) contains lactose and sucrose. If you are not tolerated with lactose (sugar in milk), you need to know in each white tablet containing 33 mg of lactose and each reddish brown tablet has the Lord 24.55 mg of lactose. If you are not tolerated with fructose (sugar in fruit), you need to know that each white tablet contains 22,459 mg of sucrose and each reddish brown tablet contains 38,295 mg of sucrose. If you've ever been informed by a doctor that you are not tolerated with some types of sugar, consult your doctor before taking this medication.

The ability to drive and operate machinery

Rigevidon (21+7) does not affect the ability to drive and operate machinery.

Pregnancy

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to have children, consult your doctor or pharmacist before taking this medication. If you are pregnant or think you may be pregnant, do not use Rigevidon (21+7).

Breastfeeding period

Do not take Rigevidon (21+7) while breastfeeding. If you are breastfeeding and want to take the medicine, you should consult your doctor.

Medicinal interaction

You need to notify your doctor, dentist or pharmacist if you are or recently taking other drugs, including non -prescribing drugs.

Some drugs may affect the effects of Rigevidon (21+7) for example: reducing the effectiveness of contraception or Rigevidon (21+7) may affect the effects of simultaneous use. These drugs include:

Treatment of epilepsy or neuropathy (such as Barbiturat, Phenytoin, Primidon, Topiramat, Lamotrigin, Carbamazepin, Oxcarbazepin, Felbamat, Hytansin, Rufinamid, Perampanel).

Antibiotics (such as Rifampicin, Rifabutin, Ritonavir, Nevirapin, Efavirenz, Nelfinavir, Ampicilin, Tetracyclin and penicillins). Cyclosporin).

The drug is used in the treatment of symptoms of joint disease (Etoricoxib sensitive to estrogen levels (ethinylelestradiol) in Rigevidon (21+7) increases in the blood. spermicide) while taking the drug or for 7 days or even longer after you have stopped the drug.

Storage

Store in a dry place, temperature below 30 ° C.

Do not quit smoking into drainage or trash. Ask your pharmacist how to quit smoking is no longer used. These measures will help protect the environment.

Expiry date: 2 years from the date of manufacture. Do not use overdue drugs stated on the packaging.

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