FEMODENE 21 tablets

What Femoden?

Type the Pill

Femoden combined oral contraceptive ("combined pill"). Each tablet contains a small amount of two different female hormones. These are gestodene (progestogen) and ethinylestradiol (estrogen). Due to the small amounts of hormones Femoden considered low-dose oral contraceptive . Since all tablets in the package are a combination of the same. hormones in the same amount, the product is defined as monophasic oral contraceptive.

Why use Femoden?

To prevent pregnancy.

Oral contraceptives are a very effective method of birth control. With proper intake (without missing tablets) has little chance of becoming pregnant.

Packaging and tablets

Femoden is provided in blister packs containing 21 tablets or 3x21.

Femoden tablets are packed in blisters made of transparent polyvinyl chloride film and

metal aluminum foil.

The tablets are biconvex, round, 5 mm in diameter.

Do not use the combined pill in the cases listed below. If any of these occur to you, tell your doctor before using Femoden.Toy may advise you to use other contraceptives or non-hormonal method of birth control.

  If you have or have ever had circulatory disorders: usually these are conditions associated with thrombosis (blood clot) in the blood vessels of the legs (deep vein thrombosis), lungs (pulmonary embolism), the heart (heart attack), brain ( stroke) or other parts of the body. (See also "The pill and thrombosis').

  If you have or have had a stroke (caused by a blood clot or ruptured blood vessel in the brain).

 If you have or have had signs of heart attack (such as angina or chest pain) or stroke (such as transient ischemic attack or small reversible stroke).

  If you suffer from migraine accompanied by visual symptoms, speech disorders or weakness or paralysis of parts of your body.

  If you suffer from diabetes mellitus with blood vessel damage

  If you have or have had pancreatitis (inflammation of the pancreas) accompanied by high levels of blood lipids

  If you have jaundice (yellowing of the skin) or severe liver disease.

 If you have or had cancer that may grow under the influence of sex hormones (eg of the breast or sex organs).

 If you have or have had benign or malignant liver tumor

  If you get vaginal bleeding of unknown origin.

  If you are pregnant or think you might be pregnant

  If you are hypersensitive (allergic) to any of the ingredients of Femoden

If any of these conditions appear for the first time while using the Pill, stop taking immediately and consult your doctor. Meanwhile, use a non-hormonal contraceptive metodi.Vizh also "General Notes" in the following sections.

General comments

This leaflet describes the different situations in which you must stop taking the pill or reliability of the Pill decreases. In such cases, you should not have sex or you should take extra non-hormonal contraceptive precautions, eg. use a condom or other barrier method. Do not use the method of measuring temperature or rhythm method. They are unreliable because the Pill affects the normal changes in temperature and cervical mucus during the menstrual cycle.

Femoden as all contraceptive pills do not protect against HIV infection (AIDS) or any other infection transmitted sexually.

  Before using Femoden

If you meet any of the conditions listed below and use combination tablets may need to be under close observation. Your doctor will explain everything. So before you start taking Femoden tell you if:

  smoke;

  have diabetes;

  you are overweight;

  have high blood pressure;

  have a defect in the heart valve or rhythm disturbances;

 suffer from inflammation of the veins (superficial phlebitis);

  you have varicose veins;

  someone in your immediate family has had thrombosis, heart attack or stroke;

  suffer from migraine;

  suffer from epilepsy;

  You or someone in your family have or have had high levels of cholesterol or triglycerides (fatty substances) in your blood

  someone in your family has suffered from breast cancer;

  have liver or gallbladder disease;

 suffer from Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);

  you have systemic lupus erythematosus (SLE disease affecting the skin all over the body);

  have haemolytic - uraemic syndrome (HUS: bleeding disorder, which leads to acute renal failure);

  suffer from sickle-cell anemia;

 have or have had chloasma (yellowish-brown pigmentation patches on the skin, especially the face), in such cases, avoid excessive exposure to sunlight or ultraviolet rays.

If any of the above conditions appear for the first time, recur or worsen while taking the Pill, you should contact your doctor.

The pill and thrombosis

Thrombosis is the formation of a blood clot which may block a blood vessel.

Sometimes it gets deep vein thrombosis in the legs (deep vein thrombosis). If the clot away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called "pulmonary embolism". Deep venous thrombosis is rare. The risk of VTE is highest during the first year of use of the Pill.

Venous thromboembolism may occur whether or not use the pill can also occur during pregnancy. The risk is higher in Pill users compared to non users, but not as high as during pregnancy.

Very rarely can get clots in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). In very rare cases, blood clots can occur in the vessels of the liver, intestines, kidneys and eyes.

Very rarely, thrombosis can cause permanent invalidizaiya or even fatal.

The risk of heart attack or stroke increases with age and tobacco use.

When you use the pill, you should stop smoking, especially if you are over 35 years

age.

If during the use of the pill your blood pressure goes up, you have stop using it.

The risk of deep venous thrombosis is temporarily increased after surgery or immobilization (eg if. Feet your cast or splint). Women who use contraceptives, the risk is higher. Tell your doctor that you are taking Femoden advance if you expect to hospital admission or surgery. Your doctor may advise you to stop taking the Pill several weeks before surgery or during inactivity. It will also tell you when you can start again after being reset.

If you notice possible signs of a thrombosis, stop taking the pills and immediately consult your doctor (see "When should you see your doctor?")

The Pill and cancer

Breast cancer has been diagnosed slightly more often in women who use the Pill than in women of the same age using tablets. This slight increase in the number of cases of breast cancer diagnoses gradually disappears during the 10 years after stopping use of the Pill. It is not known whether the differences are due to the pill. Perhaps due to the fact that women were examined more often, so that breast cancer can be detected earlier. In rare cases benign liver tumors and even more rarely - malignant liver tumors in women taking pills. These tumors may lead to internal bleeding. Immediately contact your doctor if you experience severe abdominal pain.

The most important risk factor for cancer of the cervix is available choveveshki infection with human papilloma virus. Some studies have reported an increased risk of cervical cancer after prolonged use of the pill, but they are still controversy about the extent to which this finding may be due to other factors, eg. cervical screening and sexual behavior including use of barrier contraception

Pill and pregnancy

Femoden should not be used in known or suspected pregnancy. If you suspect that you are pregnant while taking Femoden should consult your doctor as soon as possible.

The pill and breastfeeding

Femoden use is not recommended during lactation. If you wish to continue taking the pill while breastfeeding, talk to your doctor.

Pill and driving

No effects on ability to drive. The pill and other drugs

Some drugs reduce the effectiveness of the pill. These include antiepileptics (eg primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate), 5

tuberculostatics (napr.rifampitsin, rifabutin) and HIV infection (ritonavir), antibiotics (napr.penitsilin, tetracyclines, griseofulvin), applicable to certain infectious diseases, herbal products wort (primarily used to treat depressive moods ). The pill can affect the mechanism of action of other drugs.

Always tell your doctor who prescribes oral contraceptive what other medicines and herbal products you are currently using. Also tell any other doctor or dentist who prescribes another medicine you are using Femoden. They will tell you whether you need to take additional contraceptive precautions and if so, for how long should I apply them.

 When should you call your doctor?

Regular reviews

When using a pill, your doctor will tell you when to visit it again for review.

Contact your doctor immediately if:

  you notice any changes in your health, especially those listed in this leaflet (see also "When you must not use Femoden" and "Before using Femoden," do not forget about family predisposition to disease);

  groping a lump in your breast;

 you are taking other medications (See "The pill and other drugs);

  Need to immobilization or surgery (consult your doctor at least four weeks in advance);

  you have unusual vaginal bleeding heavily;

 miss tablets in the first week and had intercourse in the previous 7 days;

  you have severe diarrhea;

  Two consecutive month period have or suspect that you are pregnant (do not start the next pack until your doctor).

Stop taking the pills immediately and see your doctor akozabelezhite

Signs of thrombosis, myocardial infarction or stroke.

  an unusual cough;

  pain in the chest which may reach the left arm;

  shortness of breath;

  unusually severe or prolonged headache or migraine;

  partial or complete loss of vision or double vision;

  unclear pronunciation of words or inability speech;

  sudden changes in auditory, olfactory and taste perception;

  dizziness or fainting;

  weakness or numbness in any part of the body;

  severe pain in the abdomen

  severe pain or swelling in the legs.

Conditions and symptoms mentioned above are described and explained in more detail in other paragraphs of this leaflet.

 When and how to take the tablets?

Femoden pack contains 21 tablets. The packaging over each tablet is marked the day of the week when you will accept. Take a tablet every day at about the same time with a little water. Follow the direction of the arrows until you use up all 21 near tablets. The next seven days will not take tablets. At this time you can get bleeding. It usually begins 2-3 days after the last dose of the tablet Femoden. Start a new pack on the 8th day, even if the bleeding continues. This means that you will always start a new pack on the same day of the week and you will have bleeding almost at the same time each month.

 Starting the first pack Femoden

When last month not using hormonal contraceptives.

Start intake on the first day of menstrual bleeding. Take a tablet marked with that day of the week. Eg. If your period starts on Friday, take the tablet marked Friday. Then follow the days in order. Femoden starts working immediately, no need to use another method. Can you take 2-5 days of your cycle, in which case you should use a barrier method (barrier) in the first 7 days of tablet-taking.

When replacing other pregnancy-preventing compound tablets.

Can you take Femoden the day after you finish the previous package (without a break). If your current pack contains inactive tablets Femoden can start the day after using the last active tablet (if you are not sure who she is, ask your doctor or pharmacist). You can start Femoden and later, but not later than the day after the period in which they did not receive previous tablet (or the day after taking the last active tablet of your previous package). If you follow these instructions, it is not necessary to use an additional contraceptive method.

If you are taking tablets containing only progestogen (minipill). You can stop taking a day of your choice and start taking Femoden the next day at the same time. However, use another method konratseptiven (barrier) within 7 days of taking Femoden when you have intercourse.

When replacing an injectable, implant or a progestogen releasing intrauterine device (IUD).

Start using Femoden the day which should be your next shot or the day in which the implant removed or GSGO. However, use a barrier method (barrier) in the early days of tablet-taking.

Once you are born

If you have just given birth is your doctor may tell you to wait for the first normal period before you start taking Femoden. Sometimes it can happen earlier. Your doctor will advise you. If you are breastfeeding and want to use Femoden should discuss it with your doctor.

After miscarriage or abortion doctor will advise you.

If you take more tablets Femoden (overdose)

No severe damage after overdose. If you have taken several tablets at once can

 to nausea, vomiting, vaginal bleeding. If you find that your child is taking Femoden in error, contact your doctor and ask him.

When you want to stop taking Femoden

You can discontinue at any time Femoden. If you are pregnant, it is advisable to wait until the normal menstrual cycle before trying to conceive. This will help you estimate the term.

In case you do not want pregnancy, consult your doctor about other methods of contraception.

WHAT TO DO IF ...

... forget about Tablet

  If you have passed less than 12 hours than usual during the pill contraceptive protection remains reliable. Take the tablet as soon as you remember, and take your next tablet at the usual time.

 If more than 12 hours, reducing the reliability of the tablet. The more consecutive tablets are missed, the greater the risk of reduced contraceptive effect. It is particularly high risk of becoming pregnant if you miss tablets at the beginning or end of the pack. Therefore, we must follow the rules listed below (see also diagram).

Forgotten more than 1 tablet container Ask your doctor.

1 tablet missed in the first week

Take the missed dose as soon as you remember (even if you have to take two tablets at a time) and take the next tablets at the usual time. Use other methods of contraception (barrier method) for the next 7 days.

If you had intercourse in the week before the day you missed tablet, there is a possibility of becoming pregnant. Inform your doctor immediatel

1 tablet missed in the second week

Take the missed dose as soon as you remember (even if you have to take two tablets at a time) and take the next tablets at the usual time. The effectiveness of Femoden not reduced. No need to use other contraceptive methods.

1 tablet missed in the third week

You can select one of the following options, without the need to use other methods kontratsepivni:

  Take the missed dose as soon as you remember (even if you have to take 2 tablets at a time) and take the next tablets at the usual time. Start the next pack immediately after the first interval meyazdu without packaging. You may not get the bleeding to completion of the second pack, but you can get spotting or bleeding in the days of tablet-taking.

or

 Stop taking tablets from the pack, which you use at the moment. Do not take tablets 7 days (count and the day that you missed tablet) and continue with the next pack. When you follow this method you can start the next pack on the same day of the week as usual.

  If the package you are left forgotten tablet and do not get. Expected bleeding 7 day period does not take tablets, you may be pregnant: Ask your doctor before you start the next pack.

WHAT TO DO IF ...

... suffer from gastrointestinal disorders (eg vomiting, severe diarrhea)

If you vomit or have severe diarrhea, medicinal substances on your tablet Femoden may not be completely absorbed. If you vomit within 3 to 4 hours after taking the tablet is equivalent to passing a tablet. Follow the advice for missed tablets. If you have severe diarrhea, ask your doctor.

... If you want to delay your period

You can delay your period if you start as new packaging Femoden without rest. You can continue to take until you finish the pack. When you want to start bleeding, stop taking. When using the second pack marking may have bleeding or spotting while taking the pill. Start the next pack after the usual 7 day break

.

... want to change the starting day of bleeding

If you take the tablets as recommended bleeding will start on the same day every 4 weeks. If you want to change, shorten the time during which not to take tablets (never Extension). Eg. If you bleed usually starts on Friday, and you want to start on Tuesday (3 days earlier) should start the next pack 3 days sooner. If you shorten a long time without tablets (3 days or less) may not have bleeding at the end of the period. You can get marking bleeding or spotting during the use of the next pack.

... get unexpected

When using any pill can have irregular vaginal bleeding (spotting or breakthrough bleeding) between regular menstrual bleeding. You may need to use bandages. Continue normal tablet. This irregular bleeding stops when your body adjust (usually after using 3 packs). If bleeding continues or is heavy or starts again, contact your doctor.

... skip menstruation

If you take all tablets at the usual time, you are vomiting or have severe diarrhea and did not use other drugs, it is unlikely that you are pregnant. Continue using Femoden as usual.

If you miss your period twice in a row you may be pregnant. Inform your doctor immediately. Do not start the next pack Femoden unless your doctor rule out pregnancy.

Adverse Reactions

Like all medicines, Femoden can have side effects. Tell your doctor if you notice any side effects, especially if severe or persistent, or if there is a change in your health, you consider that due to the pill.

Serious side effects

serious side effects associated with the pill upotreoata as related symptoms, are described in the section "The Pill and thrombosis / The Pill and cancer." Please read these sections for more information and consult your doctor when necessary.

Other possible side effects

Reported adverse reactions following the use of the pill, are not necessarily caused by it. They can occur in the first few months of use, and usually decrease with time.

 If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

Combined pills have other beneficial health effects than contraception.

  your periods may be lighter and shorter. In such cases, the risk of anemia is less. Menstrual pain may lessen or completely disappear.

  It is also reported that some serious diseases occur more frequently in women taking pills containing 50 micrograms ethinyl estradiol (low dose pills). These are benign breast disease, ovarian cysts, pelvic infections (pelvic inflammatory disease or PID), ectopic pregnancy (pregnancy in which the embryo implants outside the uterus and cancer of the endometrium (the inner lining layer of the uterus) and ovarian . Such action is likely true for tablets low concentrations, but not yet confirmed for endometrial and ovarian cancer.

Keep out of reach of children.

Do not use after the expiry date stated on the packaging.

staff
 
Medicinal substances are ethinylestradiol (0.03 mg) and gestodene (0.075 mg).
 
Excipients: lactose monohydrate, corn starch, providon 25000, sodium edetate calcium, magnesium stearate, sucrose, povidone 700,000, macrogol 6000, calcium carbonate, talc, wax montaglikolov.