Belara diario

Please read this leaflet carefully before taking this medicine.

– Keep this leaflet, You may need to read it again.

– If you have any questions, Consult your doctor or pharmacist.

– This medicine has been prescribed for you Do not pass it on to others, even if their symptoms, as yours.

– If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

1. BELARA DAILY WHAT AND WHAT IT IS USED

Belara journal is a hormonal contraceptive that is taken orally. If this type of oral contraceptives contain two hormones daily Belara, also called “Combined oral contraceptives” (AOC). The,es 21 active tablets pale pink container for a cycle containing the same amount of both hormones, therefore also called daily Belara “preparation phase”.

The daily oral contraceptives Belara not protect you against AIDS (HIV infection) or other sexually transmitted diseases. Only condoms can help it.

2. BEFORE TAKING DAILY BELARA

Before you start taking daily Belara, Your doctor will do a general recognition and a gynecological examination, discard the existence of pregnancy and, considering the contraindications and precautions, Belara decide whether it is appropriate for you daily. These medical examinations should be held annually while taking daily Belara.

Do not take daily Belara

– if allergic (hypersensitive) to the active ethinylestradiol or chlormadinone acetate or any of the other components of daily Belara;

– if you have or have had blood clots in the veins or arteries (p. not., DVT, pulmonary embolism, myocardial infarction, stroke;

– if you have early symptoms of thrombosis, vein inflammation or embolism, such as the appearance of a short sharp pain, chest pain or tightness;

  • if you are forced to remain immobilized for a long time (p. not., stay

prolonged bed rest or cast) or will undergo an operation (stop taking at least daily Belara 4 weeks before the date set for operation);

– if you have diabetes and presents significant fluctuations in blood sugar level or have an abnormal blood vessels;

– if you have high blood pressure difficult to control or significantly increasing (values ​​consistently exceeding 140/90 mm Hg);

– if you have blood clotting disorders (por ejemplo, protein C deficiency);

– if you have liver inflammation (p. not., due to a virus) or jaundice, provided that their liver values ​​have not returned to normal;

– if you have generalized itching or alterations in bile flow and especially during a previous pregnancy or during estrogen treatment;

– si su bilirrubina (breakdown product of blood pigment) blood is increased, for example by altering the excretion congenital (Dubin-Johnson syndrome or Rotor syndrome);

– if you have or have had in the past a liver tumor;

– if you have severe stomach pain, enlarged liver or signs of bleeding in the abdomen;

– if you have porphyria (altered blood pigment metabolism), whether or not the first time;

– if you have ever had or were suspected of having a malignant tumor that depends on the action of hormones, p. not., breast cancer or uterine cancer;

– if you have severe disorders of lipid metabolism;

– you padece pancreatitis (inflammation of the pancreas) or history thereof, if associated with severe hypertriglyceridemia (very high levels of blood triglycerides);

– if you have migraine for the first time;

– if you have unusually severe headache episodes, frequent or persistent;

– if you have or have had migraine accompanied by alterations in sensitivity, in the perception and / or movements (Migraine accompanied);

– if you have sudden changes of perception (sight or hearing);

– if you have movement disorders (including signs of paralysis);

– if you notice worsening seizures;

– if you have severe depression;

– if you have certain types of deafness (otosclerosis) which worsened during previous pregnancies;

– if you have had missed periods (rule) unknown cause;

– if presents an abnormal thickening of the mucous membranes (singular) uterus

(endometrial hyperplasia);

– if for some reason, unexplained vaginal bleeding occurs.

Stop taking daily Belara immediately if one of these disorders during the administration of daily Belara.

You should not take daily Belara or should stop taking it immediately if you have a serious risk factor or multiple risk factors for venous or arterial thrombosis (see "Take special care with daily Belara").

Take special care with daily Belara

– You smoke, and snuff increases the risk of serious side effects to the heart and blood vessels using combined oral contraceptives. This risk increases with age and snuff consumption. Smoking affects especially women over 35 años. Women smoked more than 35 years should use other contraceptive methods.

– If you have hypertension, blood lipid levels were abnormally elevated, overweight or diabetes (see also section "Do not take Belara daily" and "Take special care with daily Belara", “Other diseases”). In this case increases the risk of serious side effects associated with combined oral contraceptives (such as myocardial infarction, embolism, stroke or liver tumors).

– Consult your doctor immediately if any of the following affects risk factors, or appear or worsen during administration of daily Belara. He will tell you whether you should continue taking daily Belara or whether to stop treatment.

Thromboembolism and other vascular diseases

There is an increased risk of arterial disease and venous thrombosis with use of oral contraceptives. This could lead to myocardial infarction, stroke, Deep vein thrombosis and pulmonary embolism. Nevertheless, its incidence is very low during treatment with oral contraceptives.

The risk of vascular obstruction (thromboembolism) is increased by taking combined oral contraceptives (AOC) compared with no use of them. The increased risk is higher during the first year of use of COCs. This increased risk with COCs is less than the risk of thromboembolism associated with pregnancy, estimated at 60 cases per 100.000 pregnancies. Venous thromboembolism is fatal in 1-2% cases.

It is unknown whether daily Belara affects the risk of venous thromboembolism compared with other COCs.

Consult your doctor promptly if you notice symptoms of thrombosis or pulmonary embolism, that can be:

– pain and / or swelling of arms and legs

– intense sudden pain in the chest that may radiate to the left arm or not

– sudden shortness of breath, sudden unexplained cough

– headache and severe unexpected long lasting

– partial or total loss of vision, double vision, difficulty speaking or finding words

– dizziness, collapse (sometimes with epileptic seizure)

– sudden weakness or numbness on one side of the body

– movement disorders

– sudden, excruciating pain in the belly.

If you notice an increase in the frequency or intensity of migraine attacks during the administration of daily Belara (that may indicate an alteration of the blood supply to the brain), as soon as possible see your doctor, who may advise you to stop taking daily immediately Belara.

The risk of vascular obstruction to the following factors increases:

– age

– smoking

– family history of vascular obstruction (p. not., siblings or parents suffered thrombosis being young). If this is the case, your doctor may refer you to a specialist (p. not., to check their blood clotting), before you start taking daily Belara

– significantly overweight, ie, body mass index greater than 30 kg/m2

– alteration abnormal blood fats and proteins (dislipoproteinemia)

– Hypertension

– valvulopathy

– heart rhythm disturbances (atrial fibrillation)

– long periods of immobilization, major surgery, leg surgery or serious injury. In these cases you should promptly consult your doctor, who may advise you to stop taking Belara daily for at least four weeks before surgery and tell you when you can take it again (it is generally recommend two weeks after standing up)

– other related diseases such as diabetes blood circulation, lupus erythematosus

systemic (immune system disease), Hemolytic uremic syndrome (blood disease that causes kidney damage), Crohn's disease or ulcerative colitis (chronic intestinal inflammation) and sickle cell anemia. Proper treatment of these diseases can reduce

the risk of arterial or venous thrombosis.

Cancer

Some studies have found a risk factor for cervical cancer (cervix) in women infected with a sexually transmitted virus (human papilloma virus) and have been taking the pills for a long time. Nevertheless, it is unclear to what extent these results may be due to other factors (p. not., multiple sexual partners, use of barrier methods).

Studies have shown a slightly increased risk of breast cancer in women taking COCs. Over a period of 10 years after stopping COC use, this increased risk is gradually returned to the risk of age-related basis. Since breast cancer is rare in women under 40 años, the number of over-diagnosis of breast cancer in users of current and recent COC is small relative to the overall risk of breast cancer.

In rare cases have been reported cases of benign liver tumors and even more rarely malignant with oral contraceptives. These can cause dangerous internal bleeding. If you have severe abdominal pain in the stomach that does not subside spontaneously, should consult your doctor.

Other diseases

Many users experience a slight increase in blood pressure while using oral contraceptives. If blood pressure rises significantly when taking daily Belara should consult your doctor who will advise discontinuation of treatment and prescribe medication to lower blood pressure. Using daily Belara can resume once the blood pressure returns to normal.

If you have had herpes gestationis in a previous pregnancy, it may recur during oral contraceptive use.

If you suffer from blood lipid levels in hypertriglyceridemia) or a family history, there is an increased risk of inflammation of the pancreas. In case of acute or chronic disturbances of liver function, your doctor may advise you to stop taking Belara daily until the values ​​of liver function return to normal. If you have had jaundice during a previous pregnancy or during oral contraceptive use, and it reappears, Your doctor will advise you to stop taking daily Belara.

If you are diabetic and blood sugar level is controlled and takes daily Belara, Your doctor will closely monitor daily while taking Belara. May need to modify their treatment for diabetes.

Rarely can appear brown spots on the skin (cloasma), especially if it appeared in a previous pregnancy. If you know who is predisposed to it, should avoid long periods of exposure to sunlight or ultraviolet radiation when taking daily Belara.

Diseases that can negatively affect

You also need special medical supervision if you have

– epilepsy;

– multiple sclerosis;

– severe muscle cramps (tetania);

– migraine (see also "Do not take Belara newspaper);

– suspended;

– heart or kidney disease (see also "Do not take Belara newspaper);

– baile de San Vito (chorea minor);

– diabetes (see also section "Do not take Belara daily" and "Take special care with daily Belara", “Other diseases”);

– liver disease (see also "Do not take Belara newspaper);

– lipid metabolism (see also "Do not take Belara newspaper);

– immune system diseases (including systemic lupus erythematosus);

– excessive overweight;

– Hypertension (see also "Do not take Belara newspaper);

– endometriosis (the lining of the uterine cavity, called the endometrium, is out of the coating layer) (see also "Do not take Belara newspaper);

– swelling of varicose veins (see also "Do not take Belara newspaper);

– blood coagulation disorders (see also "Do not take Belara newspaper);

– breast disease (mastopatía);

– benign (myomas) in utero;

– blisters (herpes gestationis) in a previous pregnancy;

– depression (see also "Do not take Belara newspaper);

– chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis).

Consult your doctor if you have, or had, any of the conditions mentioned or if it occurs during the administration of daily Belara.

Effectiveness

If you do not take regular birth control, vomiting or diarrhea after administration (see "If you stop taking daily Belara") or take other drugs simultaneously (see "Taking other medicines"), the effectiveness of contraception may be affected. In very rare metabolic disorders affect contraceptive efficacy.

Even taking oral contraceptives correctly, not fully guarantee that it can not become pregnant.

Irregular bleeding

Particularly in the first few months of oral contraceptive use, may appear irregular vaginal bleeding (bleeding bleeding by disruption / stained). If bleeding continues for 3 months, or recurs after several consecutive cycles, ask your doctor.

Spotting (spotting) signal can also be reduced contraceptive effect. In these cases, may not appear withdrawal bleeding after taking Belara daily for 21 days. If you have taken Belara daily, as described below in section 3, this is

unlikely to be pregnant. If you have not taken daily following the instructions Belara, before the first absence of withdrawal bleeding, pregnancy should be ruled out before continuing to use.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken other drugs, even those not prescribed.

The contraceptive effect of daily Belara can affect if you take other substances active at the same time. These include drugs for the treatment of epilepsy, (as carbamazepine, phenytoin, and topiramate), medicines for the treatment of tuberculosis (por ejemplo, rifampin, rifabutina), certain antibiotics, as ampicillin, tetracyclines and griseofulvin, barbiturates, barbexaclona, primidona, modafinilo, certain drugs for the treatment of HIV infection (p. not. ritonavir) and preparations containing St John's Wort (Hypericum perforatum). The drugs that stimulate intestinal movement (por ejemplo, metoclopramide) and activated carbon can affect the absorption of active substances daily Belara.

You should not take herbal remedies containing St John's Wort along with daily Belara.

If you are taking or start taking a medicine containing a substance of the above

mentioned (except St. John's Wort), can continue to take daily Belara. During treatment with these agents should use additional barrier methods (por ejemplo, condoms). If you take these medicines, must also use a barrier method for at least 7 a,en 28 days after stopping treatment. If necessary, the long-term treatment with the active substances mentioned above, must use non-hormonal contraceptive methods. Consult your doctor or pharmacist.

If co-administration of medication is continued until after completion of active tablets blister AOC, must start the next pack of COCs without the usual interval of placebo tablets.

Tell your doctor if you take insulin or other drugs to lower blood sugar. It may be necessary to change the dose of these medicines.

When using oral contraceptives, excretion of diazepam, cyclosporine, theophylline or prednisolone can be reduced, what causes these substances have a greater and longer lasting. The effect of preparations containing clofibrate, paracetamol, morphine or lorazepam can be reduced if taken at the same time.

Please note that the above details also apply if you have taken any of these drugs shortly before starting daily administration Belara.

The use of daily Belara may affect some laboratory tests, such as liver function tests, adrenal and thyroid, plasma concentrations of certain proteins, the parameters of carbohydrate metabolism and coagulation. Therefore, before undergoing a blood test, tell your doctor that you are taking daily Belara.

Pregnancy and lactation

Belara daily is not indicated during pregnancy. If you become pregnant while taking daily Belara, should stop taking it immediately. Nevertheless, prior use of daily Belara not justify termination of pregnancy.

If you take daily Belara, Remember that milk production may decrease and their quality may be affected. Very small amounts of active ingredients pass into breast milk. The daily oral contraceptives Belara should only be used once it has finished breast-feeding.

Driving and using machines

There are no known negative effect of combined oral contraceptive use on the ability to drive and use machines.

Important information about some of the components daily Belara

Lactose daily Belara. If your doctor has told you have an intolerance to some sugars, Consult your doctor before taking this medicine.

3. HOW TO TAKE DAILY BELARA

Always follow dosing instructions for daily Belara provided by your doctor. Consult your doctor or pharmacist if.

The blisters of each package are designed to help you remember to take tablets. Each blister contains 28 tablets: 21 comprimidos activos de color rosa pálido en la zona blanca (tablets 1-21) and 7 white inactive tablets in the red zone (tablets 22-28).

Management Mode

Take orally.

How and when should take daily Belara

Remove the first pink active tablet position in the container which indicates cycle "start" and swallow without chewing. Take:

• a pink active tablet daily in the direction of the arrow in 21 days and then

• a white inactive tablet daily in the direction of the arrow in 7 days.

If possible, take the tablet at the same time of day, preferably at night. If possible, the interval between taking two tablets must always be 24 hours. When you start taking daily Belara should mark the day of the week on the packaging cycle. The numbers printed on the packaging of the cycle correspond to the day of the week they started taking (día 1), allowing you to determine the day of the week for each number printed on the packaging cycle and check every day if you have already taken the tablet for that day.

Normally, withdrawal bleeding, equivalent to the menstrual period, start 2-4 days after taking the last active tablet pink. After completing the 28 tablets, Keep taking the tablets the next pack daily cycle Belara, has ceased or no bleeding.

¿When can you start taking daily Belara ?

If you have not previously taken any hormonal contraceptive (during the last period) Take your first pink active tablet daily for Belara the first day of your next menstrual cycle.

Contraception begins on the first day of administration and continued during the interval of seven days with inactive tablets.

It is about time he comenzado ya, take the first pink active tablet on 2-5th day of your period,

regardless if the bleeding stopped or not. Nevertheless, In this case you must use additional barrier contraceptive methods during the 7 early days of the administration (standard seven days).

If your period started more than five days, please wait until the next period to start taking daily Belara.

If you have previously taken other combined hormonal contraceptive

Take all the tablets from ancient container according to the usual patterns. Belara should start taking daily the day after the interval with no active or placebo tablet of their normal combined hormonal contraceptive method prior.

If you have taken an oral contraceptive containing only progestogens (“minipíldora”)

If you are taking oral contraceptive progesterone-only (minipíldora) may not have withdrawal bleeding, equivalent to the menstrual period. Take the first active tablet daily Belara pale pink the next day after the last mini pill. In this case,es, should take additional contraceptive measures during the first seven days.

If you have previously used hormonal injections or implants

Take the first active tablet daily Belara pale pink on the day of implant removal or the day that corresponds to the next injection. In this case,es, should take additional contraceptive measures during the first seven days.

If you have suffered a miscarriage or abortion in the first three months of pregnancy

After a miscarriage or abortion can start taking daily immediately Belara. In this case you need to use additional birth control.

If you have recently given birth or have had an abortion or miscarriage between the third and sixth month of pregnancy

If you are not breast-feeding, can start taking daily Belara 21-28 days after delivery. Not have to use additional birth control barrier.

Nevertheless, if more of 28 days after birth, must use additional barrier contraceptive methods during the first seven days.

If you have already had sex, be ruled out that a pregnancy has occurred or wait for the next period before you start taking daily Belara.

Remember not to take daily Belara if you are breast-feeding (see section “Pregnancy and lactation”).

¿How long can take daily Belara ?

Belara can take daily for as long as you want, provided there are no health risks (see section "Do not take Belara daily" and "Take special care with daily Belara"). Once you stop taking daily Belara the beginning of the next cycle may be delayed about a week.

¿What to do if vomiting or diarrhea while taking daily Belara ?

If vomiting or diarrhea appeared during 4 hours after the administration of pink active tablet, the absorption of the active ingredients may be incomplete daily Belara. This situation is similar to have forgotten the pink active tablet and immediately taking a new active compressed light of a new blister pack. If possible, take the new compressed active in 12 hours after taking the last active tablet and keep taking daily Belara following

your regular schedule. If it is not possible or if it has been over 12 hours, follow the instructions in

"If you take more daily Belara that could" or consult your doctor.

If you take more than you should Belara daily

No evidence of severe toxicity symptoms occur after eating a large number of tablets in a dose. Symptoms such as nausea, vomiting, particularly in the case of girls, light vaginal bleeding. En this case see al doctor. If necessary, He will control electrolyte and fluid balance, and liver function.

If you forget to take daily Belara

The white tablets blister red zone (tablets 22-28) are inactive placebo tablets. If you miss one of these tablets, have no effect on the reliability of daily Belara. Should discard the inactive tablet forgot not to lengthen the period of placebo, as this could have a negative effect on the reliability of daily Belara.

Yes forget to take one tablet active pink white area of ​​blister (tablets 1-21) should follow the following instructions:

• Si have not passed 12 hours since he should have taken the tablet, the effect is not reduced daily Belara. Take the tablet as soon as you have noticed and then take these tablets following their usual pattern. In this case no other contraception is needed.

• If more than 12 hours, does not guarantee the contraceptive effect of daily Belara. In this case,es, immediately take the pink active tablet missed dose and continue taking daily Belara following his usual pattern. This may even mean that you should take 2 pink active tablets at a time. In this case,es, should use additional birth control methods (por ejemplo, condoms) Over the next seven days. If the current package contains less than seven active pink tablets, must begin with the next pack of daily Belara, as soon as you finish the pink active tablets of current packaging, ie, that there should be an interval between packages placebo tablets. Probably not appear withdrawal bleeding (menstrual period) until you have exhausted the next pack. However, may increase breakthrough bleeding or spotting while taking the tablets of the new packaging. The more active tablets have forgotten, the greater the risk of contraceptive protection is diminished. If you have missed one or more active tablets during the week 1 and has had sex in the previous week to forget, should take into account that there is a risk of pregnancy. The same applies to the case you have forgotten one or more active tablets and no menstruation for the next period of placebo tablets. In these cases, ask your doctor.

If you want to delay menstrual period

Although not recommended, can delay your period (withdrawal bleeding) beginning to take active tablet of a new daily strip Belara, rather than the period of placebo tablets, to complete the strip segundia. May appear stained (drops or spotting) or breakthrough bleeding while using this second strip. After the usual period of placebo tablets 7 days, continue with the first active tablet the next strip.

Before you decide to delay your period, ask your doctor.

If you want to change the first day of menstrual period

If you are taking the tablets as directed, then your period / withdrawal bleed during the period begin making tablets placabo. To change this day, shortening can do (ever widening) the period of placebo tablets. Por ejemplo, If your period begins placebo tablets on a Friday, and want to change it to Tuesday (3 days before), should start taking the first tablet of a new test active 3 days earlier than usual. If extremely short period of placebo tablets (por ejemplo, 3 days or less), then it may not have bleeding during the tablet-free period. May appear stained (drops or spotting) or bleeding.

If you are unsure of how to act, ask your doctor.

If you stop taking daily Belara

When you stop taking daily Belara, soon be restored ovarian function completely and can get pregnant.

4.Possible adverse effects

Like all medicines, Belara daily can cause side effects, although not everybody gets them.

The frequency with which adverse effects have been reported are defined as follows:

Very common side effects

It affects more than 1 each 10 patients / persons

Nausea, vaginal discharge, pain during menstruation, amenorrhea, withdrawal bleeding, stained (spotting), headache, breast discomfort.

Common adverse effects

That affects 1 and 10 each 100 patients / persons

Depression, irritability, nervousness, dizziness, migraine (and / or worsening of this), visual disturbances, vomiting, acne, belly pain, fatigue, feeling of heaviness in the legs, water retention, weight gain, hypertension

Uncommon side effects

That affects 1 and 10 each 1.000 patients / persons

Stomach ache, drug hypersensitivity, including allergic skin reactions, bowel sounds, diarrhea, abnormal pigmentation, brown spots on face, hair loss, dry skin, LBP, muscle disorders, galactorrhea, benign tumors of the breast tissues, vaginal yeast infection, decreased libido, increased sweating, alteration of the values ​​of blood lipids, including hipertrigliciridemia.

Rare side effects

That affects 1 and 10 each 10.000 patients / persons

Conjunctivitis, discomfort when wearing contact lenses, deafness, tinnitus, hypertension, hypotension, circulatory collapse, varicose veins, venous thrombosis, urticaria, eczema, skin inflammation, itching, worsening of psoriasis, excess body hair or face, breast enlargement, inflammation of the vagina, longer menstruating and / or heavy, premenstrual syndrome (physical and emotional problems before the onset of menstruation), increased appetite

Very rare side effects

It affects less than 1 each 10.000 patients / persons

Erythema nodosum

Combined oral contraceptives including daily Belara also been associated with an increased risk of the following diseases and serious adverse effects:

– risk of thrombosis of the veins and arteries (see "Take special care with daily Belara"),

– risk of disease of the bile ducts (see "Take special care with daily Belara"),

– risk of tumors (e.g., liver tumors, in isolated cases have caused bleeding in the abdominal cavity threatening, cervical cancer or breast cancer (see "Take special care with daily Belara"),

– worsening of chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis, see "Take special care with daily Belara").

Read the information presented under "Take special care with daily Belara" and if necessary contact your doctor immediately.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

5.BELARA DAILY STORE

No conservar a temperatura superior a 30°C. Keep out of reach and sight of children.

Do not use newspaper Belara after the expiration date on the carton and blister (container

cycle) after "Expiration”. The expiry date is the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6.FURTHER INFORMATION daily Belara

The active ingredients are estradiol and chlormadinone acetate. Each film coated tablet contains pink 0,030 mg of ethinyl estradiol and 2,0 mg chlormadinone.

The white film-coated tablets containing no active ingredients.

– The other ingredients are:

Active film coated tablets pink:

Tablet core: lactose monohydrate, cornstarch, povidone K30, magnesium stearate

Tablet film coating: hipromelosa, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide (E 171), red iron oxide (E 172).

Film-coated tablet white inactive:

Tablet core: lactose monohydrate, povidone K30, crospovidona,, magnesium stearate

Tablet film coating: hipromelosa, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide (E171)

Belara aspect of daily and contents of container

Each blister contains 21 active film coated tablets round pale pink in the white area (tablets 1-21) and 7 film-coated tablets of white placebo, larger, in the red zone (tablets 22-28).

Holder of the authorizing responsible for placing and manfacture

Belara DiarioHolder of the marketing authorization:

Grünenthal, SA. c/ Doctor Zamenhof, 36. 28027 MADRID.

Responsible for manufacturing:

Grünhenthal GmbH, Zieglerstrasse 6, 52078 Aachen, Germany.

For any information regarding this product, please contact the local representative of the marketing authorization.

This product is authorized in the Member States of the EEA under the following names:

Francia Belaracontinu film-coated tablets

Germany Belara 21 + 7 Tablets

Spain newspaper Belara 0,03 mg / 2 mg film-coated tablets

This leaflet was approved in February 2010

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