Edelsin ®

Please read this leaflet carefully before taking this medicine.

– Keep this leaflet. You may have to read it again.

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

– This medicine has been prescribed for you personally and not pass it on to others. Yours, even if their symptoms are the same as yours.

In this leaflet:

1. What is Edelsin tablets and what it is used

2. Before taking tablets Edelsin

3. As tablets take Edelsin

4. Possible side effects

5. Conservation tablets Edelsin

Each tablet contains Edelsin 250 micrograms norgestimato and 35 micrograms etinil-estradiol as active.

The other ingredients (excipients) its: anhydrous lactose, estearato magnésico, pregelatinized starch and indigo carmine (E132).

Authorisation Holder Marketing:

EFFIK, SA. Antonio de Cabezon, 27 28034 Madrid

Responsible for manufacturing: Quality Assistant Technopark de Thudinie, 1

B 6536 Dostiennes (Belgium)

1. EDELSIN WHAT IS AND WHAT IT IS USED

Edelsin tablets belong to the group of hormonal. It comes in blister 21 blue tablets, round. Each box contains: 1 the blister 21 the tablets 3 blisters de 21 tablets.

Edelsin is indicated as an oral contraceptive female.

2. BEFORE YOU TAKE Cilest

Do NOT take Edelsin:

– If you have or have had a venous thrombosis: DVT (blood clots in the veins), pulmonary embolism (blood clots in the vessels of the lungs).

– If you have or have had an arterial thrombosis (blood clots in the arteries, eg, stroke, myocardial infarction) or situations that may indicate risk for dementia.

– If you have or have a history of deep vein thrombophlebitis or thromboembolic disorders.

– If you suffer from cerebral vascular disease oo heart arteries.

– If you have been diagnosed with diabetes with vascular involvement.

– If suffers hyperhomocysteinemia and antibodies to the body's own substance (phospholipids).

– If you suffer from migraine with aura.

– If you have or have a history of severe liver disease, while the liver function values ​​have not returned to normal.

– If you have any type of liver tumor (malignant or benign).

– If you have conditions known or suspected malignancies of the genital organs or the breasts

(Breast cancer), if sex steroid-dependent.

– If you are pregnant. or think you might be.

– If you have unexplained vaginal bleeding.

– If you have high blood pressure (Persistent systolic of ≥ figures 160 persistent or numbers ≥ 100 mmHg diastolic).

– If you have hypersensitivity to any component of this medication.

– If you have endometrial hyperplasia

Take special care with Edelsin:

If some of the risk situations mentioned below are present, Your doctor should assess the benefits of using Edelsin against the possible risks, and discuss them with you before you decide to start using. Tell your doctor if you have or have had any of the situations described below. Similarly, If any of these situations is introduced, worsens or worsens, debe contactar con su médico lo antes posible, who will decide whether to discontinue using Edelsin.

• Circulatory disorders:

The use of any combined oral contraceptive carries an increased risk of thrombosis compared with non-use, however, this risk is lower than that associated with pregnancy.

Symptoms of venous or arterial thrombosis may be: unilateral leg pain and / or swelling, sudden severe chest pain, which can be extended or not the left arm, sudden breathlessness, sudden coughing, Prolonged headache, severe or unusual, complete loss of vision or partial, double vision, speech problems, vertigo, collapse with or without focal crisis, weakness or very marked numbness suddenly affecting one side or a body part, impaired mobility, acute abdominal pain .

The risk of venous thrombosis increases with:

- Age

- Family history of thrombosis. If there is hereditary predisposition, Call your doctor for advice before you decide to use a hormonal contraceptive.

- Obesity (body mass index greater than 30 kg/m2).

- Prolonged immobilization, major surgery, any surgery or major trauma legs.

- Inflammation of the veins and varicose veins.

The risk of arterial thrombosis increases with:

- Age

- Family history of thrombosis. If there is hereditary predisposition, Call your doctor for advice before you decide to use a hormonal contraceptive.

- Snuff (the risk increases with age and the number of cigarettes smoked, especially in women over 35 años).

- Alteration of lipids and proteins in blood

- Obesity (body mass index greater than 30 kg/m2)

- Cardiovascular disorders or hereditary predisposition to suffer them

- High blood pressure

- AF (Heart rhythm disturbance).

It should be noted, increased risk of thromboembolism in the postpartum (see section How to take for information on "Pregnancy and Lactation").

An increase in the frequency or intensity of migraines while using contraceptives (which may be prior to cerebrovascular disease) may be grounds for immediate discontinuation of these.

Certain biochemical alterations in the blood may predispose to venous or arterial thrombosis . Consult your doctor.

• Tumores:

- Breast cancer and cervical cancer: according to data from epidemiological studies may be a slightly increased risk of suffering.

- Benign liver tumors (reported rarely) and malignant liver tumors (rarely reported)

• Other conditions:

- Triglycerides (cholesterol) or a family history of this disorder, it may increase the risk of pancreatitis using contraceptives.

- High blood pressure

- Yellowing of the skin) and / or itching associated with difficulty in the release of bile.

- Formation of gallstones

- Porphyria (can cause irregularities in the formation of red blood cells, hypersensitivity to sunlight and severe skin pigmentation)

- Lupus erythematosus (serious disorder of connective tissue)

- HUS (characterized by impaired renal function, anemia, Voucher decrease, alteration of the blood coagulation and nervous system).

- Core Sydenham (neuromuscular)

- Herpes of pregnancy (dermatitis)

- Acute or chronic disturbances of liver function

- Ossification of the bones of the middle ear (otosclerosis)

- Crohn's disease (inflammatory bowel disease) and ulcerative colitis

- Brown spots on the skin (cloasma)

− diabetes: although contraceptives may have an effect on peripheral insulin resistance and glucose tolerance, no evidence of the need to change treatment regimens in diabetic women using contraceptives. Nevertheless, if you have diabetes should use caution while using contraceptives.

Also, note that before taking Edelsin:

- Oral contraceptives do not protect against HIV infection (PAGE) or other sexually transmitted diseases.

- The risk of breast cancer increases as age increases and slightly during treatment with oral contraceptives.

- During treatment with oral contraceptives should perform regular health checks. The frequency of examinations depends whether or not birth control can affect the evolution of disease.

- It has been observed that some women may develop brown spots (cloasma), particularly if they already appeared in previous pregnancies. The risk of brown staining increases with sun exposure.

- When taking Edelsin and becomes a blood or urine can alter some of the laboratory analytical values (eg: biochemical parameters of liver, thyroid, renal and adrenal, plasma proteins, ect).

- Before prescribing tablets Edelsin, your doctor has to perform some checks, including a pelvic exam to rule out pregnancy. Sometimes your doctor will perform a scan of the breasts and monitor your blood pressure. It is important that your doctor knows your medical history prior, general and gynecological and any irregularity in menstruation.

- The effectiveness of contraceptives may decrease forget taking the tablets (see section Taking Edelsin) or joint use of medication (see section Taking other medicines).

- If using preparations containing St. John's wort there is a risk of reduced clinical effects of Edelsin (see section Taking other medicines).

- With all contraceptives may appear irregular bleeding (spotting or breakthrough bleeding), especially during the first months of use, and withdrawal bleeding during the period without taking the tablet (see section Taking Edelsin), if you have taken the tablets following the steps in 3. Taking Edelsin, decreases the risk of pregnancy.

Pregnancy

Consult your doctor or pharmacist before taking any medicine. Edelsin is contraindicated during pregnancy.

Breastfeeding

Consult your doctor or pharmacist before taking any medicine.

Breastfeeding can be affected by the use of oral contraceptives and that could reduce the amount and change the composition of milk.

Edelsin or other combined hormonal contraceptives should not be taken during breastfeeding, unless your doctor prescribes; must use other forms of contraception until the child stops sucking.

Driving and using machines

Edelsin has shown no effect on the ability to drive or operate hazardous machinery.

Important information about some of the components Edelsin

This medicine does not contain gluten.

This product contains lactose. If your doctor has told you have an intolerance to some sugars, Consult your doctor before taking this medicine.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, obtained without a prescription.

The use of certain medications can affect the efficacy of Edelsin, or Edelsin treatment may affect the efficacy of these drugs.

Some of the medicines should not be taken with Edelsin are:

– Certain antibiotics (eg.: ampicillin and tetracycline)

– Certain drugs used to combat fungal infections (eg.:

itraconazole, ketoconazole, griseofulvina, etc.)

– Certain antiepileptic (por ejemplo: topiramate, oxacarbamazepina, felbamato, primidona, hidantoínas, phenytoin, carbamacepina)

– Certain drugs used as anti-TB (rifampin). Use a further additional barrier method of contraception during the time of oral administration of rifampicin and during the 28 days after discontinuation.

– Some tranquilizers known as barbiturates.

– Certain antidepressants (eg.: the fluoxetine fluvaxamina)

– Certain medications that are metabolized by glucuronic acid conjugation (lamotrigina).

– Certain medications that increase intestinal motility ( metoclopramide)

– Activated carbon (influences the absorption of contraceptive steroids)

– An anti-inflammatory drug (phenylbutazone)

– An anti-AIDS drug (ritonavir)

– A herbal remedy containing Hypericum perforatum (St. John's wort), since use with this preparation could cause the loss of the effect of oral contraceptives and lead to bleeding or unwanted pregnancies. If you are already using a preparation of Hypericum perforatum (St. John's wort) should quit.

3. TAKING EDELSIN

Follow these instructions unless your doctor has given you different instructions. Remember to take your medicine.

Your doctor will prescribe the duration of treatment Edelsin. Do not stop treatment because they could become pregnant.

It is advisable to take the tablets Edelsin always at the same time, for example at bedtime.

First treatment cycle: One tablet once a day, during 21 consecutive days beginning the first day of the menstrual cycle.

Continuous treatment: After taking the 21 tablets from a blister, will begin a rest period 7 days. During this period, between days 2 a,en 4 after making ddaysúltima, begins bleeding similar to menstruation. Regardless of whether or not bleeding, should begin a new treatment 21Day, after pause 7 days.

When for some reason wants to delayed menstruation: Once all the tablets have been taken from one blister, will start a new one for the days you want to delay menstruation. Later, will rest for 7 days, and continue with a new blister 21 tablets, to start a new day.

Hemorragia intermenstrual: Treatment should be continued although bleeding or spotting appears. This type of bleeding off after the first three treatment cycles. If the bleeding persists you should consult a health professional.

Forgetfulness of a tablet: if they spend less than 12 hours without taking the tablet, not decrease contraceptive protection. The woman should take the tablet as soon as you remember and keep taking the tablets as did other commonly.

If the time elapsed from the time I should have taken the tablet is greater than 12 hours contraceptive protection may be diminished. For the proper handling of forgetting taking tablets you can follow the following two basic rules:

1. taking the tablet never be interrupted for more than 7 days.

2. To achieve adequate contraceptive efficacy is needed for taking the tablet 7 days continuously.

Therefore, recommended that if forgetting occurs in:

• Semana 1

The user should take the last missed tablet as soon as you remember, even if it means taking two tablets at once. Then continue taking the tablets as usual. further, you should use a barrier method during the 7 days, por ejemplo: condom. If you had sex in 7 days prior, should take into account the possibility of pregnancy. The more tablets are forgotten and the closer the usual bye, the greater the risk of pregnancy.

• Semana 2

The user should take the missed tablet as soon as remembered, even if it means taking two tablets at once. Then continue to take the other tablets in the usual way. In the event that have taken the tablets correctly in 7 days before the first tablet you missed, no need to use an additional contraceptive method. Nevertheless, if this is not the case, or has forgotten more than one tablet, must warn the client about the need for additional contraceptive precautions during 7 days.

• Semana 3

The risk of reduced reliability is imminent, due to the proximity of the week however descanso.Sin, by adjusting the timing of taking the tablet can still prevent a decline in contraceptive protection. By following any of the following two options, no need to use additional contraceptive precautions, provided the client has taken all tablets correctly in the 7 days before missing the first tablet. If this is not the case, should warn the user to use the first of the two options given below and use additional contraceptive precautions for the next 7 days.

1. The user should take the last missed tablet as soon as remembered, even if it means taking two tablets at once. Después, can continue to take the other tablets in the usual way. You should start the next pack as you finish the current, ie, there should be a rest period between packages. It is unlikely that the user have a withdrawal bleed until the end of the second container, but may have spotting or breakthrough bleeding during the days that you are taking the tablet.

2. You should also warn the user discontinue taking the tablet from the current pack. You must have an interval of time without taking the tablet up 7 days, including the days when you forget to take tablets, and then continues with the next pack.

If women forget to take a tablet and then has no withdrawal bleed in the next week off, should consider the possibility of pregnancy.

Replacement of other hormonal contraceptive Edelsin (por ejemplo: transdermal contraceptive method, vaginal contraceptive ring, injectable, ect.): To change treatment from an oral contraceptive combination therapy Edelsin, shall begin the first day after taking the last tablet of the previous treatment, and no later than the first day after the rest period 7 days.

When the previous treatment was progestin oral tablets, Edelsinse treatment should start the first day after leaving the progestogen.

Postpartum Management: If you choose not to breastfeed, initiate treatment with Edelsin the first day of the first spontaneous menstruation or three weeks after delivery, according to whichever comes first.

Administration after an abortion: You can start your treatment with oral contraceptives immediately after an abortion or miscarriage when it occurs before week 20 gestation. No need to use an additional contraceptive method. Ovulation can occur at the 10 days of an abortion or miscarriage.

Should abortion or miscarriage at or after week 20 gestation, can start using hormonal contraceptives on 21 following abortion or the first day of the next spontaneous menses, according to whichever comes first. During the first 7 days of the first cycle of treatment with Edelsin be used simultaneously a non-hormonal contraceptive.

Control treatment:

Before prescribing Edelsin, Your doctor will perform a thorough clinical history along with a pelvic exam where the possibility of pregnancy is excluded and blood pressure control.

further, will investigate changes in menstruation, such as total absence or loss of any of them. The frequency of medical examinations depends on individual factors. If one considers that the treatment can influence latent or overt disease, the frequency of examinations should be adapted taking into account this factor.

If there has been no menstruation for two consecutive cycles, should take into account the possibility of pregnancy. After the treatment, can cause a lack of menstruation for short or long periods.

You should use an additional contraceptive method, nonhormonal, during 7 days without interruption (until they have taken 7 tablets), during treatment with activated carbon, or if vomiting occurs during 3 hours after taking the pill or severe diarrhea persist for more than 24 hours, as contraceptive effectiveness may not be adequate.

If you take more than you should Edelsin

If you take more than you should Edelsin vomiting may occur, nausea and vaginal bleeding in young women.

If you have taken more than Edelsin should immediately consult your doctor or pharmacist.

In case of overdose or accidental ingestion consult the Toxicology Information Service

(Telephone: 91 5620420)

If you miss Edelsin:

If you forget to take a tablet, be taken without fail as soon as possible, taking the next tablet at the usual hour the next day. If the elapsed time from the moment the tablet should be taken is higher than 12 hours, can not make sure the effect of contraceptive protection, that must be used additional methods of protection for a week. (For more information see section 3. How to take edelsin: Forgetfulness of a tablet).

4. Possible adverse effects

Like all medicines can cause side effects Edelsin.

The following are common side effects: fluid retention, weight change, depression, mood swings, migraine, swelling, abdominal cramps, edema, acne, rash, Breast tension, hemorragia intermenstrual, stained, Missing periods, inflammation of the vagina.

Adverse effects are rare: slight increase in blood pressure, hypertension, milky fluid loss through nipples, pain or breast enlargement, nausea, vomiting, colitis, Hair loss, increased hairiness, skin spots, irritability, changes in libido, appetite changes.

Are rare adverse effects following: myocardial infarction, venous thromboembolism, skin disorders (erythema nodosum, erythema multiforme), cervical cancer, Breast cancer.

Adverse reactions that have been associated with hormonal contraceptive use are: stroke (bleeding, thrombosis), blood clots in the arteries, myocardial infarction, hypertension, benign liver tumors, malignant liver tumors, intrahepatic cholestasis (difficulty in release from liver bile), formation of gallstones, cholestatic jaundice (yellowing of the skin associated with difficulty in the release of bile), Budd-Chiari (Hepatic vein thrombosis), absence of withdrawal bleeding, change in menstrual flow, increased muscle mass of the uterus, increased surface damage and cervical secretion, temporary infertility after discontinuation, premenstrual syndrome, decreased milk, increased secretion

Skin fat, excessive hair growth, skin vesicles, Hemorrhagic rash, change the curvature of the cornea, intolerance to contact lenses, cataracts, neuro-ocular lesions, uncontrolled movements, severe headache, reduction of glucose tolerance, renal function impairment, Hemolytic uremic syndrome (characterized by impaired renal function, anemia, Voucher decrease, alteration of the blood coagulation and nervous system).

During post-marketing experience to date have not been reported other adverse drug reactions in addition to those identified in this document.

If you notice any other effects not listed in this leaflet, check with your doctor or pharmacist.

5. EDELSIN STORE

No conservar a temperatura superior a 25 º C.

Edelsin Keep out of reach and sight of children.

Expiry

Edelsin not use after the expiration date on the box.

This leaflet was approved in: May 2005

Price

Edelsin is a drug excluded from Social Security (EXO) but is subject to fixed prices established in the Ministry. Due to the continuous variations is currently undergoing the pharmacy channel shows the most reliable reference prices:

Edelsin 21 tablets – Price Range: 13-15 EUR

Edelsin 3×21 tablets – Price Range: 26-28 EUR

4 Comments

  1. yolanda
  2. Maritza,,en,What if I just take,,es,días de edelsin,,fi,what I happened esq I forgot to take the last two days before the break and not know if that has any negative effect on their effectiveness,,es
  3. JoJo,,en,Has anyone gained weight from this pill,,en

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