the package insert of the medicine Siblima. Therapeutic class of Oral Contraceptive. Active principlesEthinyl estradiol and Gestodene. Sale under medical prescription.
When should I not use?
Pregnancy, severe disturbances of liver function; previous history of or current liver tumors, a history of jaundice idiopathic or intense pruritus during pregnancy; syndromes Dubin-Johnson and Rotor; processes thromboembolic or background
(ex.: apoplexy, myocardial infarction); fi have addressed atrial; diabetes, serious vascular; sickle cell anemia; hormone-dependent tumors of the uterus or breast or a suspicion of the same; endometriosis; disorders of lipid metabolism; history of herpes gravid; genital bleeding abnormal cause undetermined, otosclerosis aggravated during pregnancy.
Use during lactation: it Is at the physician’s discretion, the convenience of use of SIBLIMA (gestodene and ethinyl estradiol )during the period of lactation. The oral contraceptives are administered in the postpartum period may interfere with lactation by decreasing the
quantity and quality of milk secreted. Small amounts of the components of hormone are excreted in the milk of lactating women.
How to use?
In the first cycle administer 1 tablet per day, from the first day of bleeding, to take for 24 consecutive days, always at the same time. In the following cycles to observe an interval of 4 days between the last pill of the cycle
the previous and the first pill of the cycle that begins. If it does not occur the bleeding in this range, one should check the car the possibility of pregnancy.
SIBLIMA (gestodene and ethinyl estradiol) is efi ective from 1st day of therapy if the tablets are taken from the 1st day of the cycle, as described. Can occur in isolated cases, bleeding by disruption and “bleeding”, especially during the
the first 3 months of use of SIBLIMA (gestodene and ethinyl estradiol), which usually ceases spontaneously. The patient should, however, continue the treatment with SIBLIMA (gestodene and ethinyl estradiol) in case of irregular bleeding.
If the bleeding persists or use, appropriate diagnosis, it is necessary to exclude organic causes. Should be also investigated the bleeding-irregular when they occur in multiple consecutive cycles, or for the first time after prolonged use of SIBLIMA (gestodene and ethinyl estradiol ) If the patient forget to take a tablet at the usual time, you should take it within 12 hours subsequent. If the missed pill is not taken within
12 hours, the patient should take it as soon as you remember, and the next tablets at the usual time.
in cases where there is elapsed more than 12 hours, contraceptive protection may be reduced in this cycle, and should be employed, in addition, barrier contraceptive methods (for ex.: diaphragm, more spermicide or male condom) until the end of the cycle. Should not be used in the methods of pace (two) and temperature.
In exchange for another oral contraceptive to SIBLIMA (gestodene and ethinyl estradiol) the start of treatment should be made on the first day that you experience bleeding deprivation, after taking the last active tablet of the contraceptive previous. SIBLIMA (gestodene and ethinylestradiol) may be prescribed during the period of post-childbirth or post-miscarriage, as soon as the first menstruation after the normal cycle. SIBLIMA (gestodene and ethinyl estradiol) should not be started before the first normal menstrual cycle pósaborto.
When, for medical reasons, another pregnancy is contraindicated, treatment with SIBLIMA (gestodene and ethinyl estradiol) must be started on day 12 after birth (not before the 7th day or the 5th day after the abortion, at the latest. It should be
consider that the administration of oral contraceptives in the period immediately after childbirth or miscarriage, increases the risk of occurrence of diseases and thromboembolic.
If you are experiencing vomiting or diarrhea within 3 to 4 hours after ingestion of SIBLIMA (gestodene and ethinyl estradiol), the active substances may not have been absorbed properly. However, you should continue the treatment the fi m to avoid bleeding
premature for deprivation, and, in addition, to use a contraceptive method non-hormonal, with the exception of the methods of pace (table), and temperature, up to the end of the cycle. If the gastrointestinal dysfunction is prolonged, you should consider switching to another method of contraception.
What are the evils that can cause me?
Headache, disorders of gastric, nausea, tension, breast tenderness, bleeding intermediate, changes of weight or libido, depressive mood, and chloasma. In isolated cases, decreased tolerance to contact lens use.
Warnings and Precautions
what should I know before using?
it is Recommended to interrupt the contraceptive treatment with SIBLIMA (gestodene and ethinyl estradiol ) in the following cases: the appearance for the first time of headaches similar to migraine, or headaches with frequency and intensity outside of the usual; sudden visual disturbances or hearing; precursors of trombofl ebites or tromboembolias;
angina pectoris; elective surgery (6 weeks before due date) ; immobilization forced (accidents, etc.); onset of jaundice; hepatitis; rash generalized; increase in epileptic seizures; significant increase in blood pressure, and pregnancy. Vomiting or diarrhea may decrease the effectiveness of oral contraceptives.
Attention: The risk of arterial thrombosis (stroke, myocardial infarction) associated with the use of combined oral contraceptives increases with age and the smoke intense.
For this reason, women above 35 years who use oral contraceptives should be strictly advised not to smoke.
what to do if someone use a larger amount than is recommended?
overdosage may cause nausea and vomiting, and in some women it may occur
Bleeding suppression. one can consider that the usual procedure of washing
Gastric and treatments of the support are suitable for the cases of an overdose.
there have been reported serious effects in the intake of acute large oral doses by
Barbiturates, fenilbutazona, hydantoin, rifampicin, primidone, carbamazepine, griseofulvin, which are inducers of liver enzymes may reduce the contraceptive effect.
The needs of medications oral hypoglycemics or insulin may be changed, as a result of the effect of glucose tolerance. Antibiotics including ampicillin and tetracycline may reduce the effectiveness of oral contraceptives by causing changes in the intestinal flora. Women receiving inductors of liver enzymes or broad-spectrum antibiotics should use concomitantly with barrier contraceptive methods (for ex.: diaphragm, more spermicide or male condom).
Interaction with laboratory tests: The use of oral contraceptives can infl influence on the outcome of some laboratory tests, including biochemical parameters liver, thyroid, adrenal and renal function, plasma levels of binding proteins, and fraction lipid/lipoprotein lipases, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis.
SIBLIMA (gestodene and ethinyl estradiol) is an oral contraceptive single-phase, which combines
the component estrogenic ethinyl estradiol with the component progestogênico gestodene in low dosage.
This medicine should be stored at room temperature between 15 and 30 degrees c, protected from light and moisture.
The validity period of the product is 18 months after the date of manufacture printed on the cartridge and inner packaging. Do not use the product after the expiry date, under the risk of not producing the expected effects.
Follow the guidance of your doctor, always respecting the schedules, doses and duration of treatment.
do Not stop treatment without the knowledge of your doctor.
Tell your doctor the occurrence of pregnancy during treatment or after its completion, in view of that SIBLIMA (gestodene and ethinyl estradiol) is contraindicated during pregnancy and breastfeeding.
Tell your doctor the appearance of reactions unpleasant.
ALL MEDICINE SHOULD BE KEPT OUT of the REACH OF CHILDREN.
Tell your doctor about any medicine you are using, before the commencement, or during the treatment.
do NOT TAKE MEDICINE WITHOUT THE KNOWLEDGE OF YOUR DOCTOR. IT CAN BE DANGEROUS TO YOUR HEALTH.
SIBLIMA (gestodene and ethinyl estradiol) acts primarily by inhibiting ovulation by suppressing the release of gonadotrofi in and promote changes in the cervical mucus (which increase the diffi culty of penetration of the sperm into the uterus). In addition,
changes in the endometrium reduce the likelihood of nidation. Ethinylestradiol and gestodene are absorbed quickly and almost completely by the gastrointestinal tract.
The peak plasma levels of each component are achieved after the period of one to two hours. The curves for deletion after the maximum concentration to be achieved, they demonstrate two phases with periods of meia-lives of approximately 1 and 15 hours for gestodene, and about 1 to 3 hours, and 24 hours for ethinyl estradiol. After
administration of oral ethinyl estradiol is subject to a considerable metabolic effect of the first pass, resulting in a bioavailability of around 40-45%. In the case of gestodene, the bioavailability is virtually complete, since this drug is not subject to the metabolism of the first passage. The gestodene binds widely
to globulin binding of sexual hormones (SHBG). The high affi nity binding of gestodene for SHBG leads to an increase in plasma levels of gestodene and a prolongation in half-life terminal. The ethinyl estradiol binds in plasma to albumin, thereby increasing the binding capacity of SHBG. The half-life of elimination of ethinyl estradiol is approximately 25 hours.
The metabolism of these drugs occurs primarily by hydroxylation, aromatic and a great variety of metabolites hidroxilados and methyl is formed, being present in the free form or conjugated with glicuronídeos and sulfates. Ethinyl estradiol
the conjugate is excreted by the bile, and is subject to the recirculation êntero-the liver.
About 40% of the drug is excreted in the urine and 60% in feces. The half-life of elimination of gestodene is approximately 16 to 18 hours, after oral administration of multiple doses. Metabolism occurs primarily by reduction of the ring
The then glicuronização. About 50% of gestodene is eliminated by the urine and 33% in feces.
The combination of 0.060 mg of gestodene, and 0,015 mg ethinyl estradiol in a regimen of 24 days with medicine and 4 without, has the same effectiveness that contraceptive dosages higher with lower side effects.
Rendering and Display
Each tablet contains:
Gestodene ….60 mcg
Ethinyl estradiol ….15 mcg
Excipients: lactose, microcrystalline cellulose, magnesium stearate, polyvidone,
croscarmelose sodium, disodium EDTA, silicon dioxide colloidal, polyethylene glycol, and
methacrylate dimethylamino…q. s. p …. 1 film-coated tablet.
Cartridge containing 1 blister pack with 24 coated tablets.
Libbs pharmaceutical Ltda.
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