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An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Infectious-inflammatory diseases caused by microorganisms sensitive to ofloxacin, including: diseases of the lower respiratory tract, ear, nose, throat, skin, soft tissues, bones, joints, infectious and inflammatory diseases of the abdominal organs (except bacterial enteritis) and pelvic infection, kidney and urinary tract, prostatitis, gonorrhea.
Each tablet contains Gestodene (Siblima) 75 mcg and ethinyl estradiol 30 mcg.
Siblima is a combined low-dose oral contraceptive. It can be considered for women who are prone to experience side effects with other progestogens eg, weight gain, headache, depression, acne and breakthrough bleeding.
How to Take Siblima: Tablets 1-21 contain active ingredients (active tablets). Tablets must be taken in the order directed on the package every day at about the same time. One tablet is to be taken daily for 21 consecutive days, followed by a 7-day tablet free interval. Each subsequent pack is started on the day after the tablet-free interval. A withdrawal bleed usually starts on days 2-3 after the last active tablet and may not have finished before the next pack is started.
How to Start Siblima: No Hormonal Contraceptive Use (within the Preceeding Month): The patient should begin taking Siblima on Day 1 of her natural menstrual cycle (i.e., the first day of menstrual bleeding).
Beginning Siblima use on days 2-7 of the menstrual cycle (e.g., Sunday start) is allowed; however, a nonhormonal back-up method of birth control (e.g., condoms, spermicide) is recommended during the first 7 days of Siblima use.
Switching from Another COC: The woman should start Siblima preferably on the day after the last active tablet of her previous COC, but no later than the day following the usual tablet-free or inactive tablet interval of her previous COC.
Switching from a Progestin Only Method of Birth Control [Pill, Implant, Intrauterine Device (IUD) Injection]: The woman may discontinue use of progestin-only pill on any day and should begin Siblima the next day. Start Siblima on the same day that a progestin-only implant or a progestin-only IUD is removed; or on the day that the next progestin-only injection is scheduled. In each of these situations, the woman should be advised to use a nonhormonal back-up method of birth control during the first 7 days of Siblima use.
Following First-Trimester Abortion: The woman may start Siblima immediately. Additional contraceptive measures are not needed.
Postpartum: Because the immediate postpartum period is associated with an increased risk of thromboembolism, Siblima use should be started no sooner than 28th postpartum day following either delivery in a nonlactating mother or second-trimester abortion. The woman should be advised to use a nonhormonal back-up method of birth control for the first 7 days of Siblima use. However, if intercourse has already occurred, pregnancy should be ruled out before Siblima use has begun; otherwise the woman has to wait for her 1st menstrual period before beginning Siblima use.
How to Delay a Period: To delay a menstrual period, the woman should skip the tablet-free interval and immediately begin a new pack of Siblima. The delay may be continued for as long as desired up until all the tablets in the new pack are taken. During the delay, the woman may experience breakthrough-bleeding or spotting. Regular intake of Siblima is then resumed after the usual 7 day tablet-free interval.
Management of Missed Tablets: Contraceptive protection may be reduced if active tablets are missed and particularly if the missed tablets extend the tablet-free interval.
If one active tablet is missed, but is remembered within 12 hours of the usual dose, it should be taken as soon as it is remembered. Subsequent tablets should be taken at the usual time.
If one active tablet is missed and is more than 12 hours after the usual dose or if 2 or more active tablets are missed, contraceptive protection may be reduced. The last missed tablet should be taken as soon as it is remembered, even if this means taking 2 tablets on the same day. Subsequent tablets should be taken at the usual time. A nonhormonal back-up method of birth control should be used for the next 7 days.
If the user takes the last active tablet before the 7-day interval during which use of a nonhormonal back-up method of birth control is required has ended, the next pack must be started as soon as the current pack is finished; there should be no tablet-free interval between packs. This prevents an extended break in tablet-taking interval thereby reducing the risk of escape ovulation. The user is unlikely to have a withdrawal bleed until all the tablets in the new pack are taken, although she may experience spotting or breakthrough bleeding on tablet-taking days. If the user does not have a withdrawal bleed after all tablets in the new pack are taken, the possibility of pregnancy must be ruled out before resuming tablet-taking.
Advise in Case of Vomiting and/or Diarrhea: If vomiting or diarrhea occurs within 4 hours after tablet-taking, absorption may not be complete. In such an event, the advice concerning Management of Missed Tablet is applicable. The woman must take the extra active tablet(s) needed from a back-up pack.
Interactions between ethinyl estradiol (EE) and other substances may lead to decreased or increased serum EE concentrations, respectively.
Decreased EE serum concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the COC.
During concomitant use of EE-containing products and substances that may lead to decreased EE serum concentrations, it is recommended that a nonhormonal back-up method of birth control (eg, condoms and spermicide) be used in addition to the regular intake of Siblima. In the case of prolonged use of such substances COCs should not be considered the primary contraceptive.
After discontinuation of substances that may lead to deceased EE serum concentrations, use of a nonhormonal back-up method is recommended for at least 7 days. Longer use of a back-up method is advisable after discontinuation of substances that have lead to induction of hepatic microsomal enzymes, resulting in decreased EE serum concentrations. It may sometimes take several weeks until enzyme induction has completely subsided, depending on dosage, duration of use and rate of elimination of the inducing substance.
Examples of substances that may decrease serum EE concentrations: Any substance that reduces gastrointestinal transit time and, therefore, EE absorption. Substances that induce hepatic microsomal enzymes eg, rifampicin, rifabutin, barbiturates, primidone, phenylbutazone, phenytoin, dexamethasone, griseofulvin, topiramate, some protease inhibitors, modafinil. Hypericum perforatum, also known as St. John's wort, and ritonavir* (possibly by induction of hepatic microsomal enzymes. Certain antibiotics (eg, ampicillin and other penicillins, tetracyclines), by a decrease of enterohepatic circulation of estrogens.
Examples of substances that may increase serum EE concentrations: Atorvastatin. Competitive inhibitors for sulfation in the gastrointestinal wall eg, ascorbic acid (vitamin C) and paracetamol (acetaminophen). Substances that inhibit cytochrome P-450 3A4 isoenzymes eg, indinavir, fluconazole, and troleandomycin*. Troleandomycin may increase the risk of intrahepatic cholestasis during co-administration with COCs.
EE may interfere with the metabolism of other drugs by inhibiting hepatic microsomal enzymes, or by inducing hepatic drug conjugation, particularly glucuronidation. Accordingly, plasma and tissue concentrations may either be increased (eg, cyclosporine, theophylline, corticosteroids) or decreased (eg, lamotrigine).
In patients treated with flunarizine, use of oral contraceptives has been reported to increase the risk of galactorrhea.
The prescribing information of concomitant medications should be consulted to identify potential interactions.
*Although ritonavir is an inhibitor of cytochrome P-450 3A4, treatment with ritonavir has been shown to decrease EE serum concentrations.
Laboratory Test Information: Estrogen-containing preparations can affect many laboratory tests. Some examples are: Increased prothrombin and Factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.
Increased thyroid-binding globulin (TBG) leading to increased circulating total-thyroid hormone, as measured by protein-bound iodine (PBI). T4 by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered.
Reduced response to metyrapone test.
The results of these tests should not be regarded as reliable until oral contraceptive use has been discontinued for 1-2 months. Abnormal tests should then be repeated.
Oral contraceptives may produce false positive results when neutrophil alkaline phosphatase activity is evaluated for the early diagnosis of pregnancy.
Siblima side effects
For serious adverse effects in COC users, see Warnings and Precautions.
For thromboemebolic events, lipid disorders, gallbladder diseases, breast cancer, see also Warnings and Precautions. The most frequently (>10%) reported adverse events during phase 3 studies and post-marketing surveillance in women using Harmonet are headache, including migraines and breakthrough bleeding/spotting.
Other adverse events have been reported in women taking COC. Frequencies are described as follows: Common (≥1% and 10%); uncommon (≥0.1% and <1%); rare (≥0.01% and <0.1%).
Infections and Infestations: Common: Vaginitis, including candidiasis.
Immune System Disorders: Rare: Anaphylactic/anaphylactoid reactions, including very rare cases of urticaria, angioedema and severe reactions with respiratory and circulatory symptoms.
Metabolism and Nutrition Disorders: Uncommon: Changes in appetite (increase or decrease). Rare: Glucose intolerance.
Psychiatric Disorders: Common: Mood changes, including depression, changes in libido.
Nervous System Disorders: Common: Nervousness, dizziness.
Eye Disorders: Rare: Intolerance to contact lenses.
Gastrointestinal Disorders: Common: Nausea, vomiting, abdominal pain. Uncommon: Abdominal cramps, bloating.
Hepatobiliary Disorder: Rare: Cholestatic jaundice.
Skin and Subcutaneous Tissue Disorders: Common: Acne. Uncommon: Rash, chloasma (melasma) which may persist, hirsutism, alopecia. Rare: Erythema nodosum.
Reproductive System and Breast Disorders: Common: Breast pain, tenderness, enlargement, secretion, dysmenorrhoea, change in menstrual Siblima, change in cervical ectropion and secretion, amenorrhea.
General Disorders and Administration: Common: Fluid retention/oedema.
Investigations: Common: Changes in weight (increase or decrease). Uncommon: Increase in blood pressure, changes in serum lipid levels, including hypertriglyceridemia. Rare: Decrease in serum folate levels (serum folate levels may be depressed by COC levels).
The following adverse events have been classified as very rare adverse events (<0.01%): Exacerbation of systemic lupus erythematosus, porphyria and chorea, optic neuritis (may lead to partial or complete loss of vision), aggravation of varicose veins, retinal vascular thrombosis, pancreatitis, hepatic adenomas, hepatocellular carcinomas, gallbladder disease including gallstones (COCs may worsen existing gallbladder disease and may accelerate the development of this disease in previously asymptomatic women), erythema multiforme and haemolytic uremic syndrome.
History of venous thromboembolism, markedly impaired liver function or cholestasis, Dubin-Johnson or Rotor syndromes, hepatic adenoma, estrogen-dependent neoplasms eg, breast or endometrial cancer, cardiovascular disease including previous, current or if at high risk of thromboembolic disorders and arterial disease or multiple risk factors for it, disorders of lipid metabolism, undiagnosed vaginal bleeding, possible pregnancy or a history of pruritus itchiness or cholestatic jaundice during pregnancy, chorea, herpes gestationis, pemphigoid gestationis, deteriorating otosclerosis, severe or focal migraine (or where there are other risk factors for cardiovascular disease).
Smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases depending on the age and frequency of smoking (≥15 cigarettes/day) especially in women >35 years. Women who are using combined oral contraceptives should not smoke. Women who smoke and need contraception are advised to take progestin-only pills.
Use in pregnancy: Siblima is not recommended for pregnant women. Pregnancy must be ruled out before taking Siblima. Should a pregnancy occur while taking the tablet, the administration has to be withdrawn at once.
Use in lactation: Breastfeeding mothers should not take Siblima. This can reduce the volume of breast milk. Breastfeeding women are advised to take progestin-only pills.
Active ingredient matches for Siblima:
Ethinylestradiol/Gestodene in Brazil.
ReviewsThe results of a survey conducted on ndrugs.com for Siblima are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Siblima. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported usefulNo survey data has been collected yet
Consumer reported price estimatesNo survey data has been collected yet
Consumer reported time for resultsNo survey data has been collected yet
Consumer reported ageNo survey data has been collected yet
Information checked by Dr. Sachin Kumar, MD Pharmacology