MELIANE Tablet Ethinylestradiol 0.02 mg  Gestodene 0.075 mg Oral Uses Side effects Dose 

Meliane (Gestodene-Ethinylestradiol) Tablet Is Used For oral contraceptive

medicine

  • Meliane Tablet Ethinylestradiol 0.02 mg  Gestodene 0.075 mg Oral Uses Side effects Dose 

    Meliane Tablet NAME OF THE MEDICINAL PRODUCT
    Tablet Meliane  uses as QUALITATIVE AND QUANTITATIVE COMPOSITION
    21 hormone-containing white coated tablets:
    Each coated tablet contains 0.02 mg ethinylestradiol, 0.075 mg gestodene

    Meliane Tablet Uses

    Meliane tablet Oral contraception.meliane tablet uses for family planning

    Dosage and method of administration

    Dosage of Meliane tablet

    Method of administration
    Oral use
    Dosage regimen
    How to take Meliane
    Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly. Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. One tablet is to be taken daily for 21 consecutive days. Each subsequent pack is started after a 7-day tablet-free interval.

    MELIANE Tablet

    How to start Meliane

    Tablet-taking has to start on day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bleeding).

    Management of missed tablets

    If the user is less than 12 hours late in taking any tablet, contraceptive protection is not reduced. The woman should take the tablet as soon as she remembers and should take further tablets at the usual time.
    If she is more than 12 hours late in taking any tablet, contraceptive protection may be reduced.

     Missed tablets treatment can be guided by the following two basic rules:
    Tablet-taking must never be discontinued for longer than 7 days.
    7 days of uninterrupted tablet-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian-axis.

    meliane tablet Accordingly the following advice can be given in daily practice:

    If the woman missed tablets and subsequently has no withdrawal bleed in the first normal tablet-free interval, the possibility of a pregnancy should be considered. The advice in case of gastro-intestinal disturbances In case of severe gastro-intestinal disturbances, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after tablet-taking, the advice concerning missed tablets, as given in section ‘Management of missed tablets’, is applicable Additional information on special populations Children and adolescents Meliane is only indicated after menarche. Geriatric patients not applicable. Meliane is not indicated after menopause. Patients with hepatic impairment Meliane is contraindicated in women with severe hepatic diseases. See also section ‘Contraindications’.
    Patients with renal impairment Meliane has not been specifically studied in really impaired patients. Available data do not suggest a change in treatment in this patient population.

    Contraindications of Meliane tablet

    • Meliane tablet Combined oral contraceptives (COCs) should not be used in the presence of any of the conditions listed below.
    • Should any of the conditions appear for the first time during COC use, the product should be stopped immediately?
      The presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis,
    • pulmonary embolism,
    • myocardial infarction) or of a cerebrovascular accident.
    • Presence or history of Post thrombosis (e.g. transient ischaemic attack, angina pectoris).
    • A high risk of venous or arterial thrombosis

     

    Meliane tablet Special warnings and precautions for use’

    •  Meliane tablet warning
    • History of migraine with focal neurological symptoms.
      Diabetes Mellitus With vascular involvement.
      Severe hepatic disease as long as liver function values have not returned to normal.
      Presence or history of liver tumors (benign or malignant) organs or the breasts)
      Undiagnosed vaginal bleeding
      Known or suspected pregnancy
      Hypersensitivity to the active substances or to any of the excipients

     

    Meliane tablet in Pregnancy

    Meliane Tablet is not indicated during pregnancy if pregnancy occurs during treatment with Meliane. Further intake must be stopped, however; extensive epidemiological studies have revealed neither an increased risk of birth defects in children born to women who used COCs prior to pregnancy nor a teratogenicity effect when COCs were taken inadvertently during early pregnancy.

    Meliane tablet In Lactation:

    Meliane in Lactation may be influenced by COCs as they may reduce the quantity and change the composition of breast milk, therefore, the use of COCs should generally not be recommended until the nursing mother has completely weaned her child small amounts of the contraceptive steroids and .or their metabolites may be exerted with the milk.

    Side effects of Meliane tablets
    • System Organ Class
      (MedDRA) Common
    • Eye disorders Contact lens
      intolerance
    • Gastrointestinal
      disorders –
    • Nausea
    • Abdominal pain Vomiting
    • Diarrhea
    • Immune system
      disorders
    • Hypersensitivity
    • Investigations Weight increased Weight decreased
      Metabolism and
    • nutrition disorders Fluid retention
    • Nervous system
      disorders
    • Headache
    • Migraine
    • Psychiatric disorders
    • Depressed mood
    • Mood altered
    • Libido
    • decreased Libido
    • increased Reproductive system
    • breast disorders Breast pain,
    • Breast tenderness Breast hypertrophy
    • Vaginal discharge
    • Breast discharge
    • Skin and subcutaneous
      tissue disorders
    • Rash
    • Urticaria
    • Erythema nodosum
    • Erythema multiform
    • Vascular disorders Venous and arterial
      thromboembolic
    • Peripheral deep venous occlusion,
    • thrombosis and embolism/Pulmonary vascular occlusion,
    • thrombosis, embolism and infarction/Myocardial infarction/Cerebral infarction and stroke not specified as hemorrhagic.

    Description of selected adverse reactions

    Tumors
    The frequency of diagnosis of breast cancer is very slightly increased among OC users.

    As breast cancer is rare in women under 40 years of age the excess number is small in relation to the overall risk of breast cancer. Causation with COC use is unknown.
    -Liver tumors (benign and malignant)
    Other conditions

    Women with hypertriglyceridemia (increased risk of pancreatitis when using
    COCs)

    Hypertension

    •  jaundice
    • pruritus related to
    •  Cholelithiasis gallstone formation;
    • porphyria;
    • systemic lupus erythematosus;
    • hemolytic uremic syndrome;
    • Sydenham’s chorea;
    • herpes gestationis;
    • otosclerosis-related hearing loss
    • in women with hereditary angioedema, exogenous estrogens may induce or
    • exacerbate symptoms of angioedema
    • Liver function disturbances
    • Changes in glucose tolerance or effect on peripheral insulin resistance
    • Crohn’s disease,
    • ulcerative colitis.
    • Chloasma

    Meliane tablet Interactions

    Meliane tablet Breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers) with oral contraceptives (see section Interaction with other medicinal products and other forms of interaction’).

    Overdose Meliane tablet

    • if a patient use increase dose of Meliane tablet is There have been no reports of serious deleterious effects from an overdose.
    • Symptoms that may occur in this case are:
    • nausea,
    • vomiting and, in young girls,
    • slight vaginal bleeding.
    • There are no antidotes and further treatment should be symptomatic.

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