Product image of Mirelle (Ethinylestradiol, Gestodene | Lactose Monohydrate) supplied by GNH India

Mirelle

Active Ingredient:
Ethinylestradiol, Gestodene | Lactose Monohydrate
Origin:
EU

Mirelle (Ethinylestradiol, Gestodene | Lactose Monohydrate)

Ethinylestradiol and Gestodene, the active ingredients in Mirelle, are a combined oral contraceptive presented as a 30 µg/75 µg tablet for oral use. It prevents pregnancy and helps regulate the menstrual cycle in women of reproductive age by inhibiting ovulation and altering cervical mucus.

GNH India supplies Mirelle as a licensed, GDP‑compliant international pharmaceutical supplier, delivering quality‑assured medication to hospitals, pharmacies and clinics worldwide while adhering to EU regulatory standards. The company ensures consistent batch release, proper labeling, and secure logistics for global distribution.

Manufacturer / TM Owner

Bayer Ag

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Indications & Clinical Uses

  • Mirelle, a combined oral contraceptive, acts on the hormonal regulation pathway to prevent pregnancy and manage menstrual disorders.
  • Contraception: Prevents pregnancy in women of childbearing potential by suppressing ovulation.
  • Menstrual cycle regulation: Provides predictable withdrawal bleeding and reduces menstrual irregularities.
  • Acne management: Improves hormonal acne by reducing androgenic activity in the skin.
  • Endometriosis symptom relief: Decreases pelvic pain associated with endometriosis.

How It Works

  • Ethinylestradiol binds to estrogen receptors while gestodene binds to progesterone receptors, together suppressing the hypothalamic‑pituitary‑gonadal axis. This reduces luteinizing hormone and follicle‑stimulating hormone secretion, preventing follicular development and ovulation. The progestogenic component also thickens cervical mucus, hindering sperm penetration, and induces endometrial changes that are unfavorable for implantation.

Side Effects

Mirelle may cause a range of adverse reactions, which are generally classified by frequency and severity.

Common Side Effects

  • Nausea: mild to moderate stomach upset, often transient.
  • Headache: tension‑type or migraine‑like pain.
  • Breast tenderness: swelling or discomfort of the breasts.
  • Spotting or irregular bleeding: breakthrough bleeding especially during the first cycles.

Serious or Rare Side Effects

  • Venous thromboembolism: deep‑vein thrombosis or pulmonary embolism, requiring immediate medical attention.
  • Stroke or transient ischemic attack: neurological symptoms such as sudden weakness or speech difficulty.
  • Hepatic adenoma: benign liver tumor, detected through imaging.

Precautions & Warnings

  • Before prescribing Mirelle, clinicians should evaluate individual risk factors and counsel patients on safe use.
  • Assess cardiovascular risk: evaluate history of thromboembolism, hypertension, or smoking before prescribing.
  • Avoid use in pregnancy: product is contraindicated for pregnant women (Category X).
  • Monitor for signs of thrombosis: educate patients to seek immediate care for leg pain or swelling.
  • Consider drug interactions: review concomitant enzyme‑inducing medications that may reduce efficacy.
  • Counsel on bleeding changes: advise patients about possible spotting or breakthrough bleeding.
  • Store at ambient temperature: keep tablets below 25 °C in the original packaging, protected from moisture.

Avoid Interactions

Mirelle can interact with other medicines, altering its effectiveness or safety profile.

Major Interactions (Avoid)

  • Enzyme‑inducing anticonvulsants (e.g., carbamazepine, phenytoin): may markedly reduce contraceptive effectiveness.
  • Rifampicin and other strong CYP3A4 inducers: can lower hormone levels, increasing risk of unintended pregnancy.
  • St. John’s Wort: herbal inducer that may compromise contraceptive efficacy.

Moderate Interactions (Monitor Closely)

  • Antibiotics such as ampicillin or tetracycline: may slightly decrease hormone levels; advise backup contraception.
  • Antifungal agents (e.g., fluconazole) and azole antivirals: can increase hormone concentrations, potentially enhancing side effects.
  • Selective serotonin reuptake inhibitors (SSRIs): may increase risk of mood changes; monitor patient.

Frequently Asked Questions

Mirelle is a combined oral contraceptive containing ethinylestradiol and gestodene. It is prescribed to prevent pregnancy in women of reproductive age and can also help regulate menstrual cycles and manage hormone‑related acne.

Ethinylestradiol provides estrogenic activity while gestodene supplies progestogenic activity. Together they suppress the hypothalamic‑pituitary‑gonadal axis, lowering LH and FSH release, which prevents ovulation. The progestogen also thickens cervical mucus and alters the endometrium, creating conditions unfavorable for sperm and implantation.

The dosing regimen for Mirelle is determined by the prescribing healthcare professional. Typically, it is taken as one tablet daily at the same time each day, but the exact schedule should follow the prescriber’s instructions.

Mirelle is contraindicated in pregnancy (Category X) and should not be started or continued by a woman who is pregnant. While limited data exist for breastfeeding, most guidelines advise caution; the prescriber should assess risks and benefits before use in lactating women.

To order Mirelle, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any required import documentation.

Mirelle contains 30 µg ethinylestradiol and 75 µg gestodene, a low‑dose estrogen‑progestogen combination similar to other second‑generation COCs. Its efficacy, safety profile and side‑effect spectrum are comparable to alternatives such as levonorgestrel‑based pills, but individual tolerability may vary, making personalized selection important.

Mirelle tablets should be stored at ambient temperature, preferably below 25 °C. Keep them in the original blister pack, protect from moisture and direct sunlight, and keep out of reach of children.

Mirelle is taken orally, usually once daily with or without food. The tablet should be swallowed whole with water at the same time each day to maintain consistent hormone levels.

Serious risks include venous thromboembolism, stroke, myocardial infarction and hepatic adenoma. These events are rare but require immediate medical attention if symptoms such as leg pain, sudden shortness of breath, severe headache, visual changes or abdominal pain occur.

Mirelle is contraindicated in women who are pregnant, have a history of thromboembolic disorders, uncontrolled hypertension, known or suspected estrogen‑dependent tumors, liver disease, or who are smokers over age 35. It should also be avoided in individuals with known hypersensitivity to any component of the tablet.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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