Product image of Madonella (Ethinylestradiol, Levonorgestrel) supplied by GNH India

Madonella

Active Ingredient:
Ethinylestradiol, Levonorgestrel
Origin:
EU

Madonella (Ethinylestradiol, Levonorgestrel)

Ethinylestradiol, the active ingredient in Madonella, is a combined oral contraceptive presented as a tablet for oral use. It prevents pregnancy and is also used to regulate menstrual cycles in women of reproductive age. It is formulated with levonorgestrel as a second active component, providing both estrogenic and progestogenic activity to inhibit ovulation.

GNH India supplies Madonella as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The product complies with European Union pharmaceutical standards and is distributed under strict Good Distribution Practice guidelines.

Manufacturer / TM Owner

Kwizda Pharma Gmbh

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Indications & Clinical Uses

  • Madonella, a combined oral contraceptive, acts on the hormonal regulation pathway to prevent pregnancy and manage menstrual-related conditions.
  • Contraception: Prevents pregnancy when taken as directed.
  • Menstrual cycle regulation: Provides more predictable bleeding patterns and reduces dysmenorrhea.
  • Acne improvement: May decrease androgen‑related acne in some women.

How It Works

  • Ethinylestradiol and levonorgestrel work together to suppress the hypothalamic‑pituitary‑ovarian axis. Ethinylestradiol provides estrogenic activity that stabilizes the endometrium, while levonorgestrel supplies progestogenic activity that inhibits the mid‑cycle luteinising hormone surge, preventing ovulation. The combination also thickens cervical mucus and alters endometrial development, creating an environment unsuitable for fertilisation and implantation.

Side Effects

Madonella may cause a range of adverse reactions, varying from mild to serious.

Common Side Effects

  • Nausea: mild stomach upset, especially during the first cycles.
  • Breast tenderness: temporary swelling or discomfort.
  • Headache: mild to moderate intensity.
  • Spotting or breakthrough bleeding: irregular bleeding between periods.
  • Mood changes: irritability or mild mood swings.

Serious or Rare Side Effects

  • Deep vein thrombosis: blood clot formation in legs or pelvis.
  • Pulmonary embolism: clot traveling to lungs, a medical emergency.
  • Stroke: rare cerebrovascular event.
  • Myocardial infarction: heart attack risk, especially in smokers over 35.
  • Severe allergic reaction: rash, swelling, or difficulty breathing.
  • Liver tumor: very rare hepatic adenoma.

Precautions & Warnings

  • Before prescribing Madonella, clinicians should consider several precautionary measures to ensure patient safety.
  • Medical review: assess personal and family history of thromboembolic disorders.
  • Smoking status: avoid use in women over 35 who smoke.
  • Medication review: evaluate concomitant drugs that may affect hormonal efficacy.
  • Pregnancy: discontinue immediately if pregnancy is confirmed.
  • Breastfeeding: consult physician before use during lactation.
  • Store at ambient temperature: keep tablets in original packaging, protect from moisture and heat.

Avoid Interactions

Madonella can interact with other medicines, altering its effectiveness or increasing risk of adverse events.

Major Interactions (Avoid)

  • Enzyme‑inducing anticonvulsants (e.g., carbamazepine, phenytoin): may reduce contraceptive efficacy.
  • Rifampicin or other strong antibiotics: can lower hormone levels, increasing pregnancy risk.
  • Antiretroviral agents (e.g., efavirenz): may diminish contraceptive effect.
  • St. John’s wort: herbal supplement that can decrease hormone concentrations.

Moderate Interactions (Monitor Closely)

  • Antifungal agents (e.g., fluconazole): may increase hormone levels, requiring monitoring for side effects.
  • Certain antidepressants (e.g., sertraline): may affect mood and bleeding patterns.
  • Diuretics: can influence fluid balance and blood pressure, requiring observation.

Frequently Asked Questions

Madonella is a combined oral contraceptive indicated for the prevention of pregnancy. It is also prescribed to help regulate menstrual cycles and may be used to improve acne related to androgen excess in women of reproductive age.

Ethinylestradiol provides estrogenic activity that stabilises the endometrium and works with levonorgestrel to suppress the mid‑cycle luteinising hormone surge. This inhibition prevents ovulation, while the estrogen component also contributes to thickening cervical mucus and altering the uterine lining.

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

Madonella is not intended for use during pregnancy and should be discontinued if pregnancy is confirmed. While limited data exist for breastfeeding, the decision to use hormonal contraceptives while nursing should be made in consultation with a physician.

To order Madonella, 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.

Madonella contains the standard dose combination of ethinylestradiol and levonorgestrel, which is comparable to many other combined oral contraceptives. Its efficacy, safety profile and side‑effect spectrum are similar to alternative products that use the same hormone classes, though individual tolerability may vary.

Madonella tablets should be stored at ambient temperature, below 25 °C, in the original blister pack. Protect them from excess moisture, direct sunlight and heat to maintain potency throughout the shelf life.

Madonella is taken orally with a glass of water, preferably at the same time each day. It is a tablet formulation and should be swallowed whole; it does not need to be chewed or dissolved.

The most serious risks include venous thromboembolism, pulmonary embolism, stroke, myocardial infarction, severe allergic reactions and, rarely, hepatic adenomas. Patients should seek immediate medical attention if they experience symptoms such as unexplained leg pain, shortness of breath, chest pain, severe headache or signs of an allergic reaction.

Madonella is contraindicated in women with a history of thromboembolic disorders, known or suspected estrogen‑dependent tumors, active liver disease, uncontrolled hypertension, smoking women over 35, and those who are pregnant or breastfeeding without medical advice.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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