Product image of Mycyclame (Drospirenone, Ethinylestradiol | Lactose) supplied by GNH India

Mycyclame

Active Ingredient:
Drospirenone, Ethinylestradiol | Lactose
Origin:
EU

Mycyclame (Drospirenone, Ethinylestradiol | Lactose)

Drospirenone/Ethinylestradiol, the active ingredient in Mycyclame, is a combined oral contraceptive presented as a tablet for oral use. It prevents pregnancy in women of reproductive age by inhibiting ovulation and altering cervical mucus.
GNH India supplies Mycyclame as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Exeltis Italia Srl

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Indications & Clinical Uses

Mycyclame, a combined oral contraceptive, acts on the hormonal regulation pathway to prevent unintended pregnancy.

  • Contraception: prevention of pregnancy in women of child‑bearing potential.
  • Menstrual cycle regulation: helps achieve predictable, regular periods.
  • Acne management: may improve mild to moderate acne associated with hormonal fluctuations.

How It Works

  • Drospirenone/Ethinylestradiol works by binding to estrogen and progestin receptors, suppressing the hypothalamic‑pituitary‑ovarian axis. This inhibition reduces luteinizing hormone (LH) and follicle‑stimulating hormone (FSH) secretion, preventing follicular development and ovulation. The progestin component also thickens cervical mucus and induces endometrial changes that reduce the likelihood of implantation.

Side Effects

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Breast tenderness: transient swelling or discomfort.
  • Headache: occasional mild to moderate pain.
  • Spotting or breakthrough bleeding: irregular light bleeding.
  • Weight gain: modest increase in body weight.
  • Mood changes: irritability or mood swings.

Serious or Rare Side Effects

  • Venous thromboembolism: deep vein thrombosis or pulmonary embolism.
  • Stroke or transient ischemic attack.
  • Myocardial infarction: heart attack risk, especially in smokers.
  • Severe hypertension: sudden rise in blood pressure.
  • Allergic reactions: rash, itching, swelling, or anaphylaxis.
  • Liver dysfunction: jaundice or abnormal liver enzymes.

Precautions & Warnings

Before prescribing Mycyclame, consider the following safety measures.

  • Contraindications: avoid in patients with a history of thromboembolic disorders or clotting disorders.
  • Smoking: do not use in women who smoke >15 cigarettes per day, especially over age 35.
  • Liver disease: caution in patients with active liver disease or impaired hepatic function.
  • Hypertension: monitor blood pressure regularly; avoid in uncontrolled hypertension.
  • Pregnancy: not indicated for use during pregnancy; discontinue if pregnancy occurs.
  • Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Mycyclame may interact with several medicines that affect its efficacy or safety.

Major Interactions (Avoid)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) – may reduce contraceptive effect.
  • St. John’s wort – can decrease hormone levels, risking breakthrough bleeding.
  • Protease inhibitors (e.g., ritonavir) – may increase hormone concentrations.
  • Certain anticonvulsants – may lower effectiveness of contraception.
  • Antimicrobial agents (e.g., griseofulvin) – can diminish hormonal activity.

Moderate Interactions (Monitor Closely)

  • Antifungals (e.g., ketoconazole) – may increase hormone levels, watch for side effects.
  • SSRIs (e.g., fluoxetine) – potential for altered metabolism.
  • Diuretics – may affect fluid balance and blood pressure.
  • Antihypertensives (e.g., ACE inhibitors) – monitor blood pressure changes.
  • Lithium – may increase lithium levels; monitor serum concentrations.

Frequently Asked Questions

Mycyclame is a combined oral contraceptive containing drospirenone and ethinylestradiol. It is prescribed to prevent unintended pregnancy in women of reproductive age by inhibiting ovulation and altering cervical mucus and the endometrial lining.

Drospirenone and ethinylestradiol bind to progesterone and estrogen receptors, suppressing the release of luteinizing hormone (LH) and follicle‑stimulating hormone (FSH). This blocks follicular development, prevents ovulation, thickens cervical mucus, and creates an endometrial environment that is unfavorable for implantation.

The dosing regimen for Mycyclame is determined by the prescribing healthcare professional. Typically, it is taken as a daily oral tablet according to the specific schedule indicated on the product label, but the exact regimen should be confirmed with the prescriber.

Mycyclame is not intended for use during pregnancy and should be discontinued if pregnancy is confirmed. Safety data for breastfeeding are limited; therefore, the benefits and risks should be evaluated by a healthcare provider before use while nursing.

To order Mycyclame, 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 necessary import documentation.

Mycyclame contains drospirenone, a progestin with anti‑androgenic and mild diuretic properties, combined with ethinylestradiol. Compared with older progestins, drospirenone may offer better control of acne and less water retention, but the overall contraceptive efficacy is similar across approved combined oral contraceptives.

Mycyclame tablets should be stored at temperatures below 25 °C, in their original packaging, protected from moisture and direct sunlight. Do not store in bathrooms or near heat sources, and keep out of reach of children.

Mycyclame is taken orally, usually once daily at the same time each day, with or without food. The tablet is swallowed whole with a glass of water. Consistency in timing helps maintain hormone levels and maximizes contraceptive effectiveness.

Serious risks include venous thromboembolism, pulmonary embolism, stroke, myocardial infarction, and severe hypertension. These events are more likely in smokers, women over 35, or those with a history of clotting disorders. Prompt medical attention is required if symptoms such as chest pain, shortness of breath, or severe headache occur.

Mycyclame is contraindicated in women with a known or suspected pregnancy, active liver disease, uncontrolled hypertension, a history of thromboembolic events, certain hormone‑sensitive cancers, or those who smoke heavily (>15 cigarettes per day) and are over 35 years old.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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