Product image of Naiwanel 28 (Drospirenone, Ethinylestradiol | Lactose) supplied by GNH India

Naiwanel 28

Active Ingredient:
Drospirenone, Ethinylestradiol | Lactose
Origin:
EU

Naiwanel 28 (Drospirenone, Ethinylestradiol | Lactose)

Drospirenone/Ethinylestradiol, the active ingredient in Naiwanel 28, is a combined oral contraceptive presented as a tablet for oral use. Approved in the European Union, it prevents pregnancy by inhibiting ovulation and altering cervical mucus in women of reproductive age.

GNH India supplies Naiwanel 28 as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality‑controlled sourcing for global healthcare providers. The company adheres to stringent regulatory standards and provides reliable logistics for timely delivery, with comprehensive technical support and product documentation.

Manufacturer / TM Owner

Medical Valley Invest Ab

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Indications & Clinical Uses

Naiwanel 28 is a combined oral contraceptive used in the hormonal regulation of reproductive health.

  • Contraception: Prevents pregnancy in women of childbearing potential by suppressing ovulation.
  • Acne treatment: Reduces moderate acne lesions by decreasing androgenic activity.
  • Premenstrual dysphoric disorder (PMDD): Alleviates emotional and physical symptoms associated with PMDD.

How It Works

  • Drospirenone/Ethinylestradiol exerts its contraceptive effect by binding to estrogen and progestin receptors, suppressing the hypothalamic‑pituitary‑ovarian axis, which prevents the mid‑cycle surge of luteinizing hormone and thus ovulation. The progestogenic component also thickens cervical mucus and induces endometrial changes that hinder sperm penetration and implantation.

Side Effects

Naiwanel 28 may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Headache: tension‑type or migraine‑like pain.
  • Breast tenderness: swelling or discomfort.
  • Weight gain: modest increase in body weight.
  • Mood changes: irritability or mild depression.
  • Spotting: irregular uterine bleeding.

Serious or Rare Side Effects

  • Venous thromboembolism: deep‑vein thrombosis or pulmonary embolism.
  • Arterial thrombosis: stroke or myocardial infarction.
  • Hypertension: sudden increase in blood pressure.
  • Liver dysfunction: jaundice or abnormal liver enzymes.
  • Severe allergic reaction: anaphylaxis or angioedema.

Precautions & Warnings

Before prescribing Naiwanel 28, clinicians should evaluate several safety considerations.

  • Contraindications: Do not use in women who are pregnant, have a history of thromboembolic disorders, or have known hypersensitivity to the components.
  • Smoking: Avoid in women over 35 who smoke, due to increased cardiovascular risk.
  • Cardiovascular disease: Use with caution in patients with hypertension, diabetes, or hyperlipidaemia.
  • Liver disease: Assess liver function; severe hepatic impairment is a contraindication.
  • Migraine with aura: Consider alternative contraception as risk of stroke is elevated.
  • Store at ambient temperature: Keep tablets below 25 °C in the original packaging, protected from moisture and light.

Avoid Interactions

Naiwanel 28 can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Anticoagulants: May reduce effectiveness of warfarin, requiring close INR monitoring.
  • Enzyme inducers: Rifampicin, carbamazepine, and phenytoin can markedly decrease hormone levels, risking contraceptive failure.
  • Selective serotonin reuptake inhibitors (SSRIs): Certain SSRIs may increase the risk of serotonin syndrome when combined with drospirenone.

Moderate Interactions (Monitor Closely)

  • Antihypertensives: Drospirenone may increase potassium levels, enhancing the effect of ACE inhibitors or potassium‑sparing diuretics.
  • Antifungals: Ketoconazole can increase plasma concentrations of ethinylestradiol.
  • Herbal supplements: St. John’s wort may modestly reduce contraceptive efficacy.

Frequently Asked Questions

Naiwanel 28 is a combined oral contraceptive indicated for the prevention of pregnancy. In addition, it is approved in many jurisdictions for the treatment of moderate acne and for relief of symptoms associated with premenstrual dysphoric disorder (PMDD).

The two hormones bind to estrogen and progestin receptors, suppressing the hypothalamic‑pituitary‑ovarian axis. This blocks the luteinizing hormone surge, preventing ovulation, while the progestin component thickens cervical mucus and alters the endometrium, creating an environment hostile to sperm and implantation.

The dosing regimen for Naiwanel 28 is determined by the prescribing healthcare professional. Typically, the product is taken once daily as directed, following the specific cycle schedule indicated on the prescription label.

Naiwanel 28 is classified as Pregnancy Category X, meaning it is contraindicated during pregnancy because it may cause fetal harm. It is also not recommended for breastfeeding mothers, as hormonal components can be transferred to the infant through breast milk.

To order Naiwanel 28, 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.

Naiwanel 28 contains drospirenone, a progestin with anti‑androgenic and mild diuretic properties, which can offer benefits such as reduced water retention and improved acne control compared with some older progestins. Its efficacy in preventing pregnancy is comparable to other FDA‑approved combined pills, while its side‑effect profile may differ slightly.

Store tablets at ambient temperature, preferably below 25 °C, in the original blister pack to protect them from moisture and light. Keep the product out of reach of children and do not use after the expiry date printed on the packaging.

Naiwanel 28 is taken orally, usually once each day at the same time, with or without food, according to the prescribing clinician’s instructions. Consistent daily intake helps maintain hormone levels and maximizes contraceptive effectiveness.

Serious risks include venous or arterial thromboembolism (such as deep‑vein thrombosis, pulmonary embolism, stroke, or myocardial infarction), severe hypertension, and liver dysfunction. Patients should seek immediate medical attention if they experience unexplained chest pain, shortness of breath, severe headache, visual changes, or abdominal pain.

Naiwanel 28 is contraindicated in women who are pregnant, have a history of thromboembolic disease, uncontrolled hypertension, severe liver disease, known hypersensitivity to any component, or who smoke cigarettes and are over 35 years of age. It should also be avoided in individuals with migraine with aura.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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