Europe — EMA
Naiwanel 28 (Drospirenone, Ethinylestradiol | Lactose)
GNH USA supplies Naiwanel 28 (Drospirenone/Ethinylestradiol), a combined oral contraceptive for pregnancy prevention, acne treatment, and PMDD relief.
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What is 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 USA 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.
What is Drospirenone, Ethinylestradiol | Lactose used for?
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.
What are the side effects of Drospirenone, Ethinylestradiol | Lactose?
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.
What precautions apply to Drospirenone, Ethinylestradiol | Lactose?
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.
What does Drospirenone, Ethinylestradiol | Lactose interact with?
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
What is Naiwanel 28 used for?+
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Who should not use Naiwanel 28?+
Product details
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