GNH USA

Europe — EMA

Kelzy

GNH USA supplies Kelcy (Dienogest/Ethinylestradiol), a combined oral contraceptive for prevention of pregnancy and menstrual cycle regulation.

Dienogest, Ethinylestradiol | Lactose

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What is Dienogest, Ethinylestradiol | Lactose?

Dienogest and ethinylestradiol, the active ingredients in Kelcy, are a combined oral contraceptive presented as a tablet for oral use. They work to prevent pregnancy and to regulate menstrual cycles in women of reproductive age by modulating hormonal pathways. It is indicated for women seeking reliable contraception and for those needing cycle control, and is marketed throughout the European Union.

GNH USA supplies Kelcy as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The product complies with EU regulatory standards and is distributed to a global network of healthcare providers.

What is Dienogest, Ethinylestradiol | Lactose used for?

Kelcy is a combined hormonal contraceptive that acts on the hypothalamic‑pituitary‑ovarian axis to prevent pregnancy and manage menstrual patterns. - Contraception: provides reliable prevention of pregnancy when taken as prescribed. - Menstrual cycle regulation: helps achieve more predictable bleeding and reduces irregular spotting. - Hormonal cycle management: assists in treating cycle‑related symptoms such as dysmenorrhea and heavy bleeding.

What are the side effects of Dienogest, Ethinylestradiol | Lactose?

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

Common Side Effects: - Nausea: mild to moderate stomach upset. - Headache: tension‑type or migraine‑like pain. - Breast tenderness: swelling or discomfort of the breasts. - Spotting or irregular bleeding: unscheduled light bleeding. - Mood changes: irritability or mild depressive symptoms. - Weight gain: modest increase in body weight.

Serious or Rare Side Effects: - Deep vein thrombosis: blood clot formation in deep veins. - Pulmonary embolism: clot migration to lung vessels. - Stroke: cerebrovascular accident due to clot or hemorrhage. - Myocardial infarction: heart attack risk, especially in high‑risk women. - Severe allergic reaction (anaphylaxis): rash, swelling, breathing difficulty. - Liver disorders: jaundice, hepatitis, or hepatic dysfunction.

What precautions apply to Dienogest, Ethinylestradiol | Lactose?

Before prescribing Kelcy, clinicians should assess individual risk factors and contraindications. - Contraindicated in pregnancy: product must not be used by pregnant women (Category X). - Avoid in smokers over 35: increased risk of cardiovascular events. - Assess thromboembolic risk: do not use in women with a history of clotting disorders. - Monitor blood pressure: may cause hypertension; regular checks recommended. - Review liver function: hepatic impairment may affect hormone metabolism. - Store at ambient temperature: keep below 25°C in the original pack, protect from moisture.

What does Dienogest, Ethinylestradiol | Lactose interact with?

Kelcy can interact with several drug classes, affecting its efficacy or safety.

Major Interactions (Avoid): - Antiepileptic enzyme inducers (e.g., carbamazepine, phenytoin): reduce contraceptive efficacy. - Rifampicin: markedly decreases hormone levels, risking pregnancy. - Antiretroviral protease inhibitors (e.g., ritonavir): may increase hormone concentrations leading to toxicity. - St. John’s wort: induces metabolism, decreasing effectiveness.

Moderate Interactions (Monitor Closely): - Antibiotics (e.g., tetracycline): may slightly reduce efficacy; monitor menstrual cycle. - Antifungals (e.g., ketoconazole): may increase hormone levels; watch for side effects. - Diuretics (e.g., spironolactone): may affect fluid balance; monitor blood pressure.

Frequently asked questions

What is Kelcy used for?+
Kelcy is a combined oral contraceptive indicated for the prevention of pregnancy and for regulation of menstrual cycles in women of reproductive age. It provides reliable birth control and helps achieve more predictable bleeding patterns, reducing irregular spotting and associated symptoms.
How does dienogest and ethinylestradiol work in Kelcy?+
Dienogest acts as a progestogen, suppressing the mid‑cycle surge of luteinising hormone (LH) and follicle‑stimulating hormone (FSH) to inhibit ovulation. Ethinylestradiol supplies estrogenic feedback that stabilises the endometrium, enhances gonadotropin suppression, and modifies cervical mucus, creating an environment less favorable for sperm penetration.
What is the usual dose of Kelcy?+
The dosing regimen for Kelcy is determined by a qualified prescriber. Typically, it is taken as one tablet daily at the same time each day, but the exact schedule, start day, and any missed‑dose instructions are individualized based on the patient’s clinical situation.
Is Kelcy safe to use during pregnancy or breastfeeding?+
Kelcy is classified as pregnancy category X, meaning it must not be used by pregnant women because it can cause fetal harm. While limited data exist for breastfeeding, the estrogen component may affect milk production; clinicians should weigh benefits against potential risks before prescribing to nursing mothers.
How do I order Kelcy from GNH USA?+
To order Kelcy, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies and procurement teams worldwide. After submission, the sales team will verify trade or institutional credentials, then provide pricing, availability, shipping details and any required import documentation.
How does Kelcy compare with other combined oral contraceptives?+
Kelcy contains dienogest, a progestogen with a lower androgenic profile than many older agents, combined with ethinylestradiol. This formulation may offer improved cycle control and a reduced risk of certain side effects such as acne, while maintaining contraceptive efficacy comparable to other standard combined oral contraceptives.
What are the storage and handling requirements for Kelcy?+
Kelcy tablets should be stored at ambient temperature, below 25 °C, in the original blister pack to protect them from moisture and light. Keep the medication out of reach of children and do not use after the expiration date printed on the packaging.
How is Kelcy administered?+
Kelcy is taken orally as a tablet, usually with or without food. It should be taken at the same time each day to maintain steady hormone levels. If a dose is missed, follow the specific missed‑dose instructions provided by the prescribing healthcare professional.
What are the most serious risks associated with Kelcy?+
The most serious risks include thromboembolic events such as deep‑vein thrombosis, pulmonary embolism, stroke, and myocardial infarction. These risks are higher in women who smoke, are over 35, or have a personal or family history of clotting disorders, and require immediate medical attention if symptoms arise.
Who should not use Kelcy?+
Kelcy should not be used by women who are pregnant, have a known hypersensitivity to any component, have a history of thromboembolic disease, uncontrolled hypertension, severe liver disease, or are smokers over the age of 35. It is also contraindicated in patients with certain hormone‑sensitive cancers.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Dienogest, Ethinylestradiol | Lactose
Route
Oral Use
Manufacturer
Exeltis Czech S.R.O.
Origin
EU

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