Europe — EMA
Lafamme
GNH USA supplies Lafamme (Estradiol valerate/dienogest), a combined oral contraceptive for contraception and menstrual cycle regulation.
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What is Dienogest, Estradiol Valerate?
Estradiol valerate and dienogest, the active ingredients in Lafamme, are a combined oral contraceptive presented as an oral tablet for oral use. The formulation works by inhibiting ovulation and modifying cervical mucus, thereby preventing pregnancy, and it also assists in the regulation of menstrual cycles in women of reproductive age.
GNH USA supplies Lafamme as a licensed, GDP‑compliant international pharmaceutical supplier, adhering to EU quality standards and providing reliable logistics for hospitals, pharmacies and clinics worldwide. The company supports regulatory compliance and offers tailored distribution solutions across multiple regions.
What is Dienogest, Estradiol Valerate used for?
Lafamme, a combined oral contraceptive, is indicated for conditions related to reproductive hormone regulation.
- Contraception: Prevents unintended pregnancy by suppressing ovulation and altering cervical mucus. - Menstrual cycle regulation: Helps achieve more predictable menstrual bleeding patterns in women with irregular cycles. - PCOS symptom management: Improves androgen levels and menstrual regularity in women with polycystic ovary syndrome.
What are the side effects of Dienogest, Estradiol Valerate?
Lafamme may cause a range of adverse reactions, varying from mild to serious.
Common Side Effects: - Nausea: mild gastrointestinal upset, often transient. - Headache: tension‑type or migraine‑like pain. - Breast tenderness: discomfort or swelling of breast tissue. - Weight gain: modest fluid‑related increase. - Mood changes: irritability or emotional fluctuations. - Spotting or irregular bleeding: breakthrough bleeding during early cycles.
Serious or Rare Side Effects: - Deep vein thrombosis: blood clot formation in deep veins. - Pulmonary embolism: clot migration to lung vessels. - Stroke: cerebrovascular event due to clot or hemorrhage. - Myocardial infarction: heart attack risk in susceptible individuals. - Severe hypertension: sudden high blood pressure episodes. - Hepatic adenoma: rare benign liver tumor.
What precautions apply to Dienogest, Estradiol Valerate?
When prescribing Lafamme, clinicians should consider several precautionary measures to ensure patient safety.
- Contraindications: Avoid in women with a history of thromboembolic disorders, estrogen‑dependent tumors, or uncontrolled hypertension. - Smoking: Do not prescribe to women over 35 who smoke, due to increased cardiovascular risk. - Medication review: Assess concurrent use of enzyme‑inducing drugs that may reduce contraceptive effectiveness. - Pregnancy testing: Confirm negative pregnancy test before initiation. - Breastfeeding: Use only if benefits outweigh risks, as estrogen may affect milk production. - Store at room temperature: keep below 25°C in the original packaging, protect from moisture and light.
What does Dienogest, Estradiol Valerate interact with?
Lafamme can interact with other medicines, altering its efficacy or safety profile.
Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampicin, phenytoin): may cause contraceptive failure. - Anticoagulants (warfarin): increased risk of thrombosis. - SSRIs with QT‑prolongation potential: may heighten cardiac event risk.
Moderate Interactions (Monitor Closely): - Antiepileptics (carbamazepine): may lower hormone levels, monitor cycle control. - Antifungals (ketoconazole): may raise hormone concentrations, watch for side effects. - Herbal supplements (St. John’s wort): may decrease effectiveness, advise caution.
Frequently asked questions
What is Lafamme used for?+
How does estradiol valerate/dienogest work?+
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Is Lafamme safe in pregnancy or breastfeeding?+
How do I order Lafamme from GNH USA?+
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Product details
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