GNH USA

Europe — EMA

Lafamme

GNH USA supplies Lafamme (Estradiol valerate/dienogest), a combined oral contraceptive for contraception and menstrual cycle regulation.

Dienogest, Estradiol Valerate

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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?+
Lafamme is a combined oral contraceptive indicated for preventing unintended pregnancy and for regulating menstrual cycles in women of reproductive age. It works by suppressing ovulation and modifying cervical mucus, providing reliable hormonal birth control while also helping to achieve more predictable bleeding patterns.
How does estradiol valerate/dienogest work?+
The product combines estradiol valerate, an estrogen, with dienogest, a progestogen. Estradiol delivers negative feedback to the hypothalamic‑pituitary‑ovarian axis, reducing follicle‑stimulating hormone release, while dienogest blocks the luteinizing hormone surge, preventing ovulation. The progestogen also thickens cervical mucus and alters the endometrial lining, making implantation unlikely.
What is the usual dose of Lafamme?+
The dosing regimen for Lafamme is determined by the prescribing healthcare professional based on the patient’s medical history and clinical guidelines. Typically, combined oral contraceptives are taken once daily, but the exact tablet strength, number of tablets per pack, and cycle length should be confirmed by the prescriber.
Is Lafamme safe in pregnancy or breastfeeding?+
Lafamme is classified as pregnancy category X, meaning it must not be used during pregnancy because it can harm the fetus. For breastfeeding women, the decision to use Lafamme should be made after weighing potential benefits against risks, as estrogen may affect milk production and infant exposure.
How do I order Lafamme from GNH USA?+
To order Lafamme, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies and procurement teams worldwide, and will request verification of trade or institutional credentials. After confirmation, the sales team provides pricing, availability, shipping details and any necessary import documentation.
How does Lafamme compare with other combined oral contraceptives?+
Lafamme contains estradiol valerate and dienogest, a progestogen with a relatively low androgenic profile, which may result in fewer acne‑related side effects compared with some older formulations. Its estrogen component is a natural estradiol derivative, offering a more physiological hormone replacement than ethinylestradiol used in many other pills.
How should Lafamme be stored and handled?+
Lafamme tablets should be stored at room temperature, below 25 °C, in their original blister pack to protect from moisture and light. Keep the medication out of reach of children and avoid storing in bathrooms or other humid environments. Do not freeze or refrigerate the tablets.
How is Lafamme administered?+
Lafamme is taken orally, usually once daily at the same time each day. The tablets are swallowed whole with water and can be taken with or without food. Patients should follow the prescriber’s instructions regarding the start of the first pack and any missed‑dose procedures.
What are the most serious risks associated with Lafamme?+
The most serious risks include thromboembolic events such as deep‑vein thrombosis, pulmonary embolism, stroke, and myocardial infarction, especially in women with pre‑existing risk factors. Severe hypertension, hepatic adenoma, and rare allergic reactions are also considered serious. Immediate medical attention is required if symptoms of these conditions appear.
Who should not use Lafamme?+
Lafamme is contraindicated for women with a history of blood clotting disorders, estrogen‑dependent tumors, uncontrolled hypertension, severe
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, Estradiol Valerate
Route
Oral Use
Manufacturer
Jenapharm Gmbh & Co Kg
Origin
EU

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