Gynalven (Progesterone, Micronised)

Gynalven is indicated for several hormonal and reproductive conditions where supplemental progesterone is required.

• Luteal phase support in assisted reproductive technologies such as in‑vitro fertilisation.
• Hormone replacement therapy to alleviate menopausal symptoms associated with low progesterone.
• Management of menstrual disorders, including amenorrhea and dysfunctional uterine bleeding.
• Prevention of preterm birth in selected high‑risk pregnancies.
• Adjunct therapy for certain cases of recurrent miscarriage linked to luteal insufficiency.
• Support of endometrial preparation for embryo implantation in fertility treatments.

Side effects reported with micronised progesterone tablets vary in frequency and severity; most are mild and transient, while a few may require medical attention.

Common

• Mild headache or dizziness.
• Nausea, abdominal discomfort or bloating.
• Breast tenderness or swelling.
• Fatigue or drowsiness.
• Mood changes or irritability.
• Weight gain or fluid retention.
• Changes in libido.

Serious

• Allergic reactions such as rash, itching, or swelling of the face.
• Signs of thromboembolic events, including sudden leg pain or shortness of breath.
• Severe abdominal pain indicating possible liver dysfunction.
• Unexplained vaginal bleeding.
• Elevated liver enzymes indicating hepatic stress.

When prescribing Gynalven, clinicians consider several precautionary measures to ensure safe use and to minimise risk.

• Assess for a history of thromboembolic disease before initiating therapy.
• Monitor liver function tests periodically during long‑term treatment.
• Use caution in patients with uncontrolled hypertension or cardiovascular disease.
• Evaluate for breast or uterine cancer, as progesterone may influence tumor growth.
• Discuss potential mood changes with patients who have a history of depression.
• Avoid use during known or suspected pregnancy unless specifically indicated.

Progesterone can interact with other medications by affecting metabolism or hormonal balance, so careful review of a patient’s drug regimen is recommended.

Avoid

• Concomitant use of strong CYP3A4 inducers (e.g., rifampicin, carbamazepine) that may reduce progesterone levels.
• Combined hormonal contraceptives containing estrogen, which can increase the risk of thromboembolic events.

Use with caution

• Antifungal agents such as ketoconazole that inhibit CYP3A4 and may raise progesterone concentrations.
• Anticoagulants, because progesterone may potentiate their effect on bleeding time.
• Sedatives or CNS depressants, as progesterone can enhance drowsiness.