Europe — EMA
Goibela
Goibela contains dydrogesterone, a progestogen used in hormone therapy for luteal phase support, menstrual disorders, and early pregnancy maintenance.
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What is Dydrogesterone?
Goibela is a prescription medication that contains dydrogesterone as its active ingredient. It is supplied in oral dosage form, although the strength is not disclosed in the available information. Marketed within the European Union, Goibela belongs to the progestogen class and is used in hormone therapy to support the luteal phase of the menstrual cycle and early pregnancy. The drug acts as a selective agonist of progesterone receptors.
What is Dydrogesterone used for?
Goibela is indicated for several reproductive health conditions where progestogenic support is required.
- Luteal phase support in assisted reproductive technologies such as in vitro fertilization. - Treatment of menstrual disorders associated with progesterone deficiency, including irregular cycles and amenorrhea. - Management of infertility related to luteal phase insufficiency. - Support in early pregnancy to help prevent miscarriage in women with a history of recurrent loss. - Hormone therapy for women with luteal phase deficiency undergoing ovulation induction protocols. - Adjunctive treatment in women experiencing premenstrual syndrome where progesterone supplementation may alleviate symptoms.
What are the side effects of Dydrogesterone?
Goibela, like other progestogens, may cause a range of side effects that vary in frequency and severity.
Common: - Nausea or mild gastrointestinal discomfort. - Breast tenderness or swelling. - Headache or mild dizziness. - Mood changes such as irritability or mild depression. - Fluid retention leading to mild swelling of the ankles. - Decreased libido or sexual desire. - Weight gain or increased appetite.
Serious: - Signs of venous thromboembolism, such as leg pain, swelling, or shortness of breath. - Severe allergic reactions, including rash, itching, swelling of the face or throat, and difficulty breathing. - Unusual vaginal bleeding or spotting. - Liver dysfunction indicated by jaundice or dark urine. - Persistent abdominal pain that may indicate gallbladder disease.
What precautions apply to Dydrogesterone?
When prescribing Goibela, healthcare professionals consider several precautions to ensure safe use and to minimize risks.
- Evaluate for a history of thromboembolic disorders before initiating therapy. - Assess liver function, as hepatic impairment may affect drug metabolism. - Use caution in patients with known hormone-sensitive cancers such as breast or endometrial carcinoma. - Monitor for signs of depression or mood disorders during treatment. - Consider the potential for fluid retention in individuals with hypertension or cardiac disease. - Review any history of allergic reactions to progestogens.
What does Dydrogesterone interact with?
Goibela may interact with other medications, influencing its effectiveness or increasing the risk of adverse effects.
Avoid: - Combined use with other hormonal contraceptives or progestogenic agents, which can increase progestogenic load. - Concomitant administration of strong CYP3A4 inducers (e.g., rifampicin, phenytoin) that may reduce dydrogesterone plasma levels.
Use with caution: - Anticoagulants such as warfarin, where progestogens may alter coagulation parameters. - Antidepressants, particularly SSRIs, which can affect mood-related side effects. - Medications that cause fluid retention (e.g., corticosteroids), potentially enhancing edema. - Herbal supplements like St. John’s wort, a CYP3A4 inducer that could lower drug exposure.
Frequently asked questions
What is the mechanism of action of dydrogesterone in Goibela?+
Is Goibela approved for use in the European Union?+
Can Goibela be used for menstrual irregularities?+
What are common side effects of Goibela?+
When should Goibela be avoided?+
Is it safe to take Goibela with anticoagulant therapy?+
Does Goibela have any impact on liver function?+
Can Goibela be used during assisted reproductive technology cycles?+
What precautions are needed for patients with a history of blood clots?+
Are there any known drug interactions with St. John’s wort?+
Is Goibela suitable for women with hormone‑sensitive cancers?+
Product details
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