Europe — EMA
Gracial
Gracial is a combined oral contraceptive containing desogestrel and ethinylestradiol, used for pregnancy prevention and menstrual regulation.
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What is Desogestrel, Ethinylestradiol?
Gracial is a combined oral contraceptive tablet that contains the synthetic estrogen ethinylestradiol and the progestogen desogestrel. It is supplied as an oral tablet in the European market, with the specific strength of each component not publicly disclosed. Gracial is prescribed by healthcare professionals for hormonal contraception and menstrual cycle regulation. The medication is taken by mouth and is classified under the ATC code G03AA07.
What is Desogestrel, Ethinylestradiol used for?
Gracial is indicated for specific reproductive health purposes in women of childbearing age who require reliable contraception and may benefit from cycle regulation.
- Prevention of pregnancy as a combined oral contraceptive. - Regulation of menstrual cycle length and flow. - Management of dysmenorrhea associated with hormonal fluctuations. - Treatment of acne that improves with estrogen–progestogen therapy (off‑label in some regions). - Reduction of the risk of ovarian cyst formation in women with functional cysts.
What are the side effects of Desogestrel, Ethinylestradiol?
Like other combined oral contraceptives, Gracial may cause a range of side effects that vary in frequency and severity.
Common: - Nausea or mild stomach upset, often transient during the first weeks. - Breast tenderness or enlargement, which usually diminishes with continued use. - Headache, including tension‑type or mild migraine‑like symptoms. - Spotting or breakthrough bleeding, especially during the initial cycles. - Mood changes or mild depressive symptoms that may improve over time. - Weight gain or fluid retention, typically modest and reversible.
Serious: - Deep vein thrombosis, pulmonary embolism, or other thromboembolic events. - Severe hypertension, stroke, or other cardiovascular complications.
What precautions apply to Desogestrel, Ethinylestradiol?
Before prescribing Gracial, clinicians evaluate several safety considerations to minimize risks for each patient.
- History of thromboembolic disorders, cardiovascular disease, or uncontrolled hypertension. - Smoking in women over 35 years of age. - Known or suspected pregnancy, as the product is not indicated for use during gestation. - Liver disease or impaired hepatic function. - Migraine with aura or other neurologic conditions that increase stroke risk. - Breast cancer or estrogen‑dependent tumors. - Concomitant use of medications that increase clotting risk.
What does Desogestrel, Ethinylestradiol interact with?
Gracial can interact with other medicines, affecting its efficacy or safety profile.
Avoid: - Enzyme‑inducing anticonvulsants (e.g., carbamazepine, phenytoin, phenobarbital). - Rifampicin or other potent CYP3A4 inducers. - Certain antiretrovirals (e.g., efavirenz) that lower hormone levels. - Antiepileptic drug oxcarbazepine, which can diminish contraceptive efficacy.
Use with caution: - Antifungal agents such as ketoconazole that may increase hormone concentrations. - St. John’s wort, a mild CYP3A4 inducer, which may reduce contraceptive effectiveness. - Certain antibiotics (e.g., clarithromycin) that can alter plasma levels. - Selective serotonin reuptake inhibitors (SSRIs) that may affect bleeding patterns.
Frequently asked questions
What active ingredients are contained in Gracial?+
How is Gracial administered?+
For what primary purpose is Gracial prescribed?+
Can Gracial be used to regulate menstrual cycles?+
What are common side effects of Gracial?+
What serious adverse events should prompt immediate medical attention while using Gracial?+
Should smokers over 35 use Gracial?+
Are there any medications that reduce the effectiveness of Gracial?+
Can Gracial be taken together with antifungal medications?+
Is Gracial safe for women with a history of migraine with aura?+
What should a patient do if they miss a dose of Gracial?+
Is Gracial available over the counter?+
Product details
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