Europe — EMA
Gracial
Gracial is a combined oral contraceptive with desogestrel and ethinylestradiol, used for pregnancy prevention and menstrual regulation. Learn uses, side effects, and precautions.
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What is Desogestrel, Ethinylestradiol?
Gracial is a combined oral contraceptive tablet containing desogestrel and ethinylestradiol. It is supplied as an oral tablet, marketed in the European Union, and available by prescription only. The medication works by inhibiting ovulation and altering cervical mucus and the endometrium to prevent pregnancy, providing a reliable, reversible birth‑control option for women of reproductive age. It is taken daily in a 21‑day active regimen followed by a 7‑day hormone‑free interval.
What is Desogestrel, Ethinylestradiol used for?
Gracial is indicated for hormonal contraception and related clinical uses.
- Prevention of pregnancy in women of reproductive age. - Regulation of menstrual cycles. - Reduction of menstrual‑related symptoms such as dysmenorrhea. - Management of acne associated with androgen excess (off‑label in some regions). - May be used after childbirth or abortion when estrogen‑containing contraception is appropriate. - Treatment of premenstrual syndrome (PMS) symptoms when clinically appropriate. - Provide cycle control for women with irregular periods.
It is taken orally once daily as part of a cyclic regimen, typically 21 active tablets followed by a 7‑day hormone‑free interval.
What are the side effects of Desogestrel, Ethinylestradiol?
The safety profile of Gracial includes a range of adverse effects that may be experienced by users.
Most side effects are mild and tend to resolve within the first few cycles of use. Users should monitor any symptoms and consult a healthcare professional if they persist or worsen. The most frequently reported events are related to the estrogen component and are generally transient. If any serious adverse event occurs, immediate medical attention is required.
Common: - Nausea or mild stomach upset. - Headache or migraine. - Breast tenderness or enlargement. - Irregular spotting or breakthrough bleeding.
Serious: - Deep vein thrombosis or pulmonary embolism. - Stroke or transient ischemic attack. - Severe hypertension or hypertensive crisis.
What precautions apply to Desogestrel, Ethinylestradiol?
Before starting Gracial, certain health considerations and contraindications should be reviewed with a healthcare provider.
The medication is not suitable for women with certain risk factors, and a thorough medical history is essential. Women should discuss any current medications, smoking habits, and family history of clotting disorders before initiating therapy. - Known or suspected pregnancy. - History of thromboembolic disorders (e.g., deep vein thrombosis, pulmonary embolism). - Uncontrolled hypertension or cardiovascular disease. - Smoking in women over 35 years of age. - Liver disease or tumors. - Migraine with aura. - Breast cancer or estrogen‑dependent tumors.
What does Desogestrel, Ethinylestradiol interact with?
Gracial may interact with other medicines, which can affect its efficacy or increase the risk of adverse events.
Avoid: - Strong enzyme inducers (e.g., rifampin, carbamazepine, phenytoin) that reduce hormone levels. - Antifungal agents such as ketoconazole that increase hormone concentrations. - Certain HIV protease inhibitors that may alter metabolism. - Certain antibiotics like griseofulvin that may reduce contraceptive effectiveness.
Use with caution: - Anticoagulants (e.g., warfarin) – may require dose adjustment. - Antidepressants (e.g., SSRIs) – possible increased risk of bleeding. - Herbal supplements like St. John’s wort – may decrease contraceptive effectiveness. - Antiepileptic drugs (e.g., valproic acid) – monitor for reduced efficacy. - Diuretics (e.g., thiazides) – may increase risk of hypertension.
Frequently asked questions
What hormones are contained in Gracial?+
How does Gracial prevent pregnancy?+
Is Gracial available without a prescription in the EU?+
Can I start Gracial immediately after giving birth?+
What are the most common side effects of Gracial?+
Are there serious risks associated with Gracial?+
Should smokers over 35 use Gracial?+
Can I take antibiotics while using Gracial?+
Does Gracial affect menstrual cycle regularity?+
What should I do if I miss a Gracial tablet?+
Can Gracial be used while breastfeeding?+
How long does it take for fertility to return after stopping Gracial?+
Product details
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