GNH USA

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.

Desogestrel, Ethinylestradiol

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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?+
Gracial contains the synthetic progestogen desogestrel and the synthetic estrogen ethinylestradiol.
How does Gracial prevent pregnancy?+
Gracial works by inhibiting ovulation and by causing changes in cervical mucus and the endometrium that make fertilization and implantation unlikely.
Is Gracial available without a prescription in the EU?+
No. Gracial is classified as a prescription‑only medication in the European Union.
Can I start Gracial immediately after giving birth?+
Gracial may be initiated after childbirth if a healthcare provider determines that estrogen‑containing contraception is appropriate and any postpartum risk factors have been evaluated.
What are the most common side effects of Gracial?+
Common side effects include nausea, headache, breast tenderness, and irregular spotting or breakthrough bleeding.
Are there serious risks associated with Gracial?+
Serious but rare risks include blood clots such as deep vein thrombosis, pulmonary embolism, stroke, and severe hypertension.
Should smokers over 35 use Gracial?+
Smoking in women older than 35 years is a contraindication for combined oral contraceptives like Gracial because of an increased risk of cardiovascular events.
Can I take antibiotics while using Gracial?+
Most antibiotics do not affect Gracial, but certain agents such as griseofulvin may reduce its effectiveness. Always inform your prescriber about any antibiotics you are prescribed.
Does Gracial affect menstrual cycle regularity?+
Gracial is often used to regulate menstrual cycles and may reduce the frequency of heavy or painful periods.
What should I do if I miss a Gracial tablet?+
If a tablet is missed, follow the guidance provided in the patient information leaflet or contact a healthcare professional for specific instructions.
Can Gracial be used while breastfeeding?+
Gracial is generally not recommended during breastfeeding because estrogen can reduce milk production; a healthcare provider can suggest alternative methods.
How long does it take for fertility to return after stopping Gracial?+
Fertility usually returns quickly after discontinuation, often within one to three menstrual cycles, but timing can vary among individuals.
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
Desogestrel, Ethinylestradiol
Route
Oral Use
Manufacturer
Aspen Pharma Trading Limited
Origin
EU

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