GNH USA

Europe — EMA

Gracial

Gracial is a combined oral contraceptive containing desogestrel and ethinylestradiol, used for reliable pregnancy prevention.

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 in the European market and is prescribed for hormonal contraception. The formulation delivers a dose of each active ingredient to inhibit ovulation, modify cervical mucus, and alter the endometrial lining, providing reliable pregnancy prevention. It is intended for women who have decided to avoid pregnancy and seek reliable contraception.

What is Desogestrel, Ethinylestradiol used for?

Gracial is indicated for the prevention of pregnancy in women of childbearing potential.

- Primary indication: hormonal contraception for preventing unintended pregnancy. - May be used as a reversible method of birth control for women seeking a non‑invasive option. - Can be part of a regimen that includes regular monthly cycles when taken as directed. - Often prescribed for women who prefer a combined estrogen‑progestin oral contraceptive. - May be considered for cycle regulation in women with irregular menstrual patterns. - Can be used in conjunction with counseling on sexual health and other contraceptive methods.

What are the side effects of Desogestrel, Ethinylestradiol?

Side effects of Gracial vary in frequency and severity; most are mild and transient.

Common: - Nausea, mild stomach upset, or occasional vomiting, especially during the first cycle. - Headache, including tension‑type or migraine‑like pain, which often resolves with continued use. - Breast tenderness, swelling, or a feeling of fullness that usually diminishes after several weeks. - Spotting, breakthrough bleeding, or irregular menstrual flow during the initial months of therapy.

Serious: - Deep vein thrombosis, pulmonary embolism, or other thromboembolic events, which require immediate medical attention. - Severe allergic reactions such as hives, swelling of the face or throat, or difficulty breathing. - Signs of liver problems, including jaundice, dark urine, or markedly elevated liver enzymes.

What precautions apply to Desogestrel, Ethinylestradiol?

Before prescribing Gracial, clinicians assess several health factors to ensure safe use and to minimize risks.

- History of thromboembolic disorders, cardiovascular disease, or uncontrolled hypertension. - Current or past smoking, especially in women over 35 years of age. - Known or suspected pregnancy, as hormonal contraceptives are not indicated during pregnancy. - Liver disease, gallbladder disease, or severe diabetes with vascular complications. - Breast cancer, estrogen‑dependent tumors, or other hormone‑sensitive conditions. - Use of medications that increase clotting risk, such as certain antiretrovirals or hormonal therapies.

What does Desogestrel, Ethinylestradiol interact with?

Gracial may interact with other medicines, affecting its efficacy or increasing the risk of adverse events.

Avoid: - Combined hormonal contraceptives or other estrogen‑containing products, which can increase estrogen‑related side effects. - Strong enzyme inducers such as rifampin, carbamazepine, phenytoin, or St. John’s wort, which may reduce contraceptive effectiveness. - Certain antiretroviral drugs (e.g., protease inhibitors) that alter hormone metabolism. - Certain anticonvulsants (e.g., phenobarbital) that may diminish contraceptive reliability.

Use with caution: - Antifungal agents like ketoconazole or itraconazole that can increase hormone levels. - Antidepressants, particularly SSRIs, that may affect bleeding patterns. - Diuretics or antihypertensive agents that could influence fluid balance and blood pressure. - Herbal supplements such as ginseng that may interfere with hormone metabolism.

Frequently asked questions

What active ingredients are in Gracial?+
Gracial contains the synthetic progestin desogestrel and the estrogen ethinylestradiol.
How does Gracial prevent pregnancy?+
It works by suppressing ovulation, thickening cervical mucus, and altering the uterine lining to prevent implantation.
Is Gracial available over the counter?+
No, Gracial is a prescription‑only medication in the European Union.
Can I start Gracial if I am a smoker over 35 years old?+
Smoking over the age of 35 increases cardiovascular risk and is generally considered a contraindication for combined oral contraceptives like Gracial.
What are the most common side effects of Gracial?+
Common side effects include nausea, headache, breast tenderness, and spotting or breakthrough bleeding during the first few cycles.
Are there any serious risks associated with Gracial?+
Rare but serious risks include blood clots such as deep vein thrombosis or pulmonary embolism, severe allergic reactions, and liver problems.
Should I take Gracial with any other medications?+
Certain drugs, especially strong enzyme inducers like rifampin or some anticonvulsants, can reduce its effectiveness and should be avoided.
Can Gracial be used while breastfeeding?+
Combined oral contraceptives are generally not recommended during breastfeeding without medical advice, as they may affect milk production.
How should Gracial be taken for optimal effectiveness?+
It should be taken once daily at the same time each day, starting on the first day of the menstrual cycle or as directed by a healthcare provider.
What should I do if I miss a dose of Gracial?+
If a dose is missed, take it as soon as you remember unless it is close to the time for the next dose; then continue with the regular schedule and consider using backup contraception.
Is Gracial suitable for women with a history of blood clots?+
Women with a personal or family history of thromboembolic events should avoid combined oral contraceptives like Gracial and discuss alternative methods with their doctor.
Can Gracial cause weight gain?+
Weight changes are not a common side effect, but fluid retention or increased appetite may occur in some 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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