GNH USA

Europe — EMA

Gracial

Gracial combined oral contraceptive containing desogestrel and ethinylestradiol – EU prescription tablet for reliable pregnancy prevention.

Desogestrel, Ethinylestradiol

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What is Desogestrel, Ethinylestradiol?

Gracial is a combined oral contraceptive tablet that contains the synthetic progestin desogestrel and the estrogen ethinylestradiol. It is supplied as an oral tablet in the European market and is prescribed for hormonal contraception. The formulation works by suppressing gonadotropin release to prevent ovulation and by altering the endometrial lining, thereby reducing the chance of pregnancy. Gracial should be taken medical supervision and is not intended for use during pregnancy.

What is Desogestrel, Ethinylestradiol used for?

Gracial is indicated for the prevention of pregnancy in women of reproductive age who are seeking a reliable, reversible contraceptive method.

- Prevents ovulation through combined estrogen and progestin action. - Provides cycle control and reduces menstrual bleeding. - Can be used as a first‑line hormonal contraceptive for women without contraindications. - May be selected for its once‑daily oral dosing convenience. - Suitable for women who require a combined oral contraceptive rather than a progestin‑only option.

What are the side effects of Desogestrel, Ethinylestradiol?

Like other combined oral contraceptives, Gracial may cause a range of side effects, most of which are mild and transient.

Common: - Nausea or mild stomach upset. - Breast tenderness or enlargement. - Headache or mild migraine. - Spotting or breakthrough bleeding between periods. - Mood changes or irritability. - Weight gain or fluid retention.

Serious: - Blood clots in veins or arteries, which can present as leg swelling, chest pain, or shortness of breath. - Severe allergic reaction, including rash, itching, swelling of the face or throat, or difficulty breathing. - Liver problems indicated by jaundice or dark urine.

What precautions apply to Desogestrel, Ethinylestradiol?

Before prescribing Gracial, clinicians evaluate several health factors to ensure safe use and to minimize risk.

- History of venous or arterial thromboembolism, including deep‑vein thrombosis or pulmonary embolism. - Current or past cardiovascular disease such as hypertension, stroke, or myocardial infarction. - Smoking in women over 35 years of age. - Known or suspected pregnancy, as the product is contraindicated (Category X). - Liver disease or tumors that may affect hormone metabolism. - Migraine with aura or other neurological conditions that increase stroke risk. - Unexplained vaginal bleeding or abnormal uterine bleeding.

What does Desogestrel, Ethinylestradiol interact with?

Gracial can interact with other medicines, which may alter its effectiveness or increase the risk of adverse events.

Avoid: - Strong enzyme inducers such as rifampin, carbamazepine, phenytoin, or St John’s wort, which can reduce hormone levels. - Certain antiviral agents (e.g., efavirenz) that accelerate hormonal metabolism. - Medications that increase the risk of clotting, such as selective estrogen receptor modulators. - Certain antibiotics (e.g., griseofulvin) that may lower contraceptive effectiveness.

Use with caution: - Antifungal agents like ketoconazole that may increase hormone concentrations. - Antidepressants, especially SSRIs, which can affect bleeding patterns. - Herbal supplements such as ginseng that may interfere with contraceptive efficacy. - Diuretics that may affect fluid balance and blood pressure, requiring monitoring.

Frequently asked questions

What active ingredients are in Gracial?+
Gracial contains the synthetic progestin desogestrel and the estrogen ethinylestradiol.
How does Gracial prevent pregnancy?+
Gracial suppresses gonadotropin secretion to inhibit ovulation and alters the endometrial lining, reducing the chance of implantation.
Is Gracial available over the counter in the EU?+
No, Gracial is a prescription‑only medication (Rx) in the European Union.
Can I take Gracial if I smoke?+
Smoking, especially in women over 35, increases cardiovascular risk and is a contraindication for combined oral contraceptives like Gracial.
What are common side effects of Gracial?+
Common side effects include nausea, breast tenderness, headache, spotting between periods, mood changes, and mild weight gain.
What serious risks are associated with Gracial?+
Serious risks include blood clots, severe allergic reactions, and liver problems such as jaundice.
Should I use another form of contraception while starting Gracial?+
It is recommended to use a backup method (e.g., condoms) for the first seven days of active tablets to ensure contraceptive effectiveness.
Can antibiotics reduce the effectiveness of Gracial?+
Most antibiotics do not affect Gracial, but certain agents like griseofulvin may lower its effectiveness, so additional contraception may be advised.
Is Gracial safe for women with a history of blood clots?+
A history of venous or arterial thromboembolism is a contraindication; women with such a history should not use Gracial.
How should Gracial be taken for optimal effectiveness?+
Gracial should be taken once daily at the same time each day, with or without food, following the prescribed cycle.
What should I do if I miss a Gracial tablet?+
If a tablet is missed, take it as soon as remembered unless it is close to the time for the next dose; follow the specific missed‑dose instructions provided by your healthcare professional.
Can Gracial be used during breastfeeding?+
Gracial is generally not recommended during breastfeeding because hormonal contraceptives may affect milk production; consult a healthcare provider for alternatives.
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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