GNH USA

Europe — EMA

Gracial

Gracial is a combined oral contraceptive tablet containing desogestrel and ethinylestradiol, used for reliable hormonal birth control.

Desogestrel, Ethinylestradiol

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What is Desogestrel, Ethinylestradiol?

Gracial is a combined oral contraceptive tablet containing the synthetic hormones desogestrel and ethinylestradiol. Marketed in the European Union, it is available by prescription only. Each tablet provides a fixed dose of the two active ingredients to deliver hormonal contraception. Gracial belongs to the drug class of combined oral contraceptives and is taken orally once daily by women of reproductive age and is intended for reliable birth control.

What is Desogestrel, Ethinylestradiol used for?

Gracial is prescribed for hormonal contraception and is used to prevent unintended pregnancy.

- Taken as a single tablet each day for three weeks followed by a one‑week hormone‑free interval. - Provides continuous suppression of ovulation by inhibiting the luteinizing hormone (LH) and follicle‑stimulating hormone (FSH) surge. - Improves cycle regularity and can reduce menstrual‑related symptoms such as heavy bleeding. - May be used to manage moderate acne that improves with combined estrogen‑progestin therapy. - Can be part of a broader contraceptive plan that includes counseling on correct use and backup methods.

What are the side effects of Desogestrel, Ethinylestradiol?

The safety profile of Gracial includes both common, usually mild, side effects and rare, potentially serious adverse events.

Common: - Nausea or mild gastrointestinal upset, especially during the first cycles. - Breast tenderness or swelling that usually resolves within a few weeks. - Headache ranging from mild to moderate intensity. - Weight fluctuations, often due to water retention. - Mood changes, including irritability or mild depressive symptoms. - Irregular spotting or breakthrough bleeding, particularly in the initial months.

Serious: - Deep vein thrombosis (DVT) presenting as leg pain, swelling, or redness. - Pulmonary embolism, which may cause sudden shortness of breath and chest pain. - Ischemic stroke, characterized by sudden neurological deficits such as weakness or speech difficulty. - Myocardial infarction (heart attack) with chest discomfort, radiating arm pain, or nausea. - Severe allergic reaction (anaphylaxis) including hives, swelling of the face, and difficulty breathing.

What precautions apply to Desogestrel, Ethinylestradiol?

Before prescribing Gracial, clinicians should evaluate individual risk factors and counsel patients on safe use.

- History of thromboembolic disorders, cardiovascular disease, or uncontrolled hypertension. - Current or recent pregnancy, as combined oral contraceptives are contraindicated. - Smoking, especially in women over 35 years of age. - Migraine with aura or other neurologic conditions that increase stroke risk. - Liver disease, including severe hepatic impairment. - Breast cancer or other estrogen‑sensitive malignancies. - Use of medications that may reduce contraceptive efficacy (e.g., certain antibiotics, anticonvulsants).

What does Desogestrel, Ethinylestradiol interact with?

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

Avoid: - Selective serotonin reuptake inhibitors (SSRIs) that increase bleeding risk when combined with estrogen. - Antifungal agents such as ketoconazole that can raise hormone levels. - Strong enzyme inducers like rifampin, carbamazepine, phenytoin, and St. John’s wort, which may lower contraceptive efficacy.

Use with caution: - Antibiotics (e.g., tetracyclines, macrolides) that may slightly reduce hormone levels. - Antiretroviral drugs used in HIV therapy, which can affect hormone metabolism. - Herbal supplements, especially those containing phytoestrogens, that could alter contraceptive action.

Frequently asked questions

What is the mechanism of action of Gracial?+
Gracial works by suppressing ovulation through inhibition of luteinizing hormone (LH) and follicle‑stimulating hormone (FSH) release, while also thickening cervical mucus and altering the endometrial lining to prevent implantation.
How should Gracial be taken for optimal contraceptive effect?+
Gracial should be taken once daily at the same time each day for 21 consecutive days, followed by a 7‑day hormone‑free interval during which withdrawal bleeding occurs.
Can Gracial be used by smokers over the age of 35?+
Smoking in women older than 35 years is a contraindication for combined oral contraceptives like Gracial because it increases the risk of cardiovascular events.
What are the most common side effects experienced with Gracial?+
Common side effects include nausea, breast tenderness, mild headache, weight changes due to fluid retention, mood fluctuations, and occasional spotting or breakthrough bleeding.
How long does it take for Gracial to become effective after starting the first pack?+
If Gracial is started within the first five days of a menstrual period, protection is immediate; otherwise, a backup method (e.g., condoms) should be used for the first seven days.
Is it safe to take Gracial while using antibiotics?+
Most antibiotics do not significantly affect Gracial’s efficacy, but a few (especially certain tetracyclines and macrolides) may slightly reduce hormone levels, so a backup method is advised.
Can Gracial cause weight gain or changes in appetite?+
Some users report mild weight fluctuations, usually related to water retention; significant weight gain is uncommon and not directly caused by the hormones.
What should I do if I miss a dose of Gracial?+
If a tablet is missed, take it as soon as remembered. If it is more than 24 hours late, use a backup contraceptive method for the next seven days and consider emergency contraception if unprotected intercourse occurred.
Are there any medical conditions that make Gracial unsuitable?+
Conditions such as a history of blood clots, uncontrolled hypertension, liver disease, estrogen‑dependent tumors, migraine with aura, and current pregnancy contraindicate the use of Gracial.
How does Gracial compare to other combined oral contraceptives?+
Gracial contains desogestrel, a third‑generation progestin, which may have a lower risk of androgenic side effects compared with some older formulations, while providing similar contraceptive efficacy.
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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