Tablets Of Levonorgestrel 0. 1 5 Mg + Ethinyloestradiol 0.03 Mg With 7 Tablets Of Ferrous Fumarate 60 Mg Eq. To Elemental Iron 19.5 Mg Combipack

Description

Product Description: The combination product consists of tablets containing Levonorgestrel 0.15 mg and Ethinyl Estradiol 0.03 mg, along with 7 tablets of Ferrous Fumarate 60 mg, equivalent to elemental iron 19.5 mg, packaged together as a combipack. Levonorgestrel and Ethinyl Estradiol are synthetic progestin and estrogen, respectively, used as hormonal contraceptives. Ferrous Fumarate is an iron supplement used to prevent or treat iron deficiency anemia.

Indications and Usage: This combipack is indicated for use as a hormonal contraceptive to prevent pregnancy in women of reproductive age. Additionally, the Ferrous Fumarate tablets are intended to supplement iron levels and prevent or treat iron deficiency anemia.

Dosage and Administration: The recommended dosage regimen involves taking one tablet containing Levonorgestrel 0.15 mg and Ethinyl Estradiol 0.03 mg daily for 21 consecutive days, followed by a 7-day interval without tablets. During the tablet-free interval, withdrawal bleeding usually occurs. The Ferrous Fumarate tablets should be taken once daily during the last 7 days of the menstrual cycle to supplement iron levels.

Dosage Forms and Strengths: The product is available as a combipack containing 21 tablets of Levonorgestrel 0.15 mg + Ethinyl Estradiol 0.03 mg and 7 tablets of Ferrous Fumarate 60 mg, equivalent to elemental iron 19.5 mg.

Contraindications: This combipack is contraindicated in women with a history of thromboembolic disorders, liver disease, hormone-sensitive cancers, or undiagnosed abnormal vaginal bleeding. It is also contraindicated in pregnant women and smokers over the age of 35.

Warnings and Precautions: Patients should be advised that this product does not protect against sexually transmitted infections (STIs) and should not be used as a sole method of contraception in high-risk populations. The risk of cardiovascular events, including stroke and myocardial infarction, increases with age and smoking status. Iron supplements may cause gastrointestinal discomfort and constipation.

Adverse Reactions/Side Effects: Common adverse reactions associated with hormonal contraceptives may include nausea, breast tenderness, headache, breakthrough bleeding, and mood changes. Adverse effects related to iron supplementation may include gastrointestinal upset, constipation, and dark stools.

Drug Interactions: Levonorgestrel + Ethinyl Estradiol tablets may interact with certain medications, including anticonvulsants, antibiotics, and herbal supplements, potentially reducing their efficacy or increasing the risk of adverse effects. Iron supplements may interact with medications that reduce stomach acid production, such as proton pump inhibitors, reducing iron absorption.

Use In Specific Populations Description: This combipack is intended for use in women of reproductive age who require contraception and may benefit from iron supplementation. It is not recommended during pregnancy or breastfeeding. Special caution should be exercised in women with certain medical conditions, such as hypertension or diabetes.

How Supplied/Storage and Handling: The combipack is typically supplied in blister packs containing 28 tablets (21 hormonal contraceptive tablets and 7 iron supplement tablets). It should be stored at room temperature (20°C to 25°C) away from moisture and heat. Unused tablets should be properly disposed of according to local regulations.