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This document outlines important safety information and warnings concerning the use of Cryselle, a combined oral contraceptive. It is crucial to understand the potential risks and take appropriate precautions. If you have any concerns, please consult your healthcare provider.

• Smoking and Heart Risks: Smoking cigarettes while using Cryselle significantly increases the risk of serious health issues, including stroke, heart attack, and blood clots. This risk is especially high for women over 35 who smoke. If you are a smoker, discuss safer alternatives with your healthcare provider.

• Blood Clots and Strokes: Cryselle can elevate the risk of developing blood clots, which may occur in various parts of the body, such as the lungs, legs, brain, or heart. It is important to seek emergency medical care if you suspect a blood clot. Individuals at higher risk include smokers over 35, those with recent surgery, high blood pressure, obesity, high cholesterol, diabetes, or those who have recently given birth.

• Cancer Risks: There is a potential increase in the risk of breast and cervical cancer associated with Cryselle use. This risk is particularly concerning for those with a history of breast cancer or long-term use of contraceptive pills.

• Liver Concerns: Though rare, Cryselle may cause liver damage or tumors, especially in those with existing liver problems. If symptoms such as fatigue, abdominal pain, or jaundice occur, contact a healthcare provider immediately.

• Blood Sugar and Triglycerides: Cryselle may raise blood sugar and triglyceride levels. Individuals with diabetes or a family history of high triglycerides should monitor their levels and report any changes to their healthcare provider.

• Blood Pressure: It is important to monitor blood pressure while taking Cryselle, as it can cause an increase. Consult your healthcare provider if you have uncontrolled high blood pressure before starting this medication.

• Headaches: If you experience severe or persistent headaches, especially migraines, contact your healthcare provider.

• Irregular Bleeding: Spotting or breakthrough bleeding is common, particularly within the first three months of use. Notify your healthcare provider if you experience unusual bleeding patterns.

• Depression: Report any new or worsening symptoms of depression to your healthcare provider, as they may recommend discontinuing use.

• Gallbladder Issues: Cryselle may increase the risk of gallbladder disease. Discuss with your healthcare provider if you have a history of gallbladder problems.

• Drug Interactions: Inform your healthcare provider about all medications you are taking, as certain drugs can affect the efficacy of Cryselle. Use additional birth control methods as advised when taking medications that interact with Cryselle.

Contraindications: Do not use Cryselle if you have any of the following conditions:

• History or presence of blood clot issues such as DVT or PE.
• Smoking and over 35 years of age.
• Cerebrovascular or coronary artery disease.
• Specific heart conditions or diabetes with vessel problems.
• Certain types of headaches, particularly migraines with aura in those over 35.
• Uncontrolled high blood pressure.
• Current or past hormone-sensitive breast cancer.
• Unexplained abnormal vaginal bleeding.
• Liver tumors or disease.
• Pregnancy.
• Use of certain hepatitis C medications.

Always consult your healthcare provider if you have concerns about using Cryselle or if any contraindications apply to you.

When taking this medication, some common side effects might occur, including nausea, vomiting, headache, bloating, and breast tenderness. You may also experience fluid retention leading to swelling of the ankles or feet, changes in weight, or irregular or missed periods, particularly in the initial months. Other mild side effects can include back pain, vaginal discharge, acne, stomach pain, cramps, increased appetite, and mood changes like depression or nervousness. These effects are usually manageable, but if they persist or worsen, it's advisable to consult your healthcare provider.

Occasionally, the medication can cause darker skin patches, fatigue, or exacerbate varicose veins. It can also lead to an increase in blood pressure, so regular monitoring is recommended. If you observe any serious symptoms, such as lumps in the breast, significant mood changes, severe stomach pain, or unusual vaginal bleeding patterns, seek medical advice promptly.

Rare, yet severe, side effects include those related to blood clots, such as heart attack, stroke, deep vein thrombosis, or pulmonary embolism. Symptoms of these conditions may include chest pain, dizziness, sudden weakness, trouble speaking, or breathing difficulties. Additionally, serious liver issues can arise, indicated by yellowing of the skin or eyes and severe fatigue. These symptoms necessitate immediate medical attention. While a severe allergic reaction is uncommon, symptoms like rash, swelling, severe dizziness, or trouble breathing require urgent care. Always report any other unexpected effects to your healthcare provider.