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This safety and warning information is essential for those considering or currently using Pirmella 1/35. It outlines potential risks, necessary precautions, and specific instructions for individuals with certain conditions or lifestyles. If you have any questions or concerns, please consult your healthcare provider.

• Cigarette Smoking and Heart Risks: Using Pirmella 1/35 while smoking cigarettes significantly increases the risk of serious heart conditions, such as heart attack and stroke, especially for women over 35 years old. Discuss alternative birth control options with your healthcare provider if you are a smoker.

• Blood Clot Risk: Pirmella 1/35 may lead to serious, potentially life-threatening blood clots due to its ethinyl estradiol content. This risk is elevated for women over 35 who smoke, individuals over 40 who do not smoke, those who have recently had surgery with prolonged bed rest, women who start COCs within a month after childbirth, people with high blood pressure, obesity, high cholesterol, diabetes, or those taking higher doses of estrogen. Be vigilant for symptoms of blood clots and seek immediate medical attention if they occur.

• Cancer Risk: The relationship between Pirmella 1/35 and increased risk of breast and cervical cancer is uncertain. However, prolonged use (over 5 years) may heighten the risk of cervical cancer. Avoid this medication if you have a history of breast or cervical cancer. Ensure regular screenings and consult your provider if you notice signs of these cancers.

• Liver Issues: Avoid Pirmella 1/35 if you have liver problems, such as viral hepatitis or liver tumors. This medication can increase the risk of benign liver tumors. Discontinue use and consult your provider if you experience symptoms like jaundice, fever, fatigue, loss of appetite, or dark urine.

• Gallbladder Concerns: Some evidence suggests Pirmella 1/35 may increase the risk of gallbladder disease. Discuss your medical history regarding gallbladder issues with your provider before starting this medication.

• Blood Sugar and Triglycerides: Pirmella 1/35 can elevate blood sugar and triglyceride levels. This poses a higher risk for individuals with prediabetes or diabetes. Consult your provider to assess your risk and possibly consider alternative birth control methods.

• Blood Pressure: This medication may raise blood pressure, particularly in older individuals or those with a history of kidney issues or uncontrolled hypertension. Regularly monitor your blood pressure and discuss the risks versus benefits of using Pirmella 1/35 with your provider.

• Headaches: Inform your provider if you develop new or worsening migraines or headaches while taking Pirmella 1/35. Discontinuation may be necessary if symptoms persist or worsen.

• Irregular Bleeding: Irregular bleeding or spotting is common during the first three months of using Pirmella 1/35. If bleeding persists, becomes heavier, or you miss a period, contact your provider for evaluation.

• Drug Interactions: Be aware that certain medications can alter how your body processes Pirmella 1/35, affecting its efficacy and side effects. Discuss all medications you are taking with your provider.

Contraindications: Do not use Pirmella 1/35 if you have or have had:

• Deep vein thrombosis (DVT), pulmonary embolism (PE), or other clotting disorders
• Cerebrovascular disease
• Coronary artery disease
• Specific heart valve issues
• Uncontrolled high blood pressure
• Diabetes with vascular complications
• Specific headaches with neurological symptoms
• Long-term post-surgical bed rest
• Breast cancer history
• Endometrial or other estrogen-dependent tumors
• Unexplained vaginal bleeding
• Jaundice in pregnancy or during birth control use
• Liver tumors or problems
• Pregnancy
• Currently taking hepatitis C medications containing ombitasvir, paritaprevir, ritonavir, with or without dasabuvir.

Always consult your healthcare provider to ensure Pirmella 1/35 is safe for you.

Common side effects:

• Nausea
• Vomiting
• Abdominal cramps
• Bloating
• Changes in menstrual cycle
• Spotting
• Change in flow
• Missed periods
• Swelling
• Brown patches on the face
• Tender or swollen breasts
• Fluctuations in weight
• Migraines

Less common but important to monitor:

• Vaginal yeast infections
• Discomfort when wearing contact lenses
• Mood changes
• Fatigue
• Rashes

Serious side effects:

• Heart attack
• Stroke
• Deep vein thrombosis
• Pulmonary embolism
• Liver problems

When taking Alyacen 1/35, it's important to be aware of potential interactions with other medications, foods, and health conditions that could affect its effectiveness or increase the risk of side effects.

Drug Interactions:

• Enzyme-Inducing Medications: Certain drugs can decrease the effectiveness of Alyacen 1/35 by accelerating the breakdown of its hormones. These include:

  • Antiepileptic drugs such as Phenytoin, Carbamazepine, and barbiturates.
  • Antibiotics like Rifampin and Rifabutin.
  • Herbal supplements such as St. John's Wort.

  If you're prescribed any of these, consult your healthcare provider about using an additional contraceptive method during treatment and for 28 days after discontinuation.

• Medications That May Increase Hormone Levels: Some substances can raise the levels of hormones in Alyacen 1/35, potentially leading to increased side effects. These include:

  • Certain antifungal medications like Itraconazole and Ketoconazole.
  • Grapefruit juice.

  It's advisable to limit grapefruit juice intake while on Alyacen 1/35.

• Other Notable Interactions: Medications such as Tizanidine, Theophylline, and certain corticosteroids may have altered effects when taken with Alyacen 1/35. Always inform your healthcare provider about all medications and supplements you're taking to assess potential interactions.

Food and Lifestyle Interactions:

• Grapefruit Juice: Consuming grapefruit juice can increase the blood levels of norethindrone, one of the active ingredients in Alyacen 1/35, which may heighten the risk of side effects. Consider limiting or avoiding grapefruit juice during treatment.

Disease Interactions:

• Hypertension (High Blood Pressure): Alyacen 1/35 may elevate blood pressure. If you have a history of hypertension, discuss this with your healthcare provider to determine if this contraceptive is appropriate for you.

• Hyperlipidemia (High Cholesterol or Triglycerides): This medication can affect lipid levels, potentially increasing triglycerides. Regular monitoring of lipid profiles is recommended for individuals with preexisting hyperlipidemia.

• Fluid Retention: Alyacen 1/35 may cause fluid retention, which can exacerbate conditions like asthma, epilepsy, migraine, and cardiovascular or renal dysfunction. Patients with these conditions should be closely monitored.

General Recommendations:

• Inform Your Healthcare Provider: Always provide a complete list of all medications, supplements, and herbal products you are using.

• Monitor for Side Effects: Be vigilant for any unusual symptoms or side effects and report them to your healthcare provider promptly.

• Regular Check-Ups: Schedule regular appointments to monitor blood pressure, lipid levels, and overall health while using Alyacen 1/35.

By staying informed and maintaining open communication with your healthcare provider, you can use Alyacen 1/35 safely and effectively.