Indications 

Alesse 28-day is an oral contraceptive comprising two female hormones: estrogen and progestin. 

The combined action of these hormones inhibits ovulation (egg release), alters the uterine lining to deter pregnancy, and modifies cervical mucus to hinder sperm entry. 

Uses and Dosage 

Before taking Alesse 28-day and every time you get a refill, thoroughly review the accompanying medication guide and patient information leaflet. Consult your healthcare provider or pharmacist for any inquiries or concerns. 

Alesse 28-day contains 21 active pills and 7 inactive “reminder” pills. 

One active pill must be taken daily for 21 consecutive days, followed by one inactive pill daily for 7 consecutive days.  

For optimal contraceptive effectiveness, each pill must be taken exactly as directed and at intervals not exceeding 24 hours. Choose a consistent time of day that suits your routine to ensure timely pill consumption. 

For first-time users of Alesse 28-day and not transitioning from other hormonal birth control methods (e.g., patch, other birth control pills), the first pill from the pack must be taken on the first Sunday following the onset of the menstrual period or on the first day of your period. If your period begins on a Sunday, take the pill that day.  

During the initial usage cycle only, use an additional non-hormonal birth control method (e.g., condoms, spermicide) for the first 7 days to prevent pregnancy until the medication takes effect. If you begin on the first day of your period, there is no need for backup birth control during the first week. 

Menstruation should occur in the fourth week of the cycle. After taking the last inactive pill, begin a new pack the next day, regardless of whether you experience your period. If you do not have your period, seek guidance from your healthcare provider. 

Breakthrough bleeding, particularly in the initial 3 months, may occur. If this bleeding persists or becomes exceptionally heavy, inform your healthcare provider. 

Do not skip any doses of this oral contraceptive. Missing pills, starting a new pack late, or altering your usual pill-taking time increases the risk of pregnancy. 

Adhere closely to the “missed dose” guidance provided in the patient information leaflet if you happen to miss taking a pill. 

Side Effects 

Listed below are the potential adverse effects of Alesse 28-day. Inform your doctor right away if any of these symptoms continue or deteriorate. 

Common Side Effects 

• Nausea 
• Vomiting 
• Headache 
• Bloating 
• Breast tenderness 
• Fluid retention leading to ankle and foot swelling 
• Weight fluctuations 
• Vaginal bleeding between periods (spotting) or irregular menstrual cycles during the first few months of pill intake 

Serious Side Effects 

• Breast lumps 
• Mental/mood changes (e.g., new or worsening depression) 
• Severe stomach/abdominal pain 
• Unusual alterations in vaginal bleeding (e.g., continuous spotting, sudden heavy bleeding, or missed periods) 
• Darkened urine 
• Yellowing of the eyes or skin 

Inform your doctor right away if you experience any of the serious side effects above. 

Rarely, the use of Alesse 28-day may lead to severe, occasionally fatal complications due to blood clots (e.g., deep vein thrombosis, heart attack, pulmonary embolism, stroke). Seek immediate medical assistance if you experience any of the following side effects: 

• Chest/jaw/left arm pain 
• Confusion 
• Sudden dizziness/fainting 
• Pain/swelling/warmth in the groin/calf 
• Difficulty speaking 
• Sudden shortness of breath/rapid breathing 
• Unusual headaches (including those with vision changes/lack of coordination, worsening of migraines, or sudden/very severe headaches) 
• Unusual sweating 
• Weakness on one side of the body 
• Vision problems/changes (e.g., double vision or partial/complete blindness) 

Allergic Reactions 

In rare cases, Alesse 28-day may trigger a serious allergic response. Seek medical attention without delay if any signs of an allergic reaction manifest, such as: 

• Facial, tongue, or throat swelling or itching 
• Rash 
• Severe dizziness 
• Difficulty breathing 

This list does not cover all side effects of Alesse 28-day. Consult your doctor or pharmacist if you experience any unexpected effects while taking this oral contraceptive. 

Cautions 

Before taking Alesse 28-day, inform your doctor if you have any known allergies, particularly to any estrogens (e.g., ethinyl estradiol or mestranol) or any progestins (e.g., norethindrone or desogestrel). 

Ask your pharmacist for more details about this oral contraceptive, as it could contain inactive ingredients that may trigger allergic reactions or other adverse effects. 

To ensure Alesse 28-day is safe for you, disclose to your doctor your medical background, especially if you have a history of: 

• Blood clots (e.g., in legs, eyes, lungs) 
• Blood clotting disorders (like protein C or protein S deficiency) 
• High blood pressure 
• Abnormal breast examination findings 
• Cancer, particularly endometrial or breast cancer 
• Elevated cholesterol or triglyceride levels 
• Depression 
• Diabetes 
• Family or personal history of angioedema (swelling disorder) 
• Gallbladder issues 
• Severe headaches/migraines 
• Heart conditions (e.g., heart valve disease, irregular heartbeat, prior heart attack) 
• Jaundice (yellowing of eyes/skin) during pregnancy or while using hormonal birth control 
• Kidney disease 
• Liver disease, including tumors 
• Obesity 
• Stroke 
• Edema (swelling) 
• Thyroid problems 
• Unexplained vaginal bleeding 

Inform all your healthcare providers about any current or recently started or discontinued medications, including prescription and over-the-counter drugs, as well as vitamins and herbal supplements, to prevent the risk of drug interaction with Alesse 28-day. 

Some of the products that may interact with Alesse 28-day include: 

• Aromatase inhibitors (e.g., anastrozole, exemestane) 
• Fezolinetant 
• Ospemifene 
• Tamoxifen 
• Tizanidine 
• Tranexamic acid 
• Specific combination products used for chronic hepatitis C treatment (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) 

Certain medications can reduce the effectiveness of Alesse 28-day by lowering hormone levels in the body, potentially leading to pregnancy. Examples of such medications include: 

• Griseofulvin 
• Modafinil 
• Rifamycins (like rifampin and rifabutin) 
• Ritonavir 
• St. John’s wort 
• Drugs used for seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate) 
• HIV drugs like nelfinavir and nevirapine  

In the event of missing two consecutive periods or one period due to incorrect pill usage, seek medical advice for a pregnancy test. 

Vomiting or diarrhea can hinder the efficacy of this oral contraceptive. In the event of experiencing these symptoms, use an additional birth control measure, like condoms or spermicide, for added protection. 

Inform your healthcare provider of any new spotting or breakthrough bleeding, as these could indicate that Alesse 28-days may not effectively prevent pregnancy. 

Individuals with diabetes should be aware that Alesse 28-days could impact their blood sugar levels. Regularly monitor blood sugar as instructed and communicate the findings with your healthcare provider. Promptly inform your doctor if you experience signs of elevated blood sugar, such as excessive thirst or urination, they may need to adjust to your diabetes medication, exercise regimen, or dietary plan. 

Alesse 28-day may elevate blood pressure. Monitor your blood pressure regularly and inform your healthcare provider if readings indicate elevated levels. 

Oral contraceptives like Alesse 28-day do not provide protection against sexually transmitted diseases, including HIV and AIDS. The use of a condom is the sole method for safeguarding against these diseases. 

Alesse 28-day might disrupt specific laboratory tests (blood clotting factors, thyroid function), potentially leading to inaccurate test outcomes. Inform laboratory staff and all your healthcare professionals about your use of this oral contraceptive. 

If you have myopia (nearsightedness) or wear contact lenses, you may experience vision difficulties or challenges with your contacts while taking Alesse 28-day. In such cases, contact your eye doctor for assistance. 

The utilization of Alesse 28-day may lead to melasma – uneven, dark patches on facial and skin areas. Sunlight exposure can aggravate this occurrence. To mitigate its effects, limit sun exposure duration and avoid tanning booths and sunlamps altogether while consistently employing sunscreen and protective clothing when outdoors. 

Alesse 28-day is contraindicated during pregnancy. If you become pregnant or suspect pregnancy, promptly inform your doctor.  

Following childbirth or a pregnancy loss/abortion beyond the first 3 months, consult your doctor regarding effective contraception options and the appropriate timing for initiating this oral contraceptive. 

The hormones in Alesse 28-day can enter breast milk, potentially posing a risk to a nursing infant and reducing milk production. Refrain from using Alesse 28-day if you are breastfeeding.