Rosen 28 Plus

Indications

Oral Contraceptive
This oral contraceptive is designed to prevent pregnancy in women who wish to avoid conception. It provides a reliable method of birth control when used as directed.

Premenstrual Dysphoric Disorder (PMDD)
This contraceptive pill is also indicated for managing the symptoms of Premenstrual Dysphoric Disorder (PMDD) in women who opt for oral contraception. PMDD is characterized by severe mood disturbances including depression, anxiety, irritability, and mood swings, as well as physical symptoms like breast tenderness, bloating, headaches, and fatigue. These symptoms occur in the luteal phase of the menstrual cycle and significantly interfere with daily life.
Note: The effectiveness of this oral contraceptive for long-term PMDD management (beyond three cycles) has not been studied. It is not intended for the treatment of Premenstrual Syndrome (PMS).

Acne Treatment
This contraceptive is indicated for treating moderate acne vulgaris in females aged 14 and older who do not have contraindications to oral contraceptive use and have reached menarche. This medication should be used for acne treatment only if the individual also seeks birth control.

Folate Supplementation
For women using this contraceptive as their birth control method, it can also help increase folate levels, potentially reducing the risk of neural tube defects in pregnancies conceived while taking the pill or shortly after discontinuation.

Always consult with a registered healthcare provider before starting this medication.

Dosage & Administration

How to Take this Contraceptive Pill:
Take one tablet daily, at the same time each day. To ensure maximum effectiveness in preventing pregnancy and managing PMDD, it is essential to follow the prescribed regimen carefully. Missing doses or incorrect use may reduce the pill’s effectiveness. If a dose is missed, take it as soon as you remember.

How to Start this Contraceptive Pill:
You may start this contraceptive either on the first day of your menstrual cycle (Day 1 Start) or on the first Sunday after your period begins (Sunday Start).

• Day 1 Start:
  Begin taking one pink tablet daily from Day 1 of your period. Continue for 24 days, then take one light orange tablet daily for the next 4 days. Ensure you follow the prescribed order and timing for optimal effectiveness. If you start the pill later than Day 1, use an additional non-hormonal contraceptive for the first 7 days.
• Sunday Start:
  Start taking one pink tablet on the first Sunday after your period begins. Continue for 24 days, followed by one light orange tablet daily for 4 days. As with Day 1 Start, use a backup non-hormonal contraceptive for the first 7 days if starting after your menstrual cycle begins.

Subsequent Cycles:
For all future 28-day cycles, begin taking the pink tablets the day after finishing the last light orange folate tablet. If you miss a cycle start date, use an alternate contraceptive method for 7 days.

Switching from Another Birth Control:
If you are switching from another oral contraceptive, begin taking this pill on the same day that you would have started a new pack of your previous pill.

Always follow the advice of your healthcare provider regarding dosage and administration.

Drug Interactions

Some medications or herbal products (like those affecting CYP3A4 enzymes) may reduce the effectiveness of this contraceptive or cause breakthrough bleeding. Patients are advised to use an alternative or backup contraceptive method when taking enzyme-inducing drugs in combination with this pill.

Contraindications

• Renal impairment
• Adrenal insufficiency
• High risk of thrombotic conditions (arterial/venous)
• Undiagnosed abnormal uterine bleeding
• Estrogen- or progestin-sensitive cancers (e.g., breast cancer)
• Liver tumors or significant liver disease
• Pregnancy

Side Effects

The most common side effects (≥ 2%) observed in clinical trials for contraception, acne, and folate supplementation include:

• Headaches/Migraines (5.9%)
• Menstrual irregularities (4.1%)
• Nausea/Vomiting (3.5%)
• Breast tenderness/pain (3.2%)

For PMDD, common side effects (≥ 2%) include:

• Menstrual irregularities (24.9%)
• Nausea (15.8%)
• Headache (13.0%)
• Breast tenderness (10.5%)
• Fatigue (4.2%)
• Irritability (2.8%)
• Decreased libido (2.8%)
• Weight changes (2.5%)
• Affective lability (2.1%)

Pregnancy & Lactation

For Nursing Mothers:
This contraceptive is not recommended for breastfeeding women, as it may reduce milk production.

Precautions & Warnings

• Vascular Risks: Discontinue the pill if a thrombotic event occurs. It should be stopped at least 4 weeks before major surgery, and not resumed until 4 weeks after delivery in non-breastfeeding women.
• Hyperkalemia: The progestin in this contraceptive can increase potassium levels. Monitor potassium levels in patients at risk.
• Liver Disease: Stop taking the pill if jaundice develops.
• High Blood Pressure: Not recommended for women with uncontrolled hypertension.
• Carbohydrate & Lipid Metabolism: Monitor women with prediabetes or diabetes closely.
• Headache: If there’s a significant change in headache patterns, reconsider use of this contraceptive.
• Uterine Bleeding: Any irregular or absent menstrual bleeding should be evaluated.

Therapeutic Class

Oral Contraceptive Preparations

Storage Conditions

Store below 30°C, away from direct light and moisture. Keep out of reach of children.