FREEDASE 30 TABLET (21 TAB) by SUN PHARMA LABORATORIES LTD.

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• Name:

  • Brand Name: Freedase 30 Tablet
  • Common Name: Combined Oral Contraceptive (COC)

• Composition:

  • Each tablet contains:
    • Ethinyl Estradiol: 30 mcg
    • Dienogest: 2 mg

• Uses: Freedase 30 Tablet is a hormonal contraceptive agent primarily used for:

  • Prevention of Pregnancy (Contraception): It works by inhibiting ovulation, thickening cervical mucus to impede sperm, and altering the uterine lining to prevent implantation of a fertilized egg.
  • Treatment of Moderate to Severe Acne: It helps regulate hormone levels to improve skin condition.
  • Management of Menorrhagia: Reduces heavy or prolonged menstrual bleeding.
  • Regulation of Irregular Menstrual Cycles: Helps in managing irregular or painful periods.
  • Treatment of Premenstrual Dysphoric Disorder (PMDD): May be prescribed to alleviate severe premenstrual mood and physical symptoms.
  • Management of Endometriosis: Reduces pelvic pain and suppresses the growth of endometrial tissue outside the uterus.

• Dosage and Administration:

  • Freedase 30 Tablet is typically taken once daily, usually around the same time each day for optimal results.
  • It can be taken with or without food, though taking it with food may help reduce nausea or vomiting.
  • Tablets should be swallowed whole with water; do not crush, chew, or break them.
  • A typical course involves taking one tablet daily for 21 days, followed by a tablet-free interval before starting a new pack.
  • If a dose is missed by more than 12 hours, backup contraception (like condoms) should be used for a specified period. If vomiting occurs within 4 hours of taking a dose, another tablet should be taken.

• Side Effects:

  • Common Side Effects: Nausea, breast soreness or tenderness, headache, dizziness, spotting or bleeding between menstrual periods, changes in weight, abdominal pain, cramps, bloating, and acne. Most of these usually resolve over time.
  • Serious Side Effects: Deep vein thrombosis (blood clots in legs), pulmonary embolism (blood clots in lungs), retinal vein thrombosis (blood clot in eyes leading to vision loss), stroke, heart attack, liver problems, and increased blood pressure.

• Precautions:

  • Contraindications: Should not be used by individuals with a history of blood clots, heart problems (e.g., heart attack, stroke, angina), liver disease, gallbladder disease, history of breast/uterine/cervical/hormone-sensitive cancers, or uncontrolled high blood pressure.
  • Pregnancy and Breastfeeding: Not recommended during pregnancy, and immediate consultation with a doctor is necessary if pregnancy is suspected. Caution is advised during breastfeeding as it may affect milk production.
  • Smoking: Women over 35 who smoke should avoid this medicine due to an increased risk of serious side effects.
  • Alcohol: It is advisable to avoid alcohol consumption while taking Freedase 30 Tablet.
  • Other Warnings: Inform your doctor if you have mental health disorders (e.g., depression), inflammatory bowel disease, anemia, or varicose veins. Individuals prone to chloasma/melasma should avoid sun exposure. Use with caution in those with a history of angioedema.
  • Drug Interactions: Can interact with certain antibiotics, blood thinners, antifungals, cholesterol-lowering medications, immunosuppressants, gastric acid reducers, and steroids.

• Storage:

  • Store in a cool and dry place, away from direct sunlight.
  • Keep at room temperature, ideally below 30°C (10-30°C or 20-25°C depending on source).
  • Keep out of reach of children and pets.

FREEDASE 30 TABLET (21 TAB) FAQs

What is FREEDASE 30 TABLET used for?

FREEDASE 30 TABLET is primarily used as a birth control pill to prevent pregnancy. It can also be prescribed to manage heavy menstrual bleeding and treat moderate to severe acne in women.

How does FREEDASE 30 TABLET work?

FREEDASE 30 TABLET is a combined oral contraceptive containing two synthetic hormones: Ethinyl Estradiol (an estrogen) and Dienogest (a progestin). These hormones work together to prevent pregnancy by:

• Stopping ovulation: They suppress the release of eggs from the ovaries.
• Thickening cervical mucus: This makes it harder for sperm to enter the uterus and reach an egg.
• Changing the uterine lining: This reduces the chance of a fertilized egg implanting in the uterus. Dienogest also helps in managing heavy menstrual bleeding and improving acne symptoms by regulating hormone levels.

What is the usual dosage of FREEDASE 30 TABLET?

The recommended dosage is one tablet daily. It should be taken at the same time each day, preferably with or after food, for 21 consecutive days. After finishing a pack, the next pack typically starts between day 2 and day 5 of your menstrual cycle. Always follow your doctor's instructions regarding the dose and duration.

What are the possible side effects of FREEDASE 30 TABLET?

Common side effects can include nausea, headache, breast tenderness or discomfort, weight changes, mood swings, and unusual spotting or bleeding between menstrual periods.

Serious but less common side effects can include blood clot formation (deep vein thrombosis, pulmonary embolism, retinal vein thrombosis), high blood pressure, liver disorders, severe migraines, and vision disturbances. If you experience persistent or severe side effects, contact your doctor immediately.

Is FREEDASE 30 TABLET safe during pregnancy or breastfeeding?

No, FREEDASE 30 TABLET is not recommended for use during pregnancy or if you are suspected to be pregnant. If you become pregnant while taking this medicine, stop immediately and consult your doctor.

It is also not recommended during breastfeeding as it can affect milk production and pass into breast milk. Your doctor may recommend alternative contraception while breastfeeding.

Can FREEDASE 30 TABLET be taken with other medications?

Certain medications can interfere with the effectiveness of FREEDASE 30 TABLET or increase side effects. It is crucial to inform your doctor about all other medicines you are taking, including:

• Antibiotics: Such as rifampicin, rifabutin, ampicillin, clarithromycin, and erythromycin.
• Antiepileptic drugs: Such as primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, and lamotrigine.
• Antiretrovirals: Used for HIV infection, such as ritonavir, nevirapine, and efavirenz.
• Antifungal medications: Such as ketoconazole and fluconazole.
• Blood thinners: Such as warfarin.
• Herbal remedies: Especially St. John's wort.
• Other medications: Including those for arthritis (e.g., etoricoxib), cholesterol-lowering agents (e.g., atorvastatin), immunosuppressants (e.g., cyclosporine), and certain blood pressure medications (e.g., diltiazem, verapamil).

What precautions should be taken?

• Do not smoke, especially if you are over 35, as it increases the risk of serious side effects like blood clots.
• Inform your doctor if you have a history of blood clots, heart problems, liver disease, kidney disease, high blood pressure, abnormal vaginal bleeding, depression, or certain cancers (breast, uterus, cervix, vagina).
• Regular blood pressure monitoring may be advised, as this medicine can increase blood pressure.
• If you have inflammatory bowel disease or anemia, use with caution.
• FREEDASE 30 TABLET does not protect against sexually transmitted infections (STIs); use barrier methods like condoms for STI protection.

What happens if a dose is missed?

If you miss a dose, take it as soon as you remember. If it's close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose. If you miss multiple doses or are more than 12 hours late in taking a dose, its effectiveness in preventing pregnancy may be reduced, and you should use a backup contraceptive method (like condoms) for a few days. Missing doses can also cause bleeding or spotting.

How should FREEDASE 30 TABLET be stored?

Store FREEDASE 30 TABLET at room temperature (10-30°C) in a cool and dry place. Protect it from light and moisture. Keep it out of reach of children and pets. Do not use the medicine after the expiry date.