Fibroease 25

FIBROEASE 25

FIBROEASE 25, manufactured by Akumentis Healthcare Ltd, is a medication primarily known for its role in women's health.

• Name: Fibroease 25 (Brand Name)

• Composition: The active ingredient in FIBROEASE 25 is Mifepristone 25mg. Mifepristone belongs to a class of medicines called progestin antagonists or anti-progestational steroids.

• Uses:

  • Medical Termination of Early Pregnancy: FIBROEASE 25 is used to medically terminate early pregnancies, typically up to 70 days (10 weeks) of gestation. It works by blocking the effects of progesterone, a hormone essential for maintaining pregnancy, leading to the breakdown of the uterine lining and expulsion of the uterine contents. It is often used in combination with Misoprostol for this purpose.
  • Emergency Contraception: It can be used as an emergency contraceptive within 72 hours of unprotected sexual intercourse to prevent pregnancy. However, it should not replace regular contraceptive methods.
  • Uterine Fibroids: FIBROEASE 25 is also prescribed to manage symptoms of uterine fibroids, which are non-cancerous growths in the uterus. It helps reduce their size and alleviate symptoms like heavy menstrual bleeding, pelvic pain, and pressure by blocking progesterone, which fibroids rely on for growth.
  • Cushing's Syndrome: In some cases, it is used to manage high blood sugar levels in individuals with Cushing's syndrome by blocking cortisol receptors.
  • Regulation of Menstrual Cycle: It can be used to regulate a delayed menstrual cycle under medical supervision.

• Dosage and Administration:

  • FIBROEASE 25 should be taken orally with a glass of water, preferably with food, or as advised by a doctor.
  • The tablet should be swallowed whole and not crushed, broken, or chewed.
  • Dosage and duration of treatment vary based on the medical condition and should be strictly adhered to as prescribed by the doctor.
  • If vomiting occurs within 30-45 minutes of taking the tablet, a doctor should be consulted or another tablet may be taken.
  • Regular check-ups and ultrasounds may be required to monitor effectiveness and potential side effects.

• Side Effects:

  • Common Side Effects: Nausea, vomiting, uterine cramps, diarrhoea, uterine bleeding, headache, dizziness, hot flushes, weakness, racing heartbeat, sleepiness, leg cramps, decreased appetite, sleeplessness, pain in arms and legs, and fatigue. Lighter periods or temporary cessation of periods may also occur.
  • Serious Side Effects: Prolonged painful bleeding, infection following abortion, or severe vaginal bleeding. Immediate medical attention is required for these.

• Precautions:

  • Pregnancy and Breastfeeding: FIBROEASE 25 is contraindicated in established pregnancy beyond 70 days of gestation and is unsafe during pregnancy as it is used for abortion. It is generally not recommended for use in breastfeeding women as it may pass into breast milk.
  • Medical Conditions: Inform your doctor if you have severe liver or kidney problems, hormonal imbalances (e.g., adrenal gland problems), unexplained vaginal bleeding, cancer in the womb, overgrowth of uterine layers (endometrial hyperplasia), bleeding disorders, ectopic pregnancy, or a history of an intrauterine device (IUD).
  • Drug Interactions: Inform your doctor about all medications you are taking, especially simvastatin, lovastatin, dihydroergotamine, ergotamine, fentanyl, sirolimus, tacrolimus, cyclosporine, and corticosteroids, as interactions can occur.
  • Alcohol: Avoid alcohol consumption during treatment as it may enhance side effects and increase uterine bleeding.
  • Activities: Do not drive or operate heavy machinery if the medicine causes dizziness or affects your ability. Avoid strenuous activities to prevent excessive bleeding.
  • Contraception: Use non-hormonal contraception (e.g., condoms, copper IUD) during treatment for uterine fibroids, as this medicine can affect pregnancy.
  • Children: Not recommended for use in male children or female children who have not attained puberty. Use in post-pubertal female children (14-18 years) only if prescribed by a physician.
  • Elderly Patients: Use with caution in elderly patients.
  • Do not stop taking the medicine abruptly without consulting the doctor.

• Storage:

  • Store FIBROEASE 25 in a cool, dry place away from sunlight.
  • Keep it in its original pack or container, tightly closed.
  • Protect from light and moisture.
  • Store below 30°C (10°C to 25°C or below 30°C for non-cold chain).
  • Keep out of sight and reach of children.
  • Do not use after the expiry date.

FIBROEASE 25, manufactured by Akumentis Healthcare Ltd., contains Mifepristone as its active ingredient. It is primarily used for the medical termination of early pregnancy and for managing symptoms associated with uterine fibroids.

Here are some frequently asked questions about FIBROEASE 25:

What is FIBROEASE 25 used for?

FIBROEASE 25 is primarily used for the medical termination of early pregnancy, typically up to 70 days (10 weeks) after the last menstrual period, often in combination with Misoprostol. It is also used to manage the symptoms of uterine fibroids, such as heavy or prolonged menstrual bleeding, lower abdominal pain, and pelvic pressure. Additionally, it can be used as an emergency contraceptive within 72 hours of unprotected intercourse, though it is not intended for regular birth control.

How does FIBROEASE 25 work?

FIBROEASE 25 contains Mifepristone, which acts as a progesterone antagonist. Progesterone is a female sex hormone essential for maintaining pregnancy and for the growth of uterine fibroids. By blocking the actions of progesterone, FIBROEASE 25 causes the lining of the uterus to break down, which helps to terminate a pregnancy or reduce the size of fibroid growths.

What is the usual dosage for FIBROEASE 25?

The dosage and duration of FIBROEASE 25 are determined by a doctor based on the specific condition being treated. For emergency contraception, it should be taken within 72 hours following unprotected intercourse. For other uses, it is typically taken orally with water, preferably with food, and at a fixed time daily. It is crucial to follow the doctor's instructions strictly.

What are the possible side effects of FIBROEASE 25?

Common side effects can include leg cramps, hot flushes, weakness, racing heartbeat, headache, sleepiness, nausea, vomiting, uterine cramps, diarrhea, dizziness, and vaginal bleeding (which can be heavy or prolonged). If any side effects persist or become severe, it is important to consult your doctor.

Is FIBROEASE 25 safe during pregnancy or breastfeeding?

FIBROEASE 25 is used to terminate pregnancy, so it is contraindicated in women who are pregnant or planning to conceive. It is also generally not recommended for use in breastfeeding women, as it may pass into breast milk and potentially harm the nursing infant. If its use is deemed necessary during breastfeeding, breastfeeding might need to be discontinued.

Can FIBROEASE 25 be taken with other medications?

FIBROEASE 25 can interact with certain medications. Inform your doctor if you are taking medicines such as cholesterol-reducing drugs (e.g., simvastatin, lovastatin), migraine medications (e.g., dihydroergotamine, ergotamine), pain relievers (e.g., fentanyl), immunosuppressants (e.g., sirolimus, tacrolimus, cyclosporin), anticoagulants (e.g., warfarin, heparin), corticosteroids (e.g., prednisone, dexamethasone), anticonvulsants (e.g., carbamazepine, phenobarbital), antifungal agents (e.g., ketoconazole, fluconazole), or HIV protease inhibitors (e.g., ritonavir, saquinavir). It is also advisable to avoid consuming grapefruit juice as it may alter the medicine's levels in the blood.

What precautions should be taken with FIBROEASE 25?

Before taking FIBROEASE 25, inform your doctor if you have severe liver or kidney problems, hormonal imbalances, unexplained vaginal bleeding, cancer in the womb, overgrowth of uterine layers (endometrial hyperplasia), or bleeding disorders. It is not recommended for individuals with an ectopic pregnancy. If you use an intrauterine device (IUD), it should be removed before taking FIBROEASE 25. Avoid alcohol consumption as it may enhance side effects. Do not drive or operate heavy machinery if you experience drowsiness. Non-hormonal contraception should be used during treatment when taking it for fibroids.

What happens if a dose of FIBROEASE 25 is missed?

If FIBROEASE 25 is being used for medical termination of pregnancy, it is often a single-dose therapy, or part of a strict regimen, so missing a dose is generally not applicable or requires immediate consultation with a doctor. For other uses, if you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed one and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. Always consult your doctor for specific instructions regarding a missed dose.

How should FIBROEASE 25 be stored?

FIBROEASE 25 should be kept out of reach of children and stored below 30°C in a cool, dry place, away from direct sunlight, light, and moisture.