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Introduction About FIBRISTONE 25MG TABLET
FIBRISTONE 25MG TABLET contains Mifepristone which belongs to the group of medicines called Progestin antagonist. It is used as an emergency contraceptive to manage pregnancy in women after an unprotected sexual intercourse. It should be used within 72 hours following sexual intercourse to achieve better birth control.
It can also be used to reduce the size of the fibroid growths (non-cancerous tumours) in the uterine layers. FIBRISTONE 25MG TABLET should only be used during emergency situations and therefore should not replace a regular contraceptive.
Before taking FIBRISTONE 25MG TABLET inform your doctor if you have any sever liver or kidney problems. You must also inform your doctor if you have any hormonal problems due to problems in adrenal gland, unexplained vaginal bleeding, cancer in the womb, overgrowth of uterine layers (endometrial hyperplasia) or bleeding disorders.
FIBRISTONE 25MG TABLET is intended for use as a contraceptive agent. Therefore, it should not be used in women who are pregnant or planning to conceive a child. It is not recommended for use in breastfeeding women and in female children who have not attained their puberty.
The most common side effects of taking FIBRISTONE 25MG TABLET are leg cramps, hot flushes, weakness, racing heartbeat, headache and sleepiness. Consult your doctor if any of these side effects trouble you.
Uses Of FIBRISTONE 25MG TABLET
- Prevents pregnancy after unprotected sex
- Controls fibroid growths (non-cancerous tumours) in the uterus
How FIBRISTONE 25MG TABLET Works
FIBRISTONE 25MG TABLET is a contraceptive medicine. It works by blocking the actions of a female sex hormone called progesterone which is responsible for sustaining pregnancy. This causes shedding of the uterine layers which makes it more difficult for the foetus to implant and grow and therefore manages pregnancy. It also reduces fibroid growth in the uterus and maintains the structure and functions of the uterine layers.
How to use FIBRISTONE 25MG TABLET
Take FIBRISTONE 25MG TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine.
Your doctor will decide the correct dose, duration of therapy and frequency of administration for you depending upon your age, body weight and disease condition.
Side Effects Of FIBRISTONE 25MG TABLET
Common
- leg cramps
- hot flushes
- weakness
- racing heartbeat
- headache
- sleepiness
Rare
Stop taking FIBRISTONE 25MG TABLET and contact your doctor immediately if you experience any of the following side effects such as:
- signs of allergic reactions (such as skin rash, itching, light headedness, wheezing, clammy skin, itchy welts, swelling (in legs and arms))
- abdominal pain, infection, sepsis
- vaginal bleeding
How To Manage Side Effects
Headache:
Take rest and relax. Drink plenty of fluids. Avoid alcohol consumption as it may aggravate your headache. Ask your doctor to recommend a painkiller. Headaches should usually go away after the first week of taking FIBRISTONE 25MG TABLET. If it lasts more than a week or became severe, inform your doctor.
Warning & Precautions
Pregnancy
FIBRISTONE 25MG TABLET is indicated as a contraceptive agent (birth control pill). Therefore, it should not be used in women who are pregnant or planning to become pregnant. However, consult your doctor before taking it.
Breastfeeding
FIBRISTONE 25MG TABLET is generally not recommended for use in breastfeeding women as it may pass to the nursing infant through the breast milk. Therefore, consult your doctor before taking it.
Driving and Using Machines
Do not drive or operate any heavy tools or machines if your ability is affected by FIBRISTONE 25MG TABLET.
Kidney
FIBRISTONE 25MG TABLET is not recommended for use in patients with severe kidney disease (such as undiagnosed renal masses). Therefore, consult your doctor before taking it.
Liver
FIBRISTONE 25MG TABLET is not recommended for use in patients with severe liver disorders. Therefore, consult your doctor before taking it.
Allergy
Do not take FIBRISTONE 25MG TABLET if you are allergic to mifepristone or to any other ingredients of this medicine.
Others
FIBRISTONE 25MG TABLET is not recommended for use if you:
- suffer from Cushing syndrome (a hormonal problem caused due to abnormal functions of the adrenal gland)
- have unexplained vaginal bleeding
- have endometrial cancer (a cancer that develops in the uterine lining)
- have endometrial hyperplasia (excessive growth of uterine tissues)
- have ectopic pregnancy (pregnancy outside the uterus)
- use intrauterine device (birth control device to manage pregnancy)
- have any bleeding disorders
- have severe anaemia
Use in Paediatrics:
FIBRISTONE 25MG TABLET should be used in post pubertal female children (aged between 14-18 years) only if prescribed by the physician. It is not intended for use in male children and should not be used in female children who have not attained their puberty. Therefore, consult your doctor before taking it.
Use in Geriatrics:
FIBRISTONE 25MG TABLET should be used with caution in the elderly patients. Therefore, consult your doctor before taking it.
Interactions
A. Drug - Drug interactions:
Before taking FIBRISTONE 25MG TABLET inform your doctor if you are taking any of the following medicines such as:
- simvastatin, lovastatin (medicines used to reduce blood cholesterol levels)
- dihydroergotamine, ergotamine (used to manage migraine)
- fentanyl (a medicine used for pain relief)
- sirolimus, tacrolimus, cyclosporin (used to suppress immune function and to manage graft rejection)
Overdosage:
If you or anyone else accidentally took more FIBRISTONE 25MG TABLET, consult your doctor immediately or visit the nearby hospital.
Synopsis
| Drug | : | Mifepristone |
| Pharmacological Category | : | Progestin antagonist |
| Therapeutic Indication | : | Prevents Pregnancy, Manages Fibroids |
| Dosage Forms | : | Tablet, Capsule, Kit |
More Information
- Keep FIBRISTONE 25MG TABLET out of reach of children
- Store FIBRISTONE 25MG TABLET below 30°C
FAQs About FIBRISTONE 25MG TABLET
What is the use of FIBRISTONE 25MG TABLET?
FIBRISTONE 25MG TABLET is an emergency contraceptive used to manage pregnancy in women after an unprotected sexual intercourse. It should be used within 72 hours following sexual intercourse to achieve better birth control. It can also be used to reduce the size of the fibroid growths (non-cancerous tumours) in the uterine layers
How FIBRISTONE 25MG TABLET works?
FIBRISTONE 25MG TABLET is a contraceptive medicine. It works by blocking the actions of a female sex hormone called progesterone which is responsible for sustaining pregnancy. This causes shedding of the uterine layers which makes it more difficult for the foetus to implant and grow and therefore manages pregnancy. It also reduces fibroid growth in the uterus and maintains the structure and functions of the uterine layers.
How should I take FIBRISTONE 25MG TABLET?
Take FIBRISTONE 25MG TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine.
What are the common side effects of taking FIBRISTONE 25MG TABLET?
The most common side effects of taking FIBRISTONE 25MG TABLET are leg cramps, hot flushes, weakness, racing heartbeat, headache, and sleepiness. Consult your doctor if any of these side effects trouble you.
What precautions need to be followed while taking FIBRISTONE 25MG TABLET?
Before taking FIBRISTONE 25MG TABLET inform your doctor if you have any sever liver or kidney problems. You must also inform your doctor if you have any hormonal problems due to problems in adrenal gland, unexplained vaginal bleeding, cancer in the womb, overgrowth of uterine layers (endometrial hyperplasia) or bleeding disorders. Visit your gynaecologist as per the schedule and confirm the management of pregnancy through blood tests and ultrasound.
Is it safe to take FIBRISTONE 25MG TABLET immediately after delivery?
Consult your doctor before taking FIBRISTONE 25MG TABLET as it may increase the risk of blood clots in such patients. However, consult your doctor before taking it.
Can FIBRISTONE 25MG TABLET be used in children?
FIBRISTONE 25MG TABLET should be used with caution in post pubertal female children aged below 18 years. It is not intended for use in male children and in female children who have not attained puberty. Therefore, consult your doctor before taking it.
Can FIBRISTONE 25MG TABLET be used in post-menopausal women?
FIBRISTONE 25MG TABLET is a contraceptive pill used to manage pregnancy. It is not intended for use in post-menopausal women.
Will the use FIBRISTONE 25MG TABLET affect my future chances for pregnancy?
Studies have not shown any negative effects of FIBRISTONE 25MG TABLET on fertility. Therefore, your chances for pregnancy in the future will not be affected by FIBRISTONE 25MG TABLET.
Can the use of FIBRISTONE 25MG TABLET cause unexpected bleeding?
Yes. Irregular vaginal bleeding or spotting may occur while you are taking FIBRISTONE 25MG TABLET. Such bleeding may be temporary and usually does not indicate any serious problems. However, consult your doctor if you experience prolonged painful bleeding.
How and when should I take FIBRISTONE 25MG TABLET?
Take FIBRISTONE 25MG TABLET within 72 hours following unprotected intercourse. You must follow the instructions of your doctor regarding the frequency of administration. Swallow FIBRISTONE 25MG TABLET with a glass of water. Do not crush or chew it.
What to do if I forgot to take FIBRISTONE 25MG TABLET?
Take FIBRISTONE 25MG TABLET within 72 hours following unprotected intercourse. Failing to do so, may increase the chances of pregnancy. Consult your doctor immediately regarding pregnancy termination if you forget to take your dose of FIBRISTONE 25MG TABLET.
Will the use of FIBRISTONE 25MG TABLET change the length of menstrual cycle?
Yes. FIBRISTONE 25MG TABLET may delay your regular menstrual periods. Also, there are chances for sudden spotting or vaginal bleeding while taking FIBRISTONE 25MG TABLET. But there is no reported evidence for long menstrual cycles.
Will the use of FIBRISTONE 25MG TABLET produce complete protection from pregnancy?
FIBRISTONE 25MG TABLET may only help in managing pregnancy during emergency conditions. You must follow your regular birth control pills along with FIBRISTONE 25MG TABLET to achieve successful birth control. After taking FIBRISTONE 25MG TABLET you must consult your doctor for advice. Your doctor will analyse your condition and confirm whether pregnancy termination is required or not.
Does FIBRISTONE 25MG TABLET stops periods?
No. FIBRISTONE 25MG TABLET is a birth control pill used to manage pregnancy. It is not proven to stop periods. However, it may delay your periods or can cause irregular or scanty periods.
References
1. KD. Tripathi. Estrogens, Progestins and Contraceptive. Essentials of medical pharmacology. Seventh edition. 2013. Page – 319
2. Blake M. Autry, Roopma Wadhwa. Mifepristone. NIH National Library of Medicine. National Center for biotechnology information. Stat Pearls [Internet]. [Revised in May 2022] [Accessed on 13th September 2022] https://www.ncbi.nlm.nih.gov/books/NBK557612/
3. Vidushi Kulshrestha, Alka Kriplani, Nutan Agarwal, Neetu Sareen, Pradeep Garg, Smriti Hari, Jyoti Thulkar. Low dose mifepristone in medical management of uterine leiomyoma - An experience from a tertiary care hospital from north India. NIH National Library of Medicine. National Center for biotechnology information. PMC Pubmed Central. June 2013. [Accessed on 13th September 2022] https:/www.ncbi.nlm.nih.gov/pmc/articles/PMC3734720/
4. Shikha Seth, Neeru Goel, Ekta Singh, A. S. Mathur, and Garima Gupta. Effect of mifepristone (25 mg) in treatment of uterine myoma in perimenopausal woman. NIH National Library of Medicine. National Center for biotechnology information. PMC Pubmed Central. January-March 2013. [Accessed on 13th September 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3702060/
5. Bethesda. Mifepristone. NIH National Library of Medicine. National Center for biotechnology information. [Revised in July 2022] [Accessed on 13th September 2022] https://www.ncbi.nlm.nih.gov/books/NBK501722/
6. Signorah Healthcare. Fibrograce. [Accessed on 13th September 2022] https://www.signorah.com/fibro-grace.html
7. Akumentis Healthcare Ltd. Fibroease. [Accessed on 13th September 2022]. https://akumentishealthcare.com/gynaecology/
8. Zizhu Pharmaceutical Co. Ltd. Mifepristone 25mg tablet. [Accessed on 13th September 2022]. http://www.zizhu-pharm.com/showproducts.asp?art_id=41
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