Fibroprist 5mg Tablet 10'S

Uterus Conditions Rx required
10 Tablet(s) in a Strip Mfr: Akumentis Healthcare Ltd Country of Origin: NA
M.R.P.: Rs.1,299.00

What is FIBROPRIST?

  • FIBROPRIST contains Ulipristal Acetate
Therapeutic Uses
Warning & Precautions
Interactions
Directions & For Use
Side Effects
More Information

What FIBROPRIST is used for?

  • It is used to treat moderate to severe symptoms of uterine fibroids (commonly known as myomas), which are non-cancerous tumours of the uterus (womb)

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Pregnancy & Breast Feeding

Children & Adolescents

Driving & Using Machines

Talk to your doctor before you take FIBROPRIST, if you:

  • are allergic to ulipristal acetate or any of the other ingredients of FIBROPRIST
  • you have hepatic impairment
  • have vaginal bleeding not caused by uterine fibroids
  • have cancer of the uterus (womb), cervix (the neck of the womb), ovary or breast
  • have liver or kidney disease
  • suffer from severe asthma
  • FIBROPRIST should not be taken if you are already pregnant
  • Currently there is no information suggesting that FIBROPRIST would harm a developing baby
  • Contact your healthcare provider for advice
  • It is not for use to terminate an existing pregnancy

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Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements including

  • digoxin, used to treat the heart conditions
  • dabigatran, etexilate, used to prevent strokes and blood clots
  • phenytoin, fosphenytoin, phenobarbital, carbamazepine, oxcarbazepine, primidone
  • medicines used to treat certain bacterial infections (e.g. rifampicin, telithromycin, clarithromycin, erythromycin, rifabutin)
  • certain medicines to treat fungal infections (e.g. ketoconazole, itraconazole)
  • medicines used to treat depression (e.g. nefazodone)
  • verapamil, used to treat hypertension
  • Take FIBROPRIST as soon as possible within 5 days (120 hours) after unprotected sex or if you had a birth control failure
  • It can be taken with or without food
  • Contact your healthcare provider right away if you vomit within 3 hours of taking FIBROPRIST. Your healthcare provider may prescribe another dose of this medicine for you
  • It can be taken at any time during the menstrual cycle
  • It is meant for emergency contraception only, and is not to be used frequently or as a regular birth control. If you need to use emergency contraception often, talk to your healthcare provider and learn about methods for birth control and sexually transmitted disease prevention that are right for you

If you take more FIBROPRIST

  • If you have taken more FIBROPRIST than you should, speak to your doctor straightaway without any delay

If you forget to take FIBROPRIST

  • If you miss a dose by less than 12 hours, take it as soon as you remember. If you miss a dose by more than 12 hours, skip the missed dose and take only a single dose as usual. Do not take a double dose to make up for a forgotten dose

If you stop taking FIBROPRIST

  • FIBROPRIST is to be taken daily during treatment courses of up to 3 months continuously. During each course of treatment, do not stop taking your medicine without the advice of your doctor even if you feel better, as symptoms may re-occur later
Serious
Common
Uncommon
Rare
Very Rare

Like all the medicines, this medicine can cause side effects although not everybody gets them.

  • allergic reactions such as swelling of face, tongue or throat, difficulty swallowing, hives and breathing difficulties
  • headache, stomach (abdominal) pain and menstrual pain (dysmenorrhea)
  • nausea, tiredness and dizziness
  • reduction or absence of menstrual bleeding (amenorrhea)
  • thickening of the lining of the womb (endometrial thickening)
  • spinning sensation (vertigo)
  • muscle and bone (musculoskeletal) pain
  • sac of fluid within the ovaries (ovarian cyst), breast tenderness/pain, lower abdominal (pelvic) pain, hot flushes
  • weight increase
  • anxiety
  • mood swings
  • dry mouth, constipation
  • hair loss, dry skin, increased sweating
  • back pain
  • leakage of urine
  • bleeding, breast discomfort
  • swelling due to fluid retention (oedema)
  • extreme tiredness (asthenia)
  • increase in blood cholesterol seen in blood tests, increase in blood fats (triglycerides) seen in blood tests
  • nosebleed
  • indigestion, bloating
  • break of sac of fluid within the ovaries (ovarian cyst ruptured)
  • breast swelling

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Additional Information
Storage

What should I do about birth control after I take FIBROPRIST?

  • Using FIBROPRIST with hormonal contraceptives such as birth control pills could reduce the effectiveness of both drugs to prevent pregnancy. After using FIBROPRIST, if you wish to use hormonal contraception, you should do so no sooner than 5 days after the intake of FIBROPRIST. Be sure to use a reliable barrier contraceptive method (such as a condom with spermicide) each time you have sex until your hormonal birth control has taken effect
  • If you do not use hormonal contraception, after using FIBROPRIST, you should use a reliable barrier contraceptive method (such as condom with spermicide) each time you have sex

What should I do if my menstrual period is delayed beyond 1 week or I have severe lower stomach (abdominal) pain?

  • After taking FIBROPRIST, your next menstrual period may begin a few days earlier or later than expected. If your period is more than 7 days later than expected, you may be pregnant. You should get a pregnancy test and follow up with your healthcare provider
  • If you have severe lower stomach (abdominal) pain about 3 to 5 weeks after taking FIBROPRIST, you may have a pregnancy outside of the uterus (womb), which is called an ectopic or tubal pregnancy. An ectopic pregnancy is a serious condition that needs medical treatment right away
  • Store at room temperature (15-25ºC)
  • Protect from light
  • Keep this medicine out of the reach of children
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