What Fibristal is used for and how to use it
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Fibristal - Consumer Medicine Information

Manufacture: Actavis
Country: Canada
Condition: Uterine Fibroids
Class: Progesterone receptor modulators
Form: Tablets
Ingredients: ulipristal acetate, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, and talc

Fibristal

ulipristal acetate

About this Medication

What the medication is used for

Fibristal is used for the treatment of signs and symptoms of uterine fibroids in adult women of reproductive age who are eligible for surgery. The duration of treatment is limited to 3 months.

What it does

Fibristal helps to reduce bleeding, reduce the size of uterine fibroids and improve other symptoms associated with uterine fibroids.

Fibristal is thought to work by selectively modifying the activity of progesterone, a naturally occurring hormone in the body.

When it should not be used

Do not use Fibristal if you:

  • Are allergic (hypersensitive) to ulipristal acetate or any of the other ingredients of Fibristal
  • Are pregnant
  • Are breastfeeding
  • Have vaginal bleeding not caused by uterine fibroids
  • Have uterine, cervical, ovarian or breast cancer
  • Have already taken Fibristal for a period of three months

What the medicinal ingredient is

Ulipristal acetate

What the nonmedicinal ingredients are

Croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, and talc.

What dosage forms it comes in

Fibristal is supplied as a tablet containing 5 mg of ulipristal acetate. These tablets are white to off-white, round and biconvex.

Warnings and Precautions

BEFORE you use Fibristal talk to your doctor or pharmacist if:

  • You have liver or kidney disease
  • You suffer from severe asthma
  • You are pregnant or suspect to be pregnant
  • You are taking a hormonal contraceptive. A non-hormonal contraceptive (such as condoms) is recommended while taking Fibristal during treatment.

Treatment with Fibristal usually leads to a significant reduction or may even stop the bleeding of your periods within the first days of treatment. However, if you continue to experience excessive bleeding, tell your doctor. Your period should generally return within 4 weeks after treatment with Fibristal is stopped.

The lining of the uterus may thicken or change as a result of taking Fibristal. These changes return to normal after treatment stops and your periods restart.

Fibristal should not be taken by children under 18 years of age.

Interactions with this Medication

Tell your doctor or pharmacist if you are taking any of the medicines listed below, as these medicines can affect Fibristal or be affected by Fibristal:

  • Phenytoin, phenobarbital, carbamazepine (drugs to treat epilepsy)
  • Ritonavir (drug to treat HIV infections)
  • Rrifampicin, telithromycin, clarithromycin, erythromycin (antibiotics)
  • Ketoconazole (except shampoo), itraconazole (drugs to treat fungal infections)
  • St John’s Wort (a herbal treatment for depression)
  • Nefazodone (drug to treat depression)

Fibristal is likely to make some hormonal contraceptives less effective. In addition hormonal contraceptives and progestogens (e.g., norethindrone or levonorgestrel) are also likely to make Fibristal less effective. Therefore hormonal contraceptives are not recommended and you should use an alternative reliable barrier contraceptive method such as condoms during Fibristal treatment.

Proper Use of this Medication

Usual dose

The usual dose for women is one 5 mg tablet per day for 3 months.

You should start taking Fibristal during the first 7 days of your menstrual period.

The tablet should be swallowed with water and may be taken with or without food.

Always take Fibristal exactly as your doctor has told you. Never exceed the prescribed dose.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you miss a dose, take it as soon as you remember. However, if it is time for your next tablet, skip the missed tablet and take only a single tablet as usual. Do not take a double dose to make up for a forgotten tablet.

Side Effects and what to do about them

Fibristal can have side effects, like all medicines, but not everybody gets them. For further information about any of these side effects, ask a doctor or pharmacist. If you experience any symptom that bothers you or does not go away, contact your doctor or seek medical attention as soon as possible.

In clinical studies, the most common side effects related to taking Fibristal were hot flash and headache.

Important Side Effects, how often they Happen and what to do about them
Symptom / EffectTalk with your
doctor or
pharmacist
Stop taking
drug and call
your doctor or
pharmacist
Only if
severe
In all
cases
Very commonHeadacheX
Hot flash X
Uncommon Abnormal uterine bleeding X
Sac of fluid within the
ovaries (ovarian cyst)
X
Worsening of uterine
bleeding
X
New uterine fibroids X

This is not a complete list of side effects. For any unexpected effects while taking Fibristal, contact your doctor or pharmacist.

How to Store it

This package is sealed for your protection. Do not use if torn or broken.

Store at controlled room temperature (15 to 30° C).

Blisters: Keep the blister cards inside the outer carton in order to protect from light.

Bottles: Keep tablets inside the bottle in order to protect from light.

Keep Fibristal out of reach of children.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at
    www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa, Ontario K1A 0K9

    Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

This document plus the full product monograph, prepared for health professionals can be found by contacting the importer, Actavis Specialty Pharmaceuticals Co., at 1-855-892-8766