Tranexamic Acid: Package Insert and Label Information (Page 4 of 4)

14.3 MBL Results over Time

The efficacy of Tranexamic acid tablets 3900 mg/day over 3 menstrual cycles and over 6 menstrual cycles was demonstrated versus placebo in the double-blind, placebo-controlled efficacy studies (see Figure 1). The change in MBL from baseline was similar across all post-baseline treatment cycles.

Figure 1 -- The efficacy of Tranexamic acid tablets 3900 mg/day over 3 menstrual cycles and over 6 menstrual cycles was demonstrated versus placebo in the double-blind, placebo-controlled efficacy studies.
(click image for full-size original)

16 HOW SUPPLIED/STORAGE AND HANDLING

Tranexamic acid tablets are provided as white to off-white, oval-shaped, film coated tablets. Each tablet is debossed with “WPI 3720” on one side of the tablet and are supplied as:

Quantity NDC Number
30 tablets 0591-3720-30
1000 tablets 0591-3720-10

Storage

Store at 20º-25º C (68º-77º F). [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information)

Instruct patients that the usual schedule is to take two tablets with liquids, three times a day during menstruation. Patients should be instructed not to exceed 3 doses (6 tablets) in a 24-hour period or to take for more than 5 days in any menstrual cycle.

Inform patients that they should immediately stop Tranexamic acid tablets if they notice any eye symptoms or change in their vision. Instruct them to report any such problems promptly to their physician and to follow-up with an ophthalmologist for a complete ophthalmic evaluation, including dilated retinal examination of the retina.

Inform patients that they should stop Tranexamic acid tablets and seek immediate medical attention if they notice symptoms of a severe allergic reaction (e.g., shortness of breath or throat tightening).

Instruct patients that common side effects of Tranexamic acid tablets include headache, sinus and nasal symptoms, back pain, abdominal pain, musculoskeletal pain, joint pain, muscle cramps, migraine, anemia and fatigue.

Advise patients to contact their healthcare provider if their heavy menstrual bleeding symptoms persist or worsen.

Remind patients to read the Patient Labeling carefully.

PATIENT INFORMATION
Tranexamic acid tablets

Read the Patient Information that comes with Tranexamic acid tablets before you start using the drug and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What are Tranexamic Acid Tablets ?

Tranexamic acid tablets are a prescription medicine used to treat your heavy monthly period (menstruation) when your bleeding gets in the way of social, leisure and physical activities. Tranexamic acid tablets do not contain any hormones. On average, Tranexamic acid tablets have been shown to lower the amount of blood lost during your monthly period by about one-third, but it is not meant to stop your period.

Tranexamic acid tablets are taken only during your period and are not meant to treat pre-menstrual symptoms (symptoms that occur before your bleeding starts). Tranexamic acid tablets do not affect your fertility and cannot be used as birth control. Tranexamic acid tablets do not protect you against diseases that you may get if you have unprotected sex.

Tranexamic acid tablets have not been studied in adolescents younger than 18 years of age.

Who should not take Tranexamic acid tablets ?

Do not take Tranexamic acid tablets if you:

  • Currently have a blood clot
  • Have ever had a blood clot
  • Have been told that you are at risk of having a blood clot
  • Are allergic to Tranexamic acid tablets or tranexamic acid

What should I tell my healthcare provider before taking Tranexamic acid tablets ?

Before taking Tranexamic acid tablets, tell your healthcare provider about all of your medical conditions, including whether:

  • You have ever had a blood clot or been told that you are at risk of having a blood clot
  • You are using a form of birth control that contains hormones (like a birth control pill, patch, vaginal ring or intrauterine device). Also tell your healthcare provider if you are taking higher than your normally-prescribed dose of birth control. Using hormonal products along with Tranexamic acid tablets, especially if you are overweight or smoke, may increase your chance of having a serious blood clot, stroke, or heart attack.
  • You are pregnant or think you may be pregnant
  • You are breastfeeding or plan to breast-feed. Tranexamic acid tablets can pass into your milk. Talk to your healthcare provider about the best way to feed your baby if you take Tranexamic acid tablets.
  • The time between the start of your periods is less than 21 days or more than 35 days
  • You have any other medical conditions

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tranexamic acid tablets and other medicines can affect each other, causing side effects. Tranexamic acid tablets can affect the way other medicines work and other medicines can affect how Tranexamic acid tablets work.

Especially tell your healthcare provider if you take:

  • Birth control pills or other hormonal birth control
  • Medicines used to help your blood clot
  • Medicines used to break up blood clots
  • Any medicines to treat leukemia

Ask your healthcare provider if you are not sure if your medicine is one that is described above.

How should I take Tranexamic acid tablets ?

  • Take Tranexamic acid tablets exactly as your healthcare provider tells you.
  • Do not take Tranexamic acid tablets until your period has started.
  • Do not take Tranexamic acid tablets for more than 5 days in a row.
  • Do not take Tranexamic acid tablets when you do not have your period.
  • Once your period has started, take 2 tablets of Tranexamic acid tablets three times per day (e.g., in the morning, afternoon, and evening).
  • Tranexamic acid tablets should be swallowed whole and not chewed or broken apart.
  • Tranexamic acid tablets may be taken with or without food.
  • Do not take more than 6 tablets of Tranexamic acid tablets in a day. If you take more than 6 tablets, call your healthcare provider.
  • If you miss a dose, take it when you remember, and then take your next dose at least six hours later. Do not take more than two tablets at a time to make up for missed doses.
  • If Tranexamic acid tablets do not help to lessen bleeding with your periods after 2 cycles or seems to stop working, talk to your healthcare provider.

What are the possible side effects of Tranexamic acid tablets ?

Tranexamic acid tablets can cause serious side effects, including:

  • Blood clots. This risk of serious blood clots may be increased when Tranexamic acid tablets are taken with:
    • hormonal contraceptives, especially if you are taking higher than your normal dose of birth control, are overweight, or if you smoke cigarettes
    • medicines used to help your blood clot
    • some medicines used to treat leukemia
  • Eye changes. Stop taking Tranexamic acid tablets and promptly report any eye problems you have while taking Tranexamic acid tablets. Your doctor will refer you to an eye doctor who will examine your eyes.
  • Allergic reaction. If you have severe shortness of breath and your throat feels tight, stop taking Tranexamic acid tablets and get medical care right away.

The most common side effects of Tranexamic acid tablets include:

  • Headaches
  • Sinus and nasal problems
  • Back pain
  • Pain in your abdomen
  • Pain in your muscles or joints
  • Anemia
  • Fatigue

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all of the possible side effects of Tranexamic acid tablets. For more information, ask your healthcare provider or pharmacist.

If you notice a change in your usual bleeding pattern that worries you, or your heavy bleeding continues, contact your healthcare provider right away. This may be a sign of a more serious condition .

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Watson Laboratories, Inc. at 1-800-272-5525.

How should I store Tranexamic acid tablets ?

Store Tranexamic acid tablets at room temperature between 20º-25º C (68º-77º F).

Keep Tranexamic acid tablets and all medicines out of the reach of children.

General information about Tranexamic acid tablets

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information Leaflets. Do not use Tranexamic acid tablets for a condition for which it was not prescribed. Do not give Tranexamic acid tablets to other people, even if they have the same symptoms that you have. It may harm them.

This patient information leaflet summarizes the most important information about Tranexamic acid tablets. If you would like more information about Tranexamic acid tablets, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Tranexamic acid tablets that is written for healthcare professionals. For more information, go to www.watson.com or call 1-800-272-5525.

What are the ingredients of Tranexamic acid tablets ?

Active ingredient: tranexamic acid

Inactive ingredients: colloidal silicon dioxide, copovidone, crospovidone, eudragit, glyceryl behenate, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and triethyl citrate.

Manufactured by:
Watson Laboratories, Inc.
Corona, CA 92880 USA

Distributed by:
Watson Pharma, Inc.
Parsippany, NJ 07054 USA

Rev. date: 11/2011

NDC 0591-3720-30
Tranexamic Acid Tablets 650 mg
PHARMACIST: PLEASE DISPENSE IN THIS CHILD-RESISTANT
CONTAINER WITH PATIENT INFORMATION LEAFLET PROVIDED.Watson 30 Tablets Rx only

NDC 0591-3720-30 Tranexamic Acid Tablets 650 mg
(click image for full-size original)

TRANEXAMIC ACID tranexamic acid tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3720
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRANEXAMIC ACID (TRANEXAMIC ACID) TRANEXAMIC ACID 650 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
COPOVIDONE K25-31
CROSPOVIDONE
GLYCERYL DIBEHENATE
LACTOSE MONOHYDRATE
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
TALC
TRIETHYL CITRATE
DIMETHYLAMINOETHYL METHACRYLATE — BUTYL METHACRYLATE — METHYL METHACRYLATE COPOLYMER
HYPROMELLOSES
Product Characteristics
Color WHITE (off-white) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code WPI;3720
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-3720-10 1000 TABLET, FILM COATED (1000 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:0591-3720-30 30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202093 01/03/2013
Labeler — Watson Laboratories, Inc. (106931488)
Establishment
Name Address ID/FEI Operations
Watson Laboratories, Inc. — Florida 020778751 ANALYSIS (0591-3720), MANUFACTURE (0591-3720)
Establishment
Name Address ID/FEI Operations
Watson Laboratories, Inc. — Florida 014759176 ANALYSIS (0591-3720), LABEL (0591-3720), MANUFACTURE (0591-3720), PACK (0591-3720)
Establishment
Name Address ID/FEI Operations
Watson Laboratories, Inc. — Florida 016002608 ANALYSIS (0591-3720)

Revised: 11/2011 Watson Laboratories, Inc.

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