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

PATIENT INFORMATION

Tranexamic Acid Tablets, for oral use

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.

Tranexamic Acid Tablets are not for women who have already gone through menopause (post-menopausal).

Who should not take Tranexamic Acid Tablets?

Do not take Tranexamic Acid Tablets if you:

Are using a form of birth control that contains estrogen and a progestin (like a birth control pill, patch, or vaginal ring). Ask your healthcare provider before taking Tranexamic Acid Tablets if you are not sure if your birth control method contains estrogen and a progestin.
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 estrogen and a progestin (like a birth control pill, patch, or vaginal ring). Using hormonal birth control along with Tranexamic Acid Tablets may increase your chance of having a serious blood clot, stroke, or heart attack. For this reason, do not use Tranexamic Acid Tablets if you use a form of birth control that contains estrogen and a progestin.
You are pregnant or think you may be pregnant
You are breastfeeding or plan to breast-feed. Tranexamic acid 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 form clots
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. You may have a higher risk of having serious blood clots if you take Tranexamic Acid Tablets with:
o
medicines used to help your blood form clots
o
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 ANI Pharmaceuticals, Inc. at 1-800-308-6755.

How should I store Tranexamic Acid Tablets?

Store Tranexamic Acid Tablets at room temperature between 68°F to 77°F (20°C to 25°C).

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.

What are the ingredients of Tranexamic Acid Tablets?

Active ingredient: tranexamic acid

Inactive ingredients: hypromellose, microcrystalline cellulose, povidone, colloidal silicon dioxide, stearic acid, and magnesium stearate.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Suzhou Amerigen Pharmaceutical Co. Ltd.

Jiangsu, China 215006

Distributed by:

ANI Pharmaceuticals, Inc.

10405 Rev 01/21

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Tranexamic Acid Tablets USP, 650 mg

NDC 62559-265 -30

Rx only

30 Tablets

Label
(click image for full-size original)

TRANEXAMIC ACID tranexamic acid tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-265
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
HYPROMELLOSE 2208 (3 MPA.S)
HYPROMELLOSE 2208 (100 MPA.S)
POVIDONE K30
SILICON DIOXIDE
STEARIC ACID
MICROCRYSTALLINE CELLULOSE 101
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to off-white) Score no score
Shape OVAL Size 17mm
Flavor Imprint Code AMG229
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-265-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203256 07/01/2021
Labeler — ANI Pharmaceuticals, Inc. (145588013)

Revised: 05/2021 ANI Pharmaceuticals, Inc.

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