Tranexamic acid (Oral)

Tranexamic acid is used to treat heavy menstrual bleeding in women. This medicine may be used by teenage females, but is not intended for use before the start of menstruation.

Tranexamic acid is an antifibrinolytic agent. It works by blocking the breakdown of blood clots, which helps to prevent bleeding.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to monitor your progress while you are using this medicine. This will help your doctor determine if the medicine is effective and whether you should keep taking it.

Inform your doctor if you are using birth control pills or other forms of birth control (such as a patch, vaginal ring, or intrauterine device). You should not use this medication if you are also using combination hormonal contraception, as it may increase your risk of a blood clot, heart attack, or stroke. Your risk is even greater if you are overweight, smoke cigarettes, or are over 35 years old.

This medicine may lead to serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical help. Contact your doctor right away if you experience shortness of breath, difficulty breathing, chest tightness, facial flushing, trouble swallowing, or any swelling of your hands, face, or mouth while using this medicine.

Contact your doctor immediately if you have any eye issues, such as a change in vision. Your doctor will want you to see an ophthalmologist (eye doctor).

If this medicine does not reduce your bleeding after two menstrual cycles or if it seems to lose effectiveness, consult your doctor.

Do not take any other medicines unless you have talked about them with your doctor. This includes both prescription and nonprescription (over-the-counter [OTC]) medicines, as well as herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits it will bring. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your health care professional about any other types of allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been done on how tranexamic acid affects children or teenage females younger than 12 years old. Safety and effectiveness have not been established.

Geriatric

Studies on how tranexamic acid affects older adults have not been performed. This medicine is not intended for use in women who are no longer having menstrual bleeding (postmenopausal).

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In such cases, your doctor may adjust the dose, or other precautions may be necessary. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been highlighted based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or change some of the other medicines you take.

• Desogestrel
• Dienogest
• Drospirenone
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Gestodene
• Levonorgestrel
• Medroxyprogesterone
• Mestranol
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Segesterone
• Ulipristal

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Anti-Inhibitor Coagulant Complex
• Chlorpromazine
• Tretinoin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or with certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to happen. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Acute promyelocytic leukemia—Use with caution. Using this medicine together with oral tretinoin in patients with this condition may cause bleeding problems.

• Blood clots, whether active or historical, or
• Deep vein thrombosis (blood clot in the leg) or
• Pulmonary embolism (blood clot in the lung) or
• Retinal artery or vein occlusion (blood clot in the eye), whether historical or
• Stroke (blood clot in the brain)—This medicine should not be used in patients with these conditions.

• Kidney disease—Use with caution. The effects may be increased due to slower removal of the medicine from the body.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Pale skin
• trouble breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

Incidence not known

• Anxiety
• change in vision
• chest pain or tightness
• confusion
• cough
• difficulty with swallowing
• dizziness or lightheadedness
• fainting
• fast heartbeat
• numbness of the hands
• pain, redness, or swelling in the arm or leg
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash, hives, or itching

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain, discomfort, or tenderness
• chills or fever
• difficulty with moving
• headache, severe and throbbing
• joint or back pain
• muscle aching or cramping
• muscle pains or stiffness
• stuffy or runny nose

Incidence not known

• Diarrhea
• nausea
• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Lysteda

Available Dosage Forms:

• Tablet

Therapeutic Class: Hemostatic

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Do not take this medicine when you do not have your period. You should wait until your monthly period has started before taking this medicine.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Swallow the tablet whole with liquids. Do not break, crush, or chew it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):To treat heavy menstrual bleeding: Adults—Two tablets (650 milligrams per tablet) three times a day in the morning, afternoon, and evening. The tablets should not be taken more than 5 days in a row for each monthly period. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you take a dose that is late, wait at least 6 hours before you take your next dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.