Patient Medication Information: uses, side effects, how to take - Lysteda
ABOUT THIS MEDICATION
What the medication is used for:
LYSTEDA is used in the treatment of women who have heavy monthly period (menstruation) bleeding.
What it does:
LYSTEDA contains tranexamic acid, an antifibrinolytic that helps reduce the amount of blood loss due to heavy monthly period bleeding. LYSTEDA does not stop or shorten your period.
When it should not be used:
LYSTEDA should not be used 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 hypersensitive (allergic) to tranexamic acid or any
ingredients in LYSTEDA
have bleeding in the brain (active subarachnoid
hemorrhage).
What the medicinal ingredient is:
The medicinal ingredient is tranexamic acid.
What the nonmedicinal ingredients are:
The nonmedicinal ingredients are: hypromellose, pregelatinized corn starch, microcrystalline cellulose, povidone, stearic acid, magnesium stearate and colloidal silicone dioxide.
What dosage forms it comes in:
LYSTEDA (tranexamic acid) tablets are provided as white oval-shaped tablets. Each tablet contains 650 mg of tranexamic acid. Each tablet is debossed with the marking “FP650”and are supplied in HDPE bottles containing 6, 30, 90 or 100 tablets.
WARNINGS AND PRECAUTIONS
Before you use LYSTEDA, talk to your doctor if you have or have had the following condition:
- a history of blood clot or been told that you are at risk of having a blood clot
- are using a birth control that contains hormones such as pill, patch, vaginal ring, or intrauterine device. Using hormonal products with LYSTEDA may increase the risk of having a blood clot, stroke, or heart attack, especially in women who are overweight or smoke
are pregnant or think you may be pregnant
- are breastfeeding or plan to breast-feed
- the time between the start of your periods is less than 21 days or more than 35 days
- have kidney problems
- have eye problems
- have any other medical conditions
LYSTEDA has not been studied in patients under 18 years of age. LYSTEDA is not intended for use by postmenopausal women.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor or pharmacist if you are taking, or have been taking, any other medicines, even medicines you buy without a prescription, vitamins, herbal supplements, and natural health products. Certain drugs may interact with tranexamic acid.
LYSTEDA and other medicines can affect each other, causing side effects. LYSTEDA can affect the way other medicines work and other medicines can affect how LYSTEDA works. 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
PROPER USE OF THIS MEDICATION
Use LYSTEDA exactly as prescribed by your doctor.
Usual dose:
1300 mg (2 x 650 mg tablets) three times a day at the beginning of your monthly period, for the maximum of 5 days in a row.
LYSTEDA tablets should be swallowed whole with water. Do not chew or break the tablet.
LYSTEDA can be taken with or without food.
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 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.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
The most common side effects: migraine, headache, sinus and nasal problems, back pain, pain in the abdomen, muscle and joint pain, low red blood cells (anemia) and tiredness (fatigue). Serious side effects:
- blood clots,
eye problem. If it happens stop taking LYSTEDA and see
to your doctor right away.
allergic reaction such as severe shortness of breath,
tightness in the throat. Stop taking LYSTEDA and get medical care right away.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
Only if severe | In all cases | |||
| Common | headache nasal & sinus problems back pain abdominal pain pain in muscles or joints migraine anemia fatigue | √ √ √ √ √ √ √ √ | ||
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and | ||
| Uncommon | blood clot to the leg (swelling pain) blood clot to the lung (severe chest pain, shortness of breath) eye changes (colour vision, acuity) allergic reactions (swelling of the face or tongue, skin rash, shortness of breath, chest pain, urticaria) | √ √ √ √ | √ √ √ √ | |
This is not a complete list of side effects. For any unexpected effects while taking LYSTEDA, contact your doctor or pharmacist.
HOW TO STORE IT
Store LYSTEDA at room temperature between 15°C to 30°C.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax: 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Ferring Inc. at: 1-800-263-4057