500 mg film-coated tablets
tranexamic acid
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WHAT TRANEXA IS AND WHAT IT IS USED FOR
The active substance in Tranexa is tranexamic acid. Tranexamic acid is an anti-bleeding agent that prevents the effect of the enzyme that dissolves clotted blood ( clot ). This leads to less blood loss and a faster healing process.
Tranexa is used:
- during heavy menstruation
- in case of bleeding or increased risk of bleeding after operations, especially in the bladder and lungs
- in case of bleeding from the gastrointestinal tract, bleeding from the urinary tract, severe epistaxis
- after the dental surgery on people with an increased risk of bleeding.
Tranexamic acid found in Tranexa may also be approved to treat
other diseases not mentioned in this leaflet. Ask a doctor, pharmacist, or
other healthcare professionals if you have further questions, and always follow their
instructions.
BEFORE YOU USE TRANEXA
Do not use Tranexa
- if you are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6)
- if you are being treated for blood clots, for example in the legs, lungs, or brain
- if you are being treated for brain bleeding.
- if you have severely impaired kidney function
- if you have previously had convulsions
Warnings and precautions
Talk to your doctor or pharmacist before taking Tranexa:
- if you have irregular periods
- if you have previously had blood clots and if blood clots have occurred in parents and/or siblings
- if you have blood in your urine (between menstrual periods)
- if you have impaired kidney function.
Use of other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Simultaneous treatment with anticoagulants (blood-thinning drugs) should only be carried out by doctors with coagulation as a special competence.
Pregnancy and breastfeeding
There is only limited experience of use during pregnancy.
Tranexamic acid passes into breast milk but is unlikely to affect children who are breastfed.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving ability and use of machinery
Side effects such as e.g. dizziness and visual disturbances have been reported, which may affect the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
HOW TO USE TRANEXA
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The recommended dose for adults is 2-3 tablets 2 or 3 times daily. The dose must be determined by a doctor who adjusts it individually for you. The dose may vary slightly depending on the area of use.
The tablet can be divided into two equal doses.
If you have used too much Tranexa
Symptoms of overdose may be the following: Nausea, diarrhea, dizziness, headache, dizziness when standing up, drop in blood pressure, muscle weakness ( myopathy ), and convulsions.
If you have used too much medicine or if, for example, a child accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Tranexa
If you forget to take your tablets, take the normal amount of tablets the next time.
Do not take a double dose to make up for a missed tablet.
If you have further questions about this medicine, contact your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people): Nausea, vomiting, diarrhea, abdominal pain, headache, dizziness.
Uncommon (may affect up to 1 in 100 users): Allergic skin reactions (e.g. skin rash, hives ).
Rare (may affect up to 1 in 1,000 users): Changes in color vision or other visual disturbances.
Has been reported (occurring in an unknown number of users): Blood clots and convulsions.
HOW TO STORE TRANEXA
Keep this medicine out of the sight and reach of children.
Store at a maximum of 30 °C.
Stored in the original box. Moisture sensitive.
Use before the expiry date which is stated on the carton after the Expiration date.
The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
OTHER INFORMATION
Contents declaration
- The active substance is tranexamic acid
- Other ingredients (excipients) are Core: Microcrystalline cellulose (E460), hydroxypropyl cellulose, talc (E553b), magnesium stearate (E470b), colloidal anhydrous silica (E551), and povidone (E1201).Coating: Basic butylated methacrylate copolymer, sodium lauryl sulfate, stearic acid, and talc.
Appearance and package sizes of the medicine
Tranexa 500 mg are capsule-shaped, biconvex film-coated tablets with a score on one side and “500” on the other side.
Tranexa 500 mg film-coated tablets are packed in Al/PVC blister foil and HDPE can.
Blisters:
20, 30, 50, 60 and 100 film-coated tablets.
HDPE can:
20, 30, 60, and 100 film-coated tablets.
Blisters/jars are packed in cartons together with a package leaflet.
Not all pack sizes may be marketed
Marketing Authorisation Holder
2care4 Generics ApS
Stenhuggervej 12-14
DK-6710 Esbjerg V
Denmark
Manufacturer
LABIANCA PHARMACEUTICALS, SLU
Casanova, 27-31, Corberá de Llobregat,
08757 Barcelona
Spain
SC Santa SA,
Str. Carpatilor no. 60, objective no. 47, 48, 58, 133,
Brasov 500269,
Romania
2care4 Generics ApS
Stenhuggervej 12-14
DK-6710 Esbjerg V
Denmark