500 mg film-coated tablets
tranexamic acid
What Tranexamic acid Orifarm is and what it is used for
Tranexamic acid Orifarm is used for heavy menstrual bleeding.
Tranexamic acid Orifarm is an anti-bleeding agent. It contains tranexamic acid, which prevents the effect of the enzyme that dissolves clotted blood ( clot ). This leads to less blood loss and a faster healing process.
Tranexamic acid contained in Tranexamic acid Orifarm may also be approved to treat other diseases not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
You must talk to a doctor if you do not feel better or if you feel worse after 1 day.
What you need to know before using Tranexamic acid Orifarm
Do not use Tranexamic acid Orifarm
Please note that Tranexamic Acid Orifarm may only be used if you have regular, heavy periods. For you to feel sure of this before you start the treatment, you must have answered yes to both questions that follow:
- Are your periods regular, i.e. occurring at 21-35 day intervals?
- When menstruation is at its heaviest, do you need to use double sanitary pads, pads, and tampons at the same time or double pads to prevent bleeding, or change sanitary pads bothersomely often?
Do not use Tranexamic acid Orifarm
- 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 are being treated for kidney disease
- if you have previously had convulsions.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Tranexamic Acid Orifarm if you:
- have irregular periods
- previously had blood clots and if blood clots have occurred in parents and/or siblings
- have blood in the urine (between menstrual periods)
- impaired kidney function.
Heavy periods can be due to diseases in the uterus, such as e.g. muscle knots or polyps. If these are remedied, heavy menstruation usually disappears. If you feel unsure, you should contact your gynecologist.
Continued gynecological health checks are recommended.
Children and young people
If you are under 15 years of age, you should consult a doctor before treatment.
Other medicines and Tranexamic acid Orifarm
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Simultaneous treatment with anticoagulants (blood-thinning drugs) must only be carried out by doctors with coagulation as a special competence.
Pregnancy, breastfeeding, and fertility
Tranexamic acid Orifarm should be used during regular heavy periods and is not intended for use during pregnancy and breastfeeding.
There is only limited experience of use during pregnancy. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Tranexamic acid passes into breast milk but is unlikely to affect children who are breastfed. However, consult a doctor for more than occasional use of Tranexamic Acid Orifarm during breastfeeding.
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 Tranexamic acid Orifarm
Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. Consult a doctor, pharmacist, or nurse if you are unsure.
The treatment should only be started when the actual menstruation begins.
The recommended dose for adults and children from 15 years of age: Take 2 tablets 3 times daily as long as needed, but no more than 4 days.
In the case of very heavy periods, the dose can be increased. However, do not use more than 8 tablets per day. Another dosage may be prescribed by a doctor.
The tablet can be divided into two equal doses.
If the effect (reduced bleeding) is not achieved already after the first day, stop the treatment and consult a doctor.
If Tranexamic acid Orifarm does not have a sufficient effect or if you cannot tolerate Tranexamic acid Orifarm, there are other methods to treat heavy menstruation. Contact a gynecologist who can provide information about these methods.
If you have used too much Tranexamic acid Orifarm
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Signs of an overdose can be dizziness, headache, drop in blood pressure, and convulsions.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
If you have forgotten to use Tranexamic acid Orifarm
Do not take a double dose to make up for a missed dose.
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, convulsions.
How to store Tranexamic acid Orifarm
Store at a maximum of 30 °C.
Use before the expiry date stated on the packaging after the Issue. data/EXP. The expiration date is the last day of the specified month.
Keep this medicine out of the sight and reach of children.
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.
Contents of the packaging and other information
Contents declaration
- The active substance is tranexamic acid. One tablet contains 500 mg of tranexamic acid.
- Other ingredients are microcrystalline cellulose, povidone, croscarmellose sodium, colloidal anhydrous silica, talc, magnesium stearate, basic butylated methacrylate copolymer, titanium dioxide (E 171), macrogol and vanillin.
Appearance and package sizes of the medicine
The tablets are white or almost white, biconvex, capsule-shaped with a score, length 18 mm, width 8 mm. The tablet can be divided into two equal doses.
Pack size: 10, 14, 18, 20 tablets in blister.
Not all pack sizes may be marketed.
Orifarm GenericsA/S
Energizer 15
5260 Odense S
Denmark
Local Representative
Orifarm Generics AB
Box 56048
102 17 Stockholm