100 mg / ml solution for injection
tranexamic acid
What Pilexam is and what it is used for
Pilexam contains tranexamic acid, which belongs to a group of medicines called hemostatics;
fibrinolysis inhibitors, amino acids.
Pilexam is used in adults and children over 1 year of age to prevent and treat bleeding due to fibrinolysis, which means that the blood has difficulty coagulating.
Specific uses include:
- Heavy menstruation in women
- Bleeding in the stomach/intestine
- Urinary tract bleeding after prostate surgery or surgery that affects the urinary tract
- Ear, nose, or throat surgery
- Cardiovascular surgery, abdominal surgery, or gynecological surgery
- Bleeding after you have been treated with another anticoagulant.
What you need to know before using Pilexam
Do not use Pilexam
- if you are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6).
- if you have a disease that causes you to get blood clots
- if you have a disease called “consumption coagulopathy”, in which the blood throughout the body begins to form blood clots
- if you have kidney problems
- if you have had seizures in the past.
Due to the risk of brain edema and seizures, use in the brain ( intrathecal and intraventricular injection or intracerebral application) is not recommended.
If you think any of the above applies to you, or if you have any further questions, ask your doctor or doctor before taking Pilexam.
Warnings and cautions
Talk to your doctor before using Pilexam.
Tell your doctor if any of the following apply to you to help him or she decides if Pilexam is right for you:
- If you have had blood in your urine: Pilexam may obstruct the urethra.
- If you have an increased risk of getting blood clots.
- If you have severe coagulation or bleeding throughout the body (disseminated intravascular coagulation ), Pilexam may not be suitable for you, unless you have acute severe bleeding and blood tests have shown that the process inhibits the blood’s ability to coagulate ( fibrinolysis ) has been activated.
- If you have had seizures before, you should not be treated with Pilexam. Your doctor should use the lowest possible dose to avoid seizures during treatment with Pilexam.
- If you are on long-term treatment with Pilexam, any changes in color vision should be monitored, and if necessary, treatment should be stopped. If you continue to use Pilexam for long-term use, you should have regular eye examinations (check for visual acuity, color vision, fundus, visual field, etc.). In case of eye changes, especially diseases of the retina, the doctor should, after consultation with a specialist, decide whether long-term treatment with Pilexam is necessary in your case.
Other medicines and Pilexam
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor if you are taking:
- other drugs to make the blood coagulate, so-called antifibrinolytic agents
- drugs that prevent blood clots, so-called thrombolytic drugs
- birth control pills.
Pregnancy and breastfeeding
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 taking this medicine.
Tranexamic acid is excreted in breast milk. The use of Pilexam during breastfeeding is therefore not recommended.
Driving and using machines
No studies have been performed on the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Pilexam
Use for children and adolescents
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Use in adults
Pilexam will be given to you by a slow injection into a blood vessel. Your doctor will decide which dose is right for you and for how long you should be treated.
Use in children
If Pilexam solution for injection is given to children from 1 year of age, dose one is based on the weight of the child. The doctor decides which dose is appropriate and how long the child should be treated.
Use in the elderly
No dose reduction is required unless there is evidence of renal failure.
Use in patients with renal impairment
In renal impairment, the dose of tranexamic acid will be reduced by taking a blood test (serum creatinine value).
Use in patients with hepatic impairment
No dose reduction is required.
Method of administration
Pilexam should only be administered slowly in a blood vessel.
Pilexam must not be injected into a muscle.
If you use more Pilexam than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you receive more Pilexam than the recommended dose, you may experience a transient drop in blood pressure. Talk to a doctor or pharmacist immediately.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects reported for tranexamic acid:
The following side effects have been observed for tranexamic acid:
Common (may affect up to 1 in 10 people)
- gastrointestinal disorders: nausea, vomiting, diarrhea
Uncommon (may affect up to 1 in 100 people)
- skin effect: rash
No known frequency (frequency can not be calculated from available data)
- feeling sick with low blood pressure, especially if the injection has been given too quickly
- blood clots
- effects on the nervous system: seizures
- effects on the eyes: changes in vision including impaired color vision
- effects on the immune system: allergic reactions
How to store Pilexam
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the label after “EXP”. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
- The active substance is tranexamic acid. Each 1 ml solution contains 100 mg tranexamic acid.
- The other ingredients are water for injections.
What the medicine looks like and the contents of the pack
Clear ampoule in type I glass containing 5 ml. Carton of 10 ampoules x 5 ml.
Clear ampoule in type I glass containing 10 ml. Carton of 10 ampoules x 10 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pilum Pharma A / S, Energivej 15, 5260 Odense S, Denmark
Local representative
Orifarm Generics AB, Box 56048, 102 17 Stockholm, info@orifarm.com
Manufacturer
Medochemie Ltd.
Ampoule Injectable Facility: 48 Iapetou Street, Agios Athanassios Industrial Area, 4101 Agios
Athanassios, Limassol
Cyprus