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Pilexam

Document: Pilexam 100 mg per ml solution for injection ENG PL change


Package leaflet: Information for the user

Pilexam100 mg / ml solution for injection

Tranexamic acid


Read all of this leaflet carefully before you are given this medicine because it contains important information for you.


What is in this leaflet

What Pilexam is and what it is used for

What you need to know before you are given Pilexam

How to use Pilexam

Possible side effects

How to store Pilexam

Contents of the pack and other information


1. What Pilexam is and what it is used for

Pilexam contains tranexamic acid which belongs to a group of medicines called antihaemorragics; antifibrinolitics, aminoacids.

Pilexam is used in adults and children above one year of age for the prevention and treatment of bleeding due to a process that inhibits blood clotting called fibrinolysis.

Specific indications include:

- Heavy periods in women

- Gastrointestinal bleeding

- Haemorrhagic urinary disorders, further to prostate surgery or surgical procedures affecting the urinary tract

- Ear, nose, or throat surgery

- Heart, abdominal, or gynecological surgery

- Bleeding after you have been treated with another medicine to break down blood clots.

2. What you need to know before you are given Pilexam

Do not use Pilexam:


Due to the risk of cerebral oedema and convulsions, intrathecal and intraventricular injection and intracerebral application are not recommended.

If you think any of these apply to you, or if you are in any doubt at all, tell your doctor before taking Pilexam.


Warnings and precautions

Talk to your doctor before you are given Pilexam.

Tell your doctor if any of these apply to you to help him or her decide if Pilexam is suitable for you:


Other medicines and Pilexam

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You should specifically tell your doctor if you take:



Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a babyask your doctor for advice before taking this medicine..

Tranexmic acid is excreted in human milk. Therefore, the use of Pilexam during breast-feeding is not recommended.


Driving and using machines

No studies have been performed on the ability to drive and use machines.


3. How to use Pilexam

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.


Use in adults

Pilexam solution for injection will be given to you by slow injection into a vein.

Your doctor will decide the correct dose for you and how long you should take it.


Use in children

If Pilexam solution for injection is given to a child above one year of age, the dose will be based on the child’s weight. Your doctor will decide the correct dose for the child and how long he/she should take it.


Use in elderly

No reduction in dosage is necessary unless there is evidence of renal failure.


Use in patients with kidney problem

If you have a kidney problem, your dose of tranexamic acid will be reduced according to a test performed on your blood (serum creatinine level).


Use in patients with hepatic impairment

No reduction in dosage is necessary.


Method of administration

Pilexam should only be administrated slowly into a vein.

Pilexam must not be injected into a muscle.


If you are given more Pilexam than you should

If you are given more Pilexam than the recommended dose you may experience a transitory blood pressure lowering. Talk to a doctor or pharmacist immediately.


4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.


Side effects reported with tranexamic acid are:

The following side effects have been observed with tranexamic acid:

Common (may affect up to 1 in 10 people)

effects on the stomach and intestines: nausea, vomiting, diarrhoea


Uncommon (may affect up to 1 in 100 people)

effects on the skin problems: rash


Not know (frequency cannot be estimated from the available data)


Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below)

[to be completed nationally]

By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Pilexam

Keep this medicine out of the sight and reach of children.


This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the label after “EXP”. The expiry date refers to the last day of that month.


Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


6. Contents of the pack and other information

What Pilexam contains

- The active substance istranexamic acid. Each 1ml of solution contains 100 mg of tranexamic acid.

- The other ingredients are: water for injection.


What Pilexam looks like and contents of the pack


Clear glass type I ampoules of 5ml capacity. Boxes of 10 ampoules × 5 ml.

Clear glass type I ampoules of 10ml capacity. Boxes of 10 ampoules × 10 ml.


Marketing Authorisation Holder

[To be completed nationally]


Manufacturer

Medochemie Ltd.

Ampoule Injectable Facility: 48 Iapetou Street, Agios Athanassios Industrial Area, 4101 Agios

Athanassios, Limassol

Cyprus


This leaflet was last revised in 2016-04-29


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