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

• Pilexam Solution for injection PL
• Pilexam 100 mg per ml solution for injection ENG PL

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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.

• Keep this leaflet. You may need to read it again.

• If you have further questions, please ask your doctor or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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:

• if you are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6)

• if you have currently a disease leading to blood clots

• if you have a condition called ‘consumption coagulopathy’ where blood in the whole body starts to clot

• if you have kidney problems.

• If you have a history of convulsions.

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:

• If you have had blood in your urine Pilexam may lead to urinary tract obstruction.

• If you have a risk of having blood clots.

• If you have excessive clotting or bleeding throughout your body (disseminated intravascular coagulation), Pilexam may not be right for you, except if you have acute severe bleeding and blood test have shown the process that inhibits blood clotting called fibrinolysis is activated.

• If you have had convulsions, Pilexam should not be administered. Your doctor must use the minimal dose possible to avoid convulsions following treatment with Pilexam.

• If you are on a long-term treatment with Pilexam, attention should be paid to possible disturbances of colour vision and if necessary the treatment should be discontinued. With continuous long-term use of Pilexam solution for injection, regular ophthalmologic examinations (eye examinations including visual acuity, colour vision, fundus, visual field etc.) are indicated. With pathological ophthalmic changes, particularly with diseases of the retina, your doctor must take a decision after consulting a specialist on the necessity for the long-term use of Pilexam solution for injection 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.

You should specifically tell your doctor if you take:

• other medicines that help blood to clot called antifibrinolytic medicines

• medicines that prevent blood clotting, called thrombolytic medicines

• oral contraceptives

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)

Uncommon (may affect up to 1 in 100 people)

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

• malaise with hypotension (low blood pressure), especially if the injection is given too quickly

• blood clots

• effects on the nervous system: convulsions

• effects on the eyes: vision disturbances including impaired color vision

• effects on the immune system: allergic reactions

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