Edevexin

Package leaflet: Information for the patient

EDEVEXIN 40 mg film-coated tablets

Aescin
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Edevexin tablets are and what they are used for
2. What you need to know before taking Edevexin tablets
3. How to take Edevexin tablets
4. Possible side effects
5. How to store Edevexin tablets
6. Contents of the pack and other information

1. What Edevexin tablets are and what they are used for

Edevexin tablets belong to the category of vasoprotective agents, i.e. substances that protect the small blood vessels (capillary-protecting agents), used for the treatment of conditions involving fragility of the small vessels (capillaries).

2. What you need to know before taking Edevexin tablets

Do not take Edevexin tablets
if you are allergic to escin or to any of the other ingredients of this medicine (listed in
section 6)
if you have diseases causing destruction of red blood cells (hemolytic disorders)
if you have fluid accumulation (edema) throughout the body due to heart, kidney disease or
blood composition disorders (dyscrasia)
if you have reduced kidney function (renal insufficiency), including that caused by a sudden drop in blood pressure (renal shock), or if you have had previous kidney diseases

• if during pregnancy you experienced incompatibility due to the presence in red blood cells of a protein called Rh (Rh in pregnancy)
• if you are at risk of blood clots forming inside blood vessels (thrombotic risk)
• if you are a woman taking oral contraceptives
• if you are in the first three months of pregnancy or are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Edevexin tablets.
Do not use Edevexin tablets if you have impaired kidney function (renal insufficiency).
Your doctor will closely monitor your kidney function if you are taking Edevexin tablets and
you suffer from diseases that may worsen due to impaired kidney function (e.g. extensive
burns, severe head and brain trauma (craniofacial), or severe crush injuries). If kidney function becomes impaired, your doctor will immediately discontinue treatment with Edevexin tablets.
Immediately inform your doctor if you develop skin inflammation, inflammation of the veins associated with blood clot formation (thrombophlebitis), hardening under the skin, severe pain, non-healing lesions (ulcers), sudden swelling of one or both legs, or reduced heart function (heart failure). These may be signs of serious conditions.
If you are taking concomitant medicines that thin the blood (anticoagulants), your doctor will have you undergo frequent blood tests to check whether your blood is clotting properly (see "Other medicines and Edevexin tablets").
It is essential that you follow any other measures prescribed by your doctor, such as leg bandaging, wearing elastic stockings, or applying cold water compresses.
Children and adolescents
Edevexin tablets are not indicated for use in children and adolescents under 18 years of age.
Other medicines and Edevexin tablets
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid concomitant administration of aminoglycoside antibiotics (such as gentamicin), as Edevexin tablets may increase their kidney toxicity.
Some antibiotics, such as cephalothin, may increase escin blood levels.
Edevexin tablets may enhance the effect of medicines that thin the blood (anticoagulants) when taken concomitantly. In such cases, your doctor will adjust your dose appropriately based on clinical test results (e.g. prothrombin time).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of Edevexin tablets during pregnancy and breastfeeding has not been established.
Do not use Edevexin tablets during the first three months of pregnancy or while breastfeeding.
Driving and using machines
Edevexin tablets may slightly impair the ability to drive vehicles or operate machinery.
Dizziness may occur after taking this medicine (see "Possible side effects").
Edevexin tablets contain lactose and sucrose
Edevexin tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
Edevexin tablets contain sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Edevexin tablets

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Initial treatment:

• 1 coated tablet of 40 mg, three times a day

Maintenance period or in milder forms:

• 1 coated tablet of 40 mg one to two times a day

Method of administration:
Take the tablets orally, after meals, with a little liquid.
Use in children and adolescents
This product is not intended for children and adolescents under 18 years of age.
If you take more Edevexin tablets than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
If you forget to take Edevexin tablets
Do not take a double dose to make up for the missed dose.
If you stop Edevexin tablets treatment
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Uncommon (may affect up to 1 in 100 people)

• Nausea, vomiting, diarrhoea
• Abdominal discomfort
• Dizziness
• Headache
• Allergic reactions (hypersensitivity)

Rare (may affect up to 1 in 1,000 people)

• Allergic skin inflammation (allergic dermatitis) with itching, skin redness and rash
• Swelling of the throat with breathing difficulty (laryngeal oedema)
• Localised skin redness (erythema)
• Itchy, red skin with swelling, erosions and crusts (eczema)

Very rare (may affect up to 1 in 10,000 people)

• Severe allergic reactions (in some cases associated with bleeding)
• Uterine bleeding between menstrual periods (metrorrhagia)
• Increased heart rate (tachycardia)
• Increased blood pressure (hypertension)

Stop treatment if you experience any of the above side effects, especially in case of bleeding or at the first signs of allergic reactions (e.g. skin rash).

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Edevexin tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.
This medicine does not require any special storage conditions.

6. Contents of the pack and other information

What Edevexin tablets contain
Edevexin 40 mg film-coated tablets

• The active substance is escin. Each film-coated tablet contains 40 mg of escin.
• The other components are hesperidin, lactose, macrogol (carbowax 1500), macrogol (carbowax 6000), acacia gum, magnesium stearate, acrylic polymer (eudragit L), triacetin, silicic acid, sucrose, talc, titanium dioxide, kepal lake.

Description of the appearance of Edevexin tablets and pack contents
Film-coated tablets, box of 30 tablets
Marketing Authorization Holder and Manufacturer
ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI S.p.A.
Via Fossignano, 2 – 04011 Aprilia (LT).

Patient information leaflet: information for the patient

EDEVEXIN 5 mg/5 ml powder and solvent for solution for infusion

Escin
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Edevexin powder and solvent for solution for infusion is and what it is used for
2. What you need to know before using Edevexin powder and solvent for solution for infusion
3. How to use Edevexin powder and solvent for solution for infusion
4. Possible side effects
5. How to store Edevexin powder and solvent for solution for infusion
6. Contents of the pack and other information

1. What Edevexin powder and solvent for solution for infusion is and what it is used for

Edevexin powder and solvent for solution for infusion belongs to the class of vasoprotective agents,
i.e. substances that protect the small blood vessels (capillary-protective agents), used for the treatment of conditions characterized by fragility of the small vessels (capillaries).

2. What you need to know before using Edevexin powder and solvent for solution for infusion

Do not use Edevexin powder and solvent for solution for infusion

• if you are allergic to escin or to any of the other ingredients of this medicine (listed in section 6)
• if you have diseases that destroy red blood cells (hemolytic disorders)
• if you retain fluid (edema) throughout the body due to heart, kidney, or blood disorders (dyscrasia)
• if you have reduced kidney function (renal insufficiency), including due to a sudden drop in blood pressure (renal shock), or if you have had previous kidney diseases
• if during pregnancy you experienced incompatibility due to the presence in red blood cells of a protein called Rh (Rh incompatibility during pregnancy)
• if you are at risk of blood clots forming inside blood vessels (thrombotic risk)
• if you are a woman taking oral contraceptives
• if you are in the first three months of pregnancy or breastfeeding.

Injections into the arteries must be absolutely avoided due to the risk of severe damage to blood vessels (vascular necrosis).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Edevexin powder and solvent for solution for infusion.
Do not use Edevexin powder and solvent for solution for infusion if you have reduced kidney function (renal insufficiency).
Your doctor will carefully monitor your kidney function if you are taking Edevexin powder and solvent for solution for infusion and suffer from conditions that may worsen due to impaired kidney function (e.g. extensive burns, severe head and brain injuries (craniofacial), or crush injuries). If kidney function becomes impaired, your doctor will immediately discontinue treatment with Edevexin powder and solvent for solution for infusion.
Inform your doctor immediately if you develop skin inflammation, vein inflammation associated with blood clot formation (thrombophlebitis), hardening under the skin, severe pain, non-healing lesions (ulcers), sudden swelling of one or both legs, or reduced heart function (heart failure). These may be signs of serious conditions.
If you are taking anticoagulant medicines (blood thinners) concomitantly, your doctor will perform frequent blood tests to check whether your blood clots properly (see "Other medicines and Edevexin powder and solvent for solution for infusion").
It is essential that you follow all other measures prescribed by your doctor, such as leg bandaging, wearing elastic stockings, or applying cold water compresses.
Edevexin powder and solvent for solution for infusion must be administered exclusively by intravenous
injection.
To avoid possible irritation of the blood vessel wall, special care must be taken to ensure that the needle is properly positioned within the lumen of the vein (which excludes injection into small-caliber veins, such as those on the back of the hand), and the injection should not be administered too slowly.
In case of accidental intra-arterial injection, leave the needle in place and inject 10 ml of 0.9% physiological saline solution containing 10,000 IU of heparin through the same needle.
If the solution is accidentally injected outside the vein, immediate standard measures must be taken (injection of procaine, hyaluronidase, immobilization of the limb).
Contact your doctor immediately or go to the nearest hospital.
Children and adolescents
Edevexin powder and solvent for solution for infusion is not indicated in children and adolescents under 18 years of age.
Other medicines and Edevexin powder and solvent for solution for infusion
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid concomitant administration of aminoglycoside antibiotics (such as gentamicin), as Edevexin powder and solvent for solution for infusion may increase their kidney toxicity.
Some antibiotics, such as cephalothin, may increase escin blood levels.
Edevexin powder and solvent for solution for infusion may enhance the effect of anticoagulant medicines (blood thinners) taken concomitantly. In such cases, your doctor will adjust your dose appropriately based on clinical test results (e.g. prothrombin time).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of Edevexin powder and solvent for solution for infusion during pregnancy and breastfeeding has not been established.
Do not use Edevexin powder and solvent for solution for infusion during the first three months of pregnancy or while breastfeeding.
Driving and using machines
Edevexin powder and solvent for solution for infusion has a minor influence on the ability to drive vehicles or use machines.
Dizziness may occur after taking this medicine (see "Possible side effects").

3. How to use Edevexin powder and solvent for solution for infusion

Use this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is:

• 1-2 vials per day, for intravenous use only
• In cases of particular urgency and severity, the injection may be repeated, but the daily dose must not exceed 20 mg (4 vials)
• For maintenance therapy, the dose is reduced by half.

Use in children and adolescents
This product is not intended for use in children and adolescents under 18 years of age.
If you take more Edevexin powder and solvent for solution for infusion than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
If you forget to take Edevexin powder and solvent for solution for infusion
Do not take a double dose to make up for the missed dose.
If you stop using Edevexin powder and solvent for solution for infusion
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Uncommon (may affect up to 1 in 100 people)

• Nausea, vomiting, diarrhoea
• Abdominal discomfort
• Dizziness
• Headache
• Allergic reactions (hypersensitivity)

Rare (may affect up to 1 in 1,000 people)

• Allergic skin inflammation (allergic dermatitis) with itching, skin redness and rash
• Swelling of the throat with breathing difficulty (laryngeal oedema)
• Localised redness of the skin (erythema)
• Itchy, red skin with swelling, erosions and crusts (eczema)

Very rare (may affect up to 1 in 10,000 people)

• Severe allergic reactions (in some cases associated with bleeding)
• Bleeding from the uterus between periods (metrorrhagia)
• Increased heart rate (tachycardia)
• Increased blood pressure (hypertension)

Stop treatment if any of the above side effects occur, especially in case of bleeding or at the first signs of allergic reactions (e.g. skin rash).

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Edevexin powder and solvent for solution for infusion

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.
This medicine requires no special storage conditions.

6. Package contents and other information

What Edevexin powder and solvent for solution for infusion contains
EDEVEXIN 5 mg/5 ml powder and solvent for solution for infusion

• The active substance is escin (as sodium salt). Each vial of powder contains 5 mg of escin.
• The other components in the solvent vial are sodium chloride, water for injections

Description of the appearance of Edevexin powder and solvent for solution for infusion and
pack contents
Powder and solvent for solution for infusion, carton containing 3 vials of powder + 3 vials of solvent 5 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI S.p.A.
Via Fossignano, 2 – 04011 Aprilia (LT)
Manufacturer
Biologici Italia Laboratories S.r.l. – via F. Serpero, 2 – 20026 Masate (MI)
Responsible person for batch release
Istituto Biochimico Italiano G. Lorenzini S.p.A.
Via Fossignano 2 – 04011 Aprilia (LT)