Sulovas

Package Leaflet: Information for the Patient

Sulovas, 250 LSU, Soft Capsules

Sulodexide
This medicinal product is subject to additional monitoring. This will allow for the quick identification of new safety information. The user of the medicinal product can also help by reporting any adverse reactions that occur after taking the medicinal product. To find out how to report adverse reactions, see section 4.

Read the package leaflet carefully before taking the medicinal product, as it contains important information for the patient.

• Keep this package leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicinal product has been prescribed to you by a doctor. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What Sulovas is and what it is used for
• 2. Important information before taking Sulovas
• 3. How to take Sulovas
• 4. Possible adverse reactions
• 5. How to store Sulovas
• 6. Package contents and other information

1. What Sulovas is and what it is used for

Sulovas contains sulodexide, a substance that, by acting on some of the factors responsible for the blood coagulation process, has an antithrombotic effect in arterial and venous vessels. Sulodexide also normalizes increased blood viscosity in patients with vascular changes and a risk of thrombosis, and reduces lipid levels.

Indications for use of Sulovas

• Symptomatic treatment of primary and secondary chronic venous insufficiency.
• Prolonged secondary prevention of venous thromboembolic disease in patients who have completed standard anticoagulant treatment due to deep vein thrombosis or pulmonary embolism.
• Treatment of hard exudates in patients with non-proliferative mild to moderate diabetic retinopathy.
• Treatment of venous leg ulcers, as an adjunct to local therapy - continuation of initial parenteral therapy.
• Symptomatic treatment of moderate chronic obstructive arterial disease of the lower limbs (grade II according to Fontaine's classification) - continuation of initial parenteral therapy.

2. Important information before taking Sulovas

When not to take Sulovas

• If you are allergic to sulodexide or any of the other ingredients of this medicinal product (listed in section 6), or to heparin or heparin-like substances.
• If you have a bleeding disorder (tendency to bleed) and diseases characterized by bleeding.
• If you are taking heparin or other anticoagulant medicinal products (including oral anticoagulants).
• If you have a known hypersensitivity to peanuts or soy.

Warnings and precautions

Before taking Sulovas, discuss it with your doctor or pharmacist.

Sulovas and other medicinal products

Tell your doctor about all the medicinal products you are taking or have recently taken, as well as any medicinal products you plan to take.

• Sulovas may enhance the effect of concomitantly administered oral anticoagulants (e.g., warfarin) (see section "When not to take Sulovas").

Taking Sulovas with food and drink

Do not take the medicinal product with meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicinal product. The use of this medicinal product is not recommended in pregnant women. The use of this medicinal product is not recommended during breastfeeding.

Driving and using machines

Sulovas does not affect the ability to drive and use machines.

Sulovas contains ethyl parahydroxybenzoate, propyl parahydroxybenzoate, and sodium

Ethyl parahydroxybenzoate, propyl parahydroxybenzoate

The medicinal product may cause allergic reactions (possible late reactions).

Sodium

The medicinal product contains 2.79 mg of sodium per capsule. The medicinal product contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".

3. How to take Sulovas

This medicinal product should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Recommended dose

• Symptomatic treatment of primary and secondary chronic venous insufficiency:
• 2 capsules (500 LSU) twice daily between meals.
• Prolonged secondary prevention of venous thromboembolic disease in patients who have completed standard anticoagulant treatment due to deep vein thrombosis or pulmonary embolism:
• 2 capsules (500 LSU) twice daily between meals.
• Treatment of hard exudates in patients with non-proliferative mild to moderate diabetic retinopathy:

• 1 capsule (250 LSU) twice daily between meals.

Continuation of initial parenteral therapy

Note: Sulovas is only available in oral form. In the first, parenteral phase of treatment, another sulodexide-containing product for parenteral administration should be used.

• Continuation of parenteral treatment of venous leg ulcers, as an adjunct to local therapy:
• 2 capsules (500 LSU) twice daily between meals for 30-70 days.
• Continuation of parenteral treatment of symptomatic chronic obstructive arterial disease of the lower limbs of moderate severity (grade II according to Fontaine's classification):
• 2 capsules (500 LSU) twice daily between meals for 6 months.

Method of administration

Oral use. Do not take the medicinal product with meals.

Overdose of Sulovas

In case of overdose, bleeding may occur. If you have taken more than the recommended dose of Sulovas, contact your doctor immediately, who will provide appropriate treatment if necessary.

Missed dose of Sulovas

Do not take a double dose to make up for a missed dose. If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose.

Stopping Sulovas treatment

Stopping Sulovas treatment does not cause adverse effects, except for the possibility of worsening symptoms of the disease for which it is being used. If you have any further questions about the use of this medicinal product, ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicinal products, Sulovas can cause adverse reactions, although not everybody gets them.

Seek immediate medical attention if you experience:

• Angioedema (severe allergic reaction - sudden swelling of the face, limbs, or joints without itching or pain). Swelling in the head and neck area may cause difficulty swallowing and breathing.

The following adverse reactions may occur:

Frequent(occurring in 1 to 10 out of 100 patients):

• Dizziness;
• Abdominal pain;
• Diarrhea;
• Stomach pain;
• Nausea;
• Rash (itchy, red bumps on the skin).

Uncommon(occurring in 1 to 10 out of 1,000 patients):

• Discomfort in the abdominal area;
• Dyspepsia (indigestion), bloating, vomiting;
• Headache;
• Flush;
• Erythema (local redness of the skin);
• Urticaria (light red, itchy blisters on the skin).

Rare(occurring in 1 out of 10,000 patients):

• Gastrointestinal bleeding;
• Edema;
• Loss of consciousness;
• Anemia;
• Abdominal pain;
• Gastrointestinal disorders;
• Tarry stools (black in color);
• Protein metabolism disorders in blood serum;
• Swelling and erythema in the genital area;
• Increased menstrual frequency;
• Petechiae (small red or purple spots on the skin).

Reporting adverse reactions

If you experience any adverse reactions, including those not listed in this package leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Adverse reactions can also be reported to the marketing authorization holder. By reporting adverse reactions, you can help provide more information on the safety of this medicinal product.

5. How to store Sulovas

Keep this medicinal product out of the sight and reach of children. Do not store above 25°C. Do not use this medicinal product after the expiry date (EXP) stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month. Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Sulovas contains

• The active substance is sulodexide. One soft capsule contains 250 LSU of sulodexide.
• The other ingredients are: sodium lauryl sulfate, yellow wax E 901, refined soybean oil.

The capsule shell contains: gelatin, glycerol E 422, purified water, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172), iron oxide brown (E 172).

What Sulovas looks like and contents of the package

Sulovas is a red to reddish-brown, oval, soft gelatin capsule. PVC/Aluminum blister pack in a carton. The package contains 50 soft capsules.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o. ul. Partyzancka 133/151, 95-200 Pabianice, Tel.: +48 42 22 53 100

Manufacturer

Catalent Italy S.p.A. Via Nettunense Km 20,100, 04011 Aprilia (Italy)

Date of last revision of the package leaflet: