PATIENT INFORMATION LEAFLET

VARIDASA Tablets

Streptokinase and Streptodornase

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you notice any of the side effects listed below or any other side effects not listed in this leaflet, tell your doctor or pharmacist.

Varidasa belongs to a group of medicines called antithrombotics.

Varidasa is indicated for the treatment of acute or chronic inflammatory conditions, infectious in combination with antibiotics or traumatic (with edema and/or hematoma).

Do not take Varidasa

• If you are allergic (hypersensitive) to streptokinase, streptodornase or any of the other components of this medication.
• If you have bleeding disorders (known diathesis hemorrhagica).
• If you have uncontrolled severe high blood pressure.
• If you have low levels of fibrinogen.
• If you have low platelet counts in the blood (thrombocytopenia).

Be especially careful with Varidasa

In case of an allergic reaction, including anaphylactic shock, shortness of breath and urticaria, treatment with Varidasa should be discontinued.

Special caution should be exercised when administering Varidasa to patients with any of the following conditions:

• Severe recent gastrointestinal bleeding.
• Recent major surgery (6th to 10th day postoperative, depending on the severity of the surgery).
• Recent trauma and cardiopulmonary resuscitation.
• Recent organ biopsy, non-compressible vessel punctures, intramuscular injections or intubation.
• Recent childbirth, abortion.
• Patients receiving concomitant treatment with oral anticoagulants (INR>1.3).
• Severe liver or kidney damage.
• Organ damage susceptible to bleeding (e.g. active peptic ulcer).
• Acute pericarditis and/or subacute bacterial endocarditis.
• Active, existing or recent internal bleeding.
• Recent stroke; intracranial or intraspinal surgery.
• Intracranial neoplasm.
• Recent cranioencephalic trauma.
• Known neoplasm with risk of bleeding.
• Acute pancreatitis.
• Hypertensive retinopathy of grades III/IV.

Varidasa should be used with caution in patients with a history of liver function impairment.

Use of other medications

Inform your doctor or pharmacist if you are using, or have recently used, other medications, including those obtained without a prescription.

Previous or simultaneous treatment with Varidasa and anticoagulants or substances affecting platelet formation or function (e.g. inhibitors of platelet aggregation, dextrans, antifibrinolytics such as aminocaproic acid, aprotinin and tranexamic acid, non-steroidal anti-inflammatory analgesics especially aspirin, indomethacin, phenylbutazone and other inhibitors of platelet aggregation especially sulfinpyrazone) may increase the risk of bleeding.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

The safety and efficacy of Varidasa have not been demonstrated during pregnancy or lactation, and its use is not recommended in these situations.

Use in children

The use of Varidasa is not recommended in patients under 18 years of age, as its safety and efficacy have not been established in these patients.

Driving and operating machinery

No effects on the ability to drive or operate machinery have been described.

Important information about some of the components of Varidasa:

Varidasa contains yellow-orange colorant S (E-110), which may cause allergic reactions.

Follow exactly the administration instructions for Varidasa as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will inform you of the duration of your treatment with Varidasa. Do not discontinue treatment beforehand, as it may not have the desired effect.

Varidasa tablets are for oral administration.

The recommended average dose is one tablet, four times a day, for 4-6 days.

In acute cases, higher doses may be used as a therapeutic attack measure consisting of two tablets three times a day, and if necessary, the dose may be increased to two tablets four times a day.

If you take more Varidasa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested).

If you forgot to take Varidasa

If you forgot a dose of the medication, take the next dose when it is due. Do not take a double dose to compensate for the missed ones.

Like all medications, Varidasa may have adverse effects, although not all people may experience them.

The following adverse effects have been described, according to the frequency categories indicated below:

Very Common:at least 1 in 10 patients

Common:at least 1 in 100 patients

Uncommon:at least 1 in 1,000 patients

Rare:at least 1 in 10,000 patients

Very Rare:less than 1 in 10,000 patients

Immune System Disorders

Common:Development of anti-streptokinase antibodies.

Uncommon:Hypersensitivity and allergic reactions including anaphylactic shock, dyspnea (difficulty breathing), and urticaria.

Gastrointestinal Disorders

Uncommon:Nausea, diarrhea, epigastric pain, vomiting.

Dermatological and Subcutaneous Tissue Disorders

Very Rare:Erythematous exanthema (inflammatory lesion at the site of administration), dermatitis, pruritus.

Hepatobiliary Disorders

Uncommon:Transient increase in liver enzymes (transaminases) and bilirubin.

General Disorders

Uncommon:Headache, back pain (dorsalgia), muscle pain (myalgia), chills, and/or increased body temperature, feeling of weakness (asthenia), general discomfort.

If you consider that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep Varidasa out of the reach and sight of children.

Store in the original packaging to protect it from light and moisture.

Do not store at a temperature above 30°C.

Do not use Varidasa after the expiration date indicated on the box. The expiration date is the last month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Varidasa Tablets

• The active principles are streptokinase and streptodornase. Each tablet contains 10,000 International Units and 2,500 Units of streptodornase.
• The other components are dibasic calcium phosphate dihydrate, cornstarch, acacia, magnesium stearate, and yellow-orange S (E-110) dye.

Appearance of the product and contents of the package

Varidasa are scored, orange-colored tablets. They are presented in packages of 20 or 40 tablets.

Holder of the marketing authorization

INDUSTRIAL FARMACEUTICA CANTABRIA, S.A.

Carretera Cazoña-Adarzo, s/n.

39011 – Santander

Responsible for manufacturing

Toll Manufacturing Services S.L.

Aragoneses, 2

28108 – Alcobendas (Madrid)

This leaflet was approved in: May 2007