VARIDASA COMPRESSES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

VARIDASA Tablets

Streptokinase and Streptodornase

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What VARIDASA Tablets are and what they are used for
2. Before you take VARIDASA Tablets
3. How to take VARIDASA Tablets
4. Possible side effects
5. Storing VARIDASA Tablets
6. Further information

1. What VARIDASA Tablets are and what they are used for

Varidasa belongs to a group of medicines called antithrombotics.

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

2. BEFORE YOU TAKE VARIDASA Tablets

Do not take Varidasa

• If you are allergic (hypersensitive) to streptokinase, streptodornase or any of the other ingredients of this medicine.
• If you have bleeding disorders (known hemorrhagic diathesis).
• If you have severe uncontrolled hypertension.
• If you have low fibrinogen levels.
• If you have low platelet counts in the blood (thrombocytopenia).

Be careful with Varidasa

In case of an allergic reaction, including anaphylactic shock, dyspnea (difficulty breathing) and urticaria, treatment with Varidasa should be discontinued.

Special precautions should be taken when administering Varidasa to patients with the following conditions:

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

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

Using other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Prior or simultaneous treatment with Varidasa and anticoagulants or substances that act on platelet formation or function (e.g. platelet aggregation inhibitors, dextran, antifibrinolytics such as aminocaproic acid, aprotinin and tranexamic acid, non-steroidal anti-inflammatory analgesics especially acetylsalicylic acid, indomethacin, phenylbutazone and other platelet aggregation inhibitors especially sulfinpyrazone) could increase the risk of bleeding.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

The safety and efficacy of Varidasa during pregnancy and breastfeeding have not been established, so its use is not recommended in these situations.

Use in children

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

Driving and using machines

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

Important information about some of the ingredients of Varidasa:

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

3. HOW TO TAKE VARIDASA Tablets

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

Your doctor will indicate the duration of your treatment with Varidasa. Do not stop treatment before, 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 conditions, 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 Toxicology Information Service, phone 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to take Varidasa

If you forget a dose of the medicine, take the next dose when it is due. Do not take a double dose to make up for the forgotten doses.

4. Possible side effects

Like all medicines, Varidasa can have side effects, although not everybody gets them.

The following side 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.

Skin 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 malaise.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storing VARIDASA Tablets

Keep Varidasa out of the reach and sight of children.

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

Do not store above 30°C.

Do not use Varidasa after the expiry date stated on the carton. The expiry date is the last month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. FURTHER INFORMATION

Composition of Varidasa Tablets

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

Appearance and packaging of the product

Varidasa are orange-colored scored tablets. They are available in packs of 20 or 40 tablets.

Marketing authorization holder

INDUSTRIAL FARMACEUTICA CANTABRIA, S.A.

Carretera Cazoña-Adarzo, s/n.

39011 – Santander

Manufacturer

Toll Manufacturing Services S.L.

Aragoneses, 2

28108 – Alcobendas (Madrid)

This leaflet was approved in: May 2007