Package Insert: Information for the User

Pentoxifilina Vir 400 mg Extended-Release Tablets EFG

Pentoxifilina

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Pentoxifilina Vir and how is it used

2. What you need to know before starting to take Pentoxifilina Vir

3. How to take Pentoxifilina Vir

4. Possible adverse effects

5. Storage of Pentoxifilina Vir

6. Contents of the package and additional information

Always under medical prescription, this medication is indicated for the treatment of peripheral circulatory disorders due to arterioesclerosis, diabetes, inflammation, or other causes; leg ulcers and gangrene.

Pentoxifilina promotes blood circulation.

Do not take Pentoxifilina Vir

• if you are allergic (hypersensitive) to pentoxifilina or to any of the other components of this medication (listed in section 6).
• if you have ever experienced an allergic reaction to another xanthine derivative such as theophylline (which are used in the treatment of asthma and bronchial spasms), you may experience a similar reaction when taking this medication.
• if you suffer from severe or significant retinal hemorrhage.
• if you have recently had a myocardial infarction.

In case of doubt about whether you should take this medication, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pentoxifilina Vir.

- in patients with severe cardiac arrhythmias.

- in patients with myocardial infarction.

- in patients with hypotension.

- in patients with severe kidney disease (creatinine clearance less than 10 ml/min).

- in patients with severe liver disease.

- in patients with an increased tendency to bleeding due to anticoagulant medication or coagulation disorders (see section “Do not take Pentoxifilina Vir”).

Children and adolescents

No experience is available on the use of pentoxifilina in children.

Pentoxifilina Vir use with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

If pentoxifilina and antihypertensive medications are administered simultaneously, it may be necessary to adjust the dose individually, so you should inform your doctor if you are taking any blood pressure medication.

The treatment with pentoxifilina in patients treated with diabetes medications (insulin or oral treatment) may potentiate the effect of these latter, so you should inform your doctor if you are taking any diabetes medication.

In the same way, simultaneous treatment with pentoxifilina and theophylline may cause an increase in theophylline levels and thus increase the side effects of this, so you will also need to inform your doctor if you are taking any medication containing theophylline.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pentoxifilina is not recommended during pregnancy.

Since pentoxifilina passes into breast milk in small amounts, your doctor will assess the convenience of continuing or not continuing treatment during breastfeeding.

Driving and operating machinery

No negative effects of pentoxifilina on the ability to drive vehicles or operate machinery have been described.

Pentoxifilina Vir contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist regarding the number of tablets you should take and how often, since the dose is directed according to the nature and severity of the disease as well as the tolerance of each patient. If in doubt, ask your doctor or pharmacist.

It is essential to inform your doctor of any disease you may be suffering from, as it may be useful in determining the correct dose for you.

The recommended dose is one tablet, two or three times a day, which should be taken whole with a small amount of liquid, after meals.

If you have a severe kidney or liver disease, your doctor will reduce the dose, adjusting it according to the disease and your tolerance to the medication.

If you have low or unstable blood pressure, or suffer from any disease that could be detrimental to a decrease in blood pressure (severe coronary heart disease or stenosis of the blood vessels that irrigate the brain), your doctor will prescribe a low initial dose that will be gradually increased, according to the response observed.

The tablets should be taken whole, with a little water, after meals.

If you take more Pentoxifilina Vir than you should

If you take too much pentoxifilina, you may experience nausea, dizziness, palpitations, or a sudden drop in blood pressure. Additionally, fever, agitation, hot flashes, loss of reflexes, seizures, skin eruptions, coffee-ground vomiting, and loss of consciousness may occur. If you observe these symptoms, go to your doctor or the nearest hospital emergency service, bringing this leaflet with you. Or, if you realize you have taken more doses than prescribed, call your doctor immediately, who will indicate the measures to be taken.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Pentoxifilina Vir

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse reactions may occur, particularly if pentoxifylline is administered at high doses:

Cardiac Disorders

Occasionally, an irregular heartbeat (e.g., palpitations) may occur.

Angina pectoris may rarely appear.

Blood and Lymphatic System Disorders

In isolated cases, a decrease in platelet count may occur.

Bleeding (e.g., from the skin and/or mucous membranes located in the stomach and/or intestine) may rarely occur, especially in patients with an increased tendency to bleed.

Nervous System Disorders

Occasionally, dizziness, headache, agitation, and sleep disturbances may occur.

Gastrointestinal Disorders

Frequent gastrointestinal disturbances, such as stomach pressure, feeling of fullness, nausea, vomiting, or diarrhea, may occur.

Skin and Subcutaneous Tissue Disorders

Allergic reactions, such as itching, skin rash, and urticaria, may occasionally occur.

Vascular Disorders

Frequent hot flushes may occur.

Low blood pressure may rarely occur.

Immune System Disorders

In isolated cases, anaphylactic/anaphylactoid reactions may occur, which may progress to angioneurotic edema, difficulty breathing, and low blood pressure. If these manifestations are observed, pentoxifylline administration should be immediately discontinued, and a doctor should be informed.

Hepatobiliary Disorders

In isolated cases, liver function disorders (intrahepatic cholestasis and elevated transaminases) may occur.

If any adverse reaction not described above is observed, consult a doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them through the national notification system: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not remove the tablets from the blister until it is time to take them, to keep them well protected.

Keep the packaging and the leaflet until the end of treatment as both contain important information about the medication.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. In this way, you will help protect the environment.

Pentoxifilina Vir Composition

• The active ingredient is pentoxifilina.
• The other components are stearic acid, carnauba wax, hypromellose, lactose, magnesium stearate, cellulose acetate, and “Opadry pink”.

“Opadry pink” is composed of: lactose, hypromellose, titanium dioxide (E171), triacetin, erythrosine (E127), and indigo carmine (E 132) aluminum lake.

Product appearance and packaging contents

Pink, oval-shaped, coated tablets.

Packages containing 60 and 500 prolonged-release tablets.

Marketing authorization holder and manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70. Pol. Ind. Urtinsa II

28923 Alcorcón (Madrid)

Spain

Last review date of this leaflet: August 2020

Detailed and updated information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/.