PENTOXIFYLLINE VIR 400 mg PROLONGED-RELEASE TABLETS

2. What you need to know before taking Pentoxifylline Vir

Do not take Pentoxifylline Vir

• if you are allergic (hypersensitive) to pentoxifylline or 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 (used in the treatment of asthma and respiratory spasms), you may suffer a similar reaction when taking this medication.
• if you have a severe bleeding disorder or a significant retinal hemorrhage.
• if you have recently suffered 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 Pentoxifylline 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 "Do not take Pentoxifylline Vir").

Children and adolescents

There is no experience with the use of pentoxifylline in children.

Using Pentoxifylline Vir with other medications

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

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

Treatment with pentoxifylline in patients treated with diabetes medications (insulin or oral treatment) may enhance the effect of these medications, so you should inform your doctor if you are taking any medication for diabetes.

Similarly, simultaneous treatment with pentoxifylline and theophylline may cause an increase in theophylline levels, thereby increasing its side effects; therefore, it is necessary to inform your doctor if you are taking any medication containing theophylline.

Pregnancy and breastfeeding

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

Pentoxifylline is not recommended during pregnancy.

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

Driving and using machines

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

Pentoxifylline Vir contains lactose

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

3. How to take Pentoxifylline Vir

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist, regarding the number of tablets to take and how often, as the dose is guided by the nature and severity of the disease, as well as the patient's tolerance. In case of doubt, ask your doctor or pharmacist.

It is essential to inform your doctor about any illness you may have, as this 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 some liquid, after meals.

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

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

If you take more Pentoxifylline Vir than you should

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

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

If you forget to take Pentoxifylline Vir

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

Cardiac disorders

Occasionally, alteration of heart rhythm (e.g., palpitations).

Rarely, angina pectoris may appear.

Blood and lymphatic system disorders

In isolated cases, decreased platelet count.

Rarely, bleeding (e.g., skin and/or mucous membrane bleeding, localized in the stomach and/or intestine) may occur, especially in patients with an increased tendency to bleeding.

Nervous system disorders

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

Gastrointestinal disorders

Frequently, gastrointestinal disturbances such as stomach pressure, feeling of fullness, nausea, vomiting, or diarrhea.

Skin and subcutaneous tissue disorders

Occasionally, allergic reactions such as itching, skin rash, and urticaria may appear.

Vascular disorders

Frequently, hot flashes.

Rarely, a drop in blood pressure may occur.

Immune system disorders

In isolated cases, anaphylactic/anaphylactoid reactions that can progress to angioedema, difficulty breathing, and a drop in blood pressure. When these manifestations are observed, the administration of pentoxifylline will be interrupted immediately, and a doctor will be informed.

Hepatobiliary disorders

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

If you observe any adverse reaction not described above, consult your doctor or pharmacist.

Reporting side effects

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

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

5. Storage of Pentoxifylline Vir

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 pack until the moment of taking them, to keep them well protected.

Keep the box and package leaflet until the end of treatment, as they contain important information about the medication.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Pentoxifylline Vir

• The active ingredient is pentoxifylline.
• The other components are stearic acid, carnauba wax, hypromellose, lactose, magnesium stearate, cellulose acetate, triacetin, and "Opadry pink".

"Opadry pink" is composed of: lactose, hypromellose, titanium dioxide (E171), triacetin, erythrosine (E127), and carmine indigo (E132)-aluminum lake.

Appearance of the product and package contents

Coated, oval, pink tablets.

Packaging with 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

Date of the last revision of this package leaflet: August 2020

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